FDA 21 CFR 820

The Quality System Regulation (QSR) is the applicable United States of America law for all economic partners involved in medical devices. The QSR consists of 15 Subparts, defined by letters from the alphabet. Find here the overview of the text and Expert explanations and opinions.

QSR

820.1

Scope

820.3

Definitions

820.5

Quality system

820.20

Management responsibility

820.22

Quality audit

820.25

Personnel

820.30

Design Control

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 (DMR)

820.184

Device hystory record (DHR)

820.186

Quality system record

820.198

Complaint files

820.200

Servicing

820.250

Statistical techniques