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  • BS 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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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    Superseded date:  20-02-2019

    Language(s):  English

    Published date:  31-10-2003

    Publisher:  British Standards Institution

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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
    Bibliography

    Abstract - (Show below) - (Hide below)

    Specifies the requirements for reference measurement laboratories in laboratory medicine.

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

    Committee CH/212
    Development Note Supersedes 00/563602 DC (11/2003)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

    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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