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Requirements for Contract Manufacturers

#1
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!
 
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#3
Sure thanks in advance. It was during our MDSAP surveillance audit:
Requirement:
Clause 4.1.5
When the organization chooses to outsource any process that affects product conformity with requirements, it shall monitor and ensure control over such processes. The organization shall retain responsibility of conformity to this International Standard and to customer and applicable regulatory requirements for outsourced processes. The controls shall be proportionate to the risk involved and the ability of the external party to meet the requirements in accordance with 7.4. The controls shall include written quality agreements.
Finding
The control over outsourced process is not fully effective as:
It isn't clear how the organization ensures conformity of the sampled outsourced processes to this international standard
Evidence
Supplier Audit Repot for Contract Maufacturer (subcontract manufacturer deemed to be a high risk supplier, audit criteria used ISO 9001).
It also did not include MDSAP requirements within the audit scope.

On discussion with the auditor they suggested we update our Supplier Aduit procedure to state that we audit our Contract Manufacturing Suppliers to ISO13485:2016 including MDSAP requirements (specific for the countries we sell the product into). They didnt give a finding on the MDR portion but in the discussion said the same would be expected when it comes to MDR i.e. include MDR in the audit criteria when auditing a CM. I went to update our procedure but I am a bit confused as I didnt think MDSAP would app;ly to our CMs.
 

Sidney Vianna

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#4
Pay close attention to sections 3 & 5 of the document available @ http://www.doks.nbog.eu/Doks/NBOG_BPG_2010_1.pdf

You, the legal manufacturer, has the responsibility to ensure that all of the relevant regulatory requirements are being complied with, during the WHOLE product realization, distribution and placement in to the market. So, if there are legal requirements that affect the assembly, marking, testing, etc. of the product, and such processes happen at your CM premises, you should verify that they are part of your critical supplier audit scope.
 
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