实验室的认可和质量管理体系的建立与运行

简要介绍了实验室认可的发展情况，开展实验室认可的必要性，实验室的质量管理体系的建立、运行及认证认可。     

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     

Laboratory accreditation in Italy for reference solution production of sucrose in water

The accreditation of Chemifarm srl laboratory for the calibration of two characteristics on the same aqueous solution has been achieved. The process has been executed by the Italian accreditation body for calibration laboratories (SIT). This is the first example of a producer of certified reference solutions in Italy. The solutions are mixtures of sucrose in water at several concentrations and are characterised for refractive index in the range of 1.33299 to 1.38115 and for mass fraction of sucrose in the range of 0 to 30 (commercially expressed in Brix degrees). Both traceability paths, obtained through refractometric and gravimetric methods, are reported. Furthermore, the paper describes the approach adopted to match the criteria based on ISO Guide 34 and ILAC-G 12, the documents with requirements for certified reference material producers, in compliance with those of ISO/IEC 17025, the norm for the laboratory accreditation.     

Laboratory accreditation: The operation of an established scheme

NAMAS, the National Measurement Accreditation Service, was formed in 1985 and has currently accredited some 1050 testing and calibration laboratories in the United Kingdom. NAMAS is managed by an Executive of 60 staff which is based at the National Physical Laboratory, one the UK's largest Government Research Establishments. Laboratories seeking accreditation are assessed by fully trained technical experts contracted by NAMAS, against the criteria set out in the NAMAS Accreditation Standard M10; the criteria contained in this document are fully consistent with the international standards for laboratory accreditation EN 45001 and ISO Guide 25. NAMAS has recently published a document which provides guidance on the interpretation of the NAMAS Accreditation Standard for analytical laboratories. Assessment involves a consultative preassessment visit which is followed by a thorough on-site assessment of a laboratory's quality system and testing activities by a team of expert assessors. Following the correction of any noncompliances found at the assessment, the laboratory receives a certificate of accreditation and a schedule which defines those tests and analyses for which the laboratory is accredited. NAMAS has negotiated a number of mutual recognition agreements with similar accreditation bodies in other countries and negotiations with other schemes are underway. The imminent approach of the European Single Market has highlighted the need for independent third party assurance of testing and calibration and this should ensure the continued growth of NAMAS and similar schemes elsewhere in Europe.     

NATA: 50 years experience with accreditation

 Laboratory accreditation is becoming increasingly accepted around the world as a means of identifying technically competent laboratories. It is also being used as a mechanism for the acceptance of test data both nationally and internationally. The concept and mechanisms of accreditation have been developed over the past 50 years. The first national laboratory accreditation system appeared in Australia in 1947. This organisation, known as the National Association of Testing Authorities (NATA), has since taken a leading role in developing accreditation practices that are now used world-wide in evaluating testing, measurement and calibration laboratories. This paper examines the development of the world's first and largest laboratory accreditation system, and looks at the difficulties and triumphs in gaining acceptance and recognition by government and industry of the benefits of laboratory accreditation. Received: 24 June 1996 Accepted: 25 June 1996     

Comparative analysis of laboratory accreditation in Bulgaria, Lithuania, Slovakia and Serbia and Montenegro

The development of an internationally recognized laboratory accreditation process, accompanied by a mutual recognition agreement (MRA), is an issue of great interest in Central and Eastern European countries. This paper presents a comparative analysis of laboratory accreditation in Bulgaria, Lithuania, Slovakia and Serbia and Montenegro. The basic analysis technique was preliminary laboratory accreditation assessment (PLAA). The analysis data were obtained via a questionnaire issued from January to June 2004, with the participation of accreditation bodies. Results from the study are presented in four sections: accreditation body standards, accreditation body organization, assessors and proficiency testing, and inter-laboratory comparisons. Research results for the countries were accessed using PLAA techniques and conformity/non conformity statements. The analysis verified that PLAA can provide low cost, rapid assessment of the key influencing factors in laboratory accreditation bodies.     

The role of an independent laboratory association in the standards,metrology, quality assurance and accreditation environment

Whilst there can be no doubt as to the benefit that an independent 3rd party conformity assessment accreditation body plays in ensuring the competency of results, personnel and processes, it is often at the expense of an adversarial relationship with the laboratory community it serves. A significant improvement in this relationship can be obtained by the formation and active participation by an independent laboratory association. This paper describes such an organisation, how it was formed, what role and the functions it currently performs and, most importantly, how it interacts with the national accreditation body and the stakeholders who are its members.     

