SQEF0002 A TTI MIL QMS Audit Check List

Form No.
:SQEF0002 Version: A Effective date:16/12/2020
TTI-MIL QMS Audit Check List

TTI Mil供应商品质管理系统审核表
Revision: A
Revision History
Description of Changes Version Revised Date Revised By
First issue ( Transfer from PRC Form No: SQEF00002 F) A 16/12/2020 Tony Phan
Page 1 of 52
Form No.: SQEF0002 Version: A Effective date:16/12/2020
SUPPLIER AUDIT REPORT

供應商審核報告
Report No. 編號:

SUPPLIER PROFILE 供應商資料
Supplier Name 供應商:
Address 地址:
Contact Person/Title 聯絡人/職務: Tel: Email:
Headquarter/ Owner (if applicable):
Address 地址:
Subsidiaries (if applicable):
Address 地址:
AUDIT TYPES 審核類型
Pre - Assessment 预评估 Result: 0.0%

Initial Audit 首次審核 Follow-up Audit 跟蹤審核
Annual Audit 年審 Others: / 其他
AUDIT SCOPE 審核范围

QSA: 品质系统稽核 HSPM: 有害物质管理体系 SER:社会责任
COMMODITY 所供產品類別
Motors Plastic Packaging Battery
Die Casting Engine Machined Parts PCBA
Chargers Stamping Switches Electronics
Other (List):
AUDIT SUMMARY 審核詳述
1.Audit Result 審核結果: Overall Audit Score 0.0%
No.
Audit Result 審核結果 Acceptance Criteria 評審標準
序號
Audit status meet any of the below items:

1) Any Zero Tolerance items
1 Not Acceptable 不合格 2) Overall audit score ＜ 70%
3) QSA score < 70%
4) Section HSPM/SER/EMS/C-TPAT <65%
Audit status meet below item:

2 Conditionally Acceptable 1) 70%<= Overall audit score < 80%
有條件合格
2) Section HSPM/SER/EMS/C-TPAT >65%
Audit status meet below item:

3 Acceptable 合格 1) Overall audit score >= 80%
2) Section HSPM/SER/EMS/C-TPAT >65%
2.Approved For :
Commodity Production:
Manufacturing Process
Location(If different)
Page 2 of 52

Report No. 編號:
Prepared by: Checked by: Approved by:

報告人: 確認人: 審核:
Page 3 of 52

Report No. 編號:

Supplier Organization
Function Key Contacts (Name, Title) Tel. Email

Management:
Quality:
Manufacturing:
Engineering:
Logistic/Materials
HR
Sales & Marketing:
Organization Chart:
Page 4 of 52
Form No.: SQEF0002 Version:A Effective date: 16/12/2020
Explanation
1. Pre-Assessment: Potential new supplier should be assessed by cross function team, which is
led by Asia Procurement.
2. Initial audit : For new supplier who has passed pre-assessment a formal factory audit will be
conducted by divisional outsource QA team
3. Follow-up Audit : If supplier fails initial audit, a follow-up audit will be arranged after corrective
actions are completed. Conducted by outsource QA team.
4. Annual Audit: for existing supplier. Conducted by outsource QA once a year.
5. Scoring Criteria,
SCORES FOR EACH QUESTION
No Not Effective Effective

Implementation Implementation Implementation
No System 0 0 1
Inadequate System 1 1 2
Adequate System 1 1 3
No System - No SOP or procedure conforming to ISO/TS16949 ,SER and HSF management system.
Inadequate System - SOP and procedure that does not meet all or the ISO/TS16949 ,SER and HSFrequierments
Adequate System – Possess the SOP and procedure meet all ISO/TS16949 ,SER and HSF requirements
No Implementation - No Implementation per SOP and ISO/TS16494,SER and HSF procedure_x0000__x0000__x0000__x00
No Effective Implementation - Implementation not meeting all the SOP and IS/TS1694,SER and HSF procedure _x0000__x0
Effective Implementation - Fully implemented against the SOP and ISO/TS16949,SER and HSF
6. Each section is scored according to the average of all the question scores
7 Indicate non-applicable item as N/A then the score will be deducted from total possible.
8 If Audittor finds any Zero Tolerance means Supplier is not passed the audit.
Page 4 of 52
Form No.: SQEF0002 Version: A Effective date: 16/12/2020
Report No. 編號: 0
Supplier Pre-assessment
供應商預評估 scoring criteria
No. Questions/问题点 Observation发现 Score得分 Remark备注
Be awarded ISO/TS16949 certificate or other

1 equivalent QMS certificates. 公司是否有获得 0
ISO/TS16949证书或其他等同的质量管理证书。
Does the production process can ensure the products

meeting specification? (Control plan, working
*2 instruction, equipment setting and maintaince) 0
生产过程是否能够确保产品符合规格。（控制计划，作
业指导书，设备设置和维护。）
Is there adequate quality control for production

process? (inspection items/quantity/frequency)
*3 0
生产过程是否得到足够的品质管控。（检验项目/数量/
频率。）
Key/Critical Product/Process Characteristics are

identified as such on Control Plan and there is an
*4 appropriate reaction plan for each characteristic. 是否 0
有定义出生产过程或产品的关键属性/过程，并且对每个
关键属性/过程是否制订反应计划。
Are gauges available and adequate in production

5 area? 0
(生产区域是否有相应的量具并且适用?)
Are the capacity, accuracy, stability of production

*6 equipment is adequate? 0
生产设备能力，精度和稳定性是否足够？
Is SPC used for process control?

7 0
是否应用SPC对过程进行管控？
8 Is automaticly production line be used for production? 0

是否使用自动化设备进行生产？
Supplier has quality department on site with

appropriate experience and knowledge to ensure the
*9 quality for products can be well controlled. 0
供应商具有品质部，相应人员具备适当的经验和知识来
确保生产品质可以得到良好控制。
Supplier has an incoming inspection strategy,

inspection criteria and results are documented.
Reaction plans exist and are followed in cases where
*10 inspection results do not meet acceptance criteria. 供 0
应商是否有设置来料检查，检验的标准及结查是否有记
录？不合格是否有相关的重检结果及不能满足接收的标
准。
Supplier has an outgoing inspection strategy,

inspection criteria and results are documented.
Reaction plans exist and are followed in cases where
*11 inspection results do not meet acceptance criteria. 供 0
应商是否有设出货检查，检验的标准及结果是否有记录
？不合格是否有相关的重检结果及不能满足接收的标准
？
Page 5 of 52
Supplier uses a structured problem solving method

12 such as 8D to address customer and internal issues. 0
供应商是否使用规定的格式来解决客户的报怨及内部的
材料异常，如8D格式。
Supplier has the required metrology, laboratory
equipment to perform verification & validation test and
ongoing in-process testing & Product validation for the
proposed sourcing. Are the accuracy and stability
adequate?
For following commodity, related equipment is
required.
Plastic/Diecasting: vision system, CMM
*13 Metal: Rockwell hardness tester, Vickers hardness 0
tester
Machining parts: vision system, CMM 供应商是否具备
为实行设计验证/相关测试/制程控制/生产确认所需的测
量和测试设备。设备的精度和稳定性是否足够。
对以下类型产品，必须具备相应的设备：
塑胶/压铸：影像仪，三坐标
五金：洛氏硬度计，维氏硬度计
机加工：影像仪，三坐标
Are the practical inspectors capable for judging the
conformance of incoming material?
*14 0
(实际检验人员是否具备足够的能力来判断来料是否符合
标准？)
Are inspection equipments be well maintanced and

15 calibrated? 0
检验设备是否有适当的维护和校准？
Is any MSA for critical equipment, gauge and fixtures,

like GR&R?
16 0
(对重要的设备，检具和夹具是否有做测量系统分析，例
如GR&R?)
Supplier has product development and process

engineering on site with appropriate experience to
manage the proposed sourcing. Including product
17 design, process design, tooling/testing and production 0
fixture design and maintance. 供应商在产品开发和制程
方面是否有适当的经验来管理好未来的资源。包括产品
设计，制程设计，模具/测试和生产制具的设计和维护。
Supplier demonstrates production experience for

relevant industry for the part(s) or commodity for
*18 similar customer(s) being considered at volume levels 0
similar to the proposed sourcing. 供应商是否具备给相
类似的客户提供相类似的产品的经验，并且产品等级符
合相应领域所需的要求。
Supplier can promise try their best to meet related

quality requirements for products, when a quality issue
occurred, supplier can deal with it timely and
*19 effeciency. 0
供应商能够承诺尽力配合品质的我公司关于品质的相关
要求，当出现品质异常时，能够配合尽快的有效的处理
。
Is there a system to manage new product develop, and

*20 ensure the production product is same as samples. 供 0
应商是否有一个系统来管理一个新产品的开发，并保证
生产产品与样板的一致性。
Page 6 of 52
Supplier has product development and process

engineering on site with appropriate experience to
manage the proposed sourcing. Including product
21 design, process design, tooling/testing and production 0
fixture design and maintance. 供应商在产品开发和制程
方面是否有适当的经验来管理好未来的资源。包括产品
设计，制程设计，模具/测试和生产制具的设计和维护。
Supplier has a process for change management

22 control, including design and process changes in both 0
development and production. 供应商是否有系统来管理
工程变更，包括新产品开发阶段和量产阶段。
The store can ensure the products be well identified,

23 and good operation on FIFO. 0
供应商仓存是否保证产品做到良好的区分，并做到先进
先出。
HSF Components/materials/products which are in
warehouse/production line are segregated and
24 identified from non-HSF Components /materials 0
/products。有害物质和非有害物质是否有区分管理和标
示（生产/货仓）？
Supplier can provide hazardous substance test report

for critical/high risk component/material. Does supplier
25 0
has internal RoHS test ability? 供应商是否能提供有害
物质含量的测试报告？供应商是否有RoHS测试能力？
Supplier demonstrates no child labors are used

26 0
throughout factory. 供应商是否有用童工？
Remarking: Total: 0.00%
1. The items with "*" marking at the from of item No. must be complied (score >=2).
2. Minimum requirement: >65%
Conclution: Terminate
Engage to further development
Page 7 of 52

1. PROCESS CONTROL AUDIT SCORE SUMMARY/制程控制評審得分狀況 Pecentage: 40
Score
No. Sections Max Actual Quality plan
序號品质计划
Possible Score % Score
總分實際得分
80.00%
1 Quality plan 9 0 0.0% 40.00%
品质计划
0.00%
2 Production process control 15 0 0.0%
生产过程控制
Advanced process control Production process control
高级制程控制生产过程控制
Advanced process control
3 3 0 0.0%
高级制程控制
Total Score 27 0 0.0%

總得分
2. QUALITY CONTROL AUDIT SCORE SUMMARY/质量控制評審得分狀況 Pecentage: 20
Score
No. Sections Max Actual Incoming quality control

序號来料质量控制
總分實際得分
80.00%
40.00%
Incoming quality control
1 12 0 0.0%
来料质量控制 0.00%
2 Out-going quality control 12 0 0.0%

出货质量控制 Other quality control Out-going quality control
其他质量控制出货质量控制
Other quality control
3 6 0 0.0%
其他质量控制
Total Score
30 0 0.0%
總得分
3. METROLOGY SYSTEM AUDIT SCORE SUMMARY/测量系统評審得分狀況 Pecentage: 20
Score
No. Max Actual

Sections
序號
Possible Score % Score Measurement Capaibility & exevutive 测量能力和执行
總分實際得分
80.00%
Measurement Capaibility & 40.00%
1 12 0 0.0%
exevutive 测量能力和执行
0.00%
2 Equipment and lab maintance 6 0 0.0%
设备和实验室的维护 Advanced measurement system maintance Equipment and lab maintance
高级测量系统维护设备和实验室的维护
Advanced measurement
3 system maintance 6 0 0.0%
高级测量系统维护

總得分
Page 8 of 52
4. QUALITY SYSTEM AUDIT SCORE SUMMARY/品質系統評審得分狀況 Pecentage: 20
Score
No. Sections Max Actual Quality management system

序號质量管理体系
總分實際得分 100.00%
80.00%
1 Quality management system 54 0 0.0% 60.00%
质量管理体系
Measurement, analysis and improvement 40.00% Management responsibility
测量，分析与改进管理责任
Management responsibility 20.00%
2 81 0 0.0%
管理责任
0.00%
3 Resource management 63 0 0.0%
资源管理
4 Product realization 384 0 0.0%

产品实现
Product realization Resource management
Measurement, analysis and 产品实现资源管理
5 improvement 243 0 0.0%
测量，分析与改进

總得分
5. HSPM AUDIT SCORE SUMMARY/HSPM系統評審得分狀況 Reference
Score
No. Max Actual
Sections
序號
總分實際得分
Total Score
總得分 144 0 0.0%
Page 9 of 52
6. Social Environmental Responsibility/社會職責 Reference
Score
Max Actual
No. Possible Score
序號 Sections 總分實際得分 % Score
Total Score
總得分 114 0 0.0%
7. Environment Management System/環境管理系統 Reference
Score
Max Actual
No. Possible Score
Total Score
總得分 33 0 0.0%
8. Factory Security (GSV & C-TPAT)/工廠安全 Reference
Score
Max Actual
No. Possible Score
Total Score
總得分 0 0 #DIV/0!
4. Auditor Team :
Name / 姓名 Position / 職務 Name / 姓名 Position / 職務
Auditor
SupplierAuditee
Team
Team Members
Members 供應商協審員
評審員
5. Audit Summary
Strengthes:
Opportunities:
Page 10 of 52
Page 11 of 52
Supplier Quality Audit Report(system)

供應商審核報告(系統部份)
Significant Need Non-

Rate No system Satisfaction
40 Deficiency improvement 完全满足 applicable
比例无系统
严重不足需要改善不适合
Part 1 – Process Control
第一部份 - 制程控制 Total Score 27
总分
0 1 2 3 N/A
Actual Score
0
实际得分
Item Requirements What to look for Assessor notes / Objective evidence Score
项目要求寻找什么评定人员的记录及客观证据得分
1.1. Quality plan 品质计划
Alignment of following items: (以下内容的一致

Are the specifications, PCP(process control plan), WI(work 性)
instruction) and the practical operations all alignment and adequate? Product specification (产品规格)
1.1.1 0
(产品规格/要求，制程控制计划，作业指导书和实际操作是否一致？ Control plan (控制计划)
是否足够用于控制产品质量？) Working instruction (控制计划）
Practical operation (实际操作）
Are all specifications adequately controlled on the quality plan? Product specification (产品规格)
1.1.2 0
(是否所有产品规格和要求都在制程计划里得到足够的控制？) Control plan (控制计划)
Are the inspection frequency and measurement methods identified

Control plan (控制计划)
1.1.3 on the plan and adequate? 0
(检验频率和检验方法是否在注明在计划中？是否足够？)
1.2. Production process control 生产过程控制
Control plan (控制计划)

Are practical processes performed as defined in WI and PCP?
1.2.1 Working instruction (控制计划） 0
(实际生产过程是否与作业指导书和制程控制计划中的定义相符？)
Are gauges available and adequate in production area? On-site review (现场检查)
1.2.2 0
(生产区域是否有相应的量具并且适用?) gauge review (检具检验)
Are the practical performed inspections capable for judging the

Inspection process review (检验过程检查)
1.2.3 conformance of product? 0
Inspector interview (检验人员考核)
(实际操作的检验是否足够用于判断产品的符合性？)
Are settings of machine and equipment available?

1.2.4 On-site review (现场检查) 0
(设备和仪器的设定是否合适?)
Are equipments consistant?

1.2.5 Equipment checking records (仪器检验记录) 0
(设备是否稳定?)
1.3 Advanced process control 高级制程控制
Does the organization has the following quality control in process:

CPK; SPC; Poke York; Preventive & Maintance Plan?
1.3.1 On-site review (现场检查) 0
(组织在过程中是否使用如下的控制方法：CPK; SPC; Poke York; 问
题预防和维护？)
Page 11 of 52


比例 20 无系统 Deficiency improvement 完全满足 applicable
Part 2 – QC Control
第二部份 - 品质控制 Total Score
30
总分
0 1 2 3 N/A
Actual Score
实际得分 0
2.1 Incoming quality control 来料质量控制
Product specification (产品规格)

Are incoming inspection specifications, product specifications and
Incoming inspection specification (来料检验规
practical operations alignment and adequate?
2.1.1 范) 0
(来料检验规范和产品规范/要求并与实际操作一致，并且足够控制来
Incoming inspection records (来料检验记录)
料质量？)
Practical operation (实际操作)
Are incoming inspection items, sample size, frequency and Product specification (产品规格)
measurement method all defined and adequate? Incoming inspection specification (来料检验规
2.1.2 0
(来料检验项目，样板数量，检验频率和检验方法都有定义，并且足够范)
？) Incoming inspection records (来料检验记录)
Are the practical inspectors capable for judging the conformance of

2.1.3 incoming material? 0
Inspector interview (检验人员审核)
(实际检验人员是否具备足够的能力来判断来料是否符合标准？)
Are equipments and gauges available and consistant?

2.1.4 Gauge records (检具相关记录) 0
(检验设备和检具是否合用并且稳定？)
2.2 Out-going quality control 出货质量控制
Product specification (产品规格)

Are out-going inspection specifications, product specifications and
Out-going inspection specification (出货料检验
practical operations alignment and adequate?
2.2.1 规范) 0
(出货检验规范和产品规范/要求并与实际操作一致，并且足够控制产
Out-going inspection records (出货检验记录)
品质量？)
Are out-going inspection items, sample size, frequency and Product specification (产品规格)
measurement method all defined and adequate? Out-going inspection specification (出货料检验
2.2.2 0
(出货检验项目，样板数量，检验频率和检验方法都有定义，并且足够规范)
？) Out-going inspection records (出货检验记录)
Are the practical inspectors capable for judging the conformance of

2.2.3 incoming material? 0
Inspector interview (检验人员审核)
(实际检验人员是否具备足够的能力来判断来料是否符合标准？)
Are equipments and gauges available and consistant?

2.2.4 Gauge records (检具相关记录) 0
(检验设备和检具是否合用并且稳定？)
2.3 Other quality control 其他质量控制
Does the organization has proper process for subsuppliers selection,

evaluation, maintance control and disqualify? Subsupplier control process & records (下级供
2.3.1 0
(组织是否具备合适的程序对下级供应商进行选择，评估，维护及取消应商控制程序和记录)
资格？)
Does the organization has proper process when non-conformance

was found or customer complaint was received? Like MRB, 8D Non-conformance & customer complaint
2.3.2 report? process & records (不良处理和客户投诉处理流 0
(当发现不良或者收到客户投诉时，组织是否具备合适的程序来应对，程和记录)
例如：MRB, 8D报告？)

比例 20 无系统 Deficiency improvement 完全满足 applicable
Part 3 – Capacity of Identify the Conformance
of Products Total Score 24
第三部份 - 识别产品符合性的能力总分
0 1 2 3 N/A
Page 12 of 52

Part 3 – Capacity of Identify the Conformance
of Products
第三部份 - 识别产品符合性的能力 Report No. 編號: 0
0 1 2 3 N/A
Actual Score
实际得分 0
3.1 Measurement Capaibility & execution 测量能力和执行
Does the organization have enough metrology equipments to

perform verification & validation for proposed design and production.
For following commodity, related equipment is required.
Plastic/Diecasting: vision system, CMM
Metal: Rockwell hardness tester, Vickers hardness tester Equipment list (设备清单)
3.1.1 Machining parts: vision system, CMM 供应商是否具备足够的测量和 On-site review (现场确认) 0
测试设备,来为设计和生产提供验证和确认.
对以下类型产品，必须具备相应的设备：
塑胶/压铸：影像仪，三坐标
五金：洛氏硬度计，维氏硬度计
机加工：影像仪，三坐标
Related person interview: (相关人员审核)

Do related persons have the enough knowledge and ability? To · Drawing, hardness, GD&T (图纸，硬度，形
understand the drawing and dimensions; to select and use proper 位公差)
equiments for measurement; to design and using gauge/fixture for · Equipment selection and operation) (仪器选
3.1.2 some special dimensions? 择和操作) 0
(相关人员是否具备足够的知识，以便能看懂图纸和尺寸标注？选择和 · Gauge and fixture design (夹具检具设计)
使用适当的设备来进行测量? 给某些特殊尺寸设计和使用夹具/检具？ Measurement records (检验记录)
) Gauge and fixture drawing and measurement
records (检具夹具图纸和检验记录)
Related person interview (相关人员审核)

Are practical measurement process capable to identify the
Related process (相关过程)
3.1.3 conformance of product? 0
Measurement records (检验记录)
(实际检验过程是否足够判断产品的符合性？)
Are practical measuring processes performed as defined in WI and

Measurement records (检验记录)
adequate?
3.1.4 Product specification (产品规格) 0
(实际测量过程是否与作业指导书和制程控制计划中的定义相符并且足
够？)
3.2 Equipment calibration and maintance 设备校检和维护
Are the equipments, fixtures, gauges located in proper position and

environment, so that they can provide consistant reading? (设备，夹 On-site review (现成确认)
3.2.1 0
具，检具是否放置在适当的地方和环境，以保证它们能提供稳定的读 Environment records (环境记录)
数？)
Are the equipments fixtures, gauges be calibrated before using, and

have proper maintanced and calibrated bo make sure they can On-site review (现成确认)
3.2.2 provide correct reading? Equipment calibration & maintance records (设 0
(设备，夹具，检具在使用之前是否经过校准，后续是否有维护和校准备校检和维护记录)
，以保证它们能提供正确的读数？)
3.3. Advanced measurement system maintance 高级测量系统维护
Is correlation analysis be done for gauge, fixture or equipment?

