During a recent audit, our auditor mentioned that repair of medical devices (returned by the customer and to be sent back to the customer after repair) required Service be within scope. Can anyone confirm or reject that statement?
Background: we have an active, audited rework program that to date has been used for failures identified prior to release. It is closely tied to our nonconforming material program. We also have an RMA program to handle returned materials from customers for complaint investigations. We have service as a scope exclusion and would not do the repairs on-site at the customer facility. Would those be sufficient to repair and return devices? Or do we need to expand our scope to do repairs?
Thanks!
Background: we have an active, audited rework program that to date has been used for failures identified prior to release. It is closely tied to our nonconforming material program. We also have an RMA program to handle returned materials from customers for complaint investigations. We have service as a scope exclusion and would not do the repairs on-site at the customer facility. Would those be sufficient to repair and return devices? Or do we need to expand our scope to do repairs?
Thanks!