Cookies on CSA Group

We use Cookies to create a secure and effective website experience for our customers. For more information about Cookies and how you can disable Cookies, visit our privacy policy page. Learn More

logo close
Privacy Preference Centre

Please manage your cookie choices by switching the consent toggles on or off under the Purposes below.

You may change your preference at any time as described in our Cookie Policy

  • Cookie Settings
  • List of Cookies
close
    Skip to content
    CSA Store
    • CSA Group
    • CSA OnDemand™
    • CSA Communities
    • Contact Us
    • Catalogue
      • Browse By Subject Area

        • Electrical
        • Fuels & Transportation
        • Petroleum & Natural Gas
        • Environment & Natural Resources
        • Construction & Infrastructure
        • Mechanical & Industrial Equipment
        • Nuclear
        • Health Care and Well-being
        • Worker & Public Safety
        • Management Systems
      • Browse By Publisher

        • ASME
        • ASTM
        • CSA Group
        • ESA
        • IEC
        • ISO
        • NRC
        • ORNAC
        • TSSA
      • ICS Catalogue

        • Browse by International Classification of Standards (ICS Codes)
    • Subscription
      • Browse By Subject Area

        • Electrical
        • Fuels & Transportation
        • Petroleum & Natural Gas
        • Environment & Natural Resources
        • Construction & Infrastructure
        • Mechanical & Industrial Equipment
        • Nuclear
        • Health Care and Well-being
        • Worker & Public Safety
        • Management Systems
      • CSA Subscriptions

        • Why choose subscriptions?
        • About CSA Advantage™
        • About CSA OnDemand™
        • CSA OnDemand™ Collections
      • ICS Catalogue

        • Browse by International Classification of Standards (ICS Codes)
    • Services
    Cart Icon0
    ×
    Login / Register
    English / CAD

    Language

    en

    fr

    Currency

    CAD

    USD

    • CSA Group
    • CSA OnDemand™
    • CSA Communities
    • Contact Us
    Wishlist

    Catalogue

    • Browse By Subject Area

      • Electrical
      • Fuels & Transportation
      • Petroleum & Natural Gas
      • Environment & Natural Resources
      • Construction & Infrastructure
      • Mechanical & Industrial Equipment
      • Nuclear
      • Health Care and Well-being
      • Worker & Public Safety
      • Management Systems
    • Browse By Publisher

      • ASME
      • ASTM
      • CSA Group
      • ESA
      • IEC
      • ISO
      • NRC
      • ORNAC
      • TSSA
    • ICS Catalogue

      • Browse by International Classification of Standards (ICS Codes)

    Subscription

    • Browse By Subject Area

      • Electrical
      • Fuels & Transportation
      • Petroleum & Natural Gas
      • Environment & Natural Resources
      • Construction & Infrastructure
      • Mechanical & Industrial Equipment
      • Nuclear
      • Health Care and Well-being
      • Worker & Public Safety
      • Management Systems
    • CSA Subscriptions

      • Why choose subscriptions?
      • About CSA Advantage™
      • About CSA OnDemand™
      • CSA OnDemand™ Collections
    • ICS Catalogue

      • Browse by International Classification of Standards (ICS Codes)

    Services

    Menu toggle Icon
    Login / Register
    English / CAD

    Language

    en

    fr

    Currency

    CAD

    USD

    Wishlist Cart (
    )

    Search Section

      • Home
      • CSA Group
      • Health Care and Well-being
      • Health Care
      • Medical Device Management
      • CSA ISO 13485:16 (R2021)

      Codes & Standards - Purchase

      CSA ISO 13485:16 (R2021)

      Medical devices - Quality management systems - Requirements for regulatory purposes (Adopted ISO 13485:2016, third edition, 2016-03-01)
      SKU: 2425077 Published by CSA Group Publication Year 2016 Reaffirmed in 2021 55 pages

      View Access for this document is only available for viewers in Canada

      Product Details

      • Preface/Scope
      • Editions

      CSA Preface


      This is the third edition of CAN/CSA-ISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 13485 (third edition, 2016-03-01). It supersedes the previous edition published in 2003 as CAN/CSA-ISO 13485 (adopted ISO 13485:2003).


      For brevity, this Standard will be referred to as “CAN/CSA-ISO 13485” throughout.


      This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group.


      Scope


      This International Standard specifies 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. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). This International Standard can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.


      Requirements of this International Standard are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.


      The processes required by this International Standard that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization’s quality management system by monitoring, maintaining, and controlling the processes.


      If applicable regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulatory requirements can provide alternative approaches that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity to this International Standard reflect any exclusion of design and development controls.


