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Obligations as a contract manufacturer during an MDSAP audit

H

Heilea

Registered
#1
#1
A customer has a MDSAP audit that is approaching and I am wondering what the obligations are as a contract manufacturer during the audit. I want to make sure the customer is taking responsibility where appropriate and not pushing it all on my company because we are considered a critical supplier. Thank you in advance
 
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Y

yodon

Staff member
Super Moderator
#2
#2
Responsibilities should be well-defined in your contract / quality agreement. If you're not already certified to 13485 by an accredited certification body then it's likely their auditor will need to visit you. Further, if they're selling into the EU, you can probably expect an unannounced audit within your client's 3-year cert window.
 
D

DannyK

Trusted Information Resource
#3
#3
I agree with yodon.
If you do not have a quality agreement with your customer, then your customer will have an issue at their MDSAP audit.
You can be proactive by asking your customer to define the responsibilities in a quality agreement.
 
H

Heilea

Registered
#4
#4
Thank you both for the reply. We are 13485 certified. There is a quality agreement in place which outlines Site Audits by the customer. Maybe I did not ask the question in the right away. While the customer is going through their MDSAP audit they have indicated that we will be audited by their auditor conducting the MDSAP. Being one of their critical suppliers we understand that we will need to provide information their auditor needs, however, I am curious on if its a requirement my company must be audited to complete our customers MDSAP audit.

I am not sure if that is more confusing or not
 
A

Anne48

Registered
#6
#6
I am not sure how to attach a seperate thread here ...... its all a bit new to me :) but I started a new discussion based on a similar question:

My company was recently audited by NB and was given a finding because the audit criteria used to audit a Supplier - Contract Manufacturer - was not audited first to ISO13485:2016 and then to MDSAP or MDR. The audit was conducted to ISO9001 as the supplier was 9001 certified. I accept they should have been audited to ISO13485 but I am confused as to the MDSAP and MDR requirement.
The CM in question is based in US so understand that 21 CFR is applicable but I presume that is all? Can anyone clarify? We do sell the product in Austrialia, Canada and Brazil but as my company is the Legal Manufacturer I presume we must meet TGA, HC and ANVISA requirements and not the CM?
We also sell the product in EU so does MDR apply to CM? I would have thought it applies to the Legal Manufacturer only.
I tried to get some further info from the auditor but didnt get very far!

If anyone can help that would be great!
 
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