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    I.S. EN ISO 15195:2003

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    LABORATORY MEDICINE - REQUIREMENTS FOR REFERENCE MEASUREMENT LABORATORIES

    Available format(s):  Hardcopy, PDF

    Superseded date:  21-02-2019

    Language(s):  English

    Published date:  01-01-2003

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Management system requirements
      4.1 Organization and management
      4.2 Quality management system
      4.3 Personnel
      4.4 Measurement documentation and records
      4.5 Contracting
    5 Technical requirements
      5.1 Premises and environmental conditions
      5.2 Handling of samples
      5.3 Equipment
      5.4 Reference materials
      5.5 Reference measurement procedures
      5.6 Metrological traceability - Uncertainty of measurement
      5.7 Quality assurance
      5.8 Reporting results
    Annex A (informative) Cross-references to ISO/IEC 17025:1999
    Annex ZA (normative) Normative references to international
             publications with their relevant European publications
    Bibliography

    Abstract - (Show below) - (Hide below)

    Covers the specific requirements for reference measurement laboratories in laboratory medicine.

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

    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Superseded
    Superseded By

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

    ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
    ISO 5725-1:1994 Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions
    ISO/IEC Guide 58:1993 Calibration and testing laboratory accreditation systems General requirements for operation and recognition
    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 15193:2009 In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Requirements for content and presentation of reference measurement procedures
    EN ISO 18153:2003 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003)
    ISO 15189:2012 Medical laboratories — Requirements for quality and competence
    ISO 18153:2003 In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials
    ISO 17511:2003 In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values assigned to calibrators and control materials
    ISO Guide 30:2015 Reference materials Selected terms and definitions
    ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
    EN ISO 17511:2003 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003)
    ISO 3534-1:2006 Statistics — Vocabulary and symbols — Part 1: General statistical terms and terms used in probability
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