The organisation must document and apply procedures for measuring, analysing and improving that meet ISO 13485 and regulatory requirements, monitor and measure product conformity throughout realization, provide feedback mechanisms that give early warning of quality problems, and drive corrective and preventive action. The procedures should cover analysing feedback, product conformity, process and product trends and supplier conformity; reviewing nonconformities including complaints; deciding on and recording actions; making sure actions work and do not harm finished devices; and recording changes to methods. Brazil: news of quality problems or nonconforming product must reach those responsible for product quality and prevention (RDC 665/2022 Art 120 VI). Clauses: ISO 13485:2016 4.2.1, 8.1, 8.2.1, 8.2.6, 8.5; TG(MD)R Sch 3 Pt 1 cl 1.4(3)(a)(b), (5)(b)(iii), (f); RDC 665/2022 Arts 88, 120, 121; MO169 Arts 54 to 64.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.