An enterprise shall, in accordance with the relevant laws and regulations of the state, establish and implement a medical device quality management system that conforms to the actual situation of the enterprise, and regularly check and evaluate the implementation of the quality system. The quality management system shall at least include: (1) quality policy and management policy; (2) quality system audit; (3) Quality responsibility system at all levels; (4) quality veto system; (5) Managing the quality management system; (6) the first business variety quality audit system; (7) Quality acceptance, warehousing and outbound review system; (eight) commodity management and return management system is not perfect; (9) Quality accident report, quality inquiry and complaint management system; (10) after-sales service management and user access system; (1 1) quality information management system; (12) related quality record management system; (13) monitoring and reporting system for the number of adverse events; (14) personnel education and training system; (15) Evaluation system for the implementation of relevant systems; (16) Special management system for special products. (17) Enterprises engaged in fitting products (such as hearing AIDS and contact lenses) should also formulate the responsibilities of fitting personnel, fitting management system, fitting product quality inspection system and hygiene system. Inspection contents of leaders: (1) Check the completeness, rationality and operability of the system. (Check at least 3 systems) (2) Check the implementation of the system. (Check at least 3 systems)
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