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  • EN ISO 13485:2016/AC:2018

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES (ISO 13485:2016)

    Available format(s): 

    Superseded date:  18-09-2021

    Language(s): 

    Published date:  28-03-2018

    Publisher:  Comite Europeen de Normalisation

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

    European foreword
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Quality management system
    5 Management responsibility
    6 Resource management
    7 Product realization
    8 Measurement, analysis and improvement
    Annex A (informative) - Comparison of content between
            ISO 13485:2003 and ISO 13485:2016
    Annex B (informative) - Correspondence between ISO 13485
            :2016 and ISO 9001:2015
    Bibliography
    Annex ZA (informative) - Relationship between this
             European Standard and the Conformity Assessment
             Requirements of EU Directive 90/385/EEC (as amended)
    Annex ZB (informative) - Relationship between this
             European Standard and the Conformity Assessment
             Requirements of EU Directive 93/42/EEC (as amended)
    Annex ZC (informative) - Relationship between this
             European Standard and the Conformity Assessment
             Requirements of EU Directive 98/79/EC

    Abstract - (Show below) - (Hide below)

    Provides requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

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

    Committee TC 3
    Development Note Supersedes EN 46001. (03/2001) Supersedes EN ISO 13488. (08/2003) Supersedes EN 46003. (07/2007) Supersedes CEN ISO/TR 14969. (02/2017)
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Superseded
    Superseded By

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

    ISO 19011:2011 Guidelines for auditing management systems
    ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
    ISO 10012:2003 Measurement management systems — Requirements for measurement processes and measuring equipment
    ISO 9001:2015 Quality management systems — Requirements
    ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    EN ISO 9000:2015 Quality management systems - Fundamentals and vocabulary (ISO 9000:2015)
    View more information

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