Does 13485 auditor have a right to inspect non-CE products?

N

nantmel

#1
Hi all,

This is a debate that I've been having with my boss at the moment... We are an ISO13485 registered company making medical devices for the EU market predominantly. However, we also have a 510K exempt product being sold in America.

We have a 13485 surveillance audit coming up, and there are some discrepancies with the paperwork for the non-CE product headed for the States. My boss argues that it doesn't matter right now as the auditor is only there to audit to CE mark, and can't challenge us on the non-CE product. I am arguing that she has a right to challenge us on all devices we produce, as 13485 is a way of assuring everything under our roof happens according to a set of procedures and controls. Who is right about this?

Secondarily, if I'm right and 13485 does apply to these products, how would a company that manufactures both medical devices and non-medical devices navigate this? Would they have to manufacture them all to 13485 requirements?

Many thanks for your help!


(NB. This is ignoring the fact that we need the paperwork in line to prove GMP for the states too! But with too much work and not enough staff the imminent audit is taking priority)
 
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Sidney Vianna

Post Responsibly
Staff member
Admin
#2
If the scope of the ISO 13485 certificate does not have any explicit exclusions, the auditor could use any medical device product as part of the sampling for the audit, including products that are not destined to the European market.

As for excluding non medical devices from the audit, this should be self-evident, and also adequately phrased in the scope of certification, but, you can always remind the auditor of that during the opening meeting s/he is supposed to conduct.
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#3
ISO 13485 and CE marking are different things.

An ISO 13485 audit will cover anything you make under that Quality Management System scope whether CE marked or not.

I'll tell you the FDA may not be happy that you excluded listed medical devices from the US from your QMS registration unless you're running a secondary QMS to meet FDA requirements.

Look at the scope on your registration certificate... does it specify CE Marked Devices? Or does it say "medical devices".
Take my meaning?
 
N

nantmel

#4
Thank you for your help. The scope specifies certain types of medical device but doesn't specify CE Marked Devices specifically.


I've been able to point my boss to this to clear up the confusion.



Thanks again!
 

Statistical Steven

Statistician
Staff member
Super Moderator
#5
Thank you for your help. The scope specifies certain types of medical device but doesn't specify CE Marked Devices specifically.


I've been able to point my boss to this to clear up the confusion.



Thanks again!
As Scott mentioned, the key driver to what is included or excluded is what QMS do the products follow. If your CAPA system is for both the CE and non-CE marked devices, then they are part of the audit. Typically, there is a single QMS for the company, but not always.
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#6
Thank you for your help. The scope specifies certain types of medical device but doesn't specify CE Marked Devices specifically.


I've been able to point my boss to this to clear up the confusion.



Thanks again!
Good news. Glad to hear it.
 
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