Pathology laboratory accreditation: the Australian experience

 The National Associating of Testing Authorities, Australia (NATA) is a laboratory accreditation company that has been involved in the accreditation of pathology laboratories since 1982. This role is carried out in conjunction with the Royal College of Pathologists of Australasia (RCPA). The accreditation process is known as the NATA/RCPA scheme. The NATA/RCPA accreditation scheme originated from the desire to raise professionalstandards in pathology. The scheme aimed to achieve this through a peer review process in which education and voluntary participation were stressed. In 1986, the Australian Federal Government adopted the scheme as its measure of the competence of testing by pathology laboratories seeking payment from the Commonwealth Department of Human Services and Health reimbursement scheme, Medicare. This meant that NATA/RCPA accreditation became mandatory for such laboratories. The benefits of peer review as a means for establishing professional competence and the challenges a mandatory accreditation program poses to such a scheme will be discussed. Received: 6 May 1996 Accepted: 29 May 1996     

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 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     

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.     

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.     

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.     

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     

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。     

A survey of non-conformances raised during accreditation inspections of medical laboratories in South Africa.

Under the auspices of the South African National Accreditation System (SANAS) the South African medical laboratory accreditation programme was established in June 1999. This study reports the non-conformances identified during the assessment of 103 medical laboratories in South Africa between September 1999 and December 2001. Laboratories were assessed by SANAS, which is the single accreditation body in the Republic of South Africa. All documentation relating to the assessment of each laboratory was reviewed in detail by the authors to identify the numbers and classification of non-conformances under each of the 25 points of the check list. A total of 862 non-conformances were raised. The top five non-conformances identified were (1) quality management system, (2) test methods, (3) records and (4) quality control and laboratory safety. The deficiencies identified in South African medical laboratories should be viewed in a positive light and promote a culture of continuous quality improvement with appropriate allocation of resources. SANAS should continue to align its requirements and procedures relating to accreditation of medical laboratories with those of their international counterparts with whom mutual recognition agreements/arrangements exist.     

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     

Revision of ISO guide 25

 ISO/IEC guide 25 is the internationally recognised base document for the accreditation of laboratories. Laboratory accreditation is a system of peer assessment and a formal recognition that a laboratory is competent to perform specific tests or types of tests ISO/IEC guide 25 plays a fundamental role in the life of the analytical chemist and is pivotal to the acceptance of the philosophy "once tested everywhere accepted" and to ensuring the mutual acceptance of test data. Within the EU, the attainment of accreditation to ISO/IEC guide 25 has become a way of life and it is now mandatory for laboratories engaged in certain regulatory work areas. Guide 25 is currently under revision and over the past 2 years or so it has been the subject of much debate among the calibration and testing community and it has engendered a considerable amount of written and oral comments. The latest revision entitled "Draft International Standard ISO/IEC DIS 17025: General Requirements for the Competence of Testing and Calibration Laboratories" was circulated to national standard organisations for their "comment and approval" in mid 1998. Voting on this document commenced on 9 July and terminates on 9 December 1998. It is anticipated that a final draft could be circulated in 1999. In accordance with the Vienna agreement this is a parallel ISO/CEN enquiry. This paper will discuss the implications of the technical requirements of the current document for analytical chemistry with particular emphasis on, the strengths, weaknesses and deficits inherent in the draft circulated in July 1998.     

The German accreditation system

 In response to the requirements of the "Global Approach" in Germany, a national accreditation system has been established based on traditional experiences in the recognition of the competence of laboratories and certification bodies. In 1991, the German Accreditation Council (DAR) was founded as a coordinating body supported by the Federal and State Ministries and German industry. In this way, it was possible to organise coordinated representation in international bodies, to offer a forum for cooperation between authorities and industry, and to provide for a structure subdivided into sectors which better fits the needs of the industrial sectors and gives them the necessary transparency and acceptance. The DAR itself does not carry out accreditations. This is done by the accreditation bodies represented in the DAR and specialised in for specific subjects, thereby having a close connection with expert groups of a high technical competence in their specific technical fields. At the end of this paper, the procedure for the assessment of the technical competence of a laboratory, an important part of the accreditation, is described.     

