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  • ECA ILAC G26 : 2012

    Current The latest, up-to-date edition.

    GUIDANCE FOR THE IMPLEMENTATION OF A MEDICAL LABORATORY ACCREDITATION SYSTEM

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    Published date:  12-01-2013

    Publisher:  European Co-operation for Accreditation

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

    PREAMBLE
    PURPOSE
    AUTHORSHIP
    1 ISO 15189 and Medical Laboratories
    2 Unique Elements of ISO 15189
    3 Development and Maintenance of Accreditation
      Programs
    4 Factors for Accreditation Bodies to Consider
      When Implementing an ILAC Accreditation System
      for Medical Laboratories using ISO 15189
    5 Companion Documents
    6 Assessment Teams
    7 Scope of Accreditation
    ANNEX A - Key Differences Between ISO 15189:2007
              and ISO/IEC 17025:2005
    REFERENCES

    Abstract - (Show below) - (Hide below)

    Describes key aspects of the standard, points out its unique elements and gives advice for the development and maintenance of an accreditation program that is based on ISO 15189.

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

    Document Type Standard
    Publisher European Co-operation for Accreditation
    Status Current

    Standards Referencing This Book - (Show below) - (Hide below)

    ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
    ISO 22870:2016 Point-of-care testing (POCT) — Requirements for quality and competence
    ECA ILAC P9 : 2014 ILAC POLICY FOR PARTICIPATION IN PROFICIENCY TESTING ACTIVITIES
    ISO 15189:2012 Medical laboratories — Requirements for quality and competence
    ECA 4-17 : 2008 EA POSITION PAPER ON THE DESCRIPTION OF SCOPES OF ACCREDITATION OF MEDICAL LABORATORIES
    ECA ILAC G22 : 2004 USE OF PROFICIENCY TESTING AS A TOOL FOR ACCREDITATION IN TESTING
    ECA ILAC G11 : 2006 GUIDELINES ON QUALIFICATIONS AND COMPETENCE OF ASSESSORS AND TECHNICAL EXPERTS
    ECA ILAC G18 : 2010 GUIDELINE FOR THE FORMULATION OF SCOPES OF ACCREDITATION FOR LABORATORIES
    ISO 15190:2003 Medical laboratories Requirements for safety
    ISO/IEC 17043:2010 Conformity assessment — General requirements for proficiency testing
    ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
    ECA ILAC P10 : 2013 ILAC POLICY ON TRACEABILITY OF MEASUREMENT RESULTS
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