Assessment of the uncertainty and the proficiency test for accrediting KOLAS of ISO 17025 for a neutron radiography facility

International Nuclear Information System (INIS)

Oh, H.; Sim, C.M.; Lim, I.C.; Hong, K.P.; Choi, B.H.

2004-01-01

KOLAS(Korea of Lab Accreditation Scheme) is the charter member of ILAS (International Lab Accreditation Scheme) and APLAS (Asia Pacific Lab Accreditation Scheme), which originates from ISO 17025. KATS (Korea Agent of Technology Standard) governs the KOLAS. The KOLAS describes the basis of satisfying those issues related to a quality assurance and management system. The requirements specify an organization, the accommodation and environmental conditions, an uncertainty in the measurement and an inter-laboratory comparison or proficiency test program. The evaluation process of the requirements of certifying KOLAS for HANARO NRF has been proceeded by a neutron radiography laboratory, NRT level II course of SNT-TC-1A II is opened, with 20 persons attending for certification. An inter-laboratory comparison or proficiency test program is conducted through with Kyoto University in accordance with ASTM method for determining the imaging quality in direct thermal neutron radiographic testing (E545-91). In order to determine the uncertainty, dimensional measurements for the calibration fuel pin of the RISO using a profile project is performed with the ASTM practice for thermal neutron radiography of materials (E748-95) (orig.)

The challenge of Ciemat internal dosimetry service for accreditation according to ISO/IEC 17025 standard, for in vivo and in vitro monitoring and dose assessment of internal exposures

International Nuclear Information System (INIS)

Lopez, M.A.; Martin, R.; Hernandez, C.; Navarro, J.F.; Navarro, T.; Perez, B.; Sierra, I.

2016-01-01

The accreditation of an Internal Dosimetry Service (IDS) according to ISO/IEC 17025 Standard is a challenge. The aim of this process is to guarantee the technical competence for the monitoring of radionuclides incorporated in the body and for the evaluation of the associated committed effective dose E(50). This publication describes the main accreditation issues addressed by CIEMAT IDS regarding all the procedures involving good practice in internal dosimetry, focussing in the difficulties to ensure the traceability in the whole process, the appropriate calculation of detection limit of measurement techniques, the validation of methods (monitoring and dose assessments), the description of all the uncertainty sources and the interpretation of monitoring data to evaluate the intake and the committed effective dose. CIEMAT Internal Dosimetry Service (IDS) has developed and implemented a quality system based on ISO/IEC 17025 to ensure compliance with the general requirements of this reference standard. The development of documentary support according to this quality system permitted to standardise the systematic activities performed within the whole body counter and in vitro bioassay laboratories as well as the procedures carried out by qualified staff in charge of internal dose assessment. There was no previous experience in the accreditation of other internal dosimetry services in Spain. Then, requirements from the national regulatory body (Nuclear Safety Council, CSN) and national accreditation entity (ENAC) have been considered. The main concerns were to guarantee the traceability in the whole process and to avoid possible charge of interpretation or subjectivity in the methodology of dose assessment due to intakes of radionuclides when calculating from monitoring data. All the related international standards dealing with internal dosimetry were taken into account: ISO 28218 'Performance criteria for radiobioassay', ISO 27048 'Dose Assessment for the

[Approval of ISO/IEC 17025 and quality control of laboratory testing].

Science.gov (United States)

Yamamoto, Shigeki; Asakura, Hiroshi; Machii, Kenji; Igimi, Shizunobu

2010-01-01

First section of Division of Biomedical Food Research, National Institute of Health Sciences (NIHS) was approved by ISO/IEC 17025 as a laboratory having an appropriate laboratory testing technique. NIHS is the first national laboratory approved by ISO/IEC 17025. NIHS has also been accepted the appropriate technique and facility for the BSL3 level pathogens by ISO/IEC 17025. NIHS is necessary to take an external audit almost every year. This approval is renewed every 4 years.

[Accreditation of medical laboratories].

Science.gov (United States)

Horváth, Andrea Rita; Ring, Rózsa; Fehér, Miklós; Mikó, Tivadar

2003-07-27

In Hungary, the National Accreditation Body was established by government in 1995 as an independent, non-profit organization, and has exclusive rights to accredit, amongst others, medical laboratories. The National Accreditation Body has two Specialist Advisory Committees in the health care sector. One is the Health Care Specialist Advisory Committee that accredits certifying bodies, which deal with certification of hospitals. The other Specialist Advisory Committee for Medical Laboratories is directly involved in accrediting medical laboratory services of health care institutions. The Specialist Advisory Committee for Medical Laboratories is a multidisciplinary peer review group of experts from all disciplines of in vitro diagnostics, i.e. laboratory medicine, microbiology, histopathology and blood banking. At present, the only published International Standard applicable to laboratories is ISO/IEC 17025:1999. Work has been in progress on the official approval of the new ISO 15189 standard, specific to medical laboratories. Until the official approval of the International Standard ISO 15189, as accreditation standard, the Hungarian National Accreditation Body has decided to progress with accreditation by formulating explanatory notes to the ISO/IEC 17025:1999 document, using ISO/FDIS 15189:2000, the European EC4 criteria and CPA (UK) Ltd accreditation standards as guidelines. This harmonized guideline provides 'explanations' that facilitate the application of ISO/IEC 17025:1999 to medical laboratories, and can be used as a checklist for the verification of compliance during the onsite assessment of the laboratory. The harmonized guideline adapted the process model of ISO 9001:2000 to rearrange the main clauses of ISO/IEC 17025:1999. This rearrangement does not only make the guideline compliant with ISO 9001:2000 but also improves understanding for those working in medical laboratories, and facilitates the training and education of laboratory staff. With the

ISO 15189 Accreditation: Navigation Between Quality Management and Patient Safety

Directory of Open Access Journals (Sweden)

Plebani Mario

2017-09-01

Full Text Available Accreditation is a valuable resource for clinical laboratories and the development of an International Standard for their accreditation represented a milestone on the path towards improved quality and safety in laboratory medicine. The recent revision of the International Standard, ISO 15189, has further strengthened its value not only for improving the quality system of a clinical laboratory but also for better answering the request for competence, focus on customers’ needs and ultimate value of laboratory services. Although in some countries more general standards such as ISO 9001 for quality systems or ISO 17025 for testing laboratories are still used, there is increasing recognition of the value of ISO 15189 as the most appropriate and useful standard for the accreditation of medical laboratories. In fact, only this International Standard recognizes the importance of all steps of the total testing process, namely extra-analytical phases, the need to focus on technical competence in addition to quality systems, and the focus on customers’ needs. However, the number of accredited laboratories largely varies between European countries and also major differences affect the approaches to accreditation promoted by the national bodies. In particular, some national accreditation bodies perpetuate the use of fixed scopes, while the European co-operation for accreditation (EA and the European Federation of Laboratory Medicine (EFLM Working Group promote the use of flexible scopes. Major issues in clinical laboratory accreditation are the verification of examination procedures for imprecision, trueness and diagnostic accuracy and for estimating measurement uncertainty. In addition, quality indicators (QIs are a fundamental requirement of the ISO 15189 International Standard.

ISO 15189 accreditation: Requirements for quality and competence of medical laboratories, experience of a laboratory I.

Science.gov (United States)

Guzel, Omer; Guner, Ebru Ilhan

2009-03-01

Medical laboratories are the key partners in patient safety. Laboratory results influence 70% of medical diagnoses. Quality of laboratory service is the major factor which directly affects the quality of health care. The clinical laboratory as a whole has to provide the best patient care promoting excellence. International Standard ISO 15189, based upon ISO 17025 and ISO 9001 standards, provides requirements for competence and quality of medical laboratories. Accredited medical laboratories enhance credibility and competency of their testing services. Our group of laboratories, one of the leading institutions in the area, had previous experience with ISO 9001 and ISO 17025 Accreditation at non-medical sections. We started to prepared for ISO 15189 Accreditation at the beginning of 2006 and were certified in March, 2007. We spent more than a year to prepare for accreditation. Accreditation scopes of our laboratory were as follows: clinical chemistry, hematology, immunology, allergology, microbiology, parasitology, molecular biology of infection serology and transfusion medicine. The total number of accredited tests is 531. We participate in five different PT programs. Inter Laboratory Comparison (ILC) protocols are performed with reputable laboratories. 82 different PT Program modules, 277 cycles per year for 451 tests and 72 ILC program organizations for remaining tests have been performed. Our laboratory also organizes a PT program for flow cytometry. 22 laboratories participate in this program, 2 cycles per year. Our laboratory has had its own custom made WEB based LIS system since 2001. We serve more than 500 customers on a real time basis. Our quality management system is also documented and processed electronically, Document Management System (DMS), via our intranet. Preparatory phase for accreditation, data management, external quality control programs, personnel related issues before, during and after accreditation process are presented. Every laboratory has

Meta-audit of laboratory ISO accreditation inspections: measuring the old emperor's clothes.

Science.gov (United States)

Wilson, Ian G; Smye, Michael; Wallace, Ian J C

2016-02-01

Accreditation to ISO/IEC 17025 is required for EC official food control and veterinary laboratories by Regulation (EC) No. 882/2004. Measurements in hospital laboratories and clinics are increasingly accredited to ISO/IEC 15189. Both of these management standards arose from command and control military standards for factory inspection during World War II. They rely on auditing of compliance and have not been validated internally as assessment bodies require of those they accredit. Neither have they been validated to criteria outside their own ideology such as the Cochrane principles of evidence-based medicine which might establish whether any benefit exceeds their cost. We undertook a retrospective meta-audit over 14 years of internal and external laboratory audits that checked compliance with ISO 17025 in a public health laboratory. Most noncompliances arose solely from clauses in the standard and would not affect users. No effect was likely from 91% of these. Fewer than 1% of noncompliances were likely to have consequences for the validity of results or quality of service. The ISO system of compliance auditing has the performance characteristics of a poor screening test. It adds substantially to costs and generates more noise (false positives) than informative signal. Ethical use of resources indicates that management standards should not be used unless proven to deliver the efficacy, effectiveness, and value required of modern healthcare interventions. © 2015 The Authors. MicrobiologyOpen published by John Wiley & Sons Ltd.

75 FR 22746 - Third Party Testing for Certain Children's Products; Notice of Requirements for Accreditation of...

Science.gov (United States)

2010-04-30

... (ISO)/International Electrotechnical Commission (IEC) Standard 17025:2005, ``General Requirements for... and of the requirements of the ISO/IEC 17025:2005 laboratory accreditation standard is provided in the.../membersbycategory.html . The accreditation must be to ISO Standard ISO/IEC 17025:2005, ``General Requirements for...

Establishment Of Physicochemical Laboratory Of CANTI In Conformity With The Requirements Of ISO/IEC 17025:2005

International Nuclear Information System (INIS)

Pham Thi Hoang Ha; Phan Thi Luan; Le Thi Thanh Tam; Huynh Thai Kim Ngan; Duong Thi Bich Chi; Vo Thi Ngoc Cam; Ho Tran The Huu; Vo Thi Cuong; Tram Thi Khanh Quynh; Tran Tri Hai; To Ba Cuong

2013-01-01

23 testing methods have been established, compiled and issued in standard forms throughout the Project implementation. Besides, the Laboratory QA/QC system have been set up and put into operation from 01/09/2011. The Laboratory was assessed on 12-13/9/2012 by Bureau of Accreditation, Ministry of Science and Technology and has been certified to conform with the requirements of ISO/IEC 17025:2005 with the accreditation number VILAS 609 in pursuant to the Decision No. 365.2012/QD-VPCNCL dated on 20/12/2012. (author)

Software validation applied to spreadsheets used in laboratories working under ISO/IEC 17025

Science.gov (United States)

Banegas, J. M.; Orué, M. W.

2016-07-01

Several documents deal with software validation. Nevertheless, more are too complex to be applied to validate spreadsheets - surely the most used software in laboratories working under ISO/IEC 17025. The method proposed in this work is intended to be directly applied to validate spreadsheets. It includes a systematic way to document requirements, operational aspects regarding to validation, and a simple method to keep records of validation results and modifications history. This method is actually being used in an accredited calibration laboratory, showing to be practical and efficient.

The American Association for Laboratory Accreditation

Science.gov (United States)

2011-03-28

ISO / IEC 17025 ...Information Technology A2LA DoD ELAP Program n All labs are assessed to ISO / IEC 17025 :2005 as the base standard. n In addition, the requirements of 2003...n Inspection Body Accreditation ( ISO / IEC 17020) n Proficiency Testing Providers ( ISO / IEC 17043) n Reference Materials Producers ( ISO Guide

Critical issues for implementation of the standard NBR ISO/IEC 17025:2005 in Testing and Calibration Laboratory: case study at a public institution; Aspectos criticos para implantacao da norma NBR ISO/IEC 17025:2005 em laboratorio de ensaio e calibracao: estudo de caso em uma instituicao publica

Energy Technology Data Exchange (ETDEWEB)

Castro, Denise Confar Carvalho de

2013-07-01

The public institution aims to promote excellence in public management to contribute to the quality of services provided to its customers and to increase competitiveness in the country, as well as its international projection. A technical barrier to trade that can lead to dissatisfaction and achieve the reputation of the institution is failing the test or calibration results and measurement data, thereby accreditation is regarded as the first essential step to facilitate the mutual acceptance of test results and calibration or measurement data. For recognition, laboratories need to demonstrate full compliance with both the sections of ISO/IEC 17025:2005, i.e. management and technical requirements. This research aims to discuss the critical aspects for implementation of ABNT NBR ISO / IEC 17025:2005 for calibration and testing of a Public Institution seeking accreditation of its laboratories with INMETRO, national accreditation body Laboratories. Besides getting preventive, corrective and improvement actions continues guidelines. Furthermore, the methodology used was to conduct a literature search and apply a questionnaire to identify the degree of agreement / disagreement of the foundations of the standard servers. Analysis of the results showed that the critical issues were: commitment, training, resources (infrastructure, human) and culture. (author)

Laboratory accreditation complying with ISO 25 Guide (IRAM 301): Industrial radiography method

International Nuclear Information System (INIS)

Schneebeli, Jorge E.; Zampini, Juan J.; Naucevich, Alfredo

2000-01-01

The ISO 25 Guide (IRAM 301) replaced by ISO 17025 is the standard applied for the implementation of a quality system in a test or calibration laboratory. This document is not known as ISO 9000, but it is the proper standard for this kind of laboratory. This document establishes requirements no just for the quality system in general, but on technical competence, that means the laboratory technical aptitude to carry out the tests. The aim of this paper is to comment the criteria used in the Radiographic Laboratory of CEMEC, that have been assessed by the United King dome Accreditation Service (UKAS). (author)

[ISO 15189 accreditation in clinical microbiology laboratory: general concepts and the status in our laboratory].

Science.gov (United States)

Akyar, Işin

2009-10-01

One important trend in the laboratory profession and quality management is the global convergence of laboratory operations. The goal of an accredited medical laboratory is to continue "offering useful laboratory service for diagnosis and treatment of the patients and also aid to the health of the nation". An accredited clinical laboratory is managed by a quality control system, it is competent technically and the laboratory service meets the needs of all its patients and physicians by taking the responsibility of all the medical tests and therapies. For this purpose, ISO 15189 international standard has been prepared by 2003. ISO 15189 standard is originated from the arrangement of ISO 17025 and ISO 9001:2000 standards. Many countries such as England, Germany, France, Canada and Australia have preferred ISO 15189 as their own laboratory accreditation programme, meeting all the requirements of their medical laboratories. The accreditation performance of a clinical microbiology laboratory is mainly based on five essential points; preanalytical, analytical, postanalytical, quality control programmes (internal, external, interlaboratory) and audits (internal, external). In this review article, general concepts on ISO 15189 accreditation standards for the clinical microbiology laboratories have been summarized and the status of a private laboratory (Acibadem LabMed, Istanbul) in Turkey has been discussed.

New way of demonstrating the competence of a laboratory measuring radionuclides - The international draft standard ISO/IEC DIS 17025

International Nuclear Information System (INIS)

Palsson, S.E.

1999-01-01

In recent years there has been increased interest, and even need, amongst laboratories performing measurements of radionuclides to obtain accreditation. It has been discussed how this could be achieved with maximum flexibility for the laboratories and with minimum effort. The issuing of a new draft international standard, the ISO/IEC DIS 17025, created speculations whether it could offer a new and better way for laboratories to obtain accreditation. It was decided within the NKS/BOK-1.1 project to explore possible options for obtaining accreditation and what possibilities the new standard could offer. The benefits of computerised document control systems were also explored. The results were reported at the 12th Annual Meeting of the Nordic Society for Radiation Protection, 23-27 August 1999. Since then the final version of the standard has been published. The voting will continue until November 16th 1999 and is not clear at present whether the standard will be accepted or not. The original version of this paper was updated to reflect these recent developments. (au)

76 FR 18645 - Third Party Testing for Certain Children's Products; Notice of Requirements for Accreditation of...

Science.gov (United States)

2011-04-05

... to the International Standards Organization (ISO)/International Electrotechnical Commission (IEC) Standard ISO/IEC 17025:2005, ``General Requirements for the Competence of Testing and Calibration... paint ban and 16 CFR part 1303, it must be accredited to ISO/IEC 17025- 2005 by an accreditation body...

Critical issues for implementation of the standard NBR ISO/IEC 17025:2005 in Testing and Calibration Laboratory: case study at a public institution

International Nuclear Information System (INIS)

Castro, Denise Confar Carvalho de

2013-01-01

The public institution aims to promote excellence in public management to contribute to the quality of services provided to its customers and to increase competitiveness in the country, as well as its international projection. A technical barrier to trade that can lead to dissatisfaction and achieve the reputation of the institution is failing the test or calibration results and measurement data, thereby accreditation is regarded as the first essential step to facilitate the mutual acceptance of test results and calibration or measurement data. For recognition, laboratories need to demonstrate full compliance with both the sections of ISO/IEC 17025:2005, i.e. management and technical requirements. This research aims to discuss the critical aspects for implementation of ABNT NBR ISO / IEC 17025:2005 for calibration and testing of a Public Institution seeking accreditation of its laboratories with INMETRO, national accreditation body Laboratories. Besides getting preventive, corrective and improvement actions continues guidelines. Furthermore, the methodology used was to conduct a literature search and apply a questionnaire to identify the degree of agreement / disagreement of the foundations of the standard servers. Analysis of the results showed that the critical issues were: commitment, training, resources (infrastructure, human) and culture. (author)

NC ISO/IEC1725:00 Accreditation process of CPHR main laboratories

International Nuclear Information System (INIS)

Marrero Garcia, Mariela; Molina perez, Daniel; Fernandez Gomez, Maria; Walwyn Salas, Gonzalo

2003-01-01

With the objective of offering technically qualified and competitive services one works in our laboratories under the requirements of a System of the Quality from 1993. In 1999 that was already with a draft of the new model ISO/IEC 17025:00 the steps they were given for the change of the Guide 25. At the moment with 3 laboratories accredited by the Cuban organ (ONARC), we are pioneer in these changes because alone a very reduced group of laboratories in the country has achieved it. The present work enunciates the antecedents of the change, the main non conformities during the evaluations for the accreditation and the obtained results

Photovoltaic Calibrations at the National Renewable Energy Laboratory and Uncertainty Analysis Following the ISO 17025 Guidelines

Energy Technology Data Exchange (ETDEWEB)

Emery, Keith [National Renewable Energy Lab. (NREL), Golden, CO (United States)

2016-09-01

The measurement of photovoltaic (PV) performance with respect to reference conditions requires measuring current versus voltage for a given tabular reference spectrum, junction temperature, and total irradiance. This report presents the procedures implemented by the PV Cell and Module Performance Characterization Group at the National Renewable Energy Laboratory (NREL) to achieve the lowest practical uncertainty. A rigorous uncertainty analysis of these procedures is presented, which follows the International Organization for Standardization (ISO) Guide to the Expression of Uncertainty in Measurement. This uncertainty analysis is required for the team’s laboratory accreditation under ISO standard 17025, “General Requirements for the Competence of Testing and Calibration Laboratories.” The report also discusses additional areas where the uncertainty can be reduced.

THE CHALLENGE OF CIEMAT INTERNAL DOSIMETRY SERVICE FOR ACCREDITATION ACCORDING TO ISO/IEC 17025 STANDARD, FOR IN VIVO AND IN VITRO MONITORING AND DOSE ASSESSMENT OF INTERNAL EXPOSURES.

Science.gov (United States)

Lopez, M A; Martin, R; Hernandez, C; Navarro, J F; Navarro, T; Perez, B; Sierra, I

2016-09-01

The accreditation of an Internal Dosimetry Service (IDS) according to ISO/IEC 17025 Standard is a challenge. The aim of this process is to guarantee the technical competence for the monitoring of radionuclides incorporated in the body and for the evaluation of the associated committed effective dose E(50). This publication describes the main accreditation issues addressed by CIEMAT IDS regarding all the procedures involving good practice in internal dosimetry, focussing in the difficulties to ensure the traceability in the whole process, the appropriate calculation of detection limit of measurement techniques, the validation of methods (monitoring and dose assessments), the description of all the uncertainty sources and the interpretation of monitoring data to evaluate the intake and the committed effective dose. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Management system - PNS ISO/IEC 17025:2005

International Nuclear Information System (INIS)

Baje, Perla F.

2009-01-01

Management system is a set of policies, processes and procedures needed for planning and execution in the core business area of the organization. It is a set of policies and objectives to direct and control an organization with regard to quality. ISO 17025:2005 is the administrative and technical systems that govern the operations of the laboratory

76 FR 49286 - Third Party Testing for Certain Children's Products; Notice of Requirements for Accreditation of...

Science.gov (United States)

2011-08-10

... history and content of the ILAC-MRA approach and of the requirements of the ISO/IEC 17025:2005 laboratory... be to ISO Standard ISO/IEC 17025:2005, ``General Requirements for the Competence of Testing and..., the product was tested by a third party conformity assessment body that was ISO/IEC 17025 accredited...

ISO 17025 validation of a next-generation sequencing assay for relationship testing

DEFF Research Database (Denmark)

Buchard, Anders; Kampmann, Marie-Louise; Poulsen, Lena

2016-01-01

17025 accredited laboratory in 2015. Here, the essential parts of the validation report submitted to the Danish Accreditation Fund are presented. A total of 100 unrelated Danes were typed in duplicates and the locus balance, heterozygote balance (Hb) and noise levels were analysed in detail. Two loci...

Validation of a single nucleotide polymorphism (SNP) typing assay with 49 SNPs for forensic genetic testing in a laboratory accredited according to the ISO 17025 standard

DEFF Research Database (Denmark)

Børsting, Claus; Rockenbauer, Eszter; Morling, Niels

2009-01-01

cases and 33 twin cases were typed at least twice for the 49 SNPs. All electropherograms were analysed independently by two expert analysts prior to approval. Based on these results, detailed guidelines for analysis of the SBE products were developed. With these guidelines, the peak height ratio...... of a heterozygous allele call or the signal to noise ratio of a homozygous allele call is compared with previously obtained ratios. A laboratory protocol for analysis of SBE products was developed where allele calls with unusual ratios were highlighted to facilitate the analysis of difficult allele calls......A multiplex assay with 49 autosomal single nucleotide polymorphisms (SNPs) developed for human identification was validated for forensic genetic casework and accredited according to the ISO 17025 standard. The multiplex assay was based on the SNPforID 52plex SNP assay [J.J. Sanchez, C. Phillips, C...

ISO/IEC 17025: custos de acreditação em uma universidade pública brasileira

Directory of Open Access Journals (Sweden)

Rodrigo S. Bender

2017-01-01

Full Text Available ISO/IEC 17025 is an international standard that specifies the general requirements for evaluating the competence of laboratories involved in testing and calibration. This standard brings several benefits to university laboratories, which, thus, seek to obtain the accreditation. However, although cost is one of the main obstacles in this process; this topic has not been sufficiently studied. Since the Universidade Federal de Santa Maria (UFSM supports its laboratories for the implementation of this standard, it was chosen for this article to identify and quantify the accreditation costs of its laboratories that have obtained it or are working toward the goal. An exploratory literature review was carried out, and the data gathered were analyzed qualitatively and quantitatively. This study observed that the costs related to hours worked are linked to staff qualification and that high expenses in equipment and infrastructure occur in laboratories that receive financial resources from external providers.

General criteria for validation of dosimetry methods in the context of a quality system ISO / IEC 17025; Criterios generales sobre validacion de metodos de dosimetria en el marco de un sistema de calidad ISO/IEC 17025

Energy Technology Data Exchange (ETDEWEB)

Martin Garcia, R.; Navarro Bravo, T.

2011-07-01

The accreditation of a testing laboratory in accordance with ISO / IEC 17025 recognizes the technical competence of a laboratory to perform certain tests. One of the requirements of that rule states that laboratories must demonstrate that the methods used are valid and appropriate for the intended use and customer needs. This demonstration is accomplished through the process of validation of methods, defined in the rule it self as {sup c}onfirmation by examination and provision of objective evidence that the requirements for a particular purpose{sup .} The process of validating a test method should be well planned and documented, including the requirements under the applicable rules and criteria established by the laboratory to comply with these requirements.

ISO/IEC 17025 Sysmex R-500 hematology reticulocyte analyzer validation.

Science.gov (United States)

Dimopoulou, H A; Theodoridis, T; Galea, V; Christopoulou-Cokkinou, V; Spyridaki, M-H E; Georgakopoulos, C G

2007-01-01

The Sysmex R-500 (R-500) Hematology Analyzer is a bench-top system appropriate for the analysis of limited batches of blood samples. The R-500 provides percentage proportional (RET%), absolute reticulocyte (RET#), and absolute red blood cell (RBC#) counts. The system was validated at the Doping Control Laboratory of Athens, according to the International Committee for Standardization in Hematology, International Standards Organization (ISO/IEC) 17025, and World Antidoping Agency (WADA) specifications. The instrument calibration was performed according to the manufacturer and validation parameters comprised linearity, precision, uncertainty (intermediate and long-term precision), comparability, effect of drift, carryover, stability, and accuracy. The linearity and the comparability studies for RET#, RET%, and RBC# were expressed in regression factors (R2) and coefficients of correlation [r(x, y)], respectively. For the precision studies, the coefficients of variation for RET#, RET%, and RBC# were 9.49%, 9.83%, and ISO/IEC 17025 and WADA specifications.

Diagnosis and definition of an action plan related to the management system conformed to the ISO 17025; case of the laboratory of Microbiology - CNSTN

International Nuclear Information System (INIS)

Adeili, Abderrahmen

2007-01-01

The accreditations permit the laboratories of tests and analysis to prove the quality of their organization and to ensure the reliability of their results. This report - ratio approaches the various stages of the installation from a system of management quality, within a microbiological analysis laboratory with the CNSTN ( National center for nuclear sciences and technologies). The setting is begin with the staff training on the requirements from the standard ISO 17025. In continuation a plan of initial diagnosis to locate the laboratory compared to the requirements of the standard to succeed finally an action plan detailing the actions to be carried out to reach the accreditation. (Author). 7 refs

General criteria for validation of dosimetry methods in the context of a quality system ISO / IEC 17025

International Nuclear Information System (INIS)

Martin Garcia, R.; Navarro Bravo, T.

2011-01-01

The accreditation of a testing laboratory in accordance with ISO / IEC 17025 recognizes the technical competence of a laboratory to perform certain tests. One of the requirements of that rule states that laboratories must demonstrate that the methods used are valid and appropriate for the intended use and customer needs. This demonstration is accomplished through the process of validation of methods, defined in the rule it self as c onfirmation by examination and provision of objective evidence that the requirements for a particular purpose . The process of validating a test method should be well planned and documented, including the requirements under the applicable rules and criteria established by the laboratory to comply with these requirements.

Situation analysis of occupational and environmental health laboratory accreditation in Thailand.

Science.gov (United States)

Sithisarankul, Pornchai; Santiyanont, Rachana; Wongpinairat, Chongdee; Silva, Panadda; Rojanajirapa, Pinnapa; Wangwongwatana, Supat; Srinetr, Vithet; Sriratanaban, Jiruth; Chuntutanon, Swanya

2002-06-01

The objective of this study was to analyze the current situation of laboratory accreditation (LA) in Thailand, especially on occupational and environmental health. The study integrated both quantitative and qualitative approaches. The response rate of the quantitative questionnaires was 54.5% (226/415). The majority of the responders was environmental laboratories located outside hospital and did not have proficiency testing. The majority used ISO 9000, ISO/IEC 17025 or ISO/ EEC Guide 25, and hospital accreditation (HA) as their quality system. However, only 30 laboratories were currently accredited by one of these systems. Qualitative research revealed that international standard for laboratory accreditation for both testing laboratory and calibration laboratory was ISO/IEC Guide 25, which has been currently revised to be ISO/IEC 17025. The National Accreditation Council (NAC) has authorized 2 organizations as Accreditation Bodies (ABs) for LA: Thai Industrial Standards Institute, Ministry of Industry, and Bureau of Laboratory Quality Standards, Department of Medical Sciences, Ministry of Public Health. Regarding LA in HA, HA considered clinical laboratory as only 1 of 31 items for accreditation. Obtaining HA might satisfy the hospital director and his management team, and hence might actually be one of the obstacles for the hospital to further improve their laboratory quality system and apply for ISO/IEC 17025 which was more technically oriented. On the other hand, HA may be viewed as a good start or even a pre-requisite for laboratories in the hospitals to further improve their quality towards ISO/IEC 17025. Interviewing the director of NAC and some key men in some large laboratories revealed several major problems of Thailand's LA. Both Thai Industrial Standards Institute and Bureau of Laboratory Quality Standards did not yet obtain Mutual Recognition Agreement (MRA) with other international ABs. Several governmental bodies had their own standards and

Meeting the measurement uncertainty and traceability requirements of ISO/AEC standard 17025 in chemical analysis.

Science.gov (United States)

King, B

2001-11-01

The new laboratory accreditation standard, ISO/IEC 17025, reflects current thinking on good measurement practice by requiring more explicit and more demanding attention to a number of activities. These include client interactions, method validation, traceability, and measurement uncertainty. Since the publication of the standard in 1999 there has been extensive debate about its interpretation. It is the author's view that if good quality practices are already in place and if the new requirements are introduced in a manner that is fit for purpose, the additional work required to comply with the new requirements can be expected to be modest. The paper argues that the rigour required in addressing the issues should be driven by customer requirements and the factors that need to be considered in this regard are discussed. The issues addressed include the benefits, interim arrangements, specifying the analytical requirement, establishing traceability, evaluating the uncertainty and reporting the information.

UNE-EN ISO/IEC 17025:2005-accredited method for the determination of pesticide residues in fruit and vegetable samples by LC-MS/MS.

Science.gov (United States)

Camino-Sánchez, F J; Zafra-Gómez, A; Oliver-Rodríguez, B; Ballesteros, O; Navalón, A; Crovetto, G; Vílchez, J L

2010-11-01

A rapid, simple and sensitive multi-residue method was developed and validated for the simultaneous quantification and confirmation of 69 pesticides in fruit and vegetables using liquid chromatography-tandem mass spectrometry (LC-MS/MS). The samples were extracted following the quick, easy, cheap, effective, rugged and safe method known as QuEChERS. Mass spectrometric conditions were individually optimised for each analyte in order to achieve maximum sensitivity in multiple reaction monitoring (MRM) mode. Using the developed chromatographic conditions, 69 pesticides can be separated in less than 17 min. Two selected reaction monitoring (SRM) assays were used for each pesticide to obtain simultaneous quantification and identification in one run. With this method in SRM mode, more than 150 pesticides can be analysed and quantified, but their confirmation is not possible in all cases according to the European regulations on pesticide residues. Nine common representative matrices (zucchini, melon, cucumber, watermelon, tomato, garlic, eggplant, lettuce and pepper) were selected to investigate the effect of different matrices on recovery and precision. Mean recoveries ranged from 70% to 120%, with relative standard deviations (RSDs) lower than 20% for all the pesticides. The proposed method was applied to the analysis of more than 2000 vegetable samples from the extensive greenhouse cultivation in the province of Almeria, Spain, during one year. The methodology combines the advantages of both QuEChERS and LC-MS/MS producing a very rapid, sensitive, accurate and reliable procedure that can be applied in routine analytical laboratories. The method was validated and accredited according to UNE-EN-ISO/IEC 17025:2005 international standard (accreditation number 278/LE1027).

Clinical laboratory accreditation in India.

Science.gov (United States)

Handoo, Anil; Sood, Swaroop Krishan

2012-06-01

Test results from clinical laboratories must ensure accuracy, as these are crucial in several areas of health care. It is necessary that the laboratory implements quality assurance to achieve this goal. The implementation of quality should be audited by independent bodies,referred to as accreditation bodies. Accreditation is a third-party attestation by an authoritative body, which certifies that the applicant laboratory meets quality requirements of accreditation body and has demonstrated its competence to carry out specific tasks. Although in most of the countries,accreditation is mandatory, in India it is voluntary. The quality requirements are described in standards developed by many accreditation organizations. The internationally acceptable standard for clinical laboratories is ISO15189, which is based on ISO/IEC standard 17025. The accreditation body in India is the National Accreditation Board for Testing and Calibration Laboratories, which has signed Mutual Recognition Agreement with the regional cooperation the Asia Pacific Laboratory Accreditation Cooperation and with the apex cooperation the International Laboratory Accreditation Cooperation.

What role can ISO 17025 play in the South African mining industry? ; Article

CSIR Research Space (South Africa)

Pretorius, CJ

2013-03-01

Full Text Available -1 Journal of the Mine Ventilation Society of South Africa March 2013/ Vol 66(1), pp 15-17 What role can ISO 17025 play in the South African mining industry? Pretorius CJ1 and Chesalokile T2 1CSIR. Centre for Mining Innovation 2South African...

Extending the accredited low flow liquid calibration range

NARCIS (Netherlands)

Platenkamp, Tom; Lötters, Joost Conrad

2017-01-01

There is an increasing demand for ISO/IEC 17025:2005 accredited liquid flow calibrations in the range of 1 g/h to 30 kg/h. The accredited Low Flow liquid Calibration Setup [1] (LFCS) at Bronkhorst® covers a flow range of 1 to 200 g/h, leaving a traceability gap in the flow range of 0.2 to 30 kg/h.

The Benefits of ISO/IEC 17025 Accreditation of Radiopharmacy laboratory

OpenAIRE

Apostolova, Paulina; Sterjova, Marija; Smilkov, Katarina; Gjorgieva Ackova, Darinka; Janevik-Ivanovska, Emilija

2015-01-01

Laboratory is a part of the Department of Pharmacy in the Faculty of Medical Sciences, at the Goce Delcev University in Štip. Main activities are focused on improving knowledge for radiopharmacy of bachelor students, master students and doing PhD thesis. Also, we are trying to provide services for external associates as a testing laboratory. As a developing country, we are facing with the begging’s of the process of accreditation. The accreditation process is a lengthy and time consuming m...

[Validation of an in-house method for the determination of zinc in serum: Meeting the requirements of ISO 17025].

Science.gov (United States)

Llorente Ballesteros, M T; Navarro Serrano, I; López Colón, J L

2015-01-01

The aim of this report is to propose a scheme for validation of an analytical technique according to ISO 17025. According to ISO 17025, the fundamental parameters tested were: selectivity, calibration model, precision, accuracy, uncertainty of measurement, and analytical interference. A protocol has been developed that has been applied successfully to quantify zinc in serum by atomic absorption spectrometry. It is demonstrated that our method is selective, linear, accurate, and precise, making it suitable for use in routine diagnostics. Copyright © 2015 SECA. Published by Elsevier Espana. All rights reserved.

[Accreditation of forensic laboratories].

Science.gov (United States)

Sołtyszewski, Ireneusz

2010-01-01

According to the framework decision of the European Union Council, genetic laboratories which perform tests for the benefit of the law enforcement agencies and the administration of justice are required to obtain a certificate of accreditation testifying to compliance with the PN EN ISO/IEC 17025:2005 standard. The certificate is the official confirmation of the competence to perform research, an acknowledgement of credibility, impartiality and professional independence. It is also the proof of establishment, implementation and maintenance of an appropriate management system. The article presents the legal basis for accreditation, the procedure of obtaining the certificate of accreditation and selected elements of the management system.

75 FR 31688 - Third Party Testing for Certain Children's Products; Infant Bath Seats: Requirements for...

Science.gov (United States)

2010-06-04

... requirements of the ISO/IEC 17025:2005 laboratory accreditation standard is provided in the CPSC staff briefing....html . The accreditation must be to ISO Standard ISO/IEC 17025:2005, ``General Requirements for the... tested by a third party conformity assessment body that was ISO/IEC 17025 accredited by an ILAC-MRA...

75 FR 42311 - Third Party Testing for Certain Children's Products; Vinyl Plastic Film: Requirements for...

Science.gov (United States)

2010-07-21

... ISO/IEC 17025:2005 laboratory accreditation standard is provided in the CPSC staff briefing memorandum....org/membersbycategory.html . The accreditation must be to ISO Standard ISO/IEC 17025:2005, ``General... conformity assessment body that was ISO/IEC 17025 accredited by an ILAC-MRA member at the time of the test...

Quality management system and accreditation of the in vivo monitoring laboratory at Karslruhe Institute of Technology.

Science.gov (United States)

Breustedt, B; Mohr, U; Biegard, N; Cordes, G

2011-03-01

The in vivo monitoring laboratory (IVM) at Karlsruhe Institute of Technology (KIT), with one whole body counter and three partial-body counters, is an approved lab for individual monitoring according to German regulation. These approved labs are required to prove their competencies by accreditation to ISO/IEC 17025:2005. In 2007 a quality management system (QMS), which was successfully audited and granted accreditation, was set up at the IVM. The system is based on the ISO 9001 certified QMS of the central safety department of the Research Centre Karlsruhe the IVM belonged to at that time. The system itself was set up to be flexible and could be adapted to the recent organisational changes (e.g. founding of KIT and an institute for radiation research) with only minor effort.

[Laboratory accreditation and proficiency testing].

Science.gov (United States)

Kuwa, Katsuhiko

2003-05-01

ISO/TC 212 covering clinical laboratory testing and in vitro diagnostic test systems will issue the international standard for medical laboratory quality and competence requirements, ISO 15189. This standard is based on the ISO/IEC 17025, general requirements for competence of testing and calibration laboratories and ISO 9001, quality management systems-requirements. Clinical laboratory services are essential to patient care and therefore should be available to meet the needs of all patients and clinical personnel responsible for human health care. If a laboratory seeks accreditation, it should select an accreditation body that operates according to this international standard and in a manner which takes into account the particular requirements of clinical laboratories. Proficiency testing should be available to evaluate the calibration laboratories and reference measurement laboratories in clinical medicine. Reference measurement procedures should be of precise and the analytical principle of measurement applied should ensure reliability. We should be prepared to establish a quality management system and proficiency testing in clinical laboratories.

75 FR 42315 - Third Party Testing for Certain Children's Products; Carpets and Rugs: Requirements for...

Science.gov (United States)

2010-07-21

... (ISO)/International Electrotechnical Commission (IEC) Standard 17025:2005, ``General Requirements for... and of the requirements of the ISO/IEC 17025:2005 laboratory accreditation standard is provided in the....org/membersbycategory.html . The accreditation must be to ISO Standard ISO/IEC 17025:2005, ``General...

75 FR 81789 - Third Party Testing for Certain Children's Products; Full-Size Baby Cribs and Non-Full-Size Baby...

Science.gov (United States)

2010-12-28

... Standardization (ISO)/International Electrotechnical Commission (IEC) Standard 17025:2005, ``General Requirements... and of the requirements of the ISO/IEC 17025:2005 laboratory accreditation standard is provided in the... accreditation must be to ISO Standard ISO/IEC 17025:2005, ``General Requirements for the Competence of Testing...

The continuous improvement of the Internal Audits Process assurance the effective compliance of ISO 17025:2005 requirements

Directory of Open Access Journals (Sweden)

Carina Di Candia

2011-04-01

Full Text Available Continuous Improvement Process started in LATU in 1996. The Impact was so important that covered all the organization. Nowadays LATU has almost all its processes certificated and most than 200 tests accredited. The Internal Audits process began in 1996 with an annual planning for all the laboratory's areas. For the UKAS accreditation in 1998, LATU improves the internal audits planning auditing not only the system but also the tests. In 1999 LATU was certified by SQS and accredited the calibrations by DKD. Since 2004 internal audits was managed as a process; in order to that was defined objectives, indicators, achievements and the necessary resources of the internal audit programme and process. The internal audit programme has a pre defined tri annual planning that includes all the laboratory areas. The results of the measures obtained till now demonstrate the improvement in the internal audit and all the laboratory processes. Auditors final staff increase their technical competence. As a consequence of managing the internal audits as a process, the internal communication has an important relevance to feedback the continuous improvement of the laboratory. This was evidence in a decrease of the documentaries non conformities, improvement of the calibrations and maintenance programme, optimization trainings and qualifications of the staff, common internal trainings, creation of a quality assurance team to improvement the tests control, improvement in the relationship with the support areas. Most of this requirements are included in ISO 17025:2005; that assurance the effective compliance of this standard.

[Effects of the ISO 15189 accreditation on Nagoya University Hospital].

Science.gov (United States)

Yoshiko, Kenichi

2012-07-01

The Department of Clinical Laboratory, Nagoya University Hospital acquired ISO 15189 accreditation in November, 2009. The operation of our Quality Management System (QMS) was first surveyed in October, 2010. In this paper, we reported the activity for the preparation and operation of our QMS and the effects of ISO 15189 accreditation. We investigated the changes in the number and content on nonconformities, incident reports and complaints before and after accreditation as indicators to evaluate the effect of ISO 15189 accreditation. Post accreditation, the number of nonconformities and incident reports decreased, seeming to show an improvement of quality of the laboratory activity; however, the number of complaints increased. We identified the increase of complaints at the phlebotomy station. There had been some problems with blood sampling in the past, but it seemed that staff had a high level of concern regarding these problems at the phlebotomy station and took appropriate measures to resolve the complaints. We confirmed that the ISO 15189 accreditation was instrumental in the improvements of the safety and efficiency on laboratory works. However there was a problem that increase of overtime works to operate the QMS. We deal with development of a laboratory management system using IT recourses to solve the problem.

Preparation and accreditation of anti-doping laboratories for the Olympic Games.

Science.gov (United States)

Botrè, Francesco; Wu, Moutian; Boghosian, Thierry

2012-07-01

This article outlines the process of preparation of an anti-doping laboratory in view of the activities to be performed on the occasion of the Olympic Games, focusing in particular on the accreditation requirements of the World Anti-Doping Agency (WADA) and ISO/IEC 17025, as well as on the additional obligations required by the International Olympic Committee, which is the testing authority responsible for the anti-doping activities at the Olympics. Due to the elevated workload expected on the occasion of the Olympic Games, the designated anti-doping laboratory needs to increase its analytical capacity (samples processed/time) and capability by increasing the laboratory's resources in terms of space, instrumentation and personnel. Two representative cases, one related to the Winter Olympic Games (Torino 2006) and one related to the Summer Olympic Games (Beijing 2008), are presented in detail, in order to discuss the main aspects of compliance with both the WADA and ISO/IEC 17025 accreditation requirements.

75 FR 35282 - Third Party Testing for Certain Children's Products; Infant Walkers: Requirements for...

Science.gov (United States)

2010-06-21

... requirements of the ISO/IEC 17025:2005 laboratory accreditation standard is provided in the CPSC staff briefing... to ISO Standard ISO/IEC 17025:2005, ``General Requirements for the Competence of Testing and... tested by a third party conformity assessment body that was ISO/IEC 17025 accredited by an ILAC-MRA...

Feasibility study on introduction of KOLAS (Korea Laboratory Accreditation Scheme) in nuclear examination facility

International Nuclear Information System (INIS)

Park, Dae Gyu; Hong, K. P.; Song, W. S.; Min, D. K.

1999-07-01

To be an institute officially authorized by the KOLAS, the understanding and the analysis of following contents is required.: the understanding of concept required to get the accreditation of testing, the system specifying an internationally accredited testing and examination organization, international organization in the field of laboratory accreditation, domestic laboratory accreditation organization(KOLAS), the investigation of the regulations with laboratory accreditation in Korea, the investigation of the procedures accrediting a testing and examination organization, the investigation of general requirements(ISO 17025) for a testing and examination organization. (author)

Comparative study on implementation of management requires from ABNT NBR ISO/IEC 17025

International Nuclear Information System (INIS)

Suplino Filho, Carlos Alberto Lucas; Souza, Luciane de Rezende; Oliveira, Estela Maria de

2014-01-01

This work was developed in order to emphasize the importance of laboratory management system in the direction and control of the company or institute with regard to the quality of delivery of ionizing radiation service to society. It was developed a comparative study of managerial points of Deming with the managerial requirements of ISO / IEC 17025, which found that the difficulties of the laboratories indicated by nonconformities tracked during audits, are related to specific points cited by Deming. (author)

Accreditation of nondestructive testing (NDT) laboratories: do we have choices?

International Nuclear Information System (INIS)

Abd Nassir Ibrahim

2003-01-01

Demand for quality of products and services by consumers throughout the world resulted in fierce competition among manufacturers and service providers. Such a competition forces NDT service providers to deliver the highest quality and most reliable results at a reasonable price to their clients. NDT beneficiaries such as oil and gas, and power generation sectors through their quality system such as ISO 9001 Version 2000 demand that the quality system adopted by organizations providing services to them must be evaluated. Such requirement leave NDT services companies with no option except to have them accredited. As for today, the most logical accreditation scheme applicable to NDT organizations is the ISO 17025. This paper reviews the current status and forecast the need for such an accreditation in Malaysia. (Author)

75 FR 70911 - Third Party Testing for Certain Children's Products; Children's Sleepwear, Sizes 0 Through 6X and...

Science.gov (United States)

2010-11-19

... ISO/IEC 17025:2005, General Requirements for the Competence of Testing and Calibration Laboratories... requirements of the ISO[sol]IEC 17025:2005 laboratory accreditation standard is provided in the CPSC staff...]IEC 17025 accredited by an ILAC-MRA signatory and the scope of the accreditation included the...

Generation of a plan for the implementation of INTE/ISO IEC 17025 in a paint industry and modification of a quality manual

International Nuclear Information System (INIS)

Salazar Gomez, Andrea Marcela

2014-01-01

A diagnosis to the integrated management system and quality control laboratories is done in a paint industry. The administrative aspects related with the documentation are evaluated: procedures, instructions, records, processes of sampling, testing, for possible accreditation of some methods of analysis under the norm ISO/IEC 17025 representing an opportunity for growth and improvement in labs. The laboratories of the paint industry have analyzed a number of materials such as products for the various stages of construction and beautification of homes, buildings and other, as well as evaluation of the requirements established by international standards to demonstrate competence regarding these. The feasibility of implementing the standard is visualized, solving the disagreements that have been found during the evaluation period. The impact of the perception of quality is determined by the direction, the need for investment in resources, training and equipment. (author) [es

75 FR 51020 - Third Party Testing for Certain Children's Products; Mattresses, Mattress Pads, and/or Mattress...

Science.gov (United States)

2010-08-18

... Standardization (ISO)/International Electrotechnical Commission (IEC) Standard 17025:2005, ``General Requirements... and of the requirements of the ISO/IEC 17025:2005 laboratory accreditation standard is provided in the... body that was ISO/IEC 17025 accredited by an ILAC-MRA member at the time of the test. For firewalled...

75 FR 76708 - Extension of the Date by Which Youth All-Terrain Vehicles Must Be Tested and Certified

Science.gov (United States)

2010-12-09

..., which at that time, was ISO/IEC 17025 accredited by an International Laboratory Accreditation... party conformity assessment body that at that time was ISO/IEC 17025 accredited by an ILAC-MRA signatory...

Accreditation experience of radioisotope metrology laboratory of Argentina

Energy Technology Data Exchange (ETDEWEB)

Iglicki, A. [Laboratorio de Metrologia de Radioisotopos, Comision Nacional de Energia Atomica (Argentina)]. E-mail: iglicki@cae.cnea.gov.ar; Mila, M.I. [Laboratorio de Metrologia de Radioisotopos, Comision Nacional de Energia Atomica (Argentina)]. E-mail: mila@cae.cnea.gov.ar; Furnari, J.C. [Laboratorio de Metrologia de Radioisotopos, Comision Nacional de Energia Atomica (Argentina); Arenillas, P. [Laboratorio de Metrologia de Radioisotopos, Comision Nacional de Energia Atomica (Argentina); Cerutti, G. [Laboratorio de Metrologia de Radioisotopos, Comision Nacional de Energia Atomica (Argentina); Carballido, M. [Laboratorio de Metrologia de Radioisotopos, Comision Nacional de Energia Atomica (Argentina); Guillen, V. [Laboratorio de Metrologia de Radioisotopos, Comision Nacional de Energia Atomica (Argentina); Araya, X. [Laboratorio de Metrologia de Radioisotopos, Comision Nacional de Energia Atomica (Argentina); Bianchini, R. [Laboratorio de Metrologia de Radioisotopos, Comision Nacional de Energia Atomica (Argentina)

2006-10-15

This work presents the experience developed by the Radioisotope Metrology Laboratory (LMR), of the Argentine National Atomic Energy Commission (CNEA), as result of the accreditation process of the Quality System by ISO 17025 Standard. Considering the LMR as a calibration laboratory, services of secondary activity determinations and calibration of activimeters used in Nuclear Medicine were accredited. A peer review of the ({alpha}/{beta})-{gamma} coincidence system was also carried out. This work shows in detail the structure of the quality system, the results of the accrediting audit and gives the number of non-conformities detected and of observations made which have all been resolved.

Accreditation experience of radioisotope metrology laboratory of Argentina

International Nuclear Information System (INIS)

Iglicki, A.; Mila, M.I.; Furnari, J.C.; Arenillas, P.; Cerutti, G.; Carballido, M.; Guillen, V.; Araya, X.; Bianchini, R.

2006-01-01

This work presents the experience developed by the Radioisotope Metrology Laboratory (LMR), of the Argentine National Atomic Energy Commission (CNEA), as result of the accreditation process of the Quality System by ISO 17025 Standard. Considering the LMR as a calibration laboratory, services of secondary activity determinations and calibration of activimeters used in Nuclear Medicine were accredited. A peer review of the (α/β)-γ coincidence system was also carried out. This work shows in detail the structure of the quality system, the results of the accrediting audit and gives the number of non-conformities detected and of observations made which have all been resolved

Accreditation - Its relevance for laboratories measuring radionuclides

Energy Technology Data Exchange (ETDEWEB)

Palsson, S E [Icelandic Radiation Protection Inst. (Iceland)

2001-11-01

Accreditation is an internationally recognised way for laboratories to demonstrate their competence. Obtaining and maintaining accreditation is, however, a costly and time-consuming procedure. The benefits of accreditation also depend on the role of the laboratory. Accreditation may be of limited relevance for a research laboratory, but essential for a laboratory associated with a national authority and e.g. issuing certificates. This report describes work done within the NKSBOK-1.1 sub-project on introducing accreditation to Nordic laboratories measuring radionuclides. Initially the focus was on the new standard ISO/IEC 17025, which was just in a draft form at the time, but which provides now a new framework for accreditation of laboratories. Later the focus was widened to include a general introduction to accreditation and providing through seminars a forum for exchanging views on the experience laboratories have had in this field. Copies of overheads from the last such seminar are included in the appendix to this report. (au)

ISO/IEC 17025–2017 "New requirements to the competence of test and calibration laboratories"

Directory of Open Access Journals (Sweden)

Baranova P. O.

2018-05-01

Full Text Available due to the continuous improvement of the regulatory framework, there is a growing demand for laboratory centers that provide services in the field of testing. The relevance of the topic lies in the transition of laboratories to the new version of ISO/IEC 17025–2017 «General requirements for the competence of test and calibration laboratories». The article compares two versions of the standard, reveals differences and similarities. And changes in the gradation of changes are also highlighted.

Combining ISO/IEC 17025:2005 and European Commission Decision 2002/657 audit requirements: a practical way forward.

Science.gov (United States)

Kay, Jack F

2012-08-01

Laboratories involved in the analyses of veterinary drug residues are under increasing pressure to demonstrate that they produce meaningful and reliable data. Quality assurance and quality control systems are implemented in laboratories to provide evidence of this and these are subject to external assessment to ensure that they are effective. Audits to ISO/IEC 17025:2005, an internationally accepted standard, and subsequent accreditation provide laboratories and their customers with a degree of assurance that the laboratories are operating in control and the data they report can be relied on. However, national or regional authorities may place additional requirements on laboratories to ensure quality data are reported. For example, in the European Union, all official control laboratories involved in veterinary drug residue analyses must also meet the requirements of European Commission Decision 2002/657/EC which sets performance criteria for analytical methods used in this area and these are subject to additional audits by national or regional authorities. All audits place considerable time and resource demands on laboratories and this paper discusses the burden audits place on laboratories and describes a UK initiative to combine these audits to the benefit of both the regulatory authority and the laboratory. © 2012 John Wiley & Sons, Ltd.

Proficiency test in the accreditation system

International Nuclear Information System (INIS)

Legarda, F.; Herranz, M.; Idoeta, R.