实验室认可基础、评审方法与发展趋势

从什么是实验室认可和中国实验室国家认可委员会、实验室评审认可依据和基本要求、实验室认可过程、现场评审技巧和国内外发展趋势五个方面对实验室认可作了介绍,可为我国实验室逐步实现与国际接轨的规范化管理提供借鉴。     

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     

Laboratory authorization versus accreditation in transitional economies: case study of Serbia

Many CEE governments are still using various systems of laboratory authorization together with ISO/IEC 17025 laboratory accreditation. It is difficult to understand from the EU prospective, the existence of two parallel laboratory competence verification systems. The basic relations between laboratory accreditation and authorization: independence and succession have been defined. The case study of testing laboratory accreditation versus authorization in Serbia, has been presented and discussed. Relevant requests and procedures for water quality, food and air quality testing laboratory authorization were analysed in detail. Comparative analyses of accreditation and authorization have established: (i) independent relations, (ii) relevant regulation is in collision and barely legal, (iii) authorization is (technically) on the far lower level than accreditation is, and (iv) authorization requests cause high space and personnel costs. It has been concluded that it is not adequate to perform two policies at the same time: one EU oriented—laboratory accreditation, and one non-EU oriented—laboratory authorization. The policy proposal is that all CEE countries should abandon existing laboratory authorization procedures and replace them by accreditation. Proposed goal could be reached in rather a short transition process of 2–3 years.     

On the specific experience of national metrology institutes (NMIs) with national accreditation bodies (NABs)

The following paper addresses the experience of certain national metrology institutes (NMIs) with national accreditation bodies (NABs), in particular in small countries with emerging economies in new EU or candidate member states. Specific cases have been analysed primarily in some Central and South-East European countries. NABs under consideration are, in principle, members of European Co-operation for Accreditation (EA). EA cross-frontier policy in these cases will be discussed and resulting dilemmas outlined. Focus will be given to the problems of NMIs also performing calibrations, commercial calibration laboratories, and their relations with NABs. Due to numerous problems of smaller NABs, cross-frontier policy should stimulate cooperation between foreign and local accreditation bodies not only at the request of the calibration laboratory or some other conformity assessment body, but at the request of the local accreditation body in order to provide the best service for their local economy. As a solution to the accreditation problems, this paper proposes a process of gradual formation of a common European pool of experts, real-life common practices and, finally, maybe even some form of joint European accreditation service. The opinions expressed in the paper are personal statements of the author, and do not necessarily reflect the official opinions of the institutions of the author. Papers published in this section do not necessarily reflect the opinion of the Editors, the Editorial Board and the Publisher.     

Use of ISO Guides 25, 30, 31, 34, 35, and 9001 in re-engineering Bethlehem Steel Corporation's analytical chemistry reference materials program

 Many certified reference materials are needed to calibrate and control analytical measurement processes in integrated steel works. It is beyond the scope and capacity of most national laboratories to supply all of these needs. Yet, the demand for these materials is steadily increasing as more steel producers update their quality systems in preparation for ISO 9000 registration and/or ISO Guide 25 laboratory accreditation assessments. This paper describes how the Bethlehem Steel Corporation updated its reference materials program to meet its internal needs and offers a model for use by others in improving their programs. Received: 22 April 1998 · Accepted: 12 May 1998     

Flexibilization of the scope of accreditation: an important asset for food and water microbiology laboratories

Beltest, the Belgian accreditation body, has investigated flexibilization of the scope of accreditation for chemistry laboratories and food and water microbiology laboratories. This flexibilization, synonymous with test-type accreditation, allows a laboratory to add new test methods or retry previous test methods without having to undergo a new audit by Beltest. It has been used for nearly ten years by German and Swiss accreditation bodies. Flexibilization permits the validation of methods and results, given that the competence of the particular laboratory is already well established. This new concept in microbiology allows client’s needs to be adequately met, and facilitates the quick establishment of a method in several laboratories at once in case of a public health crisis. The first laboratory to participate at this investigation on the flexibilization concept, as a test of the concept, was the Belgian reference laboratory for food microbiology.     

Accreditation system for reference material producers and certified reference materials for iron and steel in Japan

  ISO 9000 series strictly requires traceability to national or international measurement standards. It is becoming more necessary to make clear the concept of traceability of measurement standards with respect to chemical composition and to accredit the reference material producers. In Japan, the accreditation system for reference material producers is considered to satisfy the requirement of ISO Guide 34, ISO 9000 series and ISO/IEC Guide 25, while the producer fulfills the concept of traceability of measurement standards. This paper describes the production of iron and steel reference materials in Japan relating to the international standardization of methods (written standards) and accreditation of reference material producers. Received: 11 October 1996 Accepted: 5 December 1996     

Accreditation of PT providers – is it worth the money?

