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.     

The attitude of laboratory personnel towards accreditation

 A multiple-choice questionnaire was submitted to medical technologists in two medical laboratories, 10 months after the laboratories had obtained an EN 45001 (Beltest) accreditation. The majority of the technologists (85–90%) considered that their workload had been increased by the accreditation process but they did not think that the process had improved the quality of their results. The major advantages were: traceability, the fact that the technologists felt more confident about the procedures followed, they also received more responsibility and had a better knowledge of the tests performed. The major disadvantages were the increased paperwork, discrepancies between written procedures and the same procedures in practice, the fact that more attention was paid to the formalities rather than to the quality of the results and that the accreditation process decreased the technologists' adaptability. A small majority of the technologists prefered working in an accredited laboratory rather than in a non-accredited one. Received: 5 October 1998 · Accepted: 20 October 1998     

Accreditation of small laboratories

 This paper presents the result of an investigation concerning which areas of EN 45001 are considered as especially problematic by small laboratories (<10 employees). The investigation was performed by distributing questionnaires to European laboratories. To be able to differentiate between areas considered as problematic only by small laboratories and areas considered as problematic by laboratories in general, some questionnaires sent in by larger (>10 employees) laboratories were used. The determination of measurement uncertainties within reasonable efforts and the requirements to take part in round robin and proficiency testing were considered problematic by laboratories of all sizes. Training is an area where small laboratories have specific problems and so are the requirements for the identification of all equipment. Other problematic areas for small laboratories are areas were there are needs for personnel, e.g. appointing supervising personnel and expenditure for internal audits. The last area to be considered as problematic is matters concerning documentation. Finally some advice concerning assessment of small laboratories is given. Received: 25 February 2000 / Accepted: 20 April 2000     

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.     

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.     

Introduction of Japan Chemical Laboratory Accreditation

 Japan Chemical Laboratory Accreditation (JCLA), a new accreditation body in chemical fields was established and the activities and organization of JCLA are outlined.     

Accreditation of reference material producers

 The use of reference materials is the most pragmatic means by which the analyst can achieve comparability of data. Reference material producers therefore need to have adequate quality systems in place for ensuring the reliability of their materials. In order to provide guidance to both producers and assessors, ISO Guide 34 has recently been produced detailing the quality system requirements for the production of reference materials. CITAC, REMCO and ILAC are now collaborating in the revision of this guide to produce a free-standing document detailing the general requirements for the competence of reference material producers. This paper discusses some of the more important issues described in these documents. The possible formation of an international register containing details of a reference material producer's quality system status is also discussed.     

Accreditation of types of tests

 DACH, the German accreditation body of chemistry, which was founded in 1992, has introduced a new model for the flexibilization of the scope of accreditation. This ensures that the accreditation of a laboratory also guarantees flexibility. Flexibilization of the scope of accreditation is of great importance, in particular if a great number of similar routine tests (standard methods) or non-routine tests are to be accredited. The main tool of flexibilization is the accreditation of types of tests. The accreditation of types of tests entitles laboratories to include additional test methods within the type of test accredited without informing the accreditation body immediately. Such information is provided at fixed surveillance intervals. The conditions for the accreditation of types of tests are described below.     

The European Eco-Management and Audit Scheme Accreditation – an overview

 Environmental quality is still deteriorating in the EU and worldwide despite all the Directives and Regulations in this field over the past 20 years. The European Community has devised a new approach to this problem with the introduction of the Eco-Management and Audit Scheme Regulation. This Regulation provides industry with an opportunity to demonstrate that it can achieve continuous improvement in its environmental performance through a voluntary scheme which is not based on the traditional command and control mechanisms of Directives. This paper gives an overview of the steps involved in implementing the European Eco-Management and Audit Scheme and the role of accreditation in supporting the scheme.     

