T
TNHunter
My reading of ISO13485:2003 para. 7.4.1 is that we shall evaluate and select suppliers but that an approved vendors list (AVL) in not required. Definately a good thing to have but not required.
We define our suppliers as either class 1 or class 2 depending on the impact to the product/processes and only require class 1 to be listed on our AVL. In doing this, we feel that we meet both the intent and the requirement of 7.4.1 and our registrar has not found a problem with this.
But one of our customers insists that ALL suppliers,(even down to the local Wal-Mart) be included on the AVL because if not, we cannot control the "product" quality.
Example, cited soap used in the bathrooms. If not on AVL, cannot guarantee that "product procured" will not impact manufacturerd product.
No amount of talking will change this auditors opinion on this.
Anybody else ever have this experience with AVL's and supplier approvals?
We define our suppliers as either class 1 or class 2 depending on the impact to the product/processes and only require class 1 to be listed on our AVL. In doing this, we feel that we meet both the intent and the requirement of 7.4.1 and our registrar has not found a problem with this.
But one of our customers insists that ALL suppliers,(even down to the local Wal-Mart) be included on the AVL because if not, we cannot control the "product" quality.
Example, cited soap used in the bathrooms. If not on AVL, cannot guarantee that "product procured" will not impact manufacturerd product.
No amount of talking will change this auditors opinion on this.
Anybody else ever have this experience with AVL's and supplier approvals?