2008-01-01

In the accreditation process of a radioactivity measurements laboratory, according to ISO standard 17025, proficiency tests play a fundamental role. These PTs constitute an irreplaceable tool for the validation of measuring methods. In the case of Spain, ENAC, which is the Spanish accreditation national body, requires that the laboratory has to take part in a PT for each one of the accredited measuring methods in the period of time between two reassessments of the accreditation, what happens every 4-5 years. In specific areas of determination procedures, among which radioactive measurements could be included, the number of methods which can be accredited is very large. The purpose of the present work is to establish a classification into families of the different radioactivity measurement procedures, as well as to establish complementary actions that guarantee that carrying out periodically proficiency-tests on any of the included procedures in each family, every measurement procedure include in that family is controlled, complying with the criteria established by ENAC

Toward the Development of a Canadian Less Lethal Weapon Approval Process: A Study of Contemporary Process Models

Science.gov (United States)

2011-10-01

they must be ISO / IEC 17025 compliant. A list of laboratories accredited to also certify terminal apparatus is available on the Industry Canada...accredited by Standards Council of Canada or Certified to ISO / IEC 17025 . The emphasis in the approval process is on the independence of testing or the...of Canada. Industry Canada takes a similar approach depending on ISO / IEC 17025 certified labs for most testing. In summary, technical/testing

75 FR 51016 - Third Party Testing for Certain Children's Products; Clothing Textiles: Requirements for...

Science.gov (United States)

2010-08-18

... (ISO)/International Electrotechnical Commission (IEC) Standard 17025:2005, ``General Requirements for... and of the requirements of the ISO/IEC 17025:2005 laboratory accreditation standard is provided in the... must be to ISO Standard ISO/IEC 17025:2005, ``General Requirements for the Competence of Testing and...

Accreditation ISO/IEC 1705 in dosimetry: Experience and results; Acreditacion ISO/IEC 17025 en dosimetria: Experiencia y resultados

Energy Technology Data Exchange (ETDEWEB)

Martin Garcia, R.; Navarro Bravo, T.

2013-07-01

The objective of this work is to present the experience in the process of accreditation of the radiation dosimetry service in which there are trials for the determination of radiation doses due to internal and external exhibitions. Is They describe the aspects that were considered for the design and development of a system of quality and results after its implementation. A review of the benefits accreditation has been reported to the organization is finally made. (Author)

Laboratory accreditation in developing economies

International Nuclear Information System (INIS)

Loesener, O.

2004-01-01

Full text: Accreditation of laboratories has been practiced for well over one hundred years with the primary objective of seeking a formal recognition for the competence of a laboratory to perform specified tests or measurements. While first accreditation schemes intended initially to serve only the immediate needs of the body making the evaluation with the purpose of minimizing testing and inspection to be conducted by laboratories, third-party accreditation enables a laboratory to demonstrate its capability as well as availability of all necessary resources to undertake particular tests correctly and that is managed in such a way that it is likely to do this consistently, taking into consideration standards developed by national and international standards-setting bodies. The international standard ISO/IEC 17025 and laboratory accreditation are concerned with competence and quality management of laboratories only, thus requiring a single common set of criteria applicable to them. Quality assurance is therefore fully relevant to laboratories in general and analytical laboratories in particular; it should not be confused with the certification approach according to ISO/IEC 9000 family of standards, that is concerned with quality management applicable to any organization as a whole. The role of laboratory accreditation can be manifold, but in all cases the recipient of the test report needs to have confidence that the data in it is reliable, particularly if the test data is important in a decision-making process. As such, it offers a comprehensive way to ensure: - the availability of managerial and technical staff with the authority and resources needed; - the effectiveness of equipment management, traceability of measurement and safety procedures; - the performance of tests, taking into consideration laboratory accommodation and facilities as well as laboratory practices. The presentation will include also some practical aspects of quality management system

75 FR 52616 - Third Party Testing for Certain Children's Products; Youth All-Terrain Vehicles: Requirements for...

Science.gov (United States)

2010-08-27

... content of the ILAC-MRA approach and of the requirements of the ISO/IEC 17025:2005 laboratory... must be to ISO Standard ISO/IEC 17025:2005, General Requirements for the Competence of Testing and... that at that time was ISO/IEC 17025 accredited by an ILAC-MRA signatory. For firewalled conformity...

Inter-Laboratory Comparison for Calibration of Relative Humidity Devices Among Accredited Laboratories in Malaysia

Science.gov (United States)

Hussain, F.; Khairuddin, S.; Othman, H.

2017-01-01

An inter-laboratory comparison in relative humidity measurements among accredited laboratories has been coordinated by the National Metrology Institute of Malaysia. It was carried out to determine the performance of the participating laboratories. The objective of the comparison was to acknowledge the participating laboratories competencies and to verify the level of accuracies declared in their scope of accreditation, in accordance with the MS ISO/IEC 17025 accreditation. The measurement parameter involved was relative humidity for the range of 30-90 %rh at a nominal temperature of 50°C. Eight accredited laboratories participated in the inter-laboratory comparison. Two units of artifacts have been circulated among the participants as the transfer standards.

Accreditation and radiation protection - the cost or smaller doses and reliable results

International Nuclear Information System (INIS)

Omahen, G.; Zdesar, U.

2011-01-01

Laboratories involved in the protection against radiation and therefore in the measurement of radioactivity, dose rate and contamination have always been tied to the quality of their measurements, particularly those that have performed measurements for nuclear power plants. However in the laboratories more than quality it was more important, that people are professional, that they are engaged in scientific work and know how to interpret the results. Very often these are things that do not go along with reviewing the measuring instruments and quality records. However customer requires measurement results that can be trusted. This is the purpose of the standard SIST EN ISO / IEC 17025 in which the requirements for testing and calibration laboratories are standardised. The standard in force since 1999. In some countries, requests for accreditation of testing laboratories according to SIST EN ISO / IEC 17025 is even in regulation. This request is for example in the Croatian and Slovenian regulations for laboratories involved in measuring the radioactivity, dose rate, contamination, or by checking the X-ray apparatus. Several laboratories have been accreditation for several years. From that experience we can conclude that customer gets reliable results from the accredited laboratories at relatively low cost. On the other side laboratory which his accredited has introduced a line of work and his laboratory, there are rules for equipment, personnel, training and all that eventually enhanced measurement expertise. With accreditation, it is much easier to compensate for the loss of workers due to pension or leaving the laboratory because every moment must always be in the laboratory at least two who know how to work on the method. Accreditation is not improving radiation protection or reducing Becquerel in the air. But at least we know how accurate mSv or Bq are and how small mSv and Bq can be measured. (author) [sr

The current status of forensic science laboratory accreditation in Europe.

Science.gov (United States)

Malkoc, Ekrem; Neuteboom, Wim

2007-04-11

Forensic science is gaining some solid ground in the area of effective crime prevention, especially in the areas where more sophisticated use of available technology is prevalent. All it takes is high-level cooperation among nations that can help them deal with criminality that adopts a cross-border nature more and more. It is apparent that cooperation will not be enough on its own and this development will require a network of qualified forensic laboratories spread over Europe. It is argued in this paper that forensic science laboratories play an important role in the fight against crime. Another, complimentary argument is that forensic science laboratories need to be better involved in the fight against crime. For this to be achieved, a good level of cooperation should be established and maintained. It is also noted that harmonization is required for such cooperation and seeking accreditation according to an internationally acceptable standard, such as ISO/IEC 17025, will eventually bring harmonization as an end result. Because, ISO/IEC 17025 as an international standard, has been a tool that helps forensic science laboratories in the current trend towards accreditation that can be observed not only in Europe, but also in the rest of the world of forensic science. In the introduction part, ISO/IEC 17025 states that "the acceptance of testing and calibration results between countries should be facilitated if laboratories comply with this international standard and if they obtain accreditation from bodies which have entered into mutual recognition agreements with equivalent bodies in other countries using this international standard." Furthermore, it is emphasized that the use of this international standard will assist in the harmonization of standards and procedures. The background of forensic science cooperation in Europe will be explained by using an existing European forensic science network, i.e. ENFSI, in order to understand the current status of forensic

Dosimetric quality assurance interpreted for ISO 17025 in public health England's personal dosimetry service

International Nuclear Information System (INIS)

Gilvin, P.J.; Gibbens, N.J.; Baker, S.T.

2016-01-01

Many individual monitoring services (IMSs) have long experience in delivering high-quality dosimetry, and many follow rigorous quality assurance (QA) procedures. Typically, these procedures have been developed through experience and are highly effective in maintaining high-quality dose measurements. However, it is not always clear how the range of QA procedures normally followed by IMSs maps on to the various requirements of ISO 17025. The Personal Dosimetry Service of Public Health England has interpreted its QA procedures both in operating existing services and in developing a new one. (authors)

Towards accreditation of MINT pesticide residue laboratory - a journey

International Nuclear Information System (INIS)

Nashriyah Mat; Salmah Moosa; Misman Sumin; Maizatul Akmam Mohd Nasir; Norimah Yusof

2005-01-01

The laboratory accreditation process under ISO/IEC 17025 is a complex journey, due to several compulsory inputs necessary for obtaining the accreditation. This paper dwells on most of those inputs in the context of MINT Pesticide Residue Laboratory (MPRL), including: 1) Quality work culture; 2) Management commitment; 3) Sustainability of laboratory service appointment; 4) Laboratory personnel; 5) Laboratory equipment; 6) Continual training of personnel; 7) Technical co-operation; 8) Laboratory safety; 9) Special and general budget; 10) Consultancy service; 11) Quality Manual, Procedure, Work Instruction and related documents; 12) Internal Quality Audit (IQA) by MINT Quality Unit, and 13) Teamwork spirit. Based on experience faced and knowledge gained, multiple problems arising during this journey towards MINT Pesticide Residue Laboratory accreditation are also discussed in general, including their solutions. (Author)

Comparative study on implementation of management requires from ABNT NBR ISO/IEC 17025; Estudo comparativo de implementacao de requisitos gerenciais da ABNT NBR ISO/TEC 17025 e boas praticas de gestao em laboratorios de calibracao da area de radiacoes ionizantes

Energy Technology Data Exchange (ETDEWEB)

Suplino Filho, Carlos Alberto Lucas; Souza, Luciane de Rezende; Oliveira, Estela Maria de, E-mail: clucas@ird.gov.br, E-mail: rluciane@ird.gov.br, E-mail: estela@ird.gov.br [Instituto de Radioprotecao e Dosimetria, (IRD/CNEN-RJ), Rio de Janeiro, RJ (Brazil)

2014-07-01

This work was developed in order to emphasize the importance of laboratory management system in the direction and control of the company or institute with regard to the quality of delivery of ionizing radiation service to society. It was developed a comparative study of managerial points of Deming with the managerial requirements of ISO / IEC 17025, which found that the difficulties of the laboratories indicated by nonconformities tracked during audits, are related to specific points cited by Deming. (author)

Validation of powder X-ray diffraction following EN ISO/IEC 17025.

Science.gov (United States)

Eckardt, Regina; Krupicka, Erik; Hofmeister, Wolfgang

2012-05-01

Powder X-ray diffraction (PXRD) is used widely in forensic science laboratories with the main focus of qualitative phase identification. Little is found in literature referring to the topic of validation of PXRD in the field of forensic sciences. According to EN ISO/IEC 17025, the method has to be tested for several parameters. Trueness, specificity, and selectivity of PXRD were tested using certified reference materials or a combination thereof. All three tested parameters showed the secure performance of the method. Sample preparation errors were simulated to evaluate the robustness of the method. These errors were either easily detected by the operator or nonsignificant for phase identification. In case of the detection limit, a statistical evaluation of the signal-to-noise ratio showed that a peak criterion of three sigma is inadequate and recommendations for a more realistic peak criterion are given. Finally, the results of an international proficiency test showed the secure performance of PXRD. © 2012 American Academy of Forensic Sciences.

Current status of accreditation for drug testing in hair.

Science.gov (United States)

Cooper, Gail; Moeller, Manfred; Kronstrand, Robert

2008-03-21

At the annual meeting of the Society of Hair Testing in Vadstena, Sweden in 2006, a committee was appointed to address the issue of guidelines for hair testing and to assess the current status of accreditation amongst laboratories offering drug testing in hair. A short questionnaire was circulated amongst the membership and interested parties. Fifty-two responses were received from hair testing laboratories providing details on the amount and type of hair tests they offered and the status of accreditation within their facilities. Although the vast majority of laboratories follow current guidelines (83%), only nine laboratories were accredited to ISO/IEC 17025 for hair testing. A significant number of laboratories reporting that they were in the process of developing quality systems with a view to accrediting their methods within 2-3 years. This study provides an insight into the status of accreditation in hair testing laboratories and supports the need for guidelines to encourage best practice.

Time and Frequency Activities at NICT, Japan

Science.gov (United States)

2009-11-01

The NITE (National Institute of Technology and Evaluation) provided an accreditation of ISO / IEC 17025 to NICT on 31 January 2003, and also provided...an accreditation of ISO / IEC 17025 for the frequency remote calibration system to NICT on 2 May 2006; the BMC of the system is 5 × 10 -14 since

Accreditation and ISO certification: do they explain differences in quality management in European hospitals?

Science.gov (United States)

Shaw, Charles; Groene, Oliver; Mora, Nuria; Sunol, Rosa

2010-12-01

Hospital accreditation and International Standardisation Organisation (ISO) certification offer alternative mechanisms for improving safety and quality, or as a mark of achievement. There is little published evidence on their relative merits. To identify systematic differences in quality management between hospitals that were accredited, or certificated, or neither. Research design of compliance with measures of quality in 89 hospitals in six countries, as assessed by external auditors using a standardized tool, as part of the EC-funded of Assessing Response to Quality Improvement Strategies project. Compliance scores in six dimensions of each hospital-grouped according to the achievement of accreditation, certification or neither. Of the 89 hospitals selected for external audit, 34 were accredited (without ISO certification), 10 were certificated under ISO 9001 (without accreditation) and 27 had neither accreditation nor certification. Overall percentage scores for 229 criteria of quality and safety were 66.9, 60.0 and 51.2, respectively. Analysis confirmed statistically significant differences comparing mean scores by the type of external assessment (accreditation, certification or neither); however, it did not substantially differentiate between accreditation and certification only. Some of these associations with external assessments were confounded by the country in which the sample hospitals were located. It appears that quality and safety structures and procedures are more evident in hospitals with either the type of external assessment and suggest that some differences exist between accredited versus certified hospitals. Interpretation of these results, however, is limited by the sample size and confounded by variations in the application of accreditation and certification within and between countries.

Source Code Analysis Laboratory (SCALe)

Science.gov (United States)

2012-04-01

products (including services) and processes. The agency has also published ISO / IEC 17025 :2005 General Requirements for the Competence of Testing...SCALe undertakes. Testing and calibration laboratories that comply with ISO / IEC 17025 also operate in accordance with ISO 9001. • NIST National...assessed by the accreditation body against all of the requirements of ISO / IEC 17025 : 2005 General requirements for the competence of testing and

Experiences of Radiochemical Lab of Faculty of Natural Sciences, Comenius University, Bratislava, Slovakia with implementation of QA/QC system

International Nuclear Information System (INIS)

Rajec, Pavol; Mackova, Jana

2002-01-01

This report gives an overview of the Laboratory experience from the participation in the Project. The Project helped the Laboratory to obtain accreditation with the Slovak National Accreditation Service, to receive more contracts and clients and to implement QA/QC principles according to ISO 17025. The future plans of the Laboratory include ISO 17025 compliance certification

Accreditation and Radiation Protection - Do We Need It Because of the Law or Because of Us

International Nuclear Information System (INIS)

Omahen, G.; Zdesar, U.

2011-01-01

Laboratories involved in the protection against radiation and therefore in the measurement of radioactivity, dose rate and contamination have always been tied to the quality of their measurements, particularly those that have performed measurements for nuclear power plants. However in the laboratories more than quality it was more important, that people are professional, that they are engaged in scientific work and know how to interpret the results. Very often these are things that do not go along with reviewing the measuring instruments and quality records. However customer requires measurement results that can be trusted. This is the purpose of the standard SIST EN ISO / IEC 17025 in which the requirements for testing and calibration laboratories are standardised. The standard is in force since 1999. In some countries, a request for accreditation of testing laboratories according to SIST EN ISO / IEC 17025 is even in regulation. This request is for example in the Croatian and Slovenian regulations for laboratories involved in measuring the radioactivity, dose rate, contamination, or by checking the X-ray apparatus. Several laboratories have been accredited for several years. From that experience we can conclude that customer gets reliable results from the accredited laboratories at relatively low cost. On the other side laboratory which is accredited has introduced a line of work in the laboratory, there are rules for equipment, personnel, training and all that eventually enhance measurement expertise. With accreditation, it is much easier to compensate for the loss of workers due to pension or leaving the laboratory because every moment must always be in the laboratory at least two who know how to work on the method. Accreditation is not improving radiation protection or reducing becquerel in the air. But at least we know how accurate mSv or Bq are and how small mSv and Bq can be measured. (author)

76 FR 22030 - Third Party Testing for Certain Children's Products; Toddler Beds: Requirements for Accreditation...

Science.gov (United States)

2011-04-20

... and content of the ILAC-MRA approach and of the requirements of the ISO/IEC 17025:2005 laboratory... to ISO Standard ISO/IEC 17025:2005, ``General Requirements for the Competence of Testing and.... The product \\1\\ was tested by a third party conformity assessment body that was ISO/IEC 17025...

Establishment of qualities mammography according to the standard IEC-61267 in the laboratory of metrology of ionizing radiation of the National Center of Dosimetry and enlargement of the accreditation by ENAC

International Nuclear Information System (INIS)

Roig Petit, F.; Mestre de Juan, V.; Alabau Albors, J.; Palma Copete, J.; Ruiz Rodriguez, J. C.; Pons Mocholi, S.

2013-01-01

The extension of the accreditation of the laboratory of the National Center Dosimetry (No. 58/LC10.036) by the national accreditation entity (ENAC), according to the ISO 17025 standard [2], for the standard qualities of mammography by the IEC 61267 comes to meet part of the needs that demand our health care environment in terms of radiation measuring instruments calibration. This work intends to publicize this enlargement commenting on the different phases of the process to get the accreditation. (Author)

Expert Assessment of Conditions for Accredited Quality Management System Functioning in Testing Laboratories

Science.gov (United States)

Mytych, Joanna; Ligarski, Mariusz J.

2018-03-01

The quality management systems compliant with the ISO 9001:2009 have been thoroughly researched and described in detail in the world literature. The accredited management systems used in the testing laboratories and compliant with the ISO/IEC 17025:2005 have been mainly described in terms of the system design and implementation. They have also been investigated from the analytical point of view. Unfortunately, a low number of studies concerned the management system functioning in the accredited testing laboratories. The aim of following study was to assess the management system functioning in the accredited testing laboratories in Poland. On 8 October 2015, 1,213 accredited testing laboratories were present in Poland. They investigated various scientific areas and substances/objects. There are more and more such laboratories that have various problems and different long-term experience when it comes to the implementation, maintenance and improvement of the management systems. The article describes the results of the conducted expert assessment (survey) carried out to examine the conditions for the functioning of a management system in an accredited laboratory. It also focuses on the characteristics of the accredited research laboratories in Poland. The authors discuss the selection of the external and internal conditions that may affect the accredited management system. They show how the experts assessing the selected conditions were chosen. The survey results are also presented.

Study on expanding the capability of laboratory and maintaining the accredited status of VILAS 524 at the Institute of Radioactive and Rare Elements

International Nuclear Information System (INIS)

Nguyen Thi Kim Dung; Le Hong Minh; Doan Thanh Son; Nguyen Thi Lien; Do Thi Anh Tuyet; Nguyen Thi Men; Do Van Thuan

2015-01-01

The study to expand the VILAS activities in the field of uranium and rare earth ores as well as environmental samples on addition of accredited test methods has been implemented in VILAS 524. The maintenance of all routine activities at VILAS 524 laboratory (Center for Analytical Chemistry-Institute for Technology of Radioactive and Rare Elements) to comply with TCVN ISO/IEC 17025:2005 has been carried out regularly after the certificate of VILAS 524 was issued. The annual audit by the experts from BOA (Bureau of Accreditation) has been applied to VILAS 524 in order to control the compliance of VILAS activities with ISO standard and the renew of VILAS certificate up to 2017 was issued. (author)

تحديد نقاط القوة والضعف في تطبيق نظام المواصفة 17025 في المختبر الانشائي في الكلية التقنية – كركوك

Directory of Open Access Journals (Sweden)

حسين نورالدين عزت البيرقدار

2016-06-01

Full Text Available Quality has become a competitive advantage, which made the strategic objective to acquire a high degree of public interest organizations, as quality has become an essential part of the culture of organizations, especially those that find their way in the application of quality and continue to grow and develop. From here, The researcher realized we had an obligation application of modern quality systems in the laboratory in the Structural Technical College - Kirkuk, came the idea of a study on the possibility of applying quality management system ISO / IEC 17025:2005 in the structural laboratory at College of Technology - Kirkuk as a step in the application of the system to effectively and the adoption of the laboratory as a laboratory accredited by the National Laboratory Accreditation Iraqi or international bodies for the accreditation of laboratories.Acoordeing with principle we had applied this system management with ISO 17025 panelized with the program for the project.

Upgrading the Medical Physics Calibration Laboratory Towards ISO/IEC 17025: Radiation Standards and Calibration in Diagnostic Radiology

International Nuclear Information System (INIS)

Asmaliza Hashim; Muhammad Jamal Md Isa; Abd Aziz Mhd Ramli; Wan Hazlinda Ismail; Norhayati Abdullah; Shahrul Azlan Azizan; Siti Sara Deraman; Nor Azlin Azraai; Md Khairusalih Md Zin

2010-01-01

Calibration of quality control (QC) test tools used in diagnostic radiology is legally required under the Ministry of Health (MOH) requirement. The Medical Physics Calibration Laboratory of the Malaysian Nuclear Agency is the national focal point for the calibration of quality control test tools used in diagnostic radiology. The Medical Physics Calibration Laboratory has measurement traceability to primary standard dosimetry laboratory (Physikalisch-Technische Bundesanstalt (PTB)), thus providing an interface between the primary standard dosimetry laboratory and Malaysian hospitals, clinics and license class H holder. The Medical Physics Calibration Laboratory facility is comprised of a constant potential x-ray system with a capability of 160 kV tube and a series of reference and working standard ion chambers. The stability of reference and working standard ion chambers was measured using strontium-90. Dosimetric instruments used in diagnostic radiology is calibrated in terms of air kerma to comply with an International Code of Practices of dosimetry for example IAEA's Technical Report Series number 457. The new series of standard radiation qualities was established based on ISO/IEC 61267. The measurement of beam homogeneity was measured using film and ion chamber to define the field size at certain distance and kV output was measured using the spectrometer and non-invasive kVp meter. The uncertainties measurement was determined with expended uncertainties to a level of confidence of approximately 95% (coverage factor k=2). This paper describes the available facility and the effort of the Medical Physics Calibration Laboratory to upgrade the laboratory towards ISO/IEC 17025. (author)

A simple method for validation and verification of pipettes mounted on automated liquid handlers

DEFF Research Database (Denmark)

Stangegaard, Michael; Hansen, Anders Johannes; Frøslev, Tobias G

2011-01-01

We have implemented a simple, inexpensive, and fast procedure for validation and verification of the performance of pipettes mounted on automated liquid handlers (ALHs) as necessary for laboratories accredited under ISO 17025. A six- or seven-step serial dilution of OrangeG was prepared in quadru......We have implemented a simple, inexpensive, and fast procedure for validation and verification of the performance of pipettes mounted on automated liquid handlers (ALHs) as necessary for laboratories accredited under ISO 17025. A six- or seven-step serial dilution of OrangeG was prepared...... are freely available. In conclusion, we have set up a simple, inexpensive, and fast solution for the continuous validation of ALHs used for accredited work according to the ISO 17025 standard. The method is easy to use for aqueous solutions but requires a spectrophotometer that can read microtiter plates....

The applies specific technical requirements to the services of radiological protection according to the 17025

Energy Technology Data Exchange (ETDEWEB)

Marrero Garcia, M.; Fernandez Gomez, I. M.; Prendes Alonso, M.; Molina Perez, D.

2004-07-01

The employment in the Center of Radiation Protection and Hygiene (CRPH) of Cuba, of the standard 17025 for the administration of the quality of the calibration laboratories and test that offer services of radiological protection requires of a technical complement to really determine the technical competence. In the standard 17025, the specific requirements, are mentioned in the annex B (with informative character), where it points out that: {sup T}he requirements specified in the standard 17025 are established in general terms and, although they can be applied to all the test laboratories and applications, they could be necessary applications{sup .} In the CRPH these applications are translated in indispensable technical requirements to evaluate the performance of the services of radiological protection that offers, specifically those of personal monitoring, the calibration of instruments and the metrology of radionuclides. Although the standard 17025 is quite rigorous in the evaluation of technical requirements, to have specific materials not serves alone of tool to the laboratories, but also for the body of accreditation . In the CRPH the permanent employment of this tool has not constituted a practice, but had been good before our clients certain nonconformities to evaluate the performance of the laboratory and to achieve the recovery of the trust in its results. With this work we seek to expose some of these experiences. The experiences of the application of some of the technical requirements, in our case, they have been applied to the service of personal monitoring that offers the Laboratory of Personal Dosimetry. This laboratory is accredited by the National Accreditation Board of the Republic of Cuba (NABC) and besides fulfilling that settled down in 17025, the Approaches of Accreditation for test laboratories and calibration and it should also implant that settled down as specific technical requirements for the recognition of technical competence. (Author

Assuring the Quality of Test Results in the Field of Nuclear Techniques and Ionizing Radiation. The Practical Implementation of Section 5.9 of the EN ISO/IEC 17025 Standard

Science.gov (United States)

Cucu, Daniela; Woods, Mike

2008-08-01

The paper aims to present a practical approach for testing laboratories to ensure the quality of their test results. It is based on the experience gained in assessing a large number of testing laboratories, discussing with management and staff, reviewing results obtained in national and international PTs and ILCs and exchanging information in the EA laboratory committee. According to EN ISO/IEC 17025, an accredited laboratory has to implement a programme to ensure the quality of its test results for each measurand. Pre-analytical, analytical and post-analytical measures shall be applied in a systematic manner. They shall include both quality control and quality assurance measures. When designing the quality assurance programme a laboratory should consider pre-analytical activities (like personnel training, selection and validation of test methods, qualifying equipment), analytical activities ranging from sampling, sample preparation, instrumental analysis and post-analytical activities (like decoding, calculation, use of statistical tests or packages, management of results). Designed on different levels (analyst, quality manager and technical manager), including a variety of measures, the programme shall ensure the validity and accuracy of test results, the adequacy of the management system, prove the laboratory's competence in performing tests under accreditation and last but not least show the comparability of test results. Laboratory management should establish performance targets and review periodically QC/QA results against them, implementing appropriate measures in case of non-compliance.

Assuring the Quality of Test Results in the Field of Nuclear Techniques and Ionizing Radiation. The Practical Implementation of Section 5.9 of the EN ISO/IEC 17025 Standard

International Nuclear Information System (INIS)

Cucu, Daniela; Woods, Mike

2008-01-01

The paper aims to present a practical approach for testing laboratories to ensure the quality of their test results. It is based on the experience gained in assessing a large number of testing laboratories, discussing with management and staff, reviewing results obtained in national and international PTs and ILCs and exchanging information in the EA laboratory committee.According to EN ISO/IEC 17025, an accredited laboratory has to implement a programme to ensure the quality of its test results for each measurand. Pre-analytical, analytical and post-analytical measures shall be applied in a systematic manner. They shall include both quality control and quality assurance measures.When designing the quality assurance programme a laboratory should consider pre-analytical activities (like personnel training, selection and validation of test methods, qualifying equipment), analytical activities ranging from sampling, sample preparation, instrumental analysis and post-analytical activities (like decoding, calculation, use of statistical tests or packages, management of results).Designed on different levels (analyst, quality manager and technical manager), including a variety of measures, the programme shall ensure the validity and accuracy of test results, the adequacy of the management system, prove the laboratory's competence in performing tests under accreditation and last but not least show the comparability of test results.Laboratory management should establish performance targets and review periodically QC/QA results against them, implementing appropriate measures in case of non-compliance

System Quality Management in Software Testing Laboratory that Chooses Accreditation

Directory of Open Access Journals (Sweden)

Yanet Brito R.

2013-12-01

Full Text Available The evaluation of software products will reach full maturity when executed by the scheme and provides third party certification. For the validity of the certification, the independent laboratory must be accredited for that function, using internationally recognized standards. This brings with it a challenge for the Industrial Laboratory Testing Software (LIPS, responsible for testing the products developed in Cuban Software Industry, define strategies that will permit it to offer services with a high level of quality. Therefore it is necessary to establish a system of quality management according to NC-ISO/IEC 17025: 2006 to continuously improve the operational capacity and technical competence of the laboratory, with a view to future accreditation of tests performed. This article discusses the process defined in the LIPS for the implementation of a Management System of Quality, from the current standards and trends, as a necessary step to opt for the accreditation of the tests performed.

[Fundamental aspects for accrediting medical equipment calibration laboratories in Colombia].

Science.gov (United States)

Llamosa-Rincón, Luis E; López-Isaza, Giovanni A; Villarreal-Castro, Milton F

2010-02-01

Analysing the fundamental methodological aspects which should be considered when drawing up calibration procedure for electro-medical equipment, thereby permitting international standard-based accreditation of electro-medical metrology laboratories in Colombia. NTC-ISO-IEC 17025:2005 and GTC-51-based procedures for calibrating electro-medical equipment were implemented and then used as patterns. The mathematical model for determining the estimated uncertainty value when calibrating electro-medical equipment for accreditation by the Electrical Variable Metrology Laboratory's Electro-medical Equipment Calibration Area accredited in compliance with Superintendence of Industry and Commerce Resolution 25771 May 26th 2009 consists of two equations depending on the case; they are: E = (Ai + sigmaAi) - (Ar + sigmaAr + deltaAr1) and E = (Ai + sigmaAi) - (Ar + sigmaA + deltaAr1). The mathematical modelling implemented for measuring uncertainty in the Universidad Tecnológica de Pereira's Electrical Variable Metrology Laboratory (Electro-medical Equipment Calibration Area) will become a good guide for calibration initiated in other laboratories in Colombia and Latin-America.

ISO-9001: An approach to accreditation for an MTR facility: SAFARI-1 research reactor

International Nuclear Information System (INIS)

Piani, C.S.B.; Du Bruyn, J.F.B.

2000-01-01

The SAFARI-1 Research Reactor obtained ISO-9001 accreditation via the South African Bureau of Standards in September 1998. In view of the commercial applications of the reactor, the value of acquisition of the accreditation was considered against the cost of implementation of the Quality System. The criteria identified in the ISO-9001 standard were appraised and a superstructure derived for management of the generation and implementation of a suitable Quality Management System (QMS) for the fairly unique application of a nuclear research reactor. A Quality Policy was established, which formed the basis of the QMS against which the various requirements and/or standards were identified. In addition, since it was considered advantageous to incorporate the management controls of Conventional and Radiological Safety as well as Plant Maintenance and Environmental Management (ISO 14001), these aspects were included in the QMS. (author)

The control of documents maintained in the electronic media and the requirements of NBR ISO/IEC 17025 and adequacy for PNQ

Directory of Open Access Journals (Sweden)

Anselmo Ferreira de Castro

2006-01-01

Full Text Available During the assessments carried out by the authors at the diverse laboratories pertaining to the network of accredited laboratories - known as the Brazilian Calibration Network (RBC - the authors verified the difficulties that these laboratories had in meeting the requirements of NBR ISO/IEC 17025:2001 (Standard, related to the maintenance of documents in the electronic media. More and more laboratories are substituting traditional control with electronic document control, which allows for more agility in the recovery of information. These laboratories implement policies and procedures; however, they still feel insecure, in some way, as to how to meet all of these requirements, thereby giving rise to difficulties in the implementation of such. The aim of this paper is to discuss the control of documents stored in the electronic media, adopting requirement 4.3 of the Standard as the reference, and aiming, in this manner, to harmonize the assessment process of the procedures of document management in the electronic media, and to assist the laboratories in the interpretation of the Standard, so that they may implement systems that are adequate to their actual necessities and to their structural size, while at the same time complying with the referred to requirement. This work will not broach the treatment given to the records (requirement 4.12 of the Standard, facts (requirement 5.4.7 nor to the electronic transmission of results (requirement 5.10.7, leaving these subjects for posterior discussions.

Quality Assurance in Engineering Education: Comparison of Accreditation Schemes and ISO 9001.

Science.gov (United States)

Karapetrovic, Stanislav; Rajamani, Divakar; Willborn, Walter

1998-01-01

Outlines quality assurance schemes for distance-education technologies that are based on the ISO 9000 family of international quality-assurance standards. Argues that engineering faculties can establish such systems on the basis of and integrated with accreditation schemes. Contains 34 references. (DDR)

The most common nonconformities encountered during the assessments of medical laboratories in Hong Kong using ISO 15189 as accreditation criteria

OpenAIRE

Ho, Bella; Ho, Eric

2012-01-01

Introduction: ISO 15189 was a new standard published in 2003 for accrediting medical laboratories. We believe that some requirements of the ISO 15189 standard are especially diffi cult to meet for majority of laboratories. The aim of this article was to present the frequency of nonconformities to requirements of the ISO 15189 accreditation standard, encountered during the assessments of medical laboratories in Hong Kong, during 2004 to 2009. Materials and methods: Nonconformities reported ...

Assessment of quality of measurement results in interlaboratory comparisons

International Nuclear Information System (INIS)

Rosskopfova, O.; Matel, L.; Rajec, P.

2009-01-01

Testing laboratory accredited according to ISO/IEC 17025:2005 has to ensure the quality of their results. Important aspect of correct evaluation of the result is the accuracy and uncertainty. Requirement of ISO/IEC 17025:2005 is the accredited laboratories to express their results with the corresponding uncertainty. Participation of laboratories in interlaboratory comparisons provides objective evidence of the level of reliability and quality of their results. Thereby the competency of accredited laboratories verified, including the verification of the declared measurement uncertainty. Some interlaboratory comparisons in which took participation the Testing Laboratory of Radiochemical Analysis (LARCHA) are presented.

Firefighting and Emergency Response Study of Advanced Composites Aircraft. Objective 3: Penetrating and Overhauling Wreckage

Science.gov (United States)

2011-10-01

ompliance with the 150/ IEC 17025 ;md is a.ccredited by tm: Ame:ricw Association for Laboratory Accreditation(A2LA~ certificatt:s +1740.01 and +1740.02...ith the ISO / IEC 1 7025 and is accredited by t he American Association for L abo:ratol)’ Accreditation (A2LA), certificates ++741)_01 and ++741) _1...Test Labs - Charleston maintains a quality system incompliance with t~ 150/ IEC 17025 and is acrredited by the A~rican AssociationforL

Accrediting of the OKTA Laboratory - Harmonizing with the European standards

International Nuclear Information System (INIS)

Denkovski, Gligor

2004-01-01

In the energetics of Republic of Macedonia, after 13 years of independence of the country, there is still chaos in applying of many standards that are not used any more, even in the countries from which they are taken over. Step forward is the applying of the new standards in the oil industry. Control of applying of these standards is still open question. Factory laboratories regardless their equipping are not formally authorized to perform analysis for purposes other than those for their own needs. With establishing of Accrediting Institute of Republic of Macedonia (IARM), and adopting of corresponding regulations, there are conditions for accrediting of laboratories in order of giving services to the State and other users. Subject of this work is accrediting of the laboratory of OKTA - Crude Oil Refinery, Skopje, according the international standard ISO / IEC 17025. Finally this will be beginning of the control of import of crude oil products with suspicious origin and quality, that have been on the Macedonian market for years. (Author)

Accreditation of laboratories in the field of radiation protection

International Nuclear Information System (INIS)

Galjanic, S.; Franic, Z.

2005-01-01

This paper gives a review of requirements and procedures for the accreditation of test and calibration laboratories in the field of radiation protection, paying particular attention to Croatia. General requirements to be met by a testing or calibration laboratory to be accredited are described in the standard HRN EN ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories. The quality of a radiation protection programme can only be as good as the quality of the measurements made to support it. Measurement quality can be assured by participation in measurement assurance programmes that evaluate the appropriateness of procedures, facilities, and equipment and include periodic checks to assure adequate performance. These also include internal consistency checks, proficiency tests, intercomparisons and site visits by technical experts to review operations. In Croatia, laboratories are yet to be accredited in the field of radiation protection. However, harmonisation of technical legislation with the EU legal system will require some changes in laws and regulations in the field of radiation protection, including the ones dealing with the notification of testing laboratories and connected procedures. Regarding the notification procedures for testing laboratories in Croatia, in the regulated area, the existing accreditation infrastructure, i.e. Croatian Accreditation Agency is ready for its implementation, as it has already established and further developed a consistent accreditation system, compatible with international requirements and procedures.(author)

Laboratory Accreditation Bureau (L-A-B)

Science.gov (United States)

2011-03-28

to all Technical Advisors. Must agree with code of conduct, confidentiality and our mission DoD ELAP Program  ISO / IEC 17025 :2005 and DoD QSM...Additional DoD QSM requirements fit well in current 17025 process … just much, much more. Sector Specific. Outcome (L-A-B case)  83

Establishment of qualities mammography according to the standard IEC-61267 in the laboratory of metrology of ionizing radiation of the National Center of Dosimetry and enlargement of the accreditation by ENAC; Establecimiento de las calidades de mamografia segun la norma IEC-61267 en el laboratorio de metrologia de radiaciones ionizantes del centro nacional de dosimetria (CND) y proceso de ampliacion de su acreditacion por ENAC

Energy Technology Data Exchange (ETDEWEB)

Roig Petit, F.; Mestre de Juan, V.; Alabau Albors, J.; Palma Copete, J.; Ruiz Rodriguez, J. C.; Pons Mocholi, S.

2013-07-01

The extension of the accreditation of the laboratory of the National Center Dosimetry (No. 58/LC10.036) by the national accreditation entity (ENAC), according to the ISO 17025 standard [2], for the standard qualities of mammography by the IEC 61267 comes to meet part of the needs that demand our health care environment in terms of radiation measuring instruments calibration. This work intends to publicize this enlargement commenting on the different phases of the process to get the accreditation. (Author)

DOD ELAP Lab Uncertainties

Science.gov (United States)

2012-03-01

ISO / IEC   17025  Inspection Bodies – ISO / IEC  17020  RMPs – ISO  Guide 34 (Reference...certify to :  ISO  9001 (QMS),  ISO  14001 (EMS),   TS 16949 (US Automotive)  etc. 2 3 DoD QSM 4.2 standard   ISO / IEC   17025 :2005  Each has uncertainty...IPV6, NLLAP, NEFAP  TRAINING Programs  Certification Bodies – ISO / IEC  17021  Accreditation for  Management System 

Quality of Control of Clinical-Biochemical Laboratories – Serbian Case

Directory of Open Access Journals (Sweden)

Vinko Peric

2014-06-01

Full Text Available In the last 20 years in medical laboratories, numerous activities regarding quality and accreditation system were taken. Approach to this problem in European countries is different, so the task of the Accreditation Work Group of the Confederation of European societies for clinical chemistry (EC 4 to help the efforts to harmonize this issue. External quality control in clinical-chemical laboratories imposed the need for the implementation of quality management system. »Good laboratory practice« and its principles were adopted by nominated bodies, both international and national. In the beginning, the standard ISO 9001 was applied for certification and for accreditation EN 45001 and ISO Guide 25, which are prepared for testing and calibration laboratories. Standard ISO 17025 is the successor of the previous documents and for now it is a reference for mentioned laboratories. Accreditation Work Group of the Confederation of European societies for clinical chemistry (EC 4 made an amendment of the requirements for medical laboratories, which this standard describes. Standard draft ISO 15189 was adopted on February 2003 as a final version with requirements for medical laboratories.

Proficiency Testing Activities of Frequency Calibration Laboratories in Taiwan, 2009

Science.gov (United States)

2009-11-01

cht.com.tw Abstract In order to meet the requirements of ISO 17025 and the demand of TAF (Taiwan Accreditation Foundation) for calibration inter... IEC 17025 General requirements for the competence of testing and calibration laboratories. The proficiency testing results are then important...on-site evaluation, an assessment team is organized to examine the technical competence of the labs and their compliance with the requirements of ISO

Improvement of customer satisfaction evaluation for quality management system and accreditation in Nuclear Malaysia

International Nuclear Information System (INIS)

Fazila Said; Noriah Ali; Siti Mariam Ibrahim

2010-01-01

Malaysian Nuclear Agency (Nuclear Malaysia) possesses seven certification of Quality Management System, namely ISO 9001:2008, and two certification of Malaysia Laboratory Accreditation Scheme, namely ISO/IEC 17025:2005. General Requirement of Standard for those two certifications needs customer satisfaction evaluation to be conducted every year. Thus, the Innovation Management Centre (IMC) undertakes improvement action to harmonise and coordinate the formulation of questionnaires in Nuclear Malaysia based on data analysis for 2009. The newly developed questionnaire that applies to all processes and laboratories that have received or awaiting certification have value addition in terms of analytical methods that are more concise, precise, simple and focus on effective action plan to enhance customer satisfaction. Methods such as Importance-Performance Analysis (IPA), Customer Satisfaction Index (CSI) and Service Quality Dimension (SERVQUAL) will be used in this research. (author)

ANSI-ASQ National Accreditation Board /ACLASS

Science.gov (United States)

2011-03-28

unclassified c. THIS PAGE unclassified Standard Form 298 (Rev. 8-98) Prescribed by ANSI Std Z39-18  Laboratories – ISO / IEC 17025  Inspection...Bodies – ISO / IEC 17020  RMPs – ISO Guide 34 (Reference Materials)  PT Providers – ISO 17043  Product Certifiers – ISO Guide 65  Government...Programs: DoD ELAP, EPA Energy Star, CPSC Toy Safety, NRC, NIST IPV6, NLLAP, NEFAP  TRAINING Programs  Certification Bodies – ISO / IEC 17021

Practice for characterization and performance of a high-dose radiation dosimetry calibration laboratory

International Nuclear Information System (INIS)

2003-01-01

This practice addresses the specific requirements for laboratories engaged in dosimetry calibrations involving ionizing radiation, namely, gamma-radiation, electron beams or X-radiation (bremsstrahlung) beams. It specifically describes the requirements for the characterization and performance criteria to be met by a high-dose radiation dosimetry calibration laboratory. The absorbed-dose range is typically between 10 and 10 5 Gy. This practice addresses criteria for laboratories seeking accreditation for performing high-dose dosimetry calibrations, and is a supplement to the general requirements described in ISO/IEC 17025. By meeting these criteria and those in ISO/IEC 17025, the laboratory may be accredited by a recognized accreditation organization. Adherence to these criteria will help to ensure high standards of performance and instill confidence regarding the competency of the accredited laboratory with respect to the services it offers

Interlaboratory comparison and accreditation in quality control testing of diagnostic X-ray equipment

International Nuclear Information System (INIS)

Kepler, K.; Vladimirov, A.; Servomaa, A.

2005-01-01

The Univ. of Tartu provides a quality control service to the majority of diagnostic X-ray departments in Estonia. Its methodology has been adopted from the IEC and other relevant standards. Recently the Testing Centre of the Univ. of Tartu was accredited on this methodology by ISO/IEC 17025. Besides the implementation of the quality management system, participation in interlaboratory comparison (ILC) was one of the prerequisites for the accreditation. Tests for estimating reproducibility of tube voltage and dose rate, accuracy of the voltage and accuracy of exposure time were carried out on a diagnostic X-ray unit in the Radiation and Nuclear Safety Authority in Helsinki. The measurement performance was judged by calculating deviation En normalised with respect to the stated uncertainties. En values for all tests were less than unity and by the common ILC criteria the testing performance could be considered as acceptable. (authors)

Role and Evaluation of Interlaboratory Comparison Results in Laboratory Accreditation

Science.gov (United States)

Bode, P.

2008-08-01

Participation in interlaboratory comparisons provides laboratories an opportunity for independent assessment of their analytical performance, both in absolute way and in comparison with those by other techniques. However, such comparisons are hindered by differences in the way laboratories participate, e.g. at best measurement capability or under routine conditions. Neutron activation analysis laboratories, determining total mass fractions, often see themselves classified as `outliers' since the majority of other participants employ techniques with incomplete digestion methods. These considerations are discussed in relation to the way results from interlaboratory comparisons are evaluated by accreditation bodies following the requirements of Clause 5.9.1 of the ISO/IEC 17025:2005. The discussion and conclusions come largely forth from experiences in the author's own laboratory.

Microanálisis de la aplicación de nch-iso 17025. of 2001 y estimación de la incertidumbre de las mediciones en un laboratorio de la Universidad del Bío-Bío

Directory of Open Access Journals (Sweden)

Hernán Arias Muñoz

2004-07-01

Full Text Available La NCh-ISO 17025. Of 2001, Requisitos generales para la competencia de los laboratorios de ensayo y calibración, especifica los requisitos generales y establece la competencia para efectuar ensayos y/o calibraciones, incluyendo muestreo. Comprende ensayos y calibraciones efectuados usando métodos  normalizados, métodos no normalizados y métodos desarrollados por el laboratorio. Es aplicable a todos los laboratorios, independiente de la cantidad de personal o la extensión del alcance de las actividades. La acreditación es un procedimiento mediante el cual, en interés de la sociedad, un organismo autorizado como el Instituto Nacional de Normalización, INN,  evalúa y declara formalmente la competencia técnica de un organismo evaluador de la conformidad (laboratorio para llevar a cabo tareas específicas en base a una normativa, como la NCh-ISO 17025. Of 2001. El objetivo de la acreditación es aumentar la confianza que la sociedad tiene en la información que proporcionan los organismos evaluadores de la conformidad o calidad (laboratorios. La NCh-ISO 17025. Of 2001 contiene dos grandes áreas, entre otras, una parte que especifica los requisitos de gestión y otra que indica la competencia técnica para el tipo de ensayos y/o calibraciones que los laboratorios realicen.  En  los requisitos técnicos, el que acarrea mayor complejidad en la práctica corresponde a la Estimación de la incertidumbre de las mediciones. El Laboratorio de Ciencias de la Construcción, perteneciente a la Universidad del Bío-Bío, funciona como organismo evaluador de la conformidad (laboratorio de ensayos. Con la finalidad de demostrar competencia al respecto, el laboratorio mantiene un proyecto que lo relaciona directamente con la NCh-ISO 17025. Of 2001 a través de uno de los requisitos técnicos de esta normativa, la Estimación de la incertidumbre de las mediciones. La  estimación de la incertidumbre de las mediciones es posible de enfrentar

Handbook of quality management according to the regulation DIN EN ISO/IEC 17025 for the national EU reference laboratory or air quality at the Federal Office for Environmental Protection. State of the art: September 2009; Qualitaetsmanagement-Handbuch nach DIN EN ISO/IEC 17025 fuer das Nationale EU-Referenzlabor fuer Luftqualitaet im Umweltbundesamt. Stand September 2009

Energy Technology Data Exchange (ETDEWEB)

Medem, Anneliese (comp.)

2010-01-15

The past quality management manual of the national EU reference laboratory for air quality completely was revised. The new quality management manual under consideration contains a determination of the following aspects: Organisation of construction processing, fundamental regulations of the management system concerning to quality, statements to the quality politics, paramount goals. The presented quality management system is regarded to all elements of the regulation DIN EN ISO/IEC 17025:2005 with consideration of the special requirements of the national European Union reference laboratory for air quality in the Federal Office for Environment Protection (Dessau-Rosslau, Federal Republic of Germany).

The most common nonconformities encountered during the assessments of medical laboratories in Hong Kong using ISO 15189 as accreditation criteria.

Science.gov (United States)

Ho, Bella; Ho, Eric

2012-01-01

ISO 15189 was a new standard published in 2003 for accrediting medical laboratories. We believe that some requirements of the ISO 15189 standard are especially difficult to meet for majority of laboratories. The aim of this article was to present the frequency of nonconformities to requirements of the ISO 15189 accreditation standard, encountered during the assessments of medical laboratories in Hong Kong, during 2004 to 2009. Nonconformities reported in assessments based on ISO 15189 were analyzed in two periods - from 2004 to 2006 and in 2009. They are categorized according to the ISO 15189 clause numbers. The performance of 27 laboratories initially assessed between 2004 and 2006 was compared to their performance in the second reassessment in 2009. For management requirements, nonconformities were most frequently reported against quality management system, quality and technical records and document control; whereas for technical requirements, they were reported against examination procedures, equipment, and assuring quality of examination procedures. There was no major difference in types of common nonconformities reported in the two study periods. The total number of nonconformities reported in the second reassessment of 27 laboratories in 2009 was almost halved compared to their initial assessments. The number of significant nonconformities per laboratory significantly decreased (P = 0.023). Similar nonconformities were reported in the two study periods though the frequency encountered decreased. The significant decrease in number of significant nonconformities encountered in the same group of laboratories in the two periods substantiated that 15015189 contributed to quality improvement of accredited laboratories.

International Organization for Standardization (ISO) 15189.

Science.gov (United States)

Schneider, Frank; Maurer, Caroline; Friedberg, Richard C

2017-09-01

The College of American Pathologists (CAP) offers a suite of laboratory accreditation programs, including one specific to accreditation to the international organization for standardization (ISO) 15189 standard for quality management specific to medical laboratories. CAP leaders offer an overview of ISO 15189 including its components, internal audits, occurrence management, document control, and risk management. The authors provide a comparison of its own ISO 15189 program, CAP 15189, to the CAP Laboratory Accreditation Program. The authors conclude with why laboratories should use ISO 15189. © The Korean Society for Laboratory Medicine.

A simple method for validation and verification of pipettes mounted on automated liquid handlers

DEFF Research Database (Denmark)

Stangegaard, Michael; Hansen, Anders Johannes; Frøslev, Tobias Guldberg

 We have implemented a simple method for validation and verification of the performance of pipettes mounted on automated liquid handlers as necessary for laboratories accredited under ISO 17025. An 8-step serial dilution of Orange G was prepared in quadruplicates in a flat bottom 96-well microtit...... available. In conclusion, we have set up a simple solution for the continuous validation of automated liquid handlers used for accredited work. The method is cheap, simple and easy to use for aqueous solutions but requires a spectrophotometer that can read microtiter plates....... We have implemented a simple method for validation and verification of the performance of pipettes mounted on automated liquid handlers as necessary for laboratories accredited under ISO 17025. An 8-step serial dilution of Orange G was prepared in quadruplicates in a flat bottom 96-well microtiter...

Attaining ISO 15189 accreditation through SLMTA: A journey by Kenya’s National HIV Reference Laboratory

Directory of Open Access Journals (Sweden)

Thomas Gachuki

2014-11-01

Objectives: This study chronicles the journey that NHRL took in pursuit of accreditation, along with the challenges and lessons learned. Methods: NHRL participated in the Strengthening Laboratory Management Toward Accreditation (SLMTA programme from 2010–2011. Improvement projects were undertaken to address gaps in the 12 quality system essentials through development of work plans, team formation, training and mentorship of personnel. Audits were conducted and the scores used to track progress along a five-star grading scale. Standard quality indicators (turn-around time, specimen rejection rates and service interruptions were measured. Costs of improvement projects and accreditation were estimated based on expenditures. Results: NHRL scored 45% (zero stars at baseline in March 2010 and 95% (five stars after programme completion in October 2011; in 2013 it became the first public health laboratory in Kenya to attain ISO 15189 accreditation. From 2010–2013, turn-around times decreased by 50% – 95%, specimen rejections decreased by 93% and service interruptions dropped from 15 to zero days. Laboratory expenditures associated with achieving accreditation were approximately US $36 500. Conclusion: International accreditation is achievable through SLMTA, even for a laboratory with limited initial quality management systems. Key success factors were dedication to a shared goal, leadership commitment, team formation and effective mentorship. Countries wishing to achieve accreditation must ensure adequate funding and support.

LEVANTAMENTO PARA IMPLANTAÇÃO DE UM SISTEMA DE GESTÃO DA QUALIDADE SEGUNDO A NORMA NBR ISO/IEC 17025:2005 NO LABORATÓRIO DE CELULOSE E PAPEL DA UNESP-ITAPEVA

Directory of Open Access Journals (Sweden)

Bruno BATAGIN

2013-11-01

Full Text Available O objetivo desse trabalho é realizar um diagnóstico situacional do Laboratório de celulose e papel da UNESP- ITAPEVA para realização de proposta de acreditação de acordo com a NBR ISO/IEC 17025:2005. A NBR ISO/IEC 17025 estabelece os critérios para aqueles laboratórios que desejem demonstrar sua competência técnica, que possuem um sistema da qualidade efetivo e que são capazes de produzir resultados tecnicamente válidos, estabelecendo um padrão internacional e único para atestar a competência dos laboratórios para realizarem ensaios e/ou calibrações, incluindo amostragem. O estudo de caso foi realizado no laboratório de Celulose e Papel da Universidade Estadual Paulista (UNESP, campus de Itapeva, onde foram comparadas as visões do técnico responsável pelo laboratório e um usuário comum. A conclusão gerada é que o laboratório não tem condições de iniciar um processo de acreditação porque falha nos requisitos, como manual da qualidade, cadastro dos subcontratados, pesquisa de satisfação dos clientes, cronograma da realização das auditorias internas, cronograma de realização da análise crítica, perfil das funções requeridas, descrição das funções atuais, documentação dos requisitos técnicos para as acomodações e condições ambientais, programas de calibração, programa de calibração dos equipamentos, programa para calibração dos padrões e relatório e/ou certificado de ensaio e/ou calibração, que são de acordo com a NBR ISO/IEC 17025:2005, além de que não há a possibilidade de desenvolver e implantar um sistema de qualidade sem o comprometimento de todas as pessoas envolvidas, independente de hierarquia funcional. 

47 CFR 2.962 - Requirements for Telecommunication Certification Bodies.

Science.gov (United States)

2010-10-01

... well as compliance with applicable parts of the ISO/IEC Standard 17025 and Guide 65, shall be taken...) The certification system shall be based on type testing as identified in sub-clause 1.2(a) of ISO/IEC... accreditation, meet all the appropriate specifications in ISO/IEC Guide 65 for the scope of equipment it will...

