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  • CLSI EP32 R : 1ED 2006

    Current The latest, up-to-date edition.

    METROLOGICAL TRACEABILITY AND ITS IMPLEMENTATION

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  17-02-2006

    Publisher:  Clinical Laboratory Standards Institute

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

    Abstract
    Committee Membership
    Foreword
    1 Scope
    2 Introduction
      2.1 Quality in Laboratory Medicine
      2.2 External Environment
    3 Definitions
    4 Traceability
      4.1 Overview of the Process for Establishing Traceability
      4.2 Process to Establish Traceability
      4.3 Reporting Traceability in Product Literature
    References
    Appendix A - Traceability and Calculating Uncertainty of
                 Calibrator Levels for hCG
    Appendix B - XYZ Glucose Analytical System Glucose Calibrator
                 Traceability Summary
    Appendix C - System X Glucose Calibrator Traceability Example
    Related CLSI/NCCLS Publications

    Abstract - (Show below) - (Hide below)

    Gives guidance on establishing traceability of the chemical calibration step in clinical laboratory measurements, based on the traceability requirements for in vitro diagnostic (IVD) medical devices as given in ISO 17511 and ISO 18153 and in accordance with the requirements for traceability as stated in the IVD Directive.

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

    Development Note Formerly CLSI X5 R. (07/2013)
    Document Type Report
    Publisher Clinical Laboratory Standards Institute
    Status Current

    Standards Referenced By This Book - (Show below) - (Hide below)

    BIS IS/ISO 15189 : 2012 MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE
    I.S. EN ISO 15189:2012 MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE (ISO 15189:2012, CORRECTED VERSION 2014-08-15)
    CLSI EP14 A3 : 2014 EVALUATION OF COMMUTABILITY OF PROCESSED SAMPLES
    PREN ISO 15189 : DRAFT 2011 MEDICAL LABORATORIES - PARTICULAR REQUIREMENTS FOR QUALITY AND COMPETENCE
    UNE-EN ISO 18113-1:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)
    UNE-EN ISO 15189:2013 Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15)
    CLSI EP30 A : 1ED 2010 CHARACTERIZATION AND QUALIFICATION OF COMMUTABLE REFERENCE MATERIALS FOR LABORATORY MEDICINE
    PD ISO Guide 34:2009 General requirements for the competence of reference material producers
    ISO Guide 34:2009 General requirements for the competence of reference material producers
    EN ISO 18113-1:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)
    UNI EN ISO 15189 : 2013 MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE
    CLSI EP31 A : 1ED 2008 VERIFICATION OF COMPARABILITY OF PATIENT RESULTS WITHIN ONE HEALTH CARE SYSTEM
    CLSI C28 P3 : 3ED 2008 DEFINING, ESTABLISHING, AND VERIFYING REFERENCE INTERVALS IN THE CLINICAL LABORATORY
    CLSI I/LA21 A2 : 2ED 2008 CLINICAL EVALUATION OF IMMUNOASSAYS
    CLSI C57 : 1ED 2015 MASS SPECTROMETRY FOR ANDROGEN AND ESTROGEN MEASUREMENTS IN SERUM
    CLSI H47 A2 : 2ED 2008 ONE-STAGE PROTHROMBIN TIME (PT) TEST AND ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) TEST
    CLSI POCT6 : 1ED 2015 EFFECTS OF DIFFERENT SAMPLE TYPES ON GLUCOSE MEASUREMENTS
    11/30173018 DC : 0 BS EN ISO 15189 - MEDICAL LABORATORIES - PARTICULAR REQUIREMENTS FOR QUALITY AND COMPETENCE
    I.S. EN ISO 18113-1:2011 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009)
    CLSI C53 P : 1ED 2008 CHARACTERIZATION AND QUALIFICATION OF COMMUTABLE REFERENCE MATERIALS FOR LABORATORY MEDICINE
    CLSI EP28 A3 : 3ED 2010 DEFINING, ESTABLISHING, AND VERIFYING REFERENCE INTERVALS IN THE CLINICAL LABORATORY
    ISO 15189:2012 Medical laboratories — Requirements for quality and competence
    ISO 18113-1:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
    BS EN ISO 15189:2012 Medical laboratories. Requirements for quality and competence
    CLSI C49 A : 1ED 2007 ANALYSIS OF BODY FLUIDS IN CLINICAL CHEMISTRY
    DIN EN ISO 18113-1:2013-01 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009)
    BS EN ISO 18113-1:2011 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Terms, definitions and general requirements
    UNI EN ISO 18113-1 : 2012 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS

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

    CLSI C24 A2 : 2ED 99 STATISTICAL QUALITY CONTROL FOR QUANTITATIVE MEASUREMENTS: PRINCIPLES AND DEFINITIONS
    CLSI EP14 A2 : 2ED 2005 EVALUATION OF MATRIX EFFECTS
    CLSI C37 A : 1ED 99 PREPARATION AND VALIDATION OF COMMUTABLE FROZEN HUMAN SERUM POOLS AS SECONDARY REFERENCE MATERIALS FOR CHOLESTEROL MEASUREMENT PROCEDURES
    CLSI EP12 A : 1ED 2002 USER PROTOCOL FOR EVALUATION OF QUALITATIVE TEST PERFORMANCE
    CLSI EP21 A : 1ED 2003 ESTIMATION OF TOTAL ANALYTICAL ERROR FOR CLINICAL LABORATORY METHODS
    CLSI EP5 A2 : 2ED 2004 EVALUATION OF PRECISION PERFORMANCE OF QUANTITATIVE MEASUREMENT METHODS
    CLSI EP10 A2 : 2ED 2002 PRELIMINARY EVALUATION OF QUANTITATIVE CLINICAL LABORATORY METHODS
    CLSI EP6 A : 1ED 2003 EVALUATION OF THE LINEARITY OF QUANTITATIVE MEASUREMENT PROCEDURES - A STATISTICAL APPROACH
    CLSI EP15 A2 : 2ED 2006 USER VERIFICATION OF PERFORMANCE FOR PRECISION AND TRUENESS
    CLSI EP9 A2 : 2ED 2002 METHOD COMPARISON AND BIAS ESTIMATION USING PATIENT SAMPLES
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