Implementation of ISO/IEC 17025 standard in a nuclear analytical laboratory: The KAERI experience

The practical experience on the implementation of ISO/IEC 17025 compliant quality system in a nuclear analytical laboratory of the Korea Atomic Energy Research Institute (KAERI) is described. This paper summarizes the need for a quality system and accreditation, the process of a quality system implementation, the quality system structures, and the formal accreditation of our laboratory by the Korean Laboratory Accreditation Scheme (KOLAS). Also, the improvements in the management, technical and service quality which resulted from implementation of this system are briefly reported.     

Towards accreditation of clinical biochemistry in the public sector on the island of Mauritius

Medical laboratories of the public sector as well as of the private sector on the island of Mauritius are preparing for accreditation. The clinical laboratory of the Central Health laboratory of the Ministry of Health and Quality of Life has undergone a pre-assessment by experts of the International Atomic Energy Agency (IAEA) through the aegis of a project targeted to members of the Africa Region. Several shortcomings were identified and respective corrective actions were recommended for implementation within a given time frame. In addition to ensuring the competence of the laboratory, accreditation has various positive aspects such as an increased awareness of the staff to quality and better training opportunities. The pre-assessment exercise has provided a gap analysis, which is an important aspect in the preparation towards accreditation.     

Establishment of a quality system at the Nuclear Analytical Laboratories of the Atomic Energy Authority, Sri Lanka

A quality system according to the requirements of ISO/IEC guidelines has been introduced at the Nuclear Analytical Laboratories of the Atomic Energy Authority, which has received appreciation from International Atomic Energy Agency (IAEA) inspection evaluation reports (RAS/2/010) showing a positive indication to accreditation. The quality system has achieved the “analytical quality” through technical competence by non-conformance management. The experience in the progression towards achieving a quality system is described with examples from zero level to a positive index. This nuclear analytical service laboratory shows long-term stability of performance and enhances its credibility to customers, through the quality system.     

On the way to formal accreditation

The Radiochemical Laboratory participated in the Technical Co-operation (TC) Project on Quality Control and Quality Assurance for Nuclear Analytical Techniques RER/2/004 organized by the International Atomic Energy Agency (IAEA) during the period June 1999 and September 2001. Motivations, major goals of participation in the project, milestones of implementation of the project, establishing the quality system, improvements fulfilling both technical and management requirements as well as major achievements for future activities of the laboratory with respect to technical and financial conditions are discussed in detail.     

Quality system implementation in Member States of the IAEA

The International Atomic Energy Agency (IAEA), through its Technical Co-operation Programme, has supported the establishment of many nuclear analytical and complementary laboratories in Member States. This included the development of capabilities for the use of various nuclear analytical techniques that include alpha, beta, and gamma spectrometry; radiochemical analysis; neutron activation analysis; energy dispersive X-ray fluorescence analysis; and total reflection X-ray fluorescence. As economic, ecological, medical, and legal decisions are frequently based on laboratory results, they need to be based on accepted national and international standards.The IAEA has taken up this important issue to enhance and foster the competitiveness of nuclear analytical laboratories with the consideration that non-nuclear capabilities are equally important. The projects aim at enhanced quality awareness, a concise system for documentation, establishment of standard operating procedures, procedures for validation of methods, surveillance of method performance, systems for sample management, regular qualification of personnel, client liaison and safety. These projects follow the ISO/IEC 17025 standard and promote participating laboratories to maintain a self-sufficient quality system by which they might be able to obtain national accreditation.This contribution describes the general concept of these projects and discusses some of the results achieved.     

Step-by-step implementation of a quality system in the laboratory

In recent years laboratories have undergone huge transformations due to the technological development of inspection and testing equipment; the introduction of computerised and automated systems; keen competitiveness between companies/laboratories as a result of demand within Europe and on the international market; and greater consumer awareness of the quality of the products available. Laboratory accreditation, though a voluntary process, is formal recognition by an accreditation body of the laboratory's competence to carry out certain tests. This article presents those aspects which should be taken into account in the step-by-step implementation of a quality system and also makes reference to the requirements for the operation of accredited laboratories in accordance with European Standard EN 45001.     

