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    NSAI/ISO Guide to ISO 13485:2016

    Current The latest, up-to-date edition.

    Medical Devices a practical guide Advice from ISO/TC 210

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  17-11-2017

    Publisher:  National Standards Authority of Ireland

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

    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 — Guidance for small organizations
    Bibliography

    Abstract - (Show below) - (Hide below)

    This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide This International Standard specifies requirements for a quality management and applicable regulatory requirements.

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

    Committee TC 210
    Document Type Guide
    Product Note THIS STANDARD ALSO REFERS TO ISO 27001, ISO 62366-1:2015, IEC/ISO 62366-1
    Publisher National Standards Authority of Ireland
    Status Current
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