By ISO 13485 definition we are a "contract manufacturer", so this is the terminology I used. Correct, we provide R&D services in that we apply different coatings in different manners to produce different results, but it is the customer who determines the needs and acceptability of the performance of the coating, and they provide all of the substrate and are responsible for all upstream and downstream processing. Our scope is typically fairly limited with regards to the entire device lifecycle.
After the customer is satisfied with the R&D outputs, we obtain a drawing for the final "coated-level" spec for the component, containing information such as coating components, coating length, lubricity specifications, FM specifications, etc. This customer-supplied drawing is held in our QMS as a reference document, and is approved by Engineering, Manufacturing, and Quality. Any revision to this document by the Customer is reviewed by us and requires approval within our QMS prior to manufacturing to the revision.
When manufacturing, this reference drawing (and revision) is checked after each customer order is placed, and if there are any discrepancies, they must be resolved prior to continuing with the processing of the order. All orders are reviewed and approved by Manufacturing.
To me, this satisfies the "records of evaluation of customer requirements" criteria. Is that too simplistic?
After the customer is satisfied with the R&D outputs, we obtain a drawing for the final "coated-level" spec for the component, containing information such as coating components, coating length, lubricity specifications, FM specifications, etc. This customer-supplied drawing is held in our QMS as a reference document, and is approved by Engineering, Manufacturing, and Quality. Any revision to this document by the Customer is reviewed by us and requires approval within our QMS prior to manufacturing to the revision.
When manufacturing, this reference drawing (and revision) is checked after each customer order is placed, and if there are any discrepancies, they must be resolved prior to continuing with the processing of the order. All orders are reviewed and approved by Manufacturing.
To me, this satisfies the "records of evaluation of customer requirements" criteria. Is that too simplistic?