Do I need to certify to ISO 13485:2016?


Scott Fine
If a company held a valid ISO 13485:2003 certification, but it lapsed due to a lack of a surveillance audit (financial issues), would the company now need to certify to the 2016 standard or can it still certify to 2003 and re-certify to 2016 in a year or two?

Thanks for your assistance.


Scott Fine
Thank you, Ronen.
It's great to have this forum back and be able to share the knowledge of those more experienced than I.
Cheers Mate.


Inactive Registered Visitor
Could you elaborate on that? What would constitute NOT having to certify to the newest revision of 13485?

When you certify to a standards, you are probably under a certification scheme (if not, your are probably being scammed :)). The rules of the certification scheme define the requirements. If the rules says that the certification is for the 2003 version, even if the 206 is already out, you will be certified to the 2003 version, not the new one.

I just mentioned this in a general way, because a lot of people thinks that because ISO 13485:2016 is out, there's an automatic need to certify to the new standard. ISO TC 210 WG 1 even published a suggested transition period, but this document is only a suggestion to the certification schemes (although it;s usually followed) - meaning, the certification schemes have to define the need to change to the new standard.
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