1.9 improvement from a system level?
供货商是否进行过外部审核(第二方审核或第三方审核),稽核的结果是否已经从系统面进行分析改善？
Does the supplier conduct management reviews of the suitability and effectiveness of the quality
4.4
Is there a system to ensure engineering change notifications are being implemented? 是否有一系统确认工程变更的导入?
4.5
Is there a system to verify the effectiveness of engineering changes? 是否有一系统来确认工程变更的有效性?
稽核员是否有足够的资格认可并保证了稽核过程的客观性和公正性？（例如︰稽核员不能稽核他们自己的工 Are the correct actions taken without undue delay to eliminate detected nonconformities and their causes as
内部稽核是否考虑拟审核的过程和区域的状况和重要性以及以往审核的结果？
Are the auditors qualified and ensured the ability objectivity and impartiality of the audit process? (e.g.
1.7 auditors shall not audit their own work.)
3.5
Are the records for design review properly documented and maintained? 设计评估是否被适当地记录并维护?
4 Engineering Change Management
4.1
Is there a procedure to govern engineering changes? 是否有一程序来监督工程变更?
1.14 system and product related to customer requirements?
管理评审是否包含了对质量管理体系和与顾客要求有关的产品改善的建议？
第 1 頁，共 9 頁
稽核结果记录
供货商质量系统审核报告
Sup pFlaiec tory
No
Check List
Has the supplier established the appropriate and effective communication processes within the 1.15 organization？
供货商是否有定义并将公司质量政策、目标及对质量的承诺文件化?
Are procedures in place to ensure this quality policy is understood, implemented and maintained at all levels 1.2 in the organization?
2.4
Is there a system to disqualify and re-qualify personnel in a job function? 是否有一系统能剔除及重新认证人员的工作任务?
3 Design Control
3.1
Is the design control procedure established to plan, control, review, verify and validate the design of the product?
是否有程序书来确保质量政策被全公司了解，导入并维持? Has the supplier defined the responsibility, authority and interrelation of all personnel who manage, perform
and verify work that affects the quality of products, materials or services? (i.e. procedures, organization 1.3 charts, quality manual )
Is there a requirement to verify the product meets design specifications prior to mass production? (e.g.,
3.4 design review/verification)
是否有在量产前确认产品符合设计的规格?
供货商是否建立品管系统，含程序、组织结构、质量手册?
Has the supplier appointed a management representative who has responsibility and authority for ensuring
1.4 that a quality management system has been implemented and maintained?
1.13 from previous management reviews?
管理评审是否包含了预防和改善对策的状况和上次管理评审的后续对策？
Does the management review include the recommendations for improvement of quality management
Are the internal audits planned taking into consideration the status and importance of the process and areas
1.6 to be audited as well as the results of previous audits?
2 供Pe货rs商o是n否ne在l 组Co织m内p建e立te了nc适e当a并nd有T效ra的in沟in透g过程？
self score
Ass ess
customer score
是否适
是否适
用？ 1 2 3 4 5 用？ 1 2 3 4 5
(Y/N)
(Y/N)
2.1
Is there a system that identifies training requirements for all personnel affecting the quality of the product? 是否有一能识别会影响产品质量之相关训练需求之系统?
供货商是否有指派一管理代表来确认质量管理系统被导入执行并维持?
1.5
Does the supplier carry out a comprehensive system of planned and documented internal quality audits? 是否有执行有计划且有记录之内部系统稽核?
供货商质量系统审核报告
Sup pFlaiec tory
No
1 Quality System Requirements
Check List
self score
Ass ess
customer score
是否适
是否适
用？ 1 2 3 4 5 用？ 1 2 3 4 5
(Y/N)
(Y/N)
Has the supplier defined and documented its corporate quality policy, objectives and commitments to 1.1 quality?
1.8 well as the verification of the actions and report of verification results?
供货商是否及时采取措施以消除内部稽核中发现的不合格及其产生的原因并验证所采取对策和报告结果？ Has the supplier been audited by customer or 3rd party and the audit results been analyzed for
2.2
Does the supplier evaluate the effectiveness of the training taken and maintain the training records? 供货商是否有评估培养训练的效果并维护其训练记录？
2.3
Does a system exist for determining which personnel are qualified for a job function? 是否有一系统能决定人员是合适于某一工作?
4.2
Are engineering changes reviewed and approved by authorized personnel prior to implementation? 在导入前，工程变更是否被评估并由被授权的人认可?
4.3
Are the engineering change notifications distributed to all affected functional areas once approved? 是否工程变更通知会分派到所有相关的单ures to control and verify the design of the product to ensure it is meeting all requirements? 验证产品的设计并确保它符合所有的要求。
3.3
Are there plans that identify the responsibility for each design and development activity? 针对每一设计及发展活动，是否有能识别责任的计划?