FDA 21 CFR Part 820 Quality System Regulation

Click the title below for complete guidelines

Table of contents

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.

FDA 21 CFR Part 820 Quality System Regulation: