Quality Audit [Food and Drugs] Law and Legal Definition

Pursuant to 21 CFR 820.3 (t) [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], the term Quality Audit means “a systematic, independent examination of a manufacturer's quality system that is performed at defined intervals and at sufficient frequency to determine whether both quality system activities and the results of such activities comply with quality system procedures, that these procedures are implemented effectively, and that these procedures are suitable to achieve quality system objectives.”