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

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Subpart A--GENERAL PROVISIONS

§820.1
Scope.
§820.3
Definitions.
§820.5
Quality system.
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Subpart B--QUALITY SYSTEM REQUIREMENTS

§820.20
Management responsibility.
§820.22
Quality audit.
§820.25
Personnel.
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Subpart C--DESIGN CONTROLS

§820.30
Design controls.
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Subpart D--DOCUMENT CONTROLS

§820.40
Document controls.
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Subpart E--PURCHASING CONTROLS

§820.50
Purchasing controls.
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Subpart F--IDENTIFICATION AND TRACEABILITY

§820.60
Identification.
§820.65
Traceability.
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Subpart G--PRODUCTION AND PROCESS CONTROLS

§820.70
Production and process controls.
§820.72
Inspection, measuring, and test equipment.
§820.75
Process validation.
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Subpart H--ACCEPTANCE ACTIVITIES

§820.80
Receiving, in-process, and finished device acceptance.
§820.86
Acceptance status.
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Subpart I--NONCONFORMING PRODUCT

§820.90
Nonconforming product.
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Subpart J--CORRECTIVE AND PREVENTIVE ACTION

§820.100
Corrective and preventive action.
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Subpart K--LABELING AND PACKAGING CONTROL

§820.120
Device labeling.
§820.130
Device packaging.
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Subpart L--HANDLING, STORAGE, DISTRIBUTION, AND INSTALLATION

§820.140
Handling.
§820.150
Storage.
§820.160
Distribution.
§820.170
Installation.
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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.
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Subpart N--SERVICING

§820.200
Servicing.
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Subpart O--STATISTICAL TECHNIQUES

§820.250
Statistical techniques.
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