Title: 21 CFR 820
Course: BTEC-1300-301-302-303-F21 > Section: Quality System Regulations and the Quality Management System

The quality system regulations include a number of specific sections. You can see the titles here, and click the links to read the actual regulations on the FDA website.

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
   § 820.72 | Inspection, measuring, and test equipment
   § 820.75 | Process validation
Subpart H--Acceptance Activities
   § 820.80  | Receiving, in-process, and finished device acceptance
   § 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--Labeling and Packaging Control
   § 820.120 | Device labeling
   § 820.130 | Device packaging
Subpart L--Handling, Storage, Distribution, and Installation
   § 820.140 | Handling
   § 820.150 | Storage
   § 820.160 | Distribution
   § 820.170  | Installation
Subpart M--Records
   § 820.180 | General requirements
   § 820.181 | Device master record
   § 820.184 | Device history record
   § 820.186 | Quality system record
   § 820.198 | Complaint files
Subpart N--Servicing
   § 820.200 | Servicing
Subpart O--Statistical Techniques
   § 820.250 | Statistical techniques

Learning Objectives:

- 1.3 - Explain how a quality management system helps a company meet the guidelines from regulatory bodies.