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public and to relevant international organizations abroad. The supervisory body of SNAS is the Slovak Accreditation Council. It consists of 27 delegated representatives of governmental agencies, institutions, and professional associations interested in the rigorous fulfilment of the accreditation principles. The Council monitors and evaluates the functionality and efficiency of SNAS, and supervises its objectivity and the impartiality of the accreditation process. The Accreditation Commission (AC) consists of nine members elected by the Slovak Accreditation Council. These are experts in applied sciences, production, policy making and the management area. AC is a decision-making, steering and inspection body of SNAS. AC takes decisions concerning granting or withdrawing the accreditation certificate, and it approves national accreditation standards and all documents of SNAS. Members of AC are elected for a three-year period. Technical Committees for Accreditation (TCAs) are executive bodies of SNAS. Their main goals are: assessment of applicants for accreditation, supervision for permanent fulfilment of accreditation criteria by accredited subjects, organization of training courses for assessors, and participation in the elaboration of accreditation documents. TCAs act as sectorial commissions for accreditation matters. The starr of each TCA consists of permanent persons (the chairman, the secretary and a typist) and of 5–7 experts selected according to the particular fields of TCA activities. The chairman and experts are approved by the AC for a three-year period. Each TCA is a nonprofit organization.

Training of the SNAS personnel SNAS uses a database of experts built up by the Slovak Office of Standards, Metrology and Testing, which represents about 690 specialists from research institutes, universities, industrial centres, testing and metrological laboratories. The database is open for all who are interested and involved in metrology, testing, accreditation and certification. This database is a main source of accreditation bodies staff, assessors, auditors and experts for the accreditation process. Each TCA has built up its own group of experts and potential assessors for the purpose of assessments and audits. Everybody involved in the assessment and audit has to take part in the training in the field of accreditation. The training of the SNAS personnel, mainly TCA staff and assessors, has been organized by Secretariat of AC very efficiently, with close international cooperation in the framework of the PHARE/ PRAQ programme and the AMOS pro-

ject of the D.A.CH, and in close cooperation with NAMAS, AFNOR and NMi Netherlands. TCAs have organized training courses for these purposes.

Present state of accreditation in Slovakia There are around 530 subjects that have already submitted applications for (re)accreditation, and 126 of these have been granted accreditation so far. SNAS became an associated member of EAL and EAC in November 1995, and

is now awaiting EAL/EAC peer evaluation. J. Garaj (Y) Department of Analytical Chemistry Slovak Technical University Radlinského 9, 812 37 Bratislava Slovakia Tel./Fax: c421-7-355 746 L. Šutek 7 M. Weidlich Slovak Office of Standards, Metrology and Testing, Štefanovicˇova 3, 814 39 Bratislava, Slovakia

POLICIES AND CONCEPTS Relevant accreditation policies and concepts in EU-, EFTA-, NAFTAand other regions Accred Qual Assur (1997) 2 : 262–263 Q Springer-Verlag 1997

K. Cammann W. Kleiböhmer

The need for quality assurance in analytical research and development Up to now in the field of non-routine analysis and also in analytical research and development (R&D) there have been no explicit proposals or even guidelines for an efficient quality assurance system, except in the Netherlands and Belgium, where supplements to EN 45001 have been drawn up, although neither of these necessarily represents the best way to adopt a QA system in R&D. Although an accepted basis for a quality assurance system is lacking, some national accreditation bodies already offer accreditation procedures for R&D laboratories. This is the result of an increasing demand for a QA system for analytical R&D and also non-routine analysis. But what is the reason for this demand, and why is quality assurance in R&D actually necessary? Present-day research and development is carried out at a very high quality level which could hardly be improved by any quality assurance system. In many R&D departments outside industrial research, interest in QA systems is often raised because of pressure from a third party. The market for analytical R&D demands confirmation from a third party that the laboratory is operating according to a quality system. Thus, more and more customers of research, e.g. national or international funding organizations,

demand a proof of the existence of a QA system even for university research laboratories before a research contract is signed, thus wrongly assuming that only in this way high quality results can be obtained. The consequence is that research groups, which once had a formative influence in analytical chemistry, are now excluded from national and international research programmes, even if they are world leaders in their field. Many analytical scientists are therefore very sceptical about the future, because they do not know what it will bring. In Spring 1995, EURACHEM established an international working group with members from industry, universities and national accreditation bodies. This working group is dominated by practical analytical experts in order to prevent a gap between theoretical considerations and practical requirements. The main goal is to develop a QA guide to support the introduction and realization of a QA system for R&D. This guide should have maximum flexibility so that bureaucracy cannot restrict scientific innovation. Target groups are first of all the R&D laboratories and their customers, and not the accreditation bodies. However, an ideal guide should meet the requirements of all groups. The difficulty in setting up a QA guide for R&D is to adapt the freedom of the researcher and the “tinkerer” to the somewhat strict and cramped framework of existing QA systems, where there is no room for the necessary freedom required by R&D. Therefore, a new way must be found of providing a reasonable QA system for R&D. There is a great demand for such a system from both sides, i.e. the customers and the

