According to the "medical device business quality management standard" to establish the program documents have what

Medical device quality management system catalog

1, quality policy, goal management system

2, medical device quality responsibility

3, medical device quality ruling process

4, quality information management system

5, document management and control system

6, departmental and post duties

7、Training and assessment and continuing education management system

8、First enterprise audit system

9、Supplier and buyer audit system

10、Product purchase and sales management system

11、Product acceptance, storage, out of storage, review management system

12、Records and archives, bills and vouchers management system

13, non-conforming products control management system

14, after-sales return product management system

15, quality tracking and implantable (interventional) medical device traceability management system

16, medical device quality incident management system

17, medical device adverse event monitoring and management system

18, recall management system < /p>

19, medical device business electronic monitoring management system

20, computerized information management system

21, customer information feedback and processing management system

22, medical device after-sales service system