3.3.1. Correlation records (相关性分析记录) 0
(设备，检具和夹具是否有做相关性分析？)
Is any MSA for critical equipment, gauge and fixtures, like GR&R?
3.3.2. MSA records (测量系统分析记录) 0
(对重要的设备，检具和夹具是否有做测量系统分析，例如GR&R?)

No system Satisfaction
Rate比例 20 Deficiency improvement 完全满足 applicable
无系统
Part 4 – Quality management system (TS16949
element 4 to element 8) Total
第四部份 - 质量管理体系 (TS16949第4章到第8章) 825
Score总分
0 1 2 3 N/A
Actual Score实际得分 0
Page 13 of 52

4. Quality management system 质量管理体系
4.1 General Requirements 总体要求
Has the organization established and documented a quality

· Quality manual according to TS 16949 or
management system in accordance with the requirements
4.1.1 one with a conversion matrix. (依据IATF16949: 0
ofIATF16949: 2016? (组织是否按照IATF16949: 2016的要求建立质
2016管理手册)
理管理体系,并形成文件。)
Has the organization implemented and maintained its established

quality management system in accordance with the requirements of · Key personnel interview. (与主要人员会谈)
4.1.2 0
ISO/TS 16949:2002 (E)?(组织是否按照ISO/TS16949的要求实施和保 · Examples of effective (有效实施的案例)
持已建立的质量管理体系？)
· Examples and status of quality management

Is the organization continually improving the effectiveness of its
system continuous improvement projects, not
quality management system in accordance with the requirements of
corrective actions. (质量管理体系持续改进的案
4.1.3 ISO/TS 16949:2002 (E)? 0
例和状态，不是纠正措施。)
(组织是否按照ISO/TS16949 的要求持续改进其质量管理体系的有效
· Management review results. (管理评审结果。
性？)
)
Does the organization’s quality management system : (组织的质量管

理体系是否:)
a) identify the processes needed for the quality management system
and their application throughout the organization? (识别质理管理体 · Quality manual according to TS 16949 or
系所需的过程及其在组织中的应用?) one with a conversion matrix. (依据
4.1.4 0
b) determine the sequence and interaction of these processes? (确 ISO/TS16949:2002或转换矩阵编制的质量手册
定这些过程的顺序和相互作用？) )
c) determine criteria and methods needed to ensure that both the
operation and control of these processes are effective? (确定可以用
于保持这些过程的运作与控制的有效性的准则和方法。)
Does the organization’s quality management system : (组织的质量管 · Review of all the elements of the quality
理体系是否:) management system to insure its continuing
a) ensure the availability of resources and information necessary suitability and effectiveness. (评审质量管理体
to support the operation and monitoring of the processes needed for 系的所有要素，以确保其持续的适宜性和有效
its quality management system? (确保可以获得必要的资源和信息，性。)
以支持这些过程的运作和监测？) · Review of quality cost indicator(质量成本指
4.1.5 0
b) monitor, measure and analyze the processes needed for its 针的评审)
quality management system? (监测、测量和分析这些过程？) · Management review meeting minutes,
c) implement actions necessary to achieve planned results and attendance and adequate frequency. (管理评
continual improvement of the processes needed for its quality 审会议记录，出席人数和充足频次)
management system? (实施必要的措施，以实现对这些过程策划的 · Action plans and follow-up. (行动计划和跟踪
结果和对这些过程的持续改进) 活动。)
Does the organization manage the processes needed for its quality
management system in accordance with the requirement of ISO/TS
4.1.6 · 0
16949:2002 (E)? (组织是否按照ISO/TS16949的要求管理其质量管理
体系所需的过程？)
Page 14 of 52

Does the organization ensure control over outsourced processes

4.1.7 that affects product conformity with requirements? (组织是否对影响 · 0
产品的符合要求的外包过程实施控制。)
Is the control of the organization’s outsourced processes that affects

product conformity with requirements identified within the quality
4.1.8 one with a conversion matrix. (依据IATF16949: 0
management system? (对影响产品符合要求的外包过程的控制，组
2016或转换矩阵编制的质量手册)
织是否在质量管理体系中加以说明)
4.2 Documentation requirements 文件要求
4.2.1 General 总则
Does the quality management system documentation include the

following: (质量管理体系文件是否包括以下方面:)
a) documented statements of a quality policy and quality objectives?
one with a conversion matrix. (依据
(形成文件的质量方针和质量目标？)
ISO/TS16949或转换矩阵编制的质量手册)
b) a quality manual? (质量手册)
· Adequacy of the procedures to the
c) documented procedures required byIATF16949: 2016? (标准要求
4.2.1 complexity of the organization. (依据组织的复 0
的形成文件的程序)
杂度决定程序的充分性)
d) documents needed by the organization to ensure the effective
· Quality management system procedures. (质
planning, operation and control of its processes? (组织为确保其过程
量管理体系程序)
有效策划、运作和控制所需的文件？)
· Quality records. (质量记录)
e) records required byIATF16949: 2016 (see element 4.2.4)? (本标
准所要求的记录)
4.2.2 Quality Manual 质量手册
Has the organization established and maintained a quality manual

that includes : (组织是否编制并保持包括以下方面的质量手册:)
a) the scope of the quality management system, including details of
and justification for any exclusions (see section 1.2 ofIATF16949:
2016)? (质量管理体系的范围，包括任何删减的细节与合理性) · Quality manual according to TS 16949 or
4.2.2 b) the documented procedures established for the quality one with a conversion matrix. (依据IATF16949: 0
management system, or reference to them? (为质量管理体系编制的 2016 或转换矩阵手册)
形成文件的程序或对其引用)
c) a description of the interaction between the processes of the
quality management system? (质量管理体系过程之间的相互作用的
表述？)
4.2.3 Control of documents 文件控制
· Quality manual according to TS 16949 or one

Does the organization control the documents required by the quality with a conversion matrix. (依据IATF16949:
4.2.3 management system? (组织是否对质量管理体系所要求的文件进行 2016或转换矩阵编制的质量手册) 0
控制？) ·Document control master list or equivalent.(文
件控制清单或类似的文件)
Page 15 of 52

Has the organization established a documented procedure to define

controls needed: (组织是否编制形成文件的程序，以规定以下方面所
需的控制。)
a) to approve documents for adequacy prior to issue? (文件发布前得 · Document approval authority. (文件批准权限
到批准，以确保文件是充分与适宜的？) )
b) to review and update as necessary and re-approve documents? · Document approval records (文件批准记录)
(必要时对文件进行评审与更新，并再次批准？) · Availability of documents in various
c) to ensure that changes and the current revision status of locations. (不同场所文件的易于获得性)
documents are identified? (确保文件的更改和现行修订状态得到识别 · Knowledge of documents location. (文件场所
？) 的知识)
4.2.4 d) to ensure that relevant versions of applicable documents are · Document accessibility. (文件的可获得性) 0
available at points of use? (确保在使用处可获得适用文件的有关版本 · Storage and disposal of obsolete
？) documents. (废弃文件的储存和处理)
e) to ensure that documents remain legible and readily identifiable? · Process for notification/distribution of
(确保文件保持清晰，易于识别？) documents from internal and external origins.
f) to ensure that documents of external origin are identified and their (内部和外部文件的通知/分发过程)
distribution controlled? (确保外来文件得到识别，并控制其分发？) · Review and approval of revised documents.
g) to prevent the unintended use of obsolete documents, and to (已修订文件的评审和批准)
apply suitable identification to them if they are retained for any
purpose? (防止作废文件的非预期使用，若因任何原因而保留文件作
废时，对这些文件进行适当的标识？)
4.2.4.1 Engineering specifications 工程范围
Does the organization have a process to assure the timely review, · Process for notification/distribution of
distribution and implementation of all customer engineering customer engineering standards changes. (顾
standards/specifications and changes (including the updating of 客工程规范更改的通知/分发过程)
4.2.5 appropriate documents) based on customer required schedule? (组 · Process for implementation of customer 0
织是否建立一个过程，以保证及时复核和发放和实施所有顾客工程标 initiated changes. (实施顾客要求的更改的过程)
准/规范要求及其基于顾客要求的安排的更改（包括适当文件的更新） · Document changes triggered by engineering
) changes. (工程更改引发的文件更改)
Does the organization maintain a record of the date on which each

· Records of engineering changes
4.2.6 change is implemented in production? (组织是否保存每项更改在生 0
implemented. (实施工程更改的记录)
产中实施的日期的记录。)
4.2.4 Control of records 记录控制
Has the organization established and maintained records to provide ·Quality management system records. (质量管
evidence of conformity to requirements and of the effective operation 理体系记录)
4.2.7 of the quality management system? · Records maintenance system, including 0
(组织是否建立并保持记录，以提供符合要求和质量管理体系有效运行 disposal of records. (记录维护体系，包括记录
的证据) 的处理)
· Quality management system records

legibility. (质量管理体系记录)
· Identification of quality management system
records. (质量管理体系记录的识别)
Are records legible, readily identifiable and retrievable? (记录是否保
4.2.8 · Environment and storage conditions must 0
持清晰，易于识别和检索)
be compatible with the file storage medium
(ex: hard copy, floppy disk, etc.) (环境和储存条
件必须符合文件的存储介质（如：硬拷贝、软
盘等）)
Page 16 of 52

· Quality manual according to TS 16949. (依据

ISO/TS16949:2002编制的质量手册。)
· Defined record retention time compared to
Has the organization established a documented procedure to define customer/regulatory requirements (根据顾客/法
the controls needed for the identification, storage, protection, 规要求规定的记录保存期限)
4.2.9 retrieval, retention time and disposition of records? (组织是否编制形 · Record disposal after retention period 0
成文件的程序，以规定记录的标识、贮存、保护、检索，保存期限和 expires (保存期满后，对记录的处理)
处置所需的控制？) · Including identification of obsolescence
documents. (包括对废旧文件的标识)
· Identification of invalid/obsolete documents.
(对无效、废旧文件的标识)
Does the organization treats quality records as a special type of · Evidence of quality records being
document and control them according to the requirements given in maintained and controlled per quality manual.
4.2.10 0
questions 4.2.7 and 4.2.8? (组织是否把记录看成是一种特殊类型的文 (每一个质量手册中维护和控制的质量记录的证
件，并必须依据4.2.7和4.2.8中提出的要求进行控制？) 据)
5 Management responsibility 管理责任
5.1 Management commitment 管理承诺
Does top management have evidence of providing commitment to · Documented policy statement with clearly
the development and implementation of its quality management defined and measurable quality objectives
5.1.1 0
system? (最高管理者是否对其建立、实施质量管理体系的承诺提供证 approved by CEO (根据CEO批准的，清楚定义
据。) 的，可测量的质量目标而文件化的方针声明。)
· Customer defined objectives (Customer

Does the organization’s top management have evidence of providing
specifications) and company goals stated in
commitment to continually improving its quality management system
the business plan and their alignment with the
effectiveness by: (组织的最高管理者是否通过以下活动对其持续改进
quality policy statement. (企业计划中说明的顾
质量管理体系有效性的承诺提供证据)
客定义的目标（顾客规范）和企业目的，和质
a) communicating to the organization the importance of meeting
量方针保持一致)
customer as well as statutory and regulatory requirements? (向组织
5.1.2 · Quality manual according to TS 16949. (依 0
传达满足顾客和法律法规要求的重要性？)
据ISO/TS16949编制的质量手册)
b) establishing the quality policy? (制定质量方针) · Management reviews meeting minutes;
c) ensuring that quality objectives are established? (确保质量目标的 attendance and adequate frequency. (管理评
制定) 审会议记录、出席人数和适当频次。)
d) conducting management reviews? (进行管理评审)
· Action plans and follow-up. (行动计划和跟踪
e) ensuring the availability of resources? (确保资源的获得)
活动。)
5.1.1 Process Efficiency 过程效率
· Review of product realization and support

Does organization’s top management monitor the product realization
processes by top management. (最高管理者对
processes and the support processes to assure their effectiveness
5.1.3 产品实现过程和支持) 0
and efficiency? (组织的最高管理者监控产品实现的过程，并且提供支
· Indicators and records. (指针和记录)
持以确保其有效性和效率。)
· Reporting process. (报告过程)
5.2 Customer Focus 以顾客为关注焦点
· Description of an objective process (客观过程

的描述)
· Methodology used for surveys (使用的调查方
Does top management ensure that customer requirements are
法)
determined and fulfilled with the aim of enhancing customer
5.2.1 · Original Customer data and scope such as 0
satisfaction? (最高管理者是否以增进顾客满意为目的，确保顾客的要
求得到确定并给予以满足) customer satisfaction feedback (surveys,
scorecards, awards, etc) (原始顾客数据和范围
，如顾客满意度的反馈（调查，记分卡，奖品
等）)
Page 17 of 52

5.3 Quality policy 质量方针
· Documented policy statement with clearly

defined and measurable quality objectives
approved by (CEO根据CEO批准的，清楚定义
的可测量目标而文件化的方针声明。)
Does top management ensure that the quality policy: (最高管理者是
· Records of improvement. (改进的记录)
否确保质量方针)
· Quality objectives included/linked to the
a) is appropriate to the purpose of the organization? (与组织的宗旨
business plan. (包含在/连接到业务计划的质量
相适应。)
目标。)
b) includes a commitment to comply with requirements and
· Scope of the Quality objectives. (质量目标的
continually improve the effectiveness of the quality management
5.3.1 范围) 0
system? (包括对满足要求和持续改进质量管理体系有效性的承诺)
· Direct interviews with randomly selected
c) provides a framework for establishing and reviewing quality
people of the organization. (与组织内随意选择
objectives? (提供制定和评审质量目标的框架。)
的员工进行直接交谈)
d) is communicated and understood within the organization? (在组织
· Evidence of periodic review of the quality
内得到沟通和理解)
policy. (定期评审质量方针的证据)
e) is reviewed for continuing suitability? (在持续适宜方面得到评审)
· Review of all the elements of the quality
system to insure its continuing suitability and
effectiveness. (评审质量体系的所有要素，以确
保其持续的适宜性和有效性。)
5.4 Quality objectives 质量目标
Does the organization’s top management ensure that quality

objectives, including those needed to meet requirements for product
(see section 7.1 of theIATF16949: 2016 technical specification) are
5.4.1 0
established at relevant functions and levels within the organization?
(最高管理者是否确保在组织的相关职能和层次上建立质量目标，质量
目标包括满足产品要求所需的内容?)
· Quality cost indicators and quality indices

Are the organization’s quality objectives measurable and consistent (质量成本指针和质量指数)
5.4.2 with the quality policy? (组织的质量目标是否可测量的，并与质量方 · Quality objectives included/linked to the 0
针保持一致？) business plan (包含在/连接到业务计划的质量
目标)

business plan. (包含在/连接业务计划的质量目
Did top management define any quality objectives and
5.4.3 标。) 0
measurements? (最高管理者是否定义了质量目标和测量方法？)
· Scope of the Quality objectives (质量目标的
范围)

Are the organization’s quality objectives and measurements included business plan. (包含在/连接到业务计划的质量
in the business plan and used by top management to deploy the 目标)
5.4.4 0
organization’s quality policy? (组织的质量目标是否包含在业务计划中 · Management review meeting minutes,
，并由最高管理者使用，以贯彻质量方针？) attendance and adequate frequency. (管理评
审会议记录，出席人数和适当的频次。)
5.4.2 Quality management system planning 质量管理体系策划
Page 18 of 52

Does top management of the organization ensure that (组织的最高

管理者是否确保:)
a) the planning of the quality management system is carried out in
order to meet the general quality management system requirements
stated in section 4.1 ofIATF16949: 2016, as well as the quality
5.4.5 objectives? (对质量管理体系进行策划，以满足质量目标以及 · Internal audit results. (内部审核结果) 0
ISO/TS16949中4.1节的要求？)
b) the integrity of the quality management system is maintained
when changes to the quality management system are planned and
implemented (在对质量管理体系的变更进行策划和实施时，保持质量
管理体系的完整性？ )
5.5 Responsibility, authority and communication 职责、权限和沟通
5.5.1 Responsibility and authority 职责和权限
Responsibilities and authority as defined in job

Does the organization’s top management ensure that the
descriptions, responsibilities matrices,
responsibilities and authorities are defined and communicated within
5.5.1 procedures, accountabilities documents. (作业 0
the organization? (组织的最高管理者是否确保组织内部的职责、权限
描述，职责矩阵，程序说明性文件中规定的职
得到规定和沟通)
责和权限)
5.5.1.1 Quality responsibility 质量职责
· Select examples of non-compliance from

suitable sources such as internal or external
Is management with responsibility and authority for corrective action
concerns/complaints, etc. (从适当的供方中选
promptly informed of products or processes which do not conform
5.5.2 择的不合格品的例子，如内部或外部忧虑/抱怨 0
with requirements? (不符合规范要求的产品或过程是否迅速通知给负
等等。)
有纠正措施职责和权限的管理者？)
· Communication channels and timeliness.
(沟通渠道和及时性。)
· Who is responsible for quality in the

Does the organization’s personnel responsible for quality have the
production process (生产过程谁对质量负责？)
5.5.3 authority to stop production to correct quality problems? (负责产品质 0
· How the authority is defined (如何定义权限)
量的人员，为了纠正质量问题是否有权停止生产？)
· Recent examples (近期的例子)
Are the organization’s production operations staffed with personnel

· Quality Assurance responsible personnel in
5.5.4 that ensure product quality across all shifts? (横跨所有班次的生产操 0
all shifts. (所在班次中负有确保质量的人员。)
作是否指定负责确保产品质量的人员？)
5.5.2 Management representative 管理者代表
Did the organization’s top management appoint a member of

management who, irrespective of other responsibilities, shall have
responsibility and authority that includes (最高管理者是否指定一名管
理者，无论该成员其他方面的职责如何，必须具有以下方面的职责和 · Who is the person in charge of this
权限：) responsibility (谁主管这项职责？)
a) ensuring that processes needed for the quality management · Evidence of activities performed including
system are established, implemented and maintained? (确保质量管 empowerment for all applicable system
5.5.5 理体系所需的过程得到建立、实施和保持) elements including design, sales, 0
b) reporting to top management on the performance of the quality manufacturing, delivery, etc. (所执行的活动（
包括对设计，销售，制造等适用体系要素的激
management system and any need for improvement? (向最高管理者
励）的证据)
报告质量管理体系的业绩和任何改进的需求)
· Management review minutes (管理评审记录)
c) ensuring the promotion of awareness of customer
requirements throughout the organization? (确保在整个组织内提高
满足顾客要求的意识)
5.5.2.1 Customer representative 客户代表
Page 19 of 52

• Quality function representative in project

Did the organization’s top management designate individual(s) to teams项目小组中的质量功能代表
represent the needs of the customer to address quality • Quality function participation in milestones
requirements, such as selection of special characteristics, setting decision points (Production release,
5.5.6 quality objectives and related training, corrective and preventive Engineering release, …) (质量功能在里程碑， 0
actions, product design and development? (最高管理者是否为人员分决策点（如生产放行、工程放行）中的参与。)
配职责和权限，以确保满足顾客的要求。包括选择特殊特性、建立质 • Responsibilities and job description of the
量目标和相关的培训、纠正和预防措施、产品设计与开发。) customer representative (ex Quality function)
(顾客代表的职责和作业描述（如质量功能）)
5.5.3 Internal communication 内部沟通
Does top management ensure that appropriate communication

• Communication channels and timeliness. (沟
5.5.7 processes are established within the organization? (最高管理者是否 0
通渠道和及时性)
确保在组织内建立适当的沟通过程)
Does top management ensure that communication takes place

within the organization regarding the effectiveness of the quality • Communication channels and timeliness. (沟
5.5.8 0
management system? (最高管理者是否确保对质量管理体系的有效通渠道和及时性)
性沟通。)
5.6 Management review 管理评审
• Review of all the elements of the quality

effectiveness (评审质量体系的所有要素，以确
Does the organization’s top management review the it's quality 保其持续的适宜性和有效性。)
management system, at planned intervals, to ensure its continuing • Review of quality cost indicators (质量成本指
5.6.1 suitability, adequacy and effectiveness? (最高管理者是否按策划的时标的评审 ) 0
间间隔评审质量管理体系，以确保其持续的适宜性、充分性和有效性 • Management review meeting minutes,
。) attendance and adequate frequency. (管理评
审会议记录，出席人数和充足的频次)
• Action plans and follow-up. (行动计划和跟踪
活动)
Do the organization’s management reviews include assessing

opportunities for improvement and the need for changes to the • Evidence of continuous improvement projects
5.6.2 quality management system, including the quality policy and quality initiated from management reviews. (由管理评 0
objectives? (组织的评审是否包括评价质量管理体系改进的机会和变审引发的持续改进项目的证据)
更的需要，包括质量方针和质量目标。)
Are the organization’s records from management reviews • Retention of management reviews meeting
5.6.3 0
maintained? (组织是否保持管理评审的记录？) minutes. (管理评审会议记录的保存期限。)
5.6.1.1 Quality management system performance 质量管理体系绩效
• Review of all the elements of the quality

