2 Quality Management System-002 Quality Responsibility of Departments, Organizations and Personnel
3 Quality Management System-003 Quality Veto Provisions
4 Quality Management System-004 Quality Management Assessment and Evaluation Provisions
5 Quality Management System-005 The First Enterprise and the first varieties of audit provisions
6 Quality Management System-006 Procurement Management Regulations
7 Quality Management System-007 Quantity Acceptance Management Regulations
8 Quality Management System-008 Warehousing, storage, maintenance, and out of the warehouse review of the management
9 Quality Management System-009 Sales and after-sales service management
10 Quality Management System-010 Management of records, vouchers and files
11 Quality Management System-011 Traceability of medical devices
12 Quality Management System-012 Management of quality information
13 Quality Management System-013 Management of nonconforming products
14 Quality Management System-014 Monitoring and Reporting of Adverse Events of Medical Devices
14 Quality Management System-014 Monitoring and Reporting of Adverse Events of Medical Devices
15 Quality Management System-016 Management of Medical Devices Monitoring and Reporting of Adverse Events of Medical Devices
15 Quality Management System-015 Recall of Medical Devices
16 Quality Management System-016 Management of Hygiene and Health Conditions of Personnel
17 Quality Management System-017 Management of Important Instruments and Equipment
18 Quality Management System-018 Management of Measuring Devices
19 Quality Management System-019 Management of Quality Management System-019 quality education, training and assessment of the provisions of the
20 Quality Management Records-001 First Enterprise / First Variety Audit Records
21 Quality Management Records-002 Purchase Records
22 Quality Management Records-003
23 Quality Management Records-004 In-store maintenance, inspection records
24 Quality Management Record-005 Outgoing, Transportation, Sales Record
25 Quality Management Record-006 Record of Quality Queries, Complaints, and Sampling
26 Quality Management Record-007 Return Record
27
Quality Management Record-008
Records related to the Disposal of Failures
28
Quality Management Record-009
Records for monitoring storage conditions in warehouses (temperature, humidity, etc.)
29
Quality Management Record-010
Records for the use of measuring instruments and calibration
30
Quality Management Record-011
Quality Accident Investigation and Handling Record
This is the first time that a quality management system has been established in China. Handling records
31
Quality Management Record-012
Adverse event investigation, reporting records
32
Quality Management Record-013
Medical device recall records
33
Quality Management Record-014
Quality Management System Implementation inspection and assessment records
34
Quality Management Record-001
Employee Health Examination Record
35
Quality Management Record-002
Employee Training Record
36
Quality Management Record-003
Sales Personnel and Sales Power of attorney file
37
Quality Management File-004
Supplier quality-related files
38
Quality Management File-005
Incoming, acceptance, maintenance, warehousing, and other related records and vouchers file
39
Quality Management File-006
User-related files
40
Quality Management File-007
Facilities and equipment and regular inspection, repair, maintenance files
41
Quality Management File-008
Measuring Instrument Management File
42
Quality Management File-009
Adverse Event Monitoring/Recall and Reporting Related Files
43
Quality Management File-010
Other Quality Related Files
44
Equipment and Facility Validation-001
Cold Storage Validation Program and Test Report (if any)
45
Equipment and Facility Validation-002
Refrigerated Truck Validation Program and Test Report (if any)
46
Equipment and Facility Validation-003
Truck-mounted Refrigerator Validation Program and Test Report (if any)
47
Equipment and Facility Validation-004
Automatic Temperature and Humidity Monitoring System Validation Program and Test Report (if any)
48
Equipment and Facility Validation-001