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.     

Conformity assessment and metrology: update on the state of affairs

A couple of years ago, ISO CASCO launched a major project of transforming all the existing ISO Guides on conformity assessment to a comprehensive series of ISO standards 17000 being now in various stages of development. As the concept of traceability underpinning all measurements has been a basic mission of metrology, a number of these standards have a direct bearing on metrology. The series is logically based on a definition standard, ISO 17000, giving, among others, a guidance which activities fall under conformity assessment. The fact that calibration does not, might have important consequences which must yet be assessed. A controversial discussion on some issues has been in progress concerning ISO 17011 on accreditation bodies which touches both on national metrology institutes (NMIs) with an accreditation function and on calibration labs at large. ISO 17040 on peer review could be used with an advantage to support mutual recognition arrangements among a limited number of bodies of a specialized expertise (e.g., CIPM MRA among NMIs under the Metre Convention). ISO 17025 has been the most important standard for the metrology community and has undergone a major overhaul taking on board the uncovered requirements from ISO 9001:2000. In general, the paper will give an update on the developments outlined above and discuss the consequences and further steps from the viewpoint of metrology.     

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     

Volume calibration of 1000 μl micropipettes. Inter-laboratory comparison

A EUROMET comparison “volume calibration of 1000 μl micropipettes”, between six national metrology institutes (NMIs), was performed during 2006 with the purpose of comparing results and uncertainty calculations. The objective of this paper is to describe the volume measure instruments, the model, the method, and to discuss the results and its associated uncertainties presented by each participating NMI.     

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 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.     

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.     

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.     

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.     

Optimising calibration and measurement capabilities in terms of economics in conformity assessment

Calibration measurement capabilities (CMC) are key factors in declaring the metrological performance of national metrology institutes (NMIs). Different countries have different CMC capabilities, reflecting both the existing measurement science competence as well as the perceived national needs for traceable calibration. This paper deals with increasing interest in decision-making in conformity assessment in terms of effective costs associated with measurement, testing and incorrect decision-making. The work examines the CMCs of calibration laboratories and NMIs with economic decision theory, in particular, in terms of customer satisfaction and with respect to conformity assessment issues. Optimal strategies for calibration costs, maintenance of national measurement standards, testing and production costs are illustrated in practical examples. CMCs are an essential instrument to enable conformity assessment both for product safety, legal metrology, quality requirements as well as scientific research. The newly defined term “target measurement uncertainty”, introduced in the latest international metrology vocabulary (VIM), should be therefore always related to appropriate CMCs and related dissemination paths in the whole conformity assessment procedure. These requirements are clear and transparent justification for the development of required national metrological infrastructures, in order to fulfil the requirements of target measurement uncertainty for intended use or application in the particular conformity assessment procedure.     

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.     

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 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.     

New ISO Guide 34 – How is the change affecting practice in the Czech Republic?

 The positive contribution of the ISO Guide 34 review is the idea of increasing responsibility of reference materials producers. The change of the main intention introduces some problems related to national legislation. There is a very important discussion going on about these problems among metrological bodies, accreditation institutes, reference material producers and laboratories.     

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.     

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).     

A way of establishing quality of measurements in gas analysis—national and international aspects

Standardising quality of measurements at both the national and international level results in a unity in measurement that may be regarded a synonym of traceability. In gas analysis, the key issue in achieving this aim is production of gaseous reference materials. Establishing a network of secondary measurement standards at gaseous CRM producers’ sites in Ukraine might be interesting for those involved in gas analysis activities. Inevitably, problems concerning the recognition of measuring capabilities of both national metrological institutes and local CRM producers are now an international issue. Thus, the problems of national adoption of international standards, as well as harmonisation between different international documents are currently relevant, and Ukrainian experience may be useful to others in this field. Presented at the 3rd International Conference on Metrology, November 2006, Tel Aviv, Israel.     

A participatory improvement activity of the EC-JRC to improve metrology in chemistry in EU candidate countries

In 2000, the European Commission-Joint Research Centre, Institute for Reference Materials and Measurements (EC-JRC-IRMM) set up a project to improve the scientific basis for metrology in chemistry (MiC) in EU candidate countries. Several activities were initiated (training, fellowships, sponsoring seminars, conferences and participation in the International Measurement Evaluation Programme – IMEP). A particular initiative, discussed here, was to assist each of the national measurement institutes of these countries to write a status report on MiC. Most importantly, the report was intended to be the end-product of a process to document the current status of MiC. Intentionally, this process involved not only the providers of services in MiC but all the major stakeholders in this activity (e.g. major field laboratories, accreditation bodies, regulatory bodies, educators, professional bodies). The status reports are intended to be the first step of the future improvement process. In those countries where writing of the status reports has been started (Slovenia, Poland, Bulgaria and Estonia) the first signs are that this process leads to better co-operation and particularly a better understanding of what the future role and activities of each of these stakeholders should be. Correspondence to N. Majcen