1, quality policy, target management system. Objective: to determine the quality policy, determine the quality objectives according to the quality policy, and promote the continuous improvement of the quality management system.

2, medical device quality responsibility. Objective: This regulation is formulated in order to ensure the operation quality of medical devices and clarify the quality responsibilities of departments and personnel engaged in medical device operation and management of the company.

3, medical device quality review process. Objective: To establish a quality veto system, establish and maintain the authority of quality management department in quality monitoring and management, ensure that quality managers exercise quality veto power and ensure the legalization of enterprise quality management.

4. Quality information management system. Objective: In order to ensure the smooth transmission of quality information, timely communicate all aspects of quality management, and continuously improve the quality of medical devices, work quality and service quality, this system is formulated.

5. Document management and control system. Objective: To establish a document control system and standardize the management of the drafting, review, approval, execution, preservation, revision and filing of the company's quality management system documents.

6, departments and job responsibilities. Objective: Clear division of labor and clear responsibilities.

7, training assessment and continuing education management system. Objective: To standardize the quality education and training of our company, improve the quality management awareness and ability of employees, and ensure the continuous and effective operation of the quality management system.

8, the first camp enterprise audit system. Objective: To strengthen the quality management of enterprises and ensure that legal and reliable medical device products are purchased from enterprises with legal qualifications.

9, suppliers and buyers audit system. Objective: To strengthen the quality management of enterprises and ensure that legal and reliable medical device products are purchased from enterprises with legal qualifications.

10, product purchase and sale management system. Objective: In order to strengthen the management of purchase and sale of medical devices and ensure the legal operation and qualified quality of medical devices, this system is formulated.

1 1, product acceptance, warehousing, warehousing and rechecking management system. Objective: In order to ensure the quality of medical devices in and out of the warehouse, ensure the accurate quantity and good quality of medical devices, and prevent unqualified medical devices and counterfeit medical devices from entering the company and flowing to the market, this system is formulated.

12, Records and Archives, Bills and Vouchers Management System. Objective: To provide evidence for the effective operation of the quality management system that meets the requirements, ensure the authenticity, integrity, standardization and traceability of quality management, effectively control quality records, documents, bills and vouchers, and formulate this system.

13. nonconforming product control management system. Objective: In order to strengthen the management of unqualified products, put an end to purchasing unqualified products and prevent unqualified products from entering the market, this system is formulated.

14, after-sales return product management system. Objective: In order to strengthen the management of returned products, eliminate errors and avoid losses, this system is formulated.

15, implantable (interventional) medical device quality tracking and traceability management system. Objective: In order to strengthen the safety supervision and quality tracking of medical devices operated by our company, strengthen the supervision and management of implantable medical devices, establish a long-term supervision mechanism, enhance the transparency of implantable medical device product information, ensure the traceability of products, and ensure the health of the people and the safety of medical devices, this system is formulated.

16, medical device quality accident handling system. Objective: To strengthen the management of medical device quality accidents operated by this enterprise, and to prevent and put an end to major quality accidents, this regulation is formulated.

17, medical device adverse event monitoring and management system. Objective: To strengthen the monitoring of medical device adverse events and formulate this regulation.

18, recall management system. Objective: This system is formulated in order to conscientiously implement the Administrative Measures for Medical Device Recall (Trial) issued by the State Medical Device Administration (Order No.82 of the Ministry of Health), protect the interests of consumers and maintain the good image of enterprises.

19, electronic supervision and management system for medical device management. Objective: This system is formulated to strengthen the quality and safety supervision of some high-risk products, ensure the authenticity and traceability of products and ensure the safety of public equipment.

20, computer information management system. Purpose:

In order to strengthen the company's computer information management, ensure the effective and good operation of the computer network system, and improve the quality management level and efficiency, this system is specially formulated.

2 1, customer information feedback and processing management system. Objective: To ensure the interests of customers, timely and effectively handle customer complaints and feedback, improve service quality, improve service system, standardize customer information feedback and complaint handling management, and ensure the quality and service quality of medical devices operated.

22, medical device after-sales service system. Objective: In order to implement the company's service commitment, maintain the company's quality reputation, stabilize and expand the market share, and ensure the safety and effectiveness of man and machine, this system is specially formulated.