Under Schedule 3 Part 1 the manufacturer must run a quality management system across design, production, packaging, labelling and final inspection and arrange its assessment by the Secretary or an Australian conformity assessment body, having ready the manufacturer and site details, device information, system documentation and written undertakings to keep complying, keep the system adequate and effective, and pass on serious incident and recall information. The system must ensure every device complies with the essential principles, classification rules and procedures from design to final inspection, and must include systematic post-production review, corrective action on design or production and prompt notification to the assessing body or the sponsor of malfunctions, deterioration, design, labelling, instruction or advertising inadequacies, or use that might lead or have led to death or serious deterioration in health, and of technical or medical reasons that led to a recall. The documentation must set out quality objectives, organisation, responsibilities and monitoring, design controls and specifications (standards applied, risk analysis, solutions where no standard was used, connection evidence, clause 7.4 and animal or microbial tissue statements, clinical evidence and labelling), production and purchasing controls and product identification, tests and calibration traceability, the post-production review system and whether a conformity assessment standard was applied to the system.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.