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Read the articleAUTHORS
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Philippe QUEVAUVILLER
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Eddie MAIER: Scientific executives at the European Commission, Directorate-General for Research
INTRODUCTION
Fair and reliable measurements, whether physical, chemical or biological, are essential to the smooth running of any modern society. Without such measurements, industries can hardly ensure quality production, trade is disrupted by conflicts, healthcare becomes empirical and legislation (e.g. concerning the environment, worker protection, common agricultural policy, etc.) cannot be properly implemented. The regulations in force (laws, standards, directives) are designed to harmonize measurements and technical specifications; they do not, however, free us from the technical difficulties at the root of measurement errors, and laboratories therefore need tools to check the validity of their methods and results. Quality systems are based on guides or standards (e.g. the Guide to Good Laboratory Practice, ISO 9000, ISO 14000, ISO 17025 and EN 45000, etc.). These systems rely on internal and external validation of laboratories and measurement methods. Within this framework, the availability of reference materials is one of the cornerstones of quality control: certified reference materials are used to validate the accuracy of analytical methods, while non-certified reference materials are used, on the one hand, for method development and, on the other, to validate the reproducibility of methods within the framework of interlaboratory testing (including proficiency testing for accreditation) and the establishment of control charts. These materials exist in all sectors whose activities rely on analytical results (e.g. quality control of manufactured products, environmental and food quality monitoring, medical diagnostics, etc.); they come in the form of pure substances or materials, or in the form of materials representative of natural samples.
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Bibliography
References
Trade magazines
Strictly speaking, there are no specialized journals dealing solely with reference materials. Information is regularly published in the main scientific journals dealing with fundamental or applied analytical chemistry. A reference work written by the authors of this article (dealing essentially with interlaboratory tests and reference materials for environmental analysis) was published by Elsevier in 1999
Producers of reference materials
There are over 150 producers of reference materials worldwide. Information on their products can be obtained via the COMAR database available from the Laboratoire National d'Essais. It should be noted that in the absence of mandatory production quality criteria, in particular accreditation, it is difficult to assess the quality of all materials available on the market. Among the major producers are two...
Standardization
- Normes pour le management de la qualité et l'assurance de la qualité. Partie 1 : Lignes directrices pour leur sélection et utilisation. - ISO 9000-1 - 1994
- Normes pour le management de la qualité et l'assurance de la qualité. Partie 2 : Lignes directrices génériques pour l'application de l'ISO 9001, l'ISO 9002 et l'ISO 9003. - ISO 9000-2 - 1997
- Normes pour le management de la qualité et l'assurance de la...
Economic data
Material prices obviously vary according to the nature and complexity of the certified matrices. A few grams of pure materials (e.g. alloys) cost between 60 and 200 euros; the price of ampoules of materials for clinical analysis (e.g. serum, blood) can be in the same range, while matrix materials (e.g. residual sludge, sediments, etc.) can cost up to 300 euros per unit. These cost differences are obviously linked to production...
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