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21 C.F.R. PART 820--QUALITY SYSTEM REGULATION

TITLE 21--Food and Drugs

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H--MEDICAL DEVICES

PART 820--QUALITY SYSTEM REGULATION

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.