Do the management reviews include all elements of the quality effectiveness (评审质量管理体系的所有要素，
management system and its performance trends as an essential part 以确保其持续的适宜性和有效性)
5.6.4 of the continual improvement process? • Trends in metrics (business and customer 0
(作为持续改进过程的一个重要环节，管理评审是否包括质量管理体系 satisfaction). (衡量准则的趋势（业务和顾客满
的所有要求及其在一段时间内的绩效的评审？) 意）。)
• Basis for continues improvement projects. (持
续改进项目的基础。)
Page 20 of 52

• Policy, business plan and customer

Do the management reviews include monitoring of quality objectives, satisfaction metrics reports (方针，业务计划和
and the regular reporting and evaluation of the cost of poor quality 顾客满意的衡量准则的报告。)
5.6.5 (see elements 8.4.1 and 8.5.1 of ISO/TS16949:2002(E)) ? (管理评审 • Product results (quality, cost, time) against 0
是否包括对质量目标进行监测，定期报告及对质量不良造成的损失的 quality policy goals and customer specified
评估。) targets (相对于质量方针目的和顾客规定的目标
的产品结果（质量，成本及时间）)
• Trends in metrics (business and customer

Are the results of the management reviews recorded to provide, as a
satisfaction) (衡量准则的趋势（业务及顾客满
minimum, evidence of the achievement of: (管理评审的结果是否留作
意）)
记录，为至少以下各项内容提供证据：)
• Basis for continues improvement projects (持
- objectives specified in the quality policy? (质量方针中规定的目标
续改进项目的基础)
5.6.6 。) 0
• Management review meeting minutes. (管理
- objectives specified in the business plan? (业务计划规定的质量目
评审会议记录)
标)
• Action plans and follow-up. (行动计划和跟踪
- customer satisfaction with product supplied? (顾客对提供产品的满
活动)
意度？)
5.6.2 Review input 评审输入
Does the organization’s input to its management review include

information on: (组织的管理评审输入是否包含以下方面的信息:)
a) results of audits? (审核结果) • Reports prepared for management reviews.
b) customer feedback? (顾客反馈) (为管理评审准备的报告)
c) process performance and product conformity? (过程的业绩和产 • Management review meeting minutes. (管理
品符合性) 评审会议记录)
5.6.7 d) status of preventive and corrective actions? (预防和纠正措施状况 • Action plans and follow-up. (活动计划和跟踪 0
) 活动)
e) follow-up actions from previous management reviews？(预防管理 • Content of management review meeting
行动跟进) agenda. (管理评审会议的议程活动)
f) planned changes that could affect the quality management
system? (可能影响质量管理体系的变更)
g) recommendations for improvement? (改进建议)
5.6.2.1 Review input - Supplemental 管理评审输入-补充
Do management reviews include an analysis of actual and potential

field-failures and their impact on quality, safety, or the environment? • Content of management review meeting
5.6.8 0
(管理评审是否包括以实际的和潜在的现场失效及其对质量，安全或环 agenda. (管理评审会议的议程内容)
境的影响的分析)
5.6.3 Review output 评审输出
Does the output from the organization’s management review include

• Examples of continuous improvement
any decisions and actions related to: (组织的管理评审的输出是否包
projects initiated from management reviews.
括以下方面有关的任何决定和措施)
(由管理评审引发的持续改进的项目案例)
a) improvement of the effectiveness of the quality management
5.6.9 • Examples of product improvements initiated 0
system and its processes? (质量管理体系及其过程有效性的改进)
from management reviews. (由管理评审引发的
b) improvement of product related to customer requirements? (与顾
产品改进的案例)
客要求有关的产品的改进)
c) resource needs (资源需求)
6 Resource management 资源管理
6.1 Provision of resources 资源提供
Page 21 of 52

Does the organization determine and provide the resources needed:

• Job descriptions (作业描述)
(组织是否确定并提供以下方面所需的资源)
• Training records. (培训记录)
a) to implement and maintain the quality management system and
• Quality Plans (质量计划)
6.1 continually improve its effectiveness? (实施、保持质量管理体系并持 0
• Shift staffing/supervision (轮班员工/监督)
续改进其有效性)
• Personnel workload (员工工作量)
b) to enhance customer satisfaction by meeting customer
requirements (通过满足顾客要求，增进顾客满意)
6.2 Human resources 人力资源
• Training records complementing the type of

work that the personnel perform on the
Are the personnel performing work affecting product quality
product. (用培训记录补充员工在产品上执行工
competent on the basis of appropriate education, training, skills and
6.2.1 作类型) 0
experience? (基于适当的教育、培训、技能和经验，从事影响产品质
• Personnel records (员工记录)
量工作的人员是否能够胜任)
• Interviews with design personnel (与设计人员
会谈)
6.2.2 Competence, awareness and training 能力、意识和培训
Does the organization (组织是否)

a) determine the necessary competence for personnel performing
work affecting product quality ? (确定从事影响产品质量工作的人员
所必要的能力)
b) provide training or take other actions to satisfy these needs? (提 • Job description. (作业描述)
供培训或采取其它措施以满足这些需求) • Qualification for each position. (每一个职位的
c)evaluate the effectiveness of the actions taken? (评价所采取措施资格)
6.2.2 0
的有效性) • Training plan. (培训计划)
d) ensure that its personnel are aware of the relevance and • Training records. (培训记录)
importance of their activities and how they contribute to the
achievement of the quality objectives? (确保员工认识到所从事活动
的相关性和重要性，以及如何实现质量目标做出贡献？)
e) maintain appropriate records of education, training, skills and
experience? (保持教育、培训、技能和经验的适当记录)
6.2.2.1 Product design skills 产品设计技能

Does the organization ensure that personnel with product design
design activity (补充设计活动类型的培训记录)
responsibility are qualified to achieve design requirements and are
6.2.3 • Personnel records (员工记录) 0
skilled in applicable tools and techniques? (组织是否确保负有产品设
• Interviews with design personnel (与设计人员
计职责的人员有能力达到设计要求和熟练的掌握适用的工具和技术)
会谈)
• Listing of tools needed for product design. (产

品设计所需的工具清单)
Has the organization identified applicable tools and techniques • Personnel training on product design
6.2.4 needed for product design? (组织是否对适用的工具和技术进行识别 techniques needed. (产品设计技能所需的员工 0
。) 培训)
• PO(s) on tools needed. (所需工具的P/O.)
6.2.2.2 Training 培训
Has the organization established and maintained documented

procedures for identifying training needs and achieving competence • Quality manual according to TS 16949 (依据
6.2.5 of all personnel performing activities affecting product quality. (组织 ISO/TS16949编制的质量手册) 0
是否已建立并维护文件程序以辨别培训需求，以及识别个人表现对产
品质量的影响。)
Page 22 of 52


Is the personnel performing specific assigned tasks qualified on the
tasks assigned to personnel. (用培训记录补充
basis of education, training, skills and/or experience, as required?
6.2.6 分配给员工的任务类型) 0
(对从事特殊工作的人员是否根据所受教育，培训，技能和/或经历进
• Personnel records. (员工记录)
行资格教育)
• Interviews with personnel. (与员工交谈)
Has the organization given attention to training that satisfies • Evidence of personnel training that satisfies
6.2.7 customer specific requirements? (组织是否关注满足顾客特定要求的 customer specific requirements. (员工的培训满 0
培训) 足顾客规定要求的证据)
6.2.2.4 Training on the job 在职培训
Does the organization provide on the job training for personnel in • Training records for personnel in new
any new or modified job affecting product quality including contract assignments (在新任务中的员工培训记录)
6.2.8 or agency personnel? (对所有影响产品质量的工作，组织是否对新到 • Training records for contract personnel (合同 0
职或调整工作的人员提供适当的在职培训，包括合同工或代理工作人制员工的培训记录)
员)
Is the personnel affecting quality, informed about the consequences

6.2.9 to the customer of non-conformity to quality requirements? (是否告 • Training contents (培训内容) 0
知影响质量的工作人员不符合顾客质量标准的后果。)
6.2.2.5 Employee motivation and empowerment 员工激励和授权
Does the organization have a process for motivation of employees to

achieve quality objectives, to make continual improvements, and
6.2.10 create an environment to promote innovation? (组织是否建立了一个 • Incentive systems used (使用的激励系统。) 0
促进员工实现质量目标，进行持续改进和建立促进创新的环境的过程
？)
Does the organization’s employee motivation process include

promotion of quality and technological awareness through the whole • Scope of employee motivation. (员工激励的
6.2.11 0
organization.? (组织的员工激励过程是否包括促进整个组织对质量和范围。)
技术的认知程度？)
Does the organization have a process for measurement to ensure

that its personnel are aware of the relevance and importance of their
• Measurement of employee satisfaction. (员工
6.2.12 activities and how they contribute to the achievement of the quality 0
满意度的测量)
objectives? (组织是否具有一个过程测量员工是否清楚他们的活动和
他们对达到质量目标的贡献之间的关系和重要性的程度)
6.3 Infrastructure 基础设施
Quality manual according to TS 16949. (依据

Does the organization determine, provide and maintain the
ISO/TS16949编制的质量手册)
infrastructure needed to achieve conformity to product
6.3.1 Product results – internal and external product 0
requirements? (组织是否确定，提供并维护为达到产品符合要求所需
failure rate (产品结果-内外部产品失效率)
的基础设施。)
6.3.1 Plant, facility and equipment planning 工厂、设施及设备策划
Does the organization use a multidisciplinary approach for

• Team composition has to be cross-functional
6.3.2 developing plant, facility and equipment plans? (组织是否采用多方论 0
(小组必须由跨部门的员工组成。)
证的方法制订工厂，设施及设备的计划)
Is the organization’s plant layouts optimized material travel, handling • Process flow analysis (过程流程分析)
and value-added use of floor space and shall facilitate synchronous • Plant layout (current and planned) (工厂布局
6.3.3 0
material flow? (组织的工厂布局是否尽量优化材料的转移和搬运，以（现在的和计划的）)
及对场地空间的增值利用，是否便于材料的同步流动？)
Page 23 of 52

Has the organization developed and implemented methods to • Metrics for ergonomics, automation, line
6.3.4 evaluate and monitor the effectiveness of existing operations? (组织 balance, inventory levels (人类工程学，自动化 0
是否制订评价现有操作和过程有效性的方法) ，流水线平衡，库存级别的衡量测则)
6.3.2 Contingency plans 应急计划
Has the organization prepare contingency plans to satisfy the

• Contingency plans (应急计划 )
customer requirements in the event of an emergency such as utility
• Identification of Key Equipment (关键设备的
6.3.5 interruptions, labour shortages, key equipment failure, and field 0
标识)
returns? (组织必须制订应急计划（如公用事业中断、劳动力短缺，关
键设备故障和市场退货等）以在紧急情况下满足顾客要求？)
6.4 Work environment 工作环境
Does the organization determine and manage the work environment

• Quality manual according to TS 16949. (依据
6.4.1 needed to achieve conformity to product requirements ? (组织必须确 0
ISO/TS16949编制的质量手册)
定和管理为达到产品符合要求所需的工作环境？)
6.4.1 Personnel safety 确保员工安全以达到产品质量
• Preventive activities in design and process

control (设计和过程控制中的预防性活动)
• Knowledge and application of legislation (法
律知识和应用)
Does the organization’s quality policy and practices address product
• Risk analysis such as FMEA (风险分析，如
safety and means to minimize potential risks to employees,
FMEA)
especially in design and development process and in the
6.4.2 • Results of internal/external audits including: 0
manufacturing process activities? (组织必须关注产品的安全性和方法 (内/外部审核结果)
以最大程度降低对员工造成潜在的危险，特别是在设计和开发过程和
制造过程活动中)  System certifications (体系认可)
 Corrective actions (纠正措施)
• Records of accidents (事故记录)
• Safety related customers complains (和顾客
抱怨有关的安全)
6.4.2 Cleanliness of premises 生产现场的清洁
Does the organization maintain its premises in a state of order

cleanliness and repair consistent with the product? (组织是否保持生 • Tour of plant (工厂参观)
6.4.3 0
产现场处于有序、清洁的状态，并按产品和制造过程需求进行适当的
维护)
7 Product realization 产品实现
7.1 Planning of product realization 产品实现和策划
• Quality Planning process (质量策划过程)

Has the organization planned and developed the processes • Project Planning process (项目策划过程)
7.1.1 management needed for product realization? (组织是否策划和开发 • Quality plans for new products (新产品质量策 0 0
产品实现所需的过程管理？) 划)
Is the organization’s planning of product realization consistent with

the requirements of the other processes of the quality management • Development of Quality plan(s). (质量策划的
7.1.2 0 0
system? (产品实现的策划是否与质量管理体系其它过程的要求相一致开发)
?)
Page 24 of 52

In planning product realization, does the organization determine the

• Quality plan and Design Record, Control
following, as appropriate: (在对产品实现进行策划时，组织是否确定
Plan, Operator Instructions, Product Approval
以下方面的适当内容)
records, resources/facilities and any plans to
a)quality objectives and requirements for the product? (产品的质量
enhance them
目标和要求)
(质量策划和设计记录，控制计划，操作说明，
b)the need to establish processes, documents, and provide
产品批准记录，资源/设备及任何改善它们的策
resources specific to the product? (针对产品确定过程，文件和资源
划)
7.1.3 的需求) 384 0
• Design validation at the various stages of the
c)required verification, validation, monitoring, inspection and test
design
activities specific to the product and the criteria for product
(在设计各个阶段进行设计合理性评估)
acceptance? (产品需求的验证，确认，监测，检验和试验活动，以及
• Link between process changes and updates
产品满足要求提供证据所需的记录)
in the quality plan(s)
d) records needed to provide evidence that the realization processes
(质量策划中过程更改和过程更新的关系)
and resulting product meet requirements? (实现过程及其产品满足要
求提供证据所需的记录)
Is the organization’s planning of product realization output in a form

• Product realization output format & content.
7.1.4 suitable for the organization's method of operations? 0
(产品实现的输出形式和内容)
(组织产品实现策划的输出形式是否适于组织的运行方式?)
7.1.1 Planning of product realization - supplemental 产品实现的策划-补充
Is the customer requirements and references to its technical • Quality plans (质量计划)
specifications included in the planning of product realization as a • Customer specifications (客户要求)
7.1.5 0
quality plan? (作为质量计划的一部分，产品实现的策划秘须包括顾客 • Technical specifications (技术规范)
要求和技术规范的参考？)
7.1.2 Acceptance criteria 接收准则
• Test specification. (试验说明)

Did the organization define acceptance criteria for the product being • Product validation test plan with defined
7.1.6 developed and where required, approved by the customer? (组织是 acceptance criteria. 0
否定义产品的接收准则，要求时是否由顾客批准) (具有明确的接收准则的产品确认试验计划)
Is the organization’s acceptance criteria For attribute data sampling • Acceptance criteria in test plan and test
7.1.7 zero defects? (对于计数型数据抽样，组织的接收等级是否是零缺陷 specifications. (试验策划和试验说明中的接收 0
？) 准则。)
7.1.3 Confidentiality 机密性
Does the organization ensure the confidentiality of customer • Information access security (产品访问安全)
contracted products and projects under development, and related • Security for product development. (产品开发
7.1.8 0
product information? (组织是否确保顾客采购的产品，正在开发的计安全)
划相关的信息的机密性)
7.1.4 Change control 更改控制
Does the organization have a process to control and react to • Engineering change request process (工程更
changes that impact product realization including those initiated by 改请求过程)
7.1.9 0
the supplier? (组织是否有对影响产品实现的更改（包括由任何供方引 • Change records. (产品开发安全)
起的更改）进行控制和反应的过程?)
•Impact study including proprietary design. (影

Does organization assess the effects of changes? 响研究，包括专利设计)
7.1.10 0
(组织是否评定更改的影响) •Change management process
(更改管理过程)
• Test specification.(测试规格)
Has the organization defined the verification and validation activities • Product validation test plan with defined
7.1.11 for changes, to ensure compliance with customer requirements? acceptance criteria . 0
(组织是否定义验证和确认的活动，与确保与顾客要求一致) (具有明确的接收准则的产品确认试验计划)
• Evidence of design and production validation

Does the organization validate changes before implementation?
7.1.12 tests conducted for product changes.(产品设计 0
(组织是否在更改执行前先进行确认)
及为产品更改执行的生产试验的证据。 )
Page 25 of 52

Does the organization review proprietary designs, impact on form, • Impact study including proprietary design.(影
fit, function, (including performance, and/or durability) with the 响研究，包括专利权设计)
7.1.13 customer so that all effects can be properly evaluated. • Change management process 0
(组织的影响外形，装配和功能（包括性能或耐久性）的，具有专利的 (更改管理过程。)
设计是否由顾客评审，以适当地评价所有影响。)
Does the organization meet additional verification/identification

requirements such as those required for new product introduction
• Design and production validation test
7.1.14 when required by the customer? 0
report(设计和生产确认试验报告。)
(组织是否在顾客要求时，满足额外的验证/识别要求，例如：新产品
介绍的要求？)
7.2 Customer-related processes 与顾客有关的过程
7.2.1 Determination of requirements related to the product 与产品有关的要求的确定
Does the organization determine:(组织是否定义:)

a) requirements specified by the customer, including the
requirements for delivery and post-delivery activities?
(顾客规定的要求，包括对交付及交付后活动的要求) • Process for government, safety and
b) requirements not stated by the customer but necessary for environmental regulations compliance.
specified or intended use, where known? (政府，安全和环境法规符合性过程)
7.2.1 0
(顾客虽然没有明示，但规定的用途或已知的预期用途所必需的要求？ • Organization’s internal product specification.
) (组织的内部产品规范)
c)statutory and regulatory requirements related to the product?
(与产品有关的法律法规要求)
d) any additional requirements determined by the organization?
(组织确定的任何附加要求)
7.2.1.1 Customer designated special characteristics 顾客指定的特殊特性
• Designation and control of special

characteristics (特殊特性的指定和控制)
Can the organization demonstrate conformity to customer • Quality documents: control plan,
requirements for designation, documentation and control of special specifications ,drawings, etc shall report the
7.2.2 0
characteristics? special characteristics designation.
(组织是否证明与顾客指定、文件化和控制的特殊特性相一致？) (质量文件：控制计划，规范,图样等都必须报告
指定特殊特性。)
7.2.2 Review of requirements related to the product 与产品有关的要求的评审

Does the organization review the requirements related to a product
prior to the organization's commitment to supply to the customer?
7.2.3 • Feasibility studies.(可行性研究) 0
(组织是否在组织向顾客作出提供产品的承诺之前评审与产品有关的要
求？)
• Customer contract review.

Does the organization ensure that : (组织是否确保:)
(顾客合同评审)
a) product requirements are defined?(产品要求得到规定)
• Product specification review.
b) contract or order requirements differing from those previously
(产品规范评审)
7.2.4 expressed are resolved? 0
• Resolution of differences.(分辨差异)
(与以前表述不一致的合同或订单的要求已予解决)
• Feasibility assessments.
c) the organization has the ability to meet the defined requirements?
(可行性评定)
(组织有能力满足规定的要求？)
Does the organization maintain records of the results of the review

• Records of contract review.
7.2.5 and actions arising from the review? (组织是否保持评审结果及评审 0
(合同评审记录)
所引起的措施的记录)
Where the customer provides no documented statement of • Sign off design validation and production
requirement, does the organization confirm the customer validation test plan with acceptance criteria.
7.2.6 0
requirements before acceptance? (若顾客提供的要求没有形成文件 (标注设计确认和具有接收准则的生产确认试验
，组织在接收顾客要求前是否对顾客要求进行确认?) 计划。)
7.2.2.1 Organization manufacturing feasibility 组织制造可行性
Page 26 of 52

Does the organization investigate, confirm and document the

manufacturing feasibility of the proposed products in the contract • Feasibility studies.(可行性研究)
7.2.7 review process including risk analysis? • Risk analysis.(风险分析) 0
(组织在进行提议产品的合同评审时，是否调查、确认并文件化该产品
的制造可行性，包括风险分析？)
7.2.3 Customer communication 顾客沟通
Has the organization determine and implement effective

arrangements for communicating with customers in relation to: (组织
是否对以下有关方面确定并实施与顾客沟通的有效安排:)
a) product information? (产品信息) • Common language at the interface level. (沟
7.2.8 0
b) enquiries, contracts or order handling, including amendments? (问通中的通用语言)
询，合同或订单的处理，包括对其的修改)
c) customer feedback, including customer complaints (顾客反馈，包
括顾客抱怨)
7.2.3.1 Customer communication - supplemental 顾客沟通----补充
• Common language at the interface level. (沟

通中通用语言)
Does the organization have the ability to communicate necessary • Common language for technical
information including data in a customer specified language and specifications and important documents. (技术
7.2.9 format? (组织必须具有顾客规定的语言、按顾客规定的格式传递必要 0
规范和重要文件的通用语言。)
的信息和资料的能力（例如：计算器辅助设计数据，电子数据交换等
）。) • Customer/ supplier EDI system requirements
and supplier capabilities. (顾客/供方EDI体系要
求和供方的能力)
7.3 Design and development 设计和开发

7.3.1 Design and development planning 设计和开发策划
• The organization taking lead in product

design and development activities. (组织领导
产品设计和开发活动)
• The organization managing the product
design and development processes. (组织管理
Does the organization plan and control the design and development
7.3.1 产品设计和开发过程) 0
of product? (组织是否对产品的设计和开发进行策划和控制)
• Project records such as milestones decision
points are controlled and approved by the
organization. (项目记录，如里程碑，决策点都
由组织控制和批准)
• Product design and development process.

