FDA 21 CFR Part 820 Quality System Regulation
Quality system requirements for medical device design, production, corrective action, records and management responsibility.
Sectors
Articles (31)
§ 820.1 Scope.§ 820.3 Definitions.§ 820.5 Quality system.§ 820.20 Management responsibility.§ 820.22 Quality audit.§ 820.25 Personnel.§ 820.30 Design controls.§ 820.40 Document controls.§ 820.50 Purchasing controls.§ 820.60 Identification.§ 820.65 Traceability.§ 820.70 Production and process controls.§ 820.72 Inspection, measuring, and test equipment.§ 820.75 Process validation.§ 820.80 Receiving, in-process, and finished device acceptance.§ 820.86 Acceptance status.§ 820.90 Nonconforming product.§ 820.100 Corrective and preventive action.§ 820.120 Device labeling.§ 820.130 Device packaging.§ 820.140 Handling.§ 820.150 Storage.§ 820.160 Distribution.§ 820.170 Installation.§ 820.180 General requirements.§ 820.181 Device master record.§ 820.184 Device history record.§ 820.186 Quality system record.§ 820.198 Complaint files.§ 820.200 Servicing.§ 820.250 Statistical techniques.