ISO 13485:2016 is on the doorstep!!!

Published in March 2016, the new version of the most popular Quality Management System Standard for medical devices will be in full effect on February 28th 2019; certification to the previous version will be ending on this day. Many manufacturers, suppliers and third parties involved in the lifecycle of medical products or services will have to comply.


ISO 13485 – Medical devices — Quality management systems — Requirements for regulatory purposes……… got its first proper update since 2003. The changes may seem challenging, but the new version keeps the essence of the 2003 version. This new version is putting an emphasis on responsibility & risk-based approach on how companies should manage design, development, production all the way though the product lifecycle and post-market surveillance, because the risk never stops. You should also be aware that this new iteration is taking a lot from the ISO 9001:2008 version, that was modified last year to the ISO 9001:2015 version.

But fear not, the 13485:2016 version is not as scary as it sounds, and chances are you are probably already in line with the new version. Best way to overview these changes are to get your copy of the new standard and go directly to the page Annex A, which outlines factually those changes.


Among these changes you can find:

  • More broad definitions (Medical Device Family, Lifecycle…);
  • New Procedures (Validation of the software applications, Design Transfer, Complains processing…);
  • Additional documentation required (A “Medical device file” as well as a “design and development file” have been added, but these files were already required for CE Markings);
  • New requirements around the Control of Contamination;
  • New requirement to verify the effect of preventive, so it gives the expected results (rick assessment);
  • More clarity for non-conformities detected before or after delivery

Again, this new version is really focusing on a risk-based approach, identifying the risks to your business, as well as post market surveillance, the objective is not only patient safety, but the QMS compliancy, the respect of the regulatory requirements, suppliers and customers.

We are currently waiting for our medical accreditation body (JAS-ANZ) to confirm the guidelines regarding the shift between the 2003 to the 2016 versions, this is totally out of our hands and we cannot do anything until we are given the transition plan. As soon as we are given this we are ready to get the transition completed.

We are looking forward to offering the new version of the ISO 13485 standard to our clients globally.


If you have any medical or ISO 13485 related questions please feel free to e-mail Victor Gillet, he is our Medical Device Program Manager. His e-mail is victor@intlcert.com.

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