No. |
DOCUMENT |
文件 |
01 |
Business License |
营业执照 |
02 |
Import & Export License |
进出口证 |
03 |
Organization Chart, job description and manpower |
组织结构图, 职位描述及各部门人数 |
04 |
ISO9001 / ISO14001/ GMP Certificate (If any) |
ISO9001 / ISO14001 / GMP 等认证证书(如有) |
05 |
Quality Policy |
质量方针 |
06 |
Quality Procedure |
质量程序 |
07 |
Quality Manual |
质量手册 |
08 |
Management Review Procedure and Record |
管理评审程序/记录 |
09 |
Internal Audit Plan & Records |
内审计划/记录 |
10 |
Training and development plans & records |
员工的发展培训计划/记录 |
11 |
Machinery List |
机器设备清单 |
12 |
Machines Maintenance Plan & Records |
设备保养计划/记录 |
13 |
Regular analyses process and records for automatic |
自动化设备的操作工序和定期分析记录 |
14 |
Measuring / Testing Equipment List |
计量/ 测试仪器台帐 |
15 |
Measuring Equipment Calibration Certificate and |
计量仪器校验证书/记录 |
16 |
Master Reference Standards Calibration Certificate |
标准块的校验证书(如适用) |
17* |
All applicable and legal safety regulations and |
所有适用的产品/物料安全法规和强制性标准 |
18 |
Updated version MGB QMR (Only apply for Textile |
MGB 最新版本的 QMR (仅适用于纺织品) |
19 |
Technical Files (Product Spec., Drawing/ |
技术文件(产品规格/图纸/关键工序的生产参数 |
20 |
Products / Engineering Change Process & Records |
产品开发设计变更流程及记录 |
21 |
Suppliers / Sub-contractor Control Procedure and |
供应商/分包商控制程序和审核记录 |
22 |
Major Production Process Flow Diagram and output |
主要生产流程图及产量 |
23 |
Purchase Procedure, Purchase Order |
采购程序,采购合同 |
24 |
Material/ Finished Products Incoming & Outgoing |
材料及成品的出入库记录 |
25 |
Quality control Instructions (Incoming Materials/ |
检验作业指导书(进料检验、过程检验、外发工 |
26 |
Defect Classification (Incoming Materials/ |
疵点分类(进料、外发加工检验、过程检验、成 |
27 |
Inspection Records (Including Incoming Materials/ |
检验记录(进料、外发加工检验、过程检验、成 |
28 |
Material certification or conformity certificate for |
敏感或高风险材料/部件(如化学物质、电路板 |
29 |
Production Plan |
生产计划 |
30 |
Mass Production Authorization Documents |
生产通知单 |
31 |
Working Procedure and Instructions |
工作程序文件及作业指导书 |
32 |
Pre-Production Meeting Records |
产前会议记录 |
33 |
Pilot production inspection and analysis report |
试生产或首件检验结果的评估和分析记录 |
34 |
Packaging Instructions |
包装指示 |
35* |
Fumigation policy / procedure / process for Natural |
害虫防治的方针/程序/流程(适用于天然材料) |
36* |
Fumigation certification |
熏蒸证书(如适用) |
37* |
Sharp Tools Control Procedure, Sharp Tools Losing |
利器控制程序及利器丢失调查程序(如适用) |
38* |
Daily Issuance & Return of Sharp Tools Records (If |
利器日常收发/检查记录(如适用) |
39* |
Broken Needle Policy/ Record (If applicable) |
断针控制程序/记录(如适用) |
40 |
Glass Control Policy (If applicable) |
玻璃控制程序(如适用) |
41* |
Metal Detecting Record |
验针记录(如适用) |
42* |
Metal Detection Machine Calibration Record |
金属探测机检测记录(如适用) |
43 |
Non-conforming Material Control Procedure |
不合格品控制程序 |
44 |
Non-conformity analyzed and follow up records |
不合格品分析和跟进记录(来料,半成品,成 |
45 |
Re-inspection Records for Reworked Lots |
不合格品返工重验记录 |
46 |
Corrective & Preventive Actions Procedure/ Records |
纠正预防措施程序/记录 |
47 |
Documents Control Procedure |
文件控制程序 |
48* |
Life/ Reliability/ Functional Check/ Safety/ Actual |
寿命/可靠性/功能/安全/实际使用等测试的程序/ |
49 |
MSDS for hazardous chemical materials |
危险化学品的物质安全资料表 |
50 |
Policy / procedure for the use of personal |
个人防护用品使用程序 |
51 |
Customer Complain / Recall Procedure |
客户投诉或召回处理程序 |
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