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.     

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 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 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.     

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.     

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.     

Accreditation of medical laboratories in South Africa

Accreditation of medical laboratories is a well-established process in many parts of the world. We describe this process in South Africa under the South African National Accreditation System. The elements of accreditation, the accreditation process for medical laboratories and future prospects are outlined. Received: 4 September 2000 Accepted: 24 April 2002     

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 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.     

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.     

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.     

Reliability of food measurements – a South African perspective

 High quality analysis of food involves a comprehensive process, which includes proper sampling, validated methodology, experienced technical staff and the use of standard reference materials. Today there is more international emphasis not only on generating food composition data but also on data quality and the main issue is that South African data should be internationally recognized as acceptable and representative. Quality is multi-dimensional and should at least include aspects of accuracy, precision and representativeness. A major step forward is that laboratories can apply for accreditation, which involves, inter alia, documented, validated methodology, regular interlaboratory studies, the use of certified reference materials and the existence of a sound quality system. The South African National Accreditation System (SANAS) is a regulatory body in South Africa, which is internationally recognized. Assessment of laboratories against specific standards is performed regularly and laboratories have to comply with certain managerial and technical requirements. Once a laboratory is accredited, ongoing validation and verification of results as well as regular assessment ensure reliability of results and overall competency of the laboratory. With a quality assurance programme in place, the reliability of results of the Irene laboratory is beyond doubt and nutrient data could be included in food composition tables. Received: 31 January 2002 Accepted: 4 February 2002 Correspondence to Louwrens Erasmus Smit     

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     

From a single analyzer to multiple instruments—The GUM approach

Assessment and expression of analytical quality have become novel spotlights in medical laboratories since accreditation began in the early 1990s, in Europe. Evaluation of uncertainty of measurement by definition was launched in Finland when the Finnish Accreditation Service (FINAS) accredited the first medical laboratories in the mid 1990s. In spite of all the analytical and statistical knowledge which has been available in medical laboratories for years, evaluation of total uncertainty of measurement has not yet caught on. The concept is still unfamiliar to experts and, indeed, little guidance has been available. National and international activities, with good results, can be shown when the educational aspect is considered. The Guide to the Expression of Uncertainty in Measurement (GUM) remains the main document for uncertainty evaluation. Uncertainty of measurement together with target value of uncertainty can be used as a good measure for analytical quality in large or smaller laboratories over time, because it is a quantitative indication and the evaluation is easy to repeat as running practical tools are available.Presented at the 8th Conference on Quality in the Spotlight, 17–18 March 2003, Antwerp, Belgium     

Quality system implementation in the National Metrology Institute of Montenegro

Accreditation and Quality Assurance - Accreditation of calibration laboratories is a means for achieving competence recognition and assuring customers that their calibration services are accurate...     

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     

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).     

Current best practice for traceability in testing laboratories,when certified reference materials are unavailable

Since the implementation of ISO/IEC 17025 in 2002, all accredited laboratories (at the least) need to establish traceability in all their tests and calibration methods. Traceabilty, though well understood in the calibration field (through an unbroken chain of comparisons to the International System of Units —SI), is less straight forward and not so well understood in the testing laboratories. Traceability in analytical and biological testing is found through the use of reference materials, and the validated steps of a test method. This article describes the possibilities to comply with the traceability requirement of ISO/IEC 17025 in testing laboratories , when certified reference materials are unavailable.Presented at the Second International Conference on Metrology—Trends and Applications in Calibration and Testing Laboratories, 4–6 November, 2003, Eilat, Israel     

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.