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laboratories concerned. A simple adaptation of already existing QA systems to these special and complex problems leads to unacceptable and unreasonable guides, which fail to meet practical requirements. Therefore, to set up an approach as reasonable as possible, new paths have to be followed. The basic idea of QA meets the following requirements: – Fit for purpose. – Value for money. – Get it right at first time. – Satisfy customer’s needs. Thus, the excellent scientific result as well the trade-off between cost and time are both basic elements of quality in research and development. Research and development can be divided into the following sub-tasks: – Exact definition of the tasks and objectives: “Defining the analytical question” – Information review – Brainstorming – Experimental design – Selection and training of staff – Selection and installation of necessary equipment – Performance of experiments – Interpretation of data – Preparation and presentation of report – Project management – Technical direction. Each sub-task varies in importance for different projects or even during the course of a project. It should be mentioned that R&D is stepwise and recurrent rather than a linear process. An important and not to be underestimated guarantor for quality in R&D is an intelligent customer! Evidence of quality is provided by the following: – Scientific reputation – Goal-directed and successful work practice – Staff qualification – Attitudes and customer service – Achievements of performance targets – Audit and review. To draw up a reasonable QA guide for R&D can only be the first step towards adopting a quality system. The next and more challenging steps are to discuss the guide on an international level with the scientific community and to convince them of the advantages. Key words Quality assurance 7 Research and development

K. Cammann (Y) 7 W. Kleiböhmer Institut für Chemo- und Biosensorik, Mendelstrasse 7, D-48149 Münster, Germany

LEGISLATION AND NORMS

Relevant legislation, legislation plans and related initiatives in different countries and continents Accred Qual Assur (1997) 2 : 263–264 Q Springer-Verlag 1997

Peter J.H.A.M. van de Leemput

The revision of EN 45001 and ISO/IEC Guide 25 Abstract At present ISO/IEC Guide 25 and EN 45001 are under revision. This paper describes this process of the revision including the history. Also, the main differences between the officially published drafts and the current documents are pointed out.

History EN 45001 – General criteria for the operation of testing laboratories – was published in September 1989, having been drawn up in a very short period because of political pressure, so that its quality is not as good as it should have been. EN 45001 is the standard used by European laboratory accreditation bodies as the criteria for laboratories seeking accreditation. In the meantime, a group was working, at the ISO level, on the revision of ISO/IEC Guide 25, which led in 1990 to the publication of ISO/IEC Guide 25 – General requirements for the competence of calibration and testing laboratories. Experts agreed that this ISO/IEC Guide 25 was a better document than EN 45001. A working group within CEN/CLC/ TC1 studied the new Guide and proposed that CEN/CLC should adopt ISO/IEC Guide 25 as the revised EN 45001. Unfortunately this proposal was rejected by the members of CEN and CENELEC. In September 1993, CEN/CLC TC1 decided to recommend that ISO should start the revision of ISO/IEC Guide 25 in cooperation with CEN/CLC/TC1. The first step taken by ISO was to organize a hearing on 14 January 1994 in Geneva to discuss whether a revision of ISO/IEC Guide was necessary. A small working group, Gary Parsons (UK, chairman) John Summerfield (UK), Lam Kong Hong (Singapore), Lynne Neumann (USA) and Peter van de Leemput (NL), was appointed to investigate the

matter further. On the basis of the report of this working group, ISO/CASCO (ISO Conformity ASsessment COmmittee) decided, during its plenary meeting in June 1994, to start the revision of ISO/IEC Guide 25. For this, ISO/CASCO WG 10 was established under the chairmanship of Gary Parsons. For health reasons Gary Parsons had to resign from the chairmanship, and Peter van de Leemput was appointed as the new chairman. This change in chairmanship caused a delay of several months. The first meeting of WG 10 was held in March 1995 in Geneva. The composition of WG 10 is balanced; both accreditors and laboratory persons are very well represented. During the first meeting the basic starting points for the revision were discussed as well as the content of the current guide and what should be changed. The most important starting points were: 1. The new ISO/IEC Guide is primarily intended for laboratories whether they strive for accreditation or not. Apart from that, the document must be written in such a way that it can be used for accreditation. 2. The revision must lead to a text which will also be accepted in Europe as the new EN 45001. Parallel consultation and voting will be organized to encourage parallel acceptance. 3. The text must be written in a laboratory-friendly language. 4. The relation with the ISO 9000 series of standards must be clear. 5. The revision must lead to criteria which, when a laboratory meets the criteria, will lead to correct results. At the end of the first meeting, a small drafting group was appointed: Peter van de Leemput (RvA, NL, chairman), John Rogers (UKAS, UK), Lynne Neumann (Entela, USA) and Jarl Forstén (VTT, Finland). After slightly more than a year, the drafting group and WG 10 have accomplished their tasks. In July 1996 the draft was ready for official publication as the draft revision of ISO/IEC Guide 25 and EN 45001. Formally, until this official publication, the draft was at the working group stage and not officially available. However, several versions have been circulated all over the world. It was even available on the INTERNET, which has led to an uncoordinated stream of comments.