qc080000标准中英文对照文档格式.docx

1、a） Identify and document all hazardous substances in use in the organization.a） 確認與記錄組織使用的所有有害物質。b） identify the specific processes to be managed relevant to its HSF goals.b） 確認與 HSF目標相關且待管理的特定流程。c） determine the interdependence and interaction of these processes and develop an appropriate HSF proce

2、ss management plan.c） 決定這些流程的相互依賴關係與交互作用，並發展適當之 HSF 流程管理計畫。d） establish criteria upon which to objectively determine the effectiveness of the organizations HSF process management.d） 建立能客觀決定組織 HSF 流程管理功效的條件。e） ensure the availability of resources and information needed to support effective HSF proces

3、s management.e） 確保支援有效 HSF 流程管理所需之資源與資訊容易取得f） monitor, measure and analyze these processes, andf） 監督、量測與分析這些流程。g） implement actions to ensure continuous process improvement in achieving HSF.g） 採取行動以確保流程之持續改善以達成HSF。h） have a process established to restrict and/or eliminate the use of hazardous substa

4、nces from products and processes.h） 建立流程，以限制及（或）中止對產品與在流程中使用有害物質。4.1.2 Relationship with ISO 90014.1.2 與ISO 9001:2000的關連The intention of this document is that HSF process management is to be congruent with the elements of ISO 9001:2000 international Standard.本文件的目的是要讓 HSF 流程管理符合 ISO 9001:2000 國際標準的要

5、項。4.1.3 Outsourcing4.1.3 委外Where an organization chooses to outsource any process that affects its products HSF characteristics, and accept into its operations the product of processes outside its own operations, the organization shall ensure management of and control over such processes.若組織選擇將任何會影響

6、其產品 HSF 特性的流程外包出去，並將外包流程之產品引進其本身的作業，則該組織應確保此等流程之管理與管制。4.2 Documentation requirements4.2 文件要求4.2.1 General4.2.1概述The quality management system documentation shall include品質管理系統文件化應包括a） The HSF requirements shall be an integral part of the organizations quality management system and shall includea） HS

7、F 要求應為組織品質管理系統中不可或缺的部份，並應包含下列各項：b） a list of all hazardous substances used within the organization.b） 組織內使用之所有有害物質清單。c） statements of HSF policy and objectives with inclusion of a timeline for elimination of use of all hazardous substances, as appropriatec） HSF 政策與目標之聲明。若適當的話，包含停止使用所有有害物質之時程。d） in t

8、he organizations quality manual a section on the HSF process management plan and objectives and reference to HSF documented proceduresd） 組織的品質手冊中應說明 HSF 流程管理計畫與目標、以及 HSF 文件化程序之參考章節e） documented procedures as required by the organizations HSF process management plan with control of all such documents

9、 executed as required by section 4.2.4 of the ISO 9001:e） 按照組織 HSF 流程管理計畫要求之文件化程序，並按 ISO 9001:2000 國際標準第 4.2.4 節之規定控管所有此類文件。f） records of the organizations HSF process management performance.f） 組織 HSF 流程管理績效之記錄，Note: Consistent with the ISO 9001:2000 international Standard, “documented procedures” m

10、eans that the procedure is established, documented, implemented and maintained. Additionally, the extent of documentation required is specific to the size of the organization, complexity of processes, and the competence of personnel.說明：與ISO 9001:2000 國際標準一致，文件化程序指程序應建立、記錄、執行與維護。此外，文件記錄的程序應按照組織規模、流程複

11、雜度與人員的能力而定5. Management Responsibility5. 管理責任5.1 Management Commitment5.1承諾證據Top management shall provide evidence of its commitment to the development and implementation of practices consistent with achieving HSF products and production processes and the continuous improvement of such by 高階主管應就符合 H

12、SF 產品與作業流程、及該等產品與作業流程之持續改進，就實務發展與實施提供承諾證據，其方法如下：a） communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements.a） 與組織組織溝通達到客戶要求與達到法定與規章要求同等重要。b） establishing the HSF policy.b） 建立 HSF 政策。c） ensuring that HSF objectives are established.c） 確定 HS

13、F 目標的建立d） including HSF in management reviews, andd） 在管理階層審查時納入 HSF ，以及e） providing resources to ensure progress toward HSF products and production processes.e） 提供資源以確保朝 HSF 產品與作業流程發展。 f） ensuring the list of hazardous substances is communicated throughout the organization.f） 確保全組織均了解有害物質清單。g） Deter

14、mining HSF requirements.g） 決定 HSF 需求5.2 Customer focus7.2 客戶為重Top management shall ensure that customer HSF requirements are determined, are met and included in the measure of customer satisfaction.高階管階層應確定客戶的 HSF 要求已決定並已達到，同時納入客戶滿意度的量測中。5.3 HSF Policy5.3 HSF 政策 Top management shall ensure that the