During the design and development planning, does the organization (产品设计和开发过程)
determine: (在进行设计和开发策划时，组织是否确定：) • Product design review; verification and
a) the design and development stages? (设计和开发阶段？) validation process. (产品设计评审，验证和确
7.3.2 b) the review, verification and validation that are appropriate to each 认过程) 0
design and development stage? (适用每个设计和开发阶段的评审) • Job description for product design and
c) the responsibilities and authorities for design and development? development personnel. (为产品设计和开发员
(设计和开发的职责和权限) 工做的作业描述)
Does the organization manage the interfaces between different • Internal audit results.内部审核结果
groups involved in design and development to ensure effective • Review of organizational interfaces with roles
7.3.3 communication and clear assignment of responsibility? (组织是否对 and communication processes. (组织和任务沟 0
参与设计和开发的不同小组之间的接口实施管理，以确保有效的沟通通过程接口的评审)
，并明确职责分工)
Page 27 of 52

Is the organization’s product design and development planning • Evidence of product design and development
output updated, as appropriate, as the design and development planning output updated as design and
7.3.4 0
progresses? (随设计和开发的进展，在适当时产品设计和开发策划的 development progresses. (在设计和开发中，产
输出是否予以更新。) 品设计与开发策划的输出更新的证据。)
7.3.1.1 Multidisciplinary approach 多方论证方法
Does the organization use a multidisciplinary approach to prepare

for product realization, including: (组织是否采用多方论证的方法进行
产品实现的准备工作，包括:) • Functions represented in product
- development/ finalization and monitoring of special development teams (产品开发小组描述的功能)
characteristics? (特殊特性的开发最终确定和监测) • Personnel involved in definition of special
7.3.5 0
- development, and review of FMEAs including actions to reduce characteristics, FMEA, and Control Plan (参与
potential risks? (FMEA 的开发和评审，包括采取降低潜在风险的措施特殊特性定义,FMEA和控制计划的人员)
)
- development, and review of control plans? (控制计划的开发和评
审)
7.3.2 Design and development inputs 设计和开发的输入
Does the organization determine inputs relating to product

• Design input records & documents (设计输入
7.3.6 requirements and maintain the related records? (组织是否确定与产 0
记录和文件)
品要求有关的输入，并保持记录)
Does the organization’s inputs relating to product requirements

include: (组织与产品要求有关的输入是否包括：) • Customer specification. (顾客规范)
a) functional and performance requirements? (功能和性能要求) • Statutory and regulatory requirements. (法律
b) applicable statutory and regulatory requirements? (适用的法律法和法规要求)
7.3.7 规要求) • Previous / existing product design information 0
c) where applicable, information derived from previous similar (以前/现在的产品设计信息)
designs? (适用时，以前类似设计提供的信息) • Product benchmarking (产品标竿)
d) other requirements essential for design and development?
(设计和开发所必须的其它要求)
• Customer specification analysis. (顾客规范分

Does organization review its inputs relating to product requirements 析)
7.3.8 for adequacy? (组织是否评审其与产品要求相关的输入，以确保其充 • Feasibility contract review. (可行性合同评审 0
分性和适宜性) 记录)
• Customer specification analysis. (顾客规范分

Are the inputs relating to product requirements complete, 析)
7.3.9 unambiguous and not in conflict with each other? (与产品要求有关的 • Feasibility contract review minutes. (可行性合 0
输入是否完整，清楚，并且不能自相矛盾？) 同评审记录)
7.3.2.1 Product design input 产品设计输入
Does the organization identify, document and review the product

design inputs requirements including: (组织是否对产品设计输入要求
进行识别，形成文件并进行评审，包括:) • Customer specification analysis (顾客规范分
- customer requirements (contract review)? (顾客要求（合同评审）) 析)
7.3.10 - use of information (the organization shall have a process to deploy • Feasibility contract review minutes (可行性合 0
information gained)? (使用的信息：组织必须有程序展开获得的作息) 同评审记录)
- targets for product quality, life, reliability, durability, maintainability,
timing, and cost? (产品质量，寿命，可靠性，耐久性，可维修性，时
间安排和成本目标)
7.3.2.2 Manufacturing process design input 制造过程设计输入
Page 28 of 52

Does the organization identify, document and review the • Design FMEA (设计FMEA)
manufacturing process design input requirements, including: (组织是 • Productivity, process capability, costs targets
否对过程设计输入要求进行识别，形成文件并进行评审，包括:) (生产率，过程能力，成本目标)
- product design output data? (产品设计输出数据) • Regulations (法规)
7.3.11 0
- targets for productivity, process capability and cost? (生产效率， • Customer requirements, if any (顾客要求，如
过程能力及成本目标) 果有)
- customers requirements if any? (顾客要求，如果有？) • Experience from previous development (以往
- experience from previous developments? (以往的开发经验) 的开发经验)
7.3.2.3 Special characteristics 特殊特性
Does the organization identify special characteristics and : (组织是否

识别特殊特性和:) • Process to establish special characteristics
- include all special characteristics in the control plan? (在控制计划 (建立特殊特性的过程)
中包含所有特殊特性) • Design Record (设计记录)
- comply with customer specified definitions and symbols? (与顾客 • Review customer requirements for special
指定的定义和符号相一致) characteristics, definitions and symbol
7.3.12 - identify process control documents including drawings, FMEAs, identification. (评审顾客对特殊特性，定义符号 0
control plans, and operator instructions with the customer’s special 的要求)
characteristic symbol or the organization’s equivalent symbol or • Control plans. (控制计划)
notation to include those process steps that affect special • Product drawings. (产品图样)
characteristics? (识别过程控制文件，包括图样，FMEA、控制计划及 • Operator instructions. (操作指导书)
作业指导书，必须标明顾客的特殊特性符号或组织的等效符号或记号
，以包括对特殊特性有影响的那些过程步骤)
7.3.3 Design and development outputs 设计和开发输出
Does the organization provide outputs of design and development in

• Design output records matching criteria
a form that enables verification against the design and development
7.3.13 established in design input requirements (设计 0
input and approved prior to release? (设计和开发输出是否以能够针
输出记录符合设计输入要求规定的接收准则)
对设计和开发的输入进行验证方法提出，并在放行前得到批准)
Do the organization’s design and development outputs (组织的设计

和开发输出是否)
a) meet the input requirements for design and development? (满足设
计和开发输入的要求)
• DV test reports that show test results;
b) provide appropriate information for purchasing, production and for
acceptance criteria. (DV试验报告说明试验结果
7.3.14 service provision? (为采购、生产和服务提供的适当信息) 0
，接收准则)
c) contain or reference product acceptance criteria? (包含或引用产
• Engineering drawings. (工程图样)
品接收准则)
d) specify the characteristics of the product that are essential for its
safe and proper use? (规定对产品的安全和正常使用所必需的产品特
性)
7.3.3.1 Product design outputs - Supplemental 设计和开发输出----补充
Is the organization’s product design output expressed in terms that • Design output records matching criteria
can be verified and validated against product design input established in design input requirements (设计
7.3.15 0
requirements? (组织的产品设计输出是否能以根据产品设计输入的要输出记录符合设计输出记录符合设计输入要求
求进行验证和确认的方式来表示) 规定的接收准则)
Page 29 of 52

Does the organization’s product design output include : (组织产品设

计输出是否包括:)
- design FMEA, reliability results? (设计FMEA，可靠性结果)
- product special characteristics, specifications? (产品特殊特性，规
• Availability of all applicable product design
范)
7.3.16 output documents. (所有适用的产品设计输出文 0
- product error-proofing, as appropriate? (产品防错，适当时)
件的存在)
- product definition including drawings? (产品定义，包括图样，数
学数据)
- product design reviews results? (产品设计评审结果)
- diagnostic guidelines where applicable? (诊断指南，适当时)
7.3.3.2 Manufacturing process design output 制造过程设计输出
• Process specifications and drawings (过程说

明和图样)
• Process FMEA’s (过程FMEA)
• Job instructions (作业指导书)
• Process approval acceptance criteria (过程批
Is the organization’s manufacturing process design output 准接收准则)
expressed in terms that can be verified against manufacturing • Quality, reliability, maintainability data (质量
7.3.17 0
process design input requirements and validated? (组织的过程设计，可靠性，可维护性数据)
输出是否能以根据过程设计输入的要求进行验证和确认方式来表式) • Mistake-proofing activities results (防错活动
的结果)
• Non-conformity detection methods (不合格的
探测方法)
• Product/Process verification plans (产品/过程
设计输出文件的有效性)
Does the organization’s manufacturing process design output

include : (组织的过程设计输出是否包括:)
- specifications and drawings? (规范及图纸)
- manufacturing process flow chart / layout? (制造过程流程图，场
地平面布置图)
- manufacturing process FMEAs? (制造过程FMEA)
- control plan? (控制计划)
• Availability of all applicable process design
- work instructions? (作业指导书)
7.3.18 output documents (.所有适用过程设计输出文件 0
- process approval acceptance criteria? (过程批准接收准则)
的有效性)
- data for quality, reliability, maintainability and measurability? (有
关质量可靠性，可维护性及可测量性的数据)
- results of error-proofing activities, as appropriate? (适当时，防错
活动的结果)
- methods of rapid detection and feedback of
product/manufacturing process non-conformities? (产品/制造过程不
合格的快速探测和反馈方法)
7.3.4 Design and development review 设计和开发评审
• Design review planning and records. (设计评

Does the organization perform systematic reviews of design and 审策划和记录)
development at suitable stages in accordance with planned • Design review extended to all functions
arrangements : (在适宜的阶段，组织是否依据所策划的安排对设计和 affected by it. (设计评定涉及所有受其影响的功
开发进行系统的评审，以便:) 能)
7.3.19 0
a) to evaluate the ability of the results of design and development to • Product design and development status
fulfill requirements? (评价设计和开发的结果满足要求的能力) reviews. (产品设计和开发的状态评审)
b) to identify any problems and propose necessary actions (识别任 • Link of corrective action to status reviews. (纠
何问题并提出必要的措施？) 正措施到状态评审)
Page 30 of 52

Do the participants in the systematic reviews of design and

development identify any problems and propose necessary actions? • Link of corrective action to status/design
7.3.20 0
(设计和开发的系统评审的参加者是否识别任何问题并提出必要的措施 reviews. (纠正措施到状态/设计评审的联系)
)
Are the records of the results of the reviews and any necessary
• Design review planning and records
7.3.21 actions maintained by the organization? (组织是否保持评审结果及 0
maintained. (设计评审策划和记录保持。)
任何必要措施的记录)
7.3.4.1 Monitoring 监测
• Project reviews at different phases of product

Does the organization define and analyze measurements at
realization process for all active projects. (所有
specified stages of design and development and reported with
项目的产品实现过程不同阶段的项目评审)
7.3.22 summary results as an input to management review? (组织是否定义 0
• Policy deployment summary results. (方针贯
并分析在设计和开发特殊阶段的测量，并以概要结果的形式报告，作
彻的总结性结果)
为管理评审的输入？)
7.3.5 Design and development verification设计和开发验证
esign verification done in according to the

Does the organization perform design and development verification planning (依据策划所做的设计验证)
in accordance with planned arrangements to ensure that the design - Comparison between outputs and design
7.3.23 and development outputs have satisfied the design and requirements (输出和设计要求之间的比较) 0
development input requirements? (为确保设计和开发输出满足输入 - Corrective actions based on results (基于结
的要求，组织是否依据所策划的安排对设计和开发进行验证) 果的纠正措施)
Does the organization maintain records of the results of the

7.3.24 verification and any necessary actions? (组织是否保持验证结果及任 • Design verification reports. (设计验证报告) 0
何必要措施的记录)
7.3.6 Design and development validation 设计开发确认
Design validation against user requirements /

Does the organization perform design and development validation, needs (依据用户要求/需求所做的设计确认)
accordance with planned arrangements (see element • Comparison between customer plan and
7.3.1ofIATF16949: 2016) to ensure that the resulting product is internal development plans (顾客策划和内部开
7.3.25 capable of meeting the requirements for the specified application or 0
发策划之间的比较)
intended use, where known? (为确保产品能够满足规定的使用要求或
• Design validation records (设计确认记录)
已知的预期用途的要求，组织是否依据所策划的安排对设计和开发进
• Documented failure (文件化失效)
行确认)
Wherever practicable, does the organization complete design and • Completion of product validation testing prior
7.3.26 development validation prior to the delivery or implementation of the to start of production. (在生产之前完成产品确 0
product? (只要可行，组织的确认是否在产品交付或实施之前完成？) 认试验)
• Product validation test report. (产品有效测试

报告)
Does the organization maintain records of the results of validation
• Corrective action process for the design
7.3.27 and any necessary actions? (组织是否维护确认的结果既必要的行动 0
activity (纠正过程)
的纪录)
• Corrective Action Records (纠正行动记录)
7.3.6.1 Design and development validation – supplemental 设计和开发确认--补充
Design validation against user requirements /

needs (依据用户要求/需求所做的设计确认)
• Comparison between customer plan and
Does the organization perform design and development validation in
internal development plans (顾客策划和内部开
7.3.28 accordance with customer requirements including program timing? 0
发策划之间的比较)
(组织的设计和开发确认是否与顾客要求一致，包括项目时间)
• Design validation records (设计确认记录)
• Documented failure (文件化失效)
7.3.6.2 Prototype program 样件计划
Page 31 of 52

When required by the customer, does the organization have a • Prototype facilities. (标准件设备)
7.3.29 prototype program and control plan? (当顾客要求时，组织是否制订 • Prototype records. (标准件记录) 0
样件计划和控制计划) • Prototype control plan. (标准件控制计划)
• Design / prototype /production tooling (设计/

Wherever possible, does the organization use the same suppliers, 样件/生产工装)
7.3.30 tooling and manufacturing processes as will be used in production? • Prototype realization and test conditions must 0
(组织是否尽可能地使用与正式生产相同的供方，工装和制造过程) be known and controlled (必须了解和控制样件
实现及试验条件)
Does the organization monitor all performance testing activities for

7.3.31 timely completion and conformance to requirements? (组织是否监督 • Test records (测试记录) 0
所有的性能试验活动及时完成并符合要求)
Are the organization responsible for the subcontracted services,

• Sub-contractor management as appropriate
7.3.32 including technical leadership? (组织是否对外包服务负责，包括提供 0
(适当时的分承包方管理)
技术指导？)
7.3.6.3 Product approval process产品批准过程
Does the organization conform to a product and process approval • Compliance with customer requirements
7.3.33 procedure recognized by the customer? (组织是否符合顾客认可的产 regarding product approval process (符合顾客 0
品和过程的批准程序) 有关产品批准过程的要求)
Does the organization apply a product and process approval • Product approval process documentation and
7.3.34 procedure recognized by the customer to its suppliers? (组织是否应 records for suppliers (供方的产品批准过程文件 0
用顾客对其供方规定的产品和过程批准程序) 和记录)
7.3.7 Control of design and development changes 设计和开发更改的控制
Does the organization identifies design and development changes

7.3.35 and maintain records relevant to those changes? (组织是否识别设计 • Change records. (更改记录) 0
和开发的更改，并保持和其记录)
Does the organization review, verify and validate design and

development changes , as appropriate, and approved before • Design change approval process. (设计更改
7.3.36 0
implementation? (组织是否在适当时对设计和开发的更改进行评审，批准过程)
试验和确认，并在实施前得到批准？)
• Impact study including proprietary design. (影

Does the organization’s review of design and development changes
响研究，包括专利权设计)
include evaluation of the effect of the changes on constituent parts
7.3.37 Change management process (更改管理过程 0
and already delivered product? (组织对设计和开的评审是否包括评价
。)
更改对产品组成成份和已交付产品的影响)
Does the organization maintain records of the results for the review
7.3.38 of design and development changes and any necessary actions ? • Change records. (更改记录) 0
(组织是否保持更改评审结果及任何必要措施的记录)
7.4 Purchasing 采购
7.4.1 Purchasing process 采购过程
• Organization’s incoming inspection. (组织进

Does the organization ensure that purchased product conforms to 货检验)
7.4.1 specified purchase requirements? (组织是否确保采购的产品符合规 • Source inspection. (供方检验) 0
定的采购要求？) • Process audit at supplier’s site. (在供方现场
的审核)
Page 32 of 52

Does the organization’s type and extent of control applied to the • Control methods determined by effect of the
supplier and the purchased product dependent upon the effect of the purchased product on subsequent product
7.4.2 purchased product on subsequent product realization or the final realization or final product. (由采购的产品对随 0
product? (组织对供方及采购的产品控制的类型和程度是否取决于采后的产品实现或最终产品的影响决定的控制方
购的产品对随后要产品实现或最终产品的影响？) 法。)
Does the organization evaluate and select suppliers based on their • Selection system (选择系统)
ability to supply products in accordance with the organization’s • Performance rating system (性能等级系统)
7.4.3 0
requirements? (组织是否根据供方按组织的要求提供产品的能力评价 • Organization’s supplier manual.
和选择供方) (组织的供方手册)
Has the organization established criteria for selection, evaluation, • Selection system (选择系统)
7.4.4 and re-evaluation of its suppliers? (组织是否制定选择，评价和重新 • Performance rating system (性能等级系统) 0
评价的准则)
• Suppliers’ 2nd party audit results conducted

Does the organization maintain records of the results of supplier
by the organization.
evaluations and any necessary actions arising from the supplier
7.4.5 (由组织执行的供方的第二方审核结果) 0
evaluation?
• Approved supplier records. (批准的供方记录)
(组织是否制定评价结果及评价所引起的任何必要措施的记录？)
7.4.1.1 Regulatory compliance 法规的符合性
• Audit results from government and

environment organizations (政府和环境组织的
Do all purchased products or materials used in the organization’s 审核结果)
7.4.6 product satisfy applicable regulatory requirements? (组织中用于零件 • Supplier Internal Audits (供方内部审核) 0
制造的所有采购的产品或材料均是否满足适用的法规要求？) • Warrants or certificates of compliance. (符合
的凭证或证书)
• Audits of suppliers. (供方的审核)
7.4.1.2 Supplier quality management system development 供方质量管理体系开发
Are the organization’s suppliers registered to ISO 9001 : 2000 by a

• Copies of suppliers’ ISO 9001:2000
7.4.7 third party? (组织的供方是否通过经认可的第三方认证机构的 0
certificates. (供方ISO9001证书)
ISO9001认证)
• Supplier development process (供方开发过程

Does the organization perform quality management system
)
development with the goal of supplier compliance toIATF16949:
7.4.8 • Evidence of subcontractor development (分承 0
2016? (组织是否以供方符合ISO16949技术规范为目的进行供方质量
包方开发的证据)
体系开发)
7.4.1.3 Customer-approved sources 经顾客批准的供方
• Approved suppliers list if applicable (如果适用

Where specified by the contract, does the organization purchase
，批准的供方清单)
7.4.9 products, materials or services from approved sources? (若合同中有 0
• How are these lists used (如何使用这些清单)
规定，组织是否从顾客批准的供方处采购产品，材料或服务)
• Scope of organization’s incoming inspection

includes purchased products supplier by
Is the organization responsible for ensuring the quality of purchased customer-designated sources. (组织进货检验
products supplied by customer-designated sources, including 范围包括由顾客指定供方处采购的产品)
7.4.10 0
tool/gage suppliers? (采用顾客指定的供方，包括工装和量具供方， • Scope of organization’s supplier
组织是否对确保分承包方的零件，材料和服务质量负有责任？) management process includes customer-
designated sources. (组织的供方管理过程的范
围包括顾客指定的供方)
7.4.2 Purchasing information 采购信息
Page 33 of 52

Does the organization’s purchasing information describe the product

to be purchased, including where appropriate : (组织的采购信息是否
表述拟采购的产品，适当时包括) • Purchase order / release (采购订单/放行)
7.4.11 a) requirements for approval of product, procedures, processes and • Commercial contract (商业合同) 0
equipment? (产品，程序，过程和设备的批准要求)
b)requirements for qualification of personnel? (人员资格的要求)
c)quality management system requirements? (质量管理体系要求？)
Does the organization ensure the adequacy of specified purchase

