This procedure defines the process for Returned Material Authorization (RMA) in accordance with ISO 13485:2016 and FDA requirements.
This returned material authorization (RMA) procedure defines the process for authorization of returned materials. The procedure has been updated to the requirements for ISO 13485:2016. This is the primary document meeting the applicable regulatory requirements for handling of returned product, as defined in your company’s Quality System Manual (POL-001).
The purchase of this procedure includes the following documents:
- SYS-045 A D1 Returned Materials Authorization (RMA) Procedure
- LST-014 A D1 RMA Log
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