TITLE 21CFR 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.

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