Deadline for implementation ISO 13485:2016 quality management system

Published in: CE Marking, Medical Devices
Published on: 4 February 2018

The ISO 13485:2016 standard has been published in March 2016 to replace the ISO 13485:2012 version. The 2012 version will be superseded from March 2019 after a transition period of three (3) years. This means that companies that have implemented an ISO 13485:2012 quality management system shall update their system to meet the requirements of an ISO 13485:2016 quality management system by the end of March 2019.

Companies have over one (1) year to adapt their quality management system to the requirements of the ISO 13485:2016 standard. This seems to be a long time. However, don’t underestimate the work to be done in order to fully adapt your current quality management system. A gap analysis shall indicate the required modifications, which then shall be implemented.

If your company does not have a certified quality management system for medical devices and is willing to implement a certified quality management system, then it is of upmost importance to set up and implement a quality management system in accordance with the ISO 13485:2016 standard.CE Medical can guide you through the entire process of setting up and implementing a certified quality management system for medical devices. If your company already has a certified ISO 13485:2012 quality management system, our experts can guide you through the required steps to adapt the system in order to comply with the 2016 version of the standard.


About the author
Rebecca Brust

Marketing & Sales Coördinator

Blog Posts

Find More Insights

Full-service product compliance

Leave it to us.