Title 21

PART 820

Part 820 - Quality System Regulation

PART 820 - QUALITY SYSTEM REGULATION Authority:21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371, 374, 381, 383; 42 U.S.C. 216, 262, 263a, 264. Source:61 FR 52654, Oct. 7, 1996, unless otherwise noted.

21:8.0.1.1.12.1SUBPART A
Subpart A - General Provisions
21:8.0.1.1.12.1.1.1SECTION 820.1
   820.1 Scope.
21:8.0.1.1.12.1.1.2SECTION 820.3
   820.3 Definitions.
21:8.0.1.1.12.1.1.3SECTION 820.5
   820.5 Quality system.
21:8.0.1.1.12.2SUBPART B
Subpart B - Quality System Requirements
21:8.0.1.1.12.2.1.1SECTION 820.20
   820.20 Management responsibility.
21:8.0.1.1.12.2.1.2SECTION 820.22
   820.22 Quality audit.
21:8.0.1.1.12.2.1.3SECTION 820.25
   820.25 Personnel.
21:8.0.1.1.12.3SUBPART C
Subpart C - Design Controls
21:8.0.1.1.12.3.1.1SECTION 820.30
   820.30 Design controls.
21:8.0.1.1.12.4SUBPART D
Subpart D - Document Controls
21:8.0.1.1.12.4.1.1SECTION 820.40
   820.40 Document controls.
21:8.0.1.1.12.5SUBPART E
Subpart E - Purchasing Controls
21:8.0.1.1.12.5.1.1SECTION 820.50
   820.50 Purchasing controls.
21:8.0.1.1.12.6SUBPART F
Subpart F - Identification and Traceability
21:8.0.1.1.12.6.1.1SECTION 820.60
   820.60 Identification.
21:8.0.1.1.12.6.1.2SECTION 820.65
   820.65 Traceability.
21:8.0.1.1.12.7SUBPART G
Subpart G - Production and Process Controls
21:8.0.1.1.12.7.1.1SECTION 820.70
   820.70 Production and process controls.
21:8.0.1.1.12.7.1.2SECTION 820.72
   820.72 Inspection, measuring, and test equipment.
21:8.0.1.1.12.7.1.3SECTION 820.75
   820.75 Process validation.
21:8.0.1.1.12.8SUBPART H
Subpart H - Acceptance Activities
21:8.0.1.1.12.8.1.1SECTION 820.80
   820.80 Receiving, in-process, and finished device acceptance.
21:8.0.1.1.12.8.1.2SECTION 820.86
   820.86 Acceptance status.
21:8.0.1.1.12.9SUBPART I
Subpart I - Nonconforming Product
21:8.0.1.1.12.9.1.1SECTION 820.90
   820.90 Nonconforming product.
21:8.0.1.1.12.10SUBPART J
Subpart J - Corrective and Preventive Action
21:8.0.1.1.12.10.1.1SECTION 820.100
   820.100 Corrective and preventive action.
21:8.0.1.1.12.11SUBPART K
Subpart K - Labeling and Packaging Control
21:8.0.1.1.12.11.1.1SECTION 820.120
   820.120 Device labeling.
21:8.0.1.1.12.11.1.2SECTION 820.130
   820.130 Device packaging.
21:8.0.1.1.12.12SUBPART L
Subpart L - Handling, Storage, Distribution, and Installation
21:8.0.1.1.12.12.1.1SECTION 820.140
   820.140 Handling.
21:8.0.1.1.12.12.1.2SECTION 820.150
   820.150 Storage.
21:8.0.1.1.12.12.1.3SECTION 820.160
   820.160 Distribution.
21:8.0.1.1.12.12.1.4SECTION 820.170
   820.170 Installation.
21:8.0.1.1.12.13SUBPART M
Subpart M - Records
21:8.0.1.1.12.13.1.1SECTION 820.180
   820.180 General requirements.
21:8.0.1.1.12.13.1.2SECTION 820.181
   820.181 Device master record.
21:8.0.1.1.12.13.1.3SECTION 820.184
   820.184 Device history record.
21:8.0.1.1.12.13.1.4SECTION 820.186
   820.186 Quality system record.
21:8.0.1.1.12.13.1.5SECTION 820.198
   820.198 Complaint files.
21:8.0.1.1.12.14SUBPART N
Subpart N - Servicing
21:8.0.1.1.12.14.1.1SECTION 820.200
   820.200 Servicing.
21:8.0.1.1.12.15SUBPART O
Subpart O - Statistical Techniques
21:8.0.1.1.12.15.1.1SECTION 820.250
   820.250 Statistical techniques.