Section 22-B10700. SCOPE

Section 22-B10701. QUALITY SYSTEM

Section 22-B10702. MANAGEMENT RESPONSIBILITY

Section 22-B10703. QUALITY AUDIT: TRAINED PERSONNEL

Section 22-B10704. [RESERVED]

Section 22-B10705. DESIGN CONTROLS

Section 22-B10706. DOCUMENT CONTROLS

Section 22-B10707. PURCHASING CONTROLS

Section 22-B10708. IDENTIFICATION

Section 22-B10709. TRACEABILITY

Section 22-B10710. PRODUCTION AND PROCESS CONTROLS

Section 22-B10711. INSPECTION, MEASURING, AND TEST EQUIPMENT

Section 22-B10712. PROCESS VALIDATION

Section 22-B10713. RECEIVING, IN-PROCESS, AND FINISHED DEVICE ACCEPTANCE

Section 22-B10714. ACCEPTANCE STATUS

Section 22-B10715. NON-CONFORMING PRODUCT

Section 22-B10716. CORRECTIVE AND PREVENTIVE ACTION

Section 22-B10717. DEVICE LABELING

Section 22-B10718. DEVICE PACKAGING

Section 22-B10719. HANDLING

Section 22-B10720. STORAGE

Section 22-B10721. DISTRIBUTION

Section 22-B10722. INSTALLATION

Section 22-B10723. GENERAL REQUIREMENTS

Section 22-B10724. DEVICE MASTER RECORD

Section 22-B10725. DEVICE HISTORY RECORD

Section 22-B10726. QUALITY SYSTEM RECORD

Section 22-B10727. COMPLAINT FILES

Section 22-B10728. SERVICING

Section 22-B10729. STATISTICAL TECHNIQUES

Section 22-B10799. DEFINITIONS