Quality assurance in immunogenetics and histocompatibility: experience with EFI Accreditation

 The European Federation for Immunogenetics (EFI) has its own standards for histocompatibility testing. Compared with EN 45001 and ISO Standards, EFI Standards are more detailed, actually stating "what to do" in the laboratory. The decision of Eurotransplant that all its organ transplantation programmes must be EFI-accredited by the year 2000, illustrates the importance of the these standards. It took us 11 months to prepare the EFI questionnaire, describing the main features of our laboratory and how they complied with EFI Standards. After approval of this file, inspection was performed by a team of two peers who routinely worked in an EFI-accredited tissue typing laboratory. The pre-analytical, analytical and post-analytical phases were inspected during a one day visit. Furthermore, a checklist was reviewed against the laboratory's documentation system. Within 1 month of reception of the inspection report, we were expected to send a reply listing the corrective actions taken. Upon acknowledgement of the latter, EFI Accreditation was granted, for 1 year. We feel that detailed standards, specifically designed for a certain type of laboratory, offer many advantages. Received: 15 April 2000 · Accepted: 15 April 2000     

Integrating accreditation, good laboratory practice and good manufacturing practice in an industrial analytical laboratory

 The Analytical Laboratory of BASF is a central service unit for chemical analysis which can be used by all departments within the company. It carries out routine as well as non-routine work and has a high amount of R&D orders. A quality system conforming with GMP rules was installed in the 1970s, followed by a GLP system about 6 years later. In 1995 an EN 45001 certificate was granted, which also stated the conformity with ISO 9002. A "types of test" orientated system was chosen for accreditation. This was better suited to the needs of a testing laboratory with a high amount of non-routine work than a purely test-procedure orientated accreditation. An integrated quality system has now been developed from these activities. It has partly common elements and partly differing elements taking into account specific regulations. For example, instrument calibration, staff training, validation of test procedures and the use of computerized systems are covered by uniform rules. Other elements such as handling of samples and report generation are arranged according to the individual requirements of the various standards. Rules and regulations are laid down in a system of documents which comprise the quality manual, general standard operating procedures (SOPs), laboratory-specific SOPs and test procedures. The quality system has been accepted by other accreditiation bodies on application of special accreditations (workplace safety, biodegradable polymers). But it has had no advantageous influence on getting GLP certification. An integrated system is very complex and requires appreciable resources. Management of processes and documentation can only be handled by extensive use of computers. Frequent training of staff and internal audits are necessary to keep the system at an acceptable level. In order to reduce the complexity of quality management regulations a harmonization of the different quality systems would be desirable. Received: 1 October 1998 · Accepted: 10 January 1999     

Accreditation: a challenge

 This paper describes a real accreditation case from VTT Chemical Technology in Finland. The laboratory has acquired accreditation according to ISO/IEC Guide 25 and EN 45001 for a variety of organic and inorganic environmental tests. The present paper summarizes the reasons for applying for accreditation and selecting the test methods, gives the costs involved, and describes some future developments and views. Also, some details of laboratory intercomparisons and quality system structures are briefly reported.     

The Japan Accreditation Board for Conformity Assessment – Introduction to the Japanese accreditation system

 The background to the establishment of the Japan Accreditation Board for Conformity Assessment (JAB) is reviewed in relation to the latest global developments in conformity assessment activities. JAB (known as the Japan Accreditation Board for Quality System Registration at the time of its establishment) was established in 1993 as the accreditation body for quality system registration, the focal point for conformity assessment in the private sector in Japan. The extension of the area of accreditation was made in June 1996, covering all conformity assessment activities including laboratory accreditation, which resulted in the amendment of the name of the body to the current one. Various elements of the laboratory accreditation program are introduced to give the overview of this new program. Received: 2 October 1996 Accepted: 5 December 1996     

Accreditation system for reference material producers and certified reference materials for iron and steel in Japan

  ISO 9000 series strictly requires traceability to national or international measurement standards. It is becoming more necessary to make clear the concept of traceability of measurement standards with respect to chemical composition and to accredit the reference material producers. In Japan, the accreditation system for reference material producers is considered to satisfy the requirement of ISO Guide 34, ISO 9000 series and ISO/IEC Guide 25, while the producer fulfills the concept of traceability of measurement standards. This paper describes the production of iron and steel reference materials in Japan relating to the international standardization of methods (written standards) and accreditation of reference material producers. Received: 11 October 1996 Accepted: 5 December 1996     

Accreditation: worth the trouble?

