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  • CSA PLUS 15189 : 2010

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    THE ISO 15189:2007 ESSENTIALS - A PRACTICAL HANDBOOK FOR IMPLEMENTING THE ISO 15189:2007 STANDARD FOR MEDICAL LABORATORIES

    Available format(s):  Hardcopy, PDF

    Withdrawn date:  22-04-2014

    Language(s):  English

    Published date:  31-12-2009

    Publisher:  Canadian Standards Association

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

    Preface
    How to use this handbook
    Introduction
    4 Management requirements
    5 Technical Requirements
    Annexes
    A (informative) - Correlation with ISO 9001:2000 and
      ISO/IEC 17025:2005
    B (informative) - Recommendations for protection of
      laboratory information systems (LIS)
    C (informative) - Ethics in laboratory medicine
    Glossary
    Reference publications

    Abstract - (Show below) - (Hide below)

    Provides guidance on the implementation of the second edition of ISO 15189, Medical laboratories - Particular requirements for quality and competence, published in 2007.

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

    Document Type Standard
    Publisher Canadian Standards Association
    Status Withdrawn

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

    ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
    ISO 15189:2012 Medical laboratories — Requirements for quality and competence
    ISO/IEC Guide 43-1:1997 Proficiency testing by interlaboratory comparisons Part 1: Development and operation of proficiency testing schemes
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO/IEC Guide 25:1990 General requirements for the competence of calibration and testing laboratories
    ISO/IEC 17011:2004 Conformity assessment General requirements for accreditation bodies accrediting conformity assessment bodies
    ISO 15190:2003 Medical laboratories Requirements for safety
    ISO/IEC 17043:2010 Conformity assessment — General requirements for proficiency testing
    ISO 9001:2015 Quality management systems — Requirements
    ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
    ISO 9000-1:1994 Quality management and quality assurance standards — Part 1: Guidelines for selection and use
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