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Conclusion The demands on employers are increasing and these are reflected in the demands made on graduates and school leavers [6]. Educators and employers need to get together to discuss the deficiencies, identify the cause and then set about trying to improve the situation. The lack of the key skills of communication, application of number and use of information technology are cited along with the limited subject knowledge and lack of practical skills. It is easy to forget that skills have to be taught and learned. The scaffolding used during the construction of a house is removed once the house is finished. However, it is required again when another house is being built. Experienced chemists can help provide the students with their necessary scaffolding. This is what the education and training group of the VAM programme tries to

achieve. It attempts to instil the ideas of good laboratory practice in those aspiring to become scientists and provides case studies which develop the key skills. Employers should not expect the students to be fully trained even at the graduate level; that has to come after the education process when the person is regularly performing the particular tasks. Acknowledgements The work described in this paper was supported under contract with the Department of Trade and Industry as part of the national Measurement System Valid Analytical Measurement programme.

References 1. Hanson J, Hoppé J, Prichard WH (1993) Chem Br 29 : 871–872 2. Fleming J, Sargent M, Singleton V (1994) Chem Br 30 : 29–31

POLICIES AND CONCEPTS

Relevant accreditation policies and concepts in EU-, EFTA-, NAFTAand other regions

Accred Qual Assur (1999) 4 : 39–42 Q Springer-Verlag 1999

Jane Beaumont

Accreditation in the United Kingdom: responding to needs or ‘changing the goalposts’? Abstract 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 ac-

creditation 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. Key words Accreditation 7 United Kingdom Accreditation Service

Introduction The United Kingdom Accreditation Service (UKAS) has been in existence in one form or another since 1966, when the British Calibration Service was established to assess and accredit the competence of calibration laboratories. The de-

3. Murray R (1993) Study of the supply and demand for analytical chemists. LGC, London 4. Kuwana T (1997) Curriculum developments in the analytical sciences. NSF grant no. 9615091, Kansas, USA 5. Hunt A, Taylor J (1998) Accred Qual Assur 3nnnnn 6. Mason G (1998) Change and diversity: the challenges facing chemistry higher education. The Royal Society of Chemistry, London

E. Prichard Laboratory of the Government Chemist (LGC), Queens Road, Teddington, Middlesex TW11 0LY, UK e-mail: fep6lgc.co.uk Tel: c44-181-9437553 Fax: c44-181-9432767

velopment of the National Testing Laboratory Accreditation Scheme in 1981 ensured that a similar scheme was available for testing laboratories. A merger between the two organisations in 1985 resulted in the formation of the National Measurement Accreditation Service (NAMAS) and in the same year the National Accreditation Council for Certification Bodies (NACCB) was established. NAMAS was privatised and merged with the NACCB in 1995 to form UKAS; in the following year its activities were extended to provide accreditation for inspection bodies. UKAS operates as a company limited by guarantee under the terms of a Memorandum of Understanding with the Department of Trade and Industry, which records a joint commitment to maintaining and developing a strong and unified national accreditation service in the United Kingdom. Laboratories seeking or maintaining accreditation with UKAS are assessed against the NAMAS Accreditation Standard, M10 [1], which is consistent with ISO/IEC Guide 25 [2] and EN 45001 [3]. Amplification and interpretation of the standard for different types of testing and calibration is provided in publications produced either by UKAS or the European cooperation for Accreditation. Certification bodies are required to comply with the criteria in EN 45011 [4], EN 45012 [5], and/or EN 45013 [6] and ISO/ IEC Guide 62 [7]. Inspection bodies are assessed against the requirements of EN 45004 [8].

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Changing the goalposts Accreditation bodies are often accused of ‘changing the goalposts’ and ‘expecting continuous improvement’. In some cases the criticism is not justified. The ‘sampling’ nature of assessment means that certain aspects of an organisation’s operations may not be examined in detail on one occasion but may receive much more attention on another visit. Issues may therefore be recorded on future visits when they had not previously been noted. The goalposts have remained the same but this time the assessor noticed that the laboratory’s shot was not quite on target. There are cases where claims of ‘changing the goalposts’ are entirely justified. However there may be very good reasons why this is the case. For example, UKAS believes that accreditation for ‘state of the art’ or ‘cutting edge’ technology should not be withheld purely because it does not have a history; obviously organisations must meet the requirements of the accreditation standards but these have to be interpreted flexibly to cope with the understanding of the situation at the time. However, with new technologies knowledge and experience in particular areas/disciplines/methodologies etc. will develop with time and may mean that what was previously acceptable for a particular situation is no langer acceptable in the light of new information. There are also occasions when an accreditation body assessor may make suggestions which are misinterpreted as being ‘requirements’. If an organisation is implementing procedures which are ‘fitfor-purpose’ there should be no need to change in order to satisfy the accreditation body. However if circumstances have changed, an assessor must give consideration to whether or not the purpose has changed and therefore query whether the procedures are still ‘fit’ for the new purpose. The original acceptance of fitness may no longer be appropriate and the organisation may be required to do more; this may be regarded as changing the goalposts, but it is the organisation under assessment or its client which has changed them rather than the accreditation body.

