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  • CEI UNI EN ISO 17034 : 1ED 2018

    Current The latest, up-to-date edition.

    GENERAL REQUIREMENTS FOR THE COMPETENCE OF REFERENCE MATERIAL PRODUCERS

    Available format(s): 

    Language(s): 

    Published date:  28-03-2018

    Publisher:  Comitato Elettrotecnico Italiano

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    Table of Contents - (Show below) - (Hide below)

    European foreword
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General requirements
    5 Structural requirements
    6 Resource requirements
    7 Technical and production requirements
    8 Management system requirements
    Annex A (informative) - Summary of production
            requirements for RMs and CRMs
    Bibliography

    Abstract - (Show below) - (Hide below)

    Defines general requirements for the competence and consistent operation of reference material producers.

    General Product Information - (Show below) - (Hide below)

    Committee CT 501
    Development Note Classificazione CEI 501-34. (02/2018) Italian translation of 1ED 2018 Issued on 01/02/2018. (04/2018)
    Document Type Standard
    Publisher Comitato Elettrotecnico Italiano
    Status Current

    Standards Referencing This Book - (Show below) - (Hide below)

    ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
    ISO/IEC 17000:2004 Conformity assessment Vocabulary and general principles
    ISO 15195:2003 Laboratory medicine Requirements for reference measurement laboratories
    ISO 15194:2009 In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Requirements for certified reference materials and the content of supporting documentation
    ISO 15189:2012 Medical laboratories — Requirements for quality and competence
    ISO/TR 16476:2016 Reference materials — Establishing and expressing metrological traceability of quantity values assigned to reference materials
    ISO Guide 35:2017 Reference materials Guidance for characterization and assessment of homogeneity and stability
    ISO/IEC 17011:2004 Conformity assessment General requirements for accreditation bodies accrediting conformity assessment bodies
    ISO/IEC Guide 99:2007 International vocabulary of metrology Basic and general concepts and associated terms (VIM)
    ISO Guide 30:2015 Reference materials Selected terms and definitions
    ISO 10012:2003 Measurement management systems — Requirements for measurement processes and measuring equipment
    ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
    ISO Guide 31:2015 Reference materials — Contents of certificates, labels and accompanying documentation
    ECA ILAC P10 : 2013 ILAC POLICY ON TRACEABILITY OF MEASUREMENT RESULTS
    ISO/IEC Guide 98-3:2008 Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)
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