qc080000标准(中英文对照)

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ISO 9001的要求事項應適用,並增加下列要求
4.2.1 General
4.2.1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 organization’s quality management system and shall include
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.
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 processes outside its own operations, the organization shall ensure management of and control over such processes.
a) HSF 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.
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 9001:2000international Standard.
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
若組織選擇將任何會影響其產品 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 requirements
4.2Hale Waihona Puke Baidu文件要求
The requirements of ISO 9001 shall apply along with the additional requirements below:
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。
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:
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.
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