• Review of contract/purchase order extends to
7.4.12 requirements prior to their communication to the supplier? (在与供方 0
suppliers. (提供给供方的合同/采购订单的评审)
沟通前，组织是否确保规定的采购要求是充分与适宜的？)
7.4.3 Verification of purchased product 采购产品的验证
Does the organization establish and implement the inspection or

other activities necessary for ensuring that purchased product meets
7.4.13 • Incoming inspection plans. (进货检验计划) 0
specified purchase requirements? (组织是否确定并实施检验或其它
必要的活动，以确保采购的产品满足规定的采购要求？)
Where the organization or its customer intends to perform

verification at the supplier's premises, does the organization state • Supplier and subcontractors. (供方和分承包
the intended verification arrangements and method of product 方)
7.4.14 0
release in the purchasing information? (当组织或其顾客拟在供方的 Purchase order and contract (采购订单和合同)
现场实施验证时，组织是否在采购信息中对拟验证的安排和产品放行
的方法做出规定)
7.4.3.1 Incoming product quality 进料品质验证
Does the organization have a process to assure the quality of

purchased product utilizing one or more of the following methods :
(组织是否有过确保采购产品质量，可以采用下列一种或多种方法)
- receipt of, and evaluation of, statistical data by the organization? • Incoming inspection. (进货检验)
(由组织对收到统计数据加以评价？) • Source inspection. (供方检验)
-receiving inspection and/or testing such as sampling based on • 2nd or 3rd party audits of supplier sites. (供方
performance? (接收检验和/或试验，例如基于性能抽样) 现场的第二方或第三方审核)
7.4.15 - second or third party assessments or audits of supplier sites, when 0
• Independent evaluation of acceptability of
coupled with records of acceptable quality performance? (结合已交
product by a designated 3rd party. (由指定的第
付人可接受的产品质量记录由第二方或第三方机构对供方现场进行评
三方机构独立地评定产品可接受性)
估或审核)
-part evaluation by a designated laboratory? (由指定的实验室评价零
件？)
- another method agreed with the customer? (顾客同意的其它方法？
)
7.4.5 Supplier monitoring 供方监测
Does the organization monitor supplier performance through the

following indicators: (组织是否通过下列指针对供方表现进行监测：)
• Subcontractor performance records (分承包
-Delivered part quality performance? (已交付产品的质量？)
方绩效记录)
7.4.16 -Customer disruptions including field returns? (顾客中断，包括使用 0
• Subcontractor corrective action (分承包方纠
中退货？)
正措施)
- Delivery schedule performance (including incidents of premium
freight)? (交付时间表现（包括发生的超额运费）？)
Page 34 of 52

• Evidence of continuous improvements

Does the organization promote supplier monitoring of their implemented by the suppliers through review
7.4.17 manufacturing processes’ performance? of their own monitoring of manufacturing 0
(组织是否促进供方监测制造过程表现？) processes’ performance. (供方通过评审他们对
过程性能的监测实施持续改进的证据。)
7.5 Production and service provision 生产和服务提供

7.5.1 Control of production and service provision 生产和服务提供的控制
Does the organization plan and carry out production and service
provision under the following controlled conditions, as applicable :
(组织是否策划并在受控条件下进行生产和服务提供。适用时受控条件
是否包括：)
a) the availability of information that describes the characteristics of
• Tour of plant and facilities. (参观工厂和设备)
the product? (获得表述产品特性的信息？)
• Master part or correct level assembly
b) the availability of work instructions, as necessary? (必要时，获得
drawings. (主要部件或正确的装备图样)
7.5.1 作业指导书？) 0
• Work instructions at work stations. (工作现场
c) the use of suitable equipment? (使用适宜的设备？)
的工作指导书。)
d) the availability and use of monitoring and measuring devices? (获
得和使用监测和测量装置？)
e) the implementation of monitoring and measurement? (实施监测
和测量？)
f) the implementation of release, delivery and post-delivery
activities? (放行，交付和交付后活动的实施？)
7.5.1.2 Control plan 控制计划
Does the organization : (组织是否:)

- develop control plans at the system, subsystem, component and/or
material level, for the product supplied, including those for bulk • Control plans for different product levels. (不
materials produced by the organization and all purchased products 同产品级别的控制计划)
and materials? (针对所提供的产品在系统，子系统，部件和/或材料 • DFMEA and PFMEA was used as inputs to
7.5.2 0
各层次上开发控制计划，包括流程性散装材料的控制过程?) the control plans. (DFMEA和PFMEA被用做控
- have a control plan for pre-launch and production that take into 制计划的输入。)
account the design FMEA and manufacturing process FMEA
outputs? (考虑了设计FMEA和制造过程FMEA的试生产和生产控制计
划？)
Does the organization’s control plan : (组织的控制计划是否:)

- list the controls used for the manufacturing process control? (列出
• Review of control plans. (控制计划的评审。)
用于制造过程控制的控制方法？)
• Control Plans for applicable stages (适当阶段
- include the customer required information if any? (包括顾客要求的
的控制计划。)
7.5.3 信息？) 0
• Control Plan framework with data (用数字表
- initiate the specified reaction plan (see 8.2.3.1 of ISO/TS
示的控制计划。)
16949:2002 (E)) when the process becomes unstable or non
capable? (当过程不稳定或不能工作时激活明确的反应计划（见
8.2.3.1，ISO/TS 16949:2002）?)
Does the organization review and update control plans when any
•Matching between product/process changes,
change occurs affecting product, manufacturing process,
instability/ non capability process results, and
measurement, logistics, supply sources or FMEA (see 7.1.4 of
7.5.4 control plans updating (产品/过程更改，不稳定 0
ISO/TS 16949:2002 (E))? (当任何影响产品﹑制造过程﹑测量﹑物流
性/能力不足的过程结果和控制计划更新之间的
﹑供应资源或FMEA的更改发生时，组织是否重新评审和更新控制计
关系。)
划（见ISO/TS 16949:2002中的7.1.4）？)
7.5.1.3 Work instructions 作业指导书
Page 35 of 52

Has the organization prepare documented work instructions for all

employees having responsibilities for the operation of processes? • Availability of job instructions at the
7.5.5 0
(组织是否为所有负责控制过程操作的人员提供文件化的作业指导书？ workstation. (工作现场作业指导书的有效性。)
)
Are the organization’s work instructions accessible for use at the

• Availability of job instructions at the
7.5.6 work-station? (组织的作业指导书在工作现场是否能不中断操作者正 0
workstation. (工作现场作业指导书的有效性。)
的进行的工作而得到？)
Are the organization’s work instructions derived from sources such • Link between job instructions and source
as the quality plan, the control plan and the product realization documents, e.g. Control Plan, Design Record,
7.5.7 0
process? (组织的作业指导书是否来源于适当的文件，如质量计划、 FMEA (作业指导书和供方文件之间的联系，如
控制计划及产品实现过程？) 控制计划，设计记录,FMEA)
7.5.1.4 Verification of job set-ups 作业准备的验证
Does the organization verify job set-ups whenever performed? (无论 • Job set-up records and approval (作业准备记
7.5.8 0
何时进行作业准备，组织是否都进行作业准备验证？) 录和批准。)
Are the organization’s work instructions available for set-up

7.5.9 • Set-up instructions (准备作业指导书) 0
personnel? (作业准备人员易于得到的作业指导书?)
Does the organization use statistical methods of verification of job

7.5.10 set-ups where applicable? (适用时，组织是否使用统计方法进行验证 • Job set-up records (作业准备记录。) 0
？)
7.5.1.5 Preventive and predictive maintenance 预防性和预知性维护
Does the organization identify key process equipment and provide

resources for machine/equipment maintenance and develop an
• Existence of preventive maintenance (存在预
7.5.11 effective planned total preventive maintenance system? (组织是否标 0
防性维护。)
识关键过程设备，为机器/设备的维护提供适当的资源，并建立有效的
、有计划的全面预防性维护系统)
• System effectiveness demonstrated by

Does the organization’s preventive maintenance system minimally
specifics measurement indicator (由特定的测
include the following: (组织的预防性维护系统是否至少包括：)
量指针证实系统的有效性)
- planned maintenance activities? (有计划的维护活动？)
• Key equipment list (关系设备清单)
- packaging and preservation of equipment, tooling and gauging? (设
7.5.12 • Maintenance records (维护记录)
备、工装和量具的包装和防护？) 0
• Predictive maintenance examples (预知性维
- availability of replacement parts for key manufacturing equipment?
护案例)
(关键生产设备备件的可获得性？)
• Plant tour。(工厂参观。)
- documenting, evaluating and improving maintenance objectives?
(文件化、评估和改进维护的目标？)
Does the organization utilize predictive maintenance methods to

• Predictive maintenance examples. (预知性维
7.5.13 continually improve the effectiveness of its preventive system? (组织 0
护案例。)
是否利用预知性维护方法以持续改进生产设备的效率和有效性？)
7.5.1.6 Tooling management 工装管理
Does the organization provide resources for tool and gauge design,
• Tool/gage design staffing and qualification
7.5.14 fabrication and verification activities? (组织是否为工具的设计、制造 0
(工具/量具设计的人员和资格)
和验证活动提供适当的技术资源？)
Page 36 of 52

Does the organization establish and implement a system for tooling

management including : (组织是否建立和实施生产工装管理的系统，
包括：)
- maintenance and repair facilities and personnel? (维护及修理
设施与人员？(
- storage and recovery? (贮存与修复？)
- set-up? (工装准备？)
7.5.15 - tool-change programmes for perishable tools? (易损工具的更 • Tool management process (工具管理过程。) 0
换计划？)
- tool design modification documentation, including engineering
change level? (具设计调整的文件，包括工程更改等级？)
- tool modification and revision to documentation? (适当时，工
具的调整和文件的修订？)
- tooling identification defining the status? (工装确认，明确其
状态，如生产、修理或处置？)
Has the organization implemented a system to monitor its tooling • Sub-contractor management system (choice,
7.5.16 management activities if any work is outsourced? (如果任何工作被分 evaluation and control) (分承包方管理系统（选 0
包，组织是否实施追踪和跃进这些活动的系统？) 择，评定和控制）。)
7.5.1.7 Production scheduling 生产安排
• Process for production scheduling生产安排过

程。
• The scheduling system should be based on a
Is the organization’s production scheduled in order to meet customer
7.5.17 “pull” and not on a “push” system. (安排系统应 0
requirements? (组织的生产计划是否满足顾客要求？) 当建立在“拉”系统而不是“推”系统的基础
上。)
7.5.1.8 Feedback of information from service 服务信息反馈
• Meeting reports, follow up and corrective

Has the organization established and maintained a process for actions/responsibility/dates (会议报告，跟踪活
communication of information on service concerns to manufacturing, 动和纠正措施/职责/日期。)
7.5.18 0
engineering and design activities? (组织是否建立并保持服务考虑的 • Product service data (产品服务资料。)
信息与制造’、工程和设计部门沟通的过程？)
7.5.1.9 Servicing agreement with customer 与顾客的服务协
When there is a servicing agreement with the customer, does the

organization verify the effectiveness of: (当与顾客达成服务协时，组 • Planning of periodical audits (定期审核计划。
织是否验证以下项目的有效性：) )
7.5.19 - any organization service centers? (组织的任何一个服务中心？) • Reports and follow up (报告和跟踪活动。) 0
- special purpose tools or measurement equipment? (任何特殊用途
的工具或测量设备？)
- training of servicing personnel? (服务人员的培训？)
7.5.2 Validation of processes for production and service provision 生产和服务提供过程的确认
Does the organization validate any processes for all its production • Process validation/capability studies results.
and service provision where the resulting output cannot be verified (过程确认/能力研究结果。)
7.5.20 by subsequent monitoring or measurement? (当生产和服务提供过程 • Process parameters monitoring and control 0
的输出不能由后续的监测或测量加以严正时，组织是否对任何这样的 evidence (过程参数的监控和控制证据。)
过程实施确认？)
Does the organization’s validation of processes for all its production

and service provision demonstrate the ability of these processes to • Process validation/capability studies results.
7.5.21 0
achieve planned results? (组织对这些生产和服务提供过程的确认是 (过程确认/能力研究结果。)
否证实这些过程实现所策划的结果的能力？)
Page 37 of 52

Has the organization establish arrangements for all its processes for
production and service provision including, as applicable : (组织是否 • Requirement specification for operations,
建立所有过程(包括生产和服务)的安排，适用时包括：) equipment and personnel (操作，设备和人员
a) defined criteria for review and approval of the processes? (为过程要求说明。)
的评审和批准所规定的准则？) • Related records of qualification (和资格有关
7.5.21 b) approval of equipment and qualification of personnel? (设备的认的记录) 0
可和人员资格的坚定？) • Frequency and conditions of revalidation. (再
c) use of specific methods and procedures? (使用特定的方法和程序确认的频率和条件。)
？)
d) requirements for records? (记录的要求？)
e) revalidation? (再确认？)
7.5.3 Identification and traceability 标识和可追溯性
• Check for positive recall (主动召回检查。)

• Suitable product identification throughout the
Does the organization identify the product by suitable means facility (所有设备合适的产品标识)
7.5.23 throughout product realization? (适当时，组织是否的产品实现的全过 • Traceability from raw materials to delivered 0
程中使用适宜的方法识别产品？) product (从原材料到交付产品的可追溯性。)
• Clear identification of work in-process;

finished goods and rejected goods and/or
Does the organization identify the product status with respect to
components. (清楚地标识工作中的过程，完成
7.5.24 monitoring and measurement requirements? (组织是否针对监测和测 0
的产品和放弃的产品和/或零部件的。)
量要求识别产品的状态？)
• Inspection records. (检验记录。)
Where traceability is a requirement, does the organization control

and record the unique identification of the product (see element
7.5.25 • Traceability system. (可追溯性系统。) 0
4.2.4 ofIATF16949: 2016)? (的有可追溯性要求的场合，组织是否控
制并记录产品的唯一性标识（见ISO/TS 16949:2002要素4.2.4）？)
7.5.4 Customer property 顾客财产
Does the organization exercise care with customer property while it

• Handling procedure of customer property. (顾
7.5.26 is under the organization's control or being used by the 0
客财产的处理程序。)
organization? (组织是否爱护在组织控制下或组织使用的顾客财产？)
Does the organization identify, verify, protect and safeguard • Product identification. (产品识别。)
customer property provided for use or incorporation into the • Storage environment. (存储环境。)
7.5.27 0
product? (组织是否识别、验证、保护和维护供其使用或构成产品的
一部分的顾客财产？)
• Damage to customer supplied product

reports (顾客已采购产品报告的损失。)
Does the organization report to the customer and maintain records • What happened to customer owned
for customer property which is lost, damaged or otherwise found to returnable packaging? How was it accounted
7.5.28 0
be unsuitable for use ? (若顾客财产发生丢失、损坏、或发现不适用 for? (顾客所有的可回收包装怎么样？如何说明
的情况时，组织是否报告顾客，并保持记录？) 它？)
7.5.4.1 Customer owned tooling 顾客所拥有的生产工装
Are the customer-owned tools, manufacturing, test, inspection

tooling and equipment permanently marked so that the ownership of • Permanent identification of tooling and
7.5.29 each item is visible, and can be determined? (顾客所拥有工装，制造 equipment ownership (工具和设备所有关系的 0
、试验、检验工具和设备是否永久性标识，以使每一工装设备的所有永久性标识。)
关系清晰可见，并可以确定？)
7.5.5 Preservation of product 产品防护
Page 38 of 52

• Procedure development and documentation.

Does the organization preserve the conformity of product during (程序开发和文件。)
internal processing and delivery to the intended destination? (在内部
7.5.30 • Plant tour. (工厂参观。) 0
处理和交付到预定的地点期间，组织是否针对产品的符合性提供防护
？)
• Product preservation procedures. (产品保护

Does the organization’s preservation of product include 程序)
7.5.31 identification, handling, packaging, storage and protection? (组织的 • Plant tour. (工厂参观。) 0
产品防护是否包括标识、搬运、包装、贮存和保护？)
• Scope product preservation procedures. (产

Does the organization’s preservation of production apply to the 品保护程序的范围。)
7.5.32 constituent parts of a product? (组织的产品防护是否也适用于产品的 • Plant tour. (工厂参观。) 0
组成部分？)
7.5.5.1 Storage and inventory 贮存和库存
• Storage product specifications (产品存储规范

Does the organization assess the condition of product in stock at )
7.5.33 appropriate planned intervals to detect deterioration? (组织是否按适 • Inspection records (检验记录。) 0
当策划的时间间隔检查库存品状况，以便及时发现变质情况？) • Plant tour。(工厂参观。)
• Inventory management system (库存管理系

统。)
Does the organization use an inventory management system to • Evidence of FIFO (先进先出的证据。)
7.5.34 optimize inventory turns over time and assure stock rotation? (组织 • Control of obsolete product (废旧产品的控制 0
是否使用库存管理系统，以优化库存周转期，确保货物周转？) 。)
Does the organization control obsolete product in a similar manner

• Obsolete products stored in quarantine area.
7.5.35 to nonconforming product? (组织是否以对待不合格品的类似方法对 0
(废旧产品储存在隔离区域。)
庆旧产品进行控制？)
7.6 Control of monitoring and measuring devices 监测和测量装置的确认
Has the organization determined the monitoring and measurement

• Test equipment accuracy and precision
to be undertaken and the monitoring and measuring devices needed
capability related to the required measurement
7.6.1 to provide evidence of conformity of product to determined 0
(与需要实施的测量有关的试验设备的准确度和
requirements? (组织是否确定需实施的监测和测量以及所需的监测和
精确度。)
测量装置，为产品符合确定的要求提供证据？ )
• Monitoring and measurement trials during

prototype builds. (在样件制造期间的监测和测
Has the organization established processes to ensure that 量试验)
monitoring and measurement can be carried out and are carried out • Procedure address in organization’s quality
7.6.2 in a manner that is consistent with the monitoring and measurement manual in accordance toIATF16949: 2016. (组 0
requirements? (组织是否建立过程，以确保监测和测量活动可行并以织的和ISO/TS 16949:2002.一至的质量手册中
与监测和测量的要求相一至的方式实施？) 的程序说明。)
Page 39 of 52

Where necessary to ensure valid results, are the organization’s

measuring equipment: (为确保结果有效，必要时组织是测量设备是
否：) • Test equipment inventory试验设备目录
a)calibrated or verified at specified intervals, or prior to use, against • Certifications for calibration masters and their
measurement standards traceable to international or national traceability to international national recognized
measurement standards? (对照能溯源到国际或国家标准的测量标准 standard (对样件及它们对于国际或国家标准的
，按照规定的时间间隔或在使用前进行校准或检定？) 可追溯性进行认可。)
b)adjusted or re-adjusted as necessary? (进行调整或必要时再调整 • Calibration results records (校准结果记录。)
7.6.3 0
？) • Method of control of calibration settings. (校
c) identified to enable the calibration status to be determined? (到识准设备的控制方法。)
别，以确定其校准状态？) • Calibration status identification. (校准状态确
d) safeguarded from adjustments that would invalidate the 定。)
measurement result? (防止可能使测量结果失效的调整？)
e) protected from damage and deterioration during handling,
maintenance and storage? (在搬运、维护和贮存期间防止损坏或失
效？)
Does the organization assess and record the validity of the previous
measuring results when the equipment is found not to conform to • Records of re-inspected product (产品再检验
7.6.4 0
requirements? (当发现设备不符合要求时，组织是否对以往的测量结的记录。)
果的有效性进行评论和记录？)
• Actions taken on the equipment that are

Does the organization take appropriate action on the equipment that
found not conforming to requirements and any
7.6.5 is found not conforming to requirements and any product affected it? 0
product that were affected by it (对发现不符合
(组织是否对该设备和任何受影响的产品采取适当的措施？)
要求的设备及受影响的任何产品采取的措施。)
Does the organization maintain records of the results of calibration

7.6.6 and verification (see element 4.2.4 ofIATF16949: 2016)? (组织是否 • Gage studies records. (量具研究记录) 0
保存校准和验证的记录（见ISO/TS 16949:2002中要.2.4）)
When the equipment is used in the monitoring and measurement of • Product labeling system (产品标注系统。)
specified requirements, has the organization confirm the ability of • Customer requirements (顾客要求。)
7.6.7 computer software to satisfy the intended application? (当计算器软 • Labeling audit (标注审核。) 0
件用于规定要求满足预期用途的能力的确认是否在初次使用前进行，
并在必要时给予以重新确认？)
Has the organization undertaken the confirmation of computer

software satisfying an intended application prior to initial use and • Test software / comparative references
7.6.8 0
reconfirmed as necessary? (组织对计算器软件满足预期用途的能力 verification (试验软件/比较的参考书的验证。)
的确认是否在初次使用前进行，并在必要时予以重新确认？)
7.6.1 Measurement system analysis 测量系统分析
Does organization conduct statistical studies to analyze the variation •Measurement system analysis studies
present in the results of each type of measuring and test equipment including Gage Repeatability & Reproducability
7.6.9 0
system? (组织是否进行适当的统计研究，以分析出现在各种测量和试 (测量系统分析研究包括量具的重复性和再生性
验设备系统测量结果的变异？) 。)
Does the organization conduct measurement system analysis for

