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Should Training Service providers be included in AVL?

SGquality

Quite Involved in Discussions
#1
We are having a big debate in our organization if training service providers should be included in the Approved Vendor List (AVL)? These training service providers are the ones who certify our internal auditors.

Can I know what others do in this regard?

Thank you!
 
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somashekar

Staff member
Super Moderator
#2
Let's see the 7.4.1 a) of the new ISO 13485.

See the word Organizational requirements....

Are your training providers good for you in meeting the training requirements of your internal auditors ?

What ever criteria you had established in the evaluation and selection has therefore worked in meeting your organizational requirements.
Now you are required to maintain such records of the results of your evaluation and selection.

The AVL is just a consolidation of your records, and your adopting the AVL into your ISO 13485 QMS, is your organization decision.
I hope you have got valid points for your big debate. Good luck.
 

Ronen E

Problem Solver
Staff member
Moderator
#3
How is training internal auditors different from any other service that affects product quality and the effectiveness of the QMS?
 

SGquality

Quite Involved in Discussions
#4
Thank you somashekhar and Ronen.

The training service providers are different from other service providers in the way there is no recurring business and is typically one time or when there is a revision to the standard. For other service providers, we typically have our requirements issued to them.
 

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#5
Thank you somashekhar and Ronen.

The training service providers are different from other service providers in the way there is no recurring business and is typically one time or when there is a revision to the standard. For other service providers, we typically have our requirements issued to them.
You can just deactivate them on your AVL. If they are used again in the future, reactivate them.
 

Ronen E

Problem Solver
Staff member
Moderator
#6
Thank you somashekhar and Ronen.

The training service providers are different from other service providers in the way there is no recurring business and is typically one time or when there is a revision to the standard. For other service providers, we typically have our requirements issued to them.
So your intention is to go through the entire supplier selection and qualification process, just not include the ones you ended up with (in this instance) on your AVL?
 

somashekar

Staff member
Super Moderator
#7
Thank you somashekhar and Ronen.

The training service providers are different from other service providers in the way there is no recurring business and is typically one time or when there is a revision to the standard. For other service providers, we typically have our requirements issued to them.
Keeping them on the AVL will at least trigger a re-evaluation by some other colleague of yours at a later point of time ... hope you agree
 
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