Skip to content
Please enter a keyword to search
  • Preview

    AS ISO 22367:2021

    Current The latest, up-to-date edition.

    Medical laboratories - Application of risk management to medical laboratories

    Available format(s):  Hardcopy, PDF 1 User, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Language(s):  English

    Published date:  16-04-2021

    Publisher:  Standards Australia

    Add To Cart

    Abstract - (Show below) - (Hide below)

    Identically adopts ISO 22367:2020, which specifies a process for a medical laboratory to identify and manage the risks associated with medical laboratory examinations. The process includes identifying, estimating, evaluating, controlling and monitoring the risks. KEYWORDS: Risk management; Medical laboratory; Clinical; Patients

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

    Committee HE-029
    Document Type Standard
    Publisher Standards Australia
    Status Current

    History - (Show below) - (Hide below)

    First published as AS ISO 22367:2021.

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

    ISO 15190:2003 Medical laboratories Requirements for safety
    ISO 14971:2019 Medical devices Application of risk management to medical devices
    ISO Guide 73:2009 Risk management — Vocabulary
    ISO/IEC Guide 51:1999 Safety aspects Guidelines for their inclusion in standards
    ISO 18113-5:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
    ISO 31000:2009 Risk management Principles and guidelines
    ISO/TR 24971:2020 Medical devices Guidance on the application of ISO 14971
    ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
    ISO/TS 22367:2008 Medical laboratories Reduction of error through risk management and continual improvement
    ISO 20916:2019 In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice
    ISO 15189:2012 Medical laboratories — Requirements for quality and competence
    IEC 61025:2006 Fault tree analysis (FTA)
    ISO/IEC Guide 99:2007 International vocabulary of metrology Basic and general concepts and associated terms (VIM)
    ISO 18113-2:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use
    IEC 60601-1:2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    ISO 18113-1:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    IEC 60812:2006 Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA)
    ISO 18113-3:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use
    IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
    ISO 18113-4:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
    View more information

    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective