Laboratory accreditation – where next?

 Laboratory accreditation is now well established and can justly claim to have had a beneficial impact on the quality of the services provided by accredited laboratories. However, the needs of laboratories and their customers are continually evolving. It is necessary for accreditation practices to keep abreast of these changing requirements if they are to continue to be of benefit to laboratories and their customers. This paper gives a brief review of current accreditation practice and suggests some changes that should be made to help laboratories meet the demands made on them by their customers. Received: 2 July 1998 · Accepted: 3 August 1998     

Quality assurance in clinical chemistry laboratories in the UK

 Since the mid-1960s quality assurance in clinical chemistry has progressed from a need to define and improve precision and accuracy in analytical test procedures to an all-embracing process of assuring that the whole process of pre-analytical, analytical and post-analytical phases of handling patient samples is managed effectively and efficiently. Automated and computer-controlled equipment has reduced many of the analytical errors, in particular in imprecision, that were present in manual analysis. New management techniques have been developed to control the quality and appropriateness of results. Developments in internal quality control and external quality assessment procedures have enabled laboratories to continually improve the quality of assays. Laboratory accreditation and external quality assessment scheme accreditation have ensured that peer review and peer pressure have been applied to both laboratory and external quality assessment scheme performance. As the NHS reviews its priorities and places more emphasis on primary care provider demands, hospital laboratories will of necessity assist with near patient testing outside the laboratory. This will provide new challenges to the quality of the service provided. Received: 2 July 1998 · Accepted: 1 August 1998     

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     

Introduction for the special issue on the Antwerp Conferences

Quality management of laboratory medicine has become a hot topic at many conferences. Also, many national and international organizations have created working groups and committees with the task of working out standards, guidelines or recommendations for quality management of medical laboratories. We have observed that there is a great deal of interest not only from professional and scientific organizations directly involved in medical laboratory tests, but also from accreditation and certification bodies, from test laboratories in general, from in vitro diagnostic devices (IVD) manufacturers and their associations, and from other medical laboratory suppliers. However, we found that all these parties were discussing from their own point of view, without taking into account the position of other involved partners and that there was a need for creating a discussion forum for quality management in clinical laboratories. So in 1995, we started the Antwerp conferences on quality (r)evolution in clinical laboratories. The aim was to bring together all concerned partners and to establish a forum for brainstorming, independently of any pressure group. The leitmotif for the Antwerp conferences (Fig. 1) is a chain model showing the interfaces and relationships between all the partners involved in laboratory tests. During the conferences, this chain model has been examined from different angles and a summary of the concepts evolving from the discussions can be found in the conference abstracts and conference review reports in this journal. A Selection of ideas emerging from these conferences are presented below. Received: 5 October 1998 · Accepted: 20 October 1998     

Accreditation and authorization in environmental analysis

 Since 1989 testing laboratories in Europe have had the possibility to confirm their competence in carrying out certain testing procedures by means of accreditation. Over the years an independent European Accreditation system has been developed, which many member states of the European Union have joined. The existing accreditation organizations joined to form the unified organization EA (European Cooperation for Accreditation) in 1997. Members of this organization are, inter alia, one representative of the accreditation authorities of each of the member states. The German accreditation system is different to the European system in that it is split. Here, we differentiate between the sector established by law and that which is not. Both sectors, however, pursue the same goal. Because of this double certification of competence and the resulting multiple reviews, German testing laboratories face a considerably greater load in comparison to their European colleagues. Several authorities are already working on the removal of this split accreditation system. The efforts must, however, be concentrated and brought into line. Efforts by the DAP and DACH for flexible accreditation and the creation of a standardized registration authority for testing laboratories in the field of workplace measures are examples of how the German accreditation system could develop in the future.     

Quality management, certification and accreditation in medical laboratories – the view of ECLM

 Increasing demands from health care planners and industrialists conducting clinical trials, as well as general competition, are forcing medical laboratories to seek third-party recognition of their quality management systems. There is a tendency to move from certification of a laboratory director, via certification of the laboratory quality system (ISO 9000 family), to accreditation needing proof of professional and technical competence in laboratory tasks. The requirements of accreditation are presented in several national schemes and in the European Standards series (EN 45 000) and the International Organization for Standardization's guide, ISO/IEC 25, to be amalgamated soon. The latter system provides transnational recognition through participation of the accrediting bodies in the European co-operation for Accreditation. Necessary supplementary guidelines exist for chemical laboratories (Eurachem) and medical laboratories CEAC/ECLM). Traceability and reliability of results are obtained by utilizing a global reference examination system and by participating in transdisciplinary work. The costs of achieving accreditation are considerable and mainly involve the production of quality handbooks and written work procedures by personnel. The rewards are an open system, smoother work, emphasis on prevention of mistakes, and satisfied stakeholders. Received: 5 October 1998 · Accepted: 20 October 1998     

