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  • CLSI EP18 A : 1ED 2002

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    QUALITY MANAGEMENT FOR UNIT-USE TESTING

    Available format(s): 

    Superseded date:  30-08-2007

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Clinical Laboratory Standards Institute

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    Abstract - (Show below) - (Hide below)

    Covers quality management system for unit-use devices that will aid in the identification, understanding and management of sources of error and help to ensure correct results.

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

    Development Note Supersedes NCCLS EP18 P. (02/2003)
    Document Type Miscellaneous Product
    Publisher Clinical Laboratory Standards Institute
    Status Superseded
    Superseded By
    Supersedes

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

    DD CEN ISO/TS 22367:2010 Medical laboratories. Reduction of error through risk management and continual improvement
    CLSI EP25 A : 1ED 2009 EVALUATION OF STABILITY OF IN VITRO DIAGNOSTIC REAGENTS
    BS ISO 17593:2007 Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
    ISO 15198:2004 Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer
    CLSI POCT4 A2 : 2ED 2006 POINT-OF-CARE IN VITRO DIAGNOSTIC (IVD) TESTING
    ISO 17593:2007 Clinical laboratory testing and in vitro medical devices Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
    CLSI EP27 P : 1ED 2009 HOW TO CONSTRUCT AND INTERPRET AN ERROR GRID FOR DIAGNOSTIC ASSAYS
    CLSI POCT7 P : 1ED 2009 QUALITY MANAGEMENT: APPROACHES TO REDUCING ERRORS AT THE POINT OF CARE
    BS ISO 15198:2004 Clinical laboratory medicine. In vitro diagnostic medical devices. Validation of user quality control procedures by the manufacturer
    UNI CEN ISO/TS 22367 : 2010 MEDICAL LABORATORIES - REDUCTION OF ERROR THROUGH RISK MANAGEMENT AND CONTINUAL IMPROVEMENT
    DD ISO/TS 22367 : 2008 MEDICAL LABORATORIES - REDUCTION OF ERROR THROUGH RISK MANAGEMENT AND CONTINUAL IMPROVEMENT
    CLSI POCT13 A2 : 2ED 2005 GLUCOSE MONITORING IN SETTINGS WITHOUT LABORATORY SUPPORT
    S.R. CEN ISO TS 22367:2010 MEDICAL LABORATORIES - REDUCTION OF ERROR THROUGH RISK MANAGEMENT AND CONTINUAL IMPROVEMENT
    ISO/TS 22367:2008 Medical laboratories Reduction of error through risk management and continual improvement
    CEN ISO/TS 22367:2010 Medical laboratories - Reduction of error through risk management and continual improvement (ISO/TS 22367:2008, including Cor 1:2009)
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