Let’s get straight to the point: the new ISO 13485:2016 has finally been published.

Since it has not yet been transposed as a harmonized standard, let’s get down to business so to understand how to handle the news.

The watchword? Think different… because change is in the air. Let’s see how.

The new ISO 13485:2016 doesn’t align at all with the recently issued ISO 9001:2015, but it resembles to international Good Manufacturing Practice requirements, especially the US ones (the notorious 21 CFR 820). This, compared to the previous version, details the and extends the requirements in several ways(software in production validation, Medical Device File section 4.2.3 that really resembles the 21 CFR 820.181 Device Master Record , for example).

Moreover, the standard scope widens greatly: this applies not only to medical device manufacturers, but also to all organizations involved in the production cycle several aspects (from design to distribution). It is important to point out how the definitions of importer and distributor are reported, which are also mentioned several times in the new in progress Regulations on Medical Devices and IVDs.

Those working in the Regulatory Affairs will be glad to know that the international Regulation compliance is highly mentioned, as it should be. Therefore, the RA role is more and more synergistically combined with the company QA (Quality Assurance).

But let us come on to the subject. In addition to everything already mentioned, the most relevant news relate to the following aspects:

  • including the Risk Management in the whole Quality Management System, from the production to the post-market analysis;
  • as regards design, more stringent requirements on verification and validation activities, and a paragraph entirely dedicated to Design Transfer (7.3.8), that is the design transfer during production; even the Design and Development Files (7.3.10) will be included so similar to the US Design History File (DHF, 21 CFR 820.30);
  • more intensive controls and statistics on suppliers activities (7.4.1);
  • the need of firmware/software evaluation, whether Quality System documents management (4.1.6) or during production and technical assistance (7.5.6, 7.6);
  • detailed instructions on claims management (8.2.2) and related reporting activities (8.2.3).

So, have you already thought about the approach strategy to the new ISO 13485:2016? Have you got in mind any news or action? No? Contact us now!


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THEMA - Logo TRASPARENTE_smallMarisa Testa
QA/RA Manager