MGB麦德龙质量验厂检查清单
MGB麦德龙质量验厂检查清单

No.
序号

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
details

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
machines

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
Records

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
requirement

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
product)

MGB 最新版本的 QMR (仅适用于纺织品)

19

Technical Files (Product Spec., Drawing/
Manufacturing Parameters of Key Processes etc.)

技术文件(产品规格/图纸/关键工序的生产参数
等)

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
Assessment Record

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
records

材料及成品的出入库记录

25

Quality control Instructions (Incoming Materials/
Sub-contracting Product Inspection, In-process
Inspection & Finished product inspection
Instructions)

检验作业指导书(进料检验、过程检验、外发工
/产品以及成品检验)

26

Defect Classification (Incoming Materials/
Subcontracting Product Inspection, In-process

疵点分类(进料、外发加工检验、过程检验、成
品检验)

27 

Inspection Records (Including Incoming Materials/
Sub-contracting Product Inspection, In-process
Inspection & Finished product inspection) .

检验记录(进料、外发加工检验、过程检验、成
品检验、功能测试)

28 

Material certification or conformity certificate for
sensitive or high risk material/ components

敏感或高风险材料/部件(如化学物质、电路板
等)的认证或合格证书

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
Material

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
Investigation Procedure (If applicable)

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
applicable)

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
(Including incoming materials, Semi-finished
Products & Finished Products)

不合格品分析和跟进记录(来料,半成品,成
品)

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
Usage Testing Procedure /Records

寿命/可靠性/功能/安全/实际使用等测试的程序/
记录

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
protective equipment

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