Setting a precedent in international accreditation

 The accreditation procedure that the Department of Laboratory Sciences, CHPPM-Europe underwent is described. The laboratory obtained ISO/IEC 25 accreditation through the American Association for Laboratory Accreditation (A2LA) and the Deutsches Akkreditierungssystem Prüfwesen (DAP) as well as EN 45001 from DAP following the A2LA and DAP joint inspection. The accreditation process and the importance of obtaining national and international accreditation are discussed. Received: 30 May 1997 · Accepted: 16 June 1997     

How IAF and ILAC manage the recognition of Regional Accreditation Groups: the peer evaluation system of IAF and ILAC for Regional Accreditation Groups

The peer evaluation of single accreditation bodies in order to sign an Arrangement for Recognition of the international accreditation organizations International Accreditation Forum, Inc. (IAF) and International Laboratory Accreditation Cooperation (ILAC), whether performed by Regional Accreditation Groups or directly by IAF and/or ILAC, is standard practice. The fundamental requirements for such evaluations are well specified in documents. However, the careful evaluation of all their Arrangement members poses an enormous logistic task for IAF and ILAC, and the signatories can be evaluated more thoroughly within their Regional Groups. Hence, IAF and ILAC typically evaluate only the Regional Accreditation Groups and accept all signatories of a Regional Accreditation Group once successfully evaluated by their respective Regional Group. However, the requirements for the evaluation of a Regional Group are extensive, and the evaluation procedure is highly complicated and must be conducted very carefully in order to assure that the results of accreditation can be trusted. This article describes the evaluation procedure used by IAF and/or ILAC for Regional Groups wishing to sign the IAF/ILAC Arrangement. We wish to inform and to aid these Regional Groups setting out for evaluation, and also to build confidence in the IAF/ILAC Arrangements.     

The American (USA) perspective six years after implementation of CLIA'88 (Federal) regulations

 On September 1, 1992 all testing sites in the United States were required to comply with the Clinical Laboratory Improvement Amendments of 1988 (CLIA'88). These regulations, based on both total quality management (TQM) and continuous quality improvement (CQI) principles, reshaped the environment for more than 90% of laboratories. CLIA'88 represented a revolutionary change by imposing universal, uniform regulations based on test complexity for all sites examining materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of disease. CLIA'88 specifies minimum requirements for personnel, quality control, and proficiency testing (PT). In addition, laboratories are required to follow manufacturers' directions and comply with other specified good laboratory practices. PT is mandated for most of the frequently run analyses and quality assurance requirements integrate the principles of CQI as well as TQM into the regulatory process. Biannual inspection is integral to CLIA'88, however, laboratories can choose other federally approved ("deemed") professional organizations, such as the Commission on Office Laboratory Accreditation, the College of American Pathologists, or the Joint Commission on Accreditation of Healthcare Organization, having standards that meet or exceed those of CLIA'88. CLIA'88 has still not been finalized. This article discusses the impact and changes since CLIA's implementation in 1992. Received: 5 October 1998 · Accepted: 20 October 1998     

Accreditation of calibration laboratories to normative documents: diversity or standardization

Calibration of measuring equipment is conducted by following some normative or applicable documents such as standards, manufacturer manuals and instructions, technical orders issued by defense organizations, or scientific papers. An accreditation body provides its recognition to the calibration laboratories by evaluating their technical competence and their compliance with the quality requirements of ISO/IEC 17025. The accreditation body must have defined criteria in order to evaluate different calibration methods which should ensure that the laboratories are performing the calibration in a technically competent manner when they are fully or even only partially based on the relevant reference documents. A discussion with different points of view about choosing the criteria, as well as the Israel Laboratory Accreditation Authority (ISRAC) policy on this issue, are presented.Presented at the 2nd International Conference on Metrology – Trends and Applications in Calibration and Testing Laboratories, November 4–6, 2003, Eilat, Israel.     

APLAC interpretation and guidance on the estimation of uncertainty of measurement in testing

The Asia Pacific Laboratory Accreditation Cooperation (APLAC) is the organization representing the community of bodies that accredit testing and calibration laboratories throughout the Asia Pacific region, including China and North America. APLAC members assess the competence of laboratories and grant them accreditation. They also provide mutual recognition of the equivalence of their accreditations, which facilitates international trade and acceptance by regulators. Harmonization of accreditation requirements is therefore vital to maintaining Mutual Recognition Arrangements. APLAC establishes management and technical criteria for accreditation and publishes guidance documents for accreditation bodies and laboratories.     