This topic is being presented from two perspectives, namely the views of an accreditation body and those of an accredited provider of external quality assessment schemes. The first perspective, from an accreditation body, is based on the experience of Australia's national laboratory accreditation body (NATA), which has accredited fourteen proficiency testing (PT) providers and is currently processing an application from another. The second perspective is based on the experience of EQUALIS, the national quality assurance organisation for laboratory medicine in Sweden, which was granted accreditation in 2002.Presented at 5^th Eurachem Workshop on Proficiency testing in analytical chemistry, microbiology and laboratory medicine, Portorož (Slovenia) 25–27 Sept 2005     

Accreditation of types of tests

 DACH, the German accreditation body of chemistry, which was founded in 1992, has introduced a new model for the flexibilization of the scope of accreditation. This ensures that the accreditation of a laboratory also guarantees flexibility. Flexibilization of the scope of accreditation is of great importance, in particular if a great number of similar routine tests (standard methods) or non-routine tests are to be accredited. The main tool of flexibilization is the accreditation of types of tests. The accreditation of types of tests entitles laboratories to include additional test methods within the type of test accredited without informing the accreditation body immediately. Such information is provided at fixed surveillance intervals. The conditions for the accreditation of types of tests are described below.     

The necessity for harmonisation of accreditation and recognition of testing laboratories, inspection bodies and certification bodies in the regulated and voluntary areas

 There have been two essential developments in current accreditation practices. One tends towards a flexible confirmation of competence of the testing laboratory for the adaptation of existing test methods and the development of new test methods. The other development attempts to assess and confirm the testing activity in terms of concrete processes for a specific application. These polarised tendencies, both in the preparatory work of the testing laboratory and in the assessment activity of the accreditation body, lead to increased costs. This paper examines the necessity for a harmonisation of these opposing sets of requirements by means of a categorised synopsis, citing actual examples. Efforts made to bring about such a harmonisation have, up to now, hardly progressed beyond first attempts and declarations of intention.     

Can single-operator laboratories comply with all of the requirements of ISO/IEC 17025:2005?

ISO/IEC 17025:2005 states that its requirements are “applicable to all laboratories regardless of the number of personnel” and would therefore include single-operator laboratories. However, there are reservations as to whether these laboratories can comply with all of the requirements without jeopardizing independence of judgement and impartiality. Similarly, there are some requirements of ISO/IEC 17025:2005 including staff supervision, internal communication processes and appointment of deputies that are considered unlikely to apply to a single-operator laboratory. The ISO/IEC 17025:2005 is widely used as the international standard of quality assurance by which accreditation bodies assess the competency of testing and calibration laboratories. There does, however, appear to exist, disagreement amongst accreditation experts when considering single-operator laboratories. Some accreditation bodies accredit single-operator laboratories, whilst others require additional human resources prior to granting accreditation. This discrepancy leads to unfair competition amongst laboratories as a single-operator laboratory by definition needs less resources (both human and financial) to achieve and maintain accreditation, compared with a laboratory where additional human resources need to be sought prior to and in order to maintain accreditation. The ISO/IEC 17025:2005 is in the process of being revised, and this is an opportune moment to address the issues aforementioned with the aim of removing ambiguity and enhancing clarity. In addition, the hope is to assist the accreditation bodies themselves to adopt a consensus approach when granting accreditation towards single-operator laboratories.     

Assuring the reliability of mass spectrometry for the routine determination of traces of doping in horse-urine

Summary This paper describes an analytical method using a nuclear-related technique for the detection of forbidden doping substances in the urine of race horses. The proposed method, adapted from the Méthode Alcaline Sur C-18 developed by the French Laboratoire de Contr?le Antidopage, is based on gas chromatography separation followed by mass spectrometry (GC-MS). The method was validated for caffeine, identified as the most frequent doping substance in the Brazilian horseracing activity. This validation is also a major requirement to achieve ISO/IEC 17025 laboratory accreditation. The validation has led to several metrological challenges because the decisions are largely based on qualitative results (“false-positive” and/or “false-negative”) and the degree of accuracy, as well as the traceability had to be determined in the absence of certified matrix reference materials.     

The ILAC Arrangement – Part I

As of August 2001, 38 laboratory accreditation bodies of the International Laboratory Accreditation Cooperation (ILAC) have signed the multi-lateral, mutual recognition arrangement (the ”ILAC Arrangement”) to promote the acceptance of accredited test and calibration data. This Arrangement provides significant technical underpinning to international trade. Until now, there has been no international mutual recognition agreement in laboratory accreditation, which has been a hindrance for some types of international trade. The key to the Arrangement is the developing global network of accredited testing and calibration laboratories that are assessed and recognised as being competent by ILAC Arrangement signatory accreditation bodies. The signatories have, in turn, been peer-reviewed and shown to meet ILAC’s criteria for competence. Now that the ILAC Arrangement is in place, governments can take advantage of it to further develop or enhance trade agreements. The ultimate aim is increased use and acceptance by industry, as well as government, of the results from accredited laboratories, including results from laboratories in other countries. In this way, the free-trade goal of ”a product tested once and accepted everywhere” can be realised.