An accredited laboratory's view of customer expectations

 Accredited laboratories are the accreditation bodies customers – all other interested parties are stakeholders. The ultimate consumer expects his product to be safe, reliable and good value for money. All other expectations in the supply chain relate to the consumer's expectations.     

The view of laboratories’ clients on the value of accreditation

The Swedish National Testing and Research Institute (SP) asked its clients in its 2001–2002 customer satisfaction survey how they valued an accredited test result on a scale of 1-6. As many as 81% of the recipients answered that it was important (a score of 5 or 6 on the scale ) to have an accredited test result. 12% found the question irrelevant, which could be interpreted as that they used some of SPs non-accredited services, or were just not interested in accredited test reports.     

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     

The correlation of laboratory performance in proficiency testing with other QA characteristics

Although it seems self-evident that proficiency testing (PT) and accreditation can be expected to improve quality, their relative benefits remain uncertain as does their efficacy. The study reported here examines the following issues: (a) Why do laboratories take part in PT schemes? (b) How does participation in PT fit in with a laboratory's overall quality assurance (QA) system? (c) Is there a link between a laboratory's performance in specific PT and it's QA system? (d) How does PT performance change with time and how do laboratories respond to poor performance? The overall conclusion is that there is no evidence from the present study that laboratories with third-party assessment (accreditation and certification) perform any better in PT than laboratories without. The validity of this conclusion and its significance for the future design and operation of such schemes requires further investigation. In particular, study is required of the degree to which good performance in open PT correlates with blind PT performance, where laboratories are not aware that the samples being analysed are part of a quality assessment exercise.     

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.     

Environmental analysis in the Czech Republic: organisation of proficiency testing and its use in laboratory assessment

The history, origin, and development of a system for monitoring and assessing water and other environmental laboratories in the Czech Republic is described. The system started in 1991 and has matured to its present complexity with similarities to the accreditation systems found in other countries. Differences from internationally recognized procedures are being corrected step by step. During the first year of its existence ASLAB, as part of its brief, organised proficiency testing (PT) programs for fifty laboratories. Today the total number of regularly participating laboratories exceeds 700 from the Czech Republic, the Slovak Republic, and Germany. This paper describes the ASLAB PT system, discusses some experiences with its use, and describes the use of PT results in assessment of the competence of laboratories. Received: 12 October 2000 Accepted: 7 January 2001     

Quality assurance in the view of a commercial analytical laboratory

 The necessity for analytical quality assurance is primarily a feature of the analytical process itself. With the full establishment of the EU domestic market, it is also becoming a legal necessity for an increasing number of analytical laboratories. The requirements which laboratories will need to fulfil are stipulated in DIN EN 45 001. Accredited testing laboratories must in fact provide evidence that they work solely in accordance with this standard. National and EU commissions, which are legislative authorities, tend therefore to specify analytical methods, e.g. in the form of regulations or appendices thereto, intended to ensure that results from different laboratories will be comparable and hence will stand up in a court of law. The analytical quality assurance system (AQS), introduced by the Baden-Württemberg Ministry for the Environment in 1984, obliges laboratories to regularly participate in collaborative studies and thereby demonstrate their ability to provide suitably accurate analyses. This alone, however, does not sufficiently demonstrate the competence of a laboratory. Only personal appraisal of the laboratory by an auditor, together with the successful analysis of a sample provided by the same and performed under his observation, can provide proof of the competence of the laboratory. From an analytical point of view, the competence of a laboratory must be regarded as the decisive factor. Competence can only be attained through analytical quality assurance, which thus must be demanded of all laboratories. Received: 4 October 1996 Accepted: 15 January 1997     

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.     

A combination of accreditation and certification in an evolving process at EMPA: A management system to meet ISO 9001, ISO 14001 and EN 45001

 The Swiss Federal Laboratories for Materials Testing and Research (EMPA) have established a quality assurance system based on EN 45001 which meets the requirements for accreditation of all EMPA's testing activities. As testing is only a part of EMPA's range of activities, and is performed in decentralised departments, the system does not satisfy the management needs. The fundamental reorganisation of EMPA's St. Gallen site was used as an opportunity to implement an overall process-oriented management system which also included quality and the needs for accreditation. Later, an environmental management system was added and then certified for ISO 9001 and 14001. The system consists of a "Management Manual" for the St. Gallen site and a customised "Quality Manual" for each department. One of the key elements is a comprehensive review and planning procedure covering all business aspects.     

