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  • PREN ISO 15189 : DRAFT 2011

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    MEDICAL LABORATORIES - PARTICULAR REQUIREMENTS FOR QUALITY AND COMPETENCE

    Available format(s): 

    Superseded date:  01-11-2012

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Comite Europeen de Normalisation

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Management requirements
    5 Technical requirements
    Annex A (informative) - Correlation with ISO 9001:2008
            and ISO/IEC 17025:2005
    Annex B (informative) - Comparison of ISO 15189:2007
            to ISO 15189: 20XX
    Annex C (informative) - Ethics in laboratory medicine
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes the requirements for quality and competence in medical laboratories. Applicable for use by medical laboratories in developing their quality management systems and assessing their own competence. Laboratory customers, regulating authorities, and accreditation bodies may also use it for confirming or recognizing the competence of medical laboratories.

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

    Comment Closes On
    Committee TC 140
    Document Type Draft
    Publisher Comite Europeen de Normalisation
    Status Superseded

    National Adoptions - (Show below) - (Hide below)

    Equivalent Standard(s) Relationship
    11/30173018 DC : 0 Identical

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

    01/561148 DC : DRAFT MAR 2001 BS EN 14136 - USE OF EXTERNAL QUALITY ASSESSMENT SCHEMES IN THE ASSESSMENT OF THE PERFORMANCE OF IN VITRO DIAGNOSTIC PROCEDURES

    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
    CLSI GP27 A2 : 2ED 2007 USING PROFICIENCY TESTING TO IMPROVE THE CLINICAL LABORATORY
    ISO 1087-1:2000 Terminology work Vocabulary Part 1: Theory and application
    CLSI GP29 A : 1ED 2002 VALIDATION OF LABORATORY TESTS WHEN PROFICIENCY TESTING IS NOT AVAILABLE
    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
    EN 1614 : 2006 HEALTH INFORMATICS - REPRESENTATION OF DEDICATED KINDS OF PROPERTY IN LABORATORY MEDICINE
    CLSI I/LA33 P : 1ED 2009 VALIDATION OF AUTOMATED DEVICES FOR IMMUNOHEMATOLOGIC TESTING PRIOR TO IMPLEMENTATION
    ISO 15189:2012 Medical laboratories — Requirements for quality and competence
    ISO/IEC Guide 43-1:1997 Proficiency testing by interlaboratory comparisons Part 1: Development and operation of proficiency testing schemes
    CLSI QMS04 A2 : 2ED 2007 LABORATORY DESIGN
    CLSI GP33 A : 1ED 2010 ACCURACY IN PATIENT AND SAMPLE IDENTIFICATION
    CLSI H57 A : 1ED 2008 PROTOCOL FOR THE EVALUATION, VALIDATION, AND IMPLEMENTATION OF COAGULOMETERS
    CLSI EP31 A : 1ED 2008 VERIFICATION OF COMPARABILITY OF PATIENT RESULTS WITHIN ONE HEALTH CARE SYSTEM
    CLSI GP17 A2 : 2ED 2004 CLINICAL LABORATORY SAFETY
    CLSI GP29 A2 : 2ED 2008 ASSESSMENT OF LABORATORY TESTS WHEN PROFICIENCY TESTING IS NOT AVAILABLE
    ISO/IEC 17011:2004 Conformity assessment General requirements for accreditation bodies accrediting conformity assessment bodies
    CLSI M29 A3 : 3ED 2005 ACQUIRED INFECTIONS; APPROVED GUIDELINE
    CLSI GP44 A4 : 4ED 2010 PROCEDURES FOR THE HANDLING AND PROCESSING OF BLOOD SPECIMENS FOR COMMON LABORATORY TESTS
    CLSI GP31 A : 1ED 2009 LABORATORY INSTRUMENT IMPLEMENTATION, VERIFICATION, AND MAINTENANCE
    CLSI AUTO10 A : 1ED 2006 AUTOVERIFICATION OF CLINICAL LABORATORY TEST RESULTS
    CLSI GP40 A4 : 4ED 2006 PREPARATION AND TESTING OF REAGENT WATER IN THE CLINICAL LABORATORY
    ISO 15190:2003 Medical laboratories Requirements for safety
    CLSI GP41 A6 : 6ED 2007 PROCEDURES FOR THE COLLECTION OF DIAGNOSTIC BLOOD SPECIMENS BY VENIPUNCTURE
    ISO/IEC 17043:2010 Conformity assessment — General requirements for proficiency testing
    ISO Guide 30:2015 Reference materials Selected terms and definitions
    CLSI EP32 R : 1ED 2006 METROLOGICAL TRACEABILITY AND ITS IMPLEMENTATION
    CLSI QMS11 A : 1ED 2007 MANAGEMENT OF NONCONFORMING LABORATORY EVENTS
    ISO/TS 22367:2008 Medical laboratories Reduction of error through risk management and continual improvement
    ISO 9001:2015 Quality management systems — Requirements
    CLSI EP17 A : 1ED 2004 PROTOCOLS FOR DETERMINATION OF LIMITS OF DETECTION AND LIMITS OF QUANTITATION
    ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
    CLSI GP42 A6 : 6ED 2008 PROCEDURES AND DEVICES FOR THE COLLECTION OF DIAGNOSTIC CAPILLARY BLOOD SPECIMENS
    CLSI GP9 A : 1ED 98 SELECTING AND EVALUATING A REFERRAL LABORATORY
    CLSI C24 A3 : 3ED 2006 STATISTICAL QUALITY CONTROL FOR QUANTITATIVE MEASUREMENT PROCEDURES: PRINCIPLES AND DEFINITIONS
    ISO/IEC Guide 43-2:1997 Proficiency testing by interlaboratory comparisons Part 2: Selection and use of proficiency testing schemes by laboratory accreditation bodies
    CLSI GP16-A3 : 2009 Urinalysis; Approved Guideline—Third Edition
    CLSI GP35 P : 1ED 2009 DEVELOPMENT AND USE OF QUALITY INDICATORS FOR PROCESS IMPROVEMENT AND MONITORING OF LABORATORY QUALITY
    CLSI AUTO8 A : 1ED 2006 MANAGING AND VALIDATING LABORATORY INFORMATION SYSTEMS
    EN 12435 : 2006 HEALTH INFORMATICS - EXPRESSION OF RESULTS OF MEASUREMENTS IN HEALTH SCIENCES
    CLSI QMS03 A3 : 3ED 2009 TRAINING AND COMPETENCE ASSESSMENT
    CLSI GP2 A5 : 5ED 2006 LABORATORY DOCUMENTS - DEVELOPMENT AND CONTROL
    CLSI H26 A2 : 2ED 2010 VALIDATION, VERIFICATION, AND QUALITY ASSURANCE OF AUTOMATED HEMATOLOGY ANALYZERS
    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
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