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 The 2012 version will be superseded from March 2019 after a transition period of three (3) years.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.
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