qc080000标准(中英文对照).doc

IECQ QC 080000 中英文對照表 DNV Taiwan PAGE 14/ NUMPAGES 14 IECQ QC 080000 IECQ QC 080000 中譯本 4 General requirements 4. 品質管理系統 4.1 Quality Management System 4.1 一般要求事项 The requirements of ISO 9001 shall apply along with the additional requirements below: ISO 9001的要求事項應適用，並增加下列要求 4.1.1 General 4.1.1 概述 Each organization shall include in its ISO 9001:2000 mandated quality management system the procedures, documentation, and process management practices necessary to achieve HSF product and production processes. 組織應在其 ISO 9001:2000指定品質管理系統中，加入達成 HSF 產品與作業流程所需之程序、文件與流程管理實務。 The organization shall 組織應 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 process 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 organization’s 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 process 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, and f) 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 substances 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 9001 4.1.2 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 國際標準的要項。 4.1.3 Outsourcing 4.1.3 委外 Where an organization chooses to outsource any process that affects its products’ HSF characteristics, and accept into its operations the product of p