On March 1, 2016 the ISO published the new standard ISO 13485:2016 applicable to the quality system management of the medical companies.

A wind of change is evident. First of all the new standard is not actually in line with the ISO 9001:2015 but very like to the international Good Manufacturing Practice, in particular to the U.S. 21 CFR 820 and often refers to the applicable regulations.

Secondly, the applicability of the standard is wider: not only requirements for medical device manufacturers but also organizations involved in one or more stages of the life-cycle of a medical device, including design, production, distribution, etc.

Other major highlights here below:

  • risk management evaluation in all the company quality system;
  • for Design controls, more restrictive verification and validation activities, attention to the Design Transfer (7.3.8) and to Design and development files (7.3.10, so close to the U.S. Design History File);
  • more intense controls and statistics on the supplier activities (7.4.1);
  • firmware/software validation, i.e. used to managed the quality system;
  • documentation (4.1.6) or in production and servicing (7.5.6, 7.6);
  • detailed complaint management (8.2.2) and reporting activities (8.2.3).


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