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 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     

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 of calibration laboratories to normative documents: diversity or standardization

Calibration of measuring equipment is conducted by following some normative or applicable documents such as standards, manufacturer manuals and instructions, technical orders issued by defense organizations, or scientific papers. An accreditation body provides its recognition to the calibration laboratories by evaluating their technical competence and their compliance with the quality requirements of ISO/IEC 17025. The accreditation body must have defined criteria in order to evaluate different calibration methods which should ensure that the laboratories are performing the calibration in a technically competent manner when they are fully or even only partially based on the relevant reference documents. A discussion with different points of view about choosing the criteria, as well as the Israel Laboratory Accreditation Authority (ISRAC) policy on this issue, are presented.Presented at the 2nd International Conference on Metrology – Trends and Applications in Calibration and Testing Laboratories, November 4–6, 2003, Eilat, Israel.     

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.     

Accreditation of GMO detection laboratories: Improving the reliability of GMO detection

Reliable and efficient methods for detecting genetically modified organisms (GMOs) are essential for establishing an effective system for traceability all along the supply chain from seed producers to final consumers. The latter is especially meaningful in European Union and other countries where strict legislations on GMOs were set up. Performance of the methods used in laboratories around the world should be uniform, in order to obtain reliable and comparable results. Accreditation is a suitable system for harmonising procedures in each testing laboratory. In this paper, key elements for the accreditation of molecular biology methods for GMO detection according to ISO/IEC 17025 are described. The procedures described are also valuable for the accreditation of molecular methods for all laboratory diagnostics where qualitative and quantitative characterisation of nucleic acids is needed.     

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.     

ISO 15189-accredited laboratories fulfill the JCI Hospital Accreditation Standard requirements for the use of referral laboratories: report of a consensus meeting

Accreditation of healthcare services is recommended to ensure operation according to the highest quality standards. Various initiatives, such as legislation or accreditation by ISO or JCI, may be active to support and improve quality. The growing trend toward JCI hospital accreditation raised the concern of redundancy between JCI requirements for the use of referral laboratories and the ISO 15189 accreditation for medical laboratories. This would result in needless administrative efforts for hospital laboratories to collect and maintain required documentation, as the JCI quality requirements would be guaranteed given that the referral laboratory is ISO 15189 accredited for those examinations. A consensus meeting was organized by the Working Group for Hospital Accreditation of the Belgian Zorgnet-Icuro network, the University Hospitals of Leuven and the Red Cross to discuss the avoidance of any redundancy between both standards and to issue best practice guidelines for referral laboratories. It was concluded that JCI measurable elements for referral laboratories are covered by the ISO 15189 accreditation scope. The article substantiates the consensus that JCI and ISO quality requirements are harmonized and that accurate knowledge and interpretation of prevailing quality standards are essential to avoid redundancy in quality measures.     

Accreditation of sampling activities

Since the introduction of ISO/IEC 17025 it is a requirement for all accredited laboratories to include sampling in their quality statements. It is well understood that sampling and handling of the sample are key factors in the validity of a result. The fact that many laboratories worldwide are not involved in sampling poses a challenge to accreditors liability. This article describes the Israel Laboratory Accreditation Authoritys (ISRAC) and other accreditors approaches to sampling.Presented at the Second International Conference on Metrology—Trends and Applications in Calibration and Testing Laboratories, 4–6 November 2003, Eilat, Israel.     

Aspects of auditing in clinical laboratories

Quality and patient safety are terms that both providers and recipients of healthcare are very familiar with. Accreditation is another term that is closely linked to quality and patient safety. Audit is a systematic, independent, and documented process for obtaining evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled. Accreditation and audit are integral components of the same process. Three different types of audit are well recognized—internal, external, and co-operative. Reading of relevant documents, observation of laboratory practices, and asking open-ended probing questions are important auditing techniques. For auditing to be successful, experienced, qualified, and well trained auditors are essential. Furthermore, the auditor should be open-minded, not prejudiced, a team player and effective communicator, both in writing and verbally. In many instances, the emphasis for seeking laboratory accreditation has shifted from building quality systems—to produce reliable results and ensure patient safety—to just passing the inspection. Recently, the emphasis for laboratory quality improvement has been placed on pre and post-analytical processes in preference to analytical quality. The analytical quality of laboratory results is still far from ideal and it may be detrimental if less emphasis is placed on this aspect of laboratory medicine. Auditing or on-site inspection as a regulatory tool does not work or present a realistic picture of laboratory quality. A continuous quality improvement approach will help laboratories to build quality into their systems. Presented at the Conference “Excellence in Laboratory Medicine”, November 2007, Al Ain, United Arab Emirates.     

Traceable measurements in clinical laboratories

 Reliable, traceable and comparable measurements provide the rational basis for evaluation of the quality of a result and the starting point for recognized laboratory accreditation in any national area. Modern medical diagnostics and treatment involve rapidly rising numbers and types of clinical laboratory measurements, that are reliable. Therefore, the basic principles to be followed to assure the traceability of clinical measurements as required by the Romanian Laws of Metrology are reviewed. Main sources affecting the quality of the unbroken chain of calibrations that relate the measurements back to appropriate measurement standards are discussed. Examples of how to achieve traceable measurements in clinical laboratories are presented. Details of specific uses of reference materials, measuring instruments and standard measurement methods are also discussed. Received: 8 January 1998 · Accepted: 21 April 1998     

Quality assurance in research laboratories

During the last decade, it has become increasingly important that researchers demonstrate that research is conducted to the highest standards. The implementation of quality assurance for research laboratories will enable all fields of research and development to be judged impartially. There are no specific standards for research laboratories but where possible, existing standards can be adapted. This review is structured around two approaches. The first considers research to be a logical extension of testing, and it is assumed that testing standards can be applied methodically to each step in a research project. The second advocates a flexible approach, with research-specific criteria for assessing quality. The important papers published on this topic have been reviewed. The conclusions are that the general quality management approach, encompassed by the ISO 9000 series of standards with the emphasis on customer satisfaction and ‘fitness for purpose’, is suitable for implementing quality assurance in research laboratories.     

The lead assessor role in the ISO/IEC 17025:2005 accreditation of Brazilian calibration and testing laboratories by the General Coordination of Accreditation (Cgcre)

This work describes the human resources organization of the General Coordination for Accreditation (Cgcre) in Brazil, in which lead and technical assessors, both internal and external to the National Institute of Metrology, Quality and Technology (Inmetro), assess the competence of calibration and testing laboratories to the ISO/IEC 17025:2005 standard. The “Lead Assessor Project” is presented, which consists of an increase in the responsibilities of lead assessors, in such a way that the Division of Laboratories Accreditation (Dicla/Cgcre) can cope with the increasing demand for ISO/IEC 17025:2005 accreditation of Brazilian calibration and testing laboratories.     

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.