Accreditation for United States environmental laboratories

 There is currently no national program for recognition of United States environmental laboratories. This situation should change sometime in 1998 as environmental testing laboratories should be able to apply for accreditation in the United States via a system developed by the National Environmental Laboratory Accreditation Conference (NELAC). NELAC is an organization whose purpose is to establish performance standards for accrediting environmental laboratories. Laboratories to be accredited will be required to demonstrate qualifications of testing personnel, pass on-site inspections, perform satisfactorily on proficiency test samples, and meet specified quality assurance standards.     

Reference materials in the Russian system of accreditation of analytical laboratories

 This article is devoted to the role of reference materials (RMs) in chemical analysis and their main applications in analytical laboratories. The principal requirements of the RMs used in accredited laboratories in the Russian Analytical Laboratories Accreditation System (SAAL) are presented. These include the basic regulatory and metrological requirements of RMs. Finally, a review of the provision of RMs used for the analytical control of various test objects is presented. Received: 9 August 1998 / Accepted: 9 November 1998     

Introduction of Japan Chemical Laboratory Accreditation

 Japan Chemical Laboratory Accreditation (JCLA), a new accreditation body in chemical fields was established and the activities and organization of JCLA are outlined.     

Accreditation of reference material producers: the example of IRMM's Reference Materials Unit

The potential approaches for third-party assessment of reference material producers are revisited and the activities of the Reference Materials (RM) Unit of the Institute for Reference Materials and Measurements (IRMM) to obtain accreditation to ISO Guide 34 and ISO 17025 are described. Accreditation was related to the Unit as all matrix RM activities of the institute are concentrated there. A management system was established that allows sufficient flexibility to be applicable to a wide range of RMs while being precise enough to ensure compliance with ISO Guides 30, 31 and especially 34 and 35. Accreditation was achieved in 2004 with independent scopes for testing and RM production and was confirmed and extended in 2005. The key aspects of the RM Unit's management system for RM production are presented. Presented at BERM-10, April 2006, Charleston, SC, USA     

The Japan Accreditation Board for Conformity Assessment – Introduction to the Japanese accreditation system

 The background to the establishment of the Japan Accreditation Board for Conformity Assessment (JAB) is reviewed in relation to the latest global developments in conformity assessment activities. JAB (known as the Japan Accreditation Board for Quality System Registration at the time of its establishment) was established in 1993 as the accreditation body for quality system registration, the focal point for conformity assessment in the private sector in Japan. The extension of the area of accreditation was made in June 1996, covering all conformity assessment activities including laboratory accreditation, which resulted in the amendment of the name of the body to the current one. Various elements of the laboratory accreditation program are introduced to give the overview of this new program. Received: 2 October 1996 Accepted: 5 December 1996     

Aspects of auditing in clinical laboratories

Quality and patient safety are terms that both providers and recipients of healthcare are very familiar with. Accreditation is another term that is closely linked to quality and patient safety. Audit is a systematic, independent, and documented process for obtaining evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled. Accreditation and audit are integral components of the same process. Three different types of audit are well recognized—internal, external, and co-operative. Reading of relevant documents, observation of laboratory practices, and asking open-ended probing questions are important auditing techniques. For auditing to be successful, experienced, qualified, and well trained auditors are essential. Furthermore, the auditor should be open-minded, not prejudiced, a team player and effective communicator, both in writing and verbally. In many instances, the emphasis for seeking laboratory accreditation has shifted from building quality systems—to produce reliable results and ensure patient safety—to just passing the inspection. Recently, the emphasis for laboratory quality improvement has been placed on pre and post-analytical processes in preference to analytical quality. The analytical quality of laboratory results is still far from ideal and it may be detrimental if less emphasis is placed on this aspect of laboratory medicine. Auditing or on-site inspection as a regulatory tool does not work or present a realistic picture of laboratory quality. A continuous quality improvement approach will help laboratories to build quality into their systems. Presented at the Conference “Excellence in Laboratory Medicine”, November 2007, Al Ain, United Arab Emirates.     

Development of laboratory accreditation in the United States

 Laboratory accreditation in the United States is an old profession. Users and regulators have, it seems, been concerned about the quality of test data they obtain from laboratories for well over half a century. These users have developed many different systems to meet their needs. As a result, there is much duplication of effort and overlapping in accreditation requirements and many laboratories have to maintain current accreditation from a number of organizations. A number of attempts have been made over the years to reduce this duplication, but it still remains. In the meantime, rapid progress has been made internationally to recognize laboratory accreditation systems in different countries. This paper describes this situation and speculates on the future, considering the international thrust to simplify and consolidate conformity assessment procedures. Received: 26 May 1998 · Accepted: 6 June 1998     

Results of the 16th proficiency test on the determination of pesticide residues in olive oil

Accreditation and Quality Assurance - The Italian National Reference Laboratory (NRL) for pesticide residues yearly organizes proficiency tests (PTs) on olive oil in cooperation with the...     

