ISO 13485:2016 – Transition Timeline

ISO 13485 was revised and released on March 1, 2016. The transition to the new revision of this standard will occur over a three-year period ending on March 1, 2019. This means all companies certified to ISO 13485:2003 will need to conduct an upgrade audit at their regular audit cycle (recertification or surveillance) prior to that date.

As ASR schedules your audits for 2017 and 2018 we will ask about your readiness and timing for the upgrade and a new contract will be issued reflecting the new standard and additional audit time for the upgrade audit.

This new version of ISO 13485 does not align with ISO 9001:2015 and maintains the structure of ISO 9001:2008 with increased emphasis on risk and regulatory requirements. The standard does contain Annexes correlating back to ISO 13485:2003 as well as ISO 9001:2015.

If you have any questions on this transition please contact Tom Droog at 888-891-9002 or This email address is being protected from spambots. You need JavaScript enabled to view it.

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  • IATF 16949
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Medical Devices

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  • Emergency Situations


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