1, quality policy, target management system. Purpose: to determine the quality policy, according to the quality policy to determine the quality objectives, to promote the continuous improvement of the quality management system.
2, medical device quality responsibility. Purpose: In order to ensure the quality of operating medical devices, the company engaged in the operation of medical equipment business and management of departments and personnel, clear quality responsibility, the development of this provision.
3, the quality of medical devices ruling process. Purpose: To establish a quality veto system, to establish and maintain the authority of the quality management department in the quality control and management work, to ensure that the quality management personnel to exercise the right of quality veto, to ensure that the enterprise in the operation of quality management of the legal system.
4, quality information management system. Purpose: In order to ensure the smooth transmission of quality information, timely communication of the quality management of all aspects of the situation, and constantly improve the quality of medical devices, quality of work and quality of service, the development of this system.
5, document management and control system. Purpose: The establishment of document management and control system, standardize the company's quality management system document drafting, review, approval, implementation, storage, revision, archiving and other aspects of management.
6, department and job responsibilities. Purpose: clear division of labor, clear responsibilities.
7, training and assessment and continuing education management system. Purpose: To standardize the company's quality education and training, improve the company's staff's quality management awareness and ability to ensure that the company's quality management system continues to operate effectively.
8, the first enterprise audit system. Purpose: to strengthen the quality management of business operations, to ensure that the purchase of legitimate and reliable quality of medical equipment products from enterprises with legal qualifications.
9, suppliers and buyers audit system. Purpose: to strengthen the quality of business management, to ensure that from the legally qualified enterprises to purchase legal and reliable quality of medical equipment products.
10, product purchase and sales management system. Purpose: In order to strengthen the management of the purchase and sale of medical equipment, to ensure that the operation of legal and qualified medical equipment, specially formulated this system.
11, product acceptance, warehousing, storage, review management system. Purpose: In order to keep the quality of medical equipment in storage and out of storage, to ensure that the purchase and sale of medical equipment is accurate in quantity and quality, to prevent unqualified medical equipment and fake medical equipment into the company and the market, this system is developed.
12, records and files, bills and vouchers management system. Purpose: In order to provide evidence of effective operation of the quality management system in accordance with the requirements to ensure the authenticity, integrity, standardization and traceability of quality management work, effective control of quality records and files and bills and vouchers, the development of this system.
13, nonconforming goods control management system. Purpose: In order to strengthen the management of nonconforming products, to prevent the purchase of nonconforming products and prevent nonconforming products into the market, the development of this system.
14, after-sales return product management system. Purpose: In order to strengthen the management of returned products, to prevent errors and avoid losses, this system is developed.
15, quality tracking and implantable (interventional) medical device traceability management system. Purpose: In order to strengthen the safety supervision and quality tracking of medical devices operated by the company, strengthen the supervision and management of implantable medical devices, establish a long-term regulatory mechanism, enhance the transparency of product information on implantable medical devices, to ensure product traceability, to safeguard the people's health and the use of medical devices safety, this system is hereby formulated.
16, the quality of medical devices incident management system. Purpose: to strengthen the management of quality accidents of medical devices operated by the enterprise, to prevent and eliminate the occurrence of major quality accidents, the development of this provision.
17, medical device adverse event monitoring management system. Purpose: In order to strengthen the monitoring of adverse events of medical devices, the development of this provision.
18, recall management system. Purpose: In order to conscientiously implement the State Drug Administration "Medical Device Recall Management (Trial)" (Ministry of Health Decree No. 82), to protect the interests of consumers, and to maintain the good image of the enterprise, the development of this system.
19, medical device business electronic monitoring and management system. Purpose: In order to strengthen some of the high-risk product quality and safety supervision, to ensure that the product is real, traceable, to protect the public with the safety of the device, the development of this system.
20, computer information management system. Purpose:
In order to strengthen the company's computer information technology management, to ensure the effective and good operation of the computer network system, improve the level of quality management work and effectiveness, the development of this system.
21, customer information feedback and processing management system. Purpose: In order to protect the interests of customers, timely and effective handling of customer complaints and feedback, improve service quality, improve the service system, standardize the management of customer feedback and complaint handling, to ensure that the quality of medical equipment and quality of service, the development of the provisions.
22, medical equipment after-sales service system. Purpose: In order to implement the company's service commitments, to maintain the quality of the company's reputation, stabilize and expand market share, to ensure that the people's use of equipment safe and effective, the development of this system.