Upgrading the Iranian national laboratory standard to conform to ISO 15189:2012

Accreditation and Quality Assurance - The Reference Health Laboratory (RHL) of Iran is the national authority responsible for making policies and plans for providing quality laboratory services...     

The Operational System of National Accreditation of Laboratories in China

This document gives a brief introduction to CNACL (China National Accreditation Committee for Laboratories). Laboratory accreditation in China is integrally administrated by the China State Bureau of Quality and Technical Supervision, a government administrative department of China State Council, which authorizes CNACL to implement Chinese laboratory accreditation activities. CNACL was established on September 20, 1994. It is a full member of both ILAC (International Laboratory Accreditation Cooperation), and APLAC (Asia Pacific laboratory Accreditation Cooperation), and signed the APLAC MRA (Mutual Recognition Arrangement) in New Delhi, India on December 3, 1999. CNACL carries out laboratory accreditation activities in full compliance with international general criteria. Its operation complies with ISO/IEC Guide 58 (1993), ISO/IEC 17025 (1999), ISO/IEC Guide 43 (1997) and other international standards.     

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.     

Metrological traceability in laboratory medicine

 The establishment of a reference examination system necessary for metrological traceability of the many types of sophisticated examination result in laboratory medicine is a daunting task, which has been made mandatory by the EU Directive on in vitro diagnostic medical devices and the requirements for accreditation. Following a definition of examinand and allowed examination uncertainty, a dedicated calibration hierarchy is established from stated reference through alternating reference examination procedures and calibrators providing a traceability chain from examination result to the reference, often a definition of a measurement unit. The various types of possible calibration hierarchy are outlined in EN ISO Standards. Recent efforts by national and international stakeholders to establish a global reference examination system have led to the creation of a Joint Committee on Traceability in Laboratory Medicine with the International Committee for Weights and Measures, International Bureau of Weights and Measures, International Federation of Clinical Chemistry and Laboratory Medicine, International Laboratory Accreditation Cooperation, and World Health Organization as the principal promoters. This structure will identify reference procedures, reference materials, and reference laboratories, and seek support for further prioritised and coordinated development of the system. Received: 1 August 2002 Accepted: 22 November 2002 Based on a lecture at an IUPAC Seminar, EC JRC Institute for Reference Materials and Measurements, Geel, BE, 2001–12–18 Correspondence to R. Dybkaer     

Accreditation to ISO 17025:2005 for the Radioactivity Metrology Group of the UK’s National Physical Laboratory

In the mid 1990s, the National Physical Laboratory (NPL) took the decision to seek external accreditation to the then UK national accreditation standard (M10, M10 supplement and M11) through the NPL’s National Measurement Accreditation Service (NAMAS). This paper details the reasoning behind that initial decision and, in particular, how this impinged on the day-to-day activities of the NPL’s Radioactivity Metrology Group (RMG). In the intervening decade, the accreditation standard has changed considerably; accreditation is now to the international standards ISO 9001:2000 (Quality Management Systems: Requirements) and ISO 17025:2005 (General Requirements for the Competence of Testing and Calibration Laboratories); accreditation is now carried out by a wholly separate successor organization to NAMAS, the United Kingdom Accreditation Service (UKAS). To meet the new accreditation requirements the RMG: realigned it’s scope of work; streamlined and consolidated written procedures, references and appendices; centralized the collection of written procedures, and clarified the document identification system. Future developments will include efforts for RMG accreditation for conducting proficiency tests and providing reference materials.     

The practical advantages of hospital quality systems such as NIAZ/PACE

 The Netherlands Institute for Accreditation of Hospitals (NIAZ) was established at the end of 1998. It was founded by the PACE foundation, the Society of University Hospitals, the Netherlands Association of General Hospitals and the Society of Medical Specialists in the Netherlands. Since then in the Netherlands 19 pilot accreditations have been performed based upon 35 NIAZ-PACE standards for hospital departments and functions, and the overall standard 'quality system'. The aims and methods of the accreditation system were inspired by examples from the other side of the Atlantic, especially from Canada. The characteristics are: voluntary-based, self-evaluation, peer-review and aiming at continuous improvement of quality of care. Received: 15 April 2000 · Accepted: 15 April 2000     

Research on the electrochemistry of oxygen ion conductors in the former Soviet Union. I. ZrO2-based ceramic materials

Developments of solid electrolytes and mixed conductors based on stabilized zirconia in the former Soviet Union are reviewed. Primary attention is given to experimental data on high-conducting electrolytes, mixed conductors obtained by doping zirconia with transition metal oxides, oxygen exchange and oxygen permeation processes, as well as properties of metal electrodes in contact with the stabilized zirconia. Received: 26 March 1998 / Accepted: 4 June 1998