The establishment of quality systems in veterinary diagnostic testing laboratories in developing countries: experiences with the FAO/IAEA External Quality Assurance Programme

Quality systems, established to internationally accepted standards, are one mechanism that can assist in evaluations of the sustainability of technology transfer, the proficiency of the user, and the reliability and comparability of data generated, resulting in potential enhancement of laboratory credibility. The means of interpreting existing standards and implementing quality systems in developing country veterinary diagnostic laboratories has become a significant adjunct to the technology transfer element within the Food and Agriculture/ International Atomic Energy Agency, FAO/IAEA programme. The FAO/IAEA External Quality Assurance Programme (EQAP) is given as an example for an initial step towards enhancing the “quality” culture in developing country veterinary laboratories. In 1995 the EQAP began as an effort to assure that test results emanating from laboratories using FAO/IAEA ELISA kits for animal disease diagnosis are valid. For this purpose 15 international external quality-assurance rounds have been performed to date for a variety of animal diseases e.g. Rinderpest, brucellosis, trypanosomosis, and foot-and-mouth disease (FMD). Results indicate that the EQAP is a valuable tool in the assessment of both the results provided by, and use of the ELISA kits provided through, the joint FAO/IAEA programme. Furthermore EQAP can assist laboratory diagnosticians to enhance quality control/quality assurance (QC/QA) procedures for conducting FAO/IAEA ELISAs and to advise on the implementation of similar QC/QA procedures in other laboratory activities. Based on the experiences made during the implementation of the EQAP a proposal for establishing a quality system standard was ratified through the World Organization for Animal Health (OIE) general conference in May 2000. The OIE Standard On Management And Technical Requirements For Laboratories Conducting Tests For Infectious Animal Diseases is based on ISO 17025 and provides a clear formula for establishing quality systems in veterinary diagnostic laboratories world-wide.     

Compliance with GLP standards and management in analytical laboratories: current status

 Analytical laboratories in Japan, operating more often as departments within a company than as independent contractors, have to contend with different good laboratory practice (GLP) standards. Problems also occur in the analytical laboratories which must comply with GLP, good manufacturing practice (GMP) and good clinical practice (GCP) regulations within the same facility. The status of these GLP-complied analytical laboratories is reviewed with regard to assurance program, validation method, laboratory information management, and security systems. The differences in the responsible authorities and scopes under the six GLPs are also briefly described. Analytical tests in GLP are not itemized as a test for accreditation. Therefore, the accreditation of analytical laboratories in Japan is currently granted as a part of ISO 9000 approvals. Received: 27 September 1996 Accepted: 11 November 1996     

The International Atomic Energy Agency's program on analytical quality control

For more than thirty years the International Atomic Energy Agency has been assisting laboratories in Member States in maintaining and improving the reliability, i.e. the quality of analyses of nuclear, industrial, environmental and biological materials, and materials of marine origin. Through the Analytical Quality Control Services (AQCS) the Agency initiates and supports improvements in the accuracy of analytical chemical and radiometric measurements and their traceability to basic standards. This is achieved by organizing worldwide and regional intercomparison exercises and by distributing reference materials. The latest biological and environmental reference and intercomparison materials are presented and general information is given on the preparation of materials, intercomparison runs, and the evaluation of reference data. Means to improve the quality of intercomparison results are presented and discussed.     

Implementation of ISO/IEC 17025 Standard for the accreditation of analytical laboratories in Russia

The history since 1992 and the current state of affairs of the Russian Accreditation system for analytical laboratories are described. Some national characteristics of the implementation of the ISO/IEC 17025 Standard in Russia are considered. The elucidation of some ISO/IEC 17025 Standard prepositions is presented to facilitate implementation of the Standard by accreditation bodies and analytical laboratories claiming accreditation.     

