qc080000标准

f)確保全組織均了解有害物質清單。
g) Determining HSF requirements.
g)決定HSF需求
5.2 Customer focus
7.2客戶為重
Top management shall ensure that customer HSF requirements are determined, are met and included in the measure of customer satisfaction.
qc080000标准
IECQ QC 080000中譯本
4 General requirements
4.品質治理系統
4.1 Quality Management System
4.1一样要求事项
The requirements of ISO 9001 shall apply along with the additional requirements below:
e)按照組織HSF流程治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 organization’s HSF process management performance.
f)組織HSF流程治理績效之記錄，
Note: Consistent with the ISO 9001:2000 international Standard, “documented procedures” means 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.
d)組織的品質手冊中應說明HSF流程治理計畫與目標、以及HSF文件化程序之參考章節
e) documented procedures as required by the organization’s HSF process management plan with control of all such documents executed as required by section 4.2.4 of the ISO 9001:2000 international 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流程治理計畫。
d) establish criteria upon which to objectively determine the effectiveness of the organization’s HSF process management.
ISO 9001的要求事項應適用，並增加下列要求
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
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、流程複雜度與人員的能力而定
5. Management Responsibility
5.治理責任
5.1 Management Commitment
5.1．承諾證據
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目標相關且待治理的特定流程。
c) determine the interdependence and interaction of these processes and develop an appropriate HSF process management plan.
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.
d)在治理階層審查時納入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.
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.
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HSF目標的建立
d) including HSF in management reviews, and
c) 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 the organization’s quality manual a section on the HSF process management plan and objectives and reference to HSF documented procedures
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。
組織應在其ISO 9001:2000指定品質治理系統中，加入達成HSF產品與作業流程所需之程序、文件與流程治理實務。
The organization shall
組織應
a) Identify and document all hazardous substances in use in the organization.
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治理與管制。
4.2 Documentation requirements
4.2文件要求
The requirements of ISO 9001 shall apply along with the additional requirements below:
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 Policy
5.3 HSF政策
Top management shall ensure that the HSF policy is appropriate for the purpose of the organization, and
高階主管應就符合HSF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.
d)建立能客觀決定組織HSF流程治理功效的條件。
e) ensure the availability of resources and information needed to support effective HSF process management.
e)確保支援有效HSF流程治理所需之資源與資訊容易取得
本文件的目的是要讓HSF流程治理符合ISO 9001:2000國際標準的要項。
4.1.3 Outsourcing
4.1.3委外
Where an organization chooses to outsourceany 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.
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.
a) HSF要求應為組織品質治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 appropriate
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
Biblioteka Baidu品質治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