ISO 13485:2016 Medical Devices Standard Published


ISO 13485:2016 establishes the requirements for a quality management system specific to the medical devices industry. It has been revised to respond to the latest developments in quality management, technology and regulatory requirements that relate to the industry.

Improvements in the new version of the standard include broadening its applicability to include all organizations involved in the life cycle of the product, from concept to end of life, greater alignment with regulatory requirements and a greater focus on post-market surveillance including complaint handling.

There is also a greater emphasis on having the appropriate infrastructure, particularly for the production of sterile medical devices, and more focus on risk management.

Some of the changes to the new standard avoid the ISO 9001:2015 standard new requirements. Examples include:

  • No alignment to high level Annex SL
  • No requirement for Context of the organization
  • Emphasizes risk-based QMS, but not “risk-based thinking” as ISO 9001:2015
  • Requires a Quality Manual
  • Avoids the confusing term “documented information,” retains documents and records
  • Maintains approach to preventive action
  • New “design and development transfer” clause added
  • Additional language on complaints handling and regulatory communication
The ISO 13485:2016 Standard is available for purchase through the ANSI Website.  Contact us with questions and for further information on how we can support your future ISO 13485:2016 Transition Needs.


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