Developments in accreditation of flexible scopes in Europe

Accreditation of testing and calibration laboratories is the most frequently used type of accreditation. European Co-operation for Accreditation (EA) as the European network of recognised national accreditation bodies covers accreditation of all types of conformity assessment bodies. In Europe, the number of accredited testing and calibration laboratories covered under the EA Multilateral Agreement is about 15,000 nowadays.     

The development of a National Accreditation System in South and Southern Africa

 In South African industry there is a strong appreciation of Quality Assurance. More than 1400 companies have been certified as complying with ISO 9000, and this, of course, has resulted in a strong demand for accredited calibration and test facilities. Work on the development of a national calibration service started in 1976, and the South African National Calibration Service (SANCS) was inaugurated in 1980 with 13 calibration laboratories. The early maturity of the SANCS can be judged by the fact that by 1984 it had the technical capability to establish a mutual recognition agreement with a European country. It now has a total of some 191 accredited laboratories, 139 calibration laboratories and 52 testing laboratories. In 1993, the SANCS signed mutual recognition agreements with the CNLA (Taiwan) and the European Co-operation for the Accreditation of Laboratories (EAL). In 1994 it entered the field of testing laboratory accreditation and is already experiencing a strong influence therefrom, and in 1997 it changed its name to National Laboratory Accreditation Service (NLA). In May 1995, the NLA was appointed by the Department of Trade and Industry to establish a South African National Accreditation System (SANAS). Progress with this work up to the present time has been substantial.     

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.     

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.     

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。     

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.     

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.     

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.     

The lead assessor role in the ISO/IEC 17025:2005 accreditation of Brazilian calibration and testing laboratories by the General Coordination of Accreditation (Cgcre)

This work describes the human resources organization of the General Coordination for Accreditation (Cgcre) in Brazil, in which lead and technical assessors, both internal and external to the National Institute of Metrology, Quality and Technology (Inmetro), assess the competence of calibration and testing laboratories to the ISO/IEC 17025:2005 standard. The “Lead Assessor Project” is presented, which consists of an increase in the responsibilities of lead assessors, in such a way that the Division of Laboratories Accreditation (Dicla/Cgcre) can cope with the increasing demand for ISO/IEC 17025:2005 accreditation of Brazilian calibration and testing 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.     

Accreditation in the United Kingdom: responding to needs or 'changing the goalposts'?

 The requirements for establishing the competence of organisations involved in testing, calibration, certification and inspection, and the criteria for their assessment and accreditation are specified in international guides and European standards. As these guides and standards are intended for use by a range of organisations and accreditation bodies, operating in different disciplines, they are written in general terms in order to be widely applicable. It follows that some interpretation of the requirements is needed in order to address the different ways in which both organisations and accreditation bodies operate. This may be seen by accredited organisations as providing an opportunity for accreditation bodies to 'change the goalposts'; the needs of these organisations and of their clients must be accommodated as far as possible, without diminishing the value of, or undermining confidence in, accreditation. The United Kingdom Accreditation Service has been listening to its customers, reviewing its activities and is offering a more flexible pragmatic approach to assessment and accreditation; some of the new developments are described.     

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     

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.     

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.     

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.     

Accreditation of pathology laboratories in Finland

 The Finnish Accreditation Service (FINAS) accredits testing laboratories in all fields including medical laboratories according to European standard EN 45001 and ISO Guide 25. At the beginning of 1998, FINAS published a recommendation on how to apply general standards in histo- and cytopathology. Four pathology laboratories have been accredited to date. FINAS has not included autopsies in these accreditations. The International Academy of Pathology (IAP)-Finnish Division has recognized 21 pathology laboratories according to standards of their own. Although accreditation by FINAS is not connected to the system of the IAP-Finnish Division, the requirements are very similar in both. Less than half of the pathology laboratories in Finland participate in national quality improvement programme or have been accredited by FINAS.     

The flexible scope of accreditation

The scope of accreditation for testing laboratories can inhibit, in certain cases, their quick response to customers needs, if the scope is too rigid with regard to the modification of test methods and the introduction of new ones using the same measurement principles. Document EA-2-05 published by the European Cooperation for Accreditation describes possibilities to allow flexibility in accredited laboratories. Several examples of a flexible scope are given.     

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.     

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.