Need for ISO 9001:2015 if we are ISO 13485:2016


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Hello everyone :bigwave:,

I am really glad :D to meet all of you here, again, after so much silence....;)
We are currently certified to ISO 9001:2008 and ISO 13485:2003. We are now evaluating the future certification.
Please let me know your comments on if we can just look for certification according to ISO 13485:2016 and give up the ISO 9001:2015?

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Re: Need for ISO 9001:2015

If your company only produces / markets medical devices, there is no need to maintain ISO 9001 certification, as the scope of the ISO 13485 will contain all activities and product technologies.
If you also market other products, the ISO 13485 scope will not cover those activities. Then you should maintain it. If you search the web, you can find the 5 main differences and should consider if it is worth the effort to maintain your certificate for ISO 9001. Also discuss with your certification body what is additionally needed for audits.

swiss quality

Re: Need for ISO 9001:2015

We are in the same boat.
Our whole Research Institute holds an ISO 9001:2008 certification and parts of the Institute EN ISO 13485:2012. We are doing basic research in the medical device field, we develop and produce medical devices and we do pre-clinical testing of medical devices in house. The basic research is far away from being applied to a medical device.
Would you think it is possible to drop the ISO 9001 certification and only go for 13485:2016 for the whole Institute?
Is there already a company that dropped ISO 9001 although not everything the company is doing is in the medical device field?


We are a contract manufacturer and our business is around 98% medical. We are (were) both 9001:2008 and 13485:2003. At our last management review we decided to drop the 9001 if that was OK with our non-medical customers. It only took a short email and response to find out they all would recognize the 13485 in lieu of 9001.We just went through a recertification audit to 13485:2003 and are starting the transition into the 2016 version. 9001 is history.
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