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  • BIS IS/ISO 15189 : 2012

    View superseded by
    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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

    Available format(s): 

    Superseded date:  06-04-2023

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Bureau of Indian Standards

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

    NATIONAL FOREWORD
    1 Scope
    2 Normative references
    3 Terms and conditions
    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 15189:2012
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes requirements for quality and competence in medical laboratories.

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

    Committee MHD 14
    Document Type Standard
    Publisher Bureau of Indian Standards
    Status Superseded
    Superseded By

    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
    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 GP37 P : 1ED 2011 QUALITY MANAGEMENT SYSTEM: EQUIPMENT
    CLSI H18 P : LATEST PROCEDURES FOR THE HANDLING AND PROCESSING OF BLOOD SPECIMENS
    CLSI QMS13 A : 1ED 2011 QUALITY MANAGEMENT SYSTEM: EQUIPMENT
    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
    CLSI H3 A5 : 5ED 2003 PROCEDURES FOR THE COLLECTION OF DIAGNOSTIC BLOOD SPECIMENS BY VENIPUNCTURE
    BIS IS/ISO/IEC 17000 : 2004 CONFORMITY ASSESSMENT - VOCABULARY AND GENERAL PRINCIPLES
    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 C3 P4 : 4ED 2005 PREPARATION AND TESTING OF REAGENT WATER IN THE CLINICAL LABORATORY
    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
    ISO/IEC Guide 99:2007 International vocabulary of metrology Basic and general concepts and associated terms (VIM)
    CLSI GP21 A2 : 2ED 2004 TRAINING AND COMPETENCE ASSESSMENT
    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
    CLSI EP32 R : 1ED 2006 METROLOGICAL TRACEABILITY AND ITS IMPLEMENTATION
    CLSI GP32 P : 1ED 2007 MANAGEMENT OF NONCONFORMING LABORATORY EVENTS
    BIS IS/ISO/IEC 17025 : 2005 AMD 1 GENERAL REQUIREMENTS FOR THE COMPETENCE OF TESTING AND CALIBRATION LABORATORIES
    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 GP26 A3 : 3ED 2004 APPLICATION OF A QUALITY MANAGEMENT SYSTEM MODEL FOR LABORATORY SERVICES
    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
    ISO/IEC Guide 2:2004 Standardization and related activities General vocabulary
    CLSI C28 P3 : 3ED 2008 DEFINING, ESTABLISHING, AND VERIFYING REFERENCE INTERVALS IN THE CLINICAL LABORATORY
    CLSI GP22 A2 : 2ED 2004 CONTINUOUS QUALITY IMPROVEMENT: INTEGRATING FIVE KEY QUALITY SYSTEM COMPONENTS
    CLSI GP42 A6 : 6ED 2008 PROCEDURES AND DEVICES FOR THE COLLECTION OF DIAGNOSTIC CAPILLARY BLOOD SPECIMENS
    CLSI GP18 A : 1ED 98 LABORATORY DESIGN
    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 H4 A5 : 5ED 2004 PROCEDURES AND DEVICES FOR THE COLLECTION OF DIAGNOSTIC CAPILLARY BLOOD SPECIMENS
    CLSI C54 P : 1ED 2007 VERIFICATION OF COMPARABILITY OF PATIENT RESULTS WITHIN ONE HEALTH CARE SYSTEM
    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 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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