Responding to needs An accreditation body may also be accused of not responding to needs and one must ask whose needs? Although laboratories, certification bodies and inspection bodies are the direct customers of accreditation bodies, there are also indirect clients such as the users of accredited ser-

vices, legislators, government departments, procurement agencies, whose needs also have to be considered when determining policy and procedures. There are a number of new issues on the horizon which UKAS will be implementing in the future. Wherever possible there will be wide consultation with interested parties before the adoption of new criteria or introduction of new types of, or approaches to, accreditation in order to try and avoid the claims of ‘changing the goalposts’ whilst trying to respond to the needs of interested parties. However it is recognised that, in some cases, responding to needs will lead to changes in criteria which will as a consequence require action from accredited organisations; by consulting with clients and adopting a pragmatic approach to the introduction of new requirements, it is hoped that a harmonious transition can be achieved.

New ISO/IEC Guide 25 ISO/IEC Guide 25 is currently undergoing revision. The new draft document has incorporated many aspects of ISO 9001 [9] and ISO 9002 [10] into the text and clearly distinguishes between management system requirements and technical requirements. It is expected that the new document will be accepted for publication during early 1999 and UKAS will seek advice from its stakeholders as to whether or not to adopt the document to replace the NAMAS Accreditation Standard, M10. If the decision is taken to adopt ISO/IEC Guide 25 this may well involve laboratories in revising their existing quality systems and/or modifying their current policies and procedures. UKAS recognises that this cannot happen overnight and that an adequate ‘lead-in’ time will be needed to allow sufficient time for adjustments to be made.

Application of additional criteria Government departments and agencies may often be required, either by legislation or need, to assure themselves of the competence of organisations providing a service on their behalf or under their authority; the government body concerned may have a statutory obligation to fulfil. In such cases there may be very specific criteria which must be adhered to by these service providers and which cannot be verified without assessment. UKAS has, at the request of some of its accredited organisations, entered into agree-

ments with other bodies which delegate the task of assessing an organisation to UKAS, provided that the additional criteria specified by the bodies are incorporated into the assessment procedures. The terms and scope of the agreements, along with the criteria to be met, are published as documents in the UKAS NIS series. Examples of existing agreements include ‘Accreditation Requirements for Sampling and Testing in Accordance with the Drinking Water Testing Specification’ NIS 70 [11] with the Drinking Water Inspectorate, ‘Accreditation for Suppliers to the National DNA Database’ NIS 96 [12] with the Custodian of the National DNA Database and ‘Accreditation of Laboratories under US Public Law 101–592, The Fastener Quality Act’ with the US National Institute for Standards and Technology, TPS 24 [13]. A forthcoming agreement with the Ministry of Agriculture, Fisheries and Food (MAFF) and the Department of Health (DH) is being drawn up to satisfy the requirements of EC Directives Nos. 89/397/EEC [14] and 93/99/EEC [15] relating to the official control of foodstuffs; the requirements for laboratories will be published in NIS 42 [16]. In these cases the goalposts are being specified by organisations other than UKAS but are being applied during assessment by the latter.

Accreditation and assessment versatility In May 1997, UKAS published a paper ‘UKAS Accreditation Practice from 1 April 1997’ [17] setting out intended changes in the way in which UKAS operates in order to improve the service we offer. One of the intentions was to develop and use individuals and teams which were capable of assessing more than one standard and more than one category of activity within a standard, for example the assessment of certification bodies for operating certification/registration of both quality systems and environmental management systems. The purpose of this was to reduce the number of visits to an accredited or applicant organisation, where multiple or more comprehensive accreditation (not certification) was being sought. Where an organisation has required accreditation for its laboratory activities and certification for its quality management activities, UKAS has been involved in carrying out assessments with certification bodies; this has meant that the organisation undergoing assessment has benefitted from both time and resource savings by having the two assessment

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bodies present at the same time. These ‘coincident’ visits have been arranged by request from the organisation undergoing assessment; similar arrangements have also been made for organisations which are accredited by UKAS and included in the Good Laboratory Practice (GLP) Monitoring Programme operated by the UK GLP Monitoring Authority.

