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Critical Supplier/Quality Agreement Procedure

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  Post Number #1  
Old 17th August 2018, 03:19 PM
Al Rosen's Avatar
Al Rosen

 
 
Total Posts: 3,690
Thank You! Critical Supplier/Quality Agreement Procedure

Does anyone have an example of a procedure for determining a critical supplier and an example of a Quality Agreement that would be used for different types of Critical Suppliers.

I would think a Quality Agreement for a component supplier would be different than a supplier of services or for an Authorized Representative.

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  Post Number #2  
Old 17th August 2018, 03:33 PM
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Re: Critical Supplier/Quality Agreement Procedure

Regarding the quality agreement, yes, it's different from suppliers and third parties.

Suppliers basically have to do their own thing, and you decide if the product they supply fulfill your requirements (this relationship is treated by 7.4 of ISO 13485).

Third parties (as in 4.1.5 of ISO 13485) are in fact acting on behalf of the organization, including doing things in the name/under the responsibility of the organization to fulfill applicable regulatory requirements. So the quality agreement has to focus on responsibilities and activities related to this compliance. Unfortunately, the only good guidance that exists right now for this in the document Contract Manufacturing Arrangements for Drugs: Quality Agreements , which is for pharma, but the generic guidance fits for devices too.

Last edited by Al Rosen; 17th August 2018 at 03:54 PM. Reason: Fixed link
Thanks to Marcelo Antunes for your informative Post and/or Attachment!
  Post Number #3  
Old 17th August 2018, 03:57 PM
Al Rosen's Avatar
Al Rosen

 
 
Total Posts: 3,690
Re: Critical Supplier/Quality Agreement Procedure

Thanks, Marcelo. I'd still like to see some examples of the procedure and agreements or templates, if anyone has something they can share without revealing sensitive information.
  Post Number #4  
Old 18th August 2018, 12:07 PM
Sidney Vianna's Avatar
Sidney Vianna

 
 
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Re: Critical Supplier/Quality Agreement Procedure

A simple google search produced some results such as https://www.helmerinc.com/Assets/hel...rms/QSR019.pdf
  Post Number #5  
Old 18th August 2018, 12:11 PM
v9991

 
 
Total Posts: 967
Re: Critical Supplier/Quality Agreement Procedure

Quote:
In Reply to Parent Post by Al Rosen View Post

Thanks, Marcelo. I'd still like to see some examples of the procedure and agreements or templates, if anyone has something they can share without revealing sensitive information.
i was working on QAg inhouse, and does some level of internet search before formalizing ours;

enclosing certain ref...just in case if you haven;t already seen these...
there are others., which i will add in next post.,
Attached Files: 1. Scan for viruses before opening, 2. Please report any 'bad' files by Reporting this post, 3. Use at your Own Risk.
File Type: pdf qualityagreementguideline_final_200912_clean.pdf (505.5 KB, 36 views)
File Type: pdf Medical_Device_Quality_Agreement_Template.pdf (81.6 KB, 40 views)
File Type: pdf QSR019-Supplier Quality Agreement.pdf (316.4 KB, 34 views)
File Type: pdf QSV-Gaudlitz-en-Quality Assurance Agreement (QAA).pdf (162.1 KB, 28 views)
File Type: pdf Quality Agreement-IVT.pdf (96.8 KB, 27 views)
Thanks to v9991 for your informative Post and/or Attachment!
  Post Number #6  
Old 18th August 2018, 12:21 PM
v9991

 
 
Total Posts: 967
Re: Critical Supplier/Quality Agreement Procedure

here's next lot.,
collated from google-searches!
Attached Files: 1. Scan for viruses before opening, 2. Please report any 'bad' files by Reporting this post, 3. Use at your Own Risk.
File Type: pdf tmp_381_9-5-2012_90458_ (1).pdf (2.34 MB, 20 views)
File Type: pdf supplier-quality-standard - Baxter.pdf (112.4 KB, 45 views)
File Type: pdf Supplier-Quality-Manual-MSP-3-A.pdf (181.7 KB, 34 views)
File Type: pdf supplier-quality-agreement.pdf (117.0 KB, 36 views)
Thanks to v9991 for your informative Post and/or Attachment!
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