21 CFR
Part 820 Quality Management System Regulation
Subpart A - General Provisions
- § 820.1 Scope
- § 820.3 Definitions
- § 820.5 § 820.5 [Reserved] removed
- § 820.7 Incorporation by reference
- § 820.10 Requirements for a quality management system
Subpart B - Supplemental Provisions
- § 820.20 Management responsibility removed 2,146 × 483
- § 820.22 Quality audit removed 2,151 × 483
- § 820.25 Personnel removed 1,364 × 483
Subpart C - Design Controls
- § 820.30 Design controls removed 6,012 × 483
Subpart B - Supplemental Provisions
- § 820.35 Control of records 13 × 483
Subpart D - Document Controls
- § 820.40 § 820.40 [Reserved] removed 1,606 × 483
Subpart B - Supplemental Provisions
Subpart E - Purchasing Controls
- § 820.50 Purchasing controls removed 3,169 × 483
Subpart F - Identification and Traceability
- § 820.60 Identification removed 119 × 483
- § 820.65 Traceability removed 6 × 483
Subpart G - Production and Process Controls
- § 820.70 Production and process con removed 2,814 × 483
- § 820.72 Inspection, removed 1,102 × 483
- § 820.75 Process validation removed 2,436 × 483
Subpart H - Acceptance Activities
- § 820.80 Receiving, in-process, and fin removed 2,538 × 483
- § 820.86 Acceptance status removed 102 × 483
Subpart I - Nonconforming
- § 820.90 Nonconforming product removed 2,475 × 483
Subpart J - Corrective and Preventive Action
- § 820.100 Corrective and preventive ac removed 6,071 × 483
Subpart K - Labeling and Packaging Control
- § 820.120 Device labeling removed 463 × 483
- § 820.130 Device packaging removed 28 × 483
Subpart L - Handling, Storage,
- § 820.140 Handling removed 49 × 483
- § 820.150 Storage removed 164 × 483
- § 820.160 Distribution removed 131 × 483
- § 820.170 Installation removed 58 × 483
Subpart M - Records
- § 820.180 General requirements removed 119 × 483
- § 820.181 Device master record removed 892 × 483
- § 820.184 Device history record removed 1,936 × 483
- § 820.186 Quality system record removed 53 × 483
- § 820.198 Complaint files removed 5,611 × 483
Subpart N - Servicing
- § 820.200 Servicing removed 330 × 483
Subpart O - Statistical Techniques
- § 820.250 Statistical techniques removed 505 × 483