ISO 13485:2016 Update

The long awaited revision is finally here! For the first time since 2003, there is a new revision of the ISO 13485 standard, as of February 25, 2016. This is the 3rd edition of this standard.

Unlike ISO 9001:2015, ISO 13485:2016 has not transitioned to the high level structure. The new version is based on ISO 9001:2008. It has been recommended by the technical committee that there be a three year window from the issuance of the standard to upgrade to the 2016 revision.  For most clients on an annual surveillance cycle, that may include at least two Surveillance audits and a Recertification audit to upgrade. Organizations on a biannual audit frequency will have a few more Surveillance audits to make this transition possible.

Considering the release date of the standard, the three year certificate upgrade window will run until February 25, 2019.  Any certificate that is not upgraded by that time to comply with the requirements of the 2016 revision will be withdrawn on the effective date of February 25, 2019.

If your ISO 13485 certification also includes ISO 9001, the timing for the upgrade should coincide with the September 2018 requirement for ISO 9001:2015.

Current certifications may be upgraded to ISO 13485:2016 at any time during the registration cycle.  It may be done as part of the Recertification audit, regularly scheduled Surveillance audits, or by having a Special audit done at the organization’s preferred time.

DQS Inc. will be planning webinars in the near future to go over the changes in ISO 13485:2016 and integration with ISO 9001:2015. Webinars and updates will provide additional information for the upgrade process and will be coming soon.

We look forward to helping you prepare for your 2016 revisions!