Corrective and Preventive Action In Medical Device Manufacturing

摘要

Representatives of the U.S. Food and Drug Administration (FDA) have been very active on several ISO 9000 technical committees, including TC 176 and TC 210. The regulatory requirements for medical devices, previously known as the good manufacturing practices, were revised in 1995 to more closely emulate ISO 9001:1994. These revisions to 21 CFR (Code of Federal Regulations) 820 were renamed the Quality System Regulation (QSR).