San Juan District Laboratory (SJN)

Data.gov (United States)

Federal Laboratory Consortium — Program CapabilitiesSJN-DO Pharmaceutical Laboratory is an A2LA/ISO/IEC 17025 accredited National Servicing Laboratory specialized in Drug Analysis, is a member of...

A Decade of Experience in Implementing Quality Management System at Radiochemistry and Environmental Laboratory (RAS)

International Nuclear Information System (INIS)

Norfaizal Mohamed; Nita Salina Abu Bakar; Zal U'yun Wan Mahmood; Wo, Y.M.; Abdul Kadir Ishak; Nurrul Assyikeen Md Jaffary; Noor Fadzilah Yusof

2016-01-01

Quality management system has been introduced to a few laboratories in the Malaysian Nuclear Agency (Nuclear Malaysia) for the purpose to enhance the delivery of quality services to customers. Radiochemistry and Environmental Laboratory (RAS) is a service center in Nuclear Malaysia has implemented a quality management system in procedures carried out and has obtained accreditation for MS ISO/ IEC 17025 since 8 December 2005. This paper is intended to share experiences RAS in implementing a quality management system in accordance with standard MS ISO/ IEC 17025 accreditation and managed to keep it to this day. In addition, the RAS achievements including issues and challenges in implementing the quality management system in the past 10 years will also be discussed. (author)

(Re)implantation of quality system of LCR (Laboratory for Radiation Sciences) for accreditation in the standard ABNT NBR ISO/IEC 17025:2005; (Re)implantacao do sistema da qualidade do LCR para acreditacao na ABNT NBR ISO/IEC 17025:2005

Energy Technology Data Exchange (ETDEWEB)

Leite, Sandro P., E-mail: leite_sp@ig.com.br [Rede Sibratec, Sao Paulo, SP (Brazil); Fernandes, Elisabeth O.; David, Mariano G.; Pires, Evandro J.; Alves, Carlos F.E.; Almeida, Carlos E. [Universidade do Estado do Rio de Janeiro (UERJ), RJ (Brazil)

2014-07-01

This paper presents preparing procedure of the metrology laboratory (LABMETRO), which belongs Laboratorio de Ciencias Radiologicas of Rio de Janeiro , for postulating accreditation of its services metrology to INMETRO. This process, supported by the Technological Services Network SIBRATEC/FINEP for Radiation Protection and Dosimetry Technological Services, had as one of its aims to avoid possible technical barriers to the purchase services in the area of ionizing radiation laboratories. Accreditation will also enable the integration of services such laboratories in Brazilian Calibration Network (RBC). (author)

78 FR 15835 - Requirements Pertaining to Third Party Conformity Assessment Bodies

Science.gov (United States)

2013-03-12

... Electrotechnical Commission (ISO/IEC) 17025(E). The commenter states: By making the accreditation and audit... International Electrotechnical Commission (IEC) Method 62321 ED 1.0 B; but because that method is designed for...

(Re)implantation of quality system of LCR (Laboratory for Radiation Sciences) for accreditation in the standard ABNT NBR ISO/IEC 17025:2005

International Nuclear Information System (INIS)

Leite, Sandro P.; Fernandes, Elisabeth O.; David, Mariano G.; Pires, Evandro J.; Alves, Carlos F.E.; Almeida, Carlos E.

2014-01-01

This paper presents preparing procedure of the metrology laboratory (LABMETRO), which belongs Laboratorio de Ciencias Radiologicas of Rio de Janeiro , for postulating accreditation of its services metrology to INMETRO. This process, supported by the Technological Services Network SIBRATEC/FINEP for Radiation Protection and Dosimetry Technological Services, had as one of its aims to avoid possible technical barriers to the purchase services in the area of ionizing radiation laboratories. Accreditation will also enable the integration of services such laboratories in Brazilian Calibration Network (RBC). (author)

Validation of the alpha spectrometry bio elimination laboratory for measuring activity in excreta; Validacion de la tecnica de espectrometria alfa por el laboratorio de bioeliminacion para la medida de actividad en excretas

Energy Technology Data Exchange (ETDEWEB)

Hernandez Gonzalez, C.; Sierra Bercero, I.; Benito Alonso, P.; Lopez Zarza, C.

2011-07-01

the Laboratory Radiation Dosimetry Service of the CIEMAT is undergoing a process of adapting its working methods and quality assurance to management and technical requirements established in ISO / IEC 17025:2005 with to obtain accreditation shortly ENAC.

Impactos da implantação de um Sistema de Gestão da Qualidade Baseado em Norma ISO na Cultura de Laboratório no Instituto Nacional de Tecnologia – INT

Directory of Open Access Journals (Sweden)

Nilço Mauro da Silva Moura

2012-04-01

Full Text Available This article describes the effects of implementation of ISO IEC ABNT NBR ISO/IEC 17025in the culture laboratory of the National Institute of Technology and examines how thisinfluences their deployment management model. As analytical model, we used the BrazilianCultural Action Model formulated by Barros and Prates (1996. The model reflected all itscomplexity in the four defined positions: concentration of power; position of spectator;personalist; avoid conflict. The main focus of the study was the influence of organizationculture in favor or prejudice to the implementation and maintenance of the Standard, as wellas their consequences in the final results; the field research confirmed the importance ofrelations between the manager and senior management and between the manager and his teamin this effort. We used descriptive study with qualitative approach and strategy case study,using interviews and direct observations. The study subjects were professionals responsiblefor laboratories in INT, with more than ten years of experience in managing laboratories andparticipating in the implementation of ISO 17025.

Development, validation and accreditation of a method for the determination of Pb, Cd, Cu and As in seafood and fish feed samples.

Science.gov (United States)

Psoma, A K; Pasias, I N; Rousis, N I; Barkonikos, K A; Thomaidis, N S

2014-05-15

A rapid, sensitive, accurate and precise method for the determination of Pb, Cd, As and Cu in seafood and fish feed samples by Simultaneous Electrothermal Atomic Absorption Spectrometry was developed in regard to Council Directive 333/2007EC and ISO/IEC 17025 (2005). Different approaches were investigated in order to shorten the analysis time, always taking into account the sensitivity. For method validation, precision (repeatability and reproducibility) and accuracy by addition recovery tests have been assessed as performance criteria. The expanded uncertainties based on the Eurachem/Citac Guidelines were calculated. The method was accredited by the Hellenic Accreditation System and it was applied for an 8 years study in seafood (n=202) and fish feeds (n=275) from the Greek market. The annual and seasonal variation of the elemental content and correlation among the elemental content in fish feeds and the respective fish samples were also accomplished. Copyright © 2013 Elsevier Ltd. All rights reserved.

Implementation of a quality management system at the PHOENIX facility (CryoMaK)

International Nuclear Information System (INIS)

Urbach, Elisabeth; Bagrets, Nadezda; Weiss, Klaus-Peter

2013-01-01

Within a variety of mechanical tests in the Cryogenic Material Test Facility Karlsruhe (CryoMaK) at Karlsruhe Institute of Technology (KIT) the PHOENIX facility was prepared for multiple standard tensile tests in liquid helium, liquid nitrogen and at room temperature. With the multiple specimens holder 10 specimens can be tested within one cool down one after another. A quality management system is needed for ensuring reproducible preconditions. For the guarantee of the competence of the laboratory and the measurement equipment, a quality management system was implemented and prepared for accreditation according to DIN EN ISO/IEC 17025 (ISO 17025). The implementation of a quality management system allows high precision test results included the estimation of measurement uncertainty. This paper gives an overview of the management and technical requirements for the accreditation of the PHOENIX testing facility

Implementation of a quality management system at the PHOENIX facility (CryoMaK)

Energy Technology Data Exchange (ETDEWEB)

Urbach, Elisabeth, E-mail: elisabeth.urbach@kit.edu; Bagrets, Nadezda; Weiss, Klaus-Peter

2013-10-15

Within a variety of mechanical tests in the Cryogenic Material Test Facility Karlsruhe (CryoMaK) at Karlsruhe Institute of Technology (KIT) the PHOENIX facility was prepared for multiple standard tensile tests in liquid helium, liquid nitrogen and at room temperature. With the multiple specimens holder 10 specimens can be tested within one cool down one after another. A quality management system is needed for ensuring reproducible preconditions. For the guarantee of the competence of the laboratory and the measurement equipment, a quality management system was implemented and prepared for accreditation according to DIN EN ISO/IEC 17025 (ISO 17025). The implementation of a quality management system allows high precision test results included the estimation of measurement uncertainty. This paper gives an overview of the management and technical requirements for the accreditation of the PHOENIX testing facility.

A training module for quality management in calibration, maintenance and repair of nuclear instrumentation

International Nuclear Information System (INIS)

2008-01-01

This learning module aims to provide practical guidelines for the organization of work and quality management practice in electronics laboratories in Member States. Nowadays, increased number of customers requires that the products are supplied with quality characteristics that satisfy their needs and expectations. The accelerated development of electronics and instrumentation during the last decades makes the electronics practice a field where competitiveness is ultimately defined by the confidence of the customers, based on their acceptance of the products and services provided. Quality management constitutes a practice encouraging the organizations to analyse customer requirements, to define the processes that contribute to the achievement of a product which is acceptable to the customer, and to keep these processes under control in order to improve the quality of the provided services and to increase customer satisfaction. The contents of this learning module are presented in three independent courses, designed for different level of interest: - Basic advice and recommendations: Practical advice for the organization of work, safety regulations and resource management. - Advanced quality management: Recommendations for the organization of a quality management system (QMS) compliant with ISO 9001 and ISO/IEC 17025 requirements and establishment of good practices. - Pursuing ISO 9001 and ISO/IEC 17025 accreditation: Recommendations for the organization of the QMS, templates of quality manual, operational procedures, records and forms. Customers' needs and expectations are changing, and due to competitive pressures and technological advances suppliers are forced to continually improve their products and services. Although the terms, definitions and concepts provided in this module are taken from the ISO 9000 standard series, the course does not constitute an ISO document as such. The recommendations and guidelines constitute an effort to help the understanding of

External quality assessment programs in the context of ISO 15189 accreditation.

Science.gov (United States)

Sciacovelli, Laura; Secchiero, Sandra; Padoan, Andrea; Plebani, Mario

2018-05-23

Effective management of clinical laboratories participating in external quality assessment schemes (EQAS) is of fundamental importance in ensuring reliable analytical results. The International Standard ISO 15189:2012 requires participation in interlaboratory comparison [e.g. external quality assessment (EQA)] for all tests provided by an individual laboratory. If EQAS is not commercially available, alternative approaches should be identified, although clinical laboratories may find it challenging to choose the EQAS that comply with the international standards and approved guidelines. Great competence is therefore required, as well as knowledge of the characteristics and key elements affecting the reliability of an EQAS, and the analytical quality specifications stated in approved documents. Another skill of fundamental importance is the ability to identify an alternative approach when the available EQAS are inadequate or missing. Yet the choice of the right EQA program alone does not guarantee its effectiveness. In fact, the fundamental steps of analysis of the information provided in EQA reports and the ability to identify improvement actions to be undertaken call for the involvement of all laboratory staff playing a role in the specific activity. The aim of this paper was to describe the critical aspects that EQA providers and laboratory professionals should control in order to guarantee effective EQAS management and compliance with ISO 15189 accreditation requirements.

The importance of having a flexible scope ISO 15189 accreditation and quality specifications based on biological variation – the case of validation of the biochemistry analyzer Dimension Vista

OpenAIRE

Fernandez-Calle, Pilar; Pelaz, Sandra; Oliver, Paloma; Alcaide, Maria Jose; Gomez-Rioja, Ruben; Buno, Antonio; Iturzaeta, Jose Manuel

2013-01-01

Introduction: Technological innovation requires the laboratories to ensure that modifications or incorporations of new techniques do not alter the quality of their results. In an ISO 15189 accredited laboratory, flexible scope accreditation facilitates the inclusion of these changes prior to accreditation body evaluation. A strategy to perform the validation of a biochemistry analyzer in an accredited laboratory having a flexible scope is shown. Materials and methods: A validation procedur...

Importance of pharmaceutical laboratory compliance with international standard requirements in respect of raising their competitiveness

Directory of Open Access Journals (Sweden)

Božanić Vojislav N.

2009-01-01

Full Text Available Current Good Manufacturing Practice (cGMP being a legal regulation in developed countries will become a legal regulation in Republic of Serbia starting with March 2010. In this paper comparative analysis between requirements of standard ISO/IEC 17025 and requirements of cEU GMP is shown. Considering the fact that in Republic of Serbia no pharmaceutical industry laboratory has been accredited according to requirements of ISO/IEC 17025, while keeping in mind that more than 90% of these laboratories have not fulfilled cEU GMP requirements, this paper aimed at pointing to the possibility of fulfilling both of mentioned requirements at the same time, which would open the way to different types of interlaboratory cooperation for pharmaceutical quality control laboratories and contribute to improving competitiveness of pharmaceutical companies. Accreditation, especially in the case of pharmaceutical quality control laboratories, is important because it guaranties the level of organizational and technical competency. It could easily be said that accreditation is becoming a must in quality control of products in order for the organization to be able to gain a leading role in the global market. Both accreditation and cGMP show the organization's commitment to having products of highest quality level. Considering the above mentioned facts, it is of greatest advantage for pharmaceutical quality control laboratories to fulfill both requirements of ISO/IEC 17025 and cGMP and reach total compliance. The aim of doing this lies in an easier acceptance of pharmaceutical products in different markets, overcoming technical barriers and affirmation of quality as key factor in reaching competitiveness, while keeping in mind the importance of strategic and competitive positioning in the global market.

78 FR 50328 - Safety Standard for Play Yards

Science.gov (United States)

2013-08-19

... following conditions are met: At the time of testing, the product was tested by a laboratory that was ISO/IEC 17025:2005(E) accredited by an ILAC-MRA member at the time of the test. At the time of testing...

Readecuación del laboratorío para análisis de materiales metalicos bajo la norma de calidad ISO 17025 y elaboración del manual de procedimientos basados en norma astm

OpenAIRE

Padilla Paredes, Carlos; Paredes V., Cecilia

2009-01-01

Este trabajo se fundamenta en la propuesta de un proyecto que consiste en desarrollar la readecuación del Laboratorio de Materiales - Área de Ensayos Metalográficos de la FIMCP bajo lineamientos de la norma ISO 17025. Para esto, se realizará una descripción clara del manejo y las características de cada uno de los equipos e instrumentos a utilizarse en el mencionado laboratorio, el cual nos permitirá complementar de manera práctica tanto la parte didáctica el estudio de los materiales ...

Harmonised procedures for producing new data on the nutritional composition of ethnic foods

DEFF Research Database (Denmark)

Khokhar, S.; Gilbert, P.A.; Moyle, C.W.A.

2009-01-01

procedures of the foods were employed. The most important nutrients were prioritised and analysed by selected accredited laboratories. The analytical methods selected were appropriate to fulfil the requirements of the resulting data. Quality assurance measures (ISO 17025, CRMs, IQC) were in place...

Challenges in the implementation of a quality management system applied to radiometric analysis

Energy Technology Data Exchange (ETDEWEB)

Dias, Danila C.S.; Bonifacio, Rodrigo L.; Nascimento, Marcos R.L.; Silva, Nivaldo C. da; Taddei, Maria Helena T., E-mail: danilacdias@gmail.com [Comissao Nacional de Energia Nuclear (LAPOC/CNEN-MG), Pocos de Caldas, MG (Brazil). Laboratorio de Pocos de Caldas

2015-07-01

The concept of quality in laboratories has been well established as an essential factor in the search for reliable results. Since its first version published (1999), the ISO/IEC 17025 has been applied in the industrial and research fields, in a wide range of laboratorial analyses. However, the implementation of a Quality Management System still poses great challenges to institutions and companies. The purpose of this work is to expose the constraints related to the implementation of ISO/IEC 17025 applied to analytical assays of radionuclides, accomplished by studying the case of the Pocos de Caldas Laboratory of the Brazilian Commission for Nuclear Energy. In this lab, a project of accreditation of techniques involving determination of radionuclides in water, soil, sediment and food samples has been conducted since 2011. The challenges presented by this project arise from the administrative view, where the governmental nature of the institution translates into unlevelled availability resources and the organizational view, whereas QMS requires inevitable changes in the organizational culture. It is important to point out that when it comes to accreditation of analysis involving radioactive elements, many aspects must be treated carefully due to the their very particular nature. Among these concerns are the determination of analysis uncertainties, accessibility to international proficiency studies, international radioactive samples and CRM transportation, the study of parameters on the validation of analytical methods and the lack of documentation and specialized personnel regarding quality at radiometric measurements. Through an effective management system, the institution is overcoming these challenges, moving toward the ISO/IEC 17025 accreditation. (author)

Valid methods: the quality assurance of test method development, validation, approval, and transfer for veterinary testing laboratories.

Science.gov (United States)

Wiegers, Ann L

2003-07-01

Third-party accreditation is a valuable tool to demonstrate a laboratory's competence to conduct testing. Accreditation, internationally and in the United States, has been discussed previously. However, accreditation is only I part of establishing data credibility. A validated test method is the first component of a valid measurement system. Validation is defined as confirmation by examination and the provision of objective evidence that the particular requirements for a specific intended use are fulfilled. The international and national standard ISO/IEC 17025 recognizes the importance of validated methods and requires that laboratory-developed methods or methods adopted by the laboratory be appropriate for the intended use. Validated methods are therefore required and their use agreed to by the client (i.e., end users of the test results such as veterinarians, animal health programs, and owners). ISO/IEC 17025 also requires that the introduction of methods developed by the laboratory for its own use be a planned activity conducted by qualified personnel with adequate resources. This article discusses considerations and recommendations for the conduct of veterinary diagnostic test method development, validation, evaluation, approval, and transfer to the user laboratory in the ISO/IEC 17025 environment. These recommendations are based on those of nationally and internationally accepted standards and guidelines, as well as those of reputable and experienced technical bodies. They are also based on the author's experience in the evaluation of method development and transfer projects, validation data, and the implementation of quality management systems in the area of method development.

Challenges in the implementation of a quality management system applied to radiometric analysis

International Nuclear Information System (INIS)

Dias, Danila C.S.; Bonifacio, Rodrigo L.; Nascimento, Marcos R.L.; Silva, Nivaldo C. da; Taddei, Maria Helena T.

2015-01-01

The concept of quality in laboratories has been well established as an essential factor in the search for reliable results. Since its first version published (1999), the ISO/IEC 17025 has been applied in the industrial and research fields, in a wide range of laboratorial analyses. However, the implementation of a Quality Management System still poses great challenges to institutions and companies. The purpose of this work is to expose the constraints related to the implementation of ISO/IEC 17025 applied to analytical assays of radionuclides, accomplished by studying the case of the Pocos de Caldas Laboratory of the Brazilian Commission for Nuclear Energy. In this lab, a project of accreditation of techniques involving determination of radionuclides in water, soil, sediment and food samples has been conducted since 2011. The challenges presented by this project arise from the administrative view, where the governmental nature of the institution translates into unlevelled availability resources and the organizational view, whereas QMS requires inevitable changes in the organizational culture. It is important to point out that when it comes to accreditation of analysis involving radioactive elements, many aspects must be treated carefully due to the their very particular nature. Among these concerns are the determination of analysis uncertainties, accessibility to international proficiency studies, international radioactive samples and CRM transportation, the study of parameters on the validation of analytical methods and the lack of documentation and specialized personnel regarding quality at radiometric measurements. Through an effective management system, the institution is overcoming these challenges, moving toward the ISO/IEC 17025 accreditation. (author)

Importance of the Primary Radioactivity Standard Laboratory and Implementation of its Quality Management

Science.gov (United States)

Sahagia, Maria; Razdolescu, Anamaria Cristina; Luca, Aurelian; Ivan, Constantin

2007-04-01

The paper presents some specific aspects of the implementation of the quality management in the Radionuclide Metrology Laboratory, from IFIN-HH, the owner of the primary Romanian standard in radioactivity. The description of the accreditation, according to the EN ISO/IEC 17025:2005, is presented.

Importance of the Primary Radioactivity Standard Laboratory and Implementation of its Quality Management

International Nuclear Information System (INIS)

Sahagia, Maria; Razdolescu, Anamaria Cristina; Luca, Aurelian; Ivan, Constantin

2007-01-01

The paper presents some specific aspects of the implementation of the quality management in the Radionuclide Metrology Laboratory, from IFIN-HH, the owner of the primary Romanian standard in radioactivity. The description of the accreditation, according to the EN ISO/IEC 17025:2005, is presented

CNEN, IAEA and ISO normative requirements for measurement management

International Nuclear Information System (INIS)

Kibrit, Eduardo

2009-01-01

International standard ISO 10012:2003 establishes requirements for measurement management systems, including requirements for measurement processes and measuring equipment. ISO 9001:2008 presents requirements for quality management systems, including requirements for the control of monitoring and measuring equipment. ISO 17025:2005 presents general requirements for the competence of testing and calibration laboratories. In the nuclear field the requirements for measurement management are established by standards published by the International Atomic Energy Agency (IAEA), and in Brazil, by the National Nuclear Energy Commission (CNEN). The present paper presents and discusses the normative requirements for measurement management, considering requirements established by National Nuclear Energy Commission (CNEN), International Atomic Energy Agency (IAEA), and International Organisation for Standardisation (ISO). (author)

Lean-Agile Adaptations in Clinical Laboratory Accredited ISO 15189

Directory of Open Access Journals (Sweden)

Carlos Vilaplana Pérez

2015-12-01

Full Text Available It’s introduced Lean techniques in a Clinical Laboratory to improve the operability and the efficiency in continuous processes of analysis, failsafe systems, analysis of areas of value pursuit of zero defects and reduction of waste, and it promote continuous improvement in presented difficulties in adapting to the changing needs of the healthcare environment. Whereas it is necessary to incorporate certification and accreditation, note that the adaptability of the clinical laboratory to the changing needs of physicians in obtaining analytical information is reduced. The application of an agile methodology on analytical systems can provide a line of work that allows the incorporation of planning short work cycles on equips quickly with operational autonomy on the basis of demand and respecting the accreditation requirements and flexibility to ensure adequate performance as the intercomparison of results from the different units analytics, analytical quality and turnaround times. Between 2012 and 2014, a process of analysis and improvement was applied to circuits, a 5 s system, transportation of samples, inventory of reactive and samples, motion of personal and samples, reductions of waiting and delays, overproduction, over processing, and defects of results and reports. At last it seems necessary to apply the Agile methodology to adapt to the evolving necessities in time and the different origins of the samples. It’s have used modular systems where the modules of this study are programmed with immunoassay techniques and it has reduced the operative modules depending on the required activity, ensuring the goals of turnaround times, analytic quality, service, health care continuity, and keeping up with the ISO 15189 accreditation requirements. The results of applying the concept of Lean-Agile to a modular system allows us to reduce the associated costs to the seasonal variation of the health care demand and to adapt the system to the changes on

Components of laboratory accreditation.

Science.gov (United States)

Royal, P D

1995-12-01

Accreditation or certification is a recognition given to an operation or product that has been evaluated against a standard; be it regulatory or voluntary. The purpose of accreditation is to provide the consumer with a level of confidence in the quality of operation (process) and the product of an organization. Environmental Protection Agency/OCM has proposed the development of an accreditation program under National Environmental Laboratory Accreditation Program for Good Laboratory Practice (GLP) laboratories as a supplement to the current program. This proposal was the result of the Inspector General Office reports that identified weaknesses in the current operation. Several accreditation programs can be evaluated and common components identified when proposing a structure for accrediting a GLP system. An understanding of these components is useful in building that structure. Internationally accepted accreditation programs provide a template for building a U.S. GLP accreditation program. This presentation will discuss the traditional structure of accreditation as presented in the Organization of Economic Cooperative Development/GLP program, ISO-9000 Accreditation and ISO/IEC Guide 25 Standard, and the Canadian Association for Environmental Analytical Laboratories, which has a biological component. Most accreditation programs are managed by a recognized third party, either privately or with government oversight. Common components often include a formal review of required credentials to evaluate organizational structure, a site visit to evaluate the facility, and a performance evaluation to assess technical competence. Laboratory performance is measured against written standards and scored. A formal report is then sent to the laboratory indicating accreditation status. Usually, there is a scheduled reevaluation built into the program. Fee structures vary considerably and will need to be examined closely when building a GLP program.

INTEGRATED MANAGEMENT SYSTEMS IN LOCAL PUBLIC ENTERPRIZE FOR PRODUCTION, DISTRIBUTION AND CLEANING OF WASTED WATER

Directory of Open Access Journals (Sweden)

Slavko Arsovski

2007-06-01

Full Text Available Appearance of large number of management systems, with different and sometimes divergent demands, needs reconsideration of their implementation strategies and their integration in one integrated management system (IMS. So defined IMS would be designed and implemented in different areas. In this paper is presented basic concept of integration of partical management systems in areas of quality (ISO 9001, environmental protection (ISO 14001, occupational health (ISO 18001, food safety (ISO 22000 and accreditation of laboratories (ISO17025/ISO17020. As a pilot organization is choosed local public enterprise for production, supply and drain of water.

A journey to accreditation: is ISO 15189 laboratory accreditation ...

African Journals Online (AJOL)

Through this journey we comprehend that the first step before accreditation is building enthusiastic team with education on quality management system. Other steps include selection of methods, developing or improving the metrology system, definition and structure of documents, preparation of a quality manual, SOPs, ...

Accreditation of a screening method for non-dioxin-like polychlorinated biphenyl detection in fishery products according to European legislation.

Science.gov (United States)

Serpe, F P; Russo, R; Ambrosio, L; Esposito, M; Severino, L

2013-06-01

European Commission Regulation 882/2004/EC requires that official control laboratories for foodstuffs in the member states are certified according to UNI EN ISO/IEC 17025:2005 (general requirement for the competence of calibration and testing laboratories). This mandatory requirement has resulted in a continuous adaptation and development of analytical procedures. The aim of this study was to develop a method for semiquantitative screening of polychlorinated biphenyls in fish for human consumption. According to the Commission Decision 657/2002/CE, the detection capability, the precision, the selectivity-specificity, and applicability-ruggedness-stability were determined to validate the method. Moreover, trueness was verified. This procedure resulted in rapid execution, which allowed immediate and effective intervention by the local health authorities to protect the health of consumers. Finally, the procedure has been recognized by the Italian accrediting body, ACCREDIA.

Quality control of achieved results of testings in interlaboratory reference measurements

International Nuclear Information System (INIS)

Rosskopfova, O.; Matel, L.; Rajec, P.

2009-01-01

The laboratory accredited according to the ISO/IEC 17025:2005 must ensure the quality of reported results including corresponding uncertainty. The important point of view of correct evaluation of results is precision and uncertainty. The validation of a method is an experimental verification and an objective proof that the method is suitable for planned application. The most frequent way of validation is a participation in an intercomparison test. LARCHA laboratory regularly participates in the proficiency tests on the determination of gamma, beta and alpha emitting radionuclides in various matrices. It is also a proof for the laboratory and client that the methods for radionuclides determination are validated according to the rules of ISO/IEC 17025:2005. (authors)

Papers of Scientific Technical Seminar on Materials Investigation for Power Industry

International Nuclear Information System (INIS)

2001-01-01

The report is an assembly of the papers concerning steel quality required during the exploitation of power station and gas pipelines. The new law of technical inspection and the changes in the prescription concerning accreditation process as results of PN-EN ISO/IEC 17025 are also discussed. (author)

Update on the Activities of The NELAC Institute (TNI)

Science.gov (United States)

2012-03-28

IEC 17025 :2005  How to Manage an Effective Quality Management System TNI Cooperative Agreements with EPA Former (2006 – 2010)  $400,000 for...Correct Use of Standard Methods  Accreditation Demonstrates Competency for Field Activities  Getting Ready for NEFAP  A Practical Foundation in ISO

Quality system implementation for nuclear analytical techniques

International Nuclear Information System (INIS)

2004-01-01

The international effort (UNIDO, ILAC, BIPM, etc.) to establish a functional infrastructure for metrology and accreditation in many developing countries needs to be complemented by assistance to implement high quality practices and high quality output by service providers and producers in the respective countries. Knowledge of how to approach QA systems that justify a formal accreditation is available in only a few countries and the dissemination of know how and development of skills is needed bottom up from the working level of laboratories and institutes. Awareness building, convincing of management, introduction of good management practices, technical expertise and good documentation will lead to the creation of a quality culture that assures a sustainability and inherent development of quality practices as a prerequisite of economic success. Quality assurance and quality control can be used as a valuable management tool and is a prerequisite for international trade and information exchange. This publication tries to assist quality managers, Laboratory Managers and staff involved in setting up a QA/QC system in a nuclear analytical laboratory to take appropriate action to start and complete the necessary steps for a successful quality system for ultimate national accreditation. This guidebook contributes to a better understanding of the basic ideas behind ISO/IEC 17025, the international standard for 'General requirements for the competence of testing and calibration laboratories'. It provides basic information and detailed explanation about the establishment of the QC system in analytical and nuclear analytical laboratories. It is a proper training material for training of trainers and makes managers with QC management and implementation familiar. This training material aims to facilitate the implementation of internationally accepted quality principles and to promote attempts by Member States' laboratories to obtain accreditation for nuclear analytical

[Determining biomedical equipment calibration in health care Institutions in the Risaralda Department of Colombia].

Science.gov (United States)

López-Isaza, Giovanni A; Llamosa-Rincón, Luis E

2008-01-01

Determining quality features related to tracking biomedical equipment calibration patterns and their electrical safety as implemented by Health Care Institutions in the Risaralda department. This was a descriptive study using non-probabilistic sampling and the criterion of a greater equipment inventory and service demand for Clinics, Aesthetic, Radiology and Dentistry Centres and Hospitals. Census; the instrument was applied to 32 health-care institutions distributed throughout the Risaralda departments 14 municipalities between September 2005 and January 2006. Hospitals was the category having a highest number of electro-medical equipment (56%). Pereira (the capital of Risaralda) had 81% of all electro-medical equipment. All the institutions lacked NTC-ISO-IEC-17025 accreditation regarding standards certified by the Superintendence of Industry and Commerce. None of the institutions externally contracted by the institutions being surveyed was accredited. There is a public health risk in the Risaralda department; all health-care institutions lacked NTC-ISO-IEC-17025 accreditation and external institutions (in turn being hired by them for calibrating their equipment) also lacked accreditation. Based on the information obtained from non-calibrated equipment having international patterns, there is a great danger that determining the quality of biomedical equipment calibration patterns may be erroneous. It also places health-care institutions at a competitive disadvantage when compared to other accredited institutions in Colombia or in other countries.

Implementation of ISO guide 25 in a medical dosimetry secondary standards calibration laboratory

International Nuclear Information System (INIS)

DeWerd, L.A.

1995-01-01

Currently, there is a great deal of discussion among industry and government agencies about ISO 9000 accreditation. U.S. manufacturers with ISO 9000 accreditation are regarded more favorably by European countries. The principles behind the ISO 9000 accreditation are based on the Total Quality Management (TQM) principles that are being implemented in many U.S. industries. This paper will deal only with the calibration issue. There is a difference in the areas covered by ISO 9000 and ISO Guide 25 documents. ISO 9000, in particular ISO 9001 - ISO 9003, cover the open-quotes calibrationclose quotes of inspection, measuring and test equipment. This equipment is basically used for open-quotes factory calibrationsclose quotes to determine that equipment is performing within manufacturer specifications. ISO Guide 25 is specifically for open-quotes calibration and testing laboratories,close quotes generally laboratories that have painstaking procedures to reduce uncertainties and establish high accuracy of the transfer of calibration. The experience of the University of Wisconsin Accredited Dosimetry Calibration Laboratory in conforming to ISO Guide 25 will be outlined. The entire laboratory staff must become familiar with the process and an individual with direct authority must become the one to maintain the quality of equipment and calibrations in the role of open-quotes quality-assurance manager.close quotes

Evaluation of a fungal collection as certified reference material producer and as a biological resource center

Directory of Open Access Journals (Sweden)

Tatiana Forti

2016-06-01

Full Text Available Abstract Considering the absence of standards for culture collections and more specifically for biological resource centers in the world, in addition to the absence of certified biological material in Brazil, this study aimed to evaluate a Fungal Collection from Fiocruz, as a producer of certified reference material and as Biological Resource Center (BRC. For this evaluation, a checklist based on the requirements of ABNT ISO GUIA34:2012 correlated with the ABNT NBR ISO/IEC17025:2005, was designed and applied. Complementing the implementation of the checklist, an internal audit was performed. An evaluation of this Collection as a BRC was also conducted following the requirements of the NIT-DICLA-061, the Brazilian internal standard from Inmetro, based on ABNT NBR ISO/IEC 17025:2005, ABNT ISO GUIA 34:2012 and OECD Best Practice Guidelines for BRCs. This was the first time that the NIT DICLA-061 was applied in a culture collection during an internal audit. The assessments enabled the proposal for the adequacy of this Collection to assure the implementation of the management system for their future accreditation by Inmetro as a certified reference material producer as well as its future accreditation as a Biological Resource Center according to the NIT-DICLA-061.

Use of Balance Calibration Certificate to Calculate the Errors of Indication and Measurement Uncertainty in Mass Determinations Performed in Medical Laboratories

Directory of Open Access Journals (Sweden)

Adriana VÂLCU

2011-09-01

Full Text Available Based on the reference document, the article proposes the way to calculate the errors of indication and associated measurement uncertainties, by resorting to the general information provided by the calibration certificate of a balance (non-automatic weighing instruments, shortly NAWI used in medical field. The paper may be also considered a useful guideline for: operators working in laboratories accredited in medical (or other various fields where the weighing operations are part of their testing activities; test houses, laboratories, or manufacturers using calibrated non-automatic weighing instruments for measurements relevant for the quality of production subject to QM requirements (e.g. ISO 9000 series, ISO 10012, ISO/IEC 17025; bodies accrediting laboratories; accredited laboratories for the calibration of NAWI. Article refers only to electronic weighing instruments having maximum capacity up to 30 kg. Starting from the results provided by a calibration certificate it is presented an example of calculation.

ISO 14000 : environmental management systems

International Nuclear Information System (INIS)

Boutin, C.; Emard, C.; Lalonde, G.; Levesque, A.; Robitaille, R.; Rollin, A.L.; Thibeault, I.

1996-01-01

This book is addressed to the managers, professionals, and government agents which wish to know the philosophy of the step as well as the stages to be followed for the establishment of a system of environmental management in conformity with the standards of the series ISO 14000. This work locates ISO 14000 in the historical context of its development by describing the bonds with other standards in place of which those of the series ISO 9000. This book answers questions that arise regarding a companies step toward accreditation to ISO 14000

Evaluation of a fungal collection as certified reference material producer and as a biological resource center.

Science.gov (United States)

Forti, Tatiana; Souto, Aline da S S; do Nascimento, Carlos Roberto S; Nishikawa, Marilia M; Hubner, Marise T W; Sabagh, Fernanda P; Temporal, Rosane Maria; Rodrigues, Janaína M; da Silva, Manuela

2016-01-01

Considering the absence of standards for culture collections and more specifically for biological resource centers in the world, in addition to the absence of certified biological material in Brazil, this study aimed to evaluate a Fungal Collection from Fiocruz, as a producer of certified reference material and as Biological Resource Center (BRC). For this evaluation, a checklist based on the requirements of ABNT ISO GUIA34:2012 correlated with the ABNT NBR ISO/IEC17025:2005, was designed and applied. Complementing the implementation of the checklist, an internal audit was performed. An evaluation of this Collection as a BRC was also conducted following the requirements of the NIT-DICLA-061, the Brazilian internal standard from Inmetro, based on ABNT NBR ISO/IEC 17025:2005, ABNT ISO GUIA 34:2012 and OECD Best Practice Guidelines for BRCs. This was the first time that the NIT DICLA-061 was applied in a culture collection during an internal audit. The assessments enabled the proposal for the adequacy of this Collection to assure the implementation of the management system for their future accreditation by Inmetro as a certified reference material producer as well as its future accreditation as a Biological Resource Center according to the NIT-DICLA-061. Copyright © 2016 Sociedade Brasileira de Microbiologia. Published by Elsevier Editora Ltda. All rights reserved.

Promoting Strong ISO 50001 Outcomes with Supportive National Infrastructure

Energy Technology Data Exchange (ETDEWEB)

McKane, Aimee, T.; Siciliano, Graziella; de los Reyes, Pamela

2015-08-04

The ISO 50001 standard is a key mechanism for reducing greenhouse gas emissions and improving energy efficiency globally. An increasing number of companies are seeking certification, creating the need for personnel that are competent to conduct ISO 50001 certification audits. The growth of ISO 50001 is expected to accelerate as more companies integrate ISO 50001 into their corporate sustainability strategies and supplier requirements. Robust implementation of ISO 50001 represents an important tool for countries with climate change mitigation goals. Because of its dual focus on continual improvement of an organization’s energy management system (EnMS) and its energy performance improvement, ISO 50001 requires skills of both implementers and certification auditors that are not well-supported by current credentials and training. This paper describes an effort to address skill gaps of certification auditors, a critical factor to ensure that ISO 50001 implementations are robust and result in continued energy performance improvement. A collaboration of governments through the Energy Management Working Group (EMWG), formerly under Global Superior Energy Performance (GSEP), has formed to build workforce capacity for ISO 50001 certification audits. The EMWG is leading the development of an internationally-relevant certification scheme for ISO 50001 Lead Auditor that meets requirements for ISO/IEC 17024 accreditation and ISO 50003 for defining ISO 50001 Lead Auditor competency. Wider availability of competent ISO 50001 Lead Auditors will ultimately increase the impact and market value of ISO 50001 certification and improve consistency of ISO 50001 certification outcomes by establishing a standardized and high level of knowledge and skills globally.

An Overview of Trials´Accreditation and Recognition of Brazilian Tests Used for the Safety Evaluation of Cosmetic Products

Directory of Open Access Journals (Sweden)

Luciana dos Santos Almeida

2016-06-01

Full Text Available For some time, Brazil has been appointed as one of the greatest consumers of cosmetic products in the world. Although cosmetics may seem harmless, destined exclusively to enhance personal appearance or to clean and protect the skin, hair and nails, new studies and events are highlighting the need to evaluate the safety of such products. The present work interrelated the lifecycle of a cosmetic product with the safety trials and tests applicable to some cycle phases. From this information, a survey was made of accredited Conformity Assessment Bodies (CAB and test facilities recognized by the General Coordination for Accreditation (CGCRE which are competent respectively to carry out safety trials and tests of cosmetics. Twenty five competent laboratories were identified to carry out chemical and/or biological trials of cosmetics, according to the legislation ABNT ISO IEC 17025:2005, and 10 test facilities recognized by the Compliance Monitoring Program that can carry out tests of the development of a product for register purposes, aiming at human health and safety. It is interesting to notice that Brazil has accredited laboratories to carry out trials that are critical for the health of the population, such as the levels of heavy metals and the presence of pathogens. On the other hand, CGCRE does not have a program to recognize safety clinical trials. The importance of this kind of study is understood, considering the world history of adverse reactions and the great consumption of cosmetics in the country.

Quality assurance in radionuclide laboratories

International Nuclear Information System (INIS)

Otto, R.; Voelkle, H.; Wershofen, H.; Wilhelm, C.

2003-01-01

The authors are members of an ad-hoc working group preparing a contribution to the procedures manual (''Loseblattsammlung'') dealing with quality assurance and quality control in radionuclide laboratories. The Loseblattsammlung is edited by the working group ''Environmental Monitoring'' of the German-Swiss Radiological Protection Association. The intention of the manual under preparation is not to give a procedure on how to establish a quality management system allowing for an accreditation in accordance with the international standard DIN EN ISO/IEC 17025:2000 04 (''ISO 17025'') [1] but to compile routine quality control procedures necessary for reliable measurements and to give tips to the practitioner on how to keep both the extent and the frequency of procedures on a reasonable level. A short version of the Loseblatt is presented here. (orig.)

Implementation of ISO 28218 quality system in the laboratory of body radioactivity counter CIEMAT

International Nuclear Information System (INIS)

Navarro Amaro, J. F.; Perez Lopez, B.; Lopez Ponte, M. A.; Perez Jimenez, C.

2011-01-01

The laboratory of body radioactivity counter has implemented IS0 28218 standard Performance Criteria for Radio bioassay in all measured in vivo techniques of internal contamination in the human organism in monitoring programs defined by the Personal Dosimetry Service Internal CIEMAT. The application of this rule in the laboratory's quality system is essential to meet the technical requirements of the standard IS0/IEC 17025 with the purpose of obtaining ENAC accreditation as a testing laboratory and calibration within the framework of the accreditation of Service CIEMAT Radiation Dosimetry. (Author)

Using high-performance ¹H NMR (HP-qNMR®) for the certification of organic reference materials under accreditation guidelines--describing the overall process with focus on homogeneity and stability assessment.

Science.gov (United States)

Weber, Michael; Hellriegel, Christine; Rueck, Alexander; Wuethrich, Juerg; Jenks, Peter

2014-05-01

Quantitative NMR spectroscopy (qNMR) is gaining interest across both analytical and industrial research applications and has become an essential tool for the content assignment and quantitative determination of impurities. The key benefits of using qNMR as measurement method for the purity determination of organic molecules are discussed, with emphasis on the ability to establish traceability to "The International System of Units" (SI). The work describes a routine certification procedure from the point of view of a commercial producer of certified reference materials (CRM) under ISO/IEC 17025 and ISO Guide 34 accreditation, that resulted in a set of essential references for (1)H qNMR measurements, and the relevant application data for these substances are given. The overall process includes specific selection criteria, pre-tests, experimental conditions, homogeneity and stability studies. The advantages of an accelerated stability study over the classical stability-test design are shown with respect to shelf-life determination and shipping conditions. Copyright © 2013 The Authors. Published by Elsevier B.V. All rights reserved.

Implementation of ISO 28218 quality system in the laboratory of body radioactivity counter CIEMAT; Implementacion de la norma ISO 28218 en el sistema de calidad del laboratorio del contador de radiactividad corporal del CIEMAT

Energy Technology Data Exchange (ETDEWEB)

Navarro Amaro, J. F.; Perez Lopez, B.; Lopez Ponte, M. A.; Perez Jimenez, C.

2011-07-01

The laboratory of body radioactivity counter has implemented IS0 28218 standard Performance Criteria for Radio bioassay in all measured in vivo techniques of internal contamination in the human organism in monitoring programs defined by the Personal Dosimetry Service Internal CIEMAT. The application of this rule in the laboratory's quality system is essential to meet the technical requirements of the standard IS0/IEC 17025 with the purpose of obtaining ENAC accreditation as a testing laboratory and calibration within the framework of the accreditation of Service CIEMAT Radiation Dosimetry. (Author)

Automated extraction of DNA from reference samples from various types of biological materials on the Qiagen BioRobot EZ1 Workstation

DEFF Research Database (Denmark)

Stangegaard, Michael; Jørgensen, Mads; Hansen, Anders Johannes

2009-01-01

, and muscle biopsies. The DNA extraction was validated according to EN/ISO 17025 for the STR kits AmpFlSTR« Identifiler« and AmpFlSTR« Yfiler« (Applied Biosystems). Of 298 samples extracted, 11 (4%) did not yield acceptable results. In conclusion, we have demonstrated that extraction of DNA from various types......We have validated and implemented a protocol for DNA extraction from various types of biological materials using a Qiagen BioRobot EZ1 Workstation. The sample materials included whole blood, blood from deceased, buccal cells on Omni swabs and FTA Cards, blood on FTA Cards and cotton swabs...... of biological material can be performed quickly and without the use of hazardous chemicals, and that the DNA may be successfully STR typed according to the requirements of forensic genetic investigations accredited according to EN/ISO 17025...

Quality management system in the CIEMAT Radiation Dosimetry Service.

Science.gov (United States)

Martín, R; Navarro, T; Romero, A M; López, M A

2011-03-01

This paper describes the activities realised by the CIEMAT Radiation Dosimetry Service (SDR) for the implementation of a quality management system (QMS) in order to achieve compliance with the requirements of ISO/IEC 17025 and to apply for the accreditation for testing measurements of radiation dose. SDR has decided the accreditation of the service as a whole and not for each of its component laboratories. This makes it necessary to design a QMS common to all, thus ensuring alignment and compliance with standard requirements, and simplifying routine works as possible.

Compressive strength test for cemented waste forms: validation process

International Nuclear Information System (INIS)

Haucz, Maria Judite A.; Candido, Francisco Donizete; Seles, Sandro Rogerio

2007-01-01

In the Cementation Laboratory (LABCIM), of the Development Centre of the Nuclear Technology (CNEN/CDTN-MG), hazardous/radioactive wastes are incorporated in cement, to transform them into monolithic products, preventing or minimizing the contaminant release to the environment. The compressive strength test is important to evaluate the cemented product quality, in which it is determined the compression load necessary to rupture the cemented waste form. In LABCIM a specific procedure was developed to determine the compressive strength of cement waste forms based on the Brazilian Standard NBR 7215. The accreditation of this procedure is essential to assure reproductive and accurate results in the evaluation of these products. To achieve this goal the Laboratory personal implemented technical and administrative improvements in accordance with the NBR ISO/IEC 17025 standard 'General requirements for the competence of testing and calibration laboratories'. As the developed procedure was not a standard one the norm ISO/IEC 17025 requests its validation. There are some methodologies to do that. In this paper it is described the current status of the accreditation project, especially the validation process of the referred procedure and its results. (author)

Guidelines for establishing quality systems in veterinary diagnostic testing laboratories. Report of a Joint FAO/IAEA consultants meeting/workshop. Draft

International Nuclear Information System (INIS)

2002-01-01

The purpose of this report is to assist veterinary testing laboratories to develop and implement a quality system based on the OIE Standard 'Management and Technical Requirements for Laboratories Conducting Tests for Infectious Animal Diseases'. The introduction to the OIE Standard states: This document describes the OIE Standard for management and technical competence that serves as the basis for accreditation of laboratories that conduct tests for infectious animal diseases, especially those laboratories involved in testing for international trade. It contains the specific requirements unique to laboratories conducting tests for infectious animal diseases. These specific requirements represent an interpretation of the generally stated requirements of ISO/IEC 17025:1999, General requirements for the competence of testing and calibration laboratories (as outlined in Annex B of ISO/IEC 17025). Accreditation bodies that recognize the competence of such testing laboratories may use this Standard as the basis for their accreditation. This report gives an example-oriented overview of the structure and contents of critical documents and procedures such as Quality Manual (QM), Standard Operating Procedures (SOPs), etc. inherent to a quality system and describes the different stages in the implementation of the OIE Standard. For that reason it can be used as a practical guide for the production of necessary documents but also as a help to determine the status of a laboratory during its journey towards establishing a QS

Accreditation ISO/IEC 1705 in dosimetry: Experience and results

International Nuclear Information System (INIS)

Martin Garcia, R.; Navarro Bravo, T.

2013-01-01

The objective of this work is to present the experience in the process of accreditation of the radiation dosimetry service in which there are trials for the determination of radiation doses due to internal and external exhibitions. Is They describe the aspects that were considered for the design and development of a system of quality and results after its implementation. A review of the benefits accreditation has been reported to the organization is finally made. (Author)

Quality control and quality assurance of nuclear analytical techniques

International Nuclear Information System (INIS)

Bondar, Yu.I.; Zabrotski, V.N.

2002-01-01

The participation of the Laboratory of Radiochemistry of Soil, Institute of Radiobiology, National Academy of Sciences of Belarus, in the IAEA project RER/2/004 in 1999-2001, provided a good base for its accreditation. This report presents: the results of the laboratory work carried out in accordance with ISO-17025; achievements and difficulties; future plans and proposals to the Agency concerning future development of the project

Proficiency test: a quality assurance method for high-purity gamma spectrometry system

Directory of Open Access Journals (Sweden)

Radulescu Ileana

2014-03-01

Full Text Available As part of the implementation of the quality system on ISO 17025 and accreditation, SALROM laboratory participated in the last year in intercomparison exercises, national and international, for determination of natural and man-made radionuclides. This paper describes results obtained in intercomparison exercise organized by IAEA in 2011. The reported values were mostly in good agreement with the resulting reference values.

Increasing Institutional Effectiveness: A Continuous Effort after Accreditation.

Science.gov (United States)

Chen, HongYu

West Virginia University at Parkersburg (WVUP) is a separately accredited campus of the University offering 2 baccalaureate, 10 associate, and 2 certificate programs. In response to concerns raised in a recent accreditation report, WVUP conducted a study examining student attitudes toward facilities, course scheduling, student advising,…

Intra-laboratory validation of chronic bee paralysis virus quantitation using an accredited standardised real-time quantitative RT-PCR method.

Science.gov (United States)

Blanchard, Philippe; Regnault, Julie; Schurr, Frank; Dubois, Eric; Ribière, Magali

2012-03-01

Chronic bee paralysis virus (CBPV) is responsible for chronic bee paralysis, an infectious and contagious disease in adult honey bees (Apis mellifera L.). A real-time RT-PCR assay to quantitate the CBPV load is now available. To propose this assay as a reference method, it was characterised further in an intra-laboratory study during which the reliability and the repeatability of results and the performance of the assay were confirmed. The qPCR assay alone and the whole quantitation method (from sample RNA extraction to analysis) were both assessed following the ISO/IEC 17025 standard and the recent XP U47-600 standard issued by the French Standards Institute. The performance of the qPCR assay and of the overall CBPV quantitation method were validated over a 6 log range from 10(2) to 10(8) with a detection limit of 50 and 100 CBPV RNA copies, respectively, and the protocol of the real-time RT-qPCR assay for CBPV quantitation was approved by the French Accreditation Committee. Copyright © 2011 Elsevier B.V. All rights reserved.

Mozambique's journey toward accreditation of the National Tuberculosis Reference Laboratory.

Science.gov (United States)

Viegas, Sofia O; Azam, Khalide; Madeira, Carla; Aguiar, Carmen; Dolores, Carolina; Mandlaze, Ana P; Chongo, Patrina; Masamha, Jessina; Cirillo, Daniela M; Jani, Ilesh V; Gudo, Eduardo S

2017-01-01

Internationally-accredited laboratories are recognised for their superior test reliability, operational performance, quality management and competence. In a bid to meet international quality standards, the Mozambique National Institute of Health enrolled the National Tuberculosis Reference Laboratory (NTRL) in a continuous quality improvement process towards ISO 15189 accreditation. Here, we describe the road map taken by the NTRL to achieve international accreditation. The NTRL adopted the Strengthening Laboratory Management Toward Accreditation (SLMTA) programme as a strategy to implement a quality management system. After SLMTA, the Mozambique National Institute of Health committed to accelerate the NTRL's process toward accreditation. An action plan was designed to streamline the process. Quality indicators were defined to benchmark progress. Staff were trained to improve performance. Mentorship from an experienced assessor was provided. Fulfilment of accreditation standards was assessed by the Portuguese Accreditation Board. Of the eight laboratories participating in SLMTA, the NTRL was the best-performing laboratory, achieving a 53.6% improvement over the SLMTA baseline conducted in February 2011 to the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) assessment in June 2013. During the accreditation assessment in September 2014, 25 minor nonconformities were identified and addressed. In March 2015, the NTRL received Portuguese Accreditation Board recognition of technical competency for fluorescence smear microscopy, and solid and liquid culture. The NTRL is the first laboratory in Mozambique to achieve ISO 15189 accreditation. From our experience, accreditation was made possible by institutional commitment, strong laboratory leadership, staff motivation, adequate infrastructure and a comprehensive action plan.

Development of Electro-Optical Standard Processes for Application

Science.gov (United States)

2011-11-01

IEC - 17025 (Reference 1.11c). The 17025 standard, which is part of the ISO -9000 series and is more familiar to industry, replaced ISO Guide 25, which...Even if the EO/IR community elects to follow a path defined by ISO / IEC 17025 , the modified criteria should be considered as a starting point. (See... 17025 and its U.S. equivalent, ANSI/NCSL Z540.3-2006. ISO / IEC - 17025 differs significantly in organization, but contains very similar quality

Automated extraction of DNA and PCR setup using a Tecan Freedom EVO® liquid handler

DEFF Research Database (Denmark)

Frøslev, Tobias Guldberg; Hansen, Anders Johannes; Stangegaard, Michael

2009-01-01

We have implemented and validated automated protocols for DNA extraction and PCR setup using a Tecan Freedom EVO® liquid handler mounted with the TeMagS magnetic separation device. The methods were validated for accredited, forensic genetic work according to ISO 17025 using the Qiagen Mag...... genetic DNA typing can be implemented on a simple robot leading to the reduction of manual work as well as increased quality and throughput....

Quality management system of Saraykoy Nuclear Research and Training center

International Nuclear Information System (INIS)

Gurellier, R.; Akchay, S.; Zararsiz, S.

