Notifying Registrar of Significant QMS changes

Hello folks!
A newbie to the forums, so go easy on me for asking what might be an obvious question:

My company successfully passed the ISO 13485:2016 Stage 1 and Stage 2 audits with a couple of minor NCs (under a previous QA Manager). One of the NCs in the Stage 2 audit was about not justifying the non-applicable clauses of the standard. Quite obvious one would say easy to fix. Unfortunately, in fixing the somewhat minor issue, the QA Manager also widened the scope of the QMS to go from just design and development, to design, development and manufacturing and took away quite a few of the clauses that were previously listed as non-applicable out in line with expansion of the scope.

However, this was all done without informing the Registrar. The company has not yet start manufacturing anything nor would intend to for at least another year or more for commercial distribution, but is doing clinical evaluations currently.

As the new QA manager, who inherited this, I'm thinking that this is a major NC waiting to happen unless I inform the registrar of the change immediately. Am I thinking rightly? Or can I just hold off until the auditor shows up for the surveillance audit in a few months to broach this topic?

Jut to clarify - the company is still pending to release a couple of SOPs to be able to really support a manufacturer certification scope but the QS Manual change was formalized 3 months ago!!

Please help me navigate this!!:confused:

Ron Rompen

Trusted Information Resource
Definitely outside the scope of my experience, but I would tend to agree with you that this is a major waiting to happen. I would suggest contacting your registrar immediately, and asking for their guidance on how to proceed.


Trusted Information Resource
I think your ok. Your certificate scope hasn't changed. The "scope" of your system has changed in words only. You could always change it back. Since you don't manufacture anything at this point, it's really a transition point -- you're prepping. And if the previous guy made the change as part of a NC/CA, you may want to look at the CA paperwork and see what he submitted. I assume your surveillance auditor will ask for some pre-audit information and that's when you can address the scope. It will be a surveillance issue since you don't manufacture at this point, the auditor will have nothing to audit.