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.

!Attention Points
* Establishing how requirements are met is typically achieved in individual appropriate procedures
* During [[management review|CFR 21.820c - Management review]] quality planning should be briefly discussed and their corrective actions should be identifies.

Any quality plan should reference existing system documentation.


<<image /static/files/FDA/Quality%20Plan.jpg width:300>>
bag
fda_public
created
Sat, 30 Jun 2012 14:30:00 GMT
creator
dirkjan
modified
Sat, 30 Jun 2012 14:30:00 GMT
modifier
dirkjan
tags
CFR
CFR 21-820.20
FDA
Term
creator
dirkjan