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Full Description

ISO 13485:2016 Plus Redline specifies requirements for a quality management system that can be used by an organization involved in one or more stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and design and development, or provision of associated activities (e.g. technical support). The requirements in this International Standard can also be used by suppliers or other external parties providing product (e.g. raw materials, components, subassemblies, medical devices, sterilization services, calibration services, distribution services, maintenance services) to such organizations. The supplier or external party can voluntarily choose to conform to the requirements of this International Standard or can be required by contract to conform.
 

Document History

  1. ISO 13485:2016 Plus Redline

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    Medical devices - Quality management systems - Requirements for regulatory purposes

    • Historical Version
  2. ISO 13485:2016


    Medical devices - Quality management systems - Requirements for regulatory purposes

    • Most Recent
  3. ISO 13485 AND 14969 PACKAGE


    ISO 13485:2003 and ISO/TR 14969:2004 Quality Managment Systems Medical Devices Package

    • Historical Version
  4. ISO/TR 14969:2004


    Medical devices - Quality mangement systems - Guidance on the application of ISO 13485: 2003

    • Historical Version
  5. ISO 13485:2003


    Medical devices - Quality management systems - Requirements for regulatory purposes

    • Historical Version
  6. ISO 13485:1996


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

    • Historical Version