ISO 13485:2016 Medical Devices

ISO published the final draft of the latest ISO 13485 quality management standard for medical devices and placed it out for voting on October 29, 2015. Therefore, publication of the 2016 version of ISO 13485 happened on March 1 2016. There is to be a three-year transition period. Of note, there is now rather of a difference between ISO 13485 and the newly published ISO 9001:2015 standard, of which companies that are certifying to both will essential to take into account.

ISO 13485 is the international standard that defines quality management system needs for organizations that are or may be involved in one or more stages of the life-cycle, including design and progress, production, storage and distribution, installation, or servicing of a medical device, and design and progress or provision of associated activities such as technical maintenance. ISO 13485:2016 can also be used by suppliers or external parties that deliver product and quality management system-related services to such organizations.

Key updates to the ISO 13485 revision include:

  • A broader focus on risk throughout the standard’s clauses, needful more senior management contribution in the quality management system
  • Greater supplier controls, including risk-based controls
  • Additional management review needs
  • The integration of competency with training needs
  • A focus on needs for software
  • Validation using pre-clinical and clinical evaluations
  • Validation of packaging and distribution necessities
  • A feedback section, including a new complaint-handling section and other direction for client communications
  • Additional enhancement measures: adding the use of post-market surveillance, risk-based choices, and timelines