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ISO 13485:2016 Clause 7.4.2 regarding Supplier Quality Agreements


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iso 13485 - medical device qms, iso 13485:2016, ivd (in vitro diagnostic) devices and reagens, supplier requirements
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  Post Number #1  
Old 11th January 2017, 11:55 AM
tebusse

 
 
Total Posts: 63
Please Help! ISO 13485:2016 Clause 7.4.2 regarding Supplier Quality Agreements

I work for a very small medical device company (8 employees) that manufactures IVDs. I'm currently working on implementation of the new ISO 13485 requirements and need some assistance with clause 7.4.2 regarding Quality Agreements.

Specifically, what is the criteria regarding which suppliers require quality agreements? Do you base it on the supplier's risk level?

Also, for those suppliers with whom a quality agreement is not obtained, how do you ensure that the supplier informs the company of changes in the purchased product?

Any assistance would be most appreciated.

Regards, Tonia

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  Post Number #2  
Old 11th January 2017, 12:49 PM
SteveK's Avatar
SteveK

 
 
Total Posts: 783
Lurker Re: ISO 13485:2016 Clause 7.4.2 regarding Supplier Quality Agreements

Im in the same boat. First off I prepared a four page formal Supplier Agreement (trying to keep it as simple as possible) and got some feedback from some of our main suppliers as to whether they would comply. However, since we have a large number of suppliers I thought I should really simplify matters. We send out an annual Supplier Questionnaire yes/no questions as to whether they have a quality system, what products they supply, equipment used etc. Since these are so simple to complete we usually get the majority returned. So basically I just added a couple of lines i.e.

10. Quality Agreement

10.1 Do you agree to inform ACME of any changes to the product, service or process provided that could affect its quality or specification? YES / NO

10.2 That ACME is informed prior to implementation of any above change YES/NO

Seems to be working so far, and as far as Im concerned it fulfils the ISO 13485:2016 requirement though only time and an audit will tell.

Note that we are only a SME - circa 30 employees.

Steve
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  Post Number #3  
Old 11th January 2017, 01:03 PM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
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Re: ISO 13485:2016 Clause 7.4.2 regarding Supplier Quality Agreements

This requirements was included more or less in the end of the development of the new standard...everyone agreed that it was necessary, but with very few examples in the medical device world. Anyway, we do have examples in other areas, and recently I've been suggesting that my clients follow the principles of the "Contract Manufacturing Arrangements for Drugs: Quality Agreements Guidance for Industry" from Pharma from the FDA (there a other examples in other areas, but this is what I think is most close to the medical device field for obvious reasons).

Regarding the criteria, yeah, it should be risk-based, depending on the risk to the patient/user/etc. and conformity to regulatory requirements, related to the supplied product or service.
Thank You to Marcelo Antunes for your informative Post and/or Attachment!
  Post Number #4  
Old 11th January 2017, 01:32 PM
tebusse

 
 
Total Posts: 63
Re: ISO 13485:2016 Clause 7.4.2 regarding Supplier Quality Agreements

Thank you, Steve.

Your idea is simplistic compared to what I was thinking of implementing.

Since were on the subject, how are you dealing with clause 7.4.3 Verification of purchased product? Specifically, when your company becomes aware of changes how are you documenting if the changes affect product realization or the medical device?

Most of the changes we receive from vendors are not applicable to us. Therefore, I'm wondering if a memo to file would suffice.

Thank you again for your assistance.

Tonia
  Post Number #5  
Old 12th January 2017, 04:59 AM
SteveK's Avatar
SteveK

 
 
Total Posts: 783
Lurker Re: ISO 13485:2016 Clause 7.4.2 regarding Supplier Quality Agreements

Hi Tonia,

A memo to file is basically what our Purchasing SOP indicates what should happen i.e. an amendment to the purchase order. Worst case we raise a supplier corrective action report (SCAR). It may then lead to a 'concession note' and then a re-work. In any case the information is recorded.

Steve
  Post Number #6  
Old 12th January 2017, 05:27 PM
Mark Meer

 
 
Total Posts: 612
Re: ISO 13485:2016 Clause 7.4.2 regarding Supplier Quality Agreements

Quote:
In Reply to Parent Post by tebusse View Post

Specifically, what is the criteria regarding which suppliers require quality agreements? Do you base it on the supplier's risk level?
Criteria for supplier approval should be based on your own risk-assessment.

Obviously, certain supplied items are more critical than others, and so ideally your system should allow for the degree of supplier control to scale accordingly.

With regards to supplier agreements, I think it's sufficient to document a risk (probability + severity) assessment of a supplier non-conformance (NC), and then go from there. Specifically:
1. What is the probability that a NC is undetected by currently established controls (e.g. receiving & production controls)?
2. What is the worst-case severity if such a NC goes undetected and hence makes it into released devices?

Quote:
In Reply to Parent Post by tebusse View Post

Also, for those suppliers with whom a quality agreement is not obtained, how do you ensure that the supplier informs the company of changes in the purchased product?
The truth is, you can't. Which is why risk-assessment and robust internal controls (receiving/production) are important.

IMHO, supplier agreements aren't necessarily any guarantee either. Sign supplier agreements, sure...but I wouldn't depend on them.

MM
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