Dirkjan: Created page with "Each manufacturer shall establish a Quality Plan which defines the quality practices, resources, and activities relevant to devices that are designed and manu..."

2020-08-25T07:18:23Z

Created page with "Each manufacturer shall establish a Quality Plan which defines the quality practices, resources, and activities relevant to devices that are designed and manu..."

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Each manufacturer shall establish a [[Quality Plan|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 [[CFR 21.820c - Management review|management review]] quality planning should be briefly discussed and their corrective actions should be identifies.

Any quality plan should reference existing system documentation.

<html><img src = "/static/files/FDA/Quality%20Plan.jpg" width="300"/></html>

[[Category:fda]]

[[Category:CFR]]

[[Category:CFR 21-820.20]]

[[Category:FDA]]

[[Category:Term]]

CFR 21-820.20d - Quality Planning - Revision history

Dirkjan: Created page with "Each manufacturer shall establish a Quality Plan which defines the quality practices, resources, and activities relevant to devices that are designed and manu..."