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  • DIN EN ISO 15189:2014-11

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15)

    Available format(s):  Hardcopy, PDF

    Superseded date:  08-03-2023

    Language(s):  English, German

    Published date:  01-11-2014

    Publisher:  German Institute for Standardisation (Deutsches Institut für Normung)

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

    National foreword
    National Annex NA (informative) - Bibliography
    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 15189:2012
    Bibliography

    Abstract - (Show below) - (Hide below)

    This standard is included in DIN Handbook 378.

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

    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Superseded
    Superseded By
    Supersedes

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

    DIN HDBK 378 : 3ED 2014
    DIN EN ISO 14971:2013-04 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
    DIN 58964:2015-09 Quality assurance of POCT results - Assessment criteria for comparison measurement and implementation

    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 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
    DIN SPEC 1106;DIN ISO/TS 22367:2010-06 MEDICAL LABORATORIES - REDUCTION OF ERROR THROUGH RISK MANAGEMENT AND CONTINUAL IMPROVEMENT
    ISO 19011:2011 Guidelines for auditing management systems
    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
    ISO/IEC 27001:2013 Information technology — Security techniques — Information security management systems — Requirements
    ISO 22870:2016 Point-of-care testing (POCT) — Requirements for quality and competence
    CLSI QMS13 A : 1ED 2011 QUALITY MANAGEMENT SYSTEM: EQUIPMENT
    EN 1614 : 2006 HEALTH INFORMATICS - REPRESENTATION OF DEDICATED KINDS OF PROPERTY IN LABORATORY MEDICINE
    CLSI QMS01 A4 : 4ED 2011 QUALITY MANAGEMENT SYSTEM: A MODEL FOR LABORATORY SERVICES
    DIN ISO 3534-1:2009-10 STATISTICS - VOCABULARY AND SYMBOLS - PART 1: GENERAL STATISTICAL TERMS AND TERMS USED IN PROBABILITY
    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
    DIN ISO 5725-1:1997-11 ACCURACY (TRUENESS AND PRECISION) OF MEASUREMENT METHODS AND RESULTS - PART 1: GENERAL PRINCIPLES AND DEFINITIONS
    CLSI GP31 A : 1ED 2009 LABORATORY INSTRUMENT IMPLEMENTATION, VERIFICATION, AND MAINTENANCE
    ISO/IEC Guide 99:2007 International vocabulary of metrology Basic and general concepts and associated terms (VIM)
    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
    CLSI EP15 A2 : 2ED 2006 USER VERIFICATION OF PERFORMANCE FOR PRECISION AND TRUENESS
    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
    DIN EN ISO 9000:2015-11 QUALITY MANAGEMENT SYSTEMS - FUNDAMENTALS AND VOCABULARY (ISO 9000:2015)
    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
    DIN EN ISO 9001:2015-11 QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS (ISO 9001:2015)
    ISO/IEC Guide 2:2004 Standardization and related activities General vocabulary
    CLSI I/LA33 A : 1ED 2009 VALIDATION OF AUTOMATED SYSTEMS FOR IMMUNOHEMATOLOGICAL TESTING BEFORE IMPLEMENTATION
    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
    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 QMS06 A3 : 3ED 2011 QUALITY MANAGEMENT SYSTEM: CONTINUAL IMPROVEMENT
    CLSI AUTO8 A : 1ED 2006 MANAGING AND VALIDATING LABORATORY INFORMATION SYSTEMS
    EN 12435 : 2006 HEALTH INFORMATICS - EXPRESSION OF RESULTS OF MEASUREMENTS IN HEALTH SCIENCES
    DIN EN ISO/IEC 17011:2016-09 (Draft) CONFORMITY ASSESSMENT - REQUIREMENTS FOR ACCREDITATION BODIES ACCREDITING CONFORMITY ASSESSMENT BODIES (ISO/IEC 17011:2017)
    DIN EN ISO 15194:2009-10 IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - REQUIREMENTS FOR CERTIFIED REFERENCE MATERIALS AND THE CONTENT OF SUPPORTING DOCUMENTATION
    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 27799:2016 Health informatics Information security management in health using ISO/IEC 27002
    ISO 3534-1:2006 Statistics — Vocabulary and symbols — Part 1: General statistical terms and terms used in probability
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