Assessment for notified body status UKAS is now able to assess organisations against a range of nationally or internationally agreed criteria, including those set out in European directives for the appointment by government of notified bodies; recommendations to this effect are made to the relevant competent authorities. In the case of notified bodies for the official control of foodstuffs (see above), the directive requires that laboratories are accredited to the requirements of EN 45001, by a body complying with the criteria specified in EN 45003 [18], and that additional criteria relating to audit, procedures, validation of methods and proficiency testing are also met. In other instances where a directive does not specify accreditation one of the criteria to become a notified body, e.g. Directive 94/9/EC [19] concerning equipment and protective systems intended for use in potentially explosive atmospheres, UKAS assesses an organisation against the criteria specified in the directive. UKAS can also respond to the needs of its customers by fielding teams capable of assessing laboratory, certification body and/or inspection body operations in one organisation at a single assessment visit where a directive encompasses these different activities.

Accreditation for broad scopes Organisations can now be accredited by UKAS for ‘broad’ or ‘generic’ scopes of activities. For certification bodies this means operating to one or more of the 39 scopes detailed in the European cooperation for the Accreditation of Certification Guidelines [20] to EN 45012. For laboratories and inspection bodies, broader scopes of accreditation can be considered on request; the operation and expression of these will depend on the particular circumstances of the organisation. The scope of a laboratory, for example, might be broad with respect to the range of standards that its testing capability can cover, particularly where standards are basically product specifications which call up testing procedures documented in oth-

er standards. Alternatively, the scope may be broad in relation to the techniques available within the laboratory; this approach is being built into the agreement with MAFF and DH for laboratories involved in the official control of foodstuffs. Guidance for laboratories on accreditation for a broad scope can be found in UKAS publication TPS 5 [21]. In all cases of accreditation for broad scopes, the onus is on the accredited organisation to demonstrate and maintain competence, discipline and appropriate control of its activities to the satisfaction of UKAS; where, during surveillance, this is found not to be the case, the withdrawal of accreditation for a broader scope will be given serious consideration.

Added value There is increasing demand for accreditation activities to demonstrably add value to the operation to which they are being applied. Added value should be an integral part of accreditation; in order to do this an accreditation body needs to use experts who are familiar with the industry, technology etc. There are difficulties associated with this in an increasingly commercial environment. Experts normally need to be practitioners which may mean that they are working for organisations considered to be competitors of the organisation being assessed; assessors also need to be independent of the body being assessed and fulfilling both of these requirements is not always an easy task. The experts will continuously need to exercise judgement during assessments and it is this aspect which often leads to claims of inconsistency. Technical discussions generally occur, particularly in laboratories, between staff at the bench and the expert assessors, and these exchanges can often result in improvements in practices; it is not always obvious in the documented report of assessments that these exchanges of information have taken place and the added value which has occurred at the operating level may therefore be overlooked at the management level. There is no doubt that accreditation must be seen to add value and it may need changes in assessment practices to highlight the added value components, which are already present in many instances.

Uncertainty of measurement Uncertainty of measurement is a topic which is under much discussion at present and is guaranteed to generate lively de-

bate whenever it is mentioned. It is certainly a candidate for the claim of ‘changing the goalposts’. For UKAS accredited calibration laboratories, the concept is not new and there has been a requirement for many years for calibration certificates to contain a statement of the uncertainty of measurement. However even within the field of calibration, the estimation of this parameter is not as straightforward as it seems, so what chance has the testing laboratory of understanding what is required? Laboratories working in areas such as chemical analysis and microbiological examination are currently debating the relevance of the traditional approach to uncertainty of measurement for their particular fields of testing. The debate is likely to continue for some time but whatever the outcome, UKAS will not act either unilaterally or in advance of its European counterparts to introduce uncertainty as a requirement in all instances. If and when it is introduced across the board, laboratories will be given sufficient lead time for implementation to ensure that unrealistic timescales are not expected. The action taken so far by UKAS is to alert laboratories through NIS 80 [22] to examine their methods and to try to identify the stages which may have a large impact on the end result. This allows laboratories to focus efforts on improvements to methods and to generate data which will contribute to the process of estimating uncertainty. Obviously where a client specifically requests, or a product specification requires a statement of uncertainty, UKAS would require a laboratory to estimate this in order for it to claim accreditation for a method.

Accreditation of proficiency testing schemes The importance of proficiency testing (PT) as a practical means of demonstrating a laboratory’s competent performance has been recognised for many years. However care must be taken when interpreting results to ensure that a recorded performance is in fact what it seems and not a function of the operation of the PT scheme. More emphasis is being placed on PT by accreditation bodies which, before making participation or satisfactory performance in a specified scheme mandatory, must be confident in the validity of the scheme itself. The second edition of ISO Guide 43 [23] was published in 1997, thereby providing a basis for providers of PT to work to. Further guidelines [24] to supplement this document are also being developed by the International Laboratory Accreditation Coopera-

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tion and it is likely that UKAS will adopt this as the set of criteria on which to offer accreditation of PT schemes. It is expected that this service will be offered during 1999 and will provide an additional means for users of PT schemes to decide which schemes to consider for their own purposes. In time accreditation of PT schemes may become one of the criteria used by accreditation bodies to decide whether or not participation and satisfactory performance in specified schemes should be made mandatory for accredited organisations.