2014-01-01

Full text : Technical competence and national/international acceptance of independency of laboratories is ensured by going through accreditations. It provides decreasing the risk of a slowdown in international trade due to unnecessary repetition of testing and analyses. It also eliminates the cost of additional experiments and analyses. Saraykoy Nuclear Research and Training Center (SANAEM) has performed intensive studies to establish an effective and well-functioning QMS (Quality Management System) by full accordance with the requirements of ISO/IEC 17025, since the begining of 2006. Laboratories, especially serving to public health studies and important trade duties require urgent accreditation. In this regard, SANAEM has established a quality management system and performed accreditation studies

Mozambique’s journey toward accreditation of the National Tuberculosis Reference Laboratory

Directory of Open Access Journals (Sweden)

Sofia O. Viegas

2017-03-01

Full Text Available Background: Internationally-accredited laboratories are recognised for their superior test reliability, operational performance, quality management and competence. In a bid to meet international quality standards, the Mozambique National Institute of Health enrolled the National Tuberculosis Reference Laboratory (NTRL in a continuous quality improvement process towards ISO 15189 accreditation. Here, we describe the road map taken by the NTRL to achieve international accreditation. Methods: The NTRL adopted the Strengthening Laboratory Management Toward Accreditation (SLMTA programme as a strategy to implement a quality management system. After SLMTA, the Mozambique National Institute of Health committed to accelerate the NTRL’s process toward accreditation. An action plan was designed to streamline the process. Quality indicators were defined to benchmark progress. Staff were trained to improve performance. Mentorship from an experienced assessor was provided. Fulfilment of accreditation standards was assessed by the Portuguese Accreditation Board. Results: Of the eight laboratories participating in SLMTA, the NTRL was the best-performing laboratory, achieving a 53.6% improvement over the SLMTA baseline conducted in February 2011 to the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA assessment in June 2013. During the accreditation assessment in September 2014, 25 minor nonconformities were identified and addressed. In March 2015, the NTRL received Portuguese Accreditation Board recognition of technical competency for fluorescence smear microscopy, and solid and liquid culture. The NTRL is the first laboratory in Mozambique toachieve ISO 15189 accreditation. Conclusions: From our experience, accreditation was made possible by institutional commitment, strong laboratory leadership, staff motivation, adequate infrastructure and a comprehensive action plan.

Mozambique’s journey toward accreditation of the National Tuberculosis Reference Laboratory

Science.gov (United States)

Madeira, Carla; Aguiar, Carmen; Dolores, Carolina; Mandlaze, Ana P.; Chongo, Patrina; Masamha, Jessina

2017-01-01

Background Internationally-accredited laboratories are recognised for their superior test reliability, operational performance, quality management and competence. In a bid to meet international quality standards, the Mozambique National Institute of Health enrolled the National Tuberculosis Reference Laboratory (NTRL) in a continuous quality improvement process towards ISO 15189 accreditation. Here, we describe the road map taken by the NTRL to achieve international accreditation. Methods The NTRL adopted the Strengthening Laboratory Management Toward Accreditation (SLMTA) programme as a strategy to implement a quality management system. After SLMTA, the Mozambique National Institute of Health committed to accelerate the NTRL’s process toward accreditation. An action plan was designed to streamline the process. Quality indicators were defined to benchmark progress. Staff were trained to improve performance. Mentorship from an experienced assessor was provided. Fulfilment of accreditation standards was assessed by the Portuguese Accreditation Board. Results Of the eight laboratories participating in SLMTA, the NTRL was the best-performing laboratory, achieving a 53.6% improvement over the SLMTA baseline conducted in February 2011 to the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) assessment in June 2013. During the accreditation assessment in September 2014, 25 minor nonconformities were identified and addressed. In March 2015, the NTRL received Portuguese Accreditation Board recognition of technical competency for fluorescence smear microscopy, and solid and liquid culture. The NTRL is the first laboratory in Mozambique to achieve ISO 15189 accreditation. Conclusions From our experience, accreditation was made possible by institutional commitment, strong laboratory leadership, staff motivation, adequate infrastructure and a comprehensive action plan. PMID:28879162

Materials and Manufacturing Research and Development Capability Assessment of the Southwest Ohio Region

Science.gov (United States)

2011-09-01

ISO / IEC 17025 :2005, NADCAP Acuren...River Road Brackenridge, PA 250 (724) 224-1000 $4.8B 11,000 ISO -9001, AS- 9100, NADCAP, ISO / IEC 17025 ATI – Allegheny Ludlum (Houston, PA) 501...Western Ave Houston, PA 233 (724) 745-2000 $4.8B 11,000 ISO -9001, AS- 9100, NADCAP, ISO / IEC 17025 ATI – Allegheny Ludlum (Louisville, OH)

Experiences with IAEA project: TC Regional Project on Quality Control and Quality Assurance for Nuclear Analytical Techniques (RER/2/004)

International Nuclear Information System (INIS)

Glavic-Cindro, Denis; Korun, Matjaz

2002-01-01

In the TC Regional Project on Quality Control and Quality Assurance for Nuclear Analytical Techniques RER/2/004, 12 laboratories from east and central European countries participated. Within this project 4 workshops, 2 audit inspections and 2 proficiency tests were organized. The aim of this project was to help these laboratories to implement quality assurance system based on the ISO 17025 standard and to help them on the way towards accreditation. (author)

Introduction to ISO 15189: a blueprint for quality systems in veterinary laboratories.

Science.gov (United States)

Freeman, Kathleen P; Bauer, Natali; Jensen, Asger L; Thoresen, Stein

2006-06-01

A trend in human and veterinary medical laboratory management is to achieve accreditation based on international standards. The International Organization for Standardization (ISO) 15189 standard is the first developed especially for accreditation of medical laboratories, and emphasizes the laboratory-client interface. European veterinary laboratories seeking to train candidates for the certification examination of the European College of Veterinary Clinical Pathology (ECVCP) require approval by the ECVCP Laboratory Standards Committee, which bases its evaluation in part on adherence to quality systems described in the ISO 15189 standards. The purpose of this article was to introduce the latest ISO quality standard and describe its application to veterinary laboratories in Europe, specifically as pertains to accreditation of laboratories involved in training veterinary clinical pathologists. Between 2003 and 2006, the Laboratory Standards Committee reviewed 12 applications from laboratories (3 commercial and 9 university) involved in training veterinary clinical pathologists. Applicants were asked to provide a description of the facilities for training and testing, current methodology and technology, health and safety policy, quality assurance policy (including internal quality control and participation in an external quality assurance program), written standard operating procedures (SOPs) and policies, a description of the laboratory information system, and personnel and training. Also during this time period multiple informal and formal discussions among ECVCP diplomates took place as to current practices and perceived areas of concern with regard to laboratory accreditation requirements. Areas in which improvement most often was needed in veterinary laboratories applying for ECVCP accreditation were the written quality plan, defined quality requirements for the tests performed, written SOPs and policies, training records, ongoing audits and competency

The process of implementing an ISO 9001 quality management system in a school of nursing.

Science.gov (United States)

Lett, M

2000-01-01

This paper documents the process undertaken during the establishment of an ISO 9000 series quality management system by a School of Nursing. Further discussion centres around the reasons why an ISO quality management system was implemented, the lessons learnt during the process and the benefits that accreditation has brought to the School of Nursing. The lessons learnt during the process could be of help to other organisations wishing to achieve a similar accreditation status.

Accreditation of Medical Laboratories – System, Process, Benefits for Labs

Directory of Open Access Journals (Sweden)

Zima Tomáš

2017-09-01

Full Text Available One and key of the priorities in laboratory medicine is improvement of quality management system for patient safety. Quality in the health care is tightly connected to the level of excellence of the health care provided in relation to the current level of knowledge and technical development. Accreditation is an effective way to demonstrate competence of the laboratory, a tool to recognize laboratories world-wide, is linked to periodical audits, to stimulate the maintenance and improvement of the quality, which leads to high standard of services for clients (patients, health care providers, etc.. The strategic plans of IFCC and EFLM include focusing on accreditation of labs based on ISO standards and cooperation with European Accreditation and national accreditation bodies. IFCC and EFLM recognised that ISO 15189:2012 Medical laboratories – Requirements for quality and competence, encompasses all the assessment criteria specified in the policy of quality. The last version is oriented to process approach with detailed division and clearly defined requirements. The accreditation of labs improves facilitation of accurate and rapid diagnostics, efficiency of treatment and reduction of errors in the laboratory process. Accreditation is not about who the best is, but who has a system of standard procedures with aim to improve the quality and patient safety. Quality system is about people, with people and for people.

Typing of 48 autosomal SNPs and amelogenin with GenPlex SNP genotyping system in forensic genetics

DEFF Research Database (Denmark)

Tomas Mas, Carmen; Stangegaard, Michael; Børsting, Claus

2008-01-01

, Somalia and Greenland were investigated with GenPlex using a Biomek 3000 (Beckman Coulter) robot. The results were compared to results obtained with an ISO 17025 accredited SNP typing assay based on single base extension (SBE). With the GenPlex SNP genotyping system, full SNP profiles were obtained in 97.......6% of the investigations. Perfect concordance was obtained in duplicate investigations and the SNP genotypes obtained with the GenPlex system were concordant with those of the accredited SBE based SNP typing system except for one result in rs901398 in one of 286 individuals most likely due to a mutation 6 bp downstream...

Quality assurance for analitical dairy laboratories

Directory of Open Access Journals (Sweden)

Šimun Zamberlin

2005-04-01

Full Text Available Quality evaluation of analytical laboratories must be estimated through accuracy, precision and traceability of measurement results. In European countries, acceptable analytical results are those which come from accredited laboratories (EN ISO/IEC 17025:2000. This paper presents examples of traceability, measurement uncertainty, inner quality control and control through the interlaboratory proficiency testing of results for milk fat. Also it demonstrates proficiency testing organization of results for fat, protein, lactose and somatic cells in milk.

Trace- and ultra-trace elemental analysis in forensic glass case work: looking back at 15 years use of ICP-MS and LA-ICP-MS at a forensic-science lab

International Nuclear Information System (INIS)

Duecking, M.; Weis, P.; Watzke, P.; Becker, S.

2009-01-01

Full text: The poster will present the use of LA-ICPMS at the BKA for forensic glass analysis. An overview will be given on the developments during the last 15 years, starting with the installation of the first ICPMS in 1993. A method for the quantification of elements in glass by LA-ICPMS was developed, validated and established in routine casework. Accreditation for the method according to ISO 17025 and ISO 17020 was received in 2007 and 2008, respectively. Latest developments of the technique will be presented. Forensic relevant features and limitations of the method such as sample size and homogeneity will be shown. (author)

45 CFR 170.420 - Application.

Science.gov (United States)

2010-10-01

...-audit against all sections of ISO/IEC 17025:2005 (incorporated by reference in § 170.499), and the following: (i) A copy of the applicant's quality system document according to section 4.2.2 of ISO/IEC 17025... according to section 4.9.1 of ISO/IEC 17025:2005; and (iii) The qualifications of each of the applicant's...

Training Accreditation Program

International Nuclear Information System (INIS)

1989-01-01

The Training Accreditation Program establishes the objectives and criteria against which DOE nuclear facility training is evaluated to determine its readiness for accreditation. Training programs are evaluated against the accreditation objectives and criteria by facility personnel during the initial self-evaluation process. From this self-evaluation, action plans are made by the contractor to address the scope of work necessary in order to upgrade any deficiencies noted. This scope of work must be formally documented in the Training Program Accreditation Plan. When reviewed and approved by the responsible Head of the Field Organization and cognizant Program Secretarial Office, EH-1 concurrence is obtained. This plan then becomes the document which guides accreditation efforts for the contractor

Uncertainty Estimation of Neutron Activation Analysis in Zinc Elemental Determination in Food Samples

International Nuclear Information System (INIS)

Endah Damastuti; Muhayatun; Diah Dwiana L

2009-01-01

Beside to complished the requirements of international standard of ISO/IEC 17025:2005, uncertainty estimation should be done to increase quality and confidence of analysis results and also to establish traceability of the analysis results to SI unit. Neutron activation analysis is a major technique used by Radiometry technique analysis laboratory and is included as scope of accreditation under ISO/IEC 17025:2005, therefore uncertainty estimation of neutron activation analysis is needed to be carried out. Sample and standard preparation as well as, irradiation and measurement using gamma spectrometry were the main activities which could give contribution to uncertainty. The components of uncertainty sources were specifically explained. The result of expanded uncertainty was 4,0 mg/kg with level of confidence 95% (coverage factor=2) and Zn concentration was 25,1 mg/kg. Counting statistic of cuplikan and standard were the major contribution of combined uncertainty. The uncertainty estimation was expected to increase the quality of the analysis results and could be applied further to other kind of samples. (author)

Detailed validation in PCDDF analysis. ISO17025 data from Brazil

Energy Technology Data Exchange (ETDEWEB)

Kernick Carvalhaes, G.; Azevedo, J.A.; Azevedo, G.; Machado, M.; Brooks, P. [Analytical Solutions, Rio de Janeiro (Brazil)

2004-09-15

When we define validation method we can use the ISO standard 8402, in reference to this, 'validation' is the 'confirmation by the examination and supplying of objective evidences that the particular requirements for a specific intended use are fulfilled'. This concept is extremely important to guarantee the quality of results. Validation method is based on the combined use of different validation procedures, but in this selection we have to analyze the cost benefit conditions. We must focus on the critical elements, and these critical factors must be the essential elements for providing good properties and results. If we have a solid validation methodology and a research of the source of uncertainty of our analytical method, we can generate results with confidence and veracity. When analyzing these two considerations, validation method and uncertainty calculations, we found out that there are very few articles and papers about these subjects, and it is even more difficult to find such materials on dioxins and furans. This short paper describes a validation and uncertainty calculation methodology using traditional studies with a few adaptations, yet it shows a new idea of recovery study as a source of uncertainty.

Tests of Shaft Seal Systems of Circulation Pumps during Station Blackout

Energy Technology Data Exchange (ETDEWEB)

Beisiegel, A.; Foppe, F.; Wich, M.

2014-07-01

AREVA GmbH operates a unique Thermal-hydraulic plat form in Germany, France and USA. It is recognised as a test body according to ISO 17025. The Deutsche Akkreditierungsstelle GmbH (DAkkS - German Society for Accreditation) has also certified the Thermal-hydraulic platform as an independent inspection body Type C according to ISO 17020. A part of this platform is the Component Laboratory located in Karlstein, Germany which is in operation since more than 50 years. The testing activities cover a wide range as: Critical Heat Flux Tests, Valve Testing and Environmental Qualification for safety related components. Since 2011 the Component Qualification Karlstein extended their testing scope for different types of Shaft Seal Systems. (Author)

Proficiency Testing in Nondestructive Testing (NDT)

International Nuclear Information System (INIS)

Amry Amin Abbas; Suhairy Sani; Mohamad Pauzi Ismail; Abd Nassir Ibrahim

2014-01-01

Department of Standard Malaysia (DSM) launched myPTP programme on 31 December 2013 in accordance to ISO/IC 17043. The standard states the requirements for Proficiency Testing. The provider of these services is called Proficiency Testing Provider (PTP). The role of PTP is to compare the proficiency level between inspection bodies or laboratories. With the assistance of expert panel, the PTP will determine the assigned value as reference to be compared to the values obtained from the inspection bodies or laboratories. Quality wise, this services is important as participation will improve wuality of the inspection quality continuously and increase confidence level of client and improve safety level. Requirement of PT in NDT is mentioned in SC1.5- Specific Criteria for Accreditation of Mechanical Testing and Non-Destructive Testing (NDT) for MS ISO/IEC17025 and MTR2- MIBAS Technical Requirements for Accreditation of NDT. This paper explains and discusses the result of this proficiency test done on a number of NDT companies that participated. (author)

A more sensitive, efficient and ISO 17025 validated Magnetic Capture real time PCR method for the detection of archetypal Toxoplasma gondii strains in meat.

Science.gov (United States)

Gisbert Algaba, Ignacio; Geerts, Manon; Jennes, Malgorzata; Coucke, Wim; Opsteegh, Marieke; Cox, Eric; Dorny, Pierre; Dierick, Katelijne; De Craeye, Stéphane

2017-11-01

Toxoplasma gondii is a globally prevalent, zoonotic parasite of major importance to public health. Various indirect and direct methods can be used for the diagnosis of toxoplasmosis. Whereas serological tests are useful to prove contact with the parasite has occurred, the actual presence of the parasite in the tissues of a seropositive animal is not demonstrated. For this, a bioassay is still the reference method. As an alternative, various PCR methods have been developed, but due to the limited amount of sample that can be tested, combined with a low tissue cyst density, those have proved to be insufficiently sensitive. A major improvement of the sensitivity was achieved with magnetic capture-based DNA extraction. By combining the hybridization of specific, biotinylated probes with the capture of those probes with streptavidin-coated paramagnetic beads, T. gondii DNA can selectively be "fished out" from a large volume of meat lysate. Still, several studies showed an insufficient sensitivity compared with the mouse bioassay. Here we present a method that is more sensitive (99% limit of detection: 65.4 tachyzoites per 100g of meat), economical and reliable (ISO 17025 validated) by adding a non-competitive PCR inhibition control (co-capture of cellular r18S) and making the release of the target DNA from the streptavidin-coated paramagnetic beads UV-dependent. The presented results demonstrate the potential of the modified Magnetic Capture real time PCR as a full alternative to the mouse bioassay for the screening of various types of tissues and meat, with the additional advantage of being quantitative. Copyright © 2017 Australian Society for Parasitology. Published by Elsevier Ltd. All rights reserved.

Evaluation of quality assurance calibration results based on repeated calibrations; Evaluacion del aseguramiento de la calidad de los resultados de calibracion en base a la repeticion de las calibraciones

Energy Technology Data Exchange (ETDEWEB)

Mestre de Juan, V.; Albau Albos, J.; Gomez Llobat, L.

2011-07-01

To ensure quality assurance of the calibration results, as indicated by the UNE-EN ISO / IEC 17025:2005 in paragraph 5.9, the laboratory has established procedures for quality control of its activity. Thus, the laboratory participates in both inter-laboratory intercomparison exercises, cycle through the entire range of radiation qualities reflected in the scope of its accreditation, such as intra-laboratory intercomparison exercises. In this case, repeat quarterly by two different operators both the calibration of an ionization chamber irradiation of a direct reading personal dosimeter.

Description and Results: Antenna Measurement Facility Comparisons [Measurements Corner

DEFF Research Database (Denmark)

Alberica Saporetti, Maria; Foged, Lars; Sierra Castañer, Manuel

2017-01-01

In recent years, formalized facility comparison activities have become important for the documentation and validation of laboratory proficiency and competence and mandatory for achieving accreditation such as that of the International Organization for Standardization (ISO) 17025 or similar...... for Antennas (VISTA) IC1102, including still ongoing campaigns [3]-[5]. Results of these activities have led to improvements in antenna measurement procedures and protocols in facilities and standards [6], [7]. Due to the direct benefits available to the participants, the activities have been very successful...

Forensic entomology: implementing quality assurance for expertise work.

Science.gov (United States)

Gaudry, Emmanuel; Dourel, Laurent

2013-09-01

The Department of Forensic Entomology (Institut de Recherche Criminelle de la Gendarmerie Nationale, France) was accredited by the French Committee of Accreditation (Cofrac's Healthcare section) in October 2007 on the basis of NF EN ISO/CEI 17025 standard. It was the first accreditation in this specific field of forensic sciences in France and in Europe. The present paper introduces the accreditation process in forensic entomology (FE) through the experience of the Department of Forensic Entomology. Based upon the identification of necrophagous insects and the study of their biology, FE must, as any other expertise work in forensic sciences, demonstrate integrity and good working practice to satisfy both the courts and the scientific community. FE does not, strictly speaking, follow an analytical method. This could explain why, to make up for a lack of appropriate quality reference, a specific documentation was drafted and written by the staff of the Department of Forensic Entomology in order to define working methods complying with quality standards (testing methods). A quality assurance system is laborious to set up and maintain and can be perceived as complex, time-consuming and never-ending. However, a survey performed in 2011 revealed that the accreditation process in the frame of expertise work has led to new well-defined working habits, based on an effort at transparency. It also requires constant questioning and a proactive approach, both profitable for customers (magistrates, investigators) and analysts (forensic entomologists).

Application of flexible scope in large testing laboratories

Directory of Open Access Journals (Sweden)

Carina Di Candia

2011-04-01

Full Text Available According as the international definition of Flexible Scope, a laboratory must demonstrate face with the accreditation body that it has the knowledge, experience and competence to work within the full range of its flexible scope, as well as possessing suitable laboratory environments and equipment. The laboratory must also demonstrate that it has a management system in place that can control its proposed approach while continuing to comply with the requirements of ISO 17025:2005. In case of UKAS (Unites Kingdom Accreditation Service, prior to offering accreditation for flexible scope they must have a high degree of confidence that the staff are technically competent and that the management system controlling certain key processes as development, review, validation and authorization.LATU apply these requirements since 2004 as "Unified Tests". Until this date, LATU was doing the same type of tests in different materials departments using different equipment, personal, and testing quality control. In order to that were defined cross disciplinary groups to analyze this topic approaching in personal competence and quality control tests improvement, and resource's decrease. For example, LATU has the Unified Test Tensile Strength accredited by UKAS in: corrugated and solid fiberboard, paper board, linerboard, cork plugs, plastic bags, plastic sheeting, paper, woven fabrics, plastic woven bags and woven plastic. As a result of the Unified Tests was generated a general unified manage procedure with unified criteria's, responsibilities and actions. Was written a unique testing procedure not only with the actual flexible scope and the flexibilities limits but also the compliance requirements of ISO 17025 and the accreditations body methodology. We could decrease the amount of documentation to control. Was defined the methodology and implemented periodicaly internal inter comparisons between departments in order to valid the unified tests and has a unique

The application of data from proficiency testing to laboratory accreditation according to ISO 17025

DEFF Research Database (Denmark)

Heydorn, Kaj

2008-01-01

Current methods of testing laboratories for their proficiency in reporting correct measurement results are liable to substantial errors of the 2nd kind. This means that laboratories with deflated uncertainties are accepted as proficient, even though their reported measurement results pave the way...

Estudo da utilização de materiais de referência nas análises de água por laboratórios envolvidos no sistema de acreditação Case study on the usage of reference materials in water analysis by laboratories involved in the accreditation system

Directory of Open Access Journals (Sweden)

Suzana Saboia de Moura

2009-01-01

Full Text Available O presente estudo propõe-se discutir o uso de materiais de referência (MR pelos laboratórios de ensaios de águas, sob o ponto de vista da aquisição dos materiais conforme o item "Aquisição de serviços e suprimentos" (4.6 da norma ABNT NBR ISO/IEC 17025. O papel dos MR nas análises químicas é fornecer referências metrológicas visando assegurar a rastreabilidade das medições. A rastreabilidade é um aspecto essencial da garantia da qualidade para se obter aceitação de dados analíticos nos mercados nacional e internacional. Neste estudo de caso, de caráter exploratório e qualitativo, uma pesquisa foi realizada junto a todos os laboratórios de ensaios prestadores de serviços analíticos para a Agência Nacional de Águas (ANA e envolvidos no sistema de acreditação pela Coordenação Geral de Acreditação do Inmetro (Cgcre/Inmetro, utilizando-se questionário estruturado e com 50% de retorno. Os resultados mostraram que são muito poucos os certificados de MR com reconhecimento de terceira parte, ou seja, por organismos de acreditação, segundo normas consagradas que tratam efetivamente da rastreabilidade metrológica. Propõe-se, finalmente, uma política para garantir, sempre que possível, a rastreabilidade dos resultados de ensaios dos laboratórios, na ausência de MR certificados.This paper aims at discussing the use of reference materials (RM by water testing laboratories, on the context of RM purchase, based on the requirements of the standard ABNT NBR ISO/IEC 17025, section "Purchasing services and supplies" (4.6. The role of RM in chemical analysis is to provide metrological reference to assure measurement traceability. This is an essential aspect of quality assurance in order to have analytical results accepted in the international market. In this case study, based on the methodological exploratory and qualitative approach, a questionnaire was sent to testing laboratories which provide analytical services to the

Accreditation of the Personal Dosimetry internal Service Tecnatom by the National Entity (ENAC); Acreditacion del Servicio de Dosimetria Personal Interna de Tecnatom por la Entidad Nacional de Acreditacion (ENAC)

Energy Technology Data Exchange (ETDEWEB)

Bravo, B.; Marchena, P.

2014-07-01

The service of personal Dosimetry internal Tecnatom has made the process of adapting its methodology and quality assurance, requirements technical and management will be required to obtain accreditation from the National Accreditation Entity according to ISO / IEC 170251 standard {sup G}eneral Requirements competence of testing and calibration laboratories. To carry out this process, the laboratory has defined quality criteria set out in their test procedures, based on ISO Standards 27048: 2011; ISO 20553: 2005 and ISO 28218: 2010. This paper describes what has been the methodology used to implement the requirements of different ISO test methods of SDPI Tecnatom. (Author)

[Efforts to achieve and effects of acquiring ISO 15189 in Tokushima University Hospital].

Science.gov (United States)

Shono, Kazuko; Kishi, Misako; Satou, Mituyo; Nagamine, Yasunori; Doi, Tosio

2009-12-01

The medical laboratory of Tokushima University Hospital acquired ISO 15189, an international standard for medical laboratories, on July 6th, 2007, resulting in it achieving the 24th place in Japan and 5th place among national university hospitals. The first surveillance was just performed on October 6th, 2008. Tokushima University Hospital, in which our medical laboratory is included as one section, already succeeded in acquiring ISO 9001, PrivacyMark System, and Quality Health Care ver. 5 before accomplishing ISO 15189. To achieve ISO 15189, we prepared documents based on ISO 9001 without any consultation, resulting in a review of the difference between ISO 9001 and ISO 15189 after the preliminary survey. Although achieving ISO 15189 resulted in an improvement in the reliability of laboratory results and accuracy, leading to the development of our technical skills and awareness, and sharing of knowledge, we consider that the considerable investment of time to prepare the requirements remains to be overcome.

Proficiency testing criteria for clearance level in solid waste gamma measurement in Taiwan

International Nuclear Information System (INIS)

Chen, Chun-Liang; Wang, Jeng-Jong; Chiu, Huang-Sheng

2013-01-01

To guarantee the measurement quality for clearance level in solid waste material, the Institute of Nuclear Energy Research (INER) established the criteria for proficiency testing of clearance level measurement. INER and the Taiwan Accreditation Foundation (TAF) organized the Technique Committee Meeting twice to discuss these criteria in 2011. The participating laboratories must completely conform to the ISO/IEC 17025, and they also must meet the requirements of the criteria. According to the criteria, the participating laboratories analyzed the minimum detectable amount (MDA) and that should be less than 20% of the clearance level (AMDA) given in the Atomic Energy Council's (AEC) “Regulations on Clearance Level for Radioactive Waste Management”. The testing results should conform to the deviation and traceability requirements. - Highlights: • The participating laboratories must completely conform to the ISO/IEC 17025 • The proficiency testing items were basically in two categories, box and barrel types • Analyzed the MDA and that should be less than 20% of the release level given in the AEC. • The are three limitations: MDA< AMDA, -0.25< Bi<+0.5, and En≤1.0 and uncertainty<20%

IMPLEMENTASI SISTEM MANAJEMEN MUTU BERBASIS ISO 9001:2000 PADA SEKOLAH MENENGAH KEJURUAN

Directory of Open Access Journals (Sweden)

Mardi Wiyono

2012-09-01

Full Text Available Abstract: The implementation of ISO 9001:2000 quality management system in vocational school. The needs of quality products and services is largerly expanded in various organizations including education. Recently, the vocational schools also realize how important the quality product and service is. For achieving the quality product or service, some organizations implement the concept of ISO 9001:2000 quality management system. In 2006/2007 it is reported that there are some vocational schools have been certified with ISO 9001:2000. ISO 9001 is a serial document consists of Quality Management System Standard which has been refised from its previous standard. ISO 9001:2000 gives a number of prerequisites for organizations having business initialized by design and development, production, installations, and services. The vocational schools which have been certified with ISO 9001:2000, have to be re-accredited after three years of implementation.

Force Measurement Services at Kebs: AN Overview of Equipment, Procedures and Uncertainty

Science.gov (United States)

Bangi, J. O.; Maranga, S. M.; Nganga, S. P.; Mutuli, S. M.

This paper describes the facilities, instrumentation and procedures currently used in the force laboratory at the Kenya Bureau of Standards (KEBS) for force measurement services. The laboratory uses the Force Calibration Machine (FCM) to calibrate force-measuring instruments. The FCM derives its traceability via comparisons using reference transfer force transducers calibrated by the Force Standard Machines (FSM) of a National Metrology Institute (NMI). The force laboratory is accredited to ISO/IEC 17025 by the Germany Accreditation Body (DAkkS). The accredited measurement scope of the laboratory is 1 MN to calibrate force transducers in both compression and tension modes. ISO 376 procedures are used while calibrating force transducers. The KEBS reference transfer standards have capacities of 10, 50, 300 and 1000 kN to cover the full range of the FCM. The uncertainty in the forces measured by the FCM were reviewed and determined in accordance to the new EURAMET calibration guide. The relative expanded uncertainty of force W realized by FCM was evaluated in a range from 10 kN-1 MN, and was found to be 5.0 × 10-4 with the coverage factor k being equal to 2. The overall normalized error (En) of the comparison results was also found to be less than 1. The accredited Calibration and Measurement Capability (CMC) of the KEBS force laboratory was based on the results of those intercomparisons. The FCM enables KEBS to provide traceability for the calibration of class ‘1’ force instruments as per the ISO 376.

Clinical Psychology Training: Accreditation and Beyond.

Science.gov (United States)

Levenson, Robert W

2017-05-08

Beginning with efforts in the late 1940s to ensure that clinical psychologists were adequately trained to meet the mental health needs of the veterans of World War II, the accreditation of clinical psychologists has largely been the province of the Commission on Accreditation of the American Psychological Association. However, in 2008 the Psychological Clinical Science Accreditation System began accrediting doctoral programs that adhere to the clinical science training model. This review discusses the goals of accreditation and the history of the accreditation of graduate programs in clinical psychology, and provides an overview of the evaluation procedures used by these two systems. Accreditation is viewed against the backdrop of the slow rate of progress in reducing the burden of mental illness and the changes in clinical psychology training that might help improve this situation. The review concludes with a set of five recommendations for improving accreditation.

Measurement Uncertainty

Science.gov (United States)

Koch, Michael

Measurement uncertainty is one of the key issues in quality assurance. It became increasingly important for analytical chemistry laboratories with the accreditation to ISO/IEC 17025. The uncertainty of a measurement is the most important criterion for the decision whether a measurement result is fit for purpose. It also delivers help for the decision whether a specification limit is exceeded or not. Estimation of measurement uncertainty often is not trivial. Several strategies have been developed for this purpose that will shortly be described in this chapter. In addition the different possibilities to take into account the uncertainty in compliance assessment are explained.

The uncertainty budget in pharmaceutical industry

DEFF Research Database (Denmark)

Heydorn, Kaj

of their uncertainty, exactly as described in GUM [2]. Pharmaceutical industry has therefore over the last 5 years shown increasing interest in accreditation according to ISO 17025 [3], and today uncertainty budgets are being developed for all so-called critical measurements. The uncertainty of results obtained...... that the uncertainty of a particular result is independent of the method used for its estimation. Several examples of uncertainty budgets for critical parameters based on the bottom-up procedure will be discussed, and it will be shown how the top-down method is used as a means of verifying uncertainty budgets, based...

Evaluation of the Ion Torrent™ HID SNP 169-plex

DEFF Research Database (Denmark)

Børsting, Claus; Fordyce, Sarah L; Olofsson, Jill Katharina

2014-01-01

The Ion Torrent™ HID SNP assay amplified 136 autosomal SNPs and 33 Y-chromosome markers in one PCR and the markers were subsequently typed using the Ion PGM™ second generation sequencing platform. A total of 51 of the autosomal SNPs were selected from the SNPforID panel that is routinely used...... in our ISO 17025 accredited laboratory. Concordance between the Ion Torrent™ HID SNP assay and the SNPforID assay was tested by typing 44 Iraqis twice with the Ion Torrent™ HID SNP assay. The same samples were previously typed with the SNPforID assay and the Y-chromosome haplogroups of the individuals...

Implantation of the NC ISO 9001 in the Radioactivity measurement service in junks of CPHR; Implantacion de la NC ISO 9001 en el servicio de medicion de radiactividad en chatarras de CPHR

Energy Technology Data Exchange (ETDEWEB)

Ramos V, E O; Dominguez L, O; Capote F, E; Fernandez G, I M; Caveda R, C; Alonso A, D; Barroso P, I; Madraso M, S [CPHR, Calle 20 No. 4113 e/41 y 47 Playa, C.P. 11300, Ciudad La Habana, Direccion Postal A.P. 6195, C.P. 10600 (Cuba)

2006-07-01

In the last years in the international environment, radiological incidents have been reported, due to the presence of radioactive materials in the junk, that have implied the adoption of measures in matter of radiological safety, to avoid affectations in the public and the environment, as well as in the international trade. The establishment of the radiological control of junk during it commercialization requires of the implantation of a quality management program. In such sense, the present work exposes the experience of our institution in the design and organization of a service for the radioactivity measurement in junks based on a quality administration system based on the requirements of the quality standards ISO 9001:2000, ISO/IEC 17050 and ISO/IEC 17025:2000. In coherence with the postulates defined in the institutional strategy related to the implantation of a total quality system and the international demands on this matter. To such ends the processes that compose the service were identified, the corresponding and implemented procedures were elaborated, the registrations associated to the same one, being worked in the design of a quality assurance program that allowed the evaluation of the conformity of the product and the customer. (Author)

Why did ISO 9001:2008 system fail to deliver?

Science.gov (United States)

Langford, Melvyn

2014-02-01

This article is based on an actual investigation undertaken, and summarises the subsequent report's findings and observations. It has been anonymised for obvious reasons. In May 2013 an analysis was undertaken by a multidisciplinary team that compared an NHS Trust estates department's managerial systems against the NHS national recommendations. The conclusions stated that: 'There was a systemic failure across a large number of topics generating intolerable/substantial risks to the organisation, its staff, and patients; this despite the department's managerial systems being accredited to the International Standard ISO 9001:2008'. The natural question raised when presented with this demonstrable and auditable evidence was: 'Why did the ISO 9001:2008 system fail?'

ISO 9001 and ISO 14001: An Integrated Quality Management System for an MTR Facility SAFARI-1 Research Reactor

International Nuclear Information System (INIS)

Du Bruyn, J.F.; Piani, C.S.B.

2005-01-01

The SAFARI-1 research reactor, owned and operated by the South African Nuclear Energy Corporation (Necsa), initially obtained ISO 9001 accreditation of its Quality, Health, Safety and Environmental (QHSE) management system via international affiliation from the South African Bureau of Standards (SABS) during 1998 and re-certification according to ISO 9001 (2000) in 2003. With ever-increasing demands on nuclear facilities to demonstrate conformance to environmental policies, SAFARI-1 has now developed an Environmental Management System (EMS) that is compliant with ISO 14001 (1996) and is fully integrated with the SAFARI-1 Quality Management System (QMS). The dynamic involvement of SAFARI-1 in commercial applications demanded that any transition of the original QMS to a fully incorporated QHSE system had to be done in a way that would ensure sustained delivery of a safe and reliable service with continuous quality. At the same time, the primary vision of operating a facility under an efficient financial management programme was essential. The criteria established by the original ISO 9001 compliant QMS were appraised against the additional requirements of ISO 14001 and a suitable superstructure derived for generation and implementation of an inclusive EMS. The transitional integration of this system was planned so as to produce a QMS suitable to quality, environmental and other management related issues for application to the unique function of a nuclear research reactor. (author)

Validation of an indirect ELISA to detect antibodies against BoHV-1 in bovine and guinea-pig serum samples using ISO/IEC 17025 standards.

Science.gov (United States)

Parreño, Viviana; Romera, S Alejandra; Makek, Lucia; Rodriguez, Daniela; Malacari, Darío; Maidana, Silvina; Compaired, Diego; Combessies, Gustavo; Vena, María Marta; Garaicoechea, Lorena; Wigdorovitz, Andrés; Marangunich, Laura; Fernandez, Fernando

2010-10-01

Two ELISAs to quantify antibodies to BoHV-1 in the sera of cattle and immunized guinea pigs were developed and validated using ISO/IEC 17025 standards. The cut-off value of the assay was established at 20% positivity of a high positive control for screening of cattle. Using this threshold, the assay properly classified the OIE bovine reference sera EU1, EU2 and EU3. For vaccine potency testing, a cut-off of 40% was selected for both species. The reliability of the assays, given by their diagnostic sensitivity and specificity, using the threshold of 40% was 89.7% and 100%, respectively, for bovines and 94.9% and 100% for guinea pigs, respectively. There was almost perfect agreement between the ELISA and virus neutralization results. In addition, after vaccination, there was a good correlation between the neutralizing and ELISA antibody titers of the serum from the same bovine or guinea pig, sampled at 60 and 30 days post-vaccination, respectively (R(bovine)=0.88, R(guinea pig)=0.92; p<0.0001). A similar correlation was observed when analyzing the mean antibody titers of groups of vaccinated animals (R(bovine)=0.95 and R(guinea pig)=0.97; p<0.0001), indicating the relevance of the ELISAs for batch to batch vaccine potency testing in the target species and in the laboratory animal model. The intermediate precision of the assays expressed as the relative coefficient of variation (CV) of the positive control assayed over a 3-year period in the same laboratory was 22.2% for bovines and 23.1% for guinea pigs. The reproducibility of both techniques obtained in inter-laboratory assays was CV=12.4% for bovines and CV approximately 0 for guinea pigs, which met the requirements of the OIE (CV<30%). The validated ELISAs represent important methods for vaccine potency testing and for controlling BoHV-1 infections. Copyright (c) 2010 Elsevier B.V. All rights reserved.

Creating Best Practices for the Submission of Actionable Food and Feed Testing Data Generated in State and Local Laboratories.

Science.gov (United States)

Wangsness, Kathryn; Salfinger, Yvonne; Randolph, Robyn; Shea, Shari; Larson, Kirsten

2017-07-01

Laboratory accreditation provides a level of standardization in laboratories and confidence in generated food and feed testing results. For some laboratories, ISO/IEC 17025:2005 accreditation may not be fiscally viable, or a requested test method may be out of the scope of the laboratory's accreditation. To assist laboratories for whom accreditation is not feasible, the Association of Public Health Laboratories Data Acceptance Work Group developed a white paper entitled "Best Practices for Submission of Actionable Food and Feed Testing Data Generated in State and Local Laboratories." The basic elements of a quality management system, along with other best practices that state and local food and feed testing laboratories should follow, are included in the white paper. It also covers program-specific requirements that may need to be addressed. Communication with programs and end data users is regarded as essential for establishing the reliability and accuracy of laboratory data. Following these suggested best practices can facilitate the acceptance of laboratory data, which can result in swift regulatory action and the quick removal of contaminated product from the food supply, improving public health nationally.

Estimation of dose ionizing radiation exposure by biological dosimetry; Estimación de dosis de exposición a radiaciones ionizantes mediante dosimetría biológica

Energy Technology Data Exchange (ETDEWEB)

Herranz Crespo, R.; Moreno Domene, M.; Prieto Rodríguez, M.J.; Lozano Barriuso, M.A.

2014-07-01

the Biological Dosimetry Laboratory of the Radiopathology Centre, at Hospital General Universitario Gregorio Marañón, is the only national laboratory accredited by UNE-EN ISO/IEC 17025:2005, and scope to ISO 19238:2004 (Radiation protection – Performance criteria for service laboratories performing biological dosimetry by citogenetics), for dose assessment by the dycentrics assay, has great experience with more than 100 real cases analyzed, and several population studies. This paper describes experience and results from more than 20 years of work under the Reference level II Centre for the attention of irradiated and/or contaminated people. [Spanish] El Laboratorio de Dosimetría Biológica, del Centro de Radiopatología del Hospital General Universitario Gregorio Marañón, es el único en España que dispone de acreditación internacional por la norma UNE-EN ISO/IEC 17025:2005 con alcance a la norma ISO 19238:2004 (Radiationprotection – Performance criteria for service laboratories performing biological dosimetry by citogenetics), para la realización de estimaciones dosimétricas mediante la técnica de dicéntricos, dispone de amplia experiencia en su aplicación en los 110 casos reales analizados, y en diferentes estudios de poblaciones españolas. En este trabajo se describe la experiencia del laboratorio y los resultados obtenidos en los más de 20 años de funcionamiento en el Centro de Referencia de nivel II para la atención a irradiados y/o contaminados por radiaciones ionizantes.

Low-Volatility Agent Permeation (LVAP) Verification and Validation Report

Science.gov (United States)

2015-05-01

custody procedures were obtained from the ISO / IEC 17025 :2005 standard13 as well as the current version of Permeation and Analytical Solutions Branch...Testing and Calibration Laboratories; ISO / IEC 17025 :2005; International Organization for Standardization: Geneva, Switzerland, 2005. 14. Box, G.E...ECBC, as detailed in Section 6.4.4 The International Organization for Standardization ( ISO ) method, 5725-3 (1994), was used to calculate the standard

Certification of ISO 9001: SSDL experiences

International Nuclear Information System (INIS)

Noriah Mod Ali

2005-01-01

Efforts given to maintain the quality management based on the ISO 9000 requirement able to improved the existing system, strengthen the customer confidence and to satisfied the worker needs. It gives direct impact on the harmonization of the Radiation Protection Program in the country. SSDL experiences towards obtaining the the ISO 9002/ISO 9001 certification and its maintenance are discussed in details. (Author)

Implantation of the NC ISO 9001 in the Radioactivity measurement service in junks of CPHR

International Nuclear Information System (INIS)

Ramos V, E.O.; Dominguez L, O.; Capote F, E.; Fernandez G, I.M.; Caveda R, C.; Alonso A, D.; Barroso P, I.; Madraso M, S.

2006-01-01

In the last years in the international environment, radiological incidents have been reported, due to the presence of radioactive materials in the junk, that have implied the adoption of measures in matter of radiological safety, to avoid affectations in the public and the environment, as well as in the international trade. The establishment of the radiological control of junk during it commercialization requires of the implantation of a quality management program. In such sense, the present work exposes the experience of our institution in the design and organization of a service for the radioactivity measurement in junks based on a quality administration system based on the requirements of the quality standards ISO 9001:2000, ISO/IEC 17050 and ISO/IEC 17025:2000. In coherence with the postulates defined in the institutional strategy related to the implantation of a total quality system and the international demands on this matter. To such ends the processes that compose the service were identified, the corresponding and implemented procedures were elaborated, the registrations associated to the same one, being worked in the design of a quality assurance program that allowed the evaluation of the conformity of the product and the customer. (Author)

[Nine-Year Experience after ISO 15189 Acquisition, How Successful was It? Focusing on the Results of Interviews and Questionnaires].

Science.gov (United States)

Fujimoto, Kazumitsu; Asai, Noriaki; Nakajima, Yoshinaga; Inoue, Kaoru

2015-11-01

Our laboratory, for the purpose of Quality Management System (QMS) improvement, acquired ISO 15189:2003 accreditation 9 years ago and completed the renewal to ISO 15189:2012 last year. In this study, we reviewed the efficacy of ISO 15189 based on an analysis of laboratory director's and managers' opinions. We could realize QMS improvement through the proactive implementation of preventive and corrective actions, and also the continuous implementation of education and delivery by means of reviewing the interview records of ISO 15189:2012 renewal with the laboratory director. All answers to the questionnaire obtained from managers with regard to the advantages of ISO 15189 acquisition agreed with the purpose of ISO 15189. From these results, we concluded that ISO 15189 acquisition was successful for QMS improvement. [Review].

ISO 9000

International Nuclear Information System (INIS)

Graham, J.F.

1992-01-01

The European Community has adopted the Single European Act. The act states that in order to do business in Europe after 1992, a supplied is expected to be ISO 9000 registered. This paper reports on ISO 9000, which is a systematic approach to implementing a quality system. It is not in the category of technical or product standards, but a standard relating to management of quality in that sector of a company seeking registration. If a company is already systematically practicing quality improvement, these efforts will be applicable to the ISO 9000 certification process. A company will need to refine and update procedures and develop a quality manual. An internal auditing and a corrective action system will also have to be established. The latter addresses audit results, customer complaints, quality system problems, and internal quality improvement suggestions

Confirmation of the correct application of the gamma spectrometric method carried out in the Cuban Center for Radiation Protection and Hygiene

International Nuclear Information System (INIS)

Fernandez Gomez, Isis M.; Carrazana Gonzalez, Jorge A.; Capote Ferrera, Eduardo

2008-01-01

One of the technical requirements of the standard ISO/IEC 17025:2006 is that the laboratories that use standard methods shall confirm that they can properly operate these before introducing the tests or calibrations. Among the testing activities that execute the Environmental Radiological Surveillance Laboratory of the Cuban Center for Radiation Protection and Hygiene, is the determination of gamma radionuclides by gamma spectrometry with HPGe detectors. This test has been accredited by the Cuban Accreditation Body, according to the standard ISO/IEC 17025:2005. Fulfilling the requirements of this standard, regarding the selection of methods, the laboratory uses internationally standard method for its gamma spectrometry determinations. For this reason it was necessary to confirm the correct application of the selected method before incorporating it as scientific-technical service that the institution offers. With this purpose the method confirmation using certified reference materials of different matrixes and for the different geometries used in the laboratory were carried out. The obtained results of this study were processed statistically to check the precision and trueness of the same ones. In this sense, the laboratory participates periodically in interlaboratory comparison programs that include the radionuclides analysis by gamma spectrometry, as another form of accuracy confirmation of the results that the laboratory reports. In this paper the design of the realized intralaboratory study, as well as the results of it are presented. From the obtained results in the realized study, as well as from the interlaboratory comparison programs, it is possible to conclude that the method used in the laboratory is executed appropriately and it is under control. (author)

Evaluation of critical indicators in the process of acquiring supplies and services LAC-UFPE

Science.gov (United States)

Caetano, V. F.; Ferreira, C. V.; dos Santos, M. J.; Honorato, F. A.

2015-01-01

In laboratories linked to public universities and accredited by the NBR ISO/IEC 17025, to meet efficiently item 4.6 (procurement of supplies and services) is a challenge that can be accomplished by programming based on historical purchases and services. In this study, we evaluated the critical procurement items to meet the quality management system of the LAC-UFPE: reagents, certified reference material, of equipment parts, maintenance and calibration of equipment and instruments. It was found that the most critical item is the certified reference material, the purchase or repair of which must be expedited within 125 days prior to the receipt to occur within the desired period.

Evaluation of Virological Microparticle Enzyme Immunoassay According to the ISO 15189: Real-Life Experience in a University Hospital.

Science.gov (United States)

Lafontaine, Sophie; Prin-Mathieu, Christine; Velay, Aurélie; Agulles, Odette; Schvoerer, Evelyne; Jeulin, Hélène

2016-01-01

The International Standard ISO 15189 based on the ISO 9001:2008 emphasizes specific requirements for quality and ability of medical laboratories. The accreditation of medical laboratories according to ISO 15189 includes the validation of biological methods, which depends on collection of bibliographic data and experimental proofs. Moreover, these results must be compared to provider data sheets and independent scientific data. In the immunodiagnostic field, independent published data are deeply lacking. The aim of our work was to share experience of method validation for virological immune markers on the widely used Architect i2000sr. After risk analysis, intra- and inter-assay variability, and inter-sample contamination were evaluated for each method, and sensitivity was investigated for antigen detection tests. A comparison between the two Architect i2000sr available in our laboratory was also performed. All tested methods were consistent with the manufacturer data (from the data sheet). No inter-sample contamination was observed. Both devices are broadly equivalent and can be used indifferently or as a backup solution of the other. To our knowledge, those results are the first independent complete data on the reliability of the Architect i2000sr in real-life experience. These data are needed to the accreditation of our platform and potentially useful for the accreditation of other laboratories using the same equipment.

Verification and accreditation schemes for climate change activities: A review of requirements for verification of greenhouse gas reductions and accreditation of verifiers—Implications for long-term carbon sequestration

Science.gov (United States)

Roed-Larsen, Trygve; Flach, Todd

The purpose of this chapter is to provide a review of existing national and international requirements for verification of greenhouse gas reductions and associated accreditation of independent verifiers. The credibility of results claimed to reduce or remove anthropogenic emissions of greenhouse gases (GHG) is of utmost importance for the success of emerging schemes to reduce such emissions. Requirements include transparency, accuracy, consistency, and completeness of the GHG data. The many independent verification processes that have developed recently now make up a quite elaborate tool kit for best practices. The UN Framework Convention for Climate Change and the Kyoto Protocol specifications for project mechanisms initiated this work, but other national and international actors also work intensely with these issues. One initiative gaining wide application is that taken by the World Business Council for Sustainable Development with the World Resources Institute to develop a "GHG Protocol" to assist companies in arranging for auditable monitoring and reporting processes of their GHG activities. A set of new international standards developed by the International Organization for Standardization (ISO) provides specifications for the quantification, monitoring, and reporting of company entity and project-based activities. The ISO is also developing specifications for recognizing independent GHG verifiers. This chapter covers this background with intent of providing a common understanding of all efforts undertaken in different parts of the world to secure the reliability of GHG emission reduction and removal activities. These verification schemes may provide valuable input to current efforts of securing a comprehensive, trustworthy, and robust framework for verification activities of CO2 capture, transport, and storage.

Framework for establishing records control in hospitals as an ISO 9001 requirement.

Science.gov (United States)

Al-Qatawneh, Lina

2017-02-13

Purpose The purpose of this paper is to present the process followed to control records in a Jordanian private community hospital as an ISO 9001:2008 standard requirement. Design/methodology/approach Under the hospital quality council's supervision, the quality management and development office staff were responsible for designing, planning and implementing the quality management system (QMS) using the ISO 9001:2008 standard. A policy for records control was established. An action plan for establishing the records control was developed and implemented. On completion, a coding system for records was specified to be used by hospital staff. Finally, an internal audit was performed to verify conformity to the ISO 9001:2008 standard requirements. Findings Successful certification by a neutral body ascertained that the hospital's QMS conformed to the ISO 9001:2008 requirements. A framework was developed that describes the records controlling process, which can be used by staff in any healthcare organization wanting to achieve ISO 9001:2008 accreditation. Originality/value Given the increased interest among healthcare organizations to achieve the ISO 9001 certification, the proposed framework for establishing records control is developed and is expected to be a valuable management tool to improve and sustain healthcare quality.

Interim Report on ISO TC 163 Working Group 3. Annual progress report

Energy Technology Data Exchange (ETDEWEB)

Fairey, Philip [Florida Solar Energy Center, Cocoa, FL (United States)

2009-04-02

This reports cover the initial year efforts of the International Standards Organization (ISO) to develop international standards for rating the energy performance of buildings. The author of this report is a participant in this effort. This report summarizes the activities of the ISO Working Group charged with development of these standards and makes recommendations to the sponsors for future U.S. involvement in this ISO effort.

Accreditation of medical laboratories in Croatia--experiences of the Institute of Clinical Chemistry, University Hospital "Merkur", Zagreb.

Science.gov (United States)

Flegar-Mestrić, Zlata; Nazor, Aida; Perkov, Sonja; Surina, Branka; Kardum-Paro, Mirjana Mariana; Siftar, Zoran; Sikirica, Mirjana; Sokolić, Ivica; Ozvald, Ivan; Vidas, Zeljko

2010-03-01

Since 2003 when the international norm for implementation of quality management in medical laboratories (EN ISO 15189, Medical laboratories--Particular requirements for quality and competence) was established and accepted, accreditation has become practical, generally accepted method of quality management and confirmation of technical competence of medical laboratories in the whole world. This norm has been translated into Croatian and accepted by the Croatian Institute for Norms as Croatian norm. Accreditation is carried out on voluntary basis by the Croatian Accreditation Agency that has up to now accredited two clinical medical biochemical laboratories in the Republic of Croatia. Advantages of accredited laboratory lie in its documented management system, constant improvement and training, reliability of test results, establishing users' trust in laboratory services, test results comparability and interlaboratory (international) test results acceptance by adopting the concept of metrological traceability in laboratory medicine.

[Certification of an ambulatory gastroenterologic service fulfilling ISO Law 9001--criteria and national guidelines of the Gastroenterologic Association].

Science.gov (United States)

Birkner, B

2000-09-01

The objectives of certification and accreditation are the deployment and examination of quality improvement measures in health care services. The quality management system of the ISO 9001 is created to install measures and tools leading to assured and improved quality in health care. Only some experiences with certification fulfilling ISO 9001 criteria exist in the German health care system. Evidence-based clinical guidelines can serve as references for the development of standards in quality measurement. Only little data exists on the implementation strategy of guidelines and evaluation, respectively. A pilot quality management system in consistence with ISO 9001 criteria was developed for ambulatory, gastroenterological services. National guidelines of the German Society of Gastroenterology and Metabolism and the recommendations of the German Association of Physicians for quality assurance of gastrointestinal endoscopy were included in the documentation and internal auditing. This pilot quality management system is suitable for the first steps in the introduction of quality management in ambulatory health care. This system shows validity for accreditation and certification of gastrointestinal health care units as well.

Approaches to quality management and accreditation in a genetic testing laboratory

Science.gov (United States)

Berwouts, Sarah; Morris, Michael A; Dequeker, Elisabeth

2010-01-01

Medical laboratories, and specifically genetic testing laboratories, provide vital medical services to different clients: clinicians requesting a test, patients from whom the sample was collected, public health and medical-legal instances, referral laboratories and authoritative bodies. All expect results that are accurate and obtained in an efficient and effective manner, within a suitable time frame and at acceptable cost. There are different ways of achieving the end results, but compliance with International Organization for Standardization (ISO) 15189, the international standard for the accreditation of medical laboratories, is becoming progressively accepted as the optimal approach to assuring quality in medical testing. We present recommendations and strategies designed to aid genetic testing laboratories with the implementation of a quality management system, including key aspects such as document control, external quality assessment, internal quality control, internal audit, management review, validation, as well as managing the human side of change. The focus is on pragmatic approaches to attain the levels of quality management and quality assurance required for accreditation according to ISO 15189, within the context of genetic testing. Attention is also given to implementing efficient and effective quality improvement. PMID:20720559

The effect of certification and accreditation on quality management in 4 clinical services in 73 European hospitals.

NARCIS (Netherlands)

Shaw, C.D.; Groene, O.; Botje, D.; Suñol, R.; Kutryba, B.; Klazinga, N.; Bruneau, C.; Hammer, A.; Wang, A.; Arah, O.A.; Wagner, C.