A process approach to ISO/IEC 17025 in the implementation of a quality management system in testing laboratories

The introduction of quality management systems (QMS) and the accreditation of laboratories according to ISO/IEC 17025 standard are not easy tasks, mainly for those laboratories located at teaching and research institutions. During the implementation of QMS at two testing laboratories of the Federal University of Rio Grande do Sul in Brazil, new solutions to overcome some of the difficulties inherent to this type of environment have been found. The knowledge acquired through this work has led to the proposition of some general steps incorporating a process approach presented in this article, which could be of use to laboratories in their pursuit for accreditation. This proposal suggests the use of strategic planning information, links the QMS objectives to the corresponding processes and sets a few indicators to monitor both performance of and improvements to the system.     

Implementation of a quality management system in a public research centre

In recent decades, it has become increasingly important for public research centres to attract external clients, including government, private and public bodies and companies. They do this by demonstrating their research excellence. A research centre??s ability to provide professional research services can be assessed by competent technical bodies which verify that the research centre??s laboratories operate according to certain predetermined criteria or standards. Although there is no set of generally accepted standards, some regional accreditation bodies already offer accreditation assessment for the R&D laboratories which are in their territory. This article analyses the successful application of a quality management system in a public research centre employing 57 people including researchers, technicians and administrative staff. This system is based on the scheme of regional accreditation of industrial research laboratories which was inspired by ISO 9001:2008 and ISO 17025:2005 and set up by the regional authority. The overall aim of the management system is to monitor all of the industrial research and services which the centre offers to external users, such as government, private and public bodies and companies, and to guarantee that final products, usually technical reports and prototypes, respond to their needs. The accreditation applies to all of the activity of the research centre except for basic research. In this article, the critical factors influencing the success of the implementation of the management system are outlined together with benefits and opportunities. Weak points and problems are analysed, and the actions which were undertaken in order to prevent and manage problems are described.     

Quality assurance in analytical laboratories engaged in research and development activities

 Research and development activities are carried out by various types of laboratories that are not the typical testing and calibration laboratories for which the ISO/IEC 17025 is the quality assurance implementation reference. In this paper, such laboratories engaged in R&D activities are classified and different approaches they can adopt with a view to implementing a quality system that are suited to their characteristics and the type of work they conduct are proposed. These approaches take account of existing standards for the certification/accreditation of laboratories and of guides on quality assurance for non-routine analytical laboratories. Received: 11 July 2002 Accepted: 29 November 2002 Presented at Analytica Conference, 23–26 April 2002, Munich, Germany Correspondence to M. Valcárcel     

Quality management, certification and accreditation in medical laboratories – the view of ECLM

 Increasing demands from health care planners and industrialists conducting clinical trials, as well as general competition, are forcing medical laboratories to seek third-party recognition of their quality management systems. There is a tendency to move from certification of a laboratory director, via certification of the laboratory quality system (ISO 9000 family), to accreditation needing proof of professional and technical competence in laboratory tasks. The requirements of accreditation are presented in several national schemes and in the European Standards series (EN 45 000) and the International Organization for Standardization's guide, ISO/IEC 25, to be amalgamated soon. The latter system provides transnational recognition through participation of the accrediting bodies in the European co-operation for Accreditation. Necessary supplementary guidelines exist for chemical laboratories (Eurachem) and medical laboratories CEAC/ECLM). Traceability and reliability of results are obtained by utilizing a global reference examination system and by participating in transdisciplinary work. The costs of achieving accreditation are considerable and mainly involve the production of quality handbooks and written work procedures by personnel. The rewards are an open system, smoother work, emphasis on prevention of mistakes, and satisfied stakeholders. Received: 5 October 1998 · Accepted: 20 October 1998     

