NEW Revision to ISO 13485:201x postponed to 1Q 2016

The publication of the next version of ISO 13485 is postponed to 2016. Welcome ISO 13485:2016!

During the last meeting of the Technical Committee Working Group held in July, the published draft version of ISO 13485 was submitted to the vote of the Working Group members. The draft was not approved.

There will be a new round of comments / changes / approval, which makes the objective of publishing the final version in 2015 very unlikely.

Revision of standards

The new standards need to be more applicable to the entire supply chain in the medical device industry, to be relevant to suppliers of components and services, as well.

Huge emphasis has been placed on risk management, due to the fact that notified bodies and international regulatory authorities are now paying greater attention to it.

After the Poly Implant Prothèse (PIP) breast implant scandal and the resulting international regulatory scrutiny around product safety — including unannounced audits from notified body — the working group wants to ensure that the quality standard covers all aspects of the product lifecycle.

The subject areas in discussion continue to be broadly consistent with that outlined in the Design Specification including:

  • Management responsibility
  • Corrective Action Preventative Action (CAPA)
  • Software validation
  • Supply chain
  • Outsourcing
  • Risk management
  • Post market activities
  • Process validation
  • Product lifecycle management
  • Annex Z’s to EN ISO 13485
  • Alignment with ISO 9001 etc.


Points of interest

  • A Transition Period of three years will apply.
  • The format of the new Standard will NOT follow the High-Level requirement (Annex SL) now applicable to all Management System Standards. It will stick with the current structure. This will create a ‘bit of a nightmare’ for organizations certified to two or more management system Standards – not to mention the difficulties of including compliance into an Integrate Management System (an illusionary prospect in any case).
  • The revised Standard has been drafted to take recognizance not only of existing European Medical Devices Directives but also the proposed European Medical Device Regulations when they are published.
  • Over the next few years there will be much change to EU/EFTA medical device regulation with the revision of the three main Medical Device Directives, and the introduction of new requirements for Notified Bodies, including the focus on Unannounced Audits of Notified Bodies.


Consequence for the manufacturers

We’ll probably have to wait for 2016 to see the next official version of ISO 13485.

This can be seen as good news:

  • No need to update the QMS, quality managers can take a (short) breath,
  • They can focus on daily business,
  • They can focus on other normative changes in the meantime (e.g. 60601 standards series).


This can also be seen as bad news:

  • Odds are high that the future European regulations come into force when the next version of ISO 13485 is published, requiring to update the QMS on both sides at the same time,
  • ISO 9001 is going its own way at its own pace. Odds are high that the next and fully refactored version of ISO 9001 becomes mandatory long before ISO 13485 is in turn refactored. Companies claiming ISO 13485 and ISO 9001 will have to do the splits to reconcile their QMS with both standards.


Next steps

The last draft published in February 2014 received more than 870 comments that were reviewed and revised text compiled. T he committee will reconvene in early December to continue their work. A new draft will be published and sent out for further comment, and then that round of comments must be incorporated into a third revision (3Q 2015)

If it were approved, a final draft (FDIS) would be released in 2015 and the new official version in 2016.

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