Does PCB need to go through IQ OQ PQ validation?


Hi All,

I hope this message finds you well. I am seeking advice on whether Printed Circuit Boards (PCBs) need to undergo IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) validation as per the ISO 13485 standard.

Could you please provide guidance on the validation process and share any relevant validation protocols with me?

Thank you for your time and assistance.



Trusted Information Resource
The manufacturing process of manufacturing PCBA used in medical devices should be validated; IQ/OQ/PQ is the most straightforward, industry standard, approach.
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