Language:
    • Available Formats
    • Options
    • Availability
    • Priced From ( in USD )
    • Secure PDF

      Secure PDF Files

      Secure PDF files include digital rights management (DRM) software. DRM is included at the request of the publisher, as it helps them protect their copyright by restricting file sharing. In order to read a Secure PDF, you will need to install the FileOpen Plug-In on your computer. The FileOpen Plug-In works with Adobe Reader and other viewers. Visit FileOpen to see the full list.

        What you can do with a Secure PDF:
      • Print
      • Search
      • Highlight
      • Bookmark
      Please note that some publishers - including IADC and NRC - do not allow printing of their documents.

    • 👥
    • Immediate download
    • $289.56
    • Add to Cart
    • Printed Edition
    • Ships in 1-2 business days
    • $289.56
    • Add to Cart
    • Printed Edition + PDF
    • Immediate download
    • $391.16
    • Add to Cart

Customers Who Bought This Also Bought

 

About This Item

 

Full Description

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.

You should use ISO 13485:2016 to show that you have commitment to quality through an internationally recognized standard.

By using ISO 13485:2016 you'll be able to:
  • Demonstrate compliance with regulatory and legal requirements
  • Ensure the establishment of quality management system practices that consistently yield safe and effective medical devices
  • Manage risk effectively
  • Improve processes and efficiencies
  • Gain a competitive advantage
 

Document History

  1. BS EN ISO 13485:2016

    👀currently
    viewing


    Medical devices. Quality management systems. Requirements for regulatory purposes

    • Most Recent
  2. BS EN ISO 13485:2012


    Medical devices. Quality management systems. Requirements for regulatory purposes

    • Historical Version
  3. BS EN ISO 13485:2003


    Medical devices. Quality management systems. Requirements for regulatory purposes

    • Historical Version
  4. BS EN ISO 13488:2001


    Quality systems. Medical devices. Particular requirements for the application of EN ISO 9002

    • Historical Version
  5. BS EN ISO 13485:2001


    Quality systems. Medical devices. Particular requirements for the application of EN ISO 9001

    • Historical Version
  6. BS EN 46003:1999


    Quality systems. Medical devices. Particular requirements for the application of EN ISO 9003

    • Historical Version
  7. BS EN 46001:1997


    Specification for application of EN ISO 9001 to the manufacture of medical devices

    • Historical Version
  8. BS EN 46002:1997


    Specification for application of EN ISO 9002 to the manufacture of medical devices

    • Historical Version