Policies and criteria on accreditation of testing laboratories in Korea

Policies and criteria for the accreditation of testing laboratories in Korea are reviewed according to the laws and regulations within the organizational framework. According to the Weights and Measures Act, the administrator of Korean Industrial Advancement Administration (KIAA) may accredit qualified testing laboratories in Korea. Criteria, procedures, and surveillance of accredited laboratories are specified in the Enforcement Regulation of the Weights and Measures Act drawn up by the Ministry of Trade, Industry, and Energy. Further detailed accreditation criteria and processes are prescribed in the Operation Guideline for the Accreditation of Testing Laboratories prepared by the KIAA. The Korean Laboratory Accreditation Scheme (KOLAS) of the KIAA is the authorized representative institution for the accreditation of testing laboratories in compliance with the ISO Guides 25/58 and the Operation Guideline for the Accreditation of Testing Laboratories. Finally, the current status of accredited laboratories in Korea is briefly described.     

Proficiency testing programmes as a tool in food quality assurance: Overview of Italian experiences

Proficiency testing involves the performance of test procedures on routine samples by a number of laboratories. Interlaboratory proficiency testings provide multiple benefits to participants since they play a key-role in the total quality control of laboratory activities. They serve as a means of self-improving, as a mechanism of continuing education and as a source of information for accreditation agencies. This review highlights basic principles, benefits, criteria and capabilities of a proficiency testing programme for food analysis laboratories as well as their role in the implementation of rapidly developing food control legislation.     

The external review committee on pure reference materials at the National Analytical Reference Laboratory

The preceding paper described the implementation of a quality assurance system suitable for accreditation to ISO Guide 34 by the Pure Substance Reference Material (PSRM) team of the National Analytical Reference Laboratory (NARL). One of the key components of this system has been the establishment of an external advisory committee that scrutinises each candidate material that is to be offered as a reference material. At the time of writing 190 reference materials were available from NARL, including a range of illicit drugs and agricultural chemicals in addition to anabolic steroids and their metabolites, and all have been reviewed by the external committee prior to final approval by the accredited production signatory.     

The correlation of laboratory performance in proficiency testing with other QA characteristics

Although it seems self-evident that proficiency testing (PT) and accreditation can be expected to improve quality, their relative benefits remain uncertain as does their efficacy. The study reported here examines the following issues: (a) Why do laboratories take part in PT schemes? (b) How does participation in PT fit in with a laboratory's overall quality assurance (QA) system? (c) Is there a link between a laboratory's performance in specific PT and it's QA system? (d) How does PT performance change with time and how do laboratories respond to poor performance? The overall conclusion is that there is no evidence from the present study that laboratories with third-party assessment (accreditation and certification) perform any better in PT than laboratories without. The validity of this conclusion and its significance for the future design and operation of such schemes requires further investigation. In particular, study is required of the degree to which good performance in open PT correlates with blind PT performance, where laboratories are not aware that the samples being analysed are part of a quality assessment exercise.     

ISO 15189-accredited laboratories fulfill the JCI Hospital Accreditation Standard requirements for the use of referral laboratories: report of a consensus meeting

Accreditation of healthcare services is recommended to ensure operation according to the highest quality standards. Various initiatives, such as legislation or accreditation by ISO or JCI, may be active to support and improve quality. The growing trend toward JCI hospital accreditation raised the concern of redundancy between JCI requirements for the use of referral laboratories and the ISO 15189 accreditation for medical laboratories. This would result in needless administrative efforts for hospital laboratories to collect and maintain required documentation, as the JCI quality requirements would be guaranteed given that the referral laboratory is ISO 15189 accredited for those examinations. A consensus meeting was organized by the Working Group for Hospital Accreditation of the Belgian Zorgnet-Icuro network, the University Hospitals of Leuven and the Red Cross to discuss the avoidance of any redundancy between both standards and to issue best practice guidelines for referral laboratories. It was concluded that JCI measurable elements for referral laboratories are covered by the ISO 15189 accreditation scope. The article substantiates the consensus that JCI and ISO quality requirements are harmonized and that accurate knowledge and interpretation of prevailing quality standards are essential to avoid redundancy in quality measures.