2014-01-01

Objective: To investigate the relationship between ISO 9001 certification, healthcare accreditation and quality management in European hospitals. Design: A mixed method multi-level cross-sectional design in seven countries. External teams assessed clinical services on the use of quality management

[ISO 9001-2000 certification for refractive laser treatment].

Science.gov (United States)

Lebuisson, D A; Arson, B; Abenhaïm, A; Albou-Ganem, C; Assouline, M; Chong Sit, D; Danan, A; Montefiore, G; Montin, J-F; Nguyen-Khoa, J-L; Pietrini, D; Saragoussi, J-J; Trong, Th; Amar, R

2005-05-01

To obtain ISO 9001-2000 certification for laser corneal refractive treatment, never before sought in Europe. The consulting firm Veritas led the certification process with the clinic's staff manager. This ISO norm is dedicated to the implementation of a quality management system. We assessed and optimized all necessary resources, evaluating customer satisfaction using patient and referring-physician surveys. We started quality rounds including surgeons, nurses, and technicians. Based on this preparation, we redefined and explained all processes including staff responsibilities and necessary resources in the quality manual. The procedure lasted 14 months with substantial involvement on the part of the management. Unconditional ISO 9001-2000 certification was granted by the independent audit firm, BVQI, in december 2003 for refractive laser treatment. The 2000 version of the new ISO 9001-2000 seeks to meet the demand for improving health care delivery in this field, most particularly by establishing a clear procedural orientation. Such certification enhances team work, stabilizes methodologies, and reinforces cohesion and self-audit. Patients notice that the center follows a consistent quality policy and are assured that the clinic respects rules and regulations. Certification is an advantageous alternative when accreditation cannot be considered. Our article discusses the steps taken in upper management, quality management, procedural guidance, as well as customer and staff counselling. It also discusses the project's cost/benefit ratio for the organization.

Towards better GHG emissions savings with use of ISO GHG standards

International Nuclear Information System (INIS)

Chan Kook Weng

2010-01-01

The 15th Conference of Parties (COP 15) at Copenhagen, Denmark in December 2009 highlighted the need to combat climate change by facing the challenge of committing to reducing our emissions at all three levels with locally appropriate mitigation actions (LAMAs) at the local level to be linked to the nationally appropriate mitigation actions (NAMAs) and then contribute onwards to globally appropriate mitigation actions (GAMAs). The aim is to find solutions for both adaptation and mitigation by ensuring sufficient means are made available to support such efforts. This is because the world in entering a new phase that will be characterised by green growth in business. Thus be it agriculture that uses local knowledge of specific crop and livestock varieties to help in secure food supply, bio-energy, transport, industries, there must be policies to understand ecosystem-based to link people, biodiversity, energy, water and carbon so as to be more resilient and adaptable to the need for a low carbon economy in todays society.Climate change therefore affects organisations in many areas and they include legal compliance, carbon market, corporate social responsibility and sustainable development. Promoting sustainability requires making efficient use of energy, water and natural resources, decrease in waste load through recycling and streamlining the processes leading to everything that decreases their CO 2 and water footprints. Currently there are many GHG schemes and programmes and the issues centres around compatibility, costs and most importantly credibility. Achieving real GHG emissions reduction requires controlled and verified emissions reductions and quantification that are sound and verifiable. Thanks to the development of the ISO suite of standards on GHG and related matters, the use of these harmonised standards has given the assurance that a tonne of carbon is a tonne of carbon be it in Malaysia, Mali or Mongolia.The use of these standards like ISO 14064 Part 1

Health Physics Society program for accreditation of calibration laboratories

International Nuclear Information System (INIS)

West, L.; Masse, F.X.; Swinth, K.L.

1988-01-01

The Health Physics Society has instituted a new program for accreditation of organizations that calibrate radiation survey instruments. The purpose of the program is to provide radiation protection professionals with an expanded means of direct and indirect access to national standards, thus introducing a means for improving the uniformity, accuracy, and quality of ionizing radiation field measurements. Secondary accredited laboratories are expected to provide a regional support basis. Tertiary accredited laboratories are expected to operate on a more local basis and provide readily available expertise to end users. The accreditation process is an effort to provide better measurement assurance for surveys of radiation fields. The status of the accreditation program, general criteria, gamma-ray calibration criteria, and x-ray calibration criteria are reviewed

ICARE improves antinuclear antibody detection by overcoming the barriers preventing accreditation.

Science.gov (United States)

Bertin, Daniel; Mouhajir, Yassin; Bongrand, Pierre; Bardin, Nathalie

2016-02-15

Antinuclear antibodies (ANA) are useful biomarkers for the diagnosis and the monitoring of rheumatic diseases. The American College of Rheumatology has stated that indirect immunofluorescence (IIF) analysis remains the gold standard for ANA screening. However, IIF is time consuming, subjective, not fully standardized and presents several issues for accreditation which is the process leading to ISO 15189 certification for medical laboratories. We propose an innovative tool for accreditation by using the quantitative evaluation of the automated image capture and analysis "ICARE" (Immunofluorescence for Computed Antinuclear antibody Rational Evaluation). We established the optimal screening dilution (1:160) and a fluorescence index (FI) cutoff for ICARE on a cohort of 91 healthy blood donors. Then, we evaluated performance of ICARE on a routine cohort of 236 patients. Precision parameters of ANA detection by IIF were evaluated according to ISO 15189. ICARE showed an excellent concordance with visual evaluation (88%, Kappa=0.76) and significantly discriminated between weak to moderate (1:160-1:320 titers) and high (>1:320 titers) ANA levels. A significant correlation was found between FI and ANA titers (Spearman's ρ=0.67; Pprocess of continuous improvement of the quality of clinical laboratories. Copyright © 2015 Elsevier B.V. All rights reserved.

Development of a Contact Permeation Test Fixture and Method

Science.gov (United States)

2013-04-01

Permeation and Analytical Solutions Team Quality System documentation and the guidance found in the ISO 17025 standard. All permeation and...annular ring (left) and no pressure (right). 2.2.4 Quality Controls Analytical permeation testing was conducted in accordance with ISO 17025 quality...internal standard. This mixture was vortexed for 20–30 s then centrifuged at 15,000 rpm for 5 min in a Micromax microcentrifuge (Thermo IEC ; Needham

Metrology Measurement Capabilities

Energy Technology Data Exchange (ETDEWEB)

Dr. Glen E. Gronniger

2007-10-02

This document contains descriptions of Federal Manufacturing & Technologies (FM&T) Metrology capabilities, traceability flow charts, and the measurement uncertainty of each measurement capability. Metrology provides NIST traceable precision measurements or equipment calibration for a wide variety of parameters, ranges, and state-of-the-art uncertainties. Metrology laboratories conform to the requirements of the Department of Energy Development and Production Manual Chapter 13.2, ANSI/ISO/IEC ANSI/ISO/IEC 17025:2005, and ANSI/NCSL Z540-1. FM&T Metrology laboratories are accredited by NVLAP for the parameters, ranges, and uncertainties listed in the specific scope of accreditation under NVLAP Lab code 200108-0. See the Internet at http://ts.nist.gov/Standards/scopes/2001080.pdf. These parameters are summarized. The Honeywell Federal Manufacturing & Technologies (FM&T) Metrology Department has developed measurement technology and calibration capability in four major fields of measurement: (1) Mechanical; (2) Environmental, Gas, Liquid; (3) Electrical (DC, AC, RF/Microwave); and (4) Optical and Radiation. Metrology Engineering provides the expertise to develop measurement capabilities for virtually any type of measurement in the fields listed above. A strong audit function has been developed to provide a means to evaluate the calibration programs of our suppliers and internal calibration organizations. Evaluation includes measurement audits and technical surveys.

The standards forum: Volume 6, Number 3 -- December 1998

Energy Technology Data Exchange (ETDEWEB)

NONE

1998-12-01

This issue contains the following articles: NIST--A call for a national standards strategy; Fourth integrated safety management lessons learned workshop; TSP [Technical Standards Program] publications support moves to headquarters; Comments on the role of the federal government in environmental technology development; Technical standards manager spotlight; Topical committee developments: Quality assurance topical committee plays an active role in the TSP, New DOE accreditation committee targets issues and resolutions at first annual meeting, DOE fire safety committee meeting in New Orleans, Third annual DOE metrology committee meeting coming in March 1999, The biota dose assessment committee providing a major forum and technical resource for DOE, and A performance-based management handbook in the works; DOE technical standards projects initiated; Recently published DOE documents; Non-government standards: American National Standards Institute and American Society for Testing and Materials; Most DOE comments on ISO 17025 upheld by ANSI review committee; and ISO 9000 compliance--Changes in the future.

States Moving from Accreditation to Accountability. Accreditation: State School Accreditation Policies

Science.gov (United States)

Wixom, Micah Ann

2014-01-01

Accreditation policies vary widely among the states. Since Education Commission of the States last reviewed public school accreditation policies in 1998, a number of states have seen their legislatures take a stronger role in accountability--resulting in a move from state-administered accreditation systems to outcomes-focused state accountability…

45 CFR 170.499 - Incorporation by reference.

Science.gov (United States)

2010-10-01

..., Switzerland, telephone +41-22-749-01-11, http://www.iso.org. (1) ISO/IEC 17025 General Requirements for the... and § 170.423. (2) ISO/IEC GUIDE 65 General Requirements for Bodies Operating Product Certification...

Quality assurance and accreditation.

Science.gov (United States)

1997-01-01

In 1996, the Joint Commission International (JCI), which is a partnership between the Joint Commission on Accreditation of Healthcare Organizations and Quality Healthcare Resources, Inc., became one of the contractors of the Quality Assurance Project (QAP). JCI recognizes the link between accreditation and quality, and uses a collaborative approach to help a country develop national quality standards that will improve patient care, satisfy patient-centered objectives, and serve the interest of all affected parties. The implementation of good standards provides support for the good performance of professionals, introduces new ideas for improvement, enhances the quality of patient care, reduces costs, increases efficiency, strengthens public confidence, improves management, and enhances the involvement of the medical staff. Such good standards are objective and measurable; achievable with current resources; adaptable to different institutions and cultures; and demonstrate autonomy, flexibility, and creativity. The QAP offers the opportunity to approach accreditation through research efforts, training programs, and regulatory processes. QAP work in the area of accreditation has been targeted for Zambia, where the goal is to provide equal access to cost-effective, quality health care; Jordan, where a consensus process for the development of standards, guidelines, and policies has been initiated; and Ecuador, where JCI has been asked to help plan an approach to the evaluation and monitoring of the health care delivery system.

ENERGY MANAGEMENT SYSTEMS AND ISO 50001 ACCREDITATION IN SHIPPING

Directory of Open Access Journals (Sweden)

BRANISLAV DRAGOVIŠ

2017-12-01

Full Text Available The shipping sector is facing new challenges in energy consumption and management. In a recent study conducted by the European Sea Ports Organization (ESPO has shown that energy consumption has risen from 7th place in 2009, to 2nd in 2016, as far as the 10 environmental priorities of European ports. Energy management is seen as the greatest risk for shipping companies, due to the variability existing in the oil and gas markets, in recent decades. Unsuccessful energy management strategies have been shown to have serious consequences for the natural environment, as well as for the companies themselves, which include the enhancement of global warming, and the destruction of a positive corporate image/reputation. Due to this, shipping companies now consider energy as an integral part of their overall strategy and adopt risk management assessments in order to attain the best returns on their investments. The ISO 50001 standard provides a useful tool to companies that are eager to develop and apply an efficient energy strategy consistent with modern Social Corporate Responsibility requirements and aspirations.

ARN results in interlaboratory comparison exercises

International Nuclear Information System (INIS)

Equillor, Hugo; Lewis, Cecilia; Fernandez, Jorge; Canoba, Analia; Gavini, Ricardo; Grinman, Ana; Palacios, Miguel; Sartori, Francisco; Giustina, Daniel; Gnoni, Gabriela; Czerniczyniec, Mariela; Cialella, Hugo; Acosta, Soledad; Diodati, Jorge; Bonino, Nestor; Campos, Juan; Mondini, Julia; Franco, Graciela

2008-01-01

For years, the Nuclear Regulatory Authority (ARN) has been involved in several laboratory intercomparison programmes. The objective of participating in these exercises is to assure the quality of the determinations that the radiochemical laboratories of ARN carries out as part of its regulatory activity. Most of these determinations are related to its environmental monitoring program in the vicinity of nuclear and radioactive facilities existing in the country, in operation or not. Other determinations are related with effluent samples and monitoring activities performed inside the facilities. On the other hand, these intercomparisons are part of the requirements for the laboratories under ISO 17025. ARN laboratories are in process to obtain or maintain ISO 17025 accreditation as a priority objective. During the development of the intercomparisons, different samples have been tested in several matrices containing alpha, beta and gamma emitters. These exercises were organized by different laboratories as the IAEA, the EML and NIST from United States, the NPL and the NRPB from England, the BFS from Germany, and so on. The results were very satisfactory not only in direct measurements (gamma spectrometry) but also in those that require a previous intensive laboratory processing (alpha spectrometry and liquid scintillation), resulting in many cases better than the general average. This paper provides a summary of the results obtained in these exercises and the results are compared with the overall average of the participating laboratories. (author)

On-site and off-site forensic analysis capabilities for proliferation and terrorism prevention

International Nuclear Information System (INIS)

Whipple, R.E.; Nunes, P.J.; Reynolds, J.G.; Alcaraz, A.; Hart, B.R.

2004-01-01

Full text: We will present current on-site technologies that can be utilized for the screening of explosives, chemical agents, and environmental contaminants. These techniques must have the capability to detect various hazardous materials at very low levels, since they pose a major challenge for first responders. Specifically, the technology must detect concealed explosives or chemical agents on-site rapidly. Lawrence Livermore National Laboratory (LLNL) is currently developing several different high explosive screening and detection technologies for field use. Two technologies that have demonstrated an ability to screen for explosives at low levels are colorimetric spot tests and thin layer chromatography (TLC). Another technology that has demonstrated usefulness for the on-site analysis of unknowns is portable gas chromatography-mass spectrometry (GC-MS) with solid phase micro-extraction (SPME) sampling. Several examples utilizing these technologies and their usefulness will be presented. In addition to developing on-site screening methods, LLNL is an Organization for the Prohibition of Chemical Weapons (OPCW) designated laboratory and is certified to accept CW suspect samples. Currently, LLNL is expanding its ISO-17025 certification to include nuclear forensics and explosives. These off-site forensic analysis capabilities and certified procedures will support the needs for homeland security. We will highlight some of the ISO-17025 requirements to accredit procedures, handle samples, and reports. Work performed under the auspices of the U.S. Department of Energy by Lawrence Livermore National Laboratory under contract W-7405-ENG-48

On-site and off-site forensic analysis capabilities for proliferation and terrorism prevention

International Nuclear Information System (INIS)

Hart, B.R.; Whipple, R.E.; Nunes, P.J.; Reynolds, J.G.; Alcaraz, A.

2004-01-01

We present current on-site technologies that can be utilized for the screening of explosives, chemical agents, and environmental contaminants. These techniques must have the capability to detect various hazardous materials at very low levels, since they pose a major challenge for first responders. Specifically, the technology must detect concealed explosives or chemical agents on-site rapidly. Lawrence Livermore National Laboratory (LLNL) is currently developing several different high explosive screening and detection technologies for field use. Two technologies that have demonstrated an ability to screen for explosives at low levels are colorimetric spot tests and thin layer chromatography (TLC). Another technology that has demonstrated usefulness for the on-site analysis of unknowns is portable gas chromatography-mass spectrometry (GC-MS) with solid phase micro-extraction (SPME) sampling. Several examples utilizing these technologies and their usefulness will be presented. In addition to developing on-site screening methods, LLNL is an Organization for the Prohibition of Chemical Weapons (OPCW) designated laboratory and is certified to accept CW suspect samples. Currently, LLNL is expanding its ISO-17025 certification to include nuclear forensics and explosives. These off-site forensic analysis capabilities and certified procedures will support the needs for homeland security. We will highlight some of the ISO-17025 requirements to accredit procedures, handle samples, and reports. Work performed under the auspices of the U.S. Department of Energy by Lawrence Livermore National Laboratory under contract W-7405-ENG-48. (author)

Public Health Agency Accreditation Among Rural Local Health Departments: Influencers and Barriers.

Science.gov (United States)

Beatty, Kate E; Erwin, Paul Campbell; Brownson, Ross C; Meit, Michael; Fey, James

Health department accreditation is a crucial strategy for strengthening public health infrastructure. The purpose of this study was to investigate local health department (LHD) characteristics that are associated with accreditation-seeking behavior. This study sought to ascertain the effects of rurality on the likelihood of seeking accreditation through the Public Health Accreditation Board (PHAB). Cross-sectional study using secondary data from the 2013 National Association of County & City Health Officials (NACCHO) National Profile of Local Health Departments Study (Profile Study). United States. LHDs (n = 490) that responded to the 2013 NACCHO Profile Survey. LHDs decision to seek PHAB accreditation. Significantly more accreditation-seeking LHDs were located in urban areas (87.0%) than in micropolition (8.9%) or rural areas (4.1%) (P < .001). LHDs residing in urban communities were 16.6 times (95% confidence interval [CI], 5.3-52.3) and micropolitan LHDs were 3.4 times (95% CI, 1.1-11.3) more likely to seek PHAB accreditation than rural LHDs (RLHDs). LHDs that had completed an agency-wide strategic plan were 8.5 times (95% CI, 4.0-17.9), LHDs with a local board of health were 3.3 times (95% CI, 1.5-7.0), and LHDs governed by their state health department were 12.9 times (95% CI, 3.3-50.0) more likely to seek accreditation. The most commonly cited barrier was time and effort required for accreditation application exceeded benefits (73.5%). The strongest predictor for seeking PHAB accreditation was serving an urban jurisdiction. Micropolitan LHDs were more likely to seek accreditation than smaller RLHDs, which are typically understaffed and underfunded. Major barriers identified by the RLHDs included fees being too high and the time and effort needed for accreditation exceeded their perceived benefits. RLHDs will need additional financial and technical support to achieve accreditation. Even with additional funds, clear messaging of the benefits of accreditation

[ISO 9001:2015 Certification in Quality Management].

Science.gov (United States)

Enders, Christian; Lang, Gabriele E; Lang, Gerhard K; Werner, Jens Ulrich

2017-07-01

Quality management improves the structures, processes and results of organizations of all kinds. Many practices and clinics have their existing quality management system certified according to ISO 9001, (e.g., to check their own quality management system or to obtain a testimonial against third parties). The latest version ISO 9001:2015 contains some changes, both structurally and in terms of content. These changes can be met with reasonable efforts. An ISO 9001:2015 certification represents a value for your organization, but these advantages are often not directly measurable. Georg Thieme Verlag KG Stuttgart · New York.

Achievements and advantages of participation in the IAEA project RER 002/004/1999-2001 'QA/QC of Nuclear Analytical Techniques'

International Nuclear Information System (INIS)

Vata, Ion; Cincu, Em.

2002-01-01

The National Institute for Physics and Engineering 'Horia Hulubei' (IFIN-HH) decided in the late 1990s to start applying nuclear techniques in economy and social life on a routine scale; reaching this goal implied achieving first-rate analytical performances and complying with the QA/QC requirements, as detailed in the ISO 17025. The IAEA Project appeared in 1999 as the best opportunity and tool for our specialists to become familiar with the standard requirements and begin to implement them in their operations, thus further enabling them to apply for accreditation according to the international criteria. This report outlines the experience gained from the participation in the project. The accomplishments of the project are presented and the main difficulties are identified

Evaluation of surface contamination based on certifiably traceable, internationally accreditable measurements

International Nuclear Information System (INIS)

Whitlock, G.D.

1992-01-01

National Accreditation and Measurement Service (NAMAS) adopted by the EUROMET agreement requires that the calibration of monitoring instruments be traceable internationally with the objective that radiation hazard assessment be improved. This objective is achieved for Tritium surface contamination by employing calibration sources and evaluation methods which comply with ISO standards including the measurement of activity removable by Volatilization as well as dust. Consideration should be given to organic binding of tritium in the skin with its implications in the event of litigation. (author)

Methodology of ABNT ISO/IEC GUIA 25 implantation in the laboratories of radionuclides analysis in environmental samples of the Analysis Division/CNEN

International Nuclear Information System (INIS)

Oliveira, Josue Peter de

1997-07-01

The ISO/EEC Guide 25: 1993 Standard G eneral requirements for the competence of calibration and testing laboratories . Is published in Brazil by Brazilian Association for Technical Standards (ABNT) as ABNT ISO/DEC GUIA 25 and establishes general requirements a laboratory must demonstrate to meet, in order to be recognized as having technical competence (accreditation) to carry out specifics calibration or testing. Therefore, the accredited laboratory starts, respectively, taking part from the Brazilian Calibration Network (RBC) or from the Brazilian Testing Laboratories Network (RBLE) . The Environmental Radioanalysis Division (DIAMB) from Environmental Radiological Protection Department (DEPRA) from Institute of Radiation Protection and Dosimetry (IRD) from Brazilian National Nuclear Energy Commission (CNEN) is a laboratory responsible for analyzing radionuclides deriving for the samples from DEPRA's Surveillance Program, research and servings, due to an eventual radionuclide contamination in environment, foods and others raw materials for human consumption; including for importation and exportation products certification purposes. For all these reasons, DIAMB needs its formal recognition for carrying out radionuclides analysis in environmental samples. This work aims to provide a methodology in order to guide a laboratory which has the intention to implement a accreditation process. It also describes policies to meet the requirements related to the Standard, guidance needed to specification of some steps and also comments some points from the Standard in order to become easier all the accreditation process comprehension. (author)

76 FR 52548 - National Veterinary Accreditation Program; Currently Accredited Veterinarians Performing...

Science.gov (United States)

2011-08-23

.... APHIS-2006-0093] RIN 0579-AC04 National Veterinary Accreditation Program; Currently Accredited... accredited in the National Veterinary Accreditation Program (NVAP) may continue to perform accredited duties..., 2011. FOR FURTHER INFORMATION CONTACT: Dr. Todd Behre, National Veterinary Accreditation Program, VS...

Mammography accreditation program

Energy Technology Data Exchange (ETDEWEB)

Wilcox, P.

1993-12-31

In the mid-1980`s, the movement toward the use of dedicated mammography equipment provided significant improvement in breast cancer detection. However, several studies demonstrated that this change was not sufficient to ensure optimal image quality at a low radiation dose. In particular, the 1985 Nationwide Evaluation of X-ray Trends identified the wide variations in image quality and radiation dose, even from dedicated units. During this time period, the American Cancer Society (ACS) launched its Breast Cancer Awareness Screening Campaign. However, there were concerns about the ability of radiology to respond to the increased demand for optimal screening examinations that would result from the ACS program. To respond to these concerns, the ACS and the American College of Radiology (ACR) established a joint committee on mammography screening in 1986. After much discussion, it was decided to use the ACR Diagnostic Practice Accreditation Program as a model for the development of a mammography accreditation program. However, some constraints were required in order to make the program meet the needs of the ACS. This voluntary, peer review program had to be timely and cost effective. It was determined that the best way to address these needs would be to conduct the program by mail. Finally, by placing emphasis on the educational nature of the program, it would provide an even greater opportunity for improving mammographic quality. The result of this effort was that, almost six years ago, in May 1987, the pilot study for the ACR Mammography Accreditation Program (MAP) began, and in August of that year, the first applications were received. In November 1987, the first 3-year accreditation certificates were awarded.

Mammography accreditation program

International Nuclear Information System (INIS)

Wilcox, P.

1993-01-01

In the mid-1980's, the movement toward the use of dedicated mammography equipment provided significant improvement in breast cancer detection. However, several studies demonstrated that this change was not sufficient to ensure optimal image quality at a low radiation dose. In particular, the 1985 Nationwide Evaluation of X-ray Trends identified the wide variations in image quality and radiation dose, even from dedicated units. During this time period, the American Cancer Society (ACS) launched its Breast Cancer Awareness Screening Campaign. However, there were concerns about the ability of radiology to respond to the increased demand for optimal screening examinations that would result from the ACS program. To respond to these concerns, the ACS and the American College of Radiology (ACR) established a joint committee on mammography screening in 1986. After much discussion, it was decided to use the ACR Diagnostic Practice Accreditation Program as a model for the development of a mammography accreditation program. However, some constraints were required in order to make the program meet the needs of the ACS. This voluntary, peer review program had to be timely and cost effective. It was determined that the best way to address these needs would be to conduct the program by mail. Finally, by placing emphasis on the educational nature of the program, it would provide an even greater opportunity for improving mammographic quality. The result of this effort was that, almost six years ago, in May 1987, the pilot study for the ACR Mammography Accreditation Program (MAP) began, and in August of that year, the first applications were received. In November 1987, the first 3-year accreditation certificates were awarded

Review of Hangar Door Design of Mountain Home AFB (MHAFB) Refurbished Non-Destructive Inspection (NDI) Facility

Science.gov (United States)

2012-06-18

Blonetics Corporation, Newark Metrology Operations, complies with the requirements of the current version of ISO / IEC 17025 on the date of...requirements of the current version of ISOIIEC 17025 on the date of calibration. 2. This report may not be reproduced, except rn full, without

78 FR 37760 - Electrical Equipment in Hazardous Locations

Science.gov (United States)

2013-06-24

... Standardization ISO/IEC Standard 17025 and related IECEx procedures. The ExTL tests the subject equipment and...)/IEC Standard 17025 and related IECEx Operational Documents and Rules of Procedure. Some foreign flag... internationally accepted independent third-party certification system, the IEC System for Certification to...

Impact of laboratory accreditation on patient care and the health system.

Science.gov (United States)

Peter, Trevor F; Rotz, Philip D; Blair, Duncan H; Khine, Aye-Aye; Freeman, Richard R; Murtagh, Maurine M

2010-10-01

Accreditation is emerging as a preferred framework for building quality medical laboratory systems in resource-limited settings. Despite the low numbers of laboratories accredited to date, accreditation has the potential to improve the quality of health care for patients through the reduction of testing errors and attendant decreases in inappropriate treatment. Accredited laboratories can become more accountable and less dependent on external support. Efforts made to achieve accreditation may also lead to improvements in the management of laboratory networks by focusing attention on areas of greatest need and accelerating improvement in areas such as supply chain, training, and instrument maintenance. Laboratory accreditation may also have a positive influence on performance in other areas of health care systems by allowing laboratories to demonstrate high standards of service delivery. Accreditation may, thus, provide an effective mechanism for health system improvement yielding long-term benefits in the quality, cost-effectiveness, and sustainability of public health programs. Further studies are needed to strengthen the evidence on the benefits of accreditation and to justify the resources needed to implement accreditation programs aimed at improving the performance of laboratory systems.

[Implementation of the technical requirements of the UNE-EN-ISO 15189 quality standard in a mycobacterial laboratory].

Science.gov (United States)

Guna Serrano, M del Remedio; Ocete Mochón, M Dolores; Lahiguera, M José; Bresó, M Carmen; Gimeno Cardona, Concepción

2013-02-01

The UNE-EN-ISO 15189:2007 standard defines the requirements for quality and competence that must be met by medical laboratories. These laboratories should use this international standard to develop their own quality management systems and to evaluate their own competencies; in turn, this standard will be used by accreditation bodies to confirm or recognize the laboratories' competence. In clinical microbiology laboratories, application of the standard implies the implementation of the technical and specific management requirements that must be met to achieve optimal quality when carrying out microbiological tests. In Spain, accreditation is granted by the Spanish Accreditation Body (Entidad Nacional de Acreditación). This review aims to discuss the practical application of the standard's technical requirements in mycobacterial laboratory. Firstly, we define the scope of accreditation. Secondly, we specify how the items of the standard on personnel management, control of equipment, environmental facilities, method validation, internal controls and customer satisfaction surveys were developed and implemented in our laboratory. Copyright © 2013 Elsevier España, S.L. All rights reserved.

Quality assurance and accreditation of engineering education in Jordan

Science.gov (United States)

Aqlan, Faisal; Al-Araidah, Omar; Al-Hawari, Tarek

2010-06-01

This paper provides a study of the quality assurance and accreditation in the Jordanian higher education sector and focuses mainly on engineering education. It presents engineering education, accreditation and quality assurance in Jordan and considers the Jordan University of Science and Technology (JUST) for a case study. The study highlights the efforts undertaken by the faculty of engineering at JUST concerning quality assurance and accreditation. Three engineering departments were accorded substantial equivalency status by the Accreditation Board of Engineering and Technology in 2009. Various measures of quality improvement, including curricula development, laboratories improvement, computer facilities, e-learning, and other supporting services are also discussed. Further assessment of the current situation is made through two surveys, targeting engineering instructors and students. Finally, the paper draws conclusions and proposes recommendations to enhance the quality of engineering education at JUST and other Jordanian educational institutions.

A review of the UK methodology used for monitoring cigarette smoke yields, aspects of analytical data variability and their impact on current and future regulatory compliance.

Science.gov (United States)

Purkis, Stephen W; Drake, Linda; Meger, Michael; Mariner, Derek C

2010-04-01

The European Union (EU) requires that tobacco products are regulated by Directive 2001/37/EC through testing and verification of results on the basis of standards developed by the International Organization for Standardization (ISO). In 2007, the European Commission provided guidance to EU Member States by issuing criteria for competent laboratories which includes accreditation to ISO 17025:2005. Another criterion requires regular laboratory participation in collaborative studies that predict the measurement tolerance that must be observed to conclude that test results on any particular product are different. However, differences will always occur when comparing overall data across products between different laboratories. A forum for technical discussion between laboratories testing products as they are manufactured and a Government appointed verification laboratory gives transparency, ensures consistency and reduces apparent compliance issues to the benefit of all parties. More than 30years ago, such a forum was set up in the UK that continued until 2007 and will be described in this document. Anticipating further testing requirements in future product regulation as proposed by the Framework Convention on Tobacco Control, cooperation between accredited laboratories, whether for testing or verification, should be established to share know-how, to ensure a standardised level of quality and to offer competent technical dialogue in the best interest of regulators and manufacturers alike. Copyright 2009 Elsevier Inc. All rights reserved.

Screening Samples for Arsenic by Inductively Coupled Plasma-Mass Spectrometry for Treaty Samples

Science.gov (United States)

2014-02-01

quality system in accordance with International Organization for Standardization/International Electrotechnical Commission ( ISO / IEC ) 17025 :2005...plasma-mass spectrometry ISO / IEC International Organization for Standardization/International Electrotechnical Commission L lewisite MDL method

Dose levels of the occupational radiation exposures in Poland based on results from the accredited dosimetry service at the IFJ PAN, Krakow.

Science.gov (United States)

Budzanowski, Maciej; Kopeć, Renata; Obryk, Barbara; Olko, Paweł

2011-03-01

Individual dosimetry service based on thermoluminescence (TLD) detectors has started its activity at the Institute of Nuclear Physics (IFJ) in Krakow in 1965. In 2002, the new Laboratory of Individual and Environment Dosimetry (Polish acronym LADIS) was established and underwent the accreditation according to the EN-PN-ISO/IEC 17025 standard. Nowadays, the service is based on the worldwide known standard thermoluminescent detectors MTS-N (LiF:Mg,Ti) and MCP-N (LiF:Mg,Cu,P), developed at IFJ, processed in automatic thermoluminescent DOSACUS or RE2000 (Rados Oy, Finland) readers. Laboratory provides individual monitoring in terms of personal dose equivalent H(p)(10) and H(p)(0.07) in photon and neutron fields, over the range from 0.1 mSv to 1 Sv, and environmental dosimetry in terms of air kerma K(a) over the range from 30 μGy to 1 Gy and also ambient dose equivalent H*(10) over the range from 30 μSv to 1 Sv. Dosimetric service is currently performed for ca. 3200 institutions from Poland and abroad, monitored on quarterly and monthly basis. The goal of this paper is to identify the main activities leading to the highest radiation exposures in Poland. The paper presents the results of statistical evaluation of ∼ 100,000 quarterly H(p)(10) and K(a) measurements performed between 2002 and 2009. Sixty-five per cent up to 90 % of all individual doses in Poland are on the level of natural radiation background. The dose levels between 0.1 and 5 mSv per quarter are the most frequent in nuclear medicine, veterinary and industrial radiography sectors.

Technical Feasibility of Integrated Laboratory in Faculty of Sports Science Universitas Negeri Semarang

Directory of Open Access Journals (Sweden)

Ipang Setiawan

2017-11-01

Full Text Available This research aims to analyze the requirements of technical integrated laboratory FIK Unnes in improving sports achievement in Central Java Province, Indonesia. Research method used in this research was qualitative descriptive, with evaluation approach, the instrument used document analysis, observation, interview and inquiry. Data analysis used by using Miles and Huberman interactive cycle then the pattern tendency was explained, qualitative analysis was initiated by describing reality happened in narration form then it was interpreted by a guidebook with ISO 17025 or SNI 17025 standard in laboratory. The result shows that the requirements of technical integrated laboratory FIK Unnes was quite maximum to contribute in improving sports achievement in Central Java Province, Indonesia, it was based on the technical standard from equipment, personnel, accommodation and environment condition, finding of test and measurement, quality assurance of measurement and test result, and reporting of result conducted based on ISO 17025 or SNI 17025 standard.

75 FR 59605 - National Veterinary Accreditation Program; Currently Accredited Veterinarians Performing...

Science.gov (United States)

2010-09-28

.... APHIS-2006-0093] RIN 0579-AC04 National Veterinary Accreditation Program; Currently Accredited... Veterinary Accreditation Program (NVAP) may continue to perform accredited duties and to elect to continue to..., National Veterinary Accreditation Program, VS, APHIS, 4700 River Road Unit 200, Riverdale, MD 20737; (301...

Pesticide residues determination in Polish organic crops in 2007-2010 applying gas chromatography-tandem quadrupole mass spectrometry.

Science.gov (United States)

Walorczyk, Stanisław; Drożdżyński, Dariusz; Kowalska, Jolanta; Remlein-Starosta, Dorota; Ziółkowski, Andrzej; Przewoźniak, Monika; Gnusowski, Bogusław

2013-08-15

A sensitive, accurate and reliable multiresidue method based on the application of gas chromatography-tandem quadrupole mass spectrometry (GC-QqQ-MS/MS) has been established for screening, identification and quantification of a large number of pesticide residues in produce. The method was accredited in compliance with PN-EN ISO/IEC 17025:2005 standard and it was operated under flexible scope as PB-11 method. The flexible scope of accreditation allowed for minor modifications and extension of the analytical scope while using the same analytical technique. During the years 2007-2010, the method was used for the purpose of verification of organic crop production by multiresidue analysis for the presence of pesticides. A total of 528 samples of differing matrices such as fruits, vegetables, cereals, plant leaves and other green parts were analysed, of which 4.4% samples contained pesticide residues above the threshold value of 0.01 mg/kg. A total of 20 different pesticide residues were determined in the samples. Copyright © 2013 Elsevier Ltd. All rights reserved.

Multiresidue method for pesticide residue analysis in food of animal and plant origin based on GC or LC and MS or MS/MS.

Science.gov (United States)

Muñoz, Eva; Muñoz, Gloria; Pineda, Laura; Serrahima, Eulalia; Centrich, Francesc

2012-01-01

A multiresidue method based on GC or LC and MS or MS/MS for the determination of 204 pesticides in diverse food matrixes of animal and plant origin is described. The method can include different stages of cleanup according to the chemical characteristics of each sample. Samples were extracted using accelerated solvent extraction. Those with a high fat content or that contained chlorophyll required further purification by gel permeation chromatography and/or SPE (ENVI-Carb). The methodology developed here was fully validated; the LOQs for the 204 pesticides are presented. The LOQ values lie between 0.01 to 0.02 mg/kg. However, in some cases, mainly in baby food, they were as low as 0.003 mg/kg, thereby meeting European Union requirements on maximum residue levels for pesticides, as outlined in European regulation 396/2005 and the Commission Directive 2003/13/EC. The procedure has been accredited for a wide scope of pesticides and matrixes by the Spanish Accreditation Body (ENAC) following ISO/IEC 17025:2005, as outlined in ENAC technical note NT-19.

CNEA's (Comision Nacional de Energia Atomica) experience in the preparation of a national system for laboratory accreditation

International Nuclear Information System (INIS)

Piacquadio, N.H.; Palacios, T.A.; Casa, V.A.; Koll, J.H.

1993-01-01

Within the regional markets, as it is the case of MERCOSUR , the laboratories which are suppliers of test and calibration results, are mutually recognized through the National Accreditation Systems. In Argentina there is a project to create a Center for the Accreditation of Test Laboratories. CNEA, which is involved in the execution of large projects and has adopted quality assurance criteria for a long time, requires for internal and external laboratories to be qualified. At the beginning of this year, a Committee for the Qualification of Laboratories was created in the Research and Development and Fuel Cycle Areas. Its objective was planning, management of documents, coordination, evaluation and quantification of laboratories, according to national IRAM and international ISO standards. This paper analyzes the organization of the system and the methods to evaluate and qualify laboratories as a process of growing up leading to the future National Accreditation System. (author). 3 figs

Guidebook for establishing a sustainable and accredited system for qualification and certification of personnel for non-destructive testing

International Nuclear Information System (INIS)

2009-01-01

Non-destructive testing (NDT) methods are used for detection, location and sizing of surface and internal defects (in welds, castings, forging, composite materials, concrete and many more). Various NDT methods are also used in preventive maintenance (nuclear power plants, aircraft, bridges, etc.). NDT methods are essential to the inspection of raw materials and half-finished products. They are applied to finished products and to in-service inspection, as well as for the design and development of new products and for plant life assessment studies. Thus NDT technology contributes significantly to the protection of life, public health and the environment through assurance of the quality and integrity of critical equipment and facilities. It is especially important in the developing Member States where the consequences of failure may be particularly severe, resulting in social, financial and environmental impacts. The IAEA has supported developing Member States for capacity building in utilization of NDT technology by providing experts, equipment, training opportunities and scientific visits. It was recognized early that NDT operator qualification and certification deserved special attention as the Member States began to apply NDT technology to local industrial problems. A series of meetings, workshops and publications have been dedicated to this issue. These efforts have led to a stage of maturity and self-sufficiency in many countries, especially in the field of training and certification of personnel, and in the provision of services to industries. ISO 9712, the international standard for qualification and certification of NDT personnel, has been adopted as the cornerstone for carrying out the training and certification activities. In 2005, a revised version of the standard, ISO 9712:2005, was published. There are some significant differences in this standard from previous editions, particularly in reference to an accreditation standard, ISO/IEC 17024:2003 (2003

Low-level Radioactivity Measurements

International Nuclear Information System (INIS)

Churtgen, C.

2007-01-01

The low-level radioactivity measurements service performs measurements of alpha or beta emitters on various types of low-radioactivity samples (biological and environmental) from internal and external clients. to maintain and develop techniques concerning the measurement of low-level radioactivity of alpha and beta emitting radionuclides in environmental or biological samples; to measure these samples by means of low-background counters (liquid scintillators, proportional counters, ZnS counters and alpha-spectrometers); to support and advise the nuclear and non-nuclear industry on problems of radioactive contamination or low level radioactivity measurements; to maintain the quality assurance system according to the ISO17025 standard for which we obtained the Beltest accreditation in 1998; to assess the internal dose from occupational intakes of radionuclides for workers of the nuclear industry;

Proficiency testing criteria for clearance level in solid waste gamma measurement in Taiwan.

Science.gov (United States)

Chen, Chun-Liang; Wang, Jeng-Jong; Chiu, Huang-Sheng

2013-11-01

To guarantee the measurement quality for clearance level in solid waste material, the Institute of Nuclear Energy Research (INER) established the criteria for proficiency testing of clearance level measurement. INER and the Taiwan Accreditation Foundation (TAF) organized the Technique Committee Meeting twice to discuss these criteria in 2011. The participating laboratories must completely conform to the ISO/IEC 17025, and they also must meet the requirements of the criteria. According to the criteria, the participating laboratories analyzed the minimum detectable amount (MDA) and that should be less than 20% of the clearance level (AMDA) given in the Atomic Energy Council's (AEC) "Regulations on Clearance Level for Radioactive Waste Management". The testing results should conform to the deviation and traceability requirements. Copyright © 2013 Elsevier Ltd. All rights reserved.

Guidelines for the detection of Trichinella larvae at the slaughterhouse in a quality assurance system.

Science.gov (United States)

Rossi, Patrizia; Pozio, Edoardo

2008-01-01

The European Community Regulation (EC) No. 2075/2005 lays down specific rules on official controls for the detection of Trichinella in fresh meat for human consumption, recommending the pooled-sample digestion method as the reference method. The aim of this document is to provide specific guidance to implement an appropriate Trichinella digestion method by a laboratory accredited according to the ISO/IEC 17025:2005 international standard, and performing microbiological testing following the EA-04/10:2002 international guideline. Technical requirements for the correct implementation of the method, such as the personnel competence, specific equipments and reagents, validation of the method, reference materials, sampling, quality assurance of results and quality control of performance are provided, pointing out the critical control points for the correct implementation of the digestion method.

Quality assurance and quality control of nuclear analytical techniques

International Nuclear Information System (INIS)

Cincu, Emanuelathor

2001-01-01

Test and analytical laboratories in East and Central European countries need to prove the reliability and credibility of their economic, environmental, medical and legal decisions and their capacity of issuing reliable, verifiable reports. These demands imposed by the European Union aimed at avoiding a possible barrier to trade for the developing countries. In June 1999, in order to help Member States to develop according to EU objectives and the overall situation of the European market, IAEA launched a new co-operation programme designed to help the nuclear analytical laboratories in nuclear institutions and universities of Member States by training in the use of some Nuclear Analytical Techniques (NAT) that include: alpha, beta and gamma-ray spectrometry, radiochemical and neutron activation analysis, total reflection X-ray fluorescence. The Regional IAEA Project, named 'Quality Assurance/Quality Control of Nuclear Analytical Techniques' (NAT) aims at implementing the QA principles via a system of defined consecutive steps leading to a level on which the QA system is self-sustainable for formal accreditation or certification and satisfies the EU technical performance criteria; the requirements are in accordance with the new ISO/IEC 17025 Standard/Dec.1999 'General requirements for the competence of testing and calibration laboratories' - First edition. The Horia Hulubei National Institute for Nuclear Physics and Engineering, IFIN-HH, was admitted for participation in the IAEA Project in June 1999 account taken of its experience in the QA and metrology fields and its performance in the fields of beta and gamma-ray spectrometry, and radiochemical and neutron activation analysis, employed in both basic research and applications for external clients. Two working groups of specialists with the QA and Standardization and Metrology Departments and six analytical groups with the departments of Nuclear Applied Physics, Life Physics and Ionising Radiation Metrology are

Institutional authorisation and accreditation of Transfusion Services and Blood Donation Sites: results of a national survey

Science.gov (United States)

Liumbruno, Giancarlo Maria; Panetta, Valentina; Bonini, Rosaria; Chianese, Rosa; Fiorin, Francesco; Lupi, Maria Antonietta; Tomasini, Ivana; Grazzini, Giuliano

2011-01-01

Introduction The aim of the survey described in this article was to determine decisional and strategic factors useful for redefining minimum structural, technological and organisational requisites for transfusion structures, as well as for the production of guidelines for accreditation of transfusion structures by the National Blood Centre. Materials and methods A structured questionnaire containing 65 questions was sent to all Transfusion Services in Italy. The questions covered: management of the quality system, accreditation, conformity with professional standards, structural and technological requisites, as well as potential to supply transfusion medicine-related health care services. All the questionnaires returned underwent statistical analysis. Results Replies were received from 64.7% of the Transfusion Services. Thirty-nine percent of these had an ISO 9001 certificate, with marked differences according to geographical location; location-related differences were also present for responses to other questions and were confirmed by multivariate statistical analysis. Over half of the Transfusion Services (53.6%) had blood donation sites run by donor associations. The statistical analysis revealed only one statistically significant difference between these donation sites: those connected to certified Transfusion Services were more likely themselves to have ISO 9001 certification than those connected to services who did not have such certification. Conclusions The data collected in this survey are representative of the Italian national transfusion system. A re-definition of the authorisation and accreditation requisites for transfusion activities must take into account European and national legislation when determining these requisites in order to facilitate their effective applicability, promote their efficient fulfilment and enhance the development of homogeneous and transparent quality systems. PMID:21839026

Center for Ecotoxicological Research of Montenegro

International Nuclear Information System (INIS)

Vucinic, Z.

2006-01-01

PI Center for Ecotoxicological Research of Montenegro (CETI) is founded 1996's in accordance with Government policy, for the purpose to: Unite the problems of protecting the environment in one institution, Organize the monitoring of the all segments of environment (air, waters soils, waste, ionizing and non-ionizing radiation, noise measurements etc.), Organize control of human and animal food and toxicological analysis of all kind of samples, forensic analyses etc. To concentrate the expensive instrumental equipment and human resources in one institution. December 1996 - CETI founded by decision of Montenegrin government 1997-CETI starting with acquisition of equipment and education of the staff March of 1998 - Officially starting with the job and realization with Program's September 2004 - Took the ISO 9001:2000 Certificate and Accreditation under ISO/IEC 17025 in November 2004 Organisation Scheme of CETI: Laboratory For Ecotoxicological Research And Radiation Protection I. Department For Laboratory Diagnostic And Monitoring II. Department For Radiation Protection And Monitoring Sector For Administration Department For Economy Department For Administration Total number of Employs is 63 of permanent staff

Audit Monitoring For Quality Management System (QMS) In Malaysian Nuclear Agency

International Nuclear Information System (INIS)

Fazila Said; Nurul Huda Mudri; Nurul Zusyakirah Ishak

2013-01-01

Auditing for Quality Management System (QMS) is a tool that helps an organization to enhance the quality performance. The audit was performed to check, maintain and improve the QMS practice. It is a compulsory for an organization to undergo series of audit in order to maintain the certification based on standard. In Malaysian Nuclear Agency, audit activities is monitored by Research and Innovation Management Centre (RIMC) that manage and ensure the internal and external audit are performed effectively. This paper will discuss the audit status of the processes that implement MS ISO 9001 and laboratories that accredited with MS ISO/ IEC 17025 for consecutive five years from year 2008 till 2012. Among the factors that show the effectiveness of QMS are cumulative of non-conformance (nc) according to duration of certification, frequency of nc by clause and comparison of non conformance and conformance clause within five years. The improvement plans from RIMC are also have been discussed according to four factors; internal audit quality, organizational setting, management support and auditee attributes. (author)

Accredited Birth Centers

Science.gov (United States)

... Danbury, CT 06810 203-748-6000 Accredited Since March 1998 Corvallis Birth & Women's Health Center Accredited 2314 NW Kings Blvd, Suite ... Washington, DC 20002 202-398-5520 Accredited Since March 2001 Flagstaff Birth and Women's Center Accredited 401 West Aspen Avenue Flagstaff, AZ ...

Accredition: An accredited utility's perspective

International Nuclear Information System (INIS)

Jambrovic, H.

1990-01-01

Accredition is a quality assurance program that applies to electricity billing meters. Under the Electricity and Gas Inspection Act, an electricity meter is not a legal billing device until a prototype has been scrutinized and approved for use by Consumer and Corporate Affairs Canada (CCAC) laboratories, and a meter cannot be used for billing purposes unless its accuracy and condition have been inspected and the meter is sealed to prevent tampering. In 1986 an ammendment to the act allowed accredited organizations to inspect, verify and seal their own billing meters. Ontario Hydro embarked on a program to become accredited in 1987, to offset spiraling government inspection fees in the order of $500,000/y, and to be less dependent on the availability of government inspectors. Ontario Hydro achieved accredition status two years after embarking on the program, which involved completion of cost benefit analysis, securing senior management commitment, preparation of a comprehensive quality assurance program manual, implementation of quality assurance program policies, procedures and controls, submitting meter shop operations and field meter handling practices to both internal Ontario Hydro and external government audit, and correction of audit findings. 2 figs

The accreditation programs and proficiency test in Taiwan for personnel dosimeter services (1991-1998)

International Nuclear Information System (INIS)

Lee, B.T.; Hwang, W.S.; Su, S.H.

2000-01-01

According to the ionizing radiation safety regulation approved by the ROC Atomic Energy Council (AEC), personnel dosimeter processors shall be accredited by the Chinese National Laboratory Accreditation (CNLA) program before offering dosimeter services and shall be accredited every two years (now has been rescheduled to be every three years since 1996). The aim of this program is to secure quality and technical capability of personnel dosimeters, and to provide systematic improvement for the internal calibration and testing laboratory applying for accreditation by means of assessment procedures. The criteria used to evaluate the capability at laboratories are ISO/IEC 25 (1990) and technical guide in different accreditation fields. The Institute of Nuclear Energy Research (INER) was entrusted by CNLA as the central laboratory to perform the proficiency test of personnel dosimeters for laboratory accreditation in December 1990. Such proficiency tests, based on ANSI N13.11 (1983), which is mainly separated to accident categories and protection categories which consists of eight parts of tests including single and mixture radiation of x-ray, gamma, beta and neutron, have been conducted four times, in 1991, 1993, 1995 and 1998. This paper deals with the test procedures and results of proficiency tests of personnel dosimeters from 1991 until 1998. The results of the four proficiency tests showed that, for accident categories, the pass rate is about 91%; for protection categories, the pass rate is about 98%. Meanwhile, the central laboratory will adopt a new version of HPS N13.11 (1993) to replace ANSI N13.11 (1983) as new criteria for the next proficiency test to be conducted in 2001. (author)

The International Standards for Solar Thermal Collectors and Components as a Medium of Quality Assurance

International Nuclear Information System (INIS)

Alkishriwi, Nouri; Schorn, Christian A.; Theis, Danjana

2014-01-01

regarding a product are fulfilled. In a certification process based on specified certification rules an authorized certification body is confirming that a solar thermal product has passed performance tests, reliability tests and further requirements according to the standards. In Europe a certification body holds an accreditation according to EN45011. At international level the standard ISO/IEC17065 is in force. Test results as a basis for product certification are determined by solar thermal test laboratories. The implementation and the business operation of such a solar thermal test laboratory is an important element within the national/regional solar thermal market. To ensure the quality of the products and to attend the role of an observer on the market, the test facility has to fulfill a number of requirements. Besides the necessary technical equipment and the implementation of tests in accordance with the various national and international standards, the laboratory shall realize a quality management system to guarantee the quality of tests and services. Based on the technical equipment, the testing scope and an implemented Quality Management System (QMS), the test laboratory can achieve an accreditation according to ISO/IEC17025 as basis for independent third party testing. Independent testing and evaluation of solar thermal collectors and components like hot water stores and controllers offers an important medium for quality assurance. To guarantee a high degree of product quality and consumer protection a quality system for the solar thermal market is necessary. Core of the quality assurance of a functioning solar thermal market are the national standards body, which is developing standards and regulations as a working basis ill technical committees, the national metrology institute that guarantees the traceability of measurements on fundamental and natural constants, and finally the national accreditation body which ensures the conformity of the various actors to a

Assessment of the uncertainties in the Radiological Protection Institute of Ireland (RPII) radon measurements service

Energy Technology Data Exchange (ETDEWEB)

Hanley, O. [Radiological Protection Institute of Ireland, 3 Clonskeagh Square, Clonskeagh Road, Dublin 14 (Ireland)], E-mail: ohanley@rpii.ie; Gutierrez-Villanueva, J.L. [Laboratorio LIBRA, Edificio I-D, Paseo Belen 3, 47011 Valladolid (Spain); Departamento de Fisica Teorica, Atomica y Optica, Facultad de Ciencias, Paseo Prado de la Magdalena, s/n. 47005 Valladolid (Spain)], E-mail: joselg@libra.uva.es; Currivan, L. [Radiological Protection Institute of Ireland, 3 Clonskeagh Square, Clonskeagh Road, Dublin 14 (Ireland)], E-mail: lcurrivan@rpii.ie; Pollard, D. [Radiological Protection Institute of Ireland, 3 Clonskeagh Square, Clonskeagh Road, Dublin 14 (Ireland)], E-mail: dpollard@rpii.ie

2008-10-15

The RPII radon (Rn) laboratory holds accreditation for the International Standard ISO/IEC 17025. A requirement of this standard is an estimate of the uncertainty of measurement. This work shows two approaches to estimate the uncertainty. The bottom-up approach involved identifying the components that were found to contribute to the uncertainty. Estimates were made for each of these components, which were combined to give a combined uncertainty of 13.5% at a Rn concentration of approximately 2500 Bq m{sup -3} at the 68% confidence level. By applying a coverage factor of k = 2, the expanded uncertainty is {+-}27% at the 95% confidence level. The top-down approach used information previously gathered from intercomparison exercises to estimate the uncertainty. This investigation found an expanded uncertainty of {+-}22% at approximately 95% confidence level. This is good agreement for such independent estimates.

Assessment of the uncertainties in the Radiological Protection Institute of Ireland (RPII) radon measurements service.

Science.gov (United States)

Hanley, O; Gutiérrez-Villanueva, J L; Currivan, L; Pollard, D

2008-10-01

The RPII radon (Rn) laboratory holds accreditation for the International Standard ISO/IEC 17025. A requirement of this standard is an estimate of the uncertainty of measurement. This work shows two approaches to estimate the uncertainty. The bottom-up approach involved identifying the components that were found to contribute to the uncertainty. Estimates were made for each of these components, which were combined to give a combined uncertainty of 13.5% at a Rn concentration of approximately 2500 Bq m(-3) at the 68% confidence level. By applying a coverage factor of k=2, the expanded uncertainty is +/-27% at the 95% confidence level. The top-down approach used information previously gathered from intercomparison exercises to estimate the uncertainty. This investigation found an expanded uncertainty of +/-22% at approximately 95% confidence level. This is good agreement for such independent estimates.