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。     

QASKI – the quality assurance system of the National Institute of Chemistry

 The quality assurance system (QASKI) developed and implemented in the National Institute of Chemistry is presented. It tries to eliminate the incompatibilies between the present methods of quality assurance used in research and development institutes such as good laboratory practice and accreditation. Since 1991, QASKI has been used for internal accreditation of laboratories located in the institute, regardless of the fact that some of them deal with routine analyses and others with research and development. Every laboratory that wishes to ensure the credibility of its research or routine work enters QASKI and at the same time chooses an external method of approval. All interested laboratories, study directors, principal investigators, internal auditing staff, heads of documentation, quality assurance unit staff, the Director of the institute and the Quality Management Board participate in the internal system.     

Approach to Quality System in Research and Development

 There is growing interest in developing a general strategy and quality standards for possible accreditation or certification of R&D laboratories. This article discusses the scope and limitations of Quality Systems in R&D activities. The extension of QA to R&D centres in general requires emphasis on project management and scientific competence in addition to quality management and technical competence. Received: 11 September 1996 Accepted: 13 November 1996     

Accuracy and reliability of radiometric measurements – results of a laboratory proficiency test with labelled sediment

 In 1995, a laboratory proficiency test was carried out in Germany with labelled sediment which was analyzed by 40 participants (operators of nuclear power plants, officially authorized institutions of the German Federal States, and laboratories of research centers). Preparation and certification of the labelled material were described in detail. The deviations of the laboratory means from the corresponding certified reference values of ten radionuclides were determined. Outliers of type 2 were recognized by means of the Grubbs test and eliminated. The consistency of laboratory means and reference values was tested by a modified t test. To describe the reliability of the measurements performed, a radioanalytical quality index which has been defined elsewhere was used. By use of this index, the radioanalytical quality of laboratory means and the means of laboratory means could be evaluated and a very realistic picture of the "state-of-the-practice" of the participating laboratories obtained. In some cases, it was possible to identify systematic errors and to explain their causes by physical phenomena. Received: 11 June 1996 Accepted: 14 September 1996     

Review of European Union requirements: quality standards for food analysis laboratories

 The European Union has prescribed strict quality standards for official food laboratories and the methods of analysis to be used in laboratories when carrying out official food control work. These requirements, which are based on accreditation, participation in proficiency testing schemes and using validated methods of analysis, are described in detail. The similar approach being taken within the Codex Alimentarius Commission is also outlined. The procedures prescribed will ensure that official food control laboratories have in place the measures to ensure that consistently reliable data can be produced. Received: 29 November 1995 Accepted: 8 January 1996     

The Slovak National Accreditation System

 After the split of the Czechoslovak Federation, the Slovak National Accreditation System was established in November 1993, being the only system in this country executing accreditation and certification. This system is strictly based on EN 45 000 and covers testing laboratories from both the mandatory and voluntary areas of metrological laboratories, products testing and certification, quality systems, and good laboratory practice. It seeks to reach the level of compatibility accepted and recognized by EU member countries. The development and basic features of the Slovak National Accreditation System, its basic principles, and the structure and competence of accreditation bodies are described in this article.     

Accreditation of proficiency-testing schemes in The Netherlands

Proficiency testing by laboratories, national accreditation bodies, and other third parties is becoming more and more considered as a standard and integral part of the quality control system. Therefore, it is of utmost importance that the quality of the provided proficiency-testing (PT) service is outstanding. If PT-schemes are set up in order to help laboratories monitor and improve their quality, PT-schemes need not only be of high quality themselves, but the organizer also needs to be able to demonstrate this. In The Netherlands formal accreditation of the organization of proficiency testing schemes is used as a tool to guarantee high quality schemes and also to enable organizers to demonstrate their competence. Since 1996, the Dutch Council for Accreditation (RvA) has used the ISO-Guide 43–1 to assess PT-organizers in The Netherlands. From January 2000, the ISO-guide 43–1 was replaced by the ILAC G13 document for assessing organizers. Up till now, four institutes have been accredited by the RvA for the organization of PT-schemes.     

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.