Re: ISO 13485:2015 and ISO 9001:2015 divergence – retain both under the EU MDD?
Good points all around and my company is in the same boat.
I expect, though, that we WILL continue to maintain both certs as we feel there is some marketing advantage.
That said, I'm tasked to figure out how to do that with the least impact. I think that the risk-centric approach in 9001:2015 is likely to cause the most impact. But all things considered, it's hard to argue that it's a bad idea. And for the most part, we already do a lot of the risk identification / management tasks. This may just drive us to formalize them (maybe) a little more.
While Preventive Actions may go away in 9001:2015, it doesn't prevent us from having them (and taking credit for them as part of the risk-based thinking!).
Similarly, the fact that 9001:2015 doesn't require documented procedures doesn't prevent me from having them so I should still be able to meet both standards' requirements by continuing to maintain a Quality Manual.
It will definitely be interesting to see how it plays out and if it will, in fact, make sense for us to maintain both certs.