Accreditation and Educational Quality: Are Students in Accredited Programs More Academically Engaged?

Science.gov (United States)

Cole, James S.; Cole, Shu T.

2008-01-01

There has been a great deal of debate regarding the value of program accreditation. Two research questions guided this study: 1) are students enrolled in accredited parks, recreation, and leisure programs more academically engaged than students enrolled in non-accredited programs, and 2) do students enrolled in accredited parks, recreation, and…

Quality assurance for measurements of the radioactivity in the area of the"Horia Hulubei" National Institute for Physics and Nuclear Engineering, IFIN-HH.

Science.gov (United States)

Stochioiu, Ana; Luca, Aurelian; Sahagia, Maria; Margineanu, Romul Mircea; Tudor, Ion

2012-10-01

This paper presents one part of the activities deployed by the Laboratory for Environment and Personnel Dosimetry (LDPM) of IFIN-HH, namely the radiological monitoring of the environment within the Institute's area and its surrounding influence zone, according to the program approved by the National Regulatory Body for Nuclear Activities, CNCAN. The representative reports regard the radioactive content of soil, surface and underground water, cultivated and spontaneous vegetation, aerosols and atmospheric fallout, sediments. The common requirement is that the measured quantities be precise and the reported values be reliable and credible. This goal is achieved by maintaining a Quality System, verified within the obtaining and maintaining of the laboratory accreditation, according to the international standard ISO/IEC 17025:2005.The LDPM is accredited by the Romanian accreditation body, RENAR, member of the European Accreditation, EA and is designed by CNCAN as a notified testing laboratory. Many measurements were performed in collaboration with the Radionuclide Metrology Laboratory (RML) from IFIN-HH, RENAR accredited and CNCAN notified for calibration and for testing in the field of radioactivity measurement. This paper proposes a short presentation of the important aspects in our activity: i. description of equipment, samplingmethods, processing and measurement of environmental samples; ii. validation of equipment and methods by participation in international and national proficiency tests; iii. a five year follow chart, containing the results in measurement of samples; iv. a recent application, with a wide impact in Romanian mass media: the credible daily report on the possible influence of Fukushima accident over the Romanian environmental radioactivity. Copyright © 2012 Elsevier Ltd. All rights reserved.

Quality assurance aspects of GSR analysis by SEM/EDX: a report of first-hand experiences

Science.gov (United States)

Charles, Sebastien; Dehan, Didier; Geusens, Nadia; Nys, Bart

2009-05-01

Like many forensic science labs, the Belgian National Institute of Forensic Science (NICC) is involved in a Quality Assurance program aiming towards an ISO17025 Accreditation. Since last year, a project is underway in the GSR lab to validate the method used in the analysis of GSR samples acquired from the hands of suspects by SEM/EDX. The project is well underway, and is planned to lead to accreditation for this technique by the start of 2010. The presentation will discuss several aspects of the functioning of the lab that have to be addressed when preparing for this accreditation. Some of these issues and problems are so involved that separate sub-projects were defined in order to provide a manageable solution. The following topics will be treated in detail: definition of the scope of the accreditation, the validation of the SEM/EDX method with respect to : accuracy, precision, reproducibility and robustness, and the documentation of the Chain of Custody (CoC) of the samples and their storage. One specific sub-project that will be discussed is the study of contamination monitoring in different relevant locations of the lab. Finally, as we have recently acquired a new microscope, the technical criteria we used in the acquisition study will be presented with a focus on their relevance in a QA context. We feel this discussion is informative, both for labs that are pursuing a formal accreditation in the future, and those that work already in such a context and are in the process of acquiring new equipment.

What motivates professionals to engage in the accreditation of healthcare organizations?

Science.gov (United States)

Greenfield, David; Pawsey, Marjorie; Braithwaite, Jeffrey

2011-02-01

Motivated staff are needed to improve quality and safety in healthcare organizations. Stimulating and engaging staff to participate in accreditation processes is a considerable challenge. The purpose of this study was to explore the experiences of health executives, managers and frontline clinicians who participated in organizational accreditation processes: what motivated them to engage, and what benefits accrued? The setting was a large public teaching hospital undergoing a planned review of its accreditation status. A research protocol was employed to conduct semi-structured interviews with a purposive sample of 30 staff with varied organizational roles, from different professions, to discuss their involvement in accreditation. Thematic analysis of the data was undertaken. The analysis identified three categories, each with sub-themes: accreditation response (reactions to accreditation and the value of surveys); survey issues (participation in the survey, learning through interactions and constraints) and documentation issues (self-assessment report, survey report and recommendations). Participants' occupational role focuses their attention to prioritize aspects of the accreditation process. Their motivations to participate and the benefits that accrue to them can be positively self-reinforcing. Participants have a desire to engage collaboratively with colleagues to learn and validate their efforts to improve. Participation in the accreditation process promoted a quality and safety culture that crossed organizational boundaries. The insights into worker motivation can be applied to engage staff to promote learning, overcome organizational boundaries and improve services. The findings can be applied to enhance involvement with accreditation and, more broadly, to other quality and safety activities.

Recommendations for accreditation of laboratories in molecular biology of hematologic malignancies.

Science.gov (United States)

Flandrin-Gresta, Pascale; Cornillet, Pascale; Hayette, Sandrine; Gachard, Nathalie; Tondeur, Sylvie; Mauté, Carole; Cayuela, Jean-Michel

2015-01-01

Over recent years, the development of molecular biology techniques has improved the hematological diseases diagnostic and follow-up. Consequently, these techniques are largely used in the biological screening of these diseases; therefore the Hemato-oncology molecular diagnostics laboratories must be actively involved in the accreditation process according the ISO 15189 standard. The French group of molecular biologists (GBMHM) provides requirements for the implementation of quality assurance for the medical molecular laboratories. This guideline states the recommendations for the pre-analytical, analytical (methods validation procedures, quality controls, reagents), and post-analytical conditions. In addition, herein we state a strategy for the internal quality control management. These recommendations will be regularly updated.

Quality management system of a university cardiac surgery department according to DIN EN ISO 9001 : 2000.

Science.gov (United States)

Beholz, S; Koch, C; Konertz, W

2003-06-01

A quality management system (QMS) will improve quality in health care units. This report describes the introduction of a QMS according to ISO 9001:2000 in a university cardiovascular surgery department. First, a thorough analysis of all processes of patient treatment and clinical research was obtained. Multiple interfaces were defined to different departments as well as to administration units. We evaluated and optimized all necessary resources, evaluating customer satisfaction using patients' and referring physicians' surveys. We started quality rounds including surgeons, nurses and technicians. Based on this preparation, we redefined and explained all processes including their responsibilities and necessary resources in the quality manual. After a process of 18 months, an independent, accredited organization recommended that our QMS be given certification according to ISO 9001:2000. Certification of a university cardiovascular surgery department according to ISO 9001:2000 is possible, and may represent the first step towards total quality management (TQM). In complex health care units, certification of separate departments may help generate a consciousness of quality on the way to TQM.

DER Certification Laboratory Pilot, Accreditation Plan, and Interconnection Agreement Handbook

Energy Technology Data Exchange (ETDEWEB)

Key, T.; Sitzlar, H. E.; Ferraro, R.

2003-11-01

This report describes the first steps toward creating the organization, procedures, plans and tools for distributed energy resources (DER) equipment certification, test laboratory accreditation, and interconnection agreements. It covers the activities and accomplishments during the first period of a multiyear effort. It summarizes steps taken to outline a certification plan to assist in the future development of an interim plan for certification and accreditation activities. It also summarizes work toward a draft plan for certification, a beta Web site to support communications and materials, and preliminary draft certification criteria.

Quality-oriented efforts in IPD, - a framework

DEFF Research Database (Denmark)

Andreasen, Mogens Myrup

1998-01-01

It is generally expected that modern quality efforts like TQM and ISO9000 should deliver a sufficient framework for quality efforts in industrial companies. Our findings in Danish industry shows a fragmented picture of islands of efforts and a weak understanding of basic quality concepts between...... designers. The paper propose a framework for quality efforts, illustrated by simple metaphors....

Quality Improvement and Performance Management Benefits of Public Health Accreditation: National Evaluation Findings.

Science.gov (United States)

Siegfried, Alexa; Heffernan, Megan; Kennedy, Mallory; Meit, Michael

To identify the quality improvement (QI) and performance management benefits reported by public health departments as a result of participating in the national, voluntary program for public health accreditation implemented by the Public Health Accreditation Board (PHAB). We gathered quantitative data via Web-based surveys of all applicant and accredited public health departments when they completed 3 different milestones in the PHAB accreditation process. Leadership from 324 unique state, local, and tribal public health departments in the United States. Public health departments that have achieved PHAB accreditation reported the following QI and performance management benefits: improved awareness and focus on QI efforts; increased QI training among staff; perceived increases in QI knowledge among staff; implemented new QI strategies; implemented strategies to evaluate effectiveness and quality; used information from QI processes to inform decision making; and perceived achievement of a QI culture. The reported implementation of QI strategies and use of information from QI processes to inform decision making was greater among recently accredited health departments than among health departments that had registered their intent to apply but not yet undergone the PHAB accreditation process. Respondents from health departments that had been accredited for 1 year reported higher levels of staff QI training and perceived increases in QI knowledge than those that were recently accredited. PHAB accreditation has stimulated QI and performance management activities within public health departments. Health departments that pursue PHAB accreditation are likely to report immediate increases in QI and performance management activities as a result of undergoing the PHAB accreditation process, and these benefits are likely to be reported at a higher level, even 1 year after the accreditation decision.

Gamma spectrometric validation of measurements test of radionuclides in food matrices

International Nuclear Information System (INIS)

Rosa, Mychelle M.L.; Custodio, Luis G.; Bonifacio, Rodrigo L.; Taddei, Maria Helena T.

2013-01-01

In a testing laboratory the quality system encompasses a set of activities planned and systematic, which ensure the traceability process of an analysis, which is based on the standards NBR ISO/TEC 17025. With the need for analysis of radionuclides in food products to meet the requirements of import and export, accreditation of testing on this standard becomes increasingly necessary. The Gamma Spectrometry is a technique used for direct determination of radionuclides in different matrices, among them the food, being possible the simultaneous determination of different radionuclides in the same sample without the need for a chemical separation. In the process of Accreditation the methodology validation is an important step that includes testing accuracy, traceability, linearity and recovery. This paper describes the procedures used to validate the assay for determining radionuclides using gamma spectrometry in food. These procedures were performed through analysis of a certificated reference material by the International Atomic Energy Agency (IAEA Soil 327), analysis of samples of milk powder prepared from the doping with certified liquid standards also by the results obtained in the participation of tests of proficiency in analysis of environmental samples. (author)

Gamma spectrometric validation of measurements test of radionuclides in food matrices; Validacao do ensaio de medidas por espectrometria gama de radionuclideos em matrizes de alimentos

Energy Technology Data Exchange (ETDEWEB)

Rosa, Mychelle M.L.; Custodio, Luis G.; Bonifacio, Rodrigo L.; Taddei, Maria Helena T., E-mail: mychelle@cnen.gov.br, E-mail: Igcustodio@hotmail.com, E-mail: rodrigo@cnen.gov.br, E-mail: mhtaddei@cnen.gov [Comissao Nacional de Energia Nuclear (LAPOC/CNEN-MG), de Pocos de Caldas, MG (Brazil). Laboratorio de Pocos de Caldas

2013-10-01

In a testing laboratory the quality system encompasses a set of activities planned and systematic, which ensure the traceability process of an analysis, which is based on the standards NBR ISO/TEC 17025. With the need for analysis of radionuclides in food products to meet the requirements of import and export, accreditation of testing on this standard becomes increasingly necessary. The Gamma Spectrometry is a technique used for direct determination of radionuclides in different matrices, among them the food, being possible the simultaneous determination of different radionuclides in the same sample without the need for a chemical separation. In the process of Accreditation the methodology validation is an important step that includes testing accuracy, traceability, linearity and recovery. This paper describes the procedures used to validate the assay for determining radionuclides using gamma spectrometry in food. These procedures were performed through analysis of a certificated reference material by the International Atomic Energy Agency (IAEA Soil 327), analysis of samples of milk powder prepared from the doping with certified liquid standards also by the results obtained in the participation of tests of proficiency in analysis of environmental samples. (author)

API and ISO standards can be combined

International Nuclear Information System (INIS)

Weightman, R.T.; Warnack, M.F.

1992-01-01

This paper reports that oil field equipment and product manufacturers can maintain a competitive advantage and minimize costs by integrating American Petroleum Institute (API) licensing programs with International Standards Organization (ISO) 9001 standards under one quality system. A combined quality system approach can position a company for quality system certification under ISO 9001 while maintaining API specifications. Furthermore, only one quality system manual is needed for API licensing and ISO certification, avoiding duplication of effort. The benefits of a documented quality program include the flowing: Job descriptions and personnel qualification requirements are documented; The improved documentation allows direct tracing of specific production activities; Laboratory test methods and calibration of test equipment follow accepted standards for more reliable and reproducible test data; Quality control becomes proactive, not reactive, through internal process controls previously not implemented; Employee attitudes improve through appreciation for the overall goals of the company; Ambiguous quality issues, such as documenting special customer requirements, are easily resolved; and The company image improves with customers, particularly for those that require API Specification Q1 or ISO 9001 compliance or those having their own quality performance standards

Accreditation and Student Consumer Protection. An Occasional Paper.

Science.gov (United States)

Jung, Steven M.

The role of postsecondary accreditation and its relation to student consumer protection are discussed in this monograph. The importance of this concept is examined in light of increased marketing efforts on the part of higher education institutions. It is emphasized that students are consumers and their rights should be protected. Possible areas…

A Threat to Accreditation: Defamation Judgment against an Accreditation Team Member.

Science.gov (United States)

Flygare, Thomas J.

1980-01-01

Delaware Law School founder Alfred Avins successfully sued accreditation team member James White for defamation as a result of comments made in 1974 and 1975. An appeals brief claims Avins was a "public figure," that he consented to accreditation, and that the accreditation process deserves court protection against such suits. (PGD)

Implementation of the ISO 9001 quality management system - process, impact and benefits

Directory of Open Access Journals (Sweden)

Aleksandar Ž. Drenovac

2013-10-01

, it is necessary to identify necessary procedures, in order to ensure fulfillment of all requirements. The aim is to establish an optimal system using as few procedures as posible. Therefore, it is necessary to choose first few procedures very carefully and implement them so that emloyees gain confidence. Procedures must be defined in such a way that they determine activities and responsibilities for particular jobs. Drawing up instructions and records Work instructions are documents that describe a way of accomplishing activities defined by procedures. Based on them, every competent executor would be able to complete a determined job. Records are documents that give objective evidence that a quality management system entirely conforms with standard requirements. As opposed to procedures, they are unchangeable and they record what was done, who did what, how something was done, and what was achieved. Implementation and control of a quality management system Implementing a quality management system opens a new process of system monitoring, reevalutation and improvement, thus entering first into a process of internal auditing. Internal audits have a purpose of marking positions at which the process in unsuccessful, of detecting deviations and improving the system. Certification Positive experience shows that a certification institution should be chosen at least three months before a formal evaluation is planned. Also, it is very important to choose a certification institution which is accepted, recognized and entirely accredited (BSI, LRQA, TÜV SUD, SGS, Bureau Veritas, etc.. Ther is no certification body that has total accreditation, but only accredited fields in which they can demonstrate relevant experience. Impact and benefits of the establishment of ISO 9001 system Entering the process of certification indicates commitment to quality, which reflects in lower costs due to fewer nonconformed products, lfewer refused products as well as in fewer faults in general

Accreditation of nuclear engineering programs

International Nuclear Information System (INIS)

Williamson, T.G.

1989-01-01

The American Nuclear Society (ANS) Professional Development and Accreditation Committee (PDAC) has the responsibility for accreditation of engineering and technology programs for nuclear and similarly named programs. This committee provides society liaison with the Accreditation Board for Engineering and Technology (ABET), is responsible for the appointment and training of accreditation visitors, nomination of members for the ABET Board and Accreditation Commissions, and review of the criteria for accreditation of nuclear-related programs. The committee is composed of 21 members representing academia and industry. The ABET consists of 19 participating bodies, primarily professional societies, and 4 affiliate bodies. Representation on ABET is determined by the size of the professional society and the number of programs accredited. The ANS, as a participating body, has one member on the ABET board, two members on the Engineering Accreditation Commission, and one on the Technology Accreditation Commission. The ABET board sets ABET policy and the commissions are responsible for accreditation visits

Reduction of Noise from the J-52 and F-404 Jet Engines During Static Testing Using the Noise Attenuation Device (NAD)

Science.gov (United States)

2009-06-01

Filters, Order 3, Type 0-C, Optional Range B.2.2 Sound Level Meter Calibration • ISO / IEC 17025 :2005 General requirements for the competence of...noise levels − NCSL -National Conference of Standards Laboratories − ISO - International Standards Organization − IEC - The International...testing and calibration laboratories • ISO 10012:2003 Measurement management systems -- Requirements for measurement processes and measuring

[Certification and quality management of a complex university cardiac center according to law EN ISO 9001: 2000].

Science.gov (United States)

Beholz, Sven; Koch, Christina; Konertz, Wolfgang

2003-04-01

Quality management systems can improve quality in health care units. The introduction of a quality management system according to ISO 9001: 2000 in a university department of cardiovascular surgery is described. First a thorough analysis of all processes of patient treatment and clinical research was obtained. Multiple interfaces had to be defined to different departments as well as to administration units. All necessary resources were evaluated and optimised. Customer satisfaction was evaluated by surveys of patients and collaborating physicians. Quality rounds including physicians, nurses and technicians were instituted. Based on these preparatory works all processes including their responsibilities and necessary resources were redefined and described in the quality manual. After 18 months' of certification of our quality management system according to ISO 9001: 2000 was recommended by an independent, accredited organisation. In summary, certification of a university department of cardiovascular surgery according to ISO 9001: 2000 is possible and may represent the first step towards total quality management. In complex health care units the certification of individual departments may help to generate a consciousness for quality on the road to total quality management.

Reliability in individual monitoring service.

Science.gov (United States)

Mod Ali, N

2011-03-01

As a laboratory certified to ISO 9001:2008 and accredited to ISO/IEC 17025, the Secondary Standard Dosimetry Laboratory (SSDL)-Nuclear Malaysia has incorporated an overall comprehensive system for technical and quality management in promoting a reliable individual monitoring service (IMS). Faster identification and resolution of issues regarding dosemeter preparation and issuing of reports, personnel enhancement, improved customer satisfaction and overall efficiency of laboratory activities are all results of the implementation of an effective quality system. Review of these measures and responses to observed trends provide continuous improvement of the system. By having these mechanisms, reliability of the IMS can be assured in the promotion of safe behaviour at all levels of the workforce utilising ionising radiation facilities. Upgradation of in the reporting program through a web-based e-SSDL marks a major improvement in Nuclear Malaysia's IMS reliability on the whole. The system is a vital step in providing a user friendly and effective occupational exposure evaluation program in the country. It provides a higher level of confidence in the results generated for occupational dose monitoring of the IMS, thus, enhances the status of the radiation protection framework of the country.

IMPLEMENTASI QUALITY MANAGEMENT SYSTEM ISO 9001:2008 DALAM PEMBELAJARAN PRODUKTIF KEAHLIAN TEKNIK MESIN DAN OTOMOTIF SMK

Directory of Open Access Journals (Sweden)

Mochammad Ariful Ulfi

2013-07-01

Full Text Available The implementation of ISO 9001:2008 quality management system in the productive learning on the mechanical engineering and automotive in vocational high school. This research uses qualitative approach in term of a case study. The research is conducted at SMKN I Purwosari. The results of this research show that (1 the reason of the ISO imple­mentation is to obtain community trust, to improve compe­titiveness, and to increase the quality of the graduates; (2 the implementation of the quality management system in the learning process refers to the concept of PDCA of the ISO system; (3 the obstacles occured during the implementation of ISO is due to the lack of teachers’ awareness on the ISO system; and (4 some efforts to overcome those obstacles include developing commitment among all elements, socialization, supervision, and doing some preventive efforts. Penelitian ini menggunakan pendekatan kualitatif dengan rancangan studi kasus. Penelitian dilaksanakan di SMK Negeri 1 Purwosari. Adapun fokus penelitian adalah alasan penerapan ISO, implementasi dalam pembelajaran, hambatan, dan upaya mengatasi hambatan pelaksanaan ISO 9001:2008. Hasil penelitian menunjukkan   (1 alasan penerapan ISO adalah agar sekolah dipercaya masyarakat, meningkatkan daya saing, dan mening­kat­kan mutu lulusan; (2 implementasi dalam pembelajaran mengacu  pada konsep PDCA ke dalam sistem manajemen mutu ISO; (3 hambat­an implementasi ISO adalah tingkat kesadaran guru terhadap ISO yang rendah; (4 upaya mengatasi hambatan adalah membangun komitmen bersama, sosiali­sasi, supervisi, dan melakukan usaha pencegahan.

Gaining competitive advantage in personal dosimetry services through ISO 9001 certification

International Nuclear Information System (INIS)

Noriah, M. A.

2007-01-01

This paper discusses the advantage of certification process in the quality assurance of individual dose monitoring in Malaysia. The demand by customers and the regulatory authority for a higher degree of quality service requires a switch in emphasis from a technically focused quality assurance program to a comprehensive quality management for service provision. Achieving the ISO 9001:2000 certification by an accredited third party demonstrates acceptable recognition and documents the fact that the methods used are capable of generating results that satisfy the performance criteria of the certification program. It also offers a proof of the commitment to quality and, as a benchmark, allows measurement of the progress for continual improvement of service performance. (authors)

Gaining competitive advantage in personal dosimetry services through ISO 9001 certification.

Science.gov (United States)

Noriah, M A

2007-01-01

This paper discusses the advantage of certification process in the quality assurance of individual dose monitoring in Malaysia. The demand by customers and the regulatory authority for a higher degree of quality service requires a switch in emphasis from a technically focused quality assurance program to a comprehensive quality management for service provision. Achieving the ISO 9001:2000 certification by an accredited third party demonstrates acceptable recognition and documents the fact that the methods used are capable of generating results that satisfy the performance criteria of the certification program. It also offers a proof of the commitment to quality and, as a benchmark, allows measurement of the progress for continual improvement of service performance.

Surviving Accreditation: A QIAS Ideas Bank. Accreditation and Beyond Series, Volume I.

Science.gov (United States)

Ferry, Jan

This publication provides information on the accreditation process for early childhood education and care providers participating in the Quality Improvement and Accreditation System (QIAS), developed by the National Childcare Accreditation Council of Australia. The publication is divided into sections corresponding to steps in the…

Twenty new ISO standards on dosimetry for radiation processing

International Nuclear Information System (INIS)

Farrar IV, H.

2000-01-01

Twenty standards on essentially all aspects of dosimetry for radiation processing were published as new ISO standards in December 1998. The standards are based on 20 standard practices and guides developed over the past 14 years by Subcommittee E10.01 of the American Society for Testing and Materials (ASTM). The transformation to ISO standards using the 'fast track' process under ISO Technical Committee 85 (ISO/TC85) commenced in 1995 and resulted in some overlap of technical information between three of the new standards and the existing ISO Standard 11137 Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization. Although the technical information in these four standards was consistent, compromise wording in the scopes of the three new ISO standards to establish precedence for use were adopted. Two of the new ISO standards are specifically for food irradiation applications, but the majority apply to all forms of gamma, X-ray, and electron beam radiation processing, including dosimetry for sterilization of health care products and the radiation processing of fruit, vegetables, meats, spices, processed foods, plastics, inks, medical wastes, and paper. Most of the standards provide exact procedures for using individual dosimetry systems or for characterizing various types of irradiation facilities, but one covers the selection and calibration of dosimetry systems, and another covers the treatment of uncertainties using the new ISO Type A and Type B evaluations. Unfortunately, nine of the 20 standards just adopted by the ISO are not the most recent versions of these standards and are therefore already out of date. To help solve this problem, efforts are being made to develop procedures to coordinate the ASTM and ISO development and revision processes for these and future ASTM-originating dosimetry standards. In the meantime, an additional four dosimetry standards have recently been published by the ASTM but have

Steel wire ropes. Proven performer of shaft winding systems; Stahldrahtseile. Bewaehrte Leistungstraeger von Schachtfoerderanlagen

Energy Technology Data Exchange (ETDEWEB)

Sindern, Winfried [DMT GmbH und Co. KG, Bochum (Germany). Fachstelle fuer Sicherheit - Seilpruefstelle; Gronau, Olivier [DMT GmbH und Co. KG, Bochum (Germany). DMT-Prueflab. fuer Zerstoerungsfreie und Zerstoerende Pruefung - Seilpruefstelle

2010-04-15

In particular, the DMT centre for safety rope inspection in Bochum (Federal Republic of Germany) accomplishes non-destructive examinations of ropes of shaft winding systems as well as of its final connections outside of the mining industry used as high-strength draft members in buildings such as bridges, broadcasting poles, fire-places and roof structures and in many areas of conveying engineering. The test laboratory is accredited according to DIN EN ISO/IEC 17025:2005. In the year 1990, the former institute for mine safety in Leipzig (Federal Republic for Germany) was integrated to DMT and forms the branch office of DMT in Leipzig. The Saarland hard coal district is cared for by a further branch office of the DMT in Saarbruecken (Federal Republic of Germany). The knowledge existing at all three locations, further experiences and the research results today are used commonly and developed further.

15th Anniversary of the Molecular Techniques Unit at the Department of Forensic Medicine at Wroclaw Medical University.

Science.gov (United States)

Pluta, Dominika; Tokarski, Miron; Karpiewska, Anna; Dobosz, Tadeusz

2017-01-01

Molecular Techniques Unit at the Department of Forensic Medicine, Wroclaw Medical University has been operating since December 2003. Soon it will be 15 years since its establishment. This anniversary become an inspiration to write down the story of this institution whose origins illustrate the immense changes that have taken place in forensic genetics. The aim of our work was also to consolidate the professional achievements of Professor Tadeusz Dobosz, chief of the Unit, one of the pioneers of introducing DNA testing technology into Polish forensic medicine. The most important achievements of the Unit include participation in two EU research projects, the development of a non-destructive method of extraction of genetic material, research in field of gene therapy and certification of the Laboratory of the Molecular Techniques Unit by the Polish Accreditation Center (PCA) confirming compliance with the requirements of the PN-EN ISO/IEC 17025:2005 standard.

ISO 9001 aspects related to performance and their level of implementation

Directory of Open Access Journals (Sweden)

Jordi Castello Dalmau

2016-12-01

Full Text Available Purpose: In the last three decades, thousands of companies around the world have embraced the ISO 9001 standard in their quest to improve company performance and customer satisfaction. In recent literature, a number of authors have identified different “levels” of ISO 9001 implementation. This study aims to analyse these implementation levels in companies from the point of view of the customer, and provide guidelines for future improvement. Design/methodology/approach: Research was conducted based on the results of the second-party audits (SPAs of 90 suppliers, (including component suppliers, assemblers, and wind farm operation and maintenance services, to one of the wind power industry’s largest wind turbine manufacturers. The audits were carried out within the ISO 9001:2008 framework and conducted by one of this study’s authors in his role as the wind turbine company’s Director of Global Quality. Findings: Auditing suppliers plays a unique role in helping to isolate system weaknesses, identify opportunities and suggest areas for improvement. This study shows that, in terms of management commitment and culture and the good practices of an organization, ISO 9001 certified companies implement differing degrees of the standard. From the results of this research, a "road map" towards improvement can be established; one that allows companies in the sector to go beyond simply being accredited with the standard and instead to take advantage of ISO 9001 certification as a catalyst for change. Research limitations/implications: This article focuses only on the wind power sector, although its findings could be extrapolated to similar sectors of high technology and high levels of customization. Originality/value: While quality audits are a customary topic for academics and researchers, few contributions are related to SPAs and their impact on the quality control process of company suppliers. Primary data from the SPAs of suppliers (objective

ISO 9001 aspects related to performance and their level of implementation

Energy Technology Data Exchange (ETDEWEB)

Castello Dalmau, J.; Gimenez, G.; Castro, R. de

2016-07-01

Purpose: In the last three decades, thousands of companies around the world have embraced the ISO 9001 standard in their quest to improve company performance and customer satisfaction. In recent literature, a number of authors have identified different “levels” of ISO 9001 implementation. This study aims to analyse these implementation levels in companies from the point of view of the customer, and provide guidelines for future improvement. Design/methodology/approach: Research was conducted based on the results of the second-party audits (SPAs) of 90 suppliers, (including component suppliers, assemblers, and wind farm operation and maintenance services), to one of the wind power industry’s largest wind turbine manufacturers. The audits were carried out within the ISO 9001:2008 framework and conducted by one of this study’s authors in his role as the wind turbine company’s Director of Global Quality. Findings: Auditing suppliers plays a unique role in helping to isolate system weaknesses, identify opportunities and suggest areas for improvement. This study shows that, in terms of management commitment and culture and the good practices of an organization, ISO 9001 certified companies implement differing degrees of the standard. From the results of this research, a road map towards improvement can be established; one that allows companies in the sector to go beyond simply being accredited with the standard and instead to take advantage of ISO 9001 certification as a catalyst for change. Research limitations/implications: This article focuses only on the wind power sector, although its findings could be extrapolated to similar sectors of high technology and high levels of customization. Originality/value: While quality audits are a customary topic for academics and researchers, few contributions are related to SPAs and their impact on the quality control process of company suppliers. Primary data from the SPAs of suppliers (objective data collected by one

ISO 9001 aspects related to performance and their level of implementation

International Nuclear Information System (INIS)

Castello Dalmau, J.; Gimenez, G.; Castro, R. de

2016-01-01

Purpose: In the last three decades, thousands of companies around the world have embraced the ISO 9001 standard in their quest to improve company performance and customer satisfaction. In recent literature, a number of authors have identified different “levels” of ISO 9001 implementation. This study aims to analyse these implementation levels in companies from the point of view of the customer, and provide guidelines for future improvement. Design/methodology/approach: Research was conducted based on the results of the second-party audits (SPAs) of 90 suppliers, (including component suppliers, assemblers, and wind farm operation and maintenance services), to one of the wind power industry’s largest wind turbine manufacturers. The audits were carried out within the ISO 9001:2008 framework and conducted by one of this study’s authors in his role as the wind turbine company’s Director of Global Quality. Findings: Auditing suppliers plays a unique role in helping to isolate system weaknesses, identify opportunities and suggest areas for improvement. This study shows that, in terms of management commitment and culture and the good practices of an organization, ISO 9001 certified companies implement differing degrees of the standard. From the results of this research, a road map towards improvement can be established; one that allows companies in the sector to go beyond simply being accredited with the standard and instead to take advantage of ISO 9001 certification as a catalyst for change. Research limitations/implications: This article focuses only on the wind power sector, although its findings could be extrapolated to similar sectors of high technology and high levels of customization. Originality/value: While quality audits are a customary topic for academics and researchers, few contributions are related to SPAs and their impact on the quality control process of company suppliers. Primary data from the SPAs of suppliers (objective data collected by one

Quality Space and Launch Requirements, Addendum to AS9100C

Science.gov (United States)

2015-05-08

Laboratories and Measuring and Test Equipment – General Requirements (1994) ISO 9001:2008 Quality management systems – Requirements (2008) ISO / IEC ...understood that not all suppliers may be compliant to AS9100 or perhaps even to ISO 9001. Section 7 provides requirements for selecting and monitoring... 17025 :2005 General requirements for the competence of testing and calibration laboratories MIL-STD-45662A Calibration Systems Requirements (Cancelled 27

Is gerontology ready for accreditation?

Science.gov (United States)

Haley, William E; Ferraro, Kenneth F; Montgomery, Rhonda J V

2012-01-01

The authors review widely accepted criteria for program accreditation and compare gerontology with well-established accredited fields including clinical psychology and social work. At present gerontology lacks many necessary elements for credible professional accreditation, including defined scope of practice, applied curriculum, faculty with applied professional credentials, and resources necessary to support professional credentialing review. Accreditation with weak requirements will be dismissed as "vanity" accreditation, and strict requirements will be impossible for many resource-poor programs to achieve, putting unaccredited programs at increased risk for elimination. Accreditation may be appropriate in the future, but it should be limited to professional or applied gerontology, perhaps for programs conferring bachelor's or master's degrees. Options other than accreditation to enhance professional skills and employability of gerontology graduates are discussed.

Implementation of quality management systems and progress towards accreditation of National Tuberculosis Reference Laboratories in Africa

Directory of Open Access Journals (Sweden)

Heidi Albert

2017-03-01

Full Text Available Background: Laboratory services are essential at all stages of the tuberculosis care cascade, from diagnosis and drug resistance testing to monitoring response to treatment. Enabling access to quality services is a challenge in low-resource settings. Implementation of a strong quality management system (QMS and laboratory accreditation are key to improving patient care. Objectives: The study objective was to determine the status of QMS implementation and progress towards accreditation of National Tuberculosis Reference Laboratories (NTRLs in the African Region. Method: An online questionnaire was administered to NTRL managers in 47 World Health Organization Regional Office for Africa member states in the region, between February and April 2015, regarding the knowledge of QMS tools and progress toward implementation to inform strategies for tuberculosis diagnostic services strengthening in the region. Results: A total of 21 laboratories (43.0% had received SLMTA/TB-SLMTA training, of which 10 had also used the Global Laboratory Initiative accreditation tool. However, only 36.7% of NTRLs had received a laboratory audit, a first step in quality improvement. Most NTRLs participated in acid-fast bacilli microscopy external quality assurance (95.8%, although external quality assurance for other techniques was lower (60.4% for first-line drug susceptibility testing, 25.0% for second-line drug susceptibility testing, and 22.9% for molecular testing. Barriers to accreditation included lack of training and accreditation programmes. Only 28.6%of NTRLs had developed strategic plans and budgets which included accreditation. Conclusion: Good foundations are in place on the continent from which to scale up accreditation efforts. Laboratory audits should be conducted as a first step in developing quality improvement action plans. Political commitment and strong leadership are needed to drive accreditation efforts; advocacy will require clear evidence of patient

The international ISOE programme. ISOE European technical centre activities

International Nuclear Information System (INIS)

Ascenzo, L. d'; Crouail, P.; Levy, F.; Livolsi, P.; Schieber, C.; Lefaure, C.

1996-01-01

The CEPN has been involved from the beginning in the NEA Information System on Occupational Exposure (ISOE). As ISOE European Technical Centre, the CEPN is responsible for the collection and distribution of European data to the various ISOE partners, the collection of data from the other regional technical centres, and the custodianship of the full ISOE data base. This full data base is updated annually and distributed to all the European participating utilities and to other Regional Technical Centres. The European data are also sent to the European Commission (EC) as a contribution to their own occupational exposure data base. In addition to these activities, the CEPN has developed two computer programmes under Windows to facilitate the management of ISOE data bases. The first software, called ASPIC, allows participating utilities to electronically complete NEA1 and NEA3 questionnaires, as well as to consult the NEA3 data base using key words search routine. This software is available in six different languages. The second programme is a relational data base for the performance of statistical analyses using data from NEA1. The CEPN also contributes significantly to the efficient flow of information through the ISOE Network. This includes participation in the preparation and distribution of the ISOE Annual Report (which presents and analyses NEAI data), ISOE Information Sheets (providing short synthesis using NEA1 and NEA3 data), and Technical Reports. Participating Authorities and Utilities have each made information requests to the CEPN concerning dosimetric data, radiation protection experiences, policies and practices. Some examples of these requests, and of the types of data provided, will be presented. (author)

Quality standards: Comparison between IAEA 50-C/SG-Q and ISO 9001:2000

International Nuclear Information System (INIS)

2002-01-01

contractors/suppliers' quality assurance programme must comply with the nuclear safety requirements. The utility/owner/operator has the ultimate responsibility to ensure that an acceptable degree of quality assurance in relation to nuclear safety has been achieved. This can be done by imposing additional requirements on the contractors/suppliers over and above those contained within the ISO 9001:2000 standard. In order to provide a description of the differences between the IAEA and ISO quality standards when applied in nuclear installations, and to support practical measures for achieving nuclear safety, the IAEA established a project for producing a guidance report. A first effort to compare the IAEA and ISO quality standards was conducted during the years 1999 and 2000. The comparison was made using the 1994 edition of the ISO:9001 standard despite the fact that the ISO 9000:2000 series of standards was in its final phase of discussion and approval. This effort was considered to be worth while and remains valid since the two versions will co-exist during the period from 15 December 2000 to 15 December 2003, during which ISO users will have to upgrade their quality management systems to meet the requirements of ISO 9001:2000. The result of the first comparison was published in IAEA-TECDOC-1182, Quality Assurance Standards: Comparison between IAEA 50-C/SG-Q and ISO 9001: 1994. After the publication of ISO 9001:2000 a new effort was initiated in 2001 to update the comparison mentioned above. The result is presented in this publication, which provides information and guidance that may be considered when ISO 9001:2000 and also ISO 9004:2000 are utilized by the nuclear industry

Field Evaluation of Solvent-Free Sampling with Di-n-butylamine for the Determination of Airborne Monomeric and Oligomeric 1,6-Hexamethylene Diisocyanate

Science.gov (United States)

2014-03-27

ISO Guide 34:2009 and ISO / IEC 17025 :2005) for HDI oligomers. Per the manufacturer, a single ASSETTM sampler may be used for over 8 hours which leads...hexamethylene diisocyanate (HDI). During this study, the Supelco ASSETTM EZ4-NCO Dry Sampler was compared to the Omega Specialty Instrument Company ISO ...detection (HPLC-MS); 2) do ASSETTM and ISO -CHEK® samplers collect equivalent HDI monomer and oligomer concentrations; and 3) what is the relative cost of

Does accreditation stimulate change? A study of the impact of the accreditation process on Canadian healthcare organizations

Directory of Open Access Journals (Sweden)

Shabah Abdo

2010-04-01

Full Text Available Abstract Background One way to improve quality and safety in healthcare organizations (HCOs is through accreditation. Accreditation is a rigorous external evaluation process that comprises self-assessment against a given set of standards, an on-site survey followed by a report with or without recommendations, and the award or refusal of accreditation status. This study evaluates how the accreditation process helps introduce organizational changes that enhance the quality and safety of care. Methods We used an embedded multiple case study design to explore organizational characteristics and identify changes linked to the accreditation process. We employed a theoretical framework to analyze various elements and for each case, we interviewed top managers, conducted focus groups with staff directly involved in the accreditation process, and analyzed self-assessment reports, accreditation reports and other case-related documents. Results The context in which accreditation took place, including the organizational context, influenced the type of change dynamics that occurred in HCOs. Furthermore, while accreditation itself was not necessarily the element that initiated change, the accreditation process was a highly effective tool for (i accelerating integration and stimulating a spirit of cooperation in newly merged HCOs; (ii helping to introduce continuous quality improvement programs to newly accredited or not-yet-accredited organizations; (iii creating new leadership for quality improvement initiatives; (iv increasing social capital by giving staff the opportunity to develop relationships; and (v fostering links between HCOs and other stakeholders. The study also found that HCOs' motivation to introduce accreditation-related changes dwindled over time. Conclusions We conclude that the accreditation process is an effective leitmotiv for the introduction of change but is nonetheless subject to a learning cycle and a learning curve. Institutions invest

Sustaining a quality improvement culture in local health departments applying for accreditation.

Science.gov (United States)

Verma, Pooja; Moran, John W

2014-01-01

This article focuses on local health departments (LHDs) that are advanced in accreditation and quality improvement (QI) efforts and the barriers and facilitators associated with sustaining improvements and building an organizational culture of QI. To understand the barriers and facilitators associated with building and sustaining progress toward a QI culture in LHDs. Quantitative data from a self-reporting survey and qualitative data from telephone interviews. Twenty-two LHDs across the United States responded to the survey. Ten of the 22 LHD respondents participated in telephone interviews. QI lead staff at LHDs that are advanced in accreditation preparation and QI. Self-reported LHD survey ratings against indicators for a QI culture, and the identified barriers and facilitators around sustaining QI initiatives. Of the 6 domains of a QI culture measured in the survey, the percentages of respondents that scored themselves highly to at least 1 indicator in each domain are as follows: leadership commitment (100%); employee empowerment (100%); teamwork and collaboration (100%); continuous process improvement (86%); customer focus (72%); and QI infrastructure (64%). Qualitative data from 10 telephone interviews revealed that key barriers to sustaining progress around QI included staff turnover, budget cuts, and major crises or events that arise as priority. Key facilitators included leadership commitment, accreditation, and dedication of resources and staff time to QI. When engaging in QI, LHDs should consider investing efforts in gaining leadership support and dedicating staff time early in the QI journey to ensure that QI efforts and initiatives are sustained. Local health departments interested in developing a QI culture should also consider pursuing accreditation, as it provides a structured framework for continuous improvement. They should also actively develop QI knowledge and skills among all staff members to minimize the negative impact of staff turnover.

CDC/NACCHO Accreditation Support Initiative: advancing readiness for local and tribal health department accreditation.

Science.gov (United States)

Monteiro, Erinn; Fisher, Jessica Solomon; Daub, Teresa; Zamperetti, Michelle Chuk

2014-01-01

Health departments have various unique needs that must be addressed in preparing for national accreditation. These needs require time and resources, shortages that many health departments face. The Accreditation Support Initiative's goal was to test the assumption that even small amounts of dedicated funding can help health departments make important progress in their readiness to apply for and achieve accreditation. Participating sites' scopes of work were unique to the needs of each site and based on the proposed activities outlined in their applications. Deliverables and various sources of data were collected from sites throughout the project period (December 2011-May 2012). Awardees included 1 tribal and 12 local health departments, as well as 5 organizations supporting the readiness of local and tribal health departments. Sites dedicated their funding toward staff time, accreditation fees, completion of documentation, and other accreditation readiness needs and produced a number of deliverables and example documents. All sites indicated that they made accreditation readiness gains that would not have occurred without this funding. Preliminary evaluation data from the first year of the Accreditation Support Initiative indicate that flexible funding arrangements may be an effective way to increase health departments' accreditation readiness.

Strengthening organizational performance through accreditation research-a framework for twelve interrelated studies: the ACCREDIT project study protocol

Directory of Open Access Journals (Sweden)

Pope Catherine

2011-10-01

Full Text Available Abstract Background Service accreditation is a structured process of recognising and promoting performance and adherence to standards. Typically, accreditation agencies either receive standards from an authorized body or develop new and upgrade existing standards through research and expert views. They then apply standards, criteria and performance indicators, testing their effects, and monitoring compliance with them. The accreditation process has been widely adopted. The international investments in accreditation are considerable. However, reliable evidence of its efficiency or effectiveness in achieving organizational improvements is sparse and the value of accreditation in cost-benefit terms has yet to be demonstrated. Although some evidence suggests that accreditation promotes the improvement and standardization of care, there have been calls to strengthen its research base. In response, the ACCREDIT (Accreditation Collaborative for the Conduct of Research, Evaluation and Designated Investigations through Teamwork project has been established to evaluate the effectiveness of Australian accreditation in achieving its goals. ACCREDIT is a partnership of key researchers, policymakers and agencies. Findings We present the framework for our studies in accreditation. Four specific aims of the ACCREDIT project, which will direct our findings, are to: (i evaluate current accreditation processes; (ii analyse the costs and benefits of accreditation; (iii improve future accreditation via evidence; and (iv develop and apply new standards of consumer involvement in accreditation. These will be addressed through 12 interrelated studies designed to examine specific issues identified as a high priority. Novel techniques, a mix of qualitative and quantitative methods, and randomized designs relevant for health-care research have been developed. These methods allow us to circumvent the fragmented and incommensurate findings that can be generated in small

Strengthening organizational performance through accreditation research-a framework for twelve interrelated studies: the ACCREDIT project study protocol.

Science.gov (United States)

Braithwaite, Jeffrey; Westbrook, Johanna; Johnston, Brian; Clark, Stephen; Brandon, Mark; Banks, Margaret; Hughes, Clifford; Greenfield, David; Pawsey, Marjorie; Corbett, Angus; Georgiou, Andrew; Callen, Joanne; Ovretveit, John; Pope, Catherine; Suñol, Rosa; Shaw, Charles; Debono, Deborah; Westbrook, Mary; Hinchcliff, Reece; Moldovan, Max

2011-10-09

Service accreditation is a structured process of recognising and promoting performance and adherence to standards. Typically, accreditation agencies either receive standards from an authorized body or develop new and upgrade existing standards through research and expert views. They then apply standards, criteria and performance indicators, testing their effects, and monitoring compliance with them. The accreditation process has been widely adopted. The international investments in accreditation are considerable. However, reliable evidence of its efficiency or effectiveness in achieving organizational improvements is sparse and the value of accreditation in cost-benefit terms has yet to be demonstrated. Although some evidence suggests that accreditation promotes the improvement and standardization of care, there have been calls to strengthen its research base.In response, the ACCREDIT (Accreditation Collaborative for the Conduct of Research, Evaluation and Designated Investigations through Teamwork) project has been established to evaluate the effectiveness of Australian accreditation in achieving its goals. ACCREDIT is a partnership of key researchers, policymakers and agencies. We present the framework for our studies in accreditation. Four specific aims of the ACCREDIT project, which will direct our findings, are to: (i) evaluate current accreditation processes; (ii) analyse the costs and benefits of accreditation; (iii) improve future accreditation via evidence; and (iv) develop and apply new standards of consumer involvement in accreditation. These will be addressed through 12 interrelated studies designed to examine specific issues identified as a high priority. Novel techniques, a mix of qualitative and quantitative methods, and randomized designs relevant for health-care research have been developed. These methods allow us to circumvent the fragmented and incommensurate findings that can be generated in small-scale, project-based studies. The overall

[Quality evaluation of the orthodontic practice for certification by ISO 9001. A procedure beneficial for medical, medico-dental or hospital service].

Science.gov (United States)

Becker, G

2001-01-01

The accreditation of the ISO 9001 certification (ISO = International Standard Organization) is an external evaluation procedure carried out by independent experts, whose object is the analysis of the operational methods and practices of a medical care facility (e.g. hospital, private clinic, general practitioner's or dentist's practice) which decided to assume the concept, implementation and control of its own quality policy. The whole accreditation procedure represents the basic structure of a continuous dynamic progressiveness within a cabinet eager to offer outstanding quality. Moreover, it guarantees active and voluntary participation of every single member of the medical administration or technical team involved in the realization of this primary objective. In other words, we are talking about a very strong dynamic innovation leading to a change of views and the improvement of communication means, while simultaneously enhancing the security and quality aspects of medical care. The continuous guarantee of high quality medical care calls for precise planning and systematization of actions. First of all, these actions are defined, analyzed and listed in precise work procedures. As they are defined with the agreement of the whole team, they implicate respect and self control. This requires of course transparency of the treatment methods, whose different steps and procedures are described in detail in a logogramm set up in common.

[Evaluation of clinical laboratories--assurance of their quality and competence].

Science.gov (United States)

Kawai, Tadashi

2007-01-01

Since ISO 15189:2003 was published, the accreditation program of clinical laboratories based on ISO 15189 has been introduced in many countries, except for those in USA where all clinical laboratories must be required to follow the federal law, CLIA'88. It will certainly help the accredited clinical laboratories improve their quality and competence. In relation to the activity of JCTLM, reference measurement laboratories will be accredited, based on ISO 15195 which is now under its review and amendment by ISO/TC212/WG2. In Japan, JCCLS (Japanese Committee for Clinical Laboratory Standards) and JAB (Japan Accreditation Board for Conformity Assessment) cojointly started the accreditation program for clinical laboratories, based on ISO 15189:2003, and a total of 15 laboratories including university hospitals, community hospitals and independent clinical laboratories have been accredited up until the end of 2006.

Demonstration of the Gore Module for Passive Ground Water Sampling

Science.gov (United States)

2014-06-01

Organization for Standardization ( ISO )/International Electrotechnical Commission ( IEC ) 17025 , DoD ELAP, and NELAC quality standards for USEPA Method...mass spectrometry GCB Geochemical Sciences Branch GT glacial till HSE Health and Safety Executive IEC International Electrotechnical Commission...IRP Installation Restoration Program ACRONYMS AND ABBREVIATIONS (continued) x ISO International Organization for Standardization ITRC

Integrated management system: The integration of ISO 9001, ISO 14001, OHSAS 18001 and ISO 31000

Science.gov (United States)

Muzaimi, Hafizzudin; Chew, Boon Cheong; Hamid, Syaiful Rizal

2017-03-01

The implementation of integrated management system (IMS) for better quality management has become a preference for many organizations. This can be seen as many organizations used the combination of quality ISO 9001, an environment ISO 14001 and occupational health and safety management system OHSAS 18001 as a core for the IMS that largely implemented. Besides, the linked between quality management with risk management system need to be identified as the management system that enhance the effectiveness of IMS. Therefore, the risk management system ISO 31000 also presented as a part of integration. In nowadays competitive environment, the increasing pressure and needs from customer or stakeholders make it compulsory for the organization to propose the new system and standards. This paper presents and discusses about the benefit of integration, the management system components that can be converged and the implementation approach. A series of interview was conducted through in-depth interviews with 8 experts in this field, while data collected were analyzed qualitatively. The results consist of 16 factors of IMS implementation that have been identified and the use of PDCA approach for an effective implementation of IMS. As a conclusion, the paper proposes the integration of four management systems (ISO 9001, ISO 14001, OHSAS 18001 and ISO 31000) and on how the IMS can be used to structure the process of management for quality management towards sustainability practices in the organization.

Gaining competitive advantage in personal dosimetry services through ISO 9001 certification

International Nuclear Information System (INIS)

Noriah, M.A.

2005-01-01

Full text: In Malaysia, the harmonization of dose monitoring for almost 12,000 radiation workers is assigned to the Secondary Standard Dosimetry Laboratory of Malaysian Institute for Nuclear Technology Research, SSDL-MINT. Established in 1980, SSDL-MINT is responsible for improving personal and workplace safety by providing high quality personal dosimetry services. It is important to demonstrate that the performance of personal dosimetry meets recognized standards, to ensure radiation doses to individual workers are within the safe limits and to verify compliance with dose limits. Concern on the quality of personal dosimetry service began to be expressed in 2000. The concern led to the ISO certification, which brought an unprecedented effort characterized by high degree coordination, proper documentation and well trained of personal dosimetry operators. These huge efforts resulted with certification ISO 9002:1994 by the SIRIM International QAS Sdn. Bhd. in January 2002. The adoption of these requirements for the ISO 9002 standard makes routine handling of the process easier, and increases the reliability and effectiveness of the services. This helps to increase the quality and uniformity of personal dosimetry. The revision of the ISO 9002:1994 to ISO 9001:2000 necessitated SSDL-MINT revising its quality management system. The work began in middle 2002, and by May 2003, SSDL-MINT has been upgraded to ISO 9001:2000. Certification to the ISO 9001:2000 demonstrates our ability to consistency provide service that meets the requirements of the customer and the regulatory authority. These includes: improved consistency of service / product performance and therefore higher customer satisfaction levels; uniformity in work processes across organizations; simplified and more uniform structure for quality documents; improved customer perception of the organizations image, culture and performance; reduced number of product and process non-conformances; greater employee

Gestión de calidad en una organización de salud pública Quality management in a public health agency

Directory of Open Access Journals (Sweden)

Joan R. Villalbí

2012-08-01

Full Text Available Se presenta la experiencia de introducción de acciones de mejora de la calidad en una organización de salud pública. Tras la acreditación ISO 17025 del laboratorio de control oficial obtenida por requisito legal, la dirección acordó en 2003 extender la política de calidad, poniendo en marcha un repertorio de acciones mediante el análisis de procesos y la formulación de acciones de mejora, la mayor formalización de procedimientos, el conocimiento de la opinión de los clientes, la creación de grupos de mejora, y la auditoría o certificación externa. La organización respondió de forma diversa a estas iniciativas. Someter los servicios a auditoría o certificación externa parece el motor más poderoso para el cambio. El estudio de costes de la actividad permite valorar que, en 2010, el 75% del gasto total se realiza en servicios de salud pública sujetos a auditoría/certificación externa.This article describes the introduction of quality improvement actions in a public health organization. After ISO 17025 accreditation, which was legally mandated, was granted to the official control laboratory, the management decided to expand a quality policy in 2003, through a series of actions based on process analysis and proposals for improvement, further definition of standard operating procedures, exploration of users' opinions, the creation of improvement groups, and external audits or certification. The organizational response to these initiatives was diverse. External audit or certification of services seems to be the most powerful tool for change. Costing studies showed that up to 75% of the total expenditure of the agency in 2010 was spent on public health services subject to external audit or certification.

Accreditation: a cultural control strategy.

Science.gov (United States)

Paccioni, André; Sicotte, Claude; Champagne, François

2008-01-01

The purpose of this paper is to describe and understand the effects of the accreditation process on organizational control and quality management practices in two Quebec primary-care health organizations. A multiple-case longitudinal study was conducted taking a mixed qualitative/quantitative approach. An analytical model was developed of the effects of the accreditation process on the type of organizational control exercised and the quality management practices implemented. The data were collected through group interviews, semi-directed interviews of key informers, non-participant observations, a review of the literature, and structured questionnaires distributed to all the employees working in both institutions. The accreditation process has fostered the implementation of consultation mechanisms in self-assessment teams. Improving assessments of client satisfaction was identified as a prime objective but, in terms of the values promoted in organizations, accreditation has little effect on the perceptions of employees not directly involved in the process. As long as not all staff members have integrated the basis for accreditation and its outcomes, the accreditation process appears to remain an external, bureaucratic control instrument. This study provides a theoretical model for understanding organizational changes brought about by accreditation of primary services. Through self-assessment of professional values and standards, accreditation may foster better quality management practices.

