【正文】 組織應對提供作為使用或組合成為產(chǎn)品的顧客財產(chǎn)予以鑒別、查。 (見 ) NOTE In some industry sectors, configuration management is a means by which identification and traceability are maintained. 注：在某些行業(yè)中是以型態(tài)管理來維持鑒別與追溯性。 The anization shall identify the product status with respect to monitoring and measurement requirements. 組織應鑒別有關于監(jiān)督和量測要求的產(chǎn)品狀況。 The anization shall establish arrangements for these processes including, as applicable 企業(yè) ()大量管理資料下載 16 組織應對確認的安排加以界定，適當時應考慮以下要求： a) defined criteria for review and approval of the processes, 流程的資格； b) approval of equipment and qualification of personnel, 設備和人員的資格； c) use of specific methods and procedures, 已界定的方法和程序的使用； d) requirements for records (see ), and 記錄所要求； e) revalidation. 重新確認。這包括可能因產(chǎn)品使用后或服務已經(jīng)提供后才顯現(xiàn)出失效的任何流程。 Production and service provision 生產(chǎn)和服務運作 Control of production and service provision 生產(chǎn)和服務運作管制 The anization shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable 組織應在既定規(guī)劃和管制的條件下，執(zhí)行生產(chǎn)和服務的供應，適當時，包括： a) the availability of information that describes the characteristics of the product, 規(guī)定產(chǎn)品特性信息的可用性； b) the availability of work instructions, as necessary, 當需要時，工作指導書之可用性； c) the use of suitable equipment, 為 了生產(chǎn)和服務的供應而使用適當?shù)脑O備； d) the availability and use of monitoring and measuring devices, 監(jiān)督和量測裝置的可用性和使用； e) the implementation of monitoring and measurement, and 監(jiān)督和量測活動的實施； f) the implementation of release, delivery and postdelivery activities. 產(chǎn)品放行、交貨和售后活動的實施。 Verification of purchased product 采購產(chǎn)品的查證 企業(yè) ()大量管理資料下載 15 The anization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements. 組織應建立和實施為了確保采購的產(chǎn)品符合所訂要求所必須的檢驗或其它活動。 (見 ) Purchasing information 采購信息 Purchasing information shall describe the product to be purchased, including where appropriate 采購文件應描述所采購產(chǎn)品的信息，適當時包括： a) requirements for approval of product, procedures, processes and equipment, 為了產(chǎn)品、程序、流程、設施和設備核準的要求； b) requirements for qualification of personnel, and 為了人員資格之要求； c) quality management system requirements. 品質管理系統(tǒng)要求。應建立選擇供貨商、評估和再評估的準則。應用于供貨商和采購的產(chǎn)品之管制的的方式和程度應依采購的產(chǎn)品對后續(xù)的產(chǎn)品實現(xiàn)或最終產(chǎn)品的沖擊而定。 Records of the results of the review of changes and any necessary actions shall be maintained (see ). 變更審查的結果和任何所需的措施應加以記錄。適當時，變更應加以審查、查證和確認，并于實施前核準。確認的結果和任何所需的措施應予以記錄。(見 ) Design and development validation 設計和開發(fā)確認 Design and development validation shall be performed in accordance with planned arrangements (see ) to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known. Wherever practicable, validation shall be pleted prior to the delivery or implementation of the product. Records of the results of validation and any necessary actions shall be maintained (see ). 應依據(jù)規(guī)劃的安排 (見 )執(zhí)行設計和開發(fā)確認，以確保最終產(chǎn)品有能力滿足其原訂或特 定使用或應用上的要求。 (見 ) Design and development verification 設計和開發(fā)查證 Verification shall be performed in accordance with planned arrangements (see ) to ensure that the design and development outputs have met the design and development input requirements. Records of the results of the verification and any necessary actions shall be maintained (see ). 應執(zhí)行查證，以確保設計和開發(fā)輸出符合設計和開發(fā)輸入。 Participants in such reviews shall include representatives of functions concerned with the design and development stage(s) being reviewed. Records of the results of the reviews and any necessary actions shall be maintained (see ). 參與這類審查的人員應包括與被審查的設計和 /或開發(fā)階段有關的功能部門代表。 Design and development outputs shall 設計和開發(fā)的輸出應： a) meet the input requirements for design and development, 符合設計和開發(fā)輸入要求； b) provide appropriate information for purchasing, production and for service provision, 為采購、生產(chǎn)和服務的供應提供適當?shù)男畔ⅲ? c) contain or reference product acceptance criteria, and 包含或引用產(chǎn)品允收準則； d) specify the characteristics of the product that are essential for its safe and proper use. 企業(yè) ()大量管理資料下載 13 規(guī)定產(chǎn)品在安全及正常使用的必要的產(chǎn)品特性。要求應完整、不含糊不清且不與其它要求相互矛 盾。這些應包括： a) functional and performance requirements, 功能及效能的要求； b) applicable statutory and regulatory requirements, 適用的法規(guī)和法令的要求； c) where applicable, information derived from previous similar designs, and 當適用時，源于以前類似設計的信息，和； d) other requirements essential for design and development. 其它對設計和開發(fā)不可或缺的要求。 Planning output shall be updated, as appropriate, as the design and development progresses. 當設計和開發(fā)進行中，適當時，規(guī)劃輸出應予以更新。 During the design and development planning, the anization shall determine 在設計和開發(fā)規(guī)劃時，組織應決定： a) the design and development states, 設計和開發(fā)流程的各階段； 企業(yè) ()大量管理資料下載 12 b) the review, verification and validation that are appropriate to each design and development stage, and 在每一設計和開發(fā)階段適當?shù)膶彶?、查證及確認活動； c) the responsibilities and authorities for the design and development. 設計和開發(fā)活動的責任與權限。 Customer munication 顧客溝通 The anization shall determine and implement effective arrangements for munication with customers in relation to 組織應決定和實施有效的安排，以便與顧客溝通有關于： a) product information, 產(chǎn)品信息； b) enquiries, contracts or order handling, including amendments, and 包括變更時的詢價、合約或訂單處理； c) customer feedback, including customer plaint. 包括 顧客抱怨在內(nèi)的顧客回饋。 NOTE In some situations, such as inter sales, a formal review is impractical for each order. Instead the review can cover relevant product information such as catalogues or advertising material. 注：在某些情形如網(wǎng)絡銷售，對每一訂單，以正規(guī)的審查可能不切實際。 Records of the results of the review and actions arising from the review shall be maintained (see ). 審查結果和 措施如審查的歸結應加以記錄 (見 ) Where the customer provides not documented statement of requirement, the customer requirements shall be confirmed by the anization b