Quality Plan: Does Your ISO 13485 Quality Manual Meet FDA’s Requirement for One?

Q: I have a question regarding the “Management Controls” quality subsystem and FDA’s requirement for a Quality Plan. We are ISO 13485 certified, so can I assume our quality manual and design and development plans cover this requirement? Or does FDA expect a more high-level statement?

A: Your ISO 13485 plan will satisfy FDA. The Agency has no specific expectation of what constitutes a Quality Plan, so use what works for ISO 13485.

Answered by Denise Dion, EduQuest VP of Regulatory and Quality Services (18 years as an FDA investigator) and lead instructor of EduQuest’s QSR Compliance Basics: Complying with FDA’s Medical Device 21 CFR 820 Quality System Regulation two-day training class.


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