• PD ISO Guide 34:2009

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    General requirements for the competence of reference material producers

    Available format(s):  Hardcopy, PDF

    Superseded date:  30-11-2016

    Language(s):  English

    Published date:  31-01-2010

    Publisher:  British Standards Institution

    Add To Cart

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Organization and management requirements
    5 Technical and production requirements
    Annex A (informative) - Metrological traceability of
            certified property values of reference
            materials
    Annex B (informative) - Commutability of reference
            materials
    Annex C (informative) - ISO/IEC 17025/ISO Guide 34
            cross-reference table
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes general requirements in accordance with which a reference material producer has demonstrate that it operates, if it is to be recognized as competent to carry out the production of reference materials.

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

    Committee RMI/1
    Development Note Supersedes BS PD6532-5(2000). (01/2010)
    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    Status Superseded
    Superseded By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/IEC 17000:2004 Conformity assessment Vocabulary and general principles
    ISO Guide 32:1997 Calibration in analytical chemistry and use of certified reference materials
    CLSI EP14 A2 : 2ED 2005 EVALUATION OF MATRIX EFFECTS
    ISO 15189:2012 Medical laboratories — Requirements for quality and competence
    ISO Guide 33:2015 Reference materials Good practice in using reference materials
    ISO Guide 35:2017 Reference materials Guidance for characterization and assessment of homogeneity and stability
    ISO/IEC Guide 99:2007 International vocabulary of metrology Basic and general concepts and associated terms (VIM)
    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 3534-2:2006 Statistics Vocabulary and symbols Part 2: Applied statistics
    ISO Guide 30:2015 Reference materials Selected terms and definitions
    CLSI EP32 R : 1ED 2006 METROLOGICAL TRACEABILITY AND ITS IMPLEMENTATION
    ISO 10012:2003 Measurement management systems — Requirements for measurement processes and measuring equipment
    ISO 9001:2015 Quality management systems — Requirements
    CLSI C53 P : 1ED 2008 CHARACTERIZATION AND QUALIFICATION OF COMMUTABLE REFERENCE MATERIALS FOR LABORATORY MEDICINE
    ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
    ECA ILAC G12 : 2000 GUIDELINES FOR THE REQUIREMENTS FOR THE COMPETENCE OF REFERENCE MATERIALS PRODUCERS
    ISO Guide 31:2015 Reference materials — Contents of certificates, labels and accompanying documentation
    ECA ILAC G24 : 2007 GUIDELINES FOR THE DETERMINATION OF CALIBRATION INTERVALS OF MEASURING INSTRUMENTS
    ECA ILAC P10 : 2013 ILAC POLICY ON TRACEABILITY OF MEASUREMENT RESULTS
    OIML D 10 : 2007 GUIDELINES FOR THE DETERMINATION OF CALIBRATION INTERVALS OF MEASURING INSTRUMENTS
    ISO/IEC Guide 98-3:2008 Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)
    ISO 3534-1:2006 Statistics — Vocabulary and symbols — Part 1: General statistical terms and terms used in probability
    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective