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OQC Standard as Importer

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Daniel Kim Created:   Jul 12, 2023 Last commented:   Jul 12, 2023

OQC Standard as Importer

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.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Jul 12, 2023

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

Jul 12, 2023