Subpart A – General Provisions......................................................Chapter 1 Scope................................................................Chapter 1
§ 820.3 Definitions..........................................................Chapter 1
§ 820.5 Quality system...................................................Chapter 1
Subpart B – Quality System Requirements............. Chapter 2
§ 820.20 Management responsibility............................Chapter 2
§ 820.22 Quality audit..................................................Chapter 2
§ 820.25 Personnel......................................................Chapter 2
Subpart C – Design Controls.....................................Chapter 3
§ 820.30 Design controls.............................................Chapter 3
Subpart D – Document Controls...............................Chapter 4
§ 820.40 Document controls........................................Chapter 4
Subpart E – Purchasing Controls.............................Chapter 5
§ 820.50 Purchasing controls......................................Chapter 5
Subpart F – Identification and Traceability..............Chapter 6
§ 820.60 Identification..................................................Chapter 6
§ 820.65 Traceability.....................................................Chapter 6
Subpart G – Production and Process Controls.......Chapter 7
§ 820.70 Production and process controls...................Chapter 7
§ 820.72 Inspection, measuring, and test equipment... .Chapter 7
§ 820.75 Process validation........................................Chapter 7
Subpart H – Acceptance Activities............................Chapter 8
§ 820.80 Receiving, in-process, and finished device acceptance.........Chapter 8
§ 820.86 Acceptance status........................................Chapter 8
Subpart I – Nonconforming Product.........................Chapter 9
§ 820.90 Nonconforming product.................................Chapter 9
Subpart J – Corrective and Preventive Action........Chapter 10
§ 820.100 Corrective and preventive action.................Chapter 10
Subpart K – Labeling and Packaging Control......... Chapter 11
§ 820.120 Device labeling............................................Chapter 11
§ 820.130 Device packaging........................................Chapter 11
Subpart L – Handling, Storage, Distribution, and Installation.........Chapter 12
§ 820.140 Handling......................................................Chapter 12
§ 820.150 Storage......................................................Chapter 12
§ 820.160 Distribution.................................................Chapter 12
§ 820.170 Installation....................................................Chapter 12
Subpart M – Records.................................................Chapter 13
§ 820.180 General requirements.................................Chapter 13
§ 820.181 Device master record.................................Chapter 13
§ 820.184 Device history record..................................Chapter 13
§ 820.186 Quality system record.................................Chapter 13
§ 820.198 Complaint files............................................Chapter 13
Subpart N – Servicing................................................Chapter 14
§ 820.200 Servicing......................................................Chapter 14
Subpart O – Statistical Techniques.......................... .Chapter 15
§ 820.250 Statistical techniques...................................Chapter 15
41AUTHORITY: 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.