ISO 13485:2015 and ISO 9001:2015 divergence ? retain both under the EU MDD?

[SteveK]

ISO 13485:2015 and ISO 9001:2015 divergence – retain both under the EU MDD?

Many Medical Device MDD 93/42/EEC compliant companies (mine included) have both current ISO 13485 and ISO 9001 Certification. It is currently quite straightforward to maintain a QMS based on both (in my view), also I suppose it looks good for customers e.g. in documentation. However, with the very obvious divergence of the two 2015 proposed standards, is there any real worth in maintaining or going for ISO 9001:2015 certification? It would appear that you would now need to maintain two very different QMS in practice, noting for example a requirement for a Quality Manual (13485) and no requirement (9001). The MDD only requires that a QMS be in place after all, which could just be based on ISO13485:2015 (when published). Would customers (a main one in our case being the NHS in the UK) understand letting ISO 9001:2008 lapse and possibly not re-certifying to the 2015 standard? Is it just me or would certification to both 2015 standards; for a medical device company in the future, be unnecessarily complicated? Any thoughts or plans, noting that there will be a three year transition period to comply with both 2015 standards?

Steve

 

[yodon]

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.

 

[Laughing Pierre]

Re: ISO 13485:2015 and ISO 9001:2015 divergence – retain both under the EU MDD?

We have been informed by our Notified Body that their medical device auditors will not be qualified to carry out audits to 9001: 2015. To maintain current certifications (9001, 13485, 13485 CMDCAS and 93/42/EEC) the 9001 audit will be transferred to one of their other offices and will incur additional auditing and management fees. The cost of the other certificates is not going to be reduced, but is increasing to account for the added burden coming from the Competent Authorities. One option is to keep 9001 going and stop all medical device activities.