Customer asking if their notified body can audit us

NikkiQSM

Quite Involved in Discussions
#1
In 15 years of Quality, I have never been asked by a customer if their notified body can audit us... Is this normal? I don't really feel comfortable to be honest.

Sorry if this question has been asked - I did search but couldn't find what I was looking for.

Thanks,
Nikki
 
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JoshuaFroud

Involved In Discussions
#2
Hi Nikki

It's a good question and one I'm sure one that will come up more frequently going forward. Do you know if you have been named as a critical supplier for the customer? It could be so if you, supply a product they relabel or perform a product critical process on their behalf.

I believe this requirement comes from the enhanced control of critical suppliers and outsourced processes from the MDR. I do not have the exact reference at the moment, I apologize. I'll have a dig a bit later if I get a chance unless one of the regulatory guru's on here beats me to it.
 

Edward Reesor

Trusted Information Resource
#3
If they are a critical supplier, then they are asking for your acknowledgement of their "Unannounced Audit" so the can complete the intended schedule of at least once every three years (at your cost by the way). If you Google up that term, you will find a fair bit of information on the procedure (I found a few papers released from the NB's themselves).
 

yodon

Staff member
Super Moderator
#4
Without more information on what you provide to your customer, it's difficult to say. Both situations @JoshuaFroud and @Edward Reesor describe are possible although they are different.

In the "critical supplier" condition, your company would be subject to audit as part of your customer's audit. If you are already holding a 13485 cert from an accredited registrar, they should accept that and not have to audit. If you don't have a cert or if it's through a registrar that isn't accredited, (or they find some just cause,) they may require an onsite audit. This would be a planned, pre-announced audit. I've seen this applied to both contract manufacturers and software development suppliers (there may be more).

The "Unannounced audit" condition is, from what I've observed, required for contract manufacturers and the process is as @Edward Reesor describes. You would need to work with your customer to block out dates when the company would not be available for audit (holidays, etc.). Your customer would coordinate that with their NB to ensure they don't show up when you're not there. They also want to be there during a production run but that may not be as predictable. If they show up to audit and you're not there (and you didn't block out the date), your customer would be still responsible for expenses (which they may try to pass on to you if they felt there was good rationale).

So you may be subject to MULTIPLE audits like this in the course of any given year! The best approach (I think) is to have a 13485 cert through an accredited registrar. That may avoid the first audit and even if they come a-knockin' for the second, you'll be well-prepared.
 

Gish

Registered
#5
Thanks to Yodon for a great explanation. In both of those conditions, this would be considered a "Supplier Audit." I haven't seen the question, so I'll ask it: Are you certified to ISO 9001:2015?

If a company finds themselves producing parts or components of medical devices, they should seriously consider certifying to ISO 13485 through a notified body. One note of caution; there is a pending release of a new edition of the standard. It was slated for 2019; it looks like it won't happen in this calendar year. When looking for a notified body, ask them when they anticipate the transition.

If this pending audit is scheduled for within a few months from now, my vote would be go ahead. Your company could them use the audit report as a baseline, an initial "gap analysis," if you will, of your compliance to the current standard. Otherwise, that can be an expensive enterprise for a company new to Quality Management System standards. If you are certified to ISO 9001:2015, getting certified will not be nearly so painful, because you'll already have the "management system" framework in place.
 
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