The method validation step of biological dosimetry accreditation process

International Nuclear Information System (INIS)

Roy, L.; Voisin, P.A.; Guillou, A.C.; Busset, A.; Gregoire, E.; Buard, V.; Delbos, M.; Voisin, Ph.

2006-01-01

One of the missions of the Laboratory of Biological Dosimetry (L.D.B.) of the Institute for Radiation and Nuclear Safety (I.R.S.N.) is to assess the radiological dose after an accidental overexposure suspicion to ionising radiation, by using radio-induced changes of some biological parameters. The 'gold standard' is the yield of dicentrics observed in patients lymphocytes, and this yield is converted in dose using dose effect relationships. This method is complementary to clinical and physical dosimetry, for medical team in charge of the patients. To obtain a formal recognition of its operational activity, the laboratory decided three years ago, to require an accreditation, by following the recommendations of both 17025 General Requirements for the Competence of Testing and Calibration Laboratories and 19238 Performance criteria for service laboratories performing biological dosimetry by cyto-genetics. Diagnostics, risks analysis were realized to control the whole analysis process leading to documents writing. Purchases, personnel department, vocational training were also included in the quality system. Audits were very helpful to improve the quality system. One specificity of this technique is that it is not normalized therefore apart from quality management aspects, several technical points needed some validations. An inventory of potentially influent factors was carried out. To estimate their real effect on the yield of dicentrics, a Placket-Burman experimental design was conducted. The effect of seven parameters was tested: the BUdr (bromodeoxyuridine), PHA (phytohemagglutinin) and colcemid concentration, the culture duration, the incubator temperature, the blood volume and the medium volume. The chosen values were calculated according to the uncertainties on the way they were measured i.e. pipettes, thermometers, test tubes. None of the factors has a significant impact on the yield of dicentrics. Therefore the uncertainty linked to their use was considered as

The method validation step of biological dosimetry accreditation process

Energy Technology Data Exchange (ETDEWEB)

Roy, L.; Voisin, P.A.; Guillou, A.C.; Busset, A.; Gregoire, E.; Buard, V.; Delbos, M.; Voisin, Ph. [Institut de Radioprotection et de Surete Nucleaire, LDB, 92 - Fontenay aux Roses (France)

2006-07-01

One of the missions of the Laboratory of Biological Dosimetry (L.D.B.) of the Institute for Radiation and Nuclear Safety (I.R.S.N.) is to assess the radiological dose after an accidental overexposure suspicion to ionising radiation, by using radio-induced changes of some biological parameters. The 'gold standard' is the yield of dicentrics observed in patients lymphocytes, and this yield is converted in dose using dose effect relationships. This method is complementary to clinical and physical dosimetry, for medical team in charge of the patients. To obtain a formal recognition of its operational activity, the laboratory decided three years ago, to require an accreditation, by following the recommendations of both 17025 General Requirements for the Competence of Testing and Calibration Laboratories and 19238 Performance criteria for service laboratories performing biological dosimetry by cyto-genetics. Diagnostics, risks analysis were realized to control the whole analysis process leading to documents writing. Purchases, personnel department, vocational training were also included in the quality system. Audits were very helpful to improve the quality system. One specificity of this technique is that it is not normalized therefore apart from quality management aspects, several technical points needed some validations. An inventory of potentially influent factors was carried out. To estimate their real effect on the yield of dicentrics, a Placket-Burman experimental design was conducted. The effect of seven parameters was tested: the BUdr (bromodeoxyuridine), PHA (phytohemagglutinin) and colcemid concentration, the culture duration, the incubator temperature, the blood volume and the medium volume. The chosen values were calculated according to the uncertainties on the way they were measured i.e. pipettes, thermometers, test tubes. None of the factors has a significant impact on the yield of dicentrics. Therefore the uncertainty linked to their use was

Reliability of High-Temperature Fixed-Point Installations over 8 Years

Science.gov (United States)

Elliott, C. J.; Ford, T.; Ongrai, O.; Pearce, J. V.

2017-12-01

At NPL, high-temperature metal-carbon eutectic fixed points have been set up for thermocouple calibration purposes since 2006, for realising reference temperatures above the highest point specified in the International Temperature Scale of 1990 for contact thermometer calibrations. Additionally, cells of the same design have been provided by NPL to other national measurement institutes (NMIs) and calibration laboratories over this period, creating traceable and ISO 17025 accredited facilities around the world for calibrating noble metal thermocouples at 1324 {°}C (Co-C) and 1492 {°}C (Pd-C). This paper shows collections of thermocouple calibration results obtained during use of the high-temperature fixed-point cells at NPL and, as further examples, the use of cells installed at CCPI Europe (UK) and NIMT (Thailand). The lifetime of the cells can now be shown to be in excess of 7 years, whether used on a weekly or monthly basis, and whether used in an NMI or industrial calibration laboratory.

Assessment of medical occupational radiation doses in Costa Rica

International Nuclear Information System (INIS)

Mora, P.; Acuna, M.

2011-01-01

Participation of the Univ. of Costa Rica (UCR) in activities in an IAEA Regional Project RLA/9/066 through training, equipment and expert missions, has enabled to setting up of a national personal monitoring laboratory. Since 2007, the UCR has been in charge of monitoring around 1800 medical radiation workers of the Social Security System. Individual external doses are measured with thermoluminescent dosemeter using a Harshaw 6600 Plus reader. The service has accreditation with ISO/IEC 17025:2005. Distribution of monitored medical personnel is as follows: 83 % in diagnostic radiology, 6 % in nuclear medicine and 6 % in radiotherapy. Preliminary values for the 75 percentile of annual H p (10) in mSv are: radiology 0.37; interventional radiology 0.41; radiotherapy 0.53 and nuclear medicine 1.55. The service provided by the UCR in a steady and reliable way can help to implement actions to limit the doses received by the medical workers and optimise their radiation protection programs. (authors)

Procedure for implementing the system of quality management in the testing laboratory of the Center for Genetic Engineering and Biotechnology in Sancti Spiritus.

Directory of Open Access Journals (Sweden)

Lídice Peraza Cruz

2014-03-01

Full Text Available Implementation of Quality Management System in testing laboratories offers the possibility of its accreditation and a frame for cooperation with other organizations, supporting information and experience exchange, as well as standards and procedures harmonization. To improve the performance of the Center for Genetic Engineering and Biotechnology of Sancti Spíritus testing laboratory, assuring technically valid data and results which promote technical competence and credibility of in vitro diagnostics and biological reagents products, a procedure was designed to implement a Quality Management System. This procedure applies Deming´s Quality Cycle and considers all relevant requirements in NC ISO/IEC 17025:2006 “General requirements for the competence of testing and calibration laboratories” and Regulation No. 20 2004 “Good Manufacturing Practices for in vitro Diagnostics” of Center for State Control of Drugs, Equipment and Medical Devices. We recommend an auto evaluation method, designed by authors, to verify quality management system accomplishment.

Assessment of medical occupational radiation doses in Costa Rica.

Science.gov (United States)

Mora, P; Acuña, M

2011-09-01

Participation of the University of Costa Rica (UCR) in activities in an IAEA Regional Project RLA/9/066 through training, equipment and expert missions, has enabled to setting up of a national personal monitoring laboratory. Since 2007, the UCR has been in charge of monitoring around 1800 medical radiation workers of the Social Security System. Individual external doses are measured with thermoluminescent dosemeter using a Harshaw 6600 Plus reader. The service has accreditation with ISO/IEC 17025:2005. Distribution of monitored medical personnel is as follows: 83 % in diagnostic radiology, 6 % in nuclear medicine and 6 % in radiotherapy. Preliminary values for the 75 percentile of annual H(p)(10) in mSv are: radiology 0.37; interventional radiology 0.41; radiotherapy 0.53 and nuclear medicine 1.55. The service provided by the UCR in a steady and reliable way can help to implement actions to limit the doses received by the medical workers and optimise their radiation protection programs.

Drop-out probabilities of IrisPlex SNP alleles

DEFF Research Database (Denmark)

Andersen, Jeppe Dyrberg; Tvedebrink, Torben; Mogensen, Helle Smidt

2013-01-01

In certain crime cases, information about a perpetrator's phenotype, including eye colour, may be a valuable tool if no DNA profile of any suspect or individual in the DNA database matches the DNA profile found at the crime scene. Often, the available DNA material is sparse and allelic drop-out...... of true alleles is possible. As part of the validation of the IrisPlex assay in our ISO17025 accredited, forensic genetic laboratory, we estimated the probability of drop-out of specific SNP alleles using 29 and 30 PCR cycles and 25, 50 and 100 Single Base Extension (SBE) cycles. We observed no drop-out...... when the amount of DNA was greater than 125 pg for 29 cycles of PCR and greater than 62 pg for 30 cycles of PCR. With the use of a logistic regression model, we estimated the allele specific probability of drop-out in heterozygote systems based on the signal strength of the observed allele...

Evaluation of the iPLEX(®) Sample ID Plus Panel designed for the Sequenom MassARRAY(®) system. A SNP typing assay developed for human identification and sample tracking based on the SNPforID panel

DEFF Research Database (Denmark)

Johansen, P; Andersen, J D; Børsting, Claus

2013-01-01

on the peak height and the signal to noise data exported from the TYPER 4.0 software. With the forensic analysis parameters, all inconsistencies were eliminated in reactions with ≥10ng DNA. However, the average call rate decreased to 69.9%. The iPLEX(®) Sample ID Plus Panel was tested on 10 degraded samples......Sequenom launched the first commercial SNP typing kit for human identification, named the iPLEX(®) Sample ID Plus Panel. The kit amplifies 47 of the 52 SNPs in the SNPforID panel, amelogenin and two Y-chromosome SNPs in one multiplex PCR. The SNPs were analyzed by single base extension (SBE......) and Matrix Assisted Laser Desorption/Ionization-Time of Flight Mass Spectrometry (MALDI-TOF MS). In this study, we evaluated the accuracy and sensitivity of the iPLEX(®) Sample ID Plus Panel by comparing the typing results of the iPLEX(®) Sample ID Plus Panel with those obtained with our ISO 17025 accredited...

ISO27001 / ISO27002 a pocket guide

CERN Document Server

Calder, Alan

2013-01-01

Information is one of your organisation's most important resources. Keeping it secure is therefore vital to your business. This handy pocket guide is an essential overview of two key information security standards that cover the formal requirements (ISO27001:2013) for creating an Information Security Management System (ISMS), and the best-practice recommendations (ISO27002:2013) for those responsible for initiating, implementing or maintaining it.

Measurements Matter in Nuclear Safeguards & Security

International Nuclear Information System (INIS)

Aregbe, Y.; Jakopic, R.; Richter, S.; Schillebeeckx, P.; Hult, M.

2015-01-01

The deliverable of any laboratory is a measurement result with stated uncertainty and traceability (ISO/IEC 17025: 2005). Measurement results, particularly in safeguards, have to be accurate, comparable and traceable to a stated reference, preferably to the SI. Results provided by operator-, safeguards- or network laboratories have to be in compliance with specific quality goals for nuclear material and environmental sample analysis. Metrological quality control tools are prerequisites to build up confidence in measurement results that have to be translated into meaningful safeguards conclusions or to demonstrate conformity of findings with declared processes. The European Commission—Joint Research Centre (EC–JRC) has dedicated facilities, laboratories and projects to provide certified nuclear reference materials (CRM), to develop reference methods and to organize inter-laboratory comparisons (ILC) in compliance with ISO Guide 34, ISO17025 and ISO17043, including respective training. Recent examples are: – cooperation with the JAEA to investigate on the application of Neutron Resonance Densitometry (NRD) to quantify the amount of special nuclear material in particlelike debris of melted fuel as formed in the nuclear accident in Fukushima – training in metrology and gamma-ray spectrometry for EURATOM safeguards inspectors – development of uranium reference particle standards under a new EC support task to the IAEA. Currently, the JRC puts major efforts in producing CRMs and conformity assessment tools for “age-dating” of uranium and plutonium samples. They are needed for method validation in determining the date of the last chemical separation of uranium or plutonium from their daughter nuclides. These type of CRMs are not only needed in nuclear safeguards and forensics, but could support in the future a possible new type of “verification mechanism” as part of the Fissile Material Cut-off Treaty (FMCT), since measurements and measurement standards

Is Gerontology Ready for Accreditation?

Science.gov (United States)

Haley, William E.; Ferraro, Kenneth F.; Montgomery, Rhonda J. V.

2012-01-01

The authors review widely accepted criteria for program accreditation and compare gerontology with well-established accredited fields including clinical psychology and social work. At present gerontology lacks many necessary elements for credible professional accreditation, including defined scope of practice, applied curriculum, faculty with…

Exploring the Role of Accreditation in Supporting Transfer and Student Mobility

Science.gov (United States)

Felder, Pamela Petrease; Arleth, Megan T.

2016-01-01

Student mobility and transfer between two-year and four-year institutions are critical issues when considering student success and degree completion. College and university administrators continually work to identify opportunities that align policy and practice with accreditation standards in an effort to facilitate self-study initiatives and meet…

IsoBank workshop held at IsoEcol10 - University of Tokyo 2016

OpenAIRE

Hayden, Brian

2016-01-01

IsoBank is a repository for stable isotope values and relevant metadata. These slides were presented at a workshop held during IsoEcol10 to refine and design the IsoBank for the needs of a diverse group of researchers.

Accreditation in general practice in Denmark

DEFF Research Database (Denmark)

Andersen, Merethe K; Pedersen, Line B; Siersma, Volkert

2017-01-01

Background: Accreditation is used increasingly in health systems worldwide. However, there is a lack of evidence on the effects of accreditation, particularly in general practice. In 2016 a mandatory accreditation scheme was initiated in Denmark, and during a 3-year period all practices, as default...... general practitioners in Denmark. Practices allocated to accreditation in 2016 serve as the intervention group, and practices allocated to accreditation in 2018 serve as controls. The selected outcomes should meet the following criteria: (1) a high degree of clinical relevance; (2) the possibility...... practice and mortality. All outcomes relate to quality indicators included in the Danish Healthcare Quality Program, which is based on general principles for accreditation. Discussion: The consequences of accreditation and standard-setting processes are generally under-researched, particularly in general...

Standards of Quality: Accreditation Guidelines Redesigned

Science.gov (United States)

Forsythe, Hazel; Andrews, Frances; Stanley, M. Sue; Anderson, Carol L.

2011-01-01

To ensure optimal standards for AAFCS program accreditation, the Council for Accreditation (CFA) conducted a review and revision of the "2001 AAFCS Standards for Accreditation." The CFA took a three-pronged approach including (a) a review of academic accreditations that had relationships to the FCS disciplines, (b) concept, content, and process…

Hospital accreditation: staff experiences and perceptions.

Science.gov (United States)

Bogh, Søren Bie; Blom, Ane; Raben, Ditte Caroline; Braithwaite, Jeffrey; Thude, Bettina; Hollnagel, Erik; Plessen, Christian von

2018-06-11

Purpose The purpose of this paper is to understand how staff at various levels perceive and understand hospital accreditation generally and in relation to quality improvement (QI) specifically. Design/methodology/approach In a newly accredited Danish hospital, the authors conducted semi-structured interviews to capture broad ranging experiences. Medical doctors, nurses, a quality coordinator and a quality department employee participated. Interviews were audio recorded and subjected to framework analysis. Findings Staff reported that The Danish Healthcare Quality Programme affected management priorities: office time and working on documentation, which reduced time with patients and on improvement activities. Organisational structures were improved during preparation for accreditation. Staff perceived that the hospital was better prepared for new QI initiatives after accreditation; staff found disease specific requirements unnecessary. Other areas benefited from accreditation. Interviewees expected that organisational changes, owing to accreditation, would be sustained and that the QI focus would continue. Practical implications Accreditation is a critical and complete hospital review, including areas that often are neglected. Accreditation dominates hospital agendas during preparation and surveyor visits, potentially reducing patient care and other QI initiatives. Improvements are less likely to occur in areas that other QI initiatives addressed. Yet, accreditation creates organisational foundations for future QI initiatives. Originality/value The authors study contributes new insights into how hospital staff at different organisational levels perceive and understand accreditation.

42 CFR 8.13 - Revocation of accreditation and accreditation body approval.

Science.gov (United States)

2010-10-01

... GENERAL PROVISIONS CERTIFICATION OF OPIOID TREATMENT PROGRAMS Certification and Treatment Standards § 8.13... period of 1 year after the date of withdrawal of approval of the accreditation body, unless SAMHSA.... (2) Within 1 year from the date of withdrawal of approval of an accreditation body, or within any...

University Accreditation using Data Warehouse

Science.gov (United States)

Sinaga, A. S.; Girsang, A. S.

2017-01-01

The accreditation aims assuring the quality the quality of the institution education. The institution needs the comprehensive documents for giving the information accurately before reviewed by assessor. Therefore, academic documents should be stored effectively to ease fulfilling the requirement of accreditation. However, the data are generally derived from various sources, various types, not structured and dispersed. This paper proposes designing a data warehouse to integrate all various data to prepare a good academic document for accreditation in a university. The data warehouse is built using nine steps that was introduced by Kimball. This method is applied to produce a data warehouse based on the accreditation assessment focusing in academic part. The data warehouse shows that it can analyse the data to prepare the accreditation assessment documents.

Source Code Analysis Laboratory (SCALe) for Energy Delivery Systems

Science.gov (United States)

2010-12-01

technical competence for the type of tests and calibrations SCALe undertakes. Testing and calibration laboratories that comply with ISO / IEC 17025 ...and exec t [ ISO / IEC 2005]. f a software system indicates that the SCALe analysis di by a CERT secure coding standard. Successful conforma antees that...to be more secure than non- systems. However, no study has yet been performed to p t ssment in accordance with ISO / IEC 17000: “a demonstr g to a

Accreditation and training on internal dosimetry in a laboratory network in Brazil: an increasing demand.

Science.gov (United States)

Dantas, B M; Dantas, A L A; Acar, M E D; Cardoso, J C S; Julião, L M Q C; Lima, M F; Taddei, M H T; Arine, D R; Alonso, T; Ramos, M A P; Fajgelj, A

2011-03-01

In recent years, Brazilian Nuclear Programme has been reviewed and updated by government authorities in face of the demand for energy supply and its associated environmental constraints. The immediate impact of new national programmes and projects in nuclear field is the increase in the number of exposed personnel and the consequent need for reliable dosimetry services in the country. Several Technical Documents related to internal dosimetry have been released by the International Atomic Energy Agency and International Commission on Radiological Protection. However, standard bioassay procedures and methodologies for bioassay data interpretation are still under discussion and, in some cases, both in routine and emergency internal monitoring, procedures can vary from one laboratory to another and responses may differ markedly among Dosimetry Laboratories. Thus, it may be difficult to interpret and use bioassay data generated from different laboratories of a network. The main goal of this work is to implement a National Network of Laboratories aimed to provide reliable internal monitoring services in Brazil. The establishment of harmonised in vivo and in vitro radioanalytical techniques, dose assessment methods and the implementation of the ISO/IEC 17025 requirements will result in the recognition of technical competence of the network.

ISO radiation protection standards

International Nuclear Information System (INIS)

Becker, K.; West, N.

1981-01-01

After a brief description of the International Organization for Standardization (ISO) and its Technical Committee (TC) 85 ''Nuclear Energy'', the work of its Sub-Committee (SC) 2 ''Radiation Protection'' is described in some detail. Several international standards on subjects closely related to radiation protection have already been published, for example ISO-361 (Basic radiation protection symbol), ISO-1757 (Photographic dosimeters), ISO-1758 and 1759 (Direct and indirect-reading pocket exposure meters), ISO-2889 (Sampling of airborne radioactive materials), ISO-4037 (X and gamma reference radiations for calibration) and ISO-4071 (Testing of exposure meters and dosimeters). TC 85/SC 2 has currently eight active Working Groups (WG) dealing with 14 standards projects, mostly in advanced stages, in such fields as neutron and beta reference radiations, and X and gamma radiations of high and low dose-rates and high energies for calibration purposes, reference radiations for surface contamination apparatus, ejection systems for gamma radiography apparatus, industrial and laboratory irradiators, lead shielding units, protective clothing, thermoluminescence dosemeters, radioelement gauges, and surface contamination and decontamination. (author)

Status of effectiveness in internal audit in Nuclear Malaysia

International Nuclear Information System (INIS)

Nik Arlina Nik Ali; Noriah Mod Ali

2010-01-01

Full text: Internal Audit (IA) is a necessity process to obtain the certification of ISO 9001 and ISO/IEC 17025.Basically the content of this paperwork is to discuss on the effectiveness of Internal Audit conducted base on the audit report result which containing the information that have been recorded regarding the non-compliance's towards the certification standard and opportunity of improvements. (author)

KIT safety management. Annual report 2012

International Nuclear Information System (INIS)

Frank, Gerhard

2013-01-01

The KIT Safety Management Service Unit (KSM) guarantees radiological and conventional technical safety and security of Karlsruhe Institute of Technology and controls the implementation and observation of legal environmental protection requirements. KSM is responsible for - licensing procedures, - industrial safety organization, - control of environmental protection measures, - planning and implementation of emergency preparedness and response, - operation of radiological laboratories and measurement stations, - extensive radiation protection support and the - the execution of security tasks in and for all organizational units of KIT. Moreover, KSM is in charge of wastewater and environmental monitoring for all facilities and nuclear installations all over the KIT campus. KSM is headed by the Safety Commissioner of KIT, who is appointed by the Presidential Committee. Within his scope of procedure for KIT, the Safety Commissioner controls the implementation of and compliance with safety-relevant requirements. The KIT Safety Management is certified according to DIN EN ISO 9001, its industrial safety management is certified by the VBG as ''AMS-Arbeitsschutz mit System'' and, hence, fulfills the requirements of NLF / ISO-OSH 2001. KSM laboratories are accredited according to DIN EN ISO/IEC 17025. To the extent possible, KSM is committed to maintaining competence in radiation protection and to supporting research and teaching activities. The present reports lists the individual tasks of the KIT Safety Management and informs about the results achieved in 2012. Status figures in principle reflect the status at the end of the year 2012. The processes described cover the areas of competence of KSM.

Pengaruh Sistem Manajemen Iso 9001:2008 Terhadap Pelayanan Kefarmasian Di Puskesmas Kabupaten Sleman

OpenAIRE

Aji Wibowo, Much Ilham Novalisa; Munawaroh, Siti; Purnama, Cahya

2015-01-01

The vision of health development organized by the district health center is achieving district healthy. The need for improving the quality of health services in health centers contained in the WHO Annual Report 2008 under the title "Primary Health Care, Now More Than Ever". The efforts to improve the quality of services in health centers is ISO 9001:2008 certification at the International level. ISO 9001 certification is expected to improve the quality of pharmacy services at health centers. ...

IADC's well control accreditation program

International Nuclear Information System (INIS)

Kropla, S.M.

1997-01-01

WellCAP is a well control accreditation program devised and implemented by the International Association of Drilling Contractors (IADC). It is a worldwide comprehensive system that defines a well control training curriculum, establishes minimum standards and recommends guidelines for course structure. The program began in mid-1993 and is viewed as a means for training institutions to demonstrate industry recognition to customers, contractors and local governments. Schools can apply to have their courses accredited. The accreditation system is administered by a review panel. The application process requires that the school perform a detailed review of its curriculum and operations and bring them in line with the WellCAP curriculum and accreditation criteria. Currently, more than 75 schools around the world have requested application materials for WellCAP. To date fifteen schools have been fully accredited

Results of first RER/8010 comparison in technological gamma ray dosimetry

International Nuclear Information System (INIS)

Stuglik, Z.

2007-01-01

To be entitled to organize proficiency testing (PT) or interlaboratory comparisons (ILC) the organizer must demonstrate implementation of quality system according to at least one of the standards: (1) ISO/IEC 9001; (2) ISO/IEC 17025; (3) ISO/IEC Guide 43-1; (4) ISO/Guide 34. Taking it into account Laboratory for Measurements of Technological Doses operated in the Institute of Nuclear Chemistry and Technology was chosen by the IAEA as organizer of the first comparison in technological gamma ray dosimetry. Lecture presents details and some results of the ILC

Tracking Success: Outputs Versus Outcomes-A Comparison of Accredited and Non-Accredited Public Health Agencies' Community Health Improvement Plan objectives.

Science.gov (United States)

Perrault, Evan K; Inderstrodt-Stephens, Jill; Hintz, Elizabeth A

2018-06-01

With funding for public health initiatives declining, creating measurable objectives that are focused on tracking and changing population outcomes (i.e., knowledge, attitudes, or behaviors), instead of those that are focused on health agencies' own outputs (e.g., promoting services, developing communication messages) have seen a renewed focus. This study analyzed 4094 objectives from the Community Health Improvement Plans (CHIPs) of 280 local PHAB-accredited and non-accredited public health agencies across the United States. Results revealed that accredited agencies were no more successful at creating outcomes-focused objectives (35% of those coded) compared to non-accredited agencies (33% of those coded; Z = 1.35, p = .18). The majority of objectives were focused on outputs (accredited: 61.2%; non-accredited: 63.3%; Z = 0.72, p = .47). Outcomes-focused objectives primarily sought to change behaviors (accredited: 85.43%; non-accredited: 80.6%), followed by changes in knowledge (accredited: 9.75%; non-accredited: 10.8%) and attitudes (accredited: 1.6%; non-accredited: 5.1%). Non-accredited agencies had more double-barreled objectives (49.9%) compared to accredited agencies (32%; Z = 11.43, p < .001). The authors recommend that accreditation procedures place a renewed focus on ensuring that public health agencies strive to achieve outcomes. It is also advocated that public health agencies work with interdisciplinary teams of Health Communicators who can help them develop procedures to effectively and efficiently measure outcomes of knowledge and attitudes that are influential drivers of behavioral changes.

On the long-term stability of calibration standards in different matrices

International Nuclear Information System (INIS)

Kandić, A.; Vukanac, I.; Djurašević, M.; Novković, D.; Šešlak, B.; Milošević, Z.

2012-01-01

In order to assure Quality Control in accordance with ISO/IEC 17025, it was important, from metrological point of view, to examine the long-term stability of calibration standards previously prepared. Comprehensive reconsideration on efficiency curves with respect to the ageing of calibration standards is presented in this paper. The calibration standards were re-used after a period of 5 years and analysis of the results showed discrepancies in efficiency values. - Highlights: ► Long-term stability of calibration standards (ISO 17025 Quality Control) was analyzed. ► Calibration standards covered the wide range of densities and chemical composition. ► Mineralized grass, powdered milk, surface soil and sand were used as standard matrices. ► Calibration standards were re-evaluated after 5 years. ► Results showed discrepancies of efficiency values.

Quality systems in veterinary diagnostics laboratories.

Science.gov (United States)

de Branco, Freitas Maia L M

2007-01-01

Quality assurance of services provided by veterinary diagnostics laboratories is a fundamental element promoted by international animal health organizations to establish trust, confidence and transparency needed for the trade of animals and their products at domestic and international levels. It requires, among other things, trained personnel, consistent and rigorous methodology, choice of suitable methods as well as appropriate calibration and traceability procedures. An important part of laboratory quality management is addressed by ISO/IEC 17025, which aims to facilitate cooperation among laboratories and their associated parties by assuring the generation of credible and consistent information derived from analytical results. Currently, according to OIE recommendation, veterinary diagnostics laboratories are only subject to voluntary compliance with standard ISO/IEC 17025; however, it is proposed here that OIE reference laboratories and collaboration centres strongly consider its adoption.

Implementación de un plan de verificación de material volumétrico en la Sección Química de la EEAOC (Tucumán, R. Argentina Plan for volumetric material verification in Sección Química of EEAOC (Tucumán, R. Argentina

Directory of Open Access Journals (Sweden)

María E. Navarro

Full Text Available Se describe un plan de verificación de material volumétrico, y como ejemplo, un procedimiento para matraces aforados, de fácil realización, para garantizar la confiabilidad de los resultados de ensayos, asegurando además el cumplimiento con los requerimientos establecidos por el Instituto Argentino de Normalización y Certificación (IRAM en su norma IRAM 301:2005 (ISO/IEC 17025:2005, aplicada a la acreditación de laboratorios de ensayos.A volumetric material verification plan which can be easily followed and an example of its practical application to the assessment of volumetric flasks are reported. The procedure would guarantee the reliability of analysis results, while ensuring that laboratories meet the requirements established by IRAM 301:2005 (ISO/IEC 17025:2005 standard.

ISO radiation sterilization standards

International Nuclear Information System (INIS)

Lambert, Byron J.; Hansen, Joyce M.

1998-01-01

This presentation provides an overview of the current status of the ISO radiation sterilization standards. The ISO standards are voluntary standards which detail both the validation and routine control of the sterilization process. ISO 11137 was approved in 1994 and published in 1995. When reviewing the standard you will note that less than 20% of the standard is devoted to requirements and the remainder is guidance on how to comply with the requirements. Future standards developments in radiation sterilization are being focused on providing additional guidance. The guidance that is currently provided in informative annexes of ISO 11137 includes: device/packaging materials, dose setting methods, and dosimeters and dose measurement, currently, there are four Technical Reports being developed to provide additional guidance: 1. AAMI Draft TIR, 'Radiation Sterilization Material Qualification' 2. ISO TR 13409-1996, 'Sterilization of health care products - Radiation sterilization - Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches' 3. ISO Draft TR, 'Sterilization of health care products - Radiation sterilization Selection of a sterilization dose for a single production batch' 4. ISO Draft TR, 'Sterilization of health care products - Radiation sterilization-Product Families, Plans for Sampling and Frequency of Dose Audits'

Accreditation Outcome Scores: Teacher Attitudes toward the Accreditation Process and Professional Development

Science.gov (United States)

Ulmer, Phillip Gregory

2015-01-01

Accreditation is an essential component in the history of education in the United States and is a central catalyst for quality education, continuous improvement, and positive growth in student achievement. Although previous researchers identified teachers as an essential component in meeting accreditation outcomes, additional information was…

Commission for the Accreditation of Birth Centers

Science.gov (United States)

... Learning Login: Commissioners Birth Centers CABC Learning Place Home Accredited Birth Centers Find CABC Accredited Birth Centers What does ... In the Pursuit of Excellence You are here: Home In the ... for the Accreditation of Birth Centers (CABC) provides support, education, and accreditation to ...

Development and implementation of the Caribbean Laboratory Quality Management Systems Stepwise Improvement Process (LQMS-SIP) Towards Accreditation.

Science.gov (United States)

Alemnji, George; Edghill, Lisa; Guevara, Giselle; Wallace-Sankarsingh, Sacha; Albalak, Rachel; Cognat, Sebastien; Nkengasong, John; Gabastou, Jean-Marc

2017-01-01

Implementing quality management systems and accrediting laboratories in the Caribbean has been a challenge. We report the development of a stepwise process for quality systems improvement in the Caribbean Region. The Caribbean Laboratory Stakeholders met under a joint Pan American Health Organization/US Centers for Disease Control and Prevention initiative and developed a user-friendly framework called 'Laboratory Quality Management System - Stepwise Improvement Process (LQMS-SIP) Towards Accreditation' to support countries in strengthening laboratory services through a stepwise approach toward fulfilling the ISO 15189: 2012 requirements. This approach consists of a three-tiered framework. Tier 1 represents the minimum requirements corresponding to the mandatory criteria for obtaining a licence from the Ministry of Health of the participating country. The next two tiers are quality improvement milestones that are achieved through the implementation of specific quality management system requirements. Laboratories that meet the requirements of the three tiers will be encouraged to apply for accreditation. The Caribbean Regional Organisation for Standards and Quality hosts the LQMS-SIP Secretariat and will work with countries, including the Ministry of Health and stakeholders, including laboratory staff, to coordinate and implement LQMS-SIP activities. The Caribbean Public Health Agency will coordinate and advocate for the LQMS-SIP implementation. This article presents the Caribbean LQMS-SIP framework and describes how it will be implemented among various countries in the region to achieve quality improvement.

22 CFR 96.99 - Converting an application for temporary accreditation to an application for full accreditation.

Science.gov (United States)

2010-04-01

... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Converting an application for temporary accreditation to an application for full accreditation. 96.99 Section 96.99 Foreign Relations DEPARTMENT OF... INTERCOUNTRY ADOPTION ACT OF 2000 (IAA) Procedures and Standards Relating to Temporary Accreditation § 96.99...

7 CFR 205.506 - Granting accreditation.

Science.gov (United States)

2010-01-01

..., Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) ORGANIC FOODS PRODUCTION ACT PROVISIONS NATIONAL ORGANIC PROGRAM Accreditation of Certifying Agents § 205.506 Granting accreditation. (a... accreditation as provided in § 205.510(c), the certifying agent voluntarily ceases its certification activities...

Proposed Accreditation Standards for Degree-Granting Correspondence Programs Offered by Accredited Institutions.

Science.gov (United States)

McGraw-Hill Continuing Education Center, Washington, DC.

A study on proposed accreditation standards grew out of a need to (1) stimulate the growth of quality correspondence degree programs; and (2) provide a policy for accreditation of correspondence degree programs so that graduates would be encouraged to pursue advanced degree programs offered elsewhere by educational institutions. The study focused…

Social Responsibility in Intra-organisational Procedures of Higher Education Institutions with AACSB Accreditation

Directory of Open Access Journals (Sweden)

Andżelika Dzięgiel

2016-10-01

Full Text Available This paper aims to identify the core elements of social responsibility which have been applied in intraorganisational procedures of higher education institutions with AACSB Accreditation. The concept of corporate social responsibility (CSR in entrepreneurial strategies means taking into account their social interests and environmental protection, as well as, relationships with different groups of stakeholders. In contemporary business, CSR activities are very important. Therefore, universities, especially those with prestigious accreditations, should also act in accordance with the rules prevailing in the business market. The Association to Advance Collegiate School of Business (AACSB is a global, nonprofit membership organisation of educational institutions, businesses, and other entities. Higher education institutions with certificates represent the highest standard of achievement for business schools all over the world. For the research and analysis, there have been selected six universities from three countries: the United States, the United Kingdom and New Zealand. According to the international standard ISO 26000 dated as of 2010, social responsibility involves seven core subjects: organisational governance, human rights, labour practices, environment, fair operating practices, customer issues, community involvement and development. All these aspects were researched in intraorganisational procedures of selected higher education institutions with AACSB Accreditation. It is a comprehensive and objective comparison of several educational institutions in the world in terms of their implemented CSR activities. The results of the research show that the institutions under the study established a wide range of procedures for respecting CSR. They took into account transparency, respect to the law, human rights, labour practices and organisational governance. While they pay less attention to the environmental issues, fair operating practices and

Does the accreditation of private dental practices work? Time to rethink how accreditation can improve patient safety.

Science.gov (United States)

Jean, Gillian

2017-10-09

Accreditation to demonstrate engagement with the National Safety and Quality Health Service Standards (Standards) is compulsory for most hospital and healthcare settings, but to date remains voluntary for private dental practices (PDPs). The regulatory framework governing the dental profession lacks a proactive element to drive improvements in quality and safety of care, and an accreditation scheme can strengthen existing regulation. The current model of accreditation operating in accordance with the Australian Health Service Safety and Quality Accreditation Scheme (Scheme) is based on the Standards, which were written for a hospital model of healthcare service. The majority of PDPs are small office-based businesses with clear leadership structure and employing six staff or fewer. The Scheme is overly bureaucratic given the simplicity of the PDP business model. This article considers whether accreditation has a proven track record of improving quality of service and offers opinions about how a more appropriate safety management program for PDPs may look. What is known about the topic? There has been minimal research about the impact of accreditation schemes in improving patient safety in PDP. What does this paper add? This paper proposes a redesign of the Scheme to make it more relevant to PDPs. The paper offers strategies to minimise duplication of purpose between accreditation and existing legislation; and to strengthen critical elements of accreditation to improve effects on patient safety. What are the implications for practitioners? A redesigned accreditation scheme will support dental practitioners to implement a quality assurance system with improved efficiency, reduced administrative burden, and optimised patient safety.

IS 2010 and ABET Accreditation: An Analysis of ABET-Accredited Information Systems Programs

Science.gov (United States)

Saulnier, Bruce; White, Bruce

2011-01-01

Many strong forces are converging on information systems academic departments. Among these forces are quality considerations, accreditation, curriculum models, declining/steady student enrollments, and keeping current with respect to emerging technologies and trends. ABET, formerly the Accrediting Board for Engineering and Technology, is at…

Food service compliance with ISO 14001 and ISO 22000

Directory of Open Access Journals (Sweden)

Laura Lyra Santos

2012-06-01

Full Text Available OBJECTIVE: The objective of this study was to assess food service environmental and food safety management systems according to two checklists based on ABNT ISO 22000 and 14001. METHODS: This exploratory and descriptive study investigated a-la-carte food services of the Federal District, Brazil. Two checklists were developed to investigate ISO 14001 and 22000 compliance. A total of 37 food services were selected from the list of the Brazilian Association of Bars and Restaurants by simple random sampling. Checklist results were analyzed according to ANVISA resolution nº 275/2002. RESULTS: Only five food services employed dietitians to supervise meal production. These establishments achieved the highest ISO compliance. However, no establishment had more than 50% ISO 14001 or 22000 compliance. Restaurants showed little concern for the environment and disobeyed waste disposal laws by not separating recyclables from non-recyclables. CONCLUSION: The study food services do not have safe meal production systems, evidenced by non-conformity with the reference standards. Additionally, they do not attempt to reduce the environmental impact of their wastes. Food services supervised by dietitians are better prepared to produce safe foods.

The role of the IEC and ISO in radiological protection

International Nuclear Information System (INIS)

White, D.F.

1976-01-01

The history, objectives, structures and functions of the International Electrotechnical Commission (IEC) and the International Organisation for Standardisation (ISO) are summarized. The IEC is affiliated to the ISO as its electrical division, but has technical and financial autonomy. Member countries of the EEC may be committed to the adoption of their formal agreements ('Standards') if these become incorporated as Directives. The national standardisation organisations, such as BSI in the U.K., form national committees and are responsible for submitting to the IEC the co-ordinated national viewpoints on particular subjects. The overall links between the technical committees and sub-committees of the ISO, IEC and BSI in the field of radiological protection are tabulated, and the relevant International Standards produced, or in the course of preparation, by the appropriate committees of the ISO and the IEC are listed. The bulk of the effort of the BSI committees is now aimed at the production of acceptable international standards. Compatible national standards then follow. This policy is in contrast to the earlier initial emphasis on national standards, and the improved international collaboration has had two welcome effects. The selection of proposals for standards is more critical, and compatibility with the relevant ICRP and ICRU publications is almost a prerequisite for any international standard. (U.K.)

Trends in Accreditation Council for Graduate Medical Education Accreditation for Subspecialty Fellowship Training in Plastic Surgery.

Science.gov (United States)

Silvestre, Jason; Serletti, Joseph M; Chang, Benjamin

2018-05-01

The purposes of this study were to (1) determine the proportion of plastic surgery residents pursuing subspecialty training relative to other surgical specialties, and (2) analyze trends in Accreditation Council for Graduate Medical Education accreditation of plastic surgery subspecialty fellowship programs. The American Medical Association provided data on career intentions of surgical chief residents graduating from 2014 to 2016. The percentage of residents pursuing fellowship training was compared by specialty. Trends in the proportion of accredited fellowship programs in craniofacial surgery, hand surgery, and microsurgery were analyzed. The percentage of accredited programs was compared between subspecialties with added-certification options (hand surgery) and subspecialties without added-certification options (craniofacial surgery and microsurgery). Most integrated and independent plastic surgery residents pursued fellowship training (61.8 percent versus 49.6 percent; p = 0.014). Differences existed by specialty from a high in orthopedic surgery (90.8 percent) to a low in colon and rectal surgery (3.2 percent). From 2005 to 2015, the percentage of accredited craniofacial fellowship programs increased, but was not significant (from 27.8 percent to 33.3 percent; p = 0.386). For hand surgery, the proportion of accredited programs that were plastic surgery (p = 0.755) and orthopedic surgery (p = 0.253) was stable, whereas general surgery decreased (p = 0.010). Subspecialty areas with added-certification options had more accredited fellowships than those without (100 percent versus 19.2 percent; p < 0.001). There has been slow adoption of accreditation among plastic surgery subspecialty fellowships, but added-certification options appear to be highly correlated.

NS [Nuclear Safety] update. Current safety and security activities and developments taking place in the Department of Nuclear Safety and Security. Issue no. 3, April 2007

International Nuclear Information System (INIS)

2007-04-01

This newsletter reports on the manual for first responders to a radiological emergency, the IAEA's testing laboratory for radiation measurement, monitoring and protection, which is the first UN laboratory accredited to the international standard ISO17025, and the International Conference on Lessons Learned fro the Decommissioning of Nuclear Facilities and the Safe Termination of Nuclear Activities. The IAEA, in recognition of this critical need, has developed a Manual for First Responders to a Radiological Emergency with the objective to provide practical guidance for those responding within the first few hours of a radiological emergency. This guidance document is co-sponsored by the Comite technique international de prevention et d'extinction du feu (CTIF), the Pan American Health Organization (PAHO) and the World Health Organization (WHO). The Manual for First Responders provides guidance in the form of action guides, instructions, and supporting data that can be easily applied by a State to build a basic capability to respond to a radiological emergency. The guidance also contains practical procedures and tools on the response to a radiological emergency again easily and quickly adaptable by Member States to prepare first responders to respond adequately to a radiological emergency. The Manual can be used for training purposes at the preparedness stage as well as during the response. The Policy and Programme Support Section (PPSS) within the Division of Radiation, Transport and Waste Security (NSRW) has been operating, for many years, a laboratory (the Testing Laboratory) for radiation safety monitoring of individuals and workplaces. The establishment of a quality management system, as required in the International Basic Safety Standards (the BSS), started in 2000 to cover all measurement methods of the laboratory. This system is based on the international standard ISO17025 (General requirements for the competence of testing and calibration laboratories). PPSS

Relationship of responsible Care and Environmental Management Systems Standard ISO 14001. Example of Sumitomo Chemical; Resuponshiburu{center_dot}kea to kankyo manejimento sisutemu kikaku ISO14001. Sumitomo kagaku no jirei

Energy Technology Data Exchange (ETDEWEB)

Kimura, Kazuo. [Sumitomo Chemical Corp., Tokyo (Japan)

1999-01-15

In the chemical sector, Responsible Care is propelled by the International Council of Chemical Associations (ICCA). The objective of Responsible Care is to improve the performance and reputation of the Chemical Industry in areas that impact on people and environment. Sumitomo Chemical is committed to supporting a continuing effort to improve the chemical industry`s responsible management of chemicals through the Japan Responsible Vare Vouncil program. One the other hand, ISO 14001 had been published on Aug.1996 and have adopted the ISO 14001 as national standards on Oct. 1996. Already 973 companies in Japan, 74 of them in the chemical sector, have been certified to ISO 14001. In this paper, I provides concise commentaries on how Responsible Care and Environmental management systems work in the chemical sector. (author)

Relationship of responsible Care and Environmental Management Systems Standard ISO 14001. Example of Sumitomo Chemical. Resuponshiburu[center dot]kea to kankyo manejimento sisutemu kikaku ISO14001. Sumitomo kagaku no jirei

Energy Technology Data Exchange (ETDEWEB)

Kimura, Kazuo. (Sumitomo Chemical Corp., Tokyo (Japan))

1999-01-15

In the chemical sector, Responsible Care is propelled by the International Council of Chemical Associations (ICCA). The objective of Responsible Care is to improve the performance and reputation of the Chemical Industry in areas that impact on people and environment. Sumitomo Chemical is committed to supporting a continuing effort to improve the chemical industry's responsible management of chemicals through the Japan Responsible Vare Vouncil program. One the other hand, ISO 14001 had been published on Aug.1996 and have adopted the ISO 14001 as national standards on Oct. 1996. Already 973 companies in Japan, 74 of them in the chemical sector, have been certified to ISO 14001. In this paper, I provides concise commentaries on how Responsible Care and Environmental management systems work in the chemical sector. (author)

Accreditation of diagnostic imaging services in developing countries.

Science.gov (United States)

Jiménez, Pablo; Borrás, Cari; Fleitas, Ileana

2006-01-01

In recent decades, medical imaging has experienced a technological revolution. After conducting several surveys to assess the quality and safety of diagnostic imaging services in Latin America and the Caribbean, the Pan American Health Organization (PAHO) developed a basic accreditation program that can be implemented by the ministry of health of any developing country. Patterned after the American College of Radiology's accreditation program, the PAHO program relies on a national accreditation committee to establish and maintain accreditation standards. The process involves a peer review evaluation of: (1) imaging and processing equipment, (2) physician and technologist staff qualifications, (3) quality control and quality assurance programs, and (4) image quality and, where applicable, radiation dose. Public and private conventional radiography/fluoroscopy, mammography, and ultrasound services may request accreditation. The radiography/fluoroscopy accreditation program has three modules from which to choose: chest radiography, general radiography, and fluoroscopy. The national accreditation committee verifies compliance with the standards. On behalf of the ministry of health, the accreditation committee also issues a three-year accreditation certificate. As needed, the accreditation committee consults with foreign technical and clinical experts.

National Environmental Field Activities Program

Science.gov (United States)

2011-03-31

holder community. –It is one of a kind! –Written for any type of field sampling  and testing  • Builds of the foundation of  ISO / IEC   17025 ! Why TNI...Why chose the TNI standard and not others – ISO  9000 – ISO / IEC  17020 – ISO  14000 – ASTM, USGS, EPA, Etc. – XXXXXX, XXX or XXXX REDUCE DATA VARIABILITY

COMPARATIVE ANALYSIS OF INNOVATION PERFORMANCE IN CERTIFIED FIRMS IN MONTENEGRO AND REPUBLIC OF SRPSKA

Directory of Open Access Journals (Sweden)

Zdravko Krivokapic

2014-03-01

Full Text Available Research subjects of this study are certified companies and their commitment to innovation, as well as their own development and implementation of innovation. Certified companies are those companies that have set one or more standards: ISO 9001:2008, ISO 14001: 2004, HACCP, OHSAS 18001, ISO 17025:2006, ISO 27001. The research is based on 60 certified companies in Montenegro and 165 certified companies Republic of Srpska. The research was conducted at certified companies from all regions, for every activity and sizes. For this purpose it was used questionnaire with 91 questions and it was filled in like interview.

A comparison of ISO 14001 to other related environmental management systems and tools

International Nuclear Information System (INIS)

White, S.E.; Byron, D.F.; Livingston, B.L.

1995-08-01

Efficient environmental management is of increasing priority for the industrial sector. The achievement of ISO 14001 certification will demonstrate that the environmental management system meets or exceeds industry standards since this standard will be the accepted international measure of environmental management. A review of published environmental management systems and tools was conducted to ensure all aspects of environmental management are covered in the establishment or formalization of an environmental management system. The objective of this effort is to compare the ISO 14001 standard with other environmental management systems and tools

Quality indicators to compare accredited independent pharmacies and accredited chain pharmacies in Thailand.

Science.gov (United States)

Arkaravichien, Wiwat; Wongpratat, Apichaya; Lertsinudom, Sunee

2016-08-01

Background Quality indicators determine the quality of actual practice in reference to standard criteria. The Community Pharmacy Association (Thailand), with technical support from the International Pharmaceutical Federation, developed a tool for quality assessment and quality improvement at community pharmacies. This tool has passed validity and reliability tests, but has not yet had feasibility testing. Objective (1) To test whether this quality tool could be used in routine settings. (2) To compare quality scores between accredited independent and accredited chain pharmacies. Setting Accredited independent pharmacies and accredited chain pharmacies in the north eastern region of Thailand. Methods A cross sectional study was conducted in 34 accredited independent pharmacies and accredited chain pharmacies. Quality scores were assessed by observation and by interviewing the responsible pharmacists. Data were collected and analyzed by independent t-test and Mann-Whitney U test as appropriate. Results were plotted by histogram and spider chart. Main outcome measure Domain's assessable scores, possible maximum scores, mean and median of measured scores. Results Domain's assessable scores were close to domain's possible maximum scores. This meant that most indicators could be assessed in most pharmacies. The spider chart revealed that measured scores in the personnel, drug inventory and stocking, and patient satisfaction and health promotion domains of chain pharmacies were significantly higher than those of independent pharmacies (p pharmacies and chain pharmacies in the premise and facility or dispensing and patient care domains. Conclusion Quality indicators developed by the Community Pharmacy Association (Thailand) could be used to assess quality of practice in pharmacies in routine settings. It is revealed that the quality scores of chain pharmacies were higher than those of independent pharmacies.

Scoping medical tourism and international hospital accreditation growth.

Science.gov (United States)

Woodhead, Anthony

2013-01-01

Uwe Reinhardt stated that medical tourism can do to the US healthcare system what the Japanese automotive industry did to American carmakers after Japanese products developed a value for money and reliability reputation. Unlike cars, however, healthcare can seldom be test-driven. Quality is difficult to assess after an intervention (posteriori), therefore, it is frequently evaluated via accreditation before an intervention (a priori). This article aims to scope the growth in international accreditation and its relationship to medical tourism markets. Using self-reported data from Accreditation Canada, Joint Commission International (JCI) and Australian Council on Healthcare Standards (ACHS), this article examines how quickly international accreditation is increasing, where it is occurring and what providers have been accredited. Since January 2000, over 350 international hospitals have been accredited; the JCI's total nearly tripling between 2007-2011. Joint Commission International staff have conducted most international accreditation (over 90 per cent). Analysing which countries and regions where the most international accreditation has occurred indicates where the most active medical tourism markets are. However, providers will not solely be providing care for medical tourists. Accreditation will not mean that mistakes will never happen, but that accredited providers are more willing to learn from them, to varying degrees. If a provider has been accredited by a large international accreditor then patients should gain some reassurance that the care they receive is likely to be a good standard. The author questions whether commercializing international accreditation will improve quality, arguing that research is necessary to assess the accreditation of these growing markets.

Beyond accreditation: excellence in medical education.

Science.gov (United States)

Ahn, Eusang; Ahn, Ducksun

2014-01-01

Medical school accreditation is a relatively new phenomenon in Korea. The development of an accreditation body and standards for a two-tiered "Must" and "Should" system in 1997 eventually led to the implementation of a third "Excellence" level of attainment. These standards were conceived out of a desire to be able to first recognize and promote outstanding performance of medical schools, second to provide role models in medical education, and furthermore to preview the third level as potential components of the pre-existing second level for the next accreditation cycle. It is a quality-assurance mechanism that, while not required for accreditation itself, pushes medical schools to go beyond the traditional requirements of mere pass-or-fail accreditation adequacy, and encourages schools to deliver an unprecedented level of medical education. The Association for Medical Education in Europe developed its own third-tier system of evaluation under the ASPIRE project, with many similar goals. Due to its advanced nature and global scope, the Korean accreditation body has decided to implement the ASPIRE system in Korea as well.

[Implementation of a quality management system according to the UNE-UN-ISO 9001:2008 standard in a nuclear medicine department].

Science.gov (United States)

Poblete García, V M; Talavera Rubio, M P; Palomar Muñoz, A; Pilkington Woll, J P; Cordero García, J M; García Vicente, A M; Bellón Guardia, M; González García, B; Cañuelo Merino, T; Núñez García, A; Peiró Valgañón, V; Soriano Castrejón, A M

2013-01-01

To describe the process of implementing a quality management system according to UNE-EN-ISO 9001:2008 standard in a Nuclear Medicine Department. In February 2008, the committee on internal quality of the Department was established, naming a responsible physician. The general operating plan was drawn up, following the requirements established by the ISO 9001:2008 standard. It defined the scope of the standard, defining, preparing and transcribing the various activities of our Department. Four training sessions were carried out. A total of nine general and two specific procedures were documented in which all the activities performed in our Department were included. Personnel records of each worker were created, including their profiles and training plan. A record of the equipment and service providers was created, as well as issues with the latter. Satisfaction surveys were obtained from external (patients) and internal customers (faculty applicants). Targets for improvement and activity markers were established. Two audits were performed to complete the process, one internal and one external. The Department was accredited in April 2010. The quality accreditation process is a tool that requires reflection on how we do things and how they can be improved. It makes it possible to measure what we do, to analyze and introduce improvement measures, and therefore, to achieve a higher level of quality in the service we provide our customers. The involvement of the Department workers with a commitment to team performance was essential. Copyright © 2011 Elsevier España, S.L. and SEMNIM. All rights reserved.

Use of statistic control of the process as part of a quality assurance plan

International Nuclear Information System (INIS)

Acosta, S.; Lewis, C.

2013-01-01

One of the technical requirements of the standard IRAM ISO 17025 for the accreditation of testing laboratories, is the assurance of the quality of the results through the control and monitoring of the factors influencing the reliability of them. The grade the factors contribute to the total measurement uncertainty, determines which of them should be considered when developing a quality assurance plan. The laboratory of environmental measurements of strontium-90 in the accreditation process, performs most of its determinations in samples with values close to the detection limit. For this reason the correct characterization of the white, is a critical parameter and is verified through a letter for statistical process control. The scope of the present work is concerned the control of whites and so it was collected a statistically significant amount of data, for a period of time that is covered of different conditions. This allowed consider significant variables in the process, such as temperature and humidity, and build a graph of white control, which forms the basis of a statistical process control. The data obtained were lower and upper limits for the preparation of the charter white control. In this way the process of characterization of white was considered to operate under statistical control and concludes that it can be used as part of a plan of insurance of the quality

Measuring Systems for Thermometer Calibration in Low-Temperature Range

Science.gov (United States)

Szmyrka-Grzebyk, A.; Lipiński, L.; Manuszkiewicz, H.; Kowal, A.; Grykałowska, A.; Jancewicz, D.