Group accreditation In general, laboratories are accredited by UKAS as separate entities whether or not they are owned or managed as part of a larger organisation. In the early days, this did not present a particular problem to organisations because, generally, laboratories on separate sites often operated as separate entities and tended to provide a large range of services to their customers from each site. However, over the last few years many organisations have restructured their laboratory services; laboratories may have been merged, closed down or their services have been rationalised and concentrated in centres of excellence. Other changes, such as the introduction of centrally controlled management systems, have also occurred. A significant number of organisations which own/manage several laboratories, each holding accreditation to the NAMAS Accreditation Standard, have approached UKAS to explore the possibility of both operating their accreditations in a ‘grouped’ manner and of UKAS managing these accreditations in a similar way. UKAS recognises the needs of these clients and is responding to these needs in a practical and pragmatic way in order to ‘add value’ for organisations without ‘devaluing’ the status of accredited laboratories. It is therefore anticipated that UKAS will offer organisations which operate a number of laboratories and/or sampling activities the opportunity, to be granted a form of ‘group accreditation’ covering all of those laboratories/activities specified by the organisation and agreed by UKAS. Many of the requirements for accreditation would be met by laboratories/sampling organisations in exactly the same manner as they currently do. However there are a number of issues which would need to be considered both by UKAS and the organisations concerned, including the quality system, auditing at different sites, use and interchange of staff at different sites, use of shared equipment, calibration of equip-

ment, handling of test items at different sites and reporting of results of samples analysed by different sites. There may be a need to specify additional requirements and to make clear the applicability of such arrangements.

Conclusion Accreditation of organisations is not an activity which can be defined in tablets of stone; the very nature of the activity is such that organisations which offer accreditation must be able to recognise the changing situations of its accredited bodies, advances in technology and methodology and must be able to respond to demands for change in a pragmatic and impartial manner whilst maintaining the standards required by stakeholders. It must be expected that further changes will occur in the future; these must only take place following appropriate consultation and if they are seen to add value to the accreditation process.

References 1. NAMAS Accreditation Standard M10 (1989), UKAS 2. ISO/IEC Guide 25 (1990) General requirements for the competence of calibration and testing laboratories, 3rd edn 3. EN 45001 (1989) General criteria for the operation of testing laboratories, CEN/CENELEC 4. EN 45011 (1998) General criteria for certification bodies operating product certification, CEN/CENELEC 5. EN 45012 (1998) General criteria for certification bodies operating quality system certification, CEN/CENELEC 6. EN 45013 (1989) General criteria for certification bodies operating certification of personnel, CEN/CENELEC 7. ISO/IEC Guide 62 (1996) General requirements for bodies operating assessment and certification/registration of quality systems 8. EN 45004 (1995) General criteria for the operation of various types of bodies performing inspection, CEN/CENELEC 9. ISO 9001 (1994) Quality systems – model for quality assurance in design, development, production, installation and servicing 10. ISO 9002 (1994) Quality systems – model for quality assurance in production, installation and servicing 11. NIS 70 (1994) Accreditation requirements for sampling and testing in accordance with the drinking water Testing specification, UKAS

12. NIS 96 (1997) Accreditation for suppliers to the national DNA database, UKAS 13. TPS 24 (1997) Accreditation of laboratories under US Public Law 101592, The Fastener Quality Act, UKAS 14. EC Directive 89/397/EEC Official control of foodstuffs directive 15. EC Directive 93/99/EEC Additional measures concerning the official control of foodstuffs directive 16. Draft NIS 42 (1997) Accreditation of official food analysis and microbiological examination laboratories, UKAS 17. UKAS Accreditation Practice from 1 April 1997 (May 1997), UKAS 18. EN 45003 (1995) Calibration and testing laboratory accreditation systems – general requirements for operation and recognition, CEN/CENELEC 19. EC Directive 94/9/EC Equipment and protective systems intended for use in potentially explosive atmospheres 20. EAC G3 (1995) Guidelines on the application of EN 45012 21. TPS 5 (1996) Accreditation for generic methods and associated specified methods or procedures based on client’s requirements, UKAS 22. NIS 80 (1994) Guide to the expression of uncertainties in testing (general principles and guidance for estimating and reporting uncertainties of measurement in testing), UKAS 23. ISO Guide 43, parts 1 and 2 (1997) Proficiency testing by interlaboratory comparisons, 2nd edn 24. Draft ILAC Guide (1997) ILAC requirements for the competence of providers of proficiency testing schemes

J. Beaumont United Kingdom Accreditation Service, 21–47 High Street, Feltham, Middlesex TW13 4UN, UK Tel.: c44-181-9178434 Fax: c44-181-9178500