• Measurement system analysis results. (测量
7.6.10 measurement systems referenced in the control plan? (组织的测量 0
系统分析结果。)
系统分析是用于在控制计划提及的测量系统？)
Page 40 of 52

• Check methods against customer

measurement system analysis requirements.
Does the organization use measurement system analytical methods (结于顾客要求测量系统分析要求的检查方法。)
and acceptance criteria that conform to those in customer reference • Customer approval records, for other
7.6.11 0
manuals on measurement systems analysis? (组织所用的分析方法 analytical methods used. (使用其它分析方法的
及接收准则是否与顾客关于测量系统分析的参考手册相一至？) 顾客批准记录。)
7.6.2 Calibration Records 校准/验证记录
Does the organization’s records of the calibration activity for all

gauges, measuring and test equipment, including employee- and
customer-owned gauges, include : (组织的所有量具、测量和试验设
备，包括员工和顾客所拥有和设备的校准/验证活动记录是否包括：)
- equipment identification including the measurement standard
against which the equipment is calibrated? (设备监定，校准的设备
• Measurement equipment records (测量设备
所用的测量标准？)
记录。)
- revisions following engineering changes? (按工程更改进行的修订
• Original specification of measurement
7.6.12 ？) 0
equipment (测量设备的初始规范。)
- any out of specification readings as received for
calibration/verification? (在校准/验证时获得的任何偏离规范的读数？)
- an assessment of the impact of out of specification condition? (对
规范以外情况的影响的评估？)
- statements of conformance to specification after
calibration/verification? (在校准/验证后，有关符合规范的说明？)
- notification to the customer if suspect product or material has been
shipped? (如果可疑材料或产品已被发运，对顾客的通知？)
7.6.4 Laboratory requirements 实验室要求

7.6.4.1 Internal laboratory 内部实验室
Does the organization’s internal laboratory facility have a defined

scope that includes capability to perform the required inspection, test
7.6.13 • Laboratory Scope (实验室范围。) 0
or calibration services? (组织的内部实验室设施是否有定义的范围，
包括有能力进行的检验、试验或校准服务？)
Is the organization’s lab scope included in the quality management

system and comply with technical requirements including : (组织的实
验室范围旨否包括在质量管理体系中，并符合以下的技术要求：)
- adequacy of the laboratory procedures? (实验室程序的充分性？)
• Organization’s quality manual perIATF16949:
- qualifications of the laboratory personnel conducting tests? (实验
7.6.14 2016. (组织根据ISO/TS16949:2002.编制的质 0
室人员的资格？)
量手册。)
- testing of the commodity? (产品试验？)
- performing these tests correctly, traceable to the relevant process
standard? (根据相关过程标准，正确的进行这些服务的能力？)
- review of the related quality records? (有关记录的评审？)
7.6.4.2 External laboratory 外部实验室
Page 41 of 52

Do the external / commercial/ independent laboratory facilities used

for inspection, test or calibration services by the organization have a
defined laboratory scope that includes capability to perform the
required inspection, test or calibration, and : (为组织提供检验、试验
或校准服务的外部/商业/独立实验室是否有定义的范围，包括有能力 • Commercial Laboratory Accreditation records
7.6.15 0
进行的检验、试验或校准服务和：) (商业实验室的认可记录。)
- be accredited to ISO/IEC 17025 or national equivalent? (实验室必
须通过ISO/IEC 17025或相等的国家标准的资格认可)
- have evidence that the external laboratory is acceptable to the
customer? (必须有证据证明外部实验室可以被顾客接受？)
8 Measurement, analysis and improvement 测量，分析与改进

8.1 General 总则
Has the organization planed and implemented the monitoring,

measurement, analysis and improvement processes needed? (组织
是否策划并实施以下方面所需的监测、测量、分析和改进过程：)
a) to demonstrate conformity of the product? (证实产品的符合性 • Internal audit results. (内部审核结果)
8.1.1 ？) • Product conformance data. (产品符合资料) 0
b) to ensure conformity of the quality management system? (确保
质量管理体系的符合性？)
c) to continually improve the effectiveness of the quality
management system (持续改进质量管理体系的有效性？)
Has the organization determined the applicable methods and the • Methods used for organization’s monitoring,
extent of their use for its monitoring, measurement, analysis and measurement, analysis and improvement
8.1.2 0
improvement processes? (组织是否确定了适用方法及其监测，测量 processes. (组织监测设备，分析和改进过程所
，分析和改进过程的必须用程度？) 使用的方法。)
8.1.1 Identification of statistical tools 统计工具的确定
• Review of control plan (控制计划的评审。)

Does the organization determine the appropriate statistical tools for
• Review of quality plan (质量计划的评审)
each process during advance quality planning and included in the
8.1.3 • Plant tour (工厂参观。) 0
control plan? (在质量先期策划中必须确定每一过程适用的统计工具，
并包括在控制计划中?)
8.1.2 Knowledge of basic statistical concepts 基本统计概念知识
• Interview with personnel including

management demonstrating the knowledge of
major statistical concepts like variation and
Does the organization understand basic statistical concepts, such as distribution, process control, cause and effect
variation, control (stability), process capability and over-adjustment? relationship, common and special causes. (和
8.1.4 0
(组织是否了解基本的统计概念，如差异、控制（稳定性）、过程能力相关人员进行面谈对主要统计知识的了解如方
和过度调整？) 差，过程控制，原因分析图及常用的相关分析
和普通的特性分析)
• Statistical techniques training records (数据统
计技术培训记录)
Does the organization utilize basic statistical concepts throughout its • Basic statistical study reports. (基本统计研究
8.1.5 0
establishment? (组织是否通过相应的途径使用基本的统计概念) 报告)
8.2 Monitoring and measurement 监测和测量

8.2.1 Customer satisfaction 顾客满意
Page 42 of 52

• Review of information relating to customer

Does the organization monitor information relating to customer
satisfaction routinely/set interval. (例行或按固
perception as to whether the organization has met customer
定间隔评审和顾客满意有关的信息。)
requirements as one of the performance of the quality management
8.2.1 • Customer satisfaction performance 0
system?
indicators. (顾客满意性能指针。)
(作为质量管理体系业绩的一种测量，组织是否对有关组织是否满足其
要求的感受的信息进行监测？)
• Methods for obtaining information relating to

Has the organization determine the methods for obtaining
customer perception as to whether the
information relating to customer perception as to whether the
8.2.2 organization has met customer requirements. 0
organization has met customer requirements? (组织是否确定获取和
(组织获取有关顾客对于其是否满足其要求的感
利用有关组织是否满足其要求的感受的信息的方法？)
受的方法。)
8.2.1.1 Customer satisfaction - Supplemental 顾客满意-补充
Does the organization monitor customer satisfaction through • Continual evaluation of performance of
8.2.3 continual evaluation of performance of the realization processes? realization processes (过程实现性能的持续评 0
(组织的顾客满意度是否通过对实现过程性能的持续评价加以监测？) 定。)
Are the organization’s performance indicators for customer

satisfaction based on objective data and include, but not be limited
to : (组织的客户满意度指针是否基于但不限于下列目标数据：)
- delivered part quality performance? (已交付零件的质量表现？)
• Review of performance indicators for
- customer disruptions including field returns? (顾客中断使用，包括
8.2.4 customer satisfaction. (评审顾客满意的性能指 0
使用中退回？)
标。)
- delivery schedule performance (including incidents of premium
freight)? (交付时间安排表现（包括发生的超额费用）？)
- customer notifications related to quality or delivery issues? (与质量
和交付问题有关的顾客通知？)
Does the organization monitor manufacturing processes

performance to demonstrate compliance with customer • Measurement of manufacturing processes
8.2.5 requirements for product quality and efficiency of the process? (组织 against compliance to customer requirements. 0
是否监测制造过程性能的表现，经证明符合顾客对产质量和过程效率 (制造过程的测量，以符合顾客要求。)
的要求？)
8.2.2 Internal audit 内部审核
Does the organization conduct internal audits at planned intervals to

determine whether the quality management system : (组织是否按策
划的时间间隔进行内部审核，以确定质量管理体系是否：)
a)conforms to the planned arrangements (see 7.1), to the
• Audit schedule (审核安排。)
requirementsIATF16949: 2016 and to the quality management
• Records of performed audits (所执行审核的记
8.2.6 system requirements established by the organization? (符合策划的 0
录。)
安排（见7.1）、ISO/TS16949:2002标准的要求以及组织所确定的质
量管理体系牟要求?)
b) is effectively implemented and maintained?
(得到有效实施与保持？)
Has the organization planned for an audit program that takes into
consideration the status and importance of the processes and areas
8.2.7 to be audited, as well as the results of previous audits? (考虑拟审核 • Appropriate prioritization (适当的优先级。) 0
的过程和区域的状况和重要性以及以往审核的结果，组织是否对审核
方案进行策划？)
Page 43 of 52

• Audit schedule (审核安排。)

Has the organization define the internal audit criteria, scope,
• Internal audit procedure stated in quality
8.2.8 frequency and methods? (组织是否规定组织的准则、范围、频次和 0
manual (质量手册中说明的内部审核程序。)
方法？)
• Organization charts组织流程图。
Does the organization ensure objectivity and impartiality of the audit
• Auditors only conduct audits in areas that are
process in the selection of auditors and conduct of internal audits?
8.2.9 independent of the job functions. (审核员只能 0
(组织是否确保审核员的选择和审核的实施审核过程的客观性和公正性
审核独立于他们职能之外的区域。)
？)
Has the organization define the responsibilities and requirements for • Department or individual responsible for
planning and conducting audits, and for reporting results and internal audit activities and also the reporting
8.2.10 maintaining records in a documented procedure? (组织是否在形成文 of audit results to upper management. (负责内 0
件的程序中规定了策划和实施审核以及报告结果和介质记录的职责和部审核活动的部门或个人，也负责把审核结果
要求？) 报告上层管理者。)
Does the management responsible for the area being audited

ensure that actions are taken without undue delay to eliminate • Closure time for audit findings (审核发现的结
8.2.11 0
detected non-conformities and their causes? (负责受审区域的管理者束时间。)
是否确保及时采取措施，以消除所发现的不合格及其原因？)
Does the organization’s internal audit follow-up activities include the

verification of the actions taken and the reporting of verification
8.2.12 results (see element 8.5.2 ofIATF16949: 2016)? (组织的内部审核的 • Records of verification. (验证的记录。) 0
跟踪活动是否包括对所采取措施的验证和验证结果的报告（见ISO/TS
16949:2002的要素8.5.2）？)
8.2.2.1 Quality management system audit 质量管理体系审核
• Audit plans and schedule (审核计划和安排。)

Does the organization audit its quality management system to verify
• Interview with the different area managers (与
compliance withIATF16949: 2016 and any additional quality
不同区域的经理会谈)
8.2.13 management system requirements? (组织是否审核质量管理体系， 0
• Audit reports (审核报告。)
以验证与ISO/TS16949:2002和任何附加的质量管理体系要求的符合
性？)
8.2.2.2 Manufacturing process audit 制造过程审核
Does the organization audit each manufacturing process to • Audit plans (审核计划。)
8.2.14 determine its effectiveness? (组织是否审核每个制造过程，以决定其 • Audit reports (审核报告。) 0
有效性？)
8.2.2.3 Product audit 产品审核
Does the organization audit products at appropriate stages of • Audit plan, process flow chart and schedule
production and delivery to verify conformance to all specified (审核计划，过程流程图和安排。)
8.2.15 requirements at a defined frequency? (组织是否以适宜的频率，在生 • Product audit procedure and reports (产品审 0
产的适当阶段对其产品及其交付情况进行审核，以验证符合所有规定核程序和报告。)
的要求（如产品尺寸、功能、包装、标签等）？)
8.2.2.4 Internal audit plans 内部审核计划
Does the organization’s internal audits cover all quality management

• Audit plan. (审核计划。)
related processes, activities and shifts, and scheduled according to
8.2.16 • Audit schedule. (审核安排。) 0
an annual plan? (组织的内部审核是否覆盖所有与质量管理有关过程
、活动和班次，且是否按年度计划进行安排？)
Does the organization increase its audit frequency appropriately

• Audit schedule. (审核安排。)
when internal/external non-conformities or customer complaints
8.2.17 • Appropriate prioritization. (适当的优先级。) 0
occur? (当内部/外部不符合或顾客抱怨发生时，组织是否适当地增加
审核频率？)
Page 44 of 52

8.2.2.5 Internal auditor qualification 内部审核员资格
Are the organization’s internal auditors qualified to audit the

requirements ofIATF16949: 2016 (see element 6.2.2.2)? (组织的内 • Compliance to customer requirements. (符合
8.2.18 0
部审核员是否有资格审核ISO/TS16949:2002的要求（见要素顾客要求。)
6.2.2.2）？)
8.2.3 Monitoring and measurement of processes 过程的监测和测量
Does the organization apply suitable methods for monitoring and,

• Methods of monitoring/measuring quality
where applicable, measurement of the quality management system
8.2.19 management system processes. (监测/测量质 0
processes? (组织是否采用适宜的方法对质量管理体系过程进行监测
量管理体系的方法。)
，并在适宜时进行测量？)
Does the organization’s methods for monitoring and measurement of

processes demonstrate the ability of the processes to achieve • Monitoring and measurement results. (监测和
8.2.20 0
planned results? (组织的过程的监测和测量方法是否证实过程实现所测量结果。)
策划的结果的能力？)
When planned results are not achieved by the organization’s

processes, does the organization take correction and corrective • Planned/executed corrective actions. (计划/执
8.2.21 0
action to ensure conformity of the product? (当未能达到所策划的结行的纠正措施。)
果时，组织是否采取适当的纠正措施，以确保产品的符合性？)
8.2.3.1 Monitoring and measurement of manufacturing processes 制造过程的监测和测量
Does the organization perform process studies on all new • Preliminary process capability results. (补充
manufacturing processes to verify process capability and to provide 过程能力的结果。)
8.2.22 0
additional input for process control? (组织是否对所有新的制造过程进 • Production control plan. (生产控制计划。)
行过程研究，以验证过程能力并为过程控制提供补充输入？)
Does the organization document the results of process studies with • Process study reports. (过程研究报告)
specifications where applicable for means of production,
• Plan/executed actions from process study
8.2.23 measurement and test, and maintenance instructions? (组织的过程 0
results (由过程研究结果决定的计划/执行的措施
研究结果是否形成文件，并附有生产、测量和试验方法的适当规范以
及维护说明？) )
Does the organization’s documents for monitoring and measurement

of manufacturing processes include objectives for manufacturing
• Monitoring & measurement of manufacturing
process capability, reliability, maintainability and availability, as well
8.2.24 processes documents. (制造过程文件的监测与 0
as acceptance criteria? (组织的制造过程的监测和测量过程的文件是测量。)
否包括过程能力、可靠性、可维护性和可获得性的目标及其接收准则
？)
• Current Cpk/Ppk versus customer approved

Cpk/Ppk (现在的Cpk/Ppk和顾客批准的
Does the organization maintain manufacturing process capability or Cpk/Ppk的对比。)
performance as specified by the customer part approval process • Existing reaction plan (现在的反应计划。)
8.2.25 0
requirements? (组织是否保持顾客规定的零部件批准过程的过程能力 • Verifying the accuracy of Cpk/Ppk
或性能？) calculations (验证Cpk/Ppk计算的准确性。)
Page 45 of 52

Does the organization ensure that the control plan and process flow
diagram are implemented, including adherence to the specified : (组
织是否确保有效实施控制计划和过程流程图，包括符合如下规定：)
• Review of production line to process flow
- measurement techniques? (测量技术？)
8.2.26 diagram and control plan. (对生产线的过程流 0
- sampling plans? (抽样计划？)
程图和控制计划的评审。)
- acceptance criteria? (接收准则？)
- reaction plans when acceptance criteria are not met? (不满足接收
准则的反应计划？)
Does the organization note significant process events on the control

8.2.27 • Review of control charts (控制图的评审。) 0
charts? (组织是否在控制图上标明了重要的过程活动？)
Does the organization initiate the appropriate reaction plan from the
control plan for characteristics that are either unstable or non- • Records of reaction taken. (实施的反应的记
8.2.28 0
capable? (组织是否对以在控制计划中标识为不稳定和能力不足的特录。)
性激活适当的反应计划？)
• Contents of reaction plan for unstable and

Does the organization’s reaction plans for characteristics that are
non-capable processes (不稳定和能力不足的
either unstable or non-capable include containment of product and
8.2.29 过程的反应计划的内容。) 0
100% inspection as appropriate? (组织地标识为不稳定和能力不足的
• Records (记录)
特性的反应计划是否包括适当地控制过程中输100%检验？)
Does the organization establish a corrective action following the

initiation of reaction plans, indicating specific timing and assigned
8.2.30 responsibilities to assure that the process becomes stable and • Corrective action reports (纠正措施报告。) 0
capable? (为确保过程变得稳定和有能力，组织是否完成明确进度和
责任要求的纠正措施计划？)
Are the organization’s corrective action plans reviewed with and • Corrective action approval process. (纠正措
8.2.31 approved by the customer when so required? (当要求时，组织的改施批准过程。) 0
良计划和行动是否交由顾客审核和批准？) • Corrective action reports. (纠正措施报告。)
Does the organization maintain records of effective dates of process • Records of process change dates. (过程更改
8.2.32 0
changes? (组织是否保持过程更改生效日期的记录？) 的记录。)
8.2.4 Monitoring and measurement of product 产品的监测和测量
• Control plans. (控制计划。)

Does the organization monitor and measure the characteristics of • Inspection instructions. (检验说明)
8.2.33 the product to verify that product requirements have been met? (组 • Records。(记录。) 0
织是否对产品的进行监测和测量，以验证产品要求已得到满足？)
Does the organization monitor and measure the characteristics of

• Control plans. (控制计划。)
the product at appropriate stages of the product realization process
• Inspection instructions. (检验说明)
in accordance with the planned arrangements (see element 7.1
8.2.34 • Records。(记录。) 0
ofIATF16949: 2016)? (组织对产品的监测和测量是否依据所策划的安
排，在产品实现过程中适当阶段进行（见ISO/TS 16949:2002中要素
7.1）？)
• Inspection records that include acceptance

Does the organization maintain evidence of product conformity with criteria, inspector performing the test, test
8.2.35 0
the acceptance criteria? (组织是否保持符合接收准则的记录？) status and, testing date (检验记录包括接收准
则，检验人员执行试验，试验状态和检验日期)
Page 46 of 52

Does the organization’s records on monitoring and measurement of

product indicate the person(s) authorizing release of product (see • Inspection records that indicate the person(s)
8.2.36 element 4.2.4 of ISO/TS 16949:2002 (E))? (组织对产品的监测和测量 authorizing release of product. (在策划的安排 0
记录是指明有权放行的人员（见ISO/TS 16949:2002(E)要素4.2.4）？圆满完成之后，放行产品和服务交付。)
)
Are the organization’s product release and service delivery proceed

only after all the planned arrangements (see element 7.1
ofIATF16949: 2016) have been satisfactorily completed, unless • Release of product and service delivery after
otherwise approved by a relevant authority, and where applicable by all planned arrangement are satisfactorily
8.2.37 0
the customer? completed (在策划的安排圆满完成之后，放行
(除非得到有关授权人员的批准，适用时得到顾客的批准，否则组织是产品和服务交付。)
否在策划的安排（见7.1）已圆满完成之前，不放行产品和交付服务（
见ISO/TS 16949:2002要素7.1）？)
8.2.4.1 Layout inspection and functional testing 全尺寸检验和功能试验
Does the organization perform a layout inspection and a functional

verification to applicable customer engineering material and
performance standards for all products at a sufficient frequency as • Layout inspection reports (尺寸检验报告)
8.2.38 0
specified in the control plan? (组织是否在按控制计划中规定足够频率 • Control plan (控制计划。)
，根据顾客要求的工艺工程材料及性能标准，对所有的产品进行全尺
寸检验和功能检证。)
• Inspection records that include acceptance

Does the organization have layout inspection and functional testing
criteria, inspector performing the test, test
8.2.39 results available for customer review? (组织的全尺寸检验和功能试验 0
status and, testing date (检验记录包括接收准
结果是否供顾客评审？)
则，检验人员执行试验，试验状态和检验日期)
8.2.4.2 Appearance items 外观项目
For organizations manufacturing parts designated by the customer

as "appearance items", does the organization provide : (若组织制造
的零件被顾客指定为“外观项目”，则组织是否提供：)
- appropriate resources including lighting for evaluation? (适当的资 • Maintenance/Control and storage conditions
源，包括评估用的光源？) of masters (样件的维护/控制和存储条件。)
- masters for color, grain, gloss, metallic brilliance, texture, • Visual aids (视觉上的帮助。)
8.2.40 distinctness of image (DOI) as appropriate? (有适当的颜色、纹理、 • Personnel qualification / training records (员 0
光泽、金属亮度、结构、形象清晰（DOI）的标准样件？) 工资格/培训记录。)
- maintenance and control of appearance masters and evaluation • Tour of facility (设备参观。)
equipment? (维护和控制标准样件及评价设备？)
- verification that personnel making appearance evaluations are
qualified to do so? (验证进行的外观评估人员具备从事该工作的资格
？)
8.3 Control of nonconforming product 不合格品控制
• Follow one or more non conforming case and

