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ISO 13485:2016

ISO 13485:2016 Quality Management System (QMS) Standard for Medical Devices


ISO 13485:2016 is the main Quality Management System (QMS) standard for medical devices. The United States plans to harmonize the Food and Drug Administration (FDA) requirements for medical devices with ISO 13485:2016. The scope of the QMS can be tailored for an organization.

ISO 13485:2016 requires the certified organization to demonstrate the quality system is effectively implemented and maintained.  

Other Specifics Include:

  • The promotion and awareness of regulatory requirements as a management responsibility;

  • Controls in the work environment to ensure product safety;

  • Focus on risk management activities and design controls activities during product development;

  • Specific requirements for inspection and traceability for implantable devices;

  • Specific requirements for documentation and validation of processes for sterile medical devices;

  • Specific requirements for verification of the effectiveness of corrective and preventive actions;

  • Specific requirements for cleanliness of products;

  • Additional requirements for preventing contamination;

  • Monitoring focuses on meeting customer requirements, rather than on subjective customer satisfaction measures;

  • Multiple documentation requirements at all stages of product development;

  • Focus on maintaining the effectiveness of the quality management system instead of continual improvement;

  • Additional requirements for regulatory reporting, advisory notices, and recalls.


Organizations that use this standard include:

  • Manufacturers of medical devices;

  • Organizations that supply products or raw materials to medical device manufacturers;

  • Quality management organizations that contract to medical device manufacturers;

  • Organizations that provide services to medical device manufacturers;

  • Makers of sterile medical devices;

  • Manufacturers of surgical medical devices.

To become ISO 13485:2016 certified, your organization must:

Have a gap analysis to determine how much needs to be done to get certified.

Get implemented to ISO 13485:2016 quality management system.

A Registrar audits the performance of your organization against the latest version of the ISO 13485:2016 Requirements.

The organization must be re-certified every three years to maintain its ISO 13485:2016 certification status.

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