15、HSF policy is appropriate for the purpose of the organization, and高階主管應確定 HSF 政策適合組織的宗旨，並a） includes a commitment to comply with requirements and continually improve the effectiveness of the HSF management practices.a） 包含遵守要求以及持續改善 HSF 管理實務績效的承諾。b） provides a framework for establishing and reviewing

16、 HSF objectives.b） 提供建立與審查 HSF 目標之架構。c） is communicated and understood within the organization, andc） 已在組織內溝通且為了解d） is reviewed for continuing suitability.d） 已對持續適用性完成評估5.4 Planning5.4 規劃5.4.1 HSF objectives5.4.1 HSF 目標a） Top management shall ensure that HSF objectives are established at relevant fu

17、nctions and levels within the organization. The HSF objectives shall be measurable and consistent with the HSF policy.a） 高階主管應確保按組織的相關職能與層級建立 HSF 目標。 HSF 目標應為可量測的，並與 HSF 政策一致。b） The HSF objectives shall include a timeline, as appropriate, for the elimination of hazardous substances identified and us

18、ed in processes or products including procured products.b） HSF 目標應包括一份時程表。若適當時，按表除去在流程或產品（包括採購產品）中所識別出與使用中之有害物質。5.4.2 HSF planning5.4.2 HSF 規劃Top management shall ensure that高階主管應確保下列各項a） the practices required to achieve HSF are integrated into the quality management system planning and are element

19、s in the quality objectives, anda） 達成 HSF 所需之實務已整合至品質管理系統規劃當中，並為品質目標之一b） the continuity of the HSF effort is maintained as improvements and changes are executed.b） 藉由改善與變更，維持持續HSF的努力。5.5 Responsibility, authority and communication5.5 責任、職權與溝通5.5.1 Responsibility and authority5.5.1 責任與職權 Top manageme

20、nt shall ensure that HSF related responsibilities and authorities are defined and communicated within the organization.高階主管應確保已制定 HSF 相關責任與職權，並在組織內溝通。5.5.2 Management representative5.5.2 管理代表Top management shall appoint a member of management who, irrespective of other responsibilities, shall have r

21、esponsibility and authority that includes最高管理階層應在管理階層中指派一員擔任管理代表，該代表不受其他責任所影響，明訂其責任與職權，包括a） ensuring that processes, procedures, and practices are established pursuant to achieving HSF goals.a） 確保流程、程序與實務是為達成 HSF 目標而建立。b） reporting to top management on the organizations performance pursuant to the H

22、SF plan and needs and recommended improvements in execution.b） 向高階主管回報按照 HSF 計畫與需求所達成之組織績效，並提出執行上的改善建議。c） ensuring that HSF related requirements and responsibilities are communicated and understood throughout the organization.c） 確定 HSF 相關要求與責任均已在組織內充份溝通與了解。d） ensuring the awareness in supplier organ

23、izations of their HSF related requirements and responsibilities.d） 確保供應商組織了解 HSF 相關要求與責任。5.5.3 Internal Communication5.5.3 內部溝通a） Top management shall ensure that the organizations personnel are informed of performance effectiveness and issues as relate to the HSF policies and execution plan.a） 高階主管

24、應確保已向員工溝通與HSF政策及執行相關之績效與議題。b） Hazardous substances information shall be communicated, as required throughout the organization.b） 當需要時，應在組織內溝通有害物質之資訊。5.6 Management review5.6 管理階層審查5.6.1 General5.6.1 概述Top management shall include and report on, during the regular management reviews, activities relat

25、ed to the HSF plan with regards to identification, use of hazardous substances, nonconformances and corrective actions.7.8.1 在例行管理階層審查時，高階主管應納入並回報 HSF 計畫相關活動，例如有害物質之識別與使用、不符合事項與矯正措施6. Resource Management6. 資源管理6.1 Provision of resources6.1 資源提供The organization shall determine and provide the resourc

26、es needed to implement and maintain HSF processes and products組織應決定並提供實施與維護 HSF 流程與產品所需之資源。6.2 Human resources6.2 人力資源6.2.1 General6.2.1 概述Personnel performing work affecting HSF product shall be competent on the basis of appropriate education, training, skills and experience.8.2.1 職務會影響 HSF 產品之員工，應

27、受過適當的教育訓練並具備技術與經驗 6.2.2 Competence, awareness and training6.2.2 能力、認知與訓練組織應：a） determine the necessary competence for personnel performing work affecting HSF product quality,a） 決定職務會影響 HSF 產品品質之員工的必備能力。b） provide training specific to the HSF plan for the identification, use, and elimination of hazardous substances.b） 專為 HSF 計畫規劃，以識別、使用與消除有害物質，提供訓練c） evaluate the effectiveness of the actions taken,c） 評估已採取之行動的有效性。d） ensure that personnel are aware of the relevan