Does the organization ensure that product which does not conform verify the flow (identification, segregation, etc.)
to product requirements is identified and controlled to prevent its (一个或多个不合格情况和验证后的流程，（标
8.3.1 0
unintended use or delivery? (组织是否确保不符合产品要求的产品得识，隔离，等）)
到识别和控制，以防止其非预期的使用或交付？) • Obsolete products (隔离产品)
Page 47 of 52

Does the organization define the controls and related responsibilities

and authorities for dealing with nonconforming product a • Procedure address in quality manual. (质量手
8.3.2 0
documented procedure? (组织是否在形成文件的程序中对不合格产册中说明程序。)
品控制以及不合格品处置的有关职责和权限做出规定？)
Does the organization deal with nonconforming product by one or

more of the following ways: (组织是否通过下列一种或几种途径，处
置不合格品：) • Follow one or more non-conforming case and
a) by taking action to eliminate the detected nonconformity? (采取措 verify the visual identification and segregation
施，消除发现的不合格品？) area. (一个或多个不合格情况和验证后的流程
8.3.3 b) by authorizing its use, release or acceptance under concession by ，视觉上的标识和区域隔离。) 0
a relevant authority and, where applicable, by the customer? • Records of concession. (让步记录。)
(经有关授人员批准，适用时经顾客批准，让步使用、放行或接收不合
格品？)
c) by taking action to preclude its original intended use or
application?(采取措施，防止其原预期的使用或应用？)
Does the organization maintain records of the nature of non-

conformities and any subsequent actions taken, including
8.3.4 concessions obtained (see element 4.2.4 of ISO/TS16949:2002(E))? • Records (查相关记录) 0
(组织是否保持不合格的性质以及随后所采取的任何措施的记录，包括
所批准的让步的记录（见ISO/TS 16949;2002要素4.2.4）？)
When nonconforming product is corrected, does the organization re- • Instruction for re-qualifying corrected
8.3.5 verify to demonstrate conformity to the requirements? (在不合格品得 nonconforming product. (再次验证之后的不合 0
到纠正之后组织是否对其再进行验证，以证实符合要求？) 格产品的说明。)
When nonconforming product is detected after delivery or use has

started, does the organization take action appropriate to the effects,
verify the flow (identification, segregation, etc.)
8.3.6 or potential effects, of the nonconformity? (当在交付或开始使用后发 0
(一个或多个不合格情况和验证后的流程，（标
现产品不合格时经组织是否采取与不合格的影响或潜在影响的程度相
识，隔离，等）)
适应的措施？)
8.3.1 Control of nonconforming product – supplemental 不合格品控制 -补充
Does the organization classify unidentified or suspect status product • Follow one or more non conforming case and
as nonconforming product (see element 7.5.3 ofIATF16949: 2016)? verify the flow (identification, segregation, etc.)
8.3.7 0
(组织是否将具可未经确定或可疑状态的产品列为不合格产品（见 (一个或多个不合格情况和验证后的流程，（标
ISO/TS 16949:2002要素7.5.3）?) 识，隔离，等）)
8.3.2 Control of reworked product 返工产品的控制
Are the organization’s instructions for rework, including re-inspection

requirements accessible and utilized by the appropriate personnel?
8.3.8 • Rework instructions.(返工说明。) 0
(组织的返工指导书，包括重新检验要求，是否易于被适当地操作者取
得和使用？)
8.3.3 Customer information 顾客信息

Does the organization inform the customers promptly in the event
8.3.9 that nonconforming product has been shipped? (当不合格产品被发 0
动时，组织是否立即通用知顾客？)
• Procedure stated in quality manual. (质量手
册中说明程序。)
8.3.4 Customer waiver 顾客放弃
Page 48 of 52

Does the organization obtain customer concession or deviation

permit prior to further processing whenever the product or
8.3.10 manufacturing process is different from that which is currently 0
approved? (无论何时当产品或制造过程与当前的批准不同时，在继续
作业之前组织是否获得顾客的让步或对偏离的许可？)
Dose the organization maintain a record of the expiration date or

• Record of concession with expiration date.
8.3.11 quantity authorized by customer concession or deviation permit? (组 0
(有效期限让步记录。)
织是否确保有效期限或顾客让步或偏离许可授权方面的记录？)
Does the organization ensure compliance with the original or

superseding specifications and requirements when the authorization
8.3.12 • Inspection results (检验结果) 0
for deviation expires? (当授权期满时，组织是否确保符合原有的或替
代的规范要求？)
Does the organization properly identify on each shipping container • Proper label/identification for material
8.3.13 material shipped on an authorization? (被批准的物料装运时，组织是 shipped on authorization. (认可的材料运装时， 0
否\在各包装箱上做适当的标识？) 要做正确的标注/标识。)
Does the organization apply the customer waiver requirements for

• Process define in quality manual. (质量手册
8.3.14 production product to purchased product as well? (组织是否把顾客 0
中定义的过程。)
让步要求应用于采购产品？)
Does the organization agree with any product concession requests

• Process define in quality manual. (质量手册
8.3.15 from suppliers before submission to the customer? (在提交给顾客之 0
中定义的过程。)
前，组织是否就供方的任何要求达成一至？)
8.4 Analysis of data 数据分析
• Internal performance data such as: (内部性能

数据，如：)
- Poor quality cost indicators (不良质量成本指
针)
- Effectiveness and efficiency of production
Does the organization determine, collect and analyze appropriate processes (生产过程的有效性和效率)
data to demonstrate the suitability and effectiveness of the quality - Test results; (试验结果)
management system and to evaluate where continual improvement
- Process capability data; (过程能力数据)
8.4.1 of the effectiveness of the quality management system can be 0
- Quality audits; (质量审核)
made? (组织是否确定、收集和分析适当的数据，以证实质量管理体 - Results of product inspections (产品检验结果
系的适宜性和有效性，并评价在任何可以持续改进质量管理体系的有
)
效性？)
- Internal and external quality data (内外部质量
数据)
- Subcontractors rating (分承\包方等级)
- Customer reports (顾客报告)
- Employees information (员工信息)
Does the organization’s data analysis include data generated as a

result of monitoring and measurement and from other relevant
8.4.2 • Data analysis report (数据分析报告。) 0
sources? (组织的数据分析是否包括来自监测和测量结果以及其它有
关来源的数据？)
Page 49 of 52

Does the organization’s analysis of data provide information relating

to (组织的数据分析是否提供有关以下方面的信息： ):
customer satisfaction (see element 8.2.1 ofIATF16949: 2016)? (顾客
满意)
conformance to product requirements (see element 7.2.1
8.4.3 • Data analysis report (数据分析报告。) 0
ofIATF16949: 2016)? (与产品要求的符合性)
characteristics and trends of processes and products including
opportunities for preventive action? (过程和产品的特性及趋势，包括
采取预防措施的机会？)
Suppliers? (供方？)
8.4.1 Analysis and use of data 数据的分析与使用
Does the organization compare trends in quality and operational

performance compared with progress toward objectives and lead to
action to support the following : (组织是否将质量和营运表现的趋势同 • Customer problem resolution
目标作对比并形成支持以下各项的行动：) (顾客问题的解决。)
- development of priorities for prompt solutions to customer-related • Comparison of trends to objectives (goals)
problems? (确定迅速解决顾客相关问题的优先级？) (趋势和目标的比较)
8.4.4 - determination of key customer related trends and correlation to • Specific actions to trend analysis (趋势分析的 0
support status review, decision making and longer term planning? 特定措施)
(确定关键的与顾客相关的趋势和相互关系以支持状况评审、决策和长 • Prioritization of action (措施的优顺序。)
期策划？)
- an information system for the timely reporting of product
information arising from usage?
(通过使用，生成及时报告产品信息的信息系统？)
8.5 Improvement 改进
8.5.1 Continual improvement 持续改进
• Examples of continuous projects initiated

Does the organization continually improve the effectiveness of the
from quality policy, quality objectives, audit
quality management system through the use of the quality policy,
results, analysis of data, corrective and
quality objectives, audit results, analysis of data, corrective and
8.5.1 preventive actions and management review 0
preventive actions and management review? (组织是否利用质量方
针、质量目标、审核结果、数据分析、纠正和预防措施以及管理评审 (由质量方针、质量目标、审核结果、数据分析
、纠正和预防措施以及管理评审引发的持续改
，持续改进质量管理体系的有效性？)
进项目的案例。)
8.5.1.1 Organization continual improvement 组织的持续改进
Has the organization define a process for continual improvement ? • Procedure as stated in quality manual. (质量
8.5.2 0
(组织是否定义持续改进的过程？) 手册中说明了程序。)
8.5.1.2 Manufacturing process improvement 制造过程改进
• Records showing improvement in special

Does the organization’s continual improvement focus upon control characteristics (说明改进特殊特性的记录。)
and reduction of variation in products of characteristics and • Reduction in process parameter variation (过
8.5.3 0
manufacturing process parameters? (组织的制造过程改进是否持续程参数变差的减少。)
于关注产品特性和制造过程参数的变差的控制和减少？)
8.5.2 Corrective action 纠正措施
Does the organization take action to eliminate the cause of non-

8.5.4 conformities in order to prevent recurrence? (组织是否采取措施，以 • Examples (案例。) 0
消除不合格的原因，防止不合格的再次发生?)
Are the organization’s corrective actions appropriate to the effects of

8.5.5 the non-conformities encountered? (组织的纠正措施是否与所遇到不 • Review examples (评审案例。) 0
合格的影响度相适应？)
Page 50 of 52

Has the organization established a documented procedure to define

requirements for (组织是否编制形成文件的程序，以规定以下方面的
要求：)
a) reviewing non-conformities (including customer complaints) (评审 • List of customer complaints (顾客抱怨清单。)
不合格（包括顾客抱怨）？) • Root Cause Analysis and records (根本原因
b) evaluating the need for action to ensure that non-conformities 分析和记录。)
do not recur? (评价确保不合格不再发生的措施的需求？) • Determination of corrective action needed (所
8.5.6 0
c) determining and implementing action needed? (确定和实施所需的纠正措施的确定)
需的措施？) • Corrective action taken (实施的纠正措施)
d) records of the results of action taken (see element 4.2.4 • Corrective action effectiveness (纠正措施的有
ofIATF16949: 2016)? (记录所采取措施的结果（见ISO/TS 效性。)
16949:2002要素4.2.4）？)
e) reviewing corrective action taken?
(评审所采取的纠正措施？（8.5.2）)
8.5.2.1 Problem solving 解决问题的方法
Does the organization have a defined process for problem-solving

• Problem solving process used by
8.5.7 leading to root cause identification and elimination? (组织是否具有定 0
organization (组织使用的解决问题的方法)
义的解决问题过程，以识别和消除根本原因？)
• Responses to customer complaints (对顾客抱

If a customer-prescribed problem solving format exists, does the 怨的反应。)
8.5.8 organization use the prescribed format? (若有顾客规定的解决问题的 • Customer formats (顾客格式。) 0
格式，组织是否采用规定的格式进行？)
8.5.2.2 Error-proofing 防措
Does the organization use error-proofing methods in their corrective

8.5.9 • Examples (案例) 0
action process? (组织是否在纠正措施过程使用防措方法)
8.5.2.3 Corrective action impact 纠正措施影响
Does the organization apply the corrective action, and controls

• Review of documents related to similar
implemented, to eliminate the cause of a nonconformity to other
8.5.10 products and processes (和类似地产品和过程 0
similar processes and products? (组织中否实施采用的纠正措施及其
有的文件的评审。)
实施的控制，来消除在其它类似的过程和产品中存在的不合格原因？)
8.5.2.4 Rejected product test/analysis 退货产品试验/分析

• List of returned parts (退回零部件清单。)
Does the organization analyze parts rejected by the customer's • Records of analysis (分析的记录)
8.5.11 manufacturing plants, engineering facilities, and dealerships? (组织 • Minimalization of cycle time (周期的最短化。) 0
是否从顾客制造厂、工程部门及其代理商退回的产品进行分析？)
Does the organization minimize the cycle time of its rejected

• Review product test/analysis process (评审产
8.5.12 product test/analysis process? (组织是否尽可能缩短该过程与退回产 0
品试验/分析过程。)
品分析有关的周期？)
Does the organization keep records of its rejected product

8.5.13 test/analyses and make available upon request? (组织是否保存退回 • Record (记录。) 0
产品试验/分析的记录，而且在需要时可获得此记录？)
Does the organization perform analysis and, initiate corrective action

8.5.14 to prevent recurrence? (组织是否进行有效的分析，并采取纠正措施 • Examples (案例) 0
以预防再次发生？)
8.5.3 Preventive action预防措施
Does the organization determine action to eliminate the causes of

8.5.15 potential non-conformities in order to prevent their occurrence? (组 • Examples (案例) 0
织是否确定措施，以消除潜在不合格的原因，防止不合格的发生？)
Are the organization’s preventive actions appropriate to the effects

8.5.16 of the potential problems? (组织的预防措施是否与潜在问题的影响程 • Examples (案例) 0
度相适应？)
Page 51 of 52

Has the organization establish a documented procedure to define

requirements for: (组织是否编制形成文件的程序，以规定以下方面的
求：)
a)determining potential non-conformities and their causes? (确定潜 • Sources of information used for preventive
在不合格及其原因？) action (使用的预防措施的来源)
b) evaluating the need for action to prevent occurrence of non- • Root cause determination (FMEA, FTA, etc)
8.5.17 conformities? (评价防止不合格发生的措施的需求？) (根本原因确定（FMEA,FTA,等等）。) 0
c) determining and implementing action needed? (确定并实施所需的 • Records and result analysis (记录和结果分析
措施？) 。)
d) records of results of action taken (see element 4.2.4
ofIATF16949: 2016)? (记录所采取措施的结果？（见
ISO/TS16949:2002要素4.2.4）？)
e) reviewing preventive action taken? (评审所采取的预防措施？)
Page 52 of 52
SUPPLIER AUDIT REPORT (HSPM)
供應商審核報告(有害物质部分）
Supplier Audit Checklist
Need non-
Max Possible: No Signifiant
144 Improve- Satisf. applicable
實際總分 System Deficiency
Hazardous Substance Process Management System (HSPM ment 不适合
System)
有害物質過程管理系統 Actual Score
0 0 1 2 3 N/A
實際得分
序號審核記錄
評審內容 Review Contents Score
Item Evidence or Records
1 Product Design. (產品設計.)

Is an updated "Restricted Substance List" available on
1.1
site? (在現場有最新的"受限物質清單"嗎?) 0
Are technical information of green components/parts
completed and available on site? Note down the types
1.2 and specifications of green components/parts assessed
on site) (現場可以提供綠色零件/部件產品的技術信息嗎?
(記錄現場零部件的型號、規格))
0
Were BoMs (bill of material) updated to distinct inclusive
1.3 of green requirements?
(最新的BOMs清楚地包含了綠色要求嗎?) 0
Is there any technical file review mechanism? (是否有技
1.4
術文件審核機製?) 0
Is there any person dedicated to review the technical file?
If yes, are the person competent? (especially on the test
1.5
report review) (是否有專人審批這些技術文件?若有,這些
人員是能夠勝任的嗎?(尤其針對測試報告的審核人員).)
0
For any design changes, has the changes been properly
1.6 reviewed for the HSF compliance? (對於設計變更,是否對
HSF符合性進行評審嗎?) 0
Is there a procedure to identify any changes that may
1.7 affect the HSF compliance? (是否針對任何影響HSF符合
性的變更通知建立程序?) 0
Has supplier signed any "Declaration of Conformity
1.8 (DOC)" to her customer?("符合性聲明(DOC)"已經簽给客
户了嗎?) 0
Are there any critical component/material without
1.9 hazardous substance test report? (是否有重要物料不能
提供有害物質測試報告?) 0
2 Supplier Selection & Evaluation (供應商評估與選擇)
Are new component/material evaluation mechanism

established and implemented against the HSF
2.1
requirements? (遵循HSF要求的新的受限物質成分、物料
評價機製是否建立、執行?)
0
Are new supplier evaluation mechanism established and
2.2 implemented against the HSF requirements? (遵循HSF
要求的新的供應商評價機製是否建立、執行?) 0
Are responsibility and authority for components,
materials/substances and suppliers evaluation
2.3
established and implemented? (成分、物料/物質、供應
商評價的職責及權限是否建立、執行?)
0
Are evaluation results recorded?
2.4
(這些評價結果保留記錄了嗎?) 0
Is a "Green" Supplier List established and implemented?
2.5
(有建立、實施"綠色"供應商名錄?) 0
3 HSF Product Purchasing. (HSF產品采購)
Does supplier understand the purchased route and
identify the possible course polluted by hazardous
substance clearly? Has supplier listed all the purchasing
activities that are related to hazardous substance de-
3.1
rating course in procedure document? (是否了解采購物
品的采購路線,並充分識別可能被受限物質污染的任何過程
? 是否在程序文件中列明與有害物質減免過程相關的采購
活動?) 0
Does supplier make sure that all hazardous substance
de-rating parts/materials avoiding of the pollution from
3.2
hazardous substance? (是否確保所有的有害物質減免部
件/材料免於受限物質的可能污染?) 0
Does supplier make sure that purchased products meet
3.3 requirement of hazardous substance de-rating? (是否確
保采購的產品符合有害物質減免要求?) 0
Have subcontractors and vendors (OEMs and
cooperating companies) established management
3.4
system to ensure free of use HS. (對于零組件外包, 是否
建立了不使用環境關聯物質的管理體系?) 0
4 Incoming Control (進料控製)
Have inspection process and criteria been clear defined

in incoming inspection procedure regarding to ban of
4.1
HS ? (進料檢驗程序是否有明確定義有關環境禁用物質的
檢驗程序與標準？)
0
Is each incoming lot verified according to inspection
4.2 criteria to ensure free of HS? (是否根據檢查標準,按每個
收貨批號確認未使用禁止物質？) 0
Have the suppliers clearly identified the incoming
components, production material and substances? Were
test report checked at incoming inspection and IQC took
4.3
sample for analysis? (對於來料的成分/生產物料/物質,供
應商清楚地識別了嗎?對來料的測試報告進行了檢查了嗎?
IQC進行了抽樣檢查,並進行了分析嗎?) 0
What is reaction plan at IQC if any incompliance or
4.4
suspecting found? (在不符合或可疑時,IQC如何处理?) 0
Are non-conforming components/materials segregated
4.5 and identified? (不符合的零部件/材料進行隔離和標識
嗎?) 0
Are inspection records available? (這些檢查的記錄可以
4.6
得到嗎?) 0
5 Process Control (過程控製)
Are components, materials and substances which are
temporarily stored in the production line segregated and
5.1
identified? (臨時存放在生產現場的物料/物質有進行隔離
、標識嗎?) 0
Are extra components, materials and substances
5.2 identified and segregated? (剩餘物料有進行隔離、標識
嗎?) 0
Are green and non-green parts and products clearly
5.3 identified on the production floor? (在生產現場綠色/非綠
色部件及產品清楚地標識了嗎?) 0
Green production lines were segregated from non-green
production line to avoid potential contaminations? (為了
5.4
避免潛在的污染,從非綠色生產線生產的綠色產品進行了隔
離?) 0
Are there a check list and HSF label for the indirect
5.5 material ? (生產線上使用的間接物料(如清洗劑)是否有检
查清單, 是否有HSF標示?) 0
Have procedures been established and implemented for
IPQC to ensure all parts / components used for green
5.6
products are correct? (為確保所有的部件/成分正確的用
在綠色產品上, IPQC的要求是否程序化,並執行?) 0
Have procedures been established and implemented for
in-process environmental checks to prevent cross-
5.7
contamination? (生產過程中是否進行環境檢查以防止交
叉污染?這些要求是否建立程序並執行?) 0
Is there a procedure to identify the risk and sampling plan
5.8 for finished goods? (是否對成品設定物料風險級別,及按
風險級別製訂抽樣測試計劃.) 0
Is there a HSF label on the carton of finished product ?
5.9
(出貨成品外箱是否有貼HSF標簽?) 0
5.10 Are inspection records available ? (有检验記錄吗?) 0
Is there any HSF non-conforming product control
procedure? Does this procedure been implemented
5.11 effectively?(e.g.identification, segregation and
disposition, authorization) (是否建立不合格HSF產品控製
程序?是否得到有效實施?(如:標識,隔離,處理以及批準))
0
Has the corrective and preventive action been taken to
5.12 prevent the HSF NC reoccurring? (是否建立糾正預防措施
程序並得到適當的實施以防止HSF不合格的再發生?) 0
6 Warehouse Control (倉庫控製)
Are components, materials, substance segregated and
6.1
identified? (成分/物料/物質進行隔離、標識了嗎?) 0
Are components, materials/substance, which are
returned from production line, clearly segregated and
6.2
identified? (從生產線退回的成分/物料/物質進行隔離、標
識了嗎?) 0
Has procedure been established for proper releasing of
6.3 materials to production line? (是否建立了适当的生產物料
的發放程序?) 0
Is inventory record clear for material tracing? (物料追蹤是
6.4
否有清楚的清單記錄?)
0
7 Green System Maintenance (系統維護)
Is HSF- awareness training provided to employees? (是

