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class ii medical device, medical device company or industry, medical devices (general), supplier evaluation/rating/approval
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  #9  
Old 3rd August 2012, 01:12 PM
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Re: Approving Suppliers by "Grandfathering"

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In Reply to Parent Post by ricerocket View Post

We have had our ISO 9001 for a few years now and are getting recertified. From my understanding, we should already be adhering to the ISO standards during the recertification.
What happened during the original certification audit? Once again: ISO 9001 requirements are not retroactive. If your grandfathered suppliers were grandfathered at the time of your original certification, they are still grandfathered.
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  #10  
Old 3rd August 2012, 01:13 PM
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Re: Approving Suppliers by "Grandfathering"

7.4.1 not only calls for evaluation, but re-evaluation of suppliers. Even if you could grandfather in established suppliers, at some point they should be re-evaluated to be sure they are maintaining their quality.
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  #11  
Old 3rd August 2012, 01:15 PM
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Re: Approving Suppliers by "Grandfathering"

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In Reply to Parent Post by silentrunning View Post

7.4.1 not only calls for evaluation, but re-evaluation of suppliers. Even if you could grandfather in established suppliers, at some point they should be re-evaluated to be sure they are maintaining their quality.
The grandfathering applies to original selection criteria, not ongoing evaluation.
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  #12  
Old 3rd August 2012, 01:53 PM
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Re: Approving Suppliers by "Grandfathering"

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In Reply to Parent Post by silentrunning View Post

7.4.1 not only calls for evaluation, but re-evaluation of suppliers. Even if you could grandfather in established suppliers, at some point they should be re-evaluated to be sure they are maintaining their quality.
I would think that you evaluate your suppliers each time you order from them. Did they provide right?
  • right material/service
  • right quantity
  • right quality
  • right timing
  • price
  • right location
  • and any other requirement
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  #13  
Old 3rd August 2012, 02:17 PM
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Re: Approving Suppliers by "Grandfathering"

Quote:
In Reply to Parent Post by db View Post

I would think that you evaluate your suppliers each time you order from them. Did they provide right?
  • right material/service
  • right quantity
  • right quality
  • right timing
  • price
  • right location
  • and any other requirement
We match our PO to our invoices for price and quantity. We have a shipping log that records expected and actual delivery times. We have a supervisor sign off any products received as inspected.
  #14  
Old 3rd August 2012, 02:38 PM
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Re: Approving Suppliers by "Grandfathering"

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In Reply to Parent Post by Jim Wynne View Post

The grandfathering applies to original selection criteria, not ongoing evaluation.
I thought my sentence structure made it pretty clear that I realized that. I was saying that even if he were to grandfather in a supplier, he is only postponing having to do an evaluation. Is that more clear?
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  #15  
Old 3rd August 2012, 03:16 PM
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Re: Approving Suppliers by "Grandfathering"

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In Reply to Parent Post by silentrunning View Post

I thought my sentence structure made it pretty clear that I realized that. I was saying that even if he were to grandfather in a supplier, he is only postponing having to do an evaluation. Is that more clear?
The initial qualification for a supplier might be substantially different from ongoing evaluation.
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