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.     

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.     

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.     

EAL interlaboratory comparison Wa1 – Testing of potable water

 The accreditation of laboratories has emphasized the use of interlaboratory comparisons as a tool to monitor the comparability and accuracy of results laboratories produce. An interlaboratory comparison for water laboratories was organized among European Cooperation for Accreditation (EA) member countries; 30 laboratories, 7 of which were not accredited, from 14 European countries participated in this intercomparison. All the laboratories were chosen by the appropriate national accreditation bodies, with the instruction to select as participants those laboratories which act as national reference laboratories in this field. About 90% of the data collected was considered satisfactory after statistical treatment. Non-accredited laboratories performed as well as accredited laboratories. The laboratories were asked to take corrective action and report the corrections to the accreditation bodies. A great variation in the reported uncertainties of the results was observed. There seems to be a need to organize EA interlaboratory comparisons for national reference laboratories analysing water. It is obvious that even reference laboratories need training in how to estimate the uncertainty of results. Received: 22 July 1998 · Accepted: 21 September 1998     

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.     

Accreditation of GMO detection laboratories: Improving the reliability of GMO detection

Reliable and efficient methods for detecting genetically modified organisms (GMOs) are essential for establishing an effective system for traceability all along the supply chain from seed producers to final consumers. The latter is especially meaningful in European Union and other countries where strict legislations on GMOs were set up. Performance of the methods used in laboratories around the world should be uniform, in order to obtain reliable and comparable results. Accreditation is a suitable system for harmonising procedures in each testing laboratory. In this paper, key elements for the accreditation of molecular biology methods for GMO detection according to ISO/IEC 17025 are described. The procedures described are also valuable for the accreditation of molecular methods for all laboratory diagnostics where qualitative and quantitative characterisation of nucleic acids is needed.     

Accreditation and authorization in environmental analysis

 Since 1989 testing laboratories in Europe have had the possibility to confirm their competence in carrying out certain testing procedures by means of accreditation. Over the years an independent European Accreditation system has been developed, which many member states of the European Union have joined. The existing accreditation organizations joined to form the unified organization EA (European Cooperation for Accreditation) in 1997. Members of this organization are, inter alia, one representative of the accreditation authorities of each of the member states. The German accreditation system is different to the European system in that it is split. Here, we differentiate between the sector established by law and that which is not. Both sectors, however, pursue the same goal. Because of this double certification of competence and the resulting multiple reviews, German testing laboratories face a considerably greater load in comparison to their European colleagues. Several authorities are already working on the removal of this split accreditation system. The efforts must, however, be concentrated and brought into line. Efforts by the DAP and DACH for flexible accreditation and the creation of a standardized registration authority for testing laboratories in the field of workplace measures are examples of how the German accreditation system could develop in the future.     

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.     

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     

Regional cooperation in proficiency testing: strategy planning and practical experiences in Western Balkan countries

The article describes the project of regional cooperation in proficiency testing within CARDS 2006 (assistance programme to the Western Balkans), which was coordinated by European Committee for Standardization, European Commission and European Free Trade Association and conducted by the University of Ljubljana, Faculty of Electrical Engineering, Laboratory of Metrology and Quality. The later is the holder of the national standard for thermodynamic temperature as well as an accredited proficiency testing provider and also accredited as a calibration, testing and inspection laboratory. It is also responsible for graduate study programme Quality Engineering. Proficiency testing was considered as a core activity of the entire project, but additionally as a very appropriate platform for knowledge transfer of EU technical legislation in selected sectors, metrology, testing and quality assurance in general. The project had a high added value for participating laboratories in countries of Western Balkans, because it required an active role of all participating laboratories, assured participation of staff from national metrology institutions, all national accreditation bodies, and was supported by national quality infrastructures, such as standardization, governmental institutions etc. in the entire Western Balkans region. The activities stimulated progress in the area of conformity assessment, added knowledge to the implementation of technical directives and development of the technical part of national legislation and therefore facilitated the process toward the accession to the European Union. The main objective was therefore to organize proficiency testing in those sectors (construction, consumer protection and environment) that were vital in the pre-accession process of countries seeking full implementation of EU technical legislation.     

Accreditation in analytical laboratories: a critical assessment of its impact on human beings and techniques

Summary The relationships between Quality, Quality Assurance and Third Party Approval by accreditation based on formal application of EN 29002, EN 45001 and ISO Guide 25 are briefly outlined for analytical chemical laboratories working in the non-regulated area. The roles of human beings in laboratories and accreditation bodies are discussed and recommendations are made on how to minimize friction during accreditation processes. The structures of the European Accreditation Systems are reviewed and the efforts towards mutual recognition of the national accreditation bodies are described and critically assessed. The lack of competition based on free market conditions in the framework of company law is deplored. The assessment of laboratory systems, rather than assessing the activity of laboratories against technical standards, is recommended (unless it is otherwise requested). The beneficial effects of the process of accreditation on competence and quality of the activity of the laboratory are emphasized.     

