宝丽来验厂质量管理体系要求

Quality System Requirements宝丽来验厂质量管理体系要求

1. Has the supplier defined and documented its corporate quality policy?

    (a) Is the Quality Policy appropriate to the purpose of the organization?

    (b) Does the Quality Policy include a commitment to comply with requirements and continually improve the effectiveness of the quality management system?

    (c) Does the Quality Policy provide a framework for establishing and reviewing quality objectives?

    (d) Is the Quality Policy communicated and understood within the organization?

    (e) Is the Quality Policy reviewed for continuing suitability?

2. Are quantifiable and measurable quality objectives, including those to meet requirements for product, established at relevant functions and levels within the organization?

3. Are the quality objectives consistent with the corporate quality policy?

4. Does the quality management system documentation include a quality manual?

5. Does the quality manual include the scope of the quality management system, including details of and justification for any exclusions?

6. Does the quality manual include a description of the interaction between the processes of the quality management system?

7. 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 charts, quality manual)

8. Has the supplier provided adequate resources for in-house verification activities such as inspection, testing, monitoring and review of processes and products?

9. Has the supplier appointed a management representative who has responsibility and authority for ensuring that a quality management system has been implemented and maintained?

10. Has the management representative tracked and drove the improvement on quality management system performance with record/report.

11. Has the improvement effectiveness verified (record/evidence required)?

12. Does the supplier conduct management reviews of the suitability and effectiveness of the quality management system at appropriate intervals? (i.e. does the quality system meet customer requirements?)

13. Does the management reviews include verification of the following input:

    (a) Achievement of quality objectives

    (b) Results of the audits

    (c) Customer feedback

    (d) Process performance and product conformity

    (e) Status of preventive and corrective actions

    (f) Follow-up actions from previous management reviews

    (g) Changes that could affect the quality management system, and

    (h) Recommendations for improvement

14. Does the output of management reviews include any decisions and actions related to:

    (a) Improvement of the effectiveness of the quality management system and its process?

    (b) Improvement of product related to customer requirements, and

    (c) Resource needs

15. Are implementation of action items from management review tracked?

16. Are records maintained of these management reviews?

17. Does the supplier conduct internal audits at planned intervals?

18. Do the internal audits verify compliance with planned arrangements, ISO standards and quality management system?

19. Do the internal audits determine whether the quality management system is effectively implemented and maintained? (e.g., meeting the customer requirements?)

20. Are the internal audits planned on the basis of the status and importance of the activity, as well as the results of previous audits?

21. Are the audit criteria, scope, frequency and methods defined for the internal audit?

22. Are the selection of auditors and conduct of audits ensuring the objectivity and impartiality of the audit process? (e.g. auditors shall not audit their own work.)

23. Is there a procedure documented the responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records ?

24. Do the follow up activities include the verification of the actions taken and the reporting of verification results ?

25. Are the audit results analyzed for improvement from a system level?

26. Is there a system that identifies training requirements for all personnel affecting the quality of the product?

27. Does a system exist for determining which personnel are qualified for a job function?

28. Is there a system to disqualify and re-qualify personnel in a job function?

29. Are accurate training records maintained?

30. Does the supplier determine, collect and analyze appropriate data to demonstrate the suitability and effectiveness of the quality system ?
31. Does the above analysis evaluate where continual improvement of the effectiveness of the quality system can be made.

32. Does supplier have ISO 14001 certification? If not, does supplier have a plan/roadmap to achieve the certification ?

33. Does supplier have OHSAS 18001 certification? If not, does supplier have a plan/roadmap to achieve the certification ?

1. 供应商是否有文件化的公司质量政策？

   （a）质量方针与组织的宗旨相适应？

   （b）质量方针是否包括对满足要求和持续改进质量管理体系的有效性？

   （C）质量方针为建立和评审质量目标提供框架？

   （D）质量方针在组织内得到沟通和理解？

   （E）质量方针在持续适宜性方面得到评审？

2. 在组织的相关职能和层次上是否建立了符合产品要求的可量化的，可测量的质量目标，？

3. 质量目标与企业的质量方针是否保持一致？

4. 是否在质量管理体系文件中包括质量手册？

5. 质量手册是否包括质量管理体系的范围，包括任何删减的细节和正当的理由？

6. 质量手册是否包括对质量管理体系过程之间的相互作用？

7. 有责任的供应商界定，所有人员的管理权限和相互关系，执行和验证影响产品质量的材料或服务？（即程序，组织图，质量手册）

8. 供应商有否提供内部验证活动，如检验，测试资源充足，产品过程监视和审查？

9. 是否有指定一名管理者代表，已确保质量管理体系得到实施和保持权力和责任？

10. 是否有管理代表跟踪推动和记录/报告对质量管理体系业绩改进.

11. 改善措施的有效性验证（记录/证据需要）？

12. 供应商是否在适当的时间间隔内对质量管理体系的适宜性和有效性进行管理评审？（即质量系统符合客户要求？）

13. 管理评审是否包括下列验证：

   （A）质量目标的实现

   （B）审计结果

   （C）顾客反馈

   （d）业绩过程和产品符合性

   （E）预防和纠正措施的状况

   （f）以前管理评审的跟进行动

   （g）可能影响质量管理体系的变更

   （H）改进建议

14. 管理评审的输出包括有关决定和措施：

   （a）质量管理体系有效性及其过程的改进？

   （b）与顾客要求有关的产品的改进

   （c）资源需求

15. 管理评审的跟踪措施和项目的实施？

16. 保存管理评审的记录？

17. 供应商按计划的时间间隔进行内部审核？

18. 内审是否符合计划安排，ISO标准和质量管理体系？

19. 做内部审核，确定质量管理体系是否得到有效实施和保持？（例如，符合客户要求？）

20. 内部审核计划是否在活动的状态和重要性的基础上，以及以往审核的结果

21. 审核的准则，范围，频率和方法对内部审计的定义？

22. 审核员和审核的实施，确保审核过程的客观性和公正性的选择？

23. 是否有文件化的程序责任和策划实施审核的要求，以及报告结果和保持记录？

24. 做的后续活动，包括对所采取措施的验证和验证结果的报告？

25. 审计结果的分析，从制度层面改善？

26. 是否有系统来识别影响产品质量的所有人员的培训需求？

27. 是否有系统性确定人员所存在的工作职能？

28. 是否有制度，取消和重新获得资格认证的工作职责的人员？

29. 准确的培训记录？

30. 供应商是否有收集和分析适当的数据，以证实质量管理体系的适宜性和有效性？

31. 上述分析评估质量体系的有效性可以持续改进.

32. 供应商是否有ISO 14001认证？如果没有，是否有计划来实现认证？

33. 供应商是否有OHSAS 18001的认证？如果没有，是否有计划来实现认证？