Transition from ISO 13485: 2012 to ISO 13485: 2016

Would you Like Assistance Transitioning your Existing Management System?

The latest version of the standard, ISO 13485: 2016, was published in March 2016 and is the new yardstick against which businesses manufacturing quality-assured, medical devices will be measured. By March 2019, all organisations already registered to ISO 13485 must have transitioned their management systems to the 2016 version of the standard or lose their certification.


If you would like any assistance meeting the requirements of this International Standard, CE-marking your medical device, or transitioning your existing quality management system to the requirements of the latest version of the Standard, then please Contact Us.


* The new version of ISO 9001: 2015 is re-structured to reflect the higher-level structure (HLS) of Annex SL. The new version of ISO 13485, which was issued in 2016, does not reflect the HSL, meaning that the two Standards are no longer aligned, making integration of the two Standards more challenging.