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U.S. Code of Federal Regula...
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Title 21-Food and Drugs
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CHAPTER I—FOOD AND DRUG ADM...
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PART 820—QUALITY SYSTEM REGULATION
PART 820—QUALITY SYSTEM REGULATION
§ 820.1 - Scope.
§ 820.3 - Definitions.
§ 820.5 - Quality system.
§ 820.20 - Management responsibility.
§ 820.22 - Quality audit.
§ 820.25 - Personnel.
§ 820.30 - Design controls.
§ 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.
§ 820.184 - Device history record.
§ 820.186 - Quality system record.
§ 820.198 - Complaint files.
§ 820.200 - Servicing.
§ 820.250 - Statistical techniques.