Software in Medical Devices, by MD101 Consulting

To content | To menu | To search

Next version of ISO 13485 postponed to 2016

Thanks to elsmar cove website, we know that the publication of the next version of ISO 13485 is postponed to 2016.
EDIT: elsmar cove forums is dead, see RIP elsmar cove.

Bye bye ISO 13485:2015,
Welcome ISO 13485:2016!

ISO TC 210 WG1

The working group in charge of writing the next version of ISO 13485 is the: ISO TC 210 WG1.
Yup, Dr Spock, what does it mean?

  • ISO TC 210 is the Technical Committee of the ISO organization, in charge of Quality management and corresponding general aspects for medical devices,
  • WG1 is the Working Group in charge of writing standards about the Application of quality systems to medical devices, namely ISO 13485.

You can pay a visit to the TC 210 page on ISO website here and browse the list of standards managed by this committee.

Result of last WG1 meeting

During the last WG1 meeting held in july, the published draft version of ISO 13485 (the one called ISO DIS 13485:201X, you've probably heard about or had a copy of the draft) was submitted to the vote of the WG 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.

A new draft (DIS) may be released by the end of the year or the beginning of next year. If it were approved, a final draft (FDIS) would be released in 2015 and the new official version in 2016.

Consequence for 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.

All in all, ISO 13485:2003 is more than 10 years old. This is a bit long for a quality management standard, compared to its sister standard ISO 9001.


1. On Thursday, 28 January 2016, 10:02 by Albert Tay

ISO 13485:2003 & ISO 14971:2009 both could be affected by ISO 9001:2015. Auditor Training is possible only after new standard is released. Certifying body needs 3 months to 6 months time to be retrained on the new standard before any company could be certified to the new standard.

All these take time. It may be possible in the future that all related standards could be changed and released around the same timing.

Add a comment

Comments can be formatted using a simple wiki syntax.

This post's comments feed