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     

The NATA scheme for accreditation of certifiers of reference materials

 Certified reference materials are widely used for the calibration of measuring equipment and for the evaluation or validation of measurement procedures. The use of reference materials makes possible the transfer of the values of measured or assigned quantities between testing, analytical and measurement laboratories, both nationally and internationally. There is an increasing number of reference materials producers in other countries, and a demonstration of their scientific and technical competence is now more widely considered to be a basic requirement for ensuring the quality of reference materials. This article outlines recent activities by international bodies and their culmination in a scheme of accreditation of certifiers of reference materials which has been developed by the National Association of Testing Authorities, Australia (NATA).     

Quality assurance in clinical chemistry laboratories in the UK

 Since the mid-1960s quality assurance in clinical chemistry has progressed from a need to define and improve precision and accuracy in analytical test procedures to an all-embracing process of assuring that the whole process of pre-analytical, analytical and post-analytical phases of handling patient samples is managed effectively and efficiently. Automated and computer-controlled equipment has reduced many of the analytical errors, in particular in imprecision, that were present in manual analysis. New management techniques have been developed to control the quality and appropriateness of results. Developments in internal quality control and external quality assessment procedures have enabled laboratories to continually improve the quality of assays. Laboratory accreditation and external quality assessment scheme accreditation have ensured that peer review and peer pressure have been applied to both laboratory and external quality assessment scheme performance. As the NHS reviews its priorities and places more emphasis on primary care provider demands, hospital laboratories will of necessity assist with near patient testing outside the laboratory. This will provide new challenges to the quality of the service provided. Received: 2 July 1998 · Accepted: 1 August 1998     

How to achieve world-wide mutual recognition of calibration and test results – or: Who accredits the accreditor?

 The ongoing globalization of the economy demands cost- and time-effective conformity assessment procedures through mutual cross-border recognition of calibration and test results. Accreditation is an important tool to ensure the technical competence of laboratories performing calibrations and tests. The question, however, arises as to which mechanisms should be applied to achieve technical equivalence of accreditations throughout the world as a basis for mutual recognition of agreements. To avoid third party "accreditation of accreditors", accreditation bodies have established a specific procedure of regional technical cooperation in order to create a climate of confidence resulting in formal mutual recognition agreements. Key elements of this cooperation are the harmonization of operation procedures in addition to existing international standards, a continuos programme of interlaboratory comparisons, and an extensive procedure for mutual peer assessments. The present article provides detailed information on such cooperation within the European region as an example, describes the present situation with respect to mutual recognition agreements within Europe, and gives a brief look into the future with respect to inter-regional cooperation. Received: 28 September 1996 Accepted: 2 November 1996     

The experience of accreditation of an analytical laboratory at the Argentine Atomic Energy Commission

The implementation of a quality system based on the ISO/IEC 17025:1999 standard is a growing necessity for analytical laboratories to demonstrate their technical competence. In 2001, the Nuclear Analytical Techniques Group of the Argentine Atomic Energy Commission obtained the recognition of the International Atomic Energy Agency in the application of neutron activation analysis and the accreditation by the national accreditation body. The importance of the participation of the group in the Agency's Regional Programme for Latin America, ARCAL XXVI on Quality Assurance in Analytical laboratories is discussed, as well as the activities performed to attain these objectives. Some improvements worth mentioning resulted from the implementation of the quality system and, following the premise of continuous improvement, changes were introduced aiming at the laboratory re-accreditation.     

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 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.     

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     

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     

The view of IRMM on accreditation of CRM producers

This article describes the views of IRMM on accreditation of CRM producers and the philosophy which is behind these views. More specifically, it explains the reasons for choosing ISO Guide 34 rather than ISO/IEC 17025 as the basis document for the proposed accreditation of its CRM activites. Received: 27 May 2002 Accepted: 11 July 2002 Acknowledgements Information on accreditation programmes in Australia and USA provided by Maree Stuart (NATA) and Randall V. Querry (AL2A) is greatly acknowledged. Correspondence to J. Pauwels     

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.     

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。     

The Italian way: Accreditation and continuous quality improvement in clinical laboratories

 The transition from quality assurance of the analytical phase to the quality management of total testing in clinical laboratories is still at an early stage. But it has begun. Accreditation through voluntary, educational and professional schemes, like the Clinical Pathology Accreditation scheme, is a useful tool for following defined standards of practice and having these independently confirmed on the basis of a peer review. Approved clinical laboratories can obtain a hallmark of performance and offer reassurance to users of their services. However, accreditation does not guarantee an error-free service; it is not the final step, but an important stage in the improvement process. Quality is a journey and continuous quality improvement is the paradigm for better addressing our efforts to satisfy customers' expectations for the desired health outcomes related to a high-quality laboratory service.     

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 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.     

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.     

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.     

Practical experience of simultaneous accreditation and certification acquired in RIVM's official medicines control laboratories

 This article presents an overview of the practical experience acquired in two governmental medicines control laboratories in the Netherlands which combine the application of EN 45001 and ISO 9002 standards in the regulatory field of quality and risk assessment, and quality control of medicines and medical devices. This practical experience also includes simultaneous accreditation and certification. The EN 45001 standard was applied to laboratory testing activities and the ISO 9002 standard to non-laboratory file assessment activities as these activities are not covered by the scope of EN 45001. It appears that a combined application of these standards is practicable because they complement each other well. EN 45001 strongly emphasises technical competence. ISO 9002, on the contrary, emphasises more strongly the efficiency of the management processes and customer requirements. Received: 1 October 1998 · Accepted: 21 December 1998     

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.     

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