 Since the late 1980s, much attention has been paid to the usefulness of ISO-9000 certification. At present more than 45000 companies and institutions worldwide have been granted an ISO-9000 certificate. In the field of quality assurance, however, the ISO-9000 series does not completely cover the aspect of traceability. Demonstrable traceability is a particular problem in quality assurance of products by chemical analysis. In this paper realisation of demonstrable traceability is discussed, using the field of gas analysis as an example. Attention is focused on the usefulness of accreditation for laboratories performing quality assurance analyses. The basic question is asked whether and, if so, when accreditation is worth the trouble in cases where demonstrable traceability is required. Received: 15 February 1996 Accepted: 6 March 1996     

Accreditation of proficiency-testing schemes in The Netherlands

Proficiency testing by laboratories, national accreditation bodies, and other third parties is becoming more and more considered as a standard and integral part of the quality control system. Therefore, it is of utmost importance that the quality of the provided proficiency-testing (PT) service is outstanding. If PT-schemes are set up in order to help laboratories monitor and improve their quality, PT-schemes need not only be of high quality themselves, but the organizer also needs to be able to demonstrate this. In The Netherlands formal accreditation of the organization of proficiency testing schemes is used as a tool to guarantee high quality schemes and also to enable organizers to demonstrate their competence. Since 1996, the Dutch Council for Accreditation (RvA) has used the ISO-Guide 43–1 to assess PT-organizers in The Netherlands. From January 2000, the ISO-guide 43–1 was replaced by the ILAC G13 document for assessing organizers. Up till now, four institutes have been accredited by the RvA for the organization of PT-schemes.     

The Italian way: Accreditation and continuous quality improvement in clinical laboratories

 The transition from quality assurance of the analytical phase to the quality management of total testing in clinical laboratories is still at an early stage. But it has begun. Accreditation through voluntary, educational and professional schemes, like the Clinical Pathology Accreditation scheme, is a useful tool for following defined standards of practice and having these independently confirmed on the basis of a peer review. Approved clinical laboratories can obtain a hallmark of performance and offer reassurance to users of their services. However, accreditation does not guarantee an error-free service; it is not the final step, but an important stage in the improvement process. Quality is a journey and continuous quality improvement is the paradigm for better addressing our efforts to satisfy customers' expectations for the desired health outcomes related to a high-quality laboratory service.     

Quality management in analytical R&D in the pharmaceutical industry: Building quality from GLP

 The pharmaceutical industry is one of the most regulated activity sectors. The regulation includes specific quality systems such as good laboratory practice (GLP), good clinical practice (GCP) and good manufacture practice (GMP). The principles of GLP mainly cover the formal quality aspects of a procedure and do not evaluate the technical aspects in depth. On the other hand, EN 45001 accreditation covers technical performance and is not suitable for pharmaceutical research and development (R&D) as it is almost impossible to comply with the requirements of the European standard in the pharmaceutical environment. The challenge to the pharmaceutical industry is, therefore, to develop quality systems, compatible with GLP principles, that not only cover formal quality items but also ensure good scientific and technical performance. An implementation process focused on real quality improvement is the best way to achieve this objective, culminating in formal recognition of the quality system by third-party assessment. In the case of analytical R&D, the EURACHEM/CITAC Guide CG2 is a very good tool that can help in the definition, analysis and selection of the non GLP quality elements that will be useful. Received: 30 June 1999 / Accepted: 18 October 1999