Updating ISO 9001 and ISO 13485

Answer:

Bot ISO 9001 and ISO 13485 have new versions, so if you implemented old versions of these standards, you need to make transition to the new versions in order to maintain the certificates. The deadline for the transition is September 2018.

If you have only ISO 9001:2008, then you only need to make transition to ISO 9001:2015. Here is one interesting article that can help you: Infographic: ISO 9001:2015 vs. 2008 revision – What has changed? https://advisera.com/9001academy/knowledgebase/infographic-iso-90012015-vs-2008-revision-what-has-changed/ Good thing with having ISO 9001:2008 implemented is that ISO 13485:2016 is based on ISO 9001:2008 and you can keep all the documents and make addition to become compliant with ISO 13485:2016, for more information, see Inf ographic: What’s new in the 2016 revision of ISO 13485 https://advisera.com/13485academy/blog/2016/12/06/infographic-whats-new-in-the-2016-revision-of-iso-13485/