QMS inside a Non medical device firm

#1
Hi there

I work for a big consultancy and one of the business units is aiming to have a QMS to produce SaMD and sell products CE marked. This BU relies on central firm services such as IT infrastructure, HR services and some tools. Obviously the scope of the QMS is the work done at BU level, but I am not sure how to describe the relationship with the firm wider services. Had anyone been in a similar situation?
Many thanks
 
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#2
Hello anaburman

The closest I've experienced was in the opposite direction - being a medical device company jammed in a pharmaceutical infrastructure, chafing under unnecessary pharma regulation that didn't rely apply to medical devices.

What particular issues are you having trouble describing?
 
#3
Hello anaburman

The closest I've experienced was in the opposite direction - being a medical device company jammed in a pharmaceutical infrastructure, chafing under unnecessary pharma regulation that didn't rely apply to medical devices.

What particular issues are you having trouble describing?
Thanks

Thanks for your reply! I have been there too and it is as much as a pain as this I think. I am inclined to have the SOPs for these process to describe how we go about getting these services from the main firm and then get a firm SME to be a reviewer in the document. Does that make sense?
 

yodon

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#4
You're effectively outsourcing those services and you can probably treat them as such. Of course, you are responsible, still, for compliance so you have to look closely. Look at section 4.1.5 in the standard. Having a firm SME review is fine (and maybe that's part of the quality agreement) but I wouldn't think they would be an approver. I think this is quite doable.

You mention tools (software, I presume). You'll need to watch that since software used in the execution of the QMS should be validated. If changes are not well-controlled then you might not be able to maintain the tool in a validated state.

A few things jump to mind regarding the IT infrastructure:
  • Be careful if you're capturing any 'protected' info on the IT infrastructure. The GDPR fines can be massive.
  • Document and record retention needs to be hammered out.
  • Certainly be cognizant of cybersecurity concerns.
 
#5
A few things jump to mind regarding the IT infrastructure:
  • Be careful if you're capturing any 'protected' info on the IT infrastructure. The GDPR fines can be massive.
  • Document and record retention needs to be hammered out.
  • Certainly be cognizant of cybersecurity concerns.
[/QUOTE]
This was a pretty good help for me. Thank you for sharing.
 
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