I'm preparing ISO 13485 QMS as Importer in Europe. Our scope of work is "Sales, Logistics and Warranty Service".
To ensure safety and quality of our product, we should conduct outcome inspection (OQC) after we repair the defective devices or reworks.
However, we do not have any inspection standard or test report forms yet.
The question is, "Do we have to have identical inspection standard(criteria) and OQC test report as our Manufacturer?"
Any feedback would be very appreciated.