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Metrology in an ISO 15189 accredited medical biologylaboratory
Published online by Cambridge University Press: 03 November 2014
Abstract
All French medical biology laboratories must be accredited according to ISO 15189 for alltests conducted. Metrology is therefore critical and covers a wide variety of areas. Thispresentation will focus on the metrology manager’s role which is tailored to the medicalbiology laboratory: human resources in place, methods used, parameters followed, equipmentused and strategies implemented when using equipment which is not connected to theInternational System of Units. It will be illustrated by examples of in vitroand in vivo clinical biochemistry, biological haematology, humantoxicology and radiotoxicology. The presentation will cover the exploitation of results ofinternal controls and interlaboratory comparisons in order to calculate uncertainties andprovide doctors with a result along with an interpretation or opinion to ensure optimumpatient care. The conclusion will present the steps carried out at the LaboratoireNational d’Essai (French National Testing Laboratory) to provide medicalbiology laboratories with certified clinical biology standards.
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- © EDP Sciences 2014