2011-12-01

The national temperature standard for the low-temperature range between 13.8033 K and 273.16 K has been established in Poland at the Institute of Low Temperature and Structure Research (INTiBS). The standard consists of sealed cells for realization of six fixed points of the International Temperature Scale of 1990 (ITS-90) in the low-temperature range, an adiabatic cryostat and Isotech water and mercury triple-point baths, capsule standard resistance thermometers (CSPRT), and AC and DC bridges with standard resistors for thermometers resistance measurements. INTiBS calibrates CSPRTs at the low-temperature fixed points with uncertainties less than 1 mK. In lower temperature range—between 2.5 K and about 25 K — rhodium-iron (RhFe) resistance thermometers are calibrated by comparison with a standard which participated in the EURAMET.T-K1.1 comparison. INTiBS offers a calibration service for industrial platinum resistance thermometers and for digital thermometers between 77 K and 273 K. These types of thermometers may be calibrated at INTiBS also in a higher temperature range up to 550°C. The Laboratory of Temperature Standard at INTiBS acquired an accreditation from the Polish Centre for Accreditation. A management system according to EN ISO/IEC 17025:2005 was established at the Laboratory and presented on EURAMET QSM Forum.

Use of statistic control of the process as part of a quality assurance plan; Empleo del control estadistico de proceso como parte de un plan de aseguramiento de la calidad

Energy Technology Data Exchange (ETDEWEB)

Acosta, S.; Lewis, C., E-mail: sacosta@am.gob.ar [Autoridad Regulatoria Nuclear (ARN), Buenos Aires (Argentina)

2013-07-01

One of the technical requirements of the standard IRAM ISO 17025 for the accreditation of testing laboratories, is the assurance of the quality of the results through the control and monitoring of the factors influencing the reliability of them. The grade the factors contribute to the total measurement uncertainty, determines which of them should be considered when developing a quality assurance plan. The laboratory of environmental measurements of strontium-90 in the accreditation process, performs most of its determinations in samples with values close to the detection limit. For this reason the correct characterization of the white, is a critical parameter and is verified through a letter for statistical process control. The scope of the present work is concerned the control of whites and so it was collected a statistically significant amount of data, for a period of time that is covered of different conditions. This allowed consider significant variables in the process, such as temperature and humidity, and build a graph of white control, which forms the basis of a statistical process control. The data obtained were lower and upper limits for the preparation of the charter white control. In this way the process of characterization of white was considered to operate under statistical control and concludes that it can be used as part of a plan of insurance of the quality.

How accreditation stimulates business school change: evidence from the Commonwealth of independent states

Directory of Open Access Journals (Sweden)

Yelena Istileulova

2015-05-01

Full Text Available There is scarce or almost non-existing research on changes that take place in business schools in the Commonwealth of Independent States (CIS. Changes in CIS business schools (B-schools are influenced by different external factors (e.g. socioeconomic system, market forces, financial crisis, demographic problems, changes in policies of higher education; influence of the Bologna process. On the other hand, B-schools in the CIS need to make internal changes to gain the external accreditation. We look into the nature of change processes taking place in CIS B-schools, observing them through the prism of ongoing external accreditation processes. The purpose of the study is to examine the effect of the accreditation process on CIS B-school changes. We used a comparative analysis based on the study of 22 Bschools from four countries (Russia, Belarus, Kazakhstan, and Kyrgyzstan. We discovered that these changes refer to introducing more strict entrance requirements, strengthening financial resources, and improving efforts to reach the accreditation standards. Moreover, schools have to review their mission, decrease their student-to-faculty ratio, introduce measurement metrics for learning goals, and internationalise their programs. The advanced B-schools in Russia and Kazakhstan usually start with an international programme accreditation, and then move to an institutional one. The trend has begun spreading to schools from non-Bologna countries like Belarus, but it is still a long-time agenda item for Kyrgyzstan.

Tinjauan Kritis Terhadap Implementasi Iso 9000

OpenAIRE

Purnama, Nursya’bani

2005-01-01

ISO 9000 telah diterima secara luas sebagai acuan sistem manajemen kualitas dan penjaminan kualitas. Perusahaan-Perusahaan yang memperoleh sertifikasi ISO dari tahun ke ke tahun mengalami pertumbu¬han yang pesat. Dengan implementasi dan memperoleh sertifikasi ISO 9000, banyak Perusahaan di dunia mem¬peroleh peningkatan kinerja. Meskipun demikian, implementasi ISO 9000 juga dihadapkan pada sejumlah ham¬batan. Implementasi ISO 9000 seringkali dikaitkan dengan Total Quality Management (TQM). Ban...

The National Accreditation Board for Hospital and Health Care Providers accreditation programme in India.

Science.gov (United States)

Gyani, Girdhar J; Krishnamurthy, B

2014-01-01

Quality in health care is important as it is directly linked with patient safety. Quality as we know is driven either by regulation or by market demand. Regulation in most developing countries has not been effective, as there is shortage of health care providers and governments have to be flexible. In such circumstances, quality has taken a back seat. Accreditation symbolizes the framework for quality governance of a hospital and is based on optimum standards. Not only is India establishing numerous state of the art hospitals, but they are also experiencing an increase in demand for quality as well as medical tourism. India launched its own accreditation system in 2006, conforming to standards accredited by ISQua. This article shows the journey to accreditation in India and describes the problems encountered by hospitals as well as the benefits it has generated for the industry and patients.

IMPLEMENTASI ISO 9001: 2000 PADA PEMBELAJARAN PRODUKTIF BIDANG KEAHLIAN BANGUNAN DI SEKOLAH MENENGAH KEJURUAN

Directory of Open Access Journals (Sweden)

Riban Riban

2012-08-01

Full Text Available The implementation of ISO 9001: 2000 in productive learning of building engineering sector in vocational education. The objtective of this study was to uncover the barriers to implementation of ISO 9001:2000 in productive learning. The study was designed using multisite study design. Tecniques of collecting the data were interview, observation to partici­pants, and documentation test. The result of the study are: (1 Implementation of the ISO 9001: 2000 in productive learning of  building engineering sector relates to the implementation of the concept of P-D-C-A in the ISO quality management system; (2 the barriers in implementation of ISO 9001:2000 in pro­ductive learning include low awareness level, inconsistencies, and disobedience; and (3 efforts to overcome the barriers to implementation of ISO 9001:2000 in produc­tive learning involve building the shared commitment, socialization in order to create together awareness, supervising, and doing the preventive action. Implementasi ISO 9001: 2000 pada Pembelajaran Produktif Bidang Keahlian Bangunan di Sekolah Menengah Kejuruan. Penelitian ini bermaksud meng­ungkap lebih mendalam tentang, imple­men­­­tasi, hambatan-hambatan, dan upaya-upaya dalam mengatasi ham­batan penerap­an ISO 9001: 2000 pada pembelajaran produktif. Penelitian ini diran­cang dengan menggunakan rancangan studi multisitus. Teknik pengum­pulan data meliputi wawan­cara, observasi partisipan, dan studi dokumentasi. Temuan penelitian adalah: (1 Penerapan ISO 9001: 2000 pada pem­belajaran pro­duktif teknik bangunan mengacu pada konsep P-D-C-A ke dalam sistem manajemen mutu ISO; (2 hambatan implementasi ISO 9001: 2000 pada pem­bel­ajaran produktif meliputi tingkat kesadaran rendah, inkonsistensi, dan ketidak­taatasasan; dan (3 upaya mengatasi hambatan dalam implementasi ISO 9001: 2000 pada pembelajar­an produk­tif meliputi membangun komitmen bersama, sosialisasi dalam rangka me­num­buhkan kesadaran bersama

The stability of iso-α-acids and reduced iso-α-acids in stored blood specimens.

Science.gov (United States)

Rodda, Luke N; Gerostamoulos, Dimitri; Drummer, Olaf H

2014-06-01

The long-term stability of the iso-α-acids, and three structurally similar but chemically altered iso-α-acids (known as 'reduced iso-α-acids' and consisting of the rho-, tetrahydro- and hexahydro-iso-α-acid groups) were investigated in whole blood. Pools of blank blood spiked with the four beer-specific ingredient congener groups at two different concentration levels were stored at 20°C, 4°C and -20°C; and extracted in duplicate in weeks 1, 3, 5 and 8, using a previously published method. A loss of 15% of the initial concentration was considered to indicate possible instability and losses greater than 30% demonstrated significant losses. The individual analytes within the four iso-α-acid groups were also measured to determine which iso-α-acids were subject to greater degradation and were responsible for the overall group instability. All four iso-α-acid groups showed significant losses after 8 weeks of storage under room temperature conditions in particularly the natural iso-α-acid group where major losses were observed (96% and 85% losses for low and high concentrations, respectively). Some degradation in all iso-α-acid groups were seen at 4°C samples predominantly due to the 'n' analogs of the groups showing an increased instability in blood. The -20°C storage conditions resulted in minimal changes in concentrations of all analytes. Higher than frozen storage temperatures can result in substantial changes on the stability of the iso-α-acid type groups in blood. The aim of this study was to highlight the stabilities of the IAA analytes in order to assist in the interpretation of IAA in stored blood specimens. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Explaining the accreditation process from the institutional isomorphism perspective: a case study of Jordanian primary healthcare centers.

Science.gov (United States)

Alyahya, Mohammad; Hijazi, Heba; Harvey, Heather

2018-01-01

While the main focus of accreditation initiatives has been on hospitals, the implementation of these programs is a relatively new notion among other types of healthcare facilities. Correspondingly, this study aims to understand how accreditation is perceived among primary public healthcare centers using an isomorphic institutional theory. Semi-structured, in-depth interviews were conducted with 56 healthcare professionals and administrative staff from seven non-profit healthcare centers in Jordan using an explanatory case-study approach. The informants' narratives revealed that all three components of institutional theory: coercive, mimetic, and normative pressure, were drivers for institutional change in seeking accreditation. There was an overlapping and blending between the three various types of pressure. While participants perceived that healthcare centers faced formal and informal pressures to achieve accreditation, health centers were reluctant about the time, amount of effort, and their ability to achieve the accreditation. Ambiguity and fear of failure forced them to model successful ones. Moreover, the findings revealed that normative values of health professionals enhanced institutional isomorphism and influenced the accreditation process. Identifying these isomorphic changes may help key stakeholders to develop plans, policies, and procedures that could improve the quality of healthcare and enhance accreditation as an organizational strategic plan. Moreover, the study provided explanations of why and how organizations move to adopt new interventions and grow over time. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Reference measurement procedure for the determination of electrolytes in human blood via ICP-OES measurement

Science.gov (United States)

Grote-Koska, D.; Klauke, R.; Brand, K.; Schumann, G.

2018-04-01

The determination of electrolytes in human body fluids is one of the most frequently performed analyses in clinical routine laboratories. Metrological traceability of measurement results in patient samples is essential and requires the involvement of higher order reference measurement procedures wherever available. Here, the authors present the evaluation of a higher order reference system for the simultaneous determination of K+, Li+, Na+, Ca2+ and Mg2+ in blood serum and plasma. In the same order, the determined measurement performances were as follows: measurement ranges: 0.75 mmol l-1-75.0 mmol l-1, 0.05 mmol l-1-5.00 mmol l-1, 5 mmol l-1-200 mmol l-1, 0.4 mmol l-1-8.0 mmol l-1 and 0.1 mmol l-1-4.0 mmol l-1. Measurement imprecision: CVs were  ⩽1.1% for intra assay investigations and  ⩽1.8% for long term inter assay investigations for all measurands. Excellent accuracy was found testing certified Standard Reference Materials from NIST: SRM 909 (deviations from 0.0% to 1.1%) and SRM 956 (deviations from 0.0% to 1.5%). Intercomparisons with the German Metrology Institute (PTB) revealed differences from 0.1% to 0.8%. Matrix influences and carry over were not detectable. The expanded combined measurement uncertainties for the determination of the reference method values were estimated as  ⩾1.5% (k  =  2) for each measurand. The reference measurement procedure is accredited by the German accreditation body (DAkkS) in association with the German calibration service (DKD) according to ISO 17025 and ISO 15195. Services comprise the certification of calibrators, control materials and samples used in proficiency testing schemes.

KIT safety management. Annual report 2012; KIT-Sicherheitsmanagement. Jahresbericht 2012

Energy Technology Data Exchange (ETDEWEB)

Frank, Gerhard (ed.)

2013-07-01

The KIT Safety Management Service Unit (KSM) guarantees radiological and conventional technical safety and security of Karlsruhe Institute of Technology and controls the implementation and observation of legal environmental protection requirements. KSM is responsible for - licensing procedures, - industrial safety organization, - control of environmental protection measures, - planning and implementation of emergency preparedness and response, - operation of radiological laboratories and measurement stations, - extensive radiation protection support and the - the execution of security tasks in and for all organizational units of KIT. Moreover, KSM is in charge of wastewater and environmental monitoring for all facilities and nuclear installations all over the KIT campus. KSM is headed by the Safety Commissioner of KIT, who is appointed by the Presidential Committee. Within his scope of procedure for KIT, the Safety Commissioner controls the implementation of and compliance with safety-relevant requirements. The KIT Safety Management is certified according to DIN EN ISO 9001, its industrial safety management is certified by the VBG as ''AMS-Arbeitsschutz mit System'' and, hence, fulfills the requirements of NLF / ISO-OSH 2001. KSM laboratories are accredited according to DIN EN ISO/IEC 17025. To the extent possible, KSM is committed to maintaining competence in radiation protection and to supporting research and teaching activities. The present reports lists the individual tasks of the KIT Safety Management and informs about the results achieved in 2012. Status figures in principle reflect the status at the end of the year 2012. The processes described cover the areas of competence of KSM.

[Implementation of quality standard UNE-EN ISO/IEC 17043 in the External Quality Control Program of the Spanish Society of Infectious Diseases and Clinical Microbiology].

Science.gov (United States)

Poveda Gabaldón, Marta; Ovies, María Rosario; Orta Mira, Nieves; Serrano, M del Remedio Guna; Avila, Javier; Giménez, Alicia; Cardona, Concepción Gimeno

2011-12-01

The quality standard "UNE-EN-ISO 17043: 2010. Conformity assessment. General requirements for proficiency testing" applies to centers that organize intercomparisons in all areas. In the case of clinical microbiology laboratories, these intercomparisons must meet the management and technical standards required to achieve maximum quality in the performance of microbiological analysis and the preparation of test items (sample, product, data or other information used in the proficiency test) to enable them to be accredited. Once accredited, these laboratories can operate as a tool for quality control laboratories and competency assessment. In Spain, accreditation is granted by the Spanish Accreditation Body [Entidad Nacional de Acreditación (ENAC)]. The objective of this review is to explain how to apply the requirements of the standard to laboratories providing intercomparisons in the field of clinical microbiology (the organization responsible for all the tasks related to the development and operation of a proficiency testing program). This requires defining the scope and specifying the technical requirements (personnel management, control of equipment, facilities and environment, the design of the proficiency testing and data analysis for performance evaluation, communication with participants and confidentiality) and management requirements (document control, purchasing control, monitoring of complaints / claims, non-compliance, internal audits and management reviews). Copyright © 2011 Elsevier España S.L. All rights reserved.

Corporate sustainability practices in accredited Brazilian hospitals: a degree-of-maturity assessment of the environmental dimension

Directory of Open Access Journals (Sweden)

Glauce Nascimento

Full Text Available Abstract The main objective of this paper is to assess the degree of maturity of Brazilian accredited hospitals in relation to sustainable practices, specifically the environmental dimension. Therefore, a questionnaire was constructed, shaped by the literature review and the evaluation method of the Corporate Sustainability Index of BM and FBovespa (n.d.. Furthermore, the relationship between three corporate sustainability tools (the certification of the International Organization for Standardization [ISO] 14001, published sustainability reports, and the existence of an area dedicated to corporate sustainability and the maturity of hospitals in relation to sustainability practices were assessed. The results show that, of the 38 hospitals that participated in the survey (43% of subjects studied, 58% obtained a maturity rating of very high or high rating, according to the established criteria. In addition, some research variables showed statistically significant differences among the hospitals that have ISO 14001 certification, those that publish sustainability reports, and those that have an area dedicated to sustainability. Consequently, hospitals should take action to include much more sustainability actions in their strategies, such as how to establish a participatory dialog with stakeholders, in order to improve and raise the level of maturity of hospitals.

Elemental Characterization of Soil and Sediment Using NAA Technique for BATAN Inter Laboratory Comparison

International Nuclear Information System (INIS)

Syukria Kurniawati; Diah Dwiana Lestiani; Natalia Adventini

2009-01-01

Elemental characterization of soil and sediment samples using neutron activation analysis (NAA) for BATAN inter laboratory comparison have been conducted. TAR laboratory have been accredited by KAN since 2006, participating the test to evaluate and maintain its capability as testing laboratory that implemented ISO/IEC 17025. Samples from PTBIN were dried at 110°C for 2 hours and homogenized. The samples were irradiated at rabbit system of Multi-Purpose Reactor G.A Siwabessy for 1, 2, 10 and 60 minutes, then counted using HPGe gamma spectrometer. Several statistical test were applied such as μ-test, relative deviation, acceptance criteria for accuracy and precision. The result showed that soil contains V, Al, Ca, Mn, Na, K, As, Fe, Zn and Hg. From accuracy and precision, final status for 9 elements were passed but Ca was rejected, while V, Al, Mn, Cr, Fe, Zn and Co were detected in sediment samples. Final status for V, Al, Mn, Cr, Fe and Co elements were passed but Zn was rejected. (author)

Influence of the incubation temperature and the batch components on the sensitivity of an enzyme-linked immunosorbent assay to detect Aujeszky's disease virus glycoprotein E (gE).

Science.gov (United States)

Cay, A B; Van der Stede, Y

2010-12-01

Although licensed batches of an enzyme-linked immunosorbent assay (ELISA) for Aujeszky's disease virus (ADV) were used, and the assays were performed within an ISO/IEC 17025 accredited quality control system, certain routine runs of the ADV ELISA were not validated using the quality system criteria, even when all technical parameters were controlled. Incubation at different temperatures and batch composition were identified as parameters that could result in non-validated assays/runs. Therefore, the effect of incubation temperature and batch composition on the analytical sensitivity of the ELISA was investigated. The World Organisation for Animal Health (OIE) standard reference serum ADV1 was diluted 1:8 and tested in 94 different glycoprotein E ELISA runs performed with different batches and different incubation temperatures. The incubation temperature and batch components had a significant influence on the qualitative result for the OIE standard reference serum. An incubation temperature of at least 22 degrees C was recommended, based on the results of this analysis. Which of the batch components caused these differences in sensitivity was not investigated further.

Science and the rules governing anti-doping violations.

Science.gov (United States)

Bowers, Larry D

2010-01-01

The fight against the use of performance-enhancing drugs in sports has been in effect for nearly 90 years. The formation of the World Anti-Doping Agency in 1999 was a major event because an independent agency was entrusted with harmonization of the antidoping program. In addition to sports governing bodies, governments have endorsed WADA and its programs by signing a United Nations Education, Science, and Cultural Organization Convention on Doping. The first step in the harmonization process was the development of the World Anti-Doping Program. This program consisted of five documents - the Code, the International Standard for Testing, the International Standard for Laboratories, the Prohibited List, and the International Standard for Therapeutic Use Exemptions - which unified the approach of the international federations and national antidoping agencies in applying antidoping rules. For laboratory testing, the International Standard for Laboratories establishes the performance expectations for and competence of laboratories recognized by WADA, including accreditation under ISO/IEC 17025. The antidoping rules are adjudicated by arbitration using the internationally recognized Court of Arbitration for Sport.

Evaluation of a multiresidue method for measuring fourteen chemical groups of pesticides in water by use of LC-MS-MS.

Science.gov (United States)

Carvalho, J J; Jerónimo, P C A; Gonçalves, C; Alpendurada, M F

2008-11-01

European Council Directive 98/83/EC on the quality of water intended for human consumption brought a new challenge for water-quality control routine laboratories, mainly on pesticides analysis. Under the guidelines of ISO/IEC 17025:2005, a multiresidue method was developed, validated, implemented in routine, and studied with real samples during a one-year period. The proposed method enables routine laboratories to handle a large number of samples, since 28 pesticides of 14 different chemical groups can be quantitated in a single procedure. The method comprises a solid-phase extraction step and subsequent analysis by liquid chromatography-mass spectrometry (LC-MS-MS). The accuracy was established on the basis of participation in interlaboratory proficiency tests, with encouraging results (majority |z-score| <2), and the precision was consistently analysed over one year. The limits of quantitation (below 0.050 microg L(-1)) are in agreement with the enforced threshold value for pesticides of 0.10 microg L(-1). Overall method performance is suitable for routine use according to accreditation rules, taking into account the data collected over one year.

Evaluation of compliance with national legislation on emissions in Portugal

Energy Technology Data Exchange (ETDEWEB)

Joao F.P. Gomes [Instituto de Soldadura e Qualidade, Oeiras (Portugal). Centro de Tecnologias Ambientais

2005-04-01

More than 13 years after publication of the first air quality laws in Portugal and more than 10 years after the publication of the respective emission limits, it seems appropriate to analyze the degree of compliance by the Portuguese manufacturing industry. Using the data from emission measurements made regularly by the Instituto de Soldadura e Qualidade, the only officially accredited laboratory according to standard ISO 17025. The author analyzed a set of 400 sources in terms of compliance with the emission limits regarding total suspended particulates, sulfur dioxide, nitrogen oxides, and volatile organic compounds. He evaluated compliance through a nondimensional parameter and plotted it versus the emission flow rate to derive conclusions: the results indicate that emission limits are generally met regarding sulfur dioxide and nitrogen oxides but not for the other pollutants considered in this study. However, noncompliance occurs mainly for very low emission flow rates, which suggests some alterations in the emission limits, which are being revised at the moment. These alterations will include the exemption of measurements in minor sources. 7 refs., 8 figs., 7 tabs.

Characterization of physical and chemical properties of QLARIVIA-line of deuterium depleted Water

International Nuclear Information System (INIS)

Ferdes, Ov. S.; Mladin, C.; Petre, R.M.; Mitu, F.; Costinel, Diana; Vremera, Raluca; Sandru, Claudia

2008-01-01

QLARIVIA is the brand-name of Deuterium Depleted Water line of products of drinking water differentiating mainly by the deuterium concentration. It is the result of a national technological transfer project and it is based on an original, patented technology for deuterium depletion from the normal water. The paper presents the measuring and analysis results of the chemical and physical properties of the QLARIVIA brand-line of drinking DDW, as: pH; water hardness; permanganate index; Ca; Mg; Cl - ; SO4 2 - ; NH 4 ; NO 3 - ; NO 2 - , as well as the deuterium concentration determination by mass spectrometry. The analysis has been performed on at least 20 batch-samples, by usual, standardized and/or validated analytical methods, in ISO 17025:2005 accredited laboratories. The results are discussed considering the requirements of the EU directive on drinking water as well as of the Romanian Act on drinking water no. 458/2002 with its supplemental modification by the Act no.363/2004. The conclusion is that QLARIVIA - brand line of drinking DDW fulfills all the official physical and chemical requirements for the drinking water. (authors)

Evaluation of compliance with national legislation on emissions in Portugal.

Science.gov (United States)

Gomes, João F P

2005-04-01

More than 13 years after publication of the first air quality laws in Portugal and more than 10 years after the publication of the respective emission limits, it seems appropriate to analyze the degree of compliance by the Portuguese manufacturing industry. Using the data from emission measurements made regularly by the Instituto de Soldadura e Qualidade, the only officially accredited laboratory according to standard ISO 17025, I analyzed a set of approximately 400 sources in terms of compliance with the emission limits regarding total suspended particulates, sulfur dioxide, nitrogen oxides, and volatile organic compounds. I evaluated compliance through a nondimensional parameter and plotted it versus the emission flow rate to derive conclusions: the results indicate that emission limits are generally met regarding sulfur dioxide and nitrogen oxides but not for the other pollutants considered in this study. However, noncompliance occurs mainly for very low emission flow rates, which suggests some alterations in the emission limits, which are being revised at the moment. These alterations will include the exemption of measurements in minor sources.

The Role of Accreditation in Consumer Protection.

Science.gov (United States)

Warner, W. Keith; Andersen, Kay J.

1982-01-01

Upper-level college administrators in the Western accreditation region were surveyed about how well the Western Association of Schools and Colleges (WASC) served its constituency. Questions concerned consumer protection as an objective of accreditation, emphasis on disseminating information about the accreditation process, and potential policy…

[Accreditation of Independent Ethics Committees].

Science.gov (United States)

Ramiro Avilés, Miguel A

According to Law 14/2007 and Royal Decree 1090/2015, biomedical research must be assessed by an Research Ethics Committee (REC), which must be accredited as an Research ethics committee for clinical trials involving medicinal products (RECm) if the opinion is issued for a clinical trial involving medicinal products or clinical research with medical devices. The aim of this study is to ascertain how IEC and IECm accreditation is regulated. National and regional legislation governing biomedical research was analysed. No clearly-defined IEC or IECm accreditation procedures exist in the national or regional legislation. Independent Ethics Committees are vital for the development of basic or clinical biomedical research, and they must be accredited by an external body in order to safeguard their independence, multidisciplinary composition and review procedures. Copyright © 2016 SESPAS. Publicado por Elsevier España, S.L.U. All rights reserved.

22 CFR 96.63 - Renewal of accreditation or approval.

Science.gov (United States)

2010-04-01

... for renewal in a timely fashion. Before deciding whether to renew the accreditation or approval of an... accrediting entity or the Secretary during its most current accreditation or approval cycle, the accrediting...

Explanation and practice on ISO 9000

International Nuclear Information System (INIS)

Kwon, Dong Myeong

2001-01-01

This book reveals introduction on revision of ISO 9000:2000 with full account and contents of revision and change method change into ISO 9001:2000, the basic principle on ISO 9000:2000 and improvement and aim, definition on explanation, method for detail term, demand for ISO/KS A 9001:2000, quality management system development and transition way, standardization for quality management, manual of quality and making procedure and guide, case of quality manual and procedure and guide and ISO 9001:2000 / KS A 9001:2001 an English-Korean translation.

Medical students' perceptions of international accreditation.

Science.gov (United States)

Ibrahim, Halah; Abdel-Razig, Sawsan; Nair, Satish C

2015-10-11

This study aimed to explore the perceptions of medical students in a developing medical education system towards international accreditation. Applicants to an Internal Medicine residency program in an academic medical center in the United Arab Emirates (UAE) accredited by the Accreditation Council for Graduate Medical Education-International (ACGME-I) were surveyed between May and June 2014. The authors analysed responses using inductive qualitative thematic analysis to identify emergent themes. Seventy-eight of 96 applicants (81%) completed the survey. The vast majority of respondents 74 (95%) reported that ACGME-I accreditation was an important factor in selecting a residency program. Five major themes were identified, namely improving the quality of education, increasing opportunities, meeting high international standards, improving program structure, and improving patient care. Seven (10%) of respondents felt they would be in a position to pursue fellowship training or future employment in the United States upon graduation from an ACGME-I program. UAE trainees have an overwhelmingly positive perception of international accreditation, with an emphasis on improving the quality of training provided. Misperceptions, however, exist about potential opportunities available to graduates of ACGME-I programs. As more countries adopt the standards of the ACGME-I or other international accrediting bodies, it is important to recognize and foster trainee "buy-in" of educational reform initiatives.

Laadun- ja riskienhallinta johtamisjärjestelmässä ISO 9001:2015 ja ISO 31000:2009 mukaisesti

OpenAIRE

Reinvall, Niko; Karhunen, Joonas

2015-01-01

Tämän opinnäytetyön tarkoituksena on tarkastella riskienhallinnan ja laadunhallintajärjestelmien suhdetta ISO 9001:2015 ja ISO 31000:2009-standardien viitekehyksessä, tutkimuskysymyksen ollessa ”miten ja miksi integroida ISO 9001 mukaista laadunhallintaa ja ISO 31000 mukaista riskienhallintaa organisaation johtamisjärjestelmään”. Lisäksi työssä tarkastellaan standardien välisiä yhtymäkohtia ja riskienhallinnan merkitystä ISO 9001:2015 mukaisessa laadunhallintajärjestelmässä. Työn tilaaja...

75 FR 7581 - RTO/ISO Performance Metrics; Notice Requesting Comments on RTO/ISO Performance Metrics

Science.gov (United States)

2010-02-22

... performance communicate about the benefits of RTOs and, where appropriate, (2) changes that need to be made to... of staff from all the jurisdictional ISOs/RTOs to develop a set of performance metrics that the ISOs/RTOs will use to report annually to the Commission. Commission staff and representatives from the ISOs...

Synergistic relationships between Analytical Chemistry and written standards.

Science.gov (United States)

Valcárcel, Miguel; Lucena, Rafael

2013-07-25

This paper describes the mutual impact of Analytical Chemistry and several international written standards (norms and guides) related to knowledge management (CEN-CWA 14924:2004), social responsibility (ISO 26000:2010), management of occupational health and safety (OHSAS 18001/2), environmental management (ISO 14001:2004), quality management systems (ISO 9001:2008) and requirements of the competence of testing and calibration laboratories (ISO 17025:2004). The intensity of this impact, based on a two-way influence, is quite different depending on the standard considered. In any case, a new and fruitful approach to Analytical Chemistry based on these relationships can be derived. Copyright © 2013 Elsevier B.V. All rights reserved.

Aligning Assessments for COSMA Accreditation

Science.gov (United States)

Laird, Curt; Johnson, Dennis A.; Alderman, Heather

2015-01-01

Many higher education sport management programs are currently in the process of seeking accreditation from the Commission on Sport Management Accreditation (COSMA). This article provides a best-practice method for aligning student learning outcomes with a sport management program's mission and goals. Formative and summative assessment procedures…

The role of CT in professionalism: accreditation, certification and the welfare of our children.

Science.gov (United States)

Frush, Donald P

2011-09-01

Defining, measuring and promoting professionalism in medicine, including radiology, has been increasingly emphasized by organizations such as ACGME, the ACR and ABR. It is clear that we as imaging experts have as an ultimate responsibility the welfare of our patients. This is the essence of professionalism, and major societies such as the ACR, ABR and RSNA are embracing professionalism through ongoing safety and training efforts. Some of those efforts in accreditation of equipment and certification of medical professionals will be discussed.

PAEA Accreditation Task Force Briefing Paper: Moving Toward Profession-Defined, Outcomes-Based Accreditation.

Science.gov (United States)

Bondy, Mary Jo; Fletcher, Sara; Lane, Steven

2017-12-01

In anticipation of a revision to the Standards for Accreditation, the Phyisician Assistant Education Association (PAEA) charged a small task force to develop a strategy for engaging its members in the revision process. Rather than focusing on the current Standards, the task force members recommend a backward design approach to determine the desired outcomes of a successful revision to the Standards. Ultimately, the group believes that shifting to a profession-defined, outcomes-based model for accreditation will allow for greater innovation in physician assistant education and reduce the strain on programs facing resource limitations, particularly clinical site shortages. Task force members value accreditation and urge a paradigm shift in the Standards revision process to focus on meaningful educational outcomes that lead to enhanced program quality and patient safety.

Drugs and devices: audit and accreditation the Malaysian Practice

International Nuclear Information System (INIS)

Eisha Abdul Rahman; Anis Ahmad

1999-01-01

important differences. Nevertheless, conforming to both GMP and ISO 9001/2 will indeed be an ideal achievement, technical and administratively. In tandem with global regulatory requirement, the device industry has taken proactive moves to meet international standards. According to a reL ent Standard Malaysian Glove Scheme survey, 26 latex examination glove manufacturers have been accredited for ISO 9001/1 9 certified for EN 46001/1 and another 14 certified for FDA: QSR/GMP. As for product certification scheme, 22 manufacturers are reported to have acquired the CE marking. Amidst current regulatory complexities, promotion of global convergence of regulatory system via harmonization is indeed vital. Establish consistent audits leading to mutual recognition acceptance will certainly achieve an economic and effective approach towards regulating drugs and devices in the interest of public health

Audit experience in external individual monitoring services accreditation in Brazil

International Nuclear Information System (INIS)

Martins, M.M.; Fonseca, E.S.; Pereira, W.W.; Ramos, M.M.O.; Salati, I.P.A.

1998-01-01

Brazilian Nuclear Energy Commission (CNEN) has been carrying out an accreditation program for the External Individual Monitoring Services (named SMIE) for about 45.000 workers involved with ionizing radiation. One of this steps of this accreditation program is the audit to each SMIE. The main audit objective is to verify and to check organizational documentation, system performance test, technical personnel ability and training, quality assurance system procedures and records, essential equipment and facilities and reliability of dose reports. In order to avoid a different audit for each SMIE, effort were made to obtain a standard process. Two aspects were considered the most relevant ones: human resources training and audit procedures. To achieve the first one, a practical and theoretical course taking into account auditing needs was elaborated. As well as experience in one of the technical related areas, an important condition to be member of an audit team is to obtain satisfactory approval in one of the offered courses. In order to accomplish the second point, a set of documents was implemented such as an audit checklist, audit report models, and procedures and recommendations to audit. Up to February 1998, 12 accreditation audits were performed. The main points of this program as well as an assessment of its difficulties and success are reported in this work

IsoDAR@KamLAND: A Conceptual Design Report for the Technical Facility

CERN Document Server

Abs, M; Alonso, J R; Axani, S; Barletta, W A; Barlow, R; Bartoszek, L; Bungau, A; Calabretta, L; Calanna, A; Campo, D; Castro, G; Celona, L; Collin, G H; Conrad, J M; Gammino, S; Johnson, R; Karagiorgi, G; Kayser, S; Kleeven, W; Kolano, A; Labrecque, F; Loinaz, W A; Minervini, J; Moulai, M H; Okuno, H; Owen, H; Papavassiliou, V; Shaevitz, M H; Shimizu, I; Shokair, T M; Sorensen, K F; Spitz, J; Toups, M; Vagins, M; Van Bibber, K; Wascko, M O; Winklehner, D; Winslow, L A; Yang, J J

2015-01-01

This conceptual design report describes the technical facility for the IsoDAR electron-antineutrino source at KamLAND. The IsoDAR source will allow an impressive program of neutrino oscillation and electroweak physics to be performed at KamLAND. This report provides information on the physics case, the conceptual design for the subsystems, alternative designs considered, specifics of installation at KamLAND, and identified needs for future development. We discuss the risks we have identified and our approach to mitigating those risks with this design. A substantial portion of the conceptual design is based on three years of experimental efforts and on industry experience. This report also includes information on the conventional facilities.

Medical students’ perceptions of international accreditation

Science.gov (United States)

Abdel-Razig, Sawsan; Nair, Satish C

2015-01-01

Objectives This study aimed to explore the perceptions of medical students in a developing medical education system towards international accreditation. Methods Applicants to an Internal Medicine residency program in an academic medical center in the United Arab Emirates (UAE) accredited by the Accreditation Council for Graduate Medical Education-International (ACGME-I) were surveyed between May and June 2014. The authors analysed responses using inductive qualitative thematic analysis to identify emergent themes. Results Seventy-eight of 96 applicants (81%) completed the survey. The vast majority of respondents 74 (95%) reported that ACGME-I accreditation was an important factor in selecting a residency program. Five major themes were identified, namely improving the quality of education, increasing opportunities, meeting high international standards, improving program structure, and improving patient care. Seven (10%) of respondents felt they would be in a position to pursue fellowship training or future employment in the United States upon graduation from an ACGME-I program. Conclusions UAE trainees have an overwhelmingly positive perception of international accreditation, with an emphasis on improving the quality of training provided. Misperceptions, however, exist about potential opportunities available to graduates of ACGME-I programs. As more countries adopt the standards of the ACGME-I or other international accrediting bodies, it is important to recognize and foster trainee “buy-in” of educational reform initiatives. PMID:26454402

Perancangan Sistem Manajemen Mutu Terintegrasi di Baristand Industri Padang

Directory of Open Access Journals (Sweden)

Yudo Purnomo

2017-10-01

Full Text Available Baristand Industri Padang is an agency under control Ministry of Industry of Indonesia which it has a duty to serve the industries involving research activities, standardization and certification. To realize the programs, Baristand Industri Padang implemented a quality management system including ISO 9001, ISO/IEC 17025, ISO/IEC 17065, and KNAPPP 02. Nevertheless, it has been running separately. Therefore, quality of products not only proven by testing the final product, but also needed other evidence as a certificate that ensuring the quality of products. This research aims to design the Quality Management System for Baristand Industri Padang which it was implemented using life cycle methodology. Finding of this study revealed there was integration of ISO 9001, ISO/IEC 17025, ISO/IEC 17065, and KNAPPP 02 in the context of the structure of the process, documents, and organization. In the context of the structure of processes, it obtained four groups of primary process involving management, research and standardization, support, and improvement. Moreover, In terms of documentation, there was three levels of the document such as the document of strategic policy, quality guideline and procedures. While aspects of the organizational structure, the integration of quality management system required to develop the organizational structure that consist of Top Management, Technical Manager, Quality/Management Representative, Researcher and Administrative/Technical Staff. In addition, this study provided an integrated quality management information system including management of quality documents and quality records. Finally, the integrated quality management system and quality management information system has been designed to meet the expectations of the organization.

Evaluation of current Australian health service accreditation processes (ACCREDIT-CAP): protocol for a mixed-method research project.

Science.gov (United States)

Hinchcliff, Reece; Greenfield, David; Moldovan, Max; Pawsey, Marjorie; Mumford, Virginia; Westbrook, Johanna Irene; Braithwaite, Jeffrey

2012-01-01

Accreditation programmes aim to improve the quality and safety of health services, and have been widely implemented. However, there is conflicting evidence regarding the outcomes of existing programmes. The Accreditation Collaborative for the Conduct of Research, Evaluation and Designated Investigations through Teamwork-Current Accreditation Processes (ACCREDIT-CAP) project is designed to address key gaps in the literature by evaluating the current processes of three accreditation programmes used across Australian acute, primary and aged care services. The project comprises three mixed-method studies involving documentary analyses, surveys, focus groups and individual interviews. Study samples will comprise stakeholders from across the Australian healthcare system: accreditation agencies; federal and state government departments; consumer advocates; professional colleges and associations; and staff of acute, primary and aged care services. Sample sizes have been determined to ensure results allow robust conclusions. Qualitative information will be thematically analysed, supported by the use of textual grouping software. Quantitative data will be subjected to a variety of analytical procedures, including descriptive and comparative statistics. The results are designed to inform health system policy and planning decisions in Australia and internationally. The project has been approved by the University of New South Wales Human Research Ethics Committee (approval number HREC 10274). Results will be reported to partner organisations, healthcare consumers and other stakeholders via peer-reviewed publications, conference and seminar presentations, and a publicly accessible website.

ISO 639-1 and ISO 639-2: International Standards for Language Codes. ISO 15924: International Standard for Names of Scripts.

Science.gov (United States)

Byrum, John D.

This paper describes two international standards for the representation of the names of languages. The first (ISO 639-1), published in 1988, provides two-letter codes for 136 languages and was produced primarily to meet terminological needs. The second (ISO 639-2) appeared in late 1998 and includes three-letter codes for 460 languages. This list…

The suitability of ISO 9001 as a quality system for a medical illustration department.

Science.gov (United States)

Fleming, C M; Armes, F M

2001-12-01

The Medical illustration Department within Bradford Hospitals NHS Trust is typical of many such units in the UK that are facing increasing competition from the commercial sector and Private Finance Initiatives, and at the same time, being driven by NHS initiatives towards having a demonstrable quality system. It was considered that having a recognized quality management system would ensure that the service provided was more efficient and effective, improve quality, guard against competition, be an asset if the organization was benchmarked against others, and provide evidence of quality assurance to our customers. This paper summarizes the history of quality management, discusses a number of quality systems in the NHS in general, and in Bradford Hospitals NHS Trust in particular, and puts forward the reasons for choosing ISO9001. Finally, the process leading to accreditation is described.

Lean environmental management integration system for sustainability of ISO 14001:2004 standard implementation

Directory of Open Access Journals (Sweden)

Perumal Puvanasvaran

2014-10-01

Full Text Available Purpose: The purpose of this study is to present a model for integrating Lean Principles with ISO 14001 Environmental Management System.Design/methodology/approach: To achieve the objective of the study, the methodology used in this study is based on preliminary literature review of ISO 14001 standards and Lean Principles as well as certain case reports from various proponents and authors of ISO 14001 and Lean as noted in various articles and journals and some books.Findings and Originality/value: The findings of this study are a new model called Lean Environmental Management Integration System (LEMIS has been developed and leads to the creation of these measurement standards for evaluating the organization, making its environmental efforts more realistic, focused and attainable.Research limitations/implications: Future research should be conducted case studies in this direction are required to be conducted for examining the feasibility of amalgamation and implementing ISO 14001:2004 standards with the philosophy of Lean Principles to enable the achievement of world class standards.Practical implications: This model helps to eliminate any wasteful processes in the organization’s implementation of the ISO 14001 standard thus leading to higher environmental performance.  Integrating the standard with Lean principles through LEMIS model helps to specify these performance measures making the standard achieve sustainability and continual improvement.Originality/value: This study presents a unique approach of integrating the two main models, namely Lean Principles and ISO 14001 Environmental Management System, as a single framework benefiting contemporary organizations.

Library Standards: Evidence of Library Effectiveness and Accreditation.

Science.gov (United States)

Ebbinghouse, Carol

1999-01-01

Discusses accreditation standards for libraries based on experiences in an academic law library. Highlights include the accreditation process; the impact of distance education and remote technologies on accreditation; and a list of Internet sources of standards and information. (LRW)

Re-engineering caused by ISO-9000 certification

DEFF Research Database (Denmark)

Hvam, Lars; Nielsen, Anders Paarup; Bjarnø, Ole-Christian

1997-01-01

Based on a project performed at a medium-sized producer of medical utensils, reviews some of the problems which the company experienced in connection with the system built up during ISO 9001 certification, and the re-engineering efforts which were performed in order to relieve these problems....... Focuses in particular on a re-structuring of the company’s system for production documentation and its relation to the traceability of their products. This system was radically altered during the project without the traceability requirements being violated or reduced. These changes resulted in a marked...... increase in productivity....

ORIGINAL ARTICLES Academic hospital accreditation strengthens ...

African Journals Online (AJOL)

This case study originated from the combined experiences of the accreditation process of a ... (iv) the benefits of hospital accreditation and quality management. The study ... Tertiary healthcare is in a crisis after nearly 3 decades of neglect,2,3.

Changes in management actions after the Hospital Accreditation

Directory of Open Access Journals (Sweden)

Andréia Guerra Siman

2016-01-01

Full Text Available Objective: to understand the changes in the management actions after the Hospital Accreditation. Methods: a case study. The study included 12 managers of a hospital accredited with excellence. Data collection was carried out with interviews with semi-structured and subjected to content analysis. Results: about changes in management actions were recorded significantly three categories: Work organization with quality tools; management actions before and after the accreditation; and challenges faced by modifying the management actions. Conclusion: accreditation mobilized changes in management actions with quality instruments of adoption used to organize the work and accountability of those involved in the process. However, there were challenges to be overcome to achieve accreditation by managers.

Practical Nursing Education: Criteria and Procedures for Accreditation.

Science.gov (United States)

National Association for Practical Nurse Education and Service, Inc., New York, NY.

The third in a series of pamphlets on practical nursing education, this document contains information on accreditation standards governing nursing programs. Included are announcements of: (1) available accreditation and consultation services, (2) policies regulating accreditation eligibility, (3) standards of ethics by which nursing programs are…

9 CFR 439.10 - Criteria for obtaining accreditation.

Science.gov (United States)

2010-01-01

... degree in chemistry, food science, food technology, or a related field. (i) For food chemistry... ACT ACCREDITATION OF NON-FEDERAL CHEMISTRY LABORATORIES § 439.10 Criteria for obtaining accreditation. (a) Analytical laboratories may be accredited for the analyses of food chemistry analytes, as defined...

Control: the effects of ISO

NARCIS (Netherlands)

Laura Ilzarbe; PhD Everard van Kemenade; Maria-Jezus Alvarez

2007-01-01

De effecten van ISO-certificering zoals gerapporteerd in wetenschappelijk onderzoek. Met speciale aandacht voor de resultaten in het onderwijs. ISO 9000:2000 doet het nadrukkelijk beter dan haar vorige versies.

Impact of quality concepts on nuclear engineering accreditation

International Nuclear Information System (INIS)

Woodall, D.M.

1993-01-01

This paper is an update of the accreditation process for nuclear engineering education at the undergraduate and graduate level in U.S. universities and colleges. The Engineering Accreditation Commission (EAC) of the Accreditation Board for Engineering and Technology (ABET) has made a number of major changes in the process for engineering accreditation in recent years. This paper identifies those changes that have taken place, discusses the rationale for those changes, and encourages U.S. universities with nuclear engineering programs to respond

What Should Gerontology Learn from Health Education Accreditation?

Science.gov (United States)

Bradley, Dana Burr; Fitzgerald, Kelly

2012-01-01

Quality assurance and accreditation are closely tied together. This article documents the work toward a unified and comprehensive national accreditation program in health education. By exploring the accreditation journey of another discipline, the field of gerontology should learn valuable lessons. These include an attention to inclusivity, a…

Standards, documents of relevance and directives in individual monitoring: is European individual monitoring in compliance with standards?

International Nuclear Information System (INIS)

Fantuzzi, E.

2005-01-01

Full text: Individual monitoring services in Europe do not comply with the same legal or approval requirements. Anyway, a degree of harmonization existing in individual monitoring practices in Europe has been achieved mainly thank to documents as standards or international recommendations, which with a different weight, represent invaluable vehicles of condensed information transfer. However, implementation of standards is not straightforward and harmonization is not directly a consequence. Somehow, 'harmony' is needed also in standards: IEC and ISO standards on performance requirements for dosemeters sometimes have different approaches (i.e. performance criteria). If used for approval, passing one will not necessarily mean passing all. Moreover, standards do not all refer to reliability, and therefore being in compliance with standards does not itself assure that dose results are reliable. This might apply only to ISO/IEC17025 'quality' standard, which represents the best available tool for the quality of laboratory work and somehow include all technical and management requirements. When accredited according to ISO/IEC17025, an Individual Monitoring Service (IMS) fulfils standards. Standards are not the only reference documents for an IMS. EURADOS working group on 'Harmonization of Individual Monitoring in Europe', who has been active in the years 2001-2004, suggested a classification of publication on individual monitoring, distinguishing between standards and documents of relevance, which can be both national and international. A standard, unlike a textbook or technical publication, does not cover the experience and opinion of one or few individuals only, but the consensus of the entire scientific and technical community concerned. Most of the standards applicable to individual monitoring are published by IEC or ISO, or both together. However, it has to be kept in mind that ISO and IEC standards, for example, are meant for manufactures and industry, which do not

The impact of laboratory quality assurance standards on laboratory operational performance

Directory of Open Access Journals (Sweden)

E Ratseou

2014-01-01

Full Text Available It has become a trend for companies to implement and be certified to various quality management systems so as to improve consistency, reliability, and quality of product delivery to customers. The most common quality management systems adopted are the ISO 9000 series of standards for manufacturing and services related organisations, with ISO 17025 and Good Laboratory Practices (GLP standards adopted specifically by laboratories as quality assurance initiatives. There are various reports on the impact of the ISO 9000 series on organisational performance but no studies or reports have been done on the performance of laboratory standards. Therefore this article reports on a study conducted to investigate the impact of ISO 17025 and GLP on the operational performance of both commercial and non-commercial laboratories. A qualitative research study was conducted to examine the impact standards on the aspects of health and safety, supplier selection and performance, human resources, customer satisfaction and profitability of the laboratory. The data collected suggest that there is no difference in laboratory operational performance with or without the standards. In other words it appears that the basic fundamental requirements inherent with laboratories are sufficient to perform both operationally and optimally. This leads to the view that standards are implemented as a customer requirement and not as an operational requirement.

Using evidence-based accreditation standards to promote continuous quality improvement: the experiences of the San Mateo County Human Services Agency.

Science.gov (United States)

Winship, Kathy; Lee, Selina Toy

2012-01-01

Following a difficult period of service provision, an agency determined that drastic changes were needed to improve agency-wide capacity and functioning. The agency engaged in an organizational level self-assessment aimed at identifying areas for improvement and beginning work towards determining professional standards for service. Results of this organizational self-assessment paved the way for pursuing accreditation of its services, and the agency became the first public agency in its state to be accredited by the Council on Accreditation in all eligible services. This case study describes this agency's efforts in engaging in an organizational self-assessment, the analysis and codification of their practices, and their eventual development of a systematized process for capturing, evaluating and improving practice. Copyright © Taylor & Francis Group, LLC

The program director and accreditation

International Nuclear Information System (INIS)

Tristan, T.A.; Capp, M.P.; Krabbenhoft, K.L.; Armbruster, J.S.

1987-01-01

Field Survey is contrasted with the Specialist Site Visitor. The discussion addresses the reasons for different types of surveys and how the surveys and the Hospital Information Form are used in evaluating a graduate residency program in radiology for accreditation. The Residency Review Committee for Radiology (RRC) and the staff of the Accreditation Council for Graduate Medical Education (ACGME) of Residencies in Radiology offer a program for program directors and other interested leaders in graduate programs in radiology. The authors explain the review and accreditation process for residencies in radiology with special emphasis on the preparation for inspection by accurate and full completion of the Hospital Information Form on which the program is judged, and the nature of the inspection procedures

Accreditation of undergraduate and graduate medical education

DEFF Research Database (Denmark)

Davis, Deborah J; Ringsted, Charlotte

2006-01-01

Accreditation organizations such as the Liaison Committee for Medical Education (LCME), the Royal College of Physicians and Surgeons of Canada (RCPSC), and the Accreditation Council for Graduate Medical Education (ACGME) are charged with the difficult task of evaluating the educational quality...... of medical education programs in North America. Traditionally accreditation includes a more quantitative rather than qualitative judgment of the educational facilities, resources and teaching provided by the programs. The focus is on the educational process but the contributions of these to the outcomes...... are not at all clear. As medical education moves toward outcome-based education related to a broad and context-based concept of competence, the accreditation paradigm should change accordingly. Udgivelsesdato: 2006-Aug...

A practical synthesis of long-chain iso-fatty acids (iso-C12–C19 and related natural products

Directory of Open Access Journals (Sweden)

Mark B. Richardson

2013-09-01

Full Text Available A gram-scale synthesis of terminally-branched iso-fatty acids (iso-C12–C19 was developed commencing with methyl undec-10-enoate (methyl undecylenate (for iso-C12–C14 or the C15 and C16 lactones pentadecanolide (for iso-C15–C17 and hexadecanolide (for iso-C18–C19. Central to the approaches outlined is the two-step construction of the terminal isopropyl group through addition of methylmagnesium bromide to the ester/lactones and selective reduction of the resulting tertiary alcohols. Thus, the C12, C17 and C18 iso-fatty acids were obtained in three steps from commercially-available starting materials, and the remaining C13–C16 and C19 iso-fatty acids were prepared by homologation or recursive dehomologations of these fatty acids or through intercepting appropriate intermediates. Highlighting the synthetic potential of the iso-fatty acids and various intermediates prepared herein, we describe the synthesis of the natural products (S-2,15-dimethylpalmitic acid, (S-2-hydroxy-15-methylpalmitic acid, and 2-oxo-14-methylpentadecane.

ISO 9000 Quality Management System

Science.gov (United States)

Hadjicostas, Evsevios

The ISO 9000 series describes a quality management system applicable to any organization. In this chapter we present the requirements of the standard in a way that is as close as possible to the needs of analytical laboratories. The sequence of the requirements follows that in the ISO 9001:2008 standard. In addition, the guidelines for performance improvement set out in the ISO 9004 are reviewed. Both standards should be used as a reference as well as the basis for further elaboration.

42 CFR 414.68 - Imaging accreditation.

Science.gov (United States)

2010-10-01

... relates to the past year's accreditations and trends. (viii) Attest that the organization will not perform... past year's accreditation activities and trends. (h) Continuing Federal oversight of approved... to compel by subpoena the production of witnesses, papers, or other evidence. (v) Within 45 calendar...

Summary

International Nuclear Information System (INIS)

2002-01-01

This report summarizes the progress made that resulted in the improvement of the organizational and analytical performance on Nuclear Analytical Laboratories at the Ankara Nuclear Research and Training Centre in accordance with ISO 17025 requirements. This report lists the main accomplishments and presents future plans of the Laboratory

Accreditation: The US framework for colleges and professional disciplines

International Nuclear Information System (INIS)

Reyes-Guerra, D.R.

1989-01-01

Accreditation is a system of verified quality control and recognition. When applied to education it becomes the instrument by which the quality of education is measure. For engineering, the recognized accrediting agency is the Accreditation board for Engineering and Technology (ABET). The American Nuclear Society (ANS) provides input to ABET and to the profession regarding the special educational needs of nuclear engineering or nuclear engineering technology and related fields. The accreditation process involves the determination of criteria applicable to the educational experience that will satisfy the profession and the individual discipline; the application, with judgment, of the criteria to an individual program; the visit to that program by an evaluation team; and the judgment of the program against the criteria. The accreditation process requires a comprehensive self-study of the specific program being evaluated. Results are verified on-site by the evaluation team. Programs are accredited for a limited time span: 6 yr at the maximum. Programs are reevaluated as necessary for continued accreditation

Accreditation and participatory design in the healthcare sector

DEFF Research Database (Denmark)

Simonsen, Jesper; Scheuer, John Damm; Hertzum, Morten

2015-01-01

, realizing, and measuring the effects from using an information technology. This approach aligns with much of the logic in accreditation but is distinguished by its focus on effects, whereas current accreditation approaches focus on processes. Thereby, effects-driven IT development might support challenging...... parts of the accreditation process and fit well with clinical evidence-based thinking. We describe and compare effects-driven IT development with accreditation, in terms of the Danish Quality Model which is used throughout the Danish healthcare sector, and we discuss the prospects and challenges...