FDA Quality Standard (CFR 820) by Subpart and Section
Prepared by Charles S. Tritt, Ph.D.
March 31, 1997
Outline of the Quality System Regulation
- Subpart A -- General Provisions
- 820.1 Scope
- 820.3 Definitions
- 820.5 Quality system
- Subpart B -- Quality System Requirements
- 820.20 Management responsibility
- 820.22 Quality audit
- 820.25 Personnel
- Subpart C -- Design Controls
- 820.30 Design controls
- Subpart D -- Document Controls
- 820.40 Document Controls
- Subpart E -- Purchasing Controls
- 820.50 Purchasing controls
- Subpart F -- Identification and Traceability
- 820.60 Identification
- 820.65 Traceability
- Subpart G -- Production and Process Controls
- 820.70 Production and process controls
- 820.75 Process validation
- Subpart H -- Acceptance Activities
- 820.80 Receiving, in-process and finished device acceptance
- 820.84 Inspection, measuring and test equipment
- 820.86 Acceptance status
- Subpart I -- Nonconforming Product
- 820.90 Nonconforming Product
- Subpart J -- Corrective and Preventive Action
- 820.100 Corrective and preventive action
- Subpart K -- Handling, Storage, Distribution and Installation
- 820.120 Handling
- 820.122 Storage
- 820.124 Distribution
- 820.126 Installation
- Subpart L -- Packaging and Labeling Control
- 820.160 Device packaging
- 820.162 Device labeling
- Subpart M -- Records
- 820.180 General requirements
- 820.181 Device master record (DMR)
- 820.184 Device history record (DHR)
- 820.186 Quality system records
- 820.198 Complaint files
- Subpart N -- Servicing
- 820.200 Servicing
- Subpart O -- Statistical Techniques
- 820.250 Statistical techniques