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  • CSA Z15189 : 2003

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    MEDICAL LABORATORIES - PARTICULAR REQUIREMENTS FOR QUALITY AND COMPETENCE

    Available format(s):  Hardcopy, PDF

    Withdrawn date:  30-06-2008

    Language(s):  English

    Published date:  31-12-2002

    Publisher:  Canadian Standards Association

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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
      4.1 Organization and management
      4.2 Quality management system
      4.3 Document control
      4.4 Review of contracts
      4.5 Examination by referral laboratories
      4.6 External services and supplies
      4.7 Advisory services
      4.8 Resolution of complaints
      4.9 Identification and control of nonconformities
      4.10 Corrective action
      4.11 Preventive action
      4.12 Continual improvement
      4.13 Quality and technical records
      4.14 Internal audits
      4.15 Management review
    5 Technical requirements
      5.1 Personnel
      5.2 Accommodation and environmental conditions
      5.3 Laboratory equipment
      5.4 Pre-examination procedures
      5.5 Examination procedures
      5.6 Assuring quality of examination procedures
      5.7 Post-examination procedures
      5.8 Reporting of results
    Annex A (normative) - Correlation with ISO 9001:2001 and
                            ISO/IEC 17025:1999
    Annex B (informative) - Recommendations for protection of
                            laboratory information systems (LIS)
    Annex C (informative) - Ethics in laboratory medicine
    Bibliography

    Abstract - (Show below) - (Hide below)

    Defines requirements for quality and competence particular to medical laboratories.

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

    Document Type Standard
    Publisher Canadian Standards Association
    Status Withdrawn

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

    CSA Z22870 : 2007 : R2013 POINT-OF-CARE TESTING (POCT) - REQUIREMENTS FOR QUALITY AND COMPETENCE
    CSA Z22870:2007 POINT-OF-CARE TESTING (POCT) - REQUIREMENTS FOR QUALITY AND COMPETENCE

    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
    ISO/IEC Guide 58:1993 Calibration and testing laboratory accreditation systems General requirements for operation and recognition
    ISO 1087-1:2000 Terminology work Vocabulary Part 1: Theory and application
    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
    CLSI M29 A2 : 2ED 2001 PROTECTION OF LABORATORY WORKERS FROM OCCUPATIONALLY ACQUIRED INFECTIONS
    EN 1614 : 2006 HEALTH INFORMATICS - REPRESENTATION OF DEDICATED KINDS OF PROPERTY IN LABORATORY MEDICINE
    ISO/IEC Guide 43-1:1997 Proficiency testing by interlaboratory comparisons Part 1: Development and operation of proficiency testing schemes
    CLSI GP16 A2 : 2ED 2001 ROUTINE URINALYSIS AND COLLECTION, TRANSPORTATION, AND PRESERVATION OF URINE SPECIMENS
    CLSI GP2 A4 : 4ED 2002 CLINICAL LABORATORY TECHNICAL PROCEDURE MANUALS
    CLSI H51 A : 1ED 2002 ASSAYS OF VONWILLEBRAND FACTOR ANTIGEN AND RISTOCETIN COFACTOR ACTIVITY
    ISO/IEC 17011:2004 Conformity assessment General requirements for accreditation bodies accrediting conformity assessment bodies
    ISO 15190:2003 Medical laboratories Requirements for safety
    ISO Guide 30:2015 Reference materials Selected terms and definitions
    ISO 9001:2015 Quality management systems — Requirements
    CLSI H3 A4 : 4ED 98 PROCEDURE FOR THE COLLECTION OF DIAGNOSTIC BLOOD SPECIMENS BY VENIPUNCTURE
    ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
    CLSI C3 A3 : 3ED 97 PREPARATION AND TESTING OF REAGENT WATER IN THE CLINICAL LABORATORY
    ISO/IEC Guide 43-2:1997 Proficiency testing by interlaboratory comparisons Part 2: Selection and use of proficiency testing schemes by laboratory accreditation bodies
    ISO Guide 31:2015 Reference materials — Contents of certificates, labels and accompanying documentation
    EN 12435 : 2006 HEALTH INFORMATICS - EXPRESSION OF RESULTS OF MEASUREMENTS IN HEALTH SCIENCES
    CLSI GP5 A2 : 2ED 2002 CLINICAL LABORATORY WASTE MANAGEMENT
    CLSI GP17 A : 1ED 96 CLINICAL LABORATORY SAFETY
    ISO 3534-1:2006 Statistics — Vocabulary and symbols — Part 1: General statistical terms and terms used in probability
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