Hello again,
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.
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
Yes, you need to have some input on what you need to monitor and what are the acceptable values. In case you do not receive it from the Manufacturer, then you need to do it by yourself.
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Jul 12, 2023