Chapter 22-B107 - QUALITY SYSTEM REGULATION
- Rule 22-B10700 - SCOPE
- Rule 22-B10701 - QUALITY SYSTEM
- Rule 22-B10702 - MANAGEMENT RESPONSIBILITY
- Rule 22-B10703 - QUALITY AUDIT: TRAINED PERSONNEL
- Rule 22-B10704 - RESERVED
- Rule 22-B10705 - DESIGN CONTROLS
- Rule 22-B10706 - DOCUMENT CONTROLS
- Rule 22-B10707 - PURCHASING CONTROLS
- Rule 22-B10708 - IDENTIFICATION
- Rule 22-B10709 - TRACEABILITY
- Rule 22-B10710 - PRODUCTION AND PROCESS CONTROLS
- Rule 22-B10711 - INSPECTION, MEASURING, AND TEST EQUIPMENT
- Rule 22-B10712 - PROCESS VALIDATION
- Rule 22-B10713 - RECEIVING, IN-PROCESS, AND FINISHED DEVICE ACCEPTANCE
- Rule 22-B10714 - ACCEPTANCE STATUS
- Rule 22-B10715 - NON-CONFORMING PRODUCT
- Rule 22-B10716 - CORRECTIVE AND PREVENTIVE ACTION
- Rule 22-B10717 - DEVICE LABELING
- Rule 22-B10718 - DEVICE PACKAGING
- Rule 22-B10719 - HANDLING
- Rule 22-B10720 - STORAGE
- Rule 22-B10721 - DISTRIBUTION
- Rule 22-B10722 - INSTALLATION
- Rule 22-B10723 - GENERAL REQUIREMENTS
- Rule 22-B10724 - DEVICE MASTER RECORD
- Rule 22-B10725 - DEVICE HISTORY RECORD
- Rule 22-B10726 - QUALITY SYSTEM RECORD
- Rule 22-B10727 - COMPLAINT FILES
- Rule 22-B10728 - SERVICING
- Rule 22-B10729 - STATISTICAL TECHNIQUES
- Rule 22-B10799 - DEFINITIONS