      If any requirement in Clauses 6, 7 or 8 of this International Standard is not applicable due to the activities undertaken by the organization or the nature of the medical device for which the quality management system is applied, the organization does not need to include such a requirement in its quality management system. For any clause that is determined to be not applicable, the organization records the justification as described in 4.2.2.

      items 1 - of 2 result(s)
      View 20 | View 100

      CAN/CSA-ISO 13485-03 (R2013)

      CAN/CSA-ISO 13485-03 (R2013) - Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes (Adopted ISO 13485:2003, second edition, 2003-07-15)

      Withdrawn

      CAN/CSA-ISO 13485-98 (R2001)

      Quality Systems - Medical Devices - Particular Requirements for the Application of ISO 9001 (Adopted ISO 13485:1996)

      Withdrawn
      copyright imgRequest Copyright Permissions

      Buy

      Language

      Radio input
      Radio input

      Format

      Radio input
      Radio input
      • Free updates to the latest version
      • Access historical versions
      • Access all supported languages
      Learn More
      • FAQs
      • Contact Us
      • Email Product

      GST REG No R119441681
      QST REG No R1006017360

      Compare Formats

      Determine the subscription format that is right for you.

      Select the subscription format that is right for you. Table with 13 rows and 3 columns, identifies features available and not available for the two different subscription formats - CSA Advantage TM and CSA OnDemand TM
      Features CSA AdvantageTM CSA OnDemandTM
      Offline access CSA AdvantageTM. feature available. Offline access CSA OnDemandTM. feature available. Offline access
      Full-text search CSA AdvantageTM. feature available. Full-text search CSA OnDemandTM. feature available. Full-text search
      Create highlights and personal notes CSA AdvantageTM. feature available. Create highlights and personal notes CSA OnDemandTM. feature available. Create highlights and personal notes
      Newest editions added automatically CSA AdvantageTM. feature available. Newest editions added automatically CSA OnDemandTM. feature available. Newest editions added automatically
      Includes all supported languages and archive versions CSA AdvantageTM. feature not available. Includes all supported languages and archive versions CSA OnDemandTM. feature available. Includes all supported languages and archive versions
      My Files - create customized files by adding multiple clauses, tables or figures from the standard into your own personal File for quick reference CSA AdvantageTM. feature available. My Files - create customized files by adding multiple clauses, tables or figures from the standard into your own personal File for quick reference CSA OnDemandTM. feature not available. My Files - create customized files by adding multiple clauses, tables or figures from the standard into your own personal File for quick reference
      Toggle between your files and the full standard to maintain context CSA AdvantageTM. feature available. Toggle between your files and the full standard to maintain context CSA OnDemandTM. feature not available. Toggle between your files and the full standard to maintain context
      Instantly preview cross referenced material within the book CSA AdvantageTM. feature available. Instantly preview cross referenced material within the book CSA OnDemandTM. feature not available. Instantly preview cross referenced material within the book
      Export personal notes to Excel CSA AdvantageTM. feature available. Export personal notes to Excel CSA OnDemandTM. feature not available. Export personal notes to Excel
      Transfer notes and highlights when updates are available CSA AdvantageTM. feature available. Transfer notes and highlights when updates are available CSA OnDemandTM. feature not available. Transfer notes and highlights when updates are available
      Adobe Reader PDF and browser compatible for iOS and Android CSA AdvantageTM. feature not available. Adobe Reader PDF and browser compatible for iOS and Android CSA OnDemandTM. feature available. Adobe Reader PDF and browser compatible for iOS and Android
      Web, Android, iOS Compatible CSA AdvantageTM. feature available. Web, Android, iOS Compatible CSA OnDemandTM. feature not available. Web, Android, iOS Compatible

      Follow Us On Social Media

      Get Our Newsletter

      Get CSA Newsletter

      • About CSA Store
      • Subscription
      • Services
      • Catalogue
      • FAQ
      • Return Policy
      • FULFILLMENT DETAILS
      • EBOOK SUPPORT
      • Product Updates
      • Contact Us
      • CSA GROUP
      • CSA COMMUNITIES
      • CSA Update Service
      • About CSA Store
      • Subscription
      • Services
      • Catalogue
      • FAQ
      • Return Policy
      • FULFILLMENT DETAILS
      • EBOOK SUPPORT
      • Product Updates
      • Contact Us
      • CSA GROUP
      • CSA COMMUNITIES
      • CSA Update Service

      • General Terms and Conditions
      • Privacy Policy
      • Accessibility
      © 2023 Canadian Standards Association. All rights reserved

      Free Login/Registration Required

      View Access for this document is only available for viewers in Canada.

      A free user account is required to view this document.

      Login or Register