CFR 21-820.20d - Quality Planning

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 quality planning should be briefly discussed and their corrective actions should be identifies.

Any quality plan should reference existing system documentation.