7.1
否提供給員工HSF方面的培訓?)
0
Are training records available for audit upon request? (檢
7.2
查所需要的培訓記錄能否得到?) 0
Is documented internal audit procedure available? (內部
7.3
審核程序是否文件化?) 0
Have internal auditor been trained and qualified as
7.4
specified? (內稽員是否有訓練與資格鑒定?) 0
Is Internal Audit conducted periodically? Does the
7.5 Internal Audit cover HSPM related requirements? (內部
審核是否周期性地舉行?是否包含HSPM的要求?)
0
Are Internal Audit results recorded and reviewed by
7.6 management? (內部審核的結果是否記錄並得到管理層的
評審?) 0
Have corrective and preventive actions been taken as
7.7
necessary? (如果需要,是否采取了相應的糾正預防措施?) 0
Does the factory establish P/N system to distinguish the
7.8 HSF or Non-HSF material ? (是否建立適當的P/N系統區
分HSF 與Non-HSF物料?) 0
審核員: 供應商協審員: 日期:
Auditor: Supplier: Date:
SUPPLIER AUDIT REPORT （SER)
供應商審核報告(社会责任职责）
Max Signifiant Need non-

No
Possible: 114 Deficienc Improve- Satisf. applicable
System
實際總分 y ment 不适合
Social Environemental Responsibility
社會環境職責 Actual Score 0 0 1 2 3 N/A
實際得分
序號審核記錄
Item 評審內容 Review Contents Evidence or Records Score
1 Forced Labor (强迫劳工)

Does factory have a written policy against the use of
1.1
forced labor? (是否存在有禁止強迫勞動的政策?) 0
No evidence that the factory use forced labor? (有無證
1.2
據證明了公司使用了強迫勞動?) 0
2 Child labor (童工)
Does supplier have a written policy specified the age for

workers hired in the facility? (No employee below the
2.1
age of 16 was/is employed by the supplier. ) (有书面文
件規定雇用勞動者的年齡要求嗎?不得小於16周歲.)
0
Is there any evidence that child labor are employed? (是
2.2
否有雇用童工?) Zero tolerance 0
Does supplier have adequate employees personal file.
2.3 registration forms and photocopies of identification
cards or passports? (是否有建立完善的員工檔案資料?) 0
Does factory use underage workers? If yes, is proper
2.4 work is arranged to underage labor(是否有雇用未成年工
?如有，是否安排适当工作) 0
Does factory offer proper physical check-up to
underage labors and keep the certification? Does
factory register the underage employment at local labor
2.5
bureau for record? (是否有對未成年工進行適當的健康
檢查並保持記錄,是否有在當地勞動部門對未成年工進行
登記?) 0
3 Limitation of freedom (自由限製.)
Check the factory policy, are workers limited to

washroom, drinking water, etc during work time? (確認
3.1
公司製度,是否工人在工作時間內是否被限製不可以上洗
手間和喝水等?)
0
No evidence that the freedom of workers is limited? (是
3.2
否有證據證明工人受到了自由的限製?) 0
Does factory hold the employee's ID/Passport? (工廠是
3.3
否有扣押了雇員的身份證?) 0
4 Working hours (勞動工時.)
Does factory have a written policy for working hours? Is

the current overtime meet local labor law requirements?
Working time 40 hours per week, over time 36hours per
4.1
month. (是否有書面政策規定了勞動工時?加班時數是否
在當地勞動部門合法要求內? (每周工作時間40小時,每月
加班不超過36小時))
0
Are workers provided with sufficient time for break and
4.2 lunch? At least 0.5hr (工廠是否有提供足夠的休息和用餐
時間? (至少半小時)) 0
4.3 Is overtime voluntary? (加班是否屬於自願?) 0
Is it guaranteed for employees at least one day rest in
4.4
one week? (是否有書面證明員工至少每周休息一天?) 0
5 Wages and Benefits (工資與福利.)

Does factory have a written policy on wages and
5.1
compensations? (是否有書面的文件定義工資和賠償?) 0
Are employees paid no lower than local minimum
5.2
wage? (工人工資是否不低於當地最低工資標準?) 0
Does factory overtime pay on working day, rest day and
holiday meet the local legal requirements ? (日加班,周
5.3
末加班和節假日加班的加班費是否有達到當地勞動部門
的要求?)
0
Does vendor have penalty regulation excessive? China
labor law require the maximum deduction below than
5.4
20% of the basic salary. ) (對於違反規章的罰款是否超
過了規定? 勞動法規定每月扣款不得超出月薪的20%.)
0
Does factory buy any insurances to employees?
5.5 Concerned records? (工廠是否有為員工買了保險,並有
記錄顯示?) 0
Does factory provide pay slip to employees in each
payment period, in which clearly indicates the
5.6 employee's compensation and any deductions in every
period? (每個月都有工資條顯示員工的各種勞動所得和
扣款?) 0
Does factory request any deposits from employees or
employees have to pay for suit, badge, etc? The first
5.7
issuance should be free. (工廠是否有收各種抵押或員工
被要求支付工衣,工卡的費用? 首次發放應免費.)
0
Is the monthly payment paid to employees no later than
5.8 last day of following month? (工資是否不遲於次月的最
後一天支付?) 0
Would the employee be compensated if he/she was
injured at work? e.g. company pays medicinal expense,
5.9
paid leaves. (員工受公傷是否得到適當補償?例如: 公司
支付醫療費,有薪假.) 0
6 Discrimination (歧視)
Does factory have a written policy against
6.1
discrimination in the facility? (是否有政策反對各種歧視) 0
Does factory make the decisions relating hiring, salary,
advancement, discipline, termination on basis of
employee or potential employee's race, color, gender,
6.2
nationality, religion, age, maturity, or marital status? (在
雇用,福利,等方面對於不同種族,性別,年齡等各方面是平
等的.) 0
7 Labor Contract. (勞動合同)
Does factory sign the labor contract with all employees

7.1 as the local labor reinstallation? (工廠是否按照当地规
定與所有員工都簽定了合法的勞動合同?) 0
Does the employee get the one copy of labor contract?
7.2
(員工是否都持有一份勞動合同複本?) 0
Does factory sign the labor contract with the employee
7.3 within 30 days since he(she) joins the factory? (工廠是
否與勞動者在進廠30天內就簽定了勞動合同?) 0
Check the item of probation period in contract, is it in
7.4 compliance with labor law? (确认合同中规定的试用期是
否与劳动法相一致） 0
8 Health and safety. (健康與安全.)
Is the factory on good ventilation situation, especially at
8.1
workshop? (廠內通風良好,尤其是車間裡.) 0
Are there any potential occupational hazard that may be
harmful to health of employees are monitored and
8.2
under control?
(是否对可能危害员工健康的职业伤害进行监控和管理？) 0
8.3 Are all work areas well lit? (工廠是否充分照明.) 0
Have fire equipments been checked and maintained
8.4
periodically? (消防設施是否被定期檢查和維護.) 0
Are the machines in factory free of risk of injury? For
example, belt & pulley are exposed to operator without
8.5 covers
(工廠內的機器是否有安全隱患. 例如皮帶和帶輪無保護
蓋.) 0
Are emergency exits blocked? (是否緊急通道暢通無
8.6 0
阻? )
Does factory have an emergency reaction plan and
8.7
does it work? (有應對緊急情況的预案並有執行.) 0
Does factory have proper first aid for employees at each
8.8
floor/shop? (工廠是否配備有急救醫療設施?) 0
Is there adequate living space for each worker? Are
living quarters clean, safe and well lit? (if factory
8.9 provides dormitory to employees) (如果工厂提供宿舍，
确认每個工人都有足夠的居住空間,並且安全干淨明亮.)
0
SUPPLIER AUDIT REPORT （Environment Management System)
供應商審核報告(環境管理系統部分）
Need non-
Environment Management System ment 不适合
環境管理系統
Actual Score 0 0 1 2 3 N/A
實際得分
序號審核記錄
評審內容 Review Contents Evidence or Records Score
Item
Does the company build, excute, continuous improve the
environment management system? Does the
1 manufactory defined the range of environment
management system? 是否建立、实施、持续改进环境管
理体系？是否确定环境管理体系的范围?
0
Does the company has a documentary environment
2 policy?
是否有一个文件化的環境方针? 0
Does the company has the organization chart of
environment management system? Does the
organization chart covered all related functional
3
department?
是否有環境管理體系的組織架構圖?該架構圖是否涵蓋了
各職能部門? 0
Does the company appointed management
4 representative?
是否任命環境管理體系管理者代表? 0
Does the company has controlled environment
5 management system documents?
是否有一套受控的環境管理体系文件? 0
Is there a company location ichnography (geography
6 position)?
是否製定公司社區平面圖(即地理位置圖)? 0
Does the company build up the organization chart of fire
brigade? Is there a name list of fire brigade? Is the
7 responsibility of everyone in fire brigade be defined?
是否建立义务消防队组织架构圖和义务消防队人員名单?
各義務消防人員的職責是否清析界定?
0
Is there a company floor plan?
8
是否建立廠區平面圖? 0
Does the company set up the environment goal? Is the

environment goal be signed by top management and use
9
as an offical document?公司是否設置環境目標指標?是否
經領導簽批並行成正式文件?
0
Does the environment management plan defined
responsible person; defined the plan and time of meeting
10 the environment target?
環境管理方案是否明確了責任人?是否明確了环境目标、
指标的實現措施和方法及完成具體時間?
0
Are the requirements of environment management
system be included in new employee training? Are the
11 training records be documented?
是否對公司新入職人員進行環境管理體系有關知識的培訓,
並留有培訓紀錄?
0
SUPPLIER AUDIT REPORT （GSV & C-TPAT)
供應商審核報告(工廠安全部分）
Need non-
Factory Security (GSV & C-TPAT) ment 不适合
工廠安全
Actual Score 0 0 1 2 3 N/A
實際得分
序號審核記錄
評審內容 Review Contents Evidence or Score
Item Records
1 Container Security 集裝箱安全
Are there procedures in place on to properly seal and

maintain the integrity of the shipping containers for
1.1
warehouse? 貨倉有程序規定如何正確密封和保持貨運
集裝箱的完整性嗎?
Does Finished Goods Warehouse have the written

procedures in place to stipulate how seals are to be
controlled and affixed to loaded containers, only
1.2 designated employees should distribute outbound
container seals (access is controlled)? 成品倉是否有書
面的程序規定如何控製和如何給在裝載後的貨櫃加封條,
並且只有指定的人員才可以派發海外貨櫃的封條嗎?
Are containers stored in a secure area to prevent

1.3 unauthorized access and/or manipulation? 集裝箱是否
被存放在安全的地方可防止未經許可的接觸或操作?
2 Physical Access Controls 出入控製
Is there single procedure about examination to cargos

passing in and out the facility?Is the container number
2.1 and seal number registered for cargos passing in and
out the facility?進出的貨車要有單獨的流程進行檢查,且
有登記集裝箱號及封條號嗎?
Is a card access system available to every outer door?

2.2 Is there a warning system to intrusion?所有外部入口是
否有安裝門禁系統?且是否有入侵警報系統?
Is there an employee identification system in place for

2.3 positive identification and access control purposes? 有
員工身份識別系統可以準確識別和控製出入權限嗎?
Is the issuance and removal of employee, visitor and

vendor identification badges adequately controlled by
security or authorized persons? And make records
2.4
while distributing and reclaiming the cards?員工,訪客和
供應商識別卡的發放和回收是由保安或者相關授權人員
統一控製的嗎?是否需要在發放和回收時做相關記錄嗎?
Should all visitors be escorted and visibly display

2.5 temporary identification? 所有訪客有陪同進入廠區且佩
戴臨時證件嗎?
Is there documented procedure on identifying and

2.6 addressing unauthorized/unidentified persons? 工廠有
書面的程序規定如何識別未經授權的人員出入控製嗎?
3 Personnel Security 人員安全

Does the factory verify the application informations
such as employee history and reference prior to
employment, such as education backgroud, working
experience, criminal background verification included?
and are the verification information be checked and
3.1 updated periodically especially for the high risk position
employees?(Store keeper, carrier and security guard
and etc.)工廠招聘組在雇佣前檢查申請信息, 例如員工過
去的情況嗎(如教育背景, 工作經驗及是否有犯罪背景)?
並定期執行內部稽查,更新嗎?(尤其是倉庫,船務和保安人
員)
Are the contractors who will passing in and out some

restricted area in facility subject to background
3.2
investigation? 對進出受限制區域的承包商要進行背景調
查嗎?
Does the identification system identify all of kinds of ID

3.3 card?(the first and second generation ID cards) 身份證
認證系統能否識別所有身份證?
供应商是否严格执行对有关反奴役和贩卖人口的标准?
3.4 Supplier if have strict execute about all forms of forced
labor and human trade standards?
4 Procedural Security 程序安全
Is all information used in the clearing of

merchandise/cargo, legible, complete, accurate, and
4.1 protected against the exchange, loss or introduction of
erroneous information? 貨物相關的所有信息都是清晰,
準確,完整和被防護的,防止變更,遺失和導入錯誤信息嗎?
Has factory safeguarding the computer access and

4.2
information?電腦權限和信息安全嗎?
Does Warehouse have adequate procedures in place
to protect against unmanifested or unapproved parts,
components or raw materials being introduced into
4.3
production? 貨倉是否有書面的程序規定如何防止未列明
的貨物(如未被列明或授權的零件, 原材料等)進入生產區
域?
Are drivers positively identified by security before
4.4 access to the facility ? 司機入廠前保安工作人員有對其
進行身份識別嗎?
Are drayage trucks required to enter and exit through a
4.5 designated entrance and exit? 貨車是從指定的進出口出
入嗎?
5 Security Training and Threat Awareness 安全培訓和反恐意識
Is there a procedure for reporting of potential security

5.1 issues observed by employees? 工廠是否有供雇員如何
上報發現潛在安全隱患的渠道或程序?
Does the facility have process in place to publicize the

security procedures throughout the facility (i.e. posters,
5.2
bulletin boards, etc)? 工廠有對於安全程序進行宣傳嗎?
(通過宣傳欄,通告板等)
Does the company require C-TPAT enrollment of its
5.3 business partner(supplier, contractor etc)? 是否對我們
的業務伙伴(供應商,承包商等)進行C-TPAT相關培訓?
Does the facility conduct a site security assessment?工

5.4
廠是否有執行現場安全的評估?
Does the facility document security improvement action

plan which summarized the identified vulnerabilities and
5.5 implement, periodically update and evaluate the
security improvement schedule? 對於安全問題點是否有
記錄並且有製定,執行,定期更新和評估安全改善計劃?
6 Physical Security 物理安全

Are finished products segregated and stored in a
6.1 designated area? 成品是被隔離和存放在指定的區域裡
嗎?
Does factory regularly inspect all fencing for integrity
6.2 and damage?
工廠有組織定期巡視圍牆嗎?
Are gates through which vehicles and/or personnel

6.3 enter or exit manned and/or monitored?車輛和人員進出
的大門有人把守或監控嗎?
Does Facility Department periodic inspect and repair

6.4
the structures? 工廠維修部有定期檢查和維修建築物嗎?
Are all external and internal windows, gates and fences

6.5 secured with locking devices? 工廠內外的門,窗,圍牆都
有鎖配裝置對其進行控製嗎?
Is facility is monitored by security personnel 24 hours?

6.6
工廠由保安人員24小時監控嗎?
Are electrical security system (CCTV cameras CCTV

cameras or automatic alarms) equipped in all critical
6.7 areas, production,packaging and storage areas
included? 所有的重要區域包括生產以及包裝區域和存儲
區域都有安裝錄像監控系統或警報系統嗎?
Are the facility's entrance doors monitored by

6.8
cameras?工廠大門是否有攝像監控?
Does the facility require the use of visual identification

for visitors,vendors and employees parking (a coded
6.9
parking sticker, tag, decal)? 訪客,供應商和雇員的停車
場是否有可視的標識牌?
7 Information Technology Security 信息安全
Is there firewall to protect information for these

7.1 computer which connect to internet? 和互聯網連接的電
腦設有防火牆嗎?
Are IT security policies, procedures and standards in

7.2
place? 有IT安全政策,程序和標準嗎?
Is there a system which identify the abuse of IT

including improper access, tampering or the altering of
7.3
business data? 工廠有系統確認IT的非正常使用,包括非
法取得,破壞,篡改業務資料嗎?
Important computer information's backup has been
7.4 stored off site?重要的計算機信息是否在隔離的區域備份
?
Is there procedure and schedule to ensure the
7.5 resuming of important IT data?有程序或計劃以實現重要
IT數據的恢複嗎?
8 Business Partner Requirement 對業務伙伴的要求
Have business partners related with transportation C-

TPAT certificate?Is Business partner without C-TPAT
8.1 certificate required to demonstrate meeting C-TPAT
security criteria? 工廠的運輸業務伙伴是否有C-TPAT證
書?沒有證書的業務伙伴是否符合C-TPAT安全標準?
Does the facility conduct periodically check for the C-

TPAT certified business partner to make sure the
8.2
certificate always within its validity? 是否有針對獲得C-
TPAT證書的業務伙伴進行定期確認以確保其有效性?
Is there procedure stipulating contractor how to report

8.3 the security violation?是否有程序規定承包商怎樣上報安
全違反項?
Does the facility make on-site examination to their

contractors regard to the security standards and
8.4
procedures? 是否在承包商工作現場進行安全標準和程
序方面的檢查?
Is there procedure stipulating the in-country carriers

8.5 how to report security violation?是否有程序規定國內運
貨員怎樣上報安全違反項?
審核員:
供應商協審員: 日期:
Auditor:
Supplier: Date:

5. Audit History 評審履歷
No Audit Date Auditor(稽核人員) Topic of Audit(稽核的目的) Audit Score Comment
AUDIT SCOPE 審核范围
COMMODITY 所供產品類別
Page 51 of 52
Page 52 of 52

Completion
Finding Description Action Plan Responsible Result follow-up
date
Page 52 of 52

SQEF0002 A TTI MIL QMS Audit Check List

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

SQEF0002 A TTI MIL QMS Audit Check List

Uploaded by

Copyright:

Available Formats

Form No.

:SQEF0002 Version: A Effective date:16/12/2020

TTI-MIL QMS Audit Check List

SUPPLIER AUDIT REPORT

Report No. 編號:

AUDIT TYPES 審核類型

Pre - Assessment 预评估 Result: 0.0%

AUDIT SCOPE 審核范围

AUDIT SUMMARY 審核詳述

1.Audit Result 審核結果: Overall Audit Score 0.0%

Audit status meet any of the below items:

Audit status meet below item:

Audit status meet below item:

SUPPLIER AUDIT REPORT

Report No. 編號:

Prepared by: Checked by: Approved by:

SUPPLIER AUDIT REPORT

Report No. 編號:

Function Key Contacts (Name, Title) Tel. Email

4. Annual Audit: for existing supplier. Conducted by outsource QA once a year.

No Not Effective Effective

No. Questions/问题点 Observation发现 Score得分 Remark备注

Be awarded ISO/TS16949 certificate or other

Does the production process can ensure the products

Is there adequate quality control for production

Key/Critical Product/Process Characteristics are

Are gauges available and adequate in production

Are the capacity, accuracy, stability of production

Is SPC used for process control?

8 Is automaticly production line be used for production? 0

Supplier has quality department on site with

Supplier has an incoming inspection strategy,

Supplier has an outgoing inspection strategy,

Supplier uses a structured problem solving method

Are inspection equipments be well maintanced and

Is any MSA for critical equipment, gauge and fixtures,

Supplier has product development and process

Supplier demonstrates production experience for

Supplier can promise try their best to meet related

Is there a system to manage new product develop, and

Supplier has product development and process

Supplier has a process for change management

The store can ensure the products be well identified,

Supplier can provide hazardous substance test report

Supplier demonstrates no child labors are used

Remarking: Total: 0.00%

SUPPLIER AUDIT REPORT

1. PROCESS CONTROL AUDIT SCORE SUMMARY/制程控制評審得分狀況 Pecentage: 40

Total Score 27 0 0.0%

2. QUALITY CONTROL AUDIT SCORE SUMMARY/质量控制評審得分狀況 Pecentage: 20

No. Sections Max Actual Incoming quality control

2 Out-going quality control 12 0 0.0%

3. METROLOGY SYSTEM AUDIT SCORE SUMMARY/测量系统評審得分狀況 Pecentage: 20

No. Max Actual

Total Score 24 0 0.0%

4. QUALITY SYSTEM AUDIT SCORE SUMMARY/品質系統評審得分狀況 Pecentage: 20

No. Sections Max Actual Quality management system

4 Product realization 384 0 0.0%

Total Score 825 0 0.0%

5. HSPM AUDIT SCORE SUMMARY/HSPM系統評審得分狀況 Reference

7. Environment Management System/環境管理系統 Reference

8. Factory Security (GSV & C-TPAT)/工廠安全 Reference

Name / 姓名 Position / 職務 Name / 姓名 Position / 職務