Joint Commission International accreditation: a laboratory perspective

Joint Commission International accreditation (JCIA) offers the international community a standards-based, objective process for evaluating healthcare organizations. The eleven JCIA standards are functionally organized. The standards are grouped by functions related to the provision of patient care and functions covering the provision of a safe, effective, and well-managed organization. The focus of the JCIA survey process is on the whole organization rather than on individual departments/services. The survey is carried out by trained and experienced healthcare peers. Healthcare organizations worldwide should be encouraged to seek accreditation such as that offered by JCIA. Where affordable, laboratories that are part of larger healthcare organizations should strive to achieve independent laboratory accreditation. The perspective of a laboratory undergoing a JCIA survey is briefly presented. Presented at the conference Quality in the Spotlight, March 2007, Antwerp, Belgium.     

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.     

Certification of reference materials and accreditation of reference material producers: Questionable terminology leads to confusion

In the view of the Deutscher Kalibrierdienst (DKD) , a certifying body for reference materials can be considered to be a calibration laboratory. Therefore, accreditation of calibration laboratories in accordance with ISO/IEC 17025 is the most appropriate way to establish confidence in certificates for reference materials. If necessary, the criteria of ISO/IEC 17025 can be tailored to specific cases. There is no need to provide any new kind of reference-material specific accreditation. However, in view of the variety of reference materials and the practice existing in other countries, accreditation of testing laboratories and product certification bodies may optionally be acceptable as long as the same stringent principles with respect to traceability and measurement uncertainty are applied. Such accreditations but not accreditations of reference material producers (ISO Guide 34) are also covered by existing international mutual recognition arrangements (MRA).     

Is accreditation useful for quality improvement?

 The Laboratory of the Government Chemist (UK) and the Institute for Reference Measurements and Materials (Belgium) evaluated the correlation between accreditation and performance in proficiency tests. It was concluded that accreditation does not have the expected positive effect on the quality of laboratory results. In this journal discussions conducted on this subject during the CITAC workshop at Pittcon in 1998, were published. No satisfactory explanation for this phenomenon was put forward. In this article, it is proposed that the main effect of accreditation is a decrease of intralaboratory spread. The effect on the trueness of laboratory results is not significant due to the lack of certified reference materials and the low frequency of participation in proficiency tests. Proficiency tests cannot be used to find a correlation between accreditation status and quality without changing the set-up of the proficiency test.     

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。     

IMEP-12: trace elements in water; objective evaluation of the performance of the laboratories when measuring quality parameters prescribed in the European Directive 98/83/EC

The International Measurement Evaluation Programme (IMEP) is an interlaboratory comparison scheme, founded, owned and co-ordinated by the Institute for Reference Materials and Measurements (IRMM) since 1988. IMEP-12, for the fourth time in the series, focused on trace elements in water and it was designed specifically to support European Commission directive 98/83/EC. Reference values for the concentration of ten elements were established with expanded uncertainties according to GUM. In total, 348 laboratories from 46 countries in five continents participated in the comparison and the degree of equivalence between the results of the laboratories and the reference values is presented graphically. Samples from the same batch were distributed to ten laboratories from European Countries, which represented their country in the framework of the EUROMET project 528. Participation in this comparison was offered to the European Co-operation for Accreditation (EA) for participation of accredited laboratories from all over Europe in the framework of the collaboration between IRMM and EA and to laboratories from the EU new member states and acceding countries in the frame of IRMM’s ‘Metrology in Chemistry support program for EU new member states and acceding countries.’     

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 College of American Pathologists laboratory accreditation program

The College of American Pathologists (CAP) operates voluntary programs in proficiency testing (PT) and quality monitors, which are briefly described. Additionally, a peer-based laboratory accreditation program covers over 6,100 clinical laboratories. Participation requires successful PT and on-site inspections using a series of 18 checklists structured along traditional subdisciplines of laboratory medicine and anatomic pathology. The laboratory general checklist contains over 250 questions covering broad issues affecting all disciplines. Among these are three items within the computer services section that specifically probe the laboratory’s use of autoverification. Data autoverification is defined as the process by which the computer performs the initial verification of test results; any data that fall outside of set parameters should be reviewed by the human operator. Central to these questions is the role of the laboratory director in approving the rules and validation. CAP does not define the specific technical details, recognizing the uniqueness of each laboratory setting and the patients it serves. Received: 8 August 2002 Accepted: 10 August 2002 Presented at the European Conference on Quality in the Spotlight in Medical Laboratories, 7–9 October 2001, Antwerp, Belgium Correspondence to A. Rabinovitch     

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.