Quality System Requirements寶麗來(lái)驗廠(chǎng)質(zhì)量管理體系要求

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. 供應商是否有文件化的公司質(zhì)量政策？

   （a）質(zhì)量方針與組織的宗旨相適應？

   （b）質(zhì)量方針是否包括對滿(mǎn)足要求和持續改進(jìn)質(zhì)量管理體系的有效性？

   （C）質(zhì)量方針為建立和評審質(zhì)量目標提供框架？

   （D）質(zhì)量方針在組織內得到溝通和理解？

   （E）質(zhì)量方針在持續適宜性方面得到評審？

2. 在組織的相關(guān)職能和層次上是否建立了符合產(chǎn)品要求的可量化的，可測量的質(zhì)量目標，？

3. 質(zhì)量目標與企業(yè)的質(zhì)量方針是否保持一致？

4. 是否在質(zhì)量管理體系文件中包括質(zhì)量手冊？

5. 質(zhì)量手冊是否包括質(zhì)量管理體系的范圍，包括任何刪減的細節和正當的理由？

6. 質(zhì)量手冊是否包括對質(zhì)量管理體系過(guò)程之間的相互作用？

7. 有責任的供應商界定，所有人員的管理權限和相互關(guān)系，執行和驗證影響產(chǎn)品質(zhì)量的材料或服務(wù)？（即程序，組織圖，質(zhì)量手冊）

8. 供應商有否提供內部驗證活動(dòng)，如檢驗，測試資源充足，產(chǎn)品過(guò)程監視和審查？

9. 是否有指定一名管理者代表，已確保質(zhì)量管理體系得到實(shí)施和保持權力和責任？

10. 是否有管理代表跟蹤推動(dòng)和記錄/報告對質(zhì)量管理體系業(yè)績(jì)改進(jìn).

11. 改善措施的有效性驗證（記錄/證據需要）？

12. 供應商是否在適當的時(shí)間間隔內對質(zhì)量管理體系的適宜性和有效性進(jìn)行管理評審？（即質(zhì)量系統符合客戶(hù)要求？）

13. 管理評審是否包括下列驗證：

   （A）質(zhì)量目標的實(shí)現

   （B）審計結果

   （C）顧客反饋

   （d）業(yè)績(jì)過(guò)程和產(chǎn)品符合性

   （E）預防和糾正措施的狀況

   （f）以前管理評審的跟進(jìn)行動(dòng)

   （g）可能影響質(zhì)量管理體系的變更

   （H）改進(jìn)建議

14. 管理評審的輸出包括有關(guān)決定和措施：

   （a）質(zhì)量管理體系有效性及其過(guò)程的改進(jìn)？

   （b）與顧客要求有關(guān)的產(chǎn)品的改進(jìn)

   （c）資源需求

15. 管理評審的跟蹤措施和項目的實(shí)施？

16. 保存管理評審的記錄？

17. 供應商按計劃的時(shí)間間隔進(jìn)行內部審核？

18. 內審是否符合計劃安排，ISO標準和質(zhì)量管理體系？

19. 做內部審核，確定質(zhì)量管理體系是否得到有效實(shí)施和保持？（例如，符合客戶(hù)要求？）

20. 內部審核計劃是否在活動(dòng)的狀態(tài)和重要性的基礎上，以及以往審核的結果

21. 審核的準則，范圍，頻率和方法對內部審計的定義？

22. 審核員和審核的實(shí)施，確保審核過(guò)程的客觀(guān)性和公正性的選擇？

23. 是否有文件化的程序責任和策劃實(shí)施審核的要求，以及報告結果和保持記錄？

24. 做的后續活動(dòng)，包括對所采取措施的驗證和驗證結果的報告？

25. 審計結果的分析，從制度層面改善？

26. 是否有系統來(lái)識別影響產(chǎn)品質(zhì)量的所有人員的培訓需求？

27. 是否有系統性確定人員所存在的工作職能？

28. 是否有制度，取消和重新獲得資格認證的工作職責的人員？

29. 準確的培訓記錄？

30. 供應商是否有收集和分析適當的數據，以證實(shí)質(zhì)量管理體系的適宜性和有效性？

31. 上述分析評估質(zhì)量體系的有效性可以持續改進(jìn).

32. 供應商是否有ISO 14001認證？如果沒(méi)有，是否有計劃來(lái)實(shí)現認證？

33. 供應商是否有OHSAS 18001的認證？如果沒(méi)有，是否有計劃來(lái)實(shí)現認證？