No.序号
|
DOCUMENT
|
文件
|
1
|
Business License
|
营业执照
|
2
|
Organization Chart
|
组织结构图
|
3
|
Key Staff Job Description & Duty Vicegerent
|
关键岗位的岗位职责/职务代理人
|
4
|
Production Flow Chart
|
生产流程图
|
5
|
Equipment List
|
设备清单
|
6
|
Machines Maintenance Plan & Records
|
设备保养计划/记录
|
7
|
Machines Repair Records
|
设备维修记录
|
8
|
Equipment Operation Instructions
|
设备操作指引
|
9
|
Building/Equipment/ Products Cleaning Products and Records
|
厂房(内,外部)/设备/产品的清洁程序/记录
|
10
|
Training Records for Cleaning Staff
|
清洁人员的培训记录
|
11
|
Quality Policy
|
质量方针
|
12
|
Quality Objective
|
质量目标
|
13
|
Quality Manual
|
质量手册
|
14
|
Products Safety Procedure
|
产品安全程序
|
15
|
Work Instruction
|
作业指导书
|
16
|
Internal Audit Procedure & Records
|
内审程序/记录
|
17
|
Management Review Procedure and Record
|
管理评审程序/记录
|
18
|
Reports of the Functioning of QMS Including Suggestions for Improvement
|
有关质量管理体系的业绩及改进需求的报告
|
19
|
Products Specifications
|
产品规范
|
20
|
Record of Customers Requirement Review
|
顾客要求评审记录
|
21
|
Document Control Procedure
|
文件控制程序
|
22
|
Record Control Procedure
|
记录控制程序
|
23
|
Products Change Records
|
产品变更记录
|
24
|
Suppliers / Sub-contractor Control Procedure
|
供应商/分包商控制程序
|
25
|
Suppliers / Sub-contractor List and Assessment Record
|
合格供方(供应商,分包商)清单及审核记录
|
26
|
CAPA Procedure and Record
|
纠正预防措施程序/记录
|
27
|
Testing Record for the Traceability System
|
可追溯性体系测试记录
|
28
|
Legal Statutes and Mandatory Standards Applicable to Products/ Materials
|
产品,物料相关的法律法规和强制性标准(生产和拟销售地区的)
|
29
|
Products Risk Assessment Procedure/ Record
|
产品风险评估程序/记录
|
30
|
Process Control Procedure
|
过程控制程序
|
31
|
Products Risk Assessment Review Record
|
产品风险评估的评审记录
|
32
|
Training Procedure/ Plan
|
员工的培训程序/计划
|
33
|
Training Records (including Internal Rule and Work Skill training)
|
员工的培训记录(规章制度,技能)
|
34
|
Training Records for Products Risk Assessment Staff
|
执行风险评估人员的培训记录
|
35
|
Training Evaluation Record
|
培训有效性评估记录
|
36
|
Customer Complain & feedback Procedure/ Records
|
顾客抱怨反馈程序/记录
|
37
|
Incident Handle Procedure & Record
|
事故处理程序/记录
|
38
|
Inside & Outside Communication System
|
内部/外部沟通机制
|
39
|
Inspection Instructions (IQC/IPQC/FQC)
|
检验规范(原材料/过程/成品)
|
40
|
Inspection Records (IQC/IPQC/FQC)
|
检验记录(原材料/过程/成品)
|
41
|
Products Preservation Procedure, Temperature and Humidity Definition & Records (if applicable)
|
产品防护程序,温湿度规定及记录 (若适用)
|
42
|
Environment Policy
|
环境方针
|
43
|
Environment Objective
|
环境目标
|
44
|
Environment Impact Identified Procedure
|
环境影响因素的识别程序
|
45
|
Documents Compliance With the Local Environment Law and Regulation
|
符合当地环保要求的文件(例如:环评报告/排污许可证/委托处理液废/固废处理方的营业执照,双方协议,资质证明,发票/ 来自当地政府的符合性申明)
|
46
|
Hazardous Waste Disposal Record
|
有害废弃物处理记录
|
47
|
Non-conforming Products Control Procedure
|
不合格品的控制程序
|
48
|
Non-conforming Products Review Record
|
不合格品的评审记录
|
49
|
Assessment/Review Records of Product Test Need
|
测试需求评审记录
|
50
|
Testing Procedure & Record
|
产品的测试程序/记录
|
51
|
Testing Report Provided by Accredited laboratory (In-house or 3rd party)
|
有资质的实验室(内部或第3方)提供的测试报告
|
52
|
Test Order/Request
|
测试订单/申请
|
53
|
Review & CAPA Record of Failed Test Result
|
测试失败的评审记录及相应的纠正措施记录
|
54
|
Re-inspection Records for the Re-worked Products
|
返工重验记录
|
55
|
Recall Procedure/ Record
|
召回程序/记录
|
56
|
Pre-Production Meeting Records
|
产前会议记录
|
57
|
First Article Inspection Records
|
首件确认记录
|
58
|
Process Monitoring Procedure and record
|
过程的监视和测量程序/记录
|
59
|
Measuring Machines/Equipments Calibration Plan and Records
|
测量仪器的校准计划/记录
|
60
|
Shipment Release Instructions
|
产品放行规定
|