Chapter: 22-B107
QUALITY SYSTEM REGULATION 

Title: 22 HEALTH
SubTitle: 22-B PUBLIC HEALTH AND MEDICINE


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Section Number Section Heading Latest Version Effective Date
22-B10700 SCOPE View text 7/12/2013
22-B10701 QUALITY SYSTEM View text 7/12/2013
22-B10702 MANAGEMENT RESPONSIBILITY View text 7/12/2013
22-B10703 QUALITY AUDIT: TRAINED PERSONNEL View text 7/12/2013
22-B10704 [RESERVED] View text 7/12/2013
22-B10705 DESIGN CONTROLS View text 7/12/2013
22-B10706 DOCUMENT CONTROLS View text 7/12/2013
22-B10707 PURCHASING CONTROLS View text 7/12/2013
22-B10708 IDENTIFICATION View text 7/12/2013
22-B10709 TRACEABILITY View text 7/12/2013
22-B10710 PRODUCTION AND PROCESS CONTROLS View text 7/12/2013
22-B10711 INSPECTION, MEASURING, AND TEST EQUIPMENT View text 7/12/2013
22-B10712 PROCESS VALIDATION View text 7/12/2013
22-B10713 RECEIVING, IN-PROCESS, AND FINISHED DEVICE ACCEPTANCE View text 7/12/2013
22-B10714 ACCEPTANCE STATUS View text 7/12/2013
22-B10715 NON-CONFORMING PRODUCT View text 7/12/2013
22-B10716 CORRECTIVE AND PREVENTIVE ACTION View text 7/12/2013
22-B10717 DEVICE LABELING View text 7/12/2013
22-B10718 DEVICE PACKAGING View text 7/12/2013
22-B10719 HANDLING View text 7/12/2013
22-B10720 STORAGE View text 7/12/2013
22-B10721 DISTRIBUTION View text 7/12/2013
22-B10722 INSTALLATION View text 7/12/2013
22-B10723 GENERAL REQUIREMENTS View text 7/12/2013
22-B10724 DEVICE MASTER RECORD View text 7/12/2013
22-B10725 DEVICE HISTORY RECORD View text 7/12/2013
22-B10726 QUALITY SYSTEM RECORD View text 7/12/2013
22-B10727 COMPLAINT FILES View text 7/12/2013
22-B10728 SERVICING View text 7/12/2013
22-B10729 STATISTICAL TECHNIQUES View text 7/12/2013
22-B10799 DEFINITIONS View text 7/12/2013