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.     

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.     

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.     

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     

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.     

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.     

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.     

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.     

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.     

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.     

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.     

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.     

Accreditation of reference material producers: Let's get it right!

The accreditation of testing and calibration laboratories to ISO/IEC 17025 is increasingly calling for the accreditation of reference material (RM) producers. Two international guides, ISO Guide 34 (2000) " General requirements for the competence of reference material producers" issued by the ISO Committee on Reference Materials and ILAC-G 12 " Guidelines for the requirements for the competence of reference material producers" issued by the International Laboratory Accreditation Cooperation (ILAC), are already in use for this purpose. Recently however initiatives have been launched to accredit RM producers to ISO 17025 as calibration laboratories and it has been suggested that a combination of ISO/IEC 17025 " General requirements for the competence of testing and calibration laboratories" and ISO Guide 34 may be the best option. This publication is an expression of the position of the ISO Committee on Reference Materials (ISO/REMCO) on the standards and guides currently in use in the accreditation of RM producers. The paper discusses the advantages and disadvantages of these standards and guides from the perspective of benefit to RM producers and RM users. In conclusion, the use of ISO Guide 34 alone or in combination with ILAC-G 12 is the preferred system for the accreditation of RM producers. Therefore ISO/REMCO strongly encourages all accreditation bodies to adopt ISO Guide 34.     

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.     

Implementation of ISO/IEC 17025 Standard for the accreditation of analytical laboratories in Russia

The history since 1992 and the current state of affairs of the Russian Accreditation system for analytical laboratories are described. Some national characteristics of the implementation of the ISO/IEC 17025 Standard in Russia are considered. The elucidation of some ISO/IEC 17025 Standard prepositions is presented to facilitate implementation of the Standard by accreditation bodies and analytical laboratories claiming accreditation.     

Tunisian traceability system

The concept of metrology first appeared in Tunisia towards 1909. At the end of the 1990s, bodies for evaluating conformity of measurement at different levels have been instituted to meet calibration and testing needs of the national industry. These bodies were divided into three categories: Class A where we find mainly the Central Laboratory for Analysis and Testing LCAE and the National Defence Laboratory DEFNAT; these two laboratories are in charge of the technological upgrading of the other bodies of Class B which, in turn, would transfer their knowledge to the industries, the latter constituting Class C. Nowadays, the accreditation of Tunisian laboratories at the international level by recognized reference foreign bodies and participation in the European proficiency network enabled the national laboratories of Tunisia to establish the degree of equivalence between their measurement results and those of other foreign laboratories.     

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     

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.     

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.