Quality System Regulation

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Medical Devices
  6. Quality System Regulation

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Subpart
A

General Provisions

Subpart
B

Quality System Requirements

Subpart
C

Design Controls

Subpart
D

Document Controls

Subpart
E

Purchasing Controls

Subpart
F

Identification and Traceability

Subpart
G

Production and Process Controls

Subpart
H

Acceptance Activities

Subpart
I

Nonconforming Product

Subpart
J

Corrective and Preventive Action

Subpart
K

Labeling and Packaging Control

Subpart
L

Handling, Storage, Distribution, and Installation

Subpart
M

Records

Subpart
N

Servicing

Subpart
O

Statistical Techniques