Key requirements for introducing quality assurance in measurement laboratories

 The implementation of a quality assurance system is fraught with difficulties. However, these difficulties may be overcome if the laboratory uses suitable means to facilitate the process. It is necessary to mobilise the intelligence and energy of all members of the laboratory. In order to command adherence, the project must be shared, and this necessitates a major effort by all concerned. Communication is a major factor in obtaining the support of all parties. Six important steps must be distinguished: – Defining quality policy – Creating awareness, information, training – Creating a quality structure – Establishing a deadline for obtaining accreditation – Progressive implementation – Experimentation and validation. Even if the task of obtaining and maintaining accreditation remains difficult, it clearly promotes a minimum level of organisation and stepwise progress in quality assurance. The laboratory must keep improving its quality system, using European Standard EN 45001 as an effective management model. Received: 9 April 1997 · Accepted: 11 September 1997     

Quality in clinical laboratory measurements

 Clinical chemistry deals with measurements and observations using samples from patients in order to supply clinicians with information to support their decisions in diagnosis and treatment. The discipline utilizes advanced chemical and biochemical methods and also sophisticated instrumentation which allows a high throughput. Clinical chemistry has a long tradition of quality assessment and improvement. The major tools have been proficiency testing or external quality assessment and internal quality control. Nowadays, total quality management has become widely recognized, and accreditation according to international, regional or national schemes has contributed to the design of quality systems and improvement of the reliability of results from clinical laboratories.     

New tools: Expert systems for uncertainty budgets

An important part of quality assurance in any analytical laboratory is the production of comprehensive results integrating uncertainty measurements. Many testing laboratories face the problem that the expenditure required to evaluate small uncertainties (high precision and high accuracy) is often uneconomic. In most cases an uncertainty of high reliability has to be calculated from only a few data (one calibration, few replications, etc.). This problem can be solved by an expert system. To achieve this the analytical procedure has to be structured into a dialouge and divided into parts. The uncertainty has to be calculated for each part of the procedure. Addition of the individual uncertainties results in the combined and expanded uncertainty. During the dialouge the system should advise the analyst how to get an efficient and effective calculation of uncertainty. All calculations, mathematical and statistical procedures have to be surveyable but running the system should not be too time consuming for economic reasons. Within the scope of the EURECA-project initiated by the Eidgenössische Materialprüfungs- und Forschungsanstalt (EMPA), St. Gallen, Switzerland, expert system software is being developed in cooperation with other research institutes and manufacturers of analytical instruments. Using this software it will be possible to calculate the uncertainty for analytical procedures such as titration, atomic emission spectrometry (ICP-OES), atomic absorption spectrometry (AAS) and gas- and liquid chromatography (GC, HPLC).     

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     

New policy in the accreditation of testing and calibration laboratories in Russia

 The structure and activities of a new accreditation body called the Russian Union of Measurement Accreditation Systems (RUMAS) are briefly described.     

Internal audits in private medical laboratory practice – a Finnish experience in 1996–2000

Internal audits inherently effect quality improvement, and concrete results can be expected by careful planning. As audits should improve the quality system in situ, the development of audits should not be neglected. ISO/IEC 17025 describes the objectives of internal audits and management reviews in more detail compared to the former standards EN 45001 and ISO/IEC Guide 25, although the main features are unchanged. This addresses continuous surveillance of the current practice. A brief questionnaire on vertical audits was distributed to 74 of 120 employees at a Finnish private medical laboratory, Medix Laboratories Ltd. A positive feed-back was received from the current management of audits. However, the study revealed that continuous supervision of audits is needed. Many employees were not willing to perform audits if they had no previous experience. Additionally, audits performed at the workbench were not considered as the best possible for fruitful discussions. Received: 20 February 2001 Accepted: 30 November 2001     

A pilot experiment of joint assessments by accreditation and certification bodies in clinical laboratories

When the quality system of the health care organization is certified and the laboratory accredited, two different types of assessments are also performed. To reduce the extra work caused by these different assessments the Finnish Accreditation Service FINAS and SFS-Certification have made a pilot experiment in combining the assessments. Joint assessments have been a positive experience to the laboratory as well as to the assessing bodies, and we find this operating model worth developing.     

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.     

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     

Introducing the concept of uncertainty of measurement in testing in association with the application of the standard ISO/IEC 17025

ISO/IEC 17025 requests laboratories to estimate the overall uncertainty associated with a test result. In many cases this means a new requirement to laboratories. It is essential to understand the importance of the knowledge of the uncertainty of measurements as well as the principle that not always the smallest possible uncertainty is needed, but fitness for purpose has to be achieved. The paper suggests a policy on the implementation of the concept of uncertainty and guidance on how to proceed, taking into account the present state of the art of understanding the problem.     

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.