Revision of ISO guide 25

 ISO/IEC guide 25 is the internationally recognised base document for the accreditation of laboratories. Laboratory accreditation is a system of peer assessment and a formal recognition that a laboratory is competent to perform specific tests or types of tests ISO/IEC guide 25 plays a fundamental role in the life of the analytical chemist and is pivotal to the acceptance of the philosophy "once tested everywhere accepted" and to ensuring the mutual acceptance of test data. Within the EU, the attainment of accreditation to ISO/IEC guide 25 has become a way of life and it is now mandatory for laboratories engaged in certain regulatory work areas. Guide 25 is currently under revision and over the past 2 years or so it has been the subject of much debate among the calibration and testing community and it has engendered a considerable amount of written and oral comments. The latest revision entitled "Draft International Standard ISO/IEC DIS 17025: General Requirements for the Competence of Testing and Calibration Laboratories" was circulated to national standard organisations for their "comment and approval" in mid 1998. Voting on this document commenced on 9 July and terminates on 9 December 1998. It is anticipated that a final draft could be circulated in 1999. In accordance with the Vienna agreement this is a parallel ISO/CEN enquiry. This paper will discuss the implications of the technical requirements of the current document for analytical chemistry with particular emphasis on, the strengths, weaknesses and deficits inherent in the draft circulated in July 1998.     

Long-term stability of pure standards and stock standard solutions for the determination of pesticide residues using gas chromatography

The regular replacement of pure standards used in pesticide residue analysis laboratories and frequent preparation of stock standard solutions, both required by many accreditation bodies, impose considerable demands on a laboratory's resources. In this study, pure standards for all but one (heptenophos) of 118 different pesticides amenable to analysis by GC, and stock standard solutions (1000 microg/ml) prepared from these in toluene, acetone or ethyl acetate have been shown to be stable at < or = -20 degrees C over long periods: 4-13 and 2-8 years, respectively, for pure standards and solutions. Suitable solvents, containers and handling procedures are essential to avoid evaporation from solutions.     

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 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     

Compliance with GLP standards and management in analytical laboratories: current status

 Analytical laboratories in Japan, operating more often as departments within a company than as independent contractors, have to contend with different good laboratory practice (GLP) standards. Problems also occur in the analytical laboratories which must comply with GLP, good manufacturing practice (GMP) and good clinical practice (GCP) regulations within the same facility. The status of these GLP-complied analytical laboratories is reviewed with regard to assurance program, validation method, laboratory information management, and security systems. The differences in the responsible authorities and scopes under the six GLPs are also briefly described. Analytical tests in GLP are not itemized as a test for accreditation. Therefore, the accreditation of analytical laboratories in Japan is currently granted as a part of ISO 9000 approvals. Received: 27 September 1996 Accepted: 11 November 1996     

Quality assurance in analytical chemical laboratories: Towards harmonization and integration of current standards

This article presents the results of a comparative study of the main quality assurance (QA) and good laboratory practice (GLP) regulation systems and standards for analytical chemical laboratories currently being applied in Europe. A growing number of laboratories are being confronted with the need to cope with two or more of these systems, which involves separate audits and inspections for certification and accreditation. As these regulatory systems have essentially the same aims, there is an increasing interest in harmonization of QA and GLP guidelines. As a first step in exploring the possibilities of harmonization, similarities and differences of the current systems, compiled in the form of cross reference tables, have been analyzed (from a laboratory practice point of view) by a study group of EURACHEM, The Netherlands. The conclusions of this study have recently been endorsed by the Committee of EURACHEM Europe.     

The Russian system for accreditation of analytical laboratories (centers)

 The history and the present state of the national system for accreditation of analytical laboratories in Russia are described. Received: 1 September 1998 / Accepted: 1 September 1998     

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.     

Pathology laboratory accreditation: the Australian experience

 The National Associating of Testing Authorities, Australia (NATA) is a laboratory accreditation company that has been involved in the accreditation of pathology laboratories since 1982. This role is carried out in conjunction with the Royal College of Pathologists of Australasia (RCPA). The accreditation process is known as the NATA/RCPA scheme. The NATA/RCPA accreditation scheme originated from the desire to raise professionalstandards in pathology. The scheme aimed to achieve this through a peer review process in which education and voluntary participation were stressed. In 1986, the Australian Federal Government adopted the scheme as its measure of the competence of testing by pathology laboratories seeking payment from the Commonwealth Department of Human Services and Health reimbursement scheme, Medicare. This meant that NATA/RCPA accreditation became mandatory for such laboratories. The benefits of peer review as a means for establishing professional competence and the challenges a mandatory accreditation program poses to such a scheme will be discussed. Received: 6 May 1996 Accepted: 29 May 1996     

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     

Use of ISO Guides 25, 30, 31, 34, 35, and 9001 in re-engineering Bethlehem Steel Corporation's analytical chemistry reference materials program

 Many certified reference materials are needed to calibrate and control analytical measurement processes in integrated steel works. It is beyond the scope and capacity of most national laboratories to supply all of these needs. Yet, the demand for these materials is steadily increasing as more steel producers update their quality systems in preparation for ISO 9000 registration and/or ISO Guide 25 laboratory accreditation assessments. This paper describes how the Bethlehem Steel Corporation updated its reference materials program to meet its internal needs and offers a model for use by others in improving their programs. Received: 22 April 1998 · Accepted: 12 May 1998     

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.     

The benefits calibration and testing laboratories may gain from ISO/IEC 17025 accreditation

By definition (effectiveness through efficiency), quality is a business interest, not a supreme value in its own right. Quality systems must be beneficial to the organization operating them. In this paper, the possible tangible advantages (both business- and operations-related) an accredited laboratory may draw from formal accreditation is viewed. Also, an attempt is made to roughly classify laboratories into those which are more likely, or less so, to benefit from accreditation.     

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.