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Auditing according to section 8.2.2
I've been asked to conduct a 13485 audit specific to complaint handling. Would I only need to audit according to section 8.2.2? Thank you!
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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
Expert
Kristina Zvonar Brkić
Dec 13, 2021
Basically yes, but of course in accordance with Records management (requirement 4.2.5) and 8.3 Control of non-conforming product.
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Dec 09, 2021
Dec 13, 2021
Dec 13, 2021