qc080000标准(中英文对照).docx

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 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
4.2 文件要求
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
4.2.1 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
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.
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
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
d) 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 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.
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 organization’s 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” 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.
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. 管理責任
5.1 Management Commitment
5.1．承諾證據
The requirements of ISO 9001 shall apply along with the additional requirements below:
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
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.
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
d) 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) 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.
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 HSF objectives.
b) 提供建立與審查 HSF 目標之架構。
c) is communicated and understood within the organization, and
c) 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 Planning
5.4 規劃
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
5.4.1 HSF objectives
5.4.1 HSF 目標
a) Top management shall ensure that HSF objectives are established at relevant functions 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 used 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 planning
5.4.2 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 elements in the quality objectives, and
a) 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 communication
5.5 責任、職權與溝通
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
5.5.1 Responsibility and authority
5.5.1 責任與職權
Top management 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 representative
5.5.2 管理代表
Top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility 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 organization’s performance pursuant to the HSF 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 organizations 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 Communication
5.5.3 內部溝通
a) Top management shall ensure that the organization’s personnel are informed of performance effectiveness and issues as relate to the HSF policies and execution plan.
a) 高階主管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 review
5.6 管理階層審查
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
5.6.1 General
5.6.1 概述
Top management shall include and report on, during the regular management reviews, activities related to the HSF plan with regards to identification, use of hazardous substances, nonconformance’s 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 Management
6. 資源管理
6.1 Provision of resources
6.1 資源提供
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
The organization shall determine and provide the resources 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 resources
6.2 人力資源
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
6.2.1 General
6.2.1 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，應受過適當的教育訓練並具備技術與經驗
6.2.2 Competence, awareness and training
6.2.2 能力、認知與訓練
The organization shall
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 relevance and importance of their activities and how they contribute to the achievement of the HSF objectives, and
d) 確保員工知道其活動之關聯與重要性，以及如何協助達成 HSF 目標。
e) maintain appropriate records of education, training, skills and experience.
e) 維持教育、訓練、技術與經驗的適當記錄。
6.3 Infrastructure
6.3 基礎架構
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
The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to HSF process and product requirements.
組織應決定、提供並維護達成 HSF 流程與產品要求所需之基礎架構。
7 Product Realization
7. 產品實現
7.1 Planning of HSF process and product realization
7.1 HSF 流程與產品實現之規劃
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
The organization shall plan and develop the processes needed for HSF product realization.
組織應規劃並發展實現 HSF 產品所需的流程。
In planning HSF product realization, the organization shall determine the following, as appropriate:
在規劃實現 HSF 產品時，若適當的話，組織應決定下列項目：
a) quality objectives and requirements for the HSF product;
a) HSF 產品的品質目標與要求：
b) the need to establish HSF processes, documents, and provide resources specific to the HSF product;
b) 建立 HSF 流程、文件的需求，並提供針對 HSF 產品的資源；
c) required verification, validation, monitoring, inspection and test activities specific to the HSF product and the criteria for product acceptance. This shall include information services providers as appropriate;
c) 針對HSF產品所需之特定的查證、確認、監測、檢驗及試驗活動，以及產品之允收準則。若適當的話，應包含資訊服務供應商；
d) documented procedures or work instructions for processes that include the use of restricted substances to include prevention where the possibility of contamination exists.
d) 對使用限制性物質的流程所準備的文件化程序或作業指示，包括如何預防可能的污染：
e) records needed to provide evidence that the HSF realization processes and resulting product meet requirements.
e) 提供 HSF 實現流程與產出產品符合要求所需的證據記錄。
f) The output of this HSF planning shall be in a form suitable for the organization’s method of operations.
f) 此HSF 規劃應以適合組織作業方法的格式輸出。
Note: A document specifying the HSF processes (including the product realization processes) and the resources to be applied to a specific product can be referred to as a quality plan.
註 1：指定 HSF 程序的文件 (包括產品實現流程)以及應用於特定產品的資源，可當成品質計畫參照
7.2 Customer-related process
7.2 客戶有關之過程
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
7.2.1 Determination of requirements related to the HSF product
7.2.1 HSF 產品之相關要求決定
The organization shall determine
組織應決定:
a) HSF requirements specified by the customer,
a) 客戶規定之 HSF 要求。
b) HSF requirements not stated by the customer but necessary for specified or intended uses, where known.
b) 非客戶所陳述之要求，但為已知的特定或意圖使用所必需者。
c) HSF statutory and regulatory requirements related to the product, and
c) 與產品相關的HSF法令與規章要求。
d) any additional HSF requirements determined by the organization.
d) 組織所決定的任何額外HSF要求。
7.2.2 Review of HSF requirements related to the product
7.2.2 HSF產品有關要求之審查
The organization shall review the requirements related to the HSF product. This review shall be conducted prior to the organization’s commitment to supply HSF product to the customer and shall ensure that;
組織應審查與HSF產品有關之要求。此審查應在組織承諾供應產品給顧客之前，且應確保：
a) HSF product requirements are defined, and
a) HSF產品要求已予界定
b) the organization has the ability to meet the HSF defined requirements.
b) 組織有能力符合所界定之HSF要求
c) any use of or possibility of contamination or mixing of processes or product that contain restricted substances shall be communicated to the customer.
c) 任何包含限制性物質的流程或產品之使用、污染可能性或混合，均應向客戶說明，
d) Records of the results of the HSF review and actions arising from the review shall be kept and maintained.
d) HSF 評估結果記錄及評估後產生之行動記錄均應保存與維護
7.3 Design and development
7.3 設計與開發
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
7.3.1 HSF design and development planning
7.3.1. HSF 設計與開發規劃
The organization shall plan and control the design and development of HSF product.
組織應規劃並管制 HSF 產品的設計與開發。
In planning the design, the use of any restricted substance shall be identified in the documentation and a plan for control and eventual replacement/elimination of the part.
在規劃設計時，任何限制性物質的使用應記錄在文件、以及一個用於管制及最終取代／演除該零件的計畫內。
7.3.2 HSF Design and development inputs
7.3.2 HSF 設計與開發輸入
Inputs relating to HSF product requirements shall be determined and records maintained.
與HSF產品要求相關之輸入，應予以決定並將紀錄加以維持
HSF inputs shall be reviewed for adequacy. Requirements shall be complete, unambiguous and not in conflict with each other.
應檢視 HSF 輸入之充足性。要求應完整、不模擬兩可且不彼此衝突。
7.3.3 HSF Design and development outputs
7.3.3 HSF 設計與開發輸出
The HSF outputs of design and development shall be provided in a form that enables verification against the design and development input and shall be approved prior to release.
HSF設計與開發之輸出，應以一種能針對設計與開發輸入進行查證之形式予以提供，並在發行前應加以核准。
When the design requires the use of a res