A customer is changing the CE mark / reference number on the documentation included with the product. I am asking him to revise his documentation (change revision level) to reflect the new CE mark. He wants me to issue him a nonconformance document where upon he will return it with a use-as-is status.
The plan is to put a label on the documentation with the new CE number BUT not to revise the part number with a label or any other method.
This is really bothering me as per ISO13485:
The organization shall ensure that nonconforming product is accepted by concession only if regulatory requirements are met.
Is there a regulatory requirement being violated here?
The plan is to put a label on the documentation with the new CE number BUT not to revise the part number with a label or any other method.
This is really bothering me as per ISO13485:
The organization shall ensure that nonconforming product is accepted by concession only if regulatory requirements are met.
Is there a regulatory requirement being violated here?