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  • Validation and verification of examination procedures in medical laboratories [Elektronski vir] : opinion of the EFLM Working Group Accreditation and ISO/CEN standards (WG-A/ISO) on dealing with ISO 15189:2012 demands for method verification and validation
    Roelofsen-de Beer, Roseri ...
    This paper reflects the opinion of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group Accreditation and ISO/CEN standards (WG-A/ISO). It aims to provide ... guidance for drawing up local/national documents about validation and verification of laboratory methods. We demonstrate how risk evaluation can be used to optimize laboratory policies to meet intended use requirements as well as requirements of standards. This is translated in a number of recommendations on how to introduce risk evaluation in various stages of the implementation of new methods ultimately covering the whole process cycle.
    Vir: Clinical chemistry and laboratory medicine. - ISSN 1437-4331 (Vol. 58, iss. 3, Mar. 2020, str. 361-367)
    Vrsta gradiva - e-članek ; neleposlovje za odrasle
    Leto - 2020
    Jezik - angleški
    COBISS.SI-ID - 2048629105

    Povezava(-e):

    https://www.degruyter.com/downloadpdf/j/cclm.2020.58.issue-3/cclm-2019-1053/cclm-2019-1053.pdf
    DiRROS - Digitalni repozitorij raziskovalnih organizacij Slovenije
    DOI

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