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How a repair under the ISO 13485 can be deemed acceptable?

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Guest user Created:   Apr 08, 2021 Last commented:   Apr 12, 2021

How a repair under the ISO 13485 can be deemed acceptable?

i would like to understand how a repair under the iso 13485 can be deemed acceptable for another manufacturers CE marking when the same processes have not been certified by the OEM company

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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.

Expert
Kristina Zvonar Brkić Apr 12, 2021

If the repair process is not certified at the OEM, it means that the original manufacturer has to have control over that process. It is usually carried out that the original manufacturer prepares the necessary documents for repair and necessary forms that will be proof that some repair has been conducted and give those documents to the OEM. In a Quality agreement between manufacturer and OEM, this should be stated together with the description of the control that the manufacturer will perform over the OEM repair process. One way to control the repair process is to conduct an audit at the OEM, so-called supplier audit.

Information on performing a supplier audit according to ISO 13485, you can find in the following link:

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Apr 08, 2021

Apr 12, 2021