Quality assurance accreditation

An integrated approach to disseminating traceability is described as it has crystallized from more than 15 years of practice with IMEP. It shows how Si-traceable values are disseminated for the benefit of the end-users, consistent with the title and objective of this CCQM workshop. It contains the essential elements needed standardization, quality assurance, accreditation, metrology and education (SQAME). The key tasks of metrological and other reference measurement institutes as well as accreditation bodies in the dissemination and use of metrological traceability naturally follow from these 15 years of experience. 

Apart from innovative work, RMs are essential during exerdses such as the introduction to a laboratory of a method from elsewhere or the transfer of an established method onto new instrumentation. Even where the conditions for the analysis have been standardized by the manufacturer of a reagent kit, some validation work should still be undertaken so as to have documented data for quality assurance purposes, e.g. accreditation, as a basis for IQC, for later reference when problems which may be related to equipment, reagents or staff etc. need to be investigated. 

GijNZLER H (1995) Accreditation and Quality Assurance in Analytical Chemistry. Springer, Germany. 

Information about forthcoming meetings and symposia can be found on the wuw sites of the organizations described above (see Table 8.4). The journal Accreditation and Quality Assurance published by Springer (see Table 8.2) includes a comprehensive review of RM related meetings. 

Over the past decade, a major trend has been the development of the use of proficiency testing (PT) or evaluation materials (Fox 2000). PT materials are a type of reference material, which aid in assessment of analytical laboratory measurement quality. There will be an increased use of such materials as part of laboratory accreditation programs and other new quality assurance efforts, including internal audits. At the same time, a number of providers have used PT schemes to produce a form of RM intended to meet the ever-growing need for RMs required for routine QC use (Jenks 1995,1997). 

Wegscheider W (1996) Proper sampling a precondition for accurate analyses. In Accreditation and quality assurance in analytical chemistry (Ed. by H. GUnzler) Springer, Berlin Heidelberg New York... 

GAT Glossary of analytical terms. Series in the journal Accreditation and Quality Assurance ... 

K. Danzer, Significance of statistical quality assurance, in Accreditation and Quality Assurance in Analytical Chemistry (ed. H. Guenzler), Springer, Berlin, 1996, p. 128. 

Pritchard, E. (1995) Quality in the analytical chemistry laboratory, John Wiley, UK. Gunzler, H. (ed.) (1996) Accreditation and quality assurance in analytical chemistry, Springer-Verlag, UK. 

Extended and updated coverage of dry reagent analysis, immunoassay, mass spectrometry, quality assurance and accreditation, affinity chromatrography and capillary electrophoresis... 

Measurement uncertainty is one of the key issues in quality assurance. It became increasingly important for analytical chemistry laboratories with the accreditation to ISO/IEC 17025. 

Sampling is just the beginning of the analytical process. On the way from sampling to the test report a lot of different requirements for high quality measurements have to be considered. There are external quality assurance requirements on the quality management system (e.g. accreditation, certification, GLP), internal quality assurance tools (e.g. method validation, the use of certified reference material, control charts) and external quality assurance measures (e.g. interlaboratoiy tests). 

Analytical method validation forms the first level of QA in the laboratory. Analytical quality assurance (AQA) is the complete set of measures a laboratory must undertake to ensure that it is able to achieve high-quality data continuously. Besides the use of validation and/or standardized methods, these measures are effective IQC procedures (use of reference materials, control charts, etc.), with participation in proficiency testing schemes and accreditation to an international standard, normally ISO/IEC 17025 [4]. Method validation and the different aspects of QA form the subject of Section 8.2.3. 

Wang, W, Zheng, J, Tholen, D W, Cao, Z, and Lu, X (2005), A statistical strategy for discouraging collusion in split-level proficiency testing schemes. Accreditation and Quality Assurance, 10 (4), 140-43. 

Many quality assurance managers, particularly for field laboratories, have learned their skills on the job. Very few tertiary courses exist to help quality assurance managers, but assiduous searching of the Internet, subscription to journals such as Accreditation and Quality Assurance, and participation in the activities of professional organizations allow analysts to build their expertise. I hope that this book will fill in some gaps for such quality assurance personnel and that it will give students and new professionals a head start. 

L. Huber, Quality assurance and instrumentation, Accredit. Qual. Assur., 1, 24, 1996. 

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