I've looked through the thread What is a Quality Plan? What Should be in a Quality Plan?, but it is dealing with ISO requirements.
As far as the FDA regulation goes, 21 CFR 820.20(d) states only:
"Each manufacturer shall establish a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured. The manufacturer shall establish how the requirements for quality will be met."
Is the expectation here that there be a specific "quality plan" documented (i.e. "here is our quality plan"). Or does the sum total of all established quality system procedures and controls implicitly make up the quality plan?
It seems like a process map (interaction of processes) would suffice as a "quality plan".
Thoughts?
As far as the FDA regulation goes, 21 CFR 820.20(d) states only:
"Each manufacturer shall establish a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured. The manufacturer shall establish how the requirements for quality will be met."
Is the expectation here that there be a specific "quality plan" documented (i.e. "here is our quality plan"). Or does the sum total of all established quality system procedures and controls implicitly make up the quality plan?
It seems like a process map (interaction of processes) would suffice as a "quality plan".
Thoughts?