【正文】 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。 7 Product Realization7. 產(chǎn)品實現(xiàn) Planning of HSF process and product realization HSF 流程與產(chǎn)品實現(xiàn)之規(guī)劃 The requirements of ISO 9001 shall apply along with the additional requirements below:ISO 9001的要求事項應(yīng)適用，并增加下列要求The organization shall plan and develop the processes needed for HSF product realization.組織應(yīng)規(guī)劃并發(fā)展實現(xiàn) HSF 產(chǎn)品所需的流程。 Internal Communication 內(nèi)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(yīng)確保已向員工溝通與HSF政策及執(zhí)行相關(guān)之績效與議題。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(biāo)應(yīng)包括一份時程表。b) establishing the HSF policy.b) 建立 HSF 政策。 Relationship with ISO 9001 與ISO 9001:2000的關(guān)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(biāo)準(zhǔn)的要項。IECQ QC 080000中英文對照表IECQ QC 080000IECQ QC 080000 中譯本4 General requirements 4. 一般要求事項 Quality Management System 質(zhì)量管理系統(tǒng)The requirements of ISO 9001 shall apply along with the additional requirements below:ISO 9001的要求事項應(yīng)適用，并增加下列要求 General 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(yīng)在其 ISO 9001:2000指定質(zhì)量管理系統(tǒng)中，加入達(dá)成 HSF 產(chǎn)品與作業(yè)流程所需之程序、文件與流程管理實務(wù)。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(chǎn)品與在流程中使用有害物質(zhì)。此外，文件記錄的程序應(yīng)按照組織規(guī)模、流程復(fù)雜度與人員的能力而定5. Management Responsibility5. 管理責(zé)任 Management Commitment．承諾證據(jù)The requirements of ISO 9001 shall apply along with the additional requirements below:ISO 9001的要求事項應(yīng)適用，并增加下列要求Top management shall provide evidence of its mitment 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(yīng)就符合 HSF 產(chǎn)品與作業(yè)流程、及該等產(chǎn)品與作業(yè)流程之持續(xù)改進(jìn)，就實務(wù)發(fā)展與實施提供承諾證據(jù)，其方法如下：a) municating to the organization the importance of meeting customer as well as statutory and regulatory requirements.a) 與組織組織溝通達(dá)到客戶要求與達(dá)到法定與規(guī)章要求同等重要。 HSF 目標(biāo)應(yīng)為可量測的，并與 HSF 政策一致。d) ensuring the awareness in supplier organizations of their HSF related requirements and responsibilities.d) 確保供貨商組織了解 HSF 相關(guān)要求與責(zé)任。 Infrastructure 基礎(chǔ)架構(gòu) The requirements of ISO 9001 shall apply along with the additional requirements below:ISO 9001的要求事項應(yīng)適用，并增加下列要求The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to HSF process and product requirements.組織應(yīng)決定、提供并維護(hù)達(dá)成 HSF 流程與產(chǎn)品要求所需之基礎(chǔ)架構(gòu)。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.注 1：指定 HSF 程序的文件 (包括產(chǎn)品實現(xiàn)流程)以及應(yīng)用于特定產(chǎn)品的資源，可當(dāng)成質(zhì)量計劃參照 Customerrelated process 客戶有關(guān)之過程The requirements of ISO 9001 shall apply along with the additional requirements below:ISO 9001的要求事項應(yīng)適用，并增加下列要求 Determination of requirements related to the HSF product HSF 產(chǎn)品之相關(guān)要求決定The organization shall determine組織應(yīng)決定:a) HSF requirements specified by the customer,a) 客戶規(guī)定之 HSF 要求。 HSF Design and development inputs HSF 設(shè)計與開發(fā)輸入Inputs relating to HSF product requirements shall be determined and records maintained.與HSF產(chǎn)品要求相關(guān)之輸入，應(yīng)予以決定并將紀(jì)錄加以維持HSF inputs shall be reviewed for adequacy. Requirements shall be plete, unambiguous and not in conflict with each other.應(yīng)檢視 HSF 輸入之充足性。b) the organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization’s HSF requirements.b) 組織應(yīng)根據(jù)供貨商能否提供符合組織 HSF 要求之產(chǎn)品進(jìn)行評估并選擇供貨商c) the organization shall ensure that any HSF part/material is free from possible contamination with a restricted substance.c) 組織應(yīng)確保任何 HSF 零件／材料不可能受到限制性物質(zhì)的污染。j) If the processes are bined with each other a documented procedure shall be established to differentiate between parts.j) 若流程彼此合并，應(yīng)建立文件化程序以區(qū)分零件。此包括唯有在產(chǎn)品使用后或服務(wù)已交付后，才會顯現(xiàn)缺陷之任何HSF過程。 Monitoring and measurement of HSF processes HSF流程的監(jiān)督與量測 Customer satisfaction 客戶滿意度The requirements of ISO 9001 shall apply along with the additional requirements below:ISO 9001的要求事項應(yīng)適用，并增加下列要求 Internal Audit 內(nèi)部稽核：The organization shall conduct internal assessments at planned intervals to determine whether the organization’s Hazardous Substance Free processes conform to the requirements of this national standard and to customer specifications, and are effectively implemented and maintained.組織外須定期進(jìn)行內(nèi)部稽核，以決定組織之有害物質(zhì)排除流程是否符合此國家標(biāo)準(zhǔn)與客戶規(guī)格之要求，并有效實施與維護(hù)。 Control of nonconforming HSF product 不符合 HSF 產(chǎn)品之管制 The requirements of ISO 9001 shall apply along with the additional requirements below:ISO 9001的要求事項應(yīng)適用，并增加下列要求The organization shall ensure that products which do not conform to HSF product requirements are identified and controlled to prevent their unintended use or delivery.. 組織應(yīng)確保能識別并管制不符合 HSF 產(chǎn)品要求之產(chǎn)品，以避免意外使用或交付。14 /