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21 CFR 820.20 - Quality Planning Requirements?

#1
How in depth do quality planning requirements need to be implemented. Is there supposed to be a plan for every device or a plan for the Quality Management System as a whole? Does ISO 13485:2016 section 5.4 cover FDA requirements or do we need to be more robust?
 
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#2
You do need a plan for every device, but this is usually separate from your quality plan. The device plan is normally documented in a design and development plan that outlines the requirements for that specific product. The quality plan is normally a higher level document that applies to the whole organization and is not specific to one product. The quality plan requirements can be met through your ISO 13485-compliant quality manual, your organizational chart, and other process flow charts. There isn't one section you can point to as the mirror to the FDA quality plan requirement.
 
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