【正文】 plement and maintain the quality management system and continually improve its effectiveness, and 執(zhí)行與維持品質(zhì)管理體系并持續(xù)改進其有效性。b) provide training or take other actions to satisfy these needs, 提供培訓或其他方式以滿足這些需求。 Infrastructure 資源結(jié)構(gòu)The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable組織應確認﹑提供﹑保持達成產(chǎn)品合格所需的資源結(jié)構(gòu)﹐資源結(jié)構(gòu)包括﹕a) buildings, workspace and associated utilities, 建筑﹑工作場地和相關(guān)設(shè)施。7 Product realization 產(chǎn)品的實現(xiàn) Planning of product realization 產(chǎn)品實現(xiàn)的規(guī)劃The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system (see ).組織應建立和實施產(chǎn)品實現(xiàn)所需的計劃和發(fā)展程序。b) the need to establish processes, documents, and provide resources specific to the product。d) records needed to provide evidence that the realization processes and resulting product meet requirements (see ). 提供証明程序執(zhí)行和產(chǎn)品符合要求的記錄The output of this planning shall be in a form suitable for the organization39。 Customerrelated processes 客戶相關(guān)流程 Determination of requirements related to the product 決定有關(guān)產(chǎn)品的各項要求The organization shall determine組織應決定a) requirements specified by the customer, including the requirements for delivery and postdelivery activities, 客戶指定之要求﹐包括運送及郵寄之要求。 Review of requirements related to the product 與產(chǎn)品相關(guān)要求的評審The organization shall review the requirements related to the product. This review shall be conducted prior to the organization39。Records of the results of the review and actions arising from the review shall be maintained (see ).Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the organization before acceptance.評審結(jié)果和由于評審引起的活動應被記錄。NOTE In some situations, such as internet sales, a formal review is impractical for each order. Instead the review can cover relevant product information such as catalogues or advertising material.備注﹕在特殊情況下如網(wǎng)絡銷售等每一訂單都進行正式的評審是不現(xiàn)實的﹐可以審查相關(guān)的產(chǎn)品的信息如﹕型號﹑廣告材料等。b) the review, verification and validation that are appropriate to each design and development stage, and 設(shè)計和開發(fā)的每個階段的評審﹑驗証和確認的活動。 Design and development inputs 設(shè)計和開發(fā)的輸入Inputs relating to product requirements shall be determined and records maintained (see ). These inputs shall include與產(chǎn)品各項需求相關(guān)之輸入應予定議和記錄()﹐其包括﹕a) functional and performance requirements, 功能與執(zhí)行的需求。These inputs shall be reviewed for adequacy. Requirements shall be plete, unambiguous and not in conflict with each other.應對這些輸入的適用性進行評審﹐所有的需求都應滿足﹐表述清楚且各部分間接口清楚。c) contain or reference product acceptance criteria, and 包括或引用設(shè)計或開發(fā)產(chǎn)品接受的標準。b) to identify any problems and propose necessary actions. 識別問題并建議解決方案。確認驗証結(jié)果及隨后的跟進措施應予以記錄() Control of design and development changes 設(shè)計和開發(fā)變更的控制Design and development changes shall be identified and records maintained. The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered.應識別設(shè)計和開發(fā)變更并記錄其修訂。The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization39。 Verification of purchased product 采購產(chǎn)品的驗証The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements.組織應識別并實施對采購進行驗証或其他必須的活動﹐確保采購的產(chǎn)品符合采購需求。b) the availability of work instructions, as necessary, 必要時編制工作指導文件﹔c) the use of suitable equipment, 使用相應設(shè)備﹔d) the availability and use of monitoring and measuring devices, 提供并使用測量和監(jiān)控設(shè)備﹔e) the implementation of monitoring and measurement, and 執(zhí)行監(jiān)控活動﹔f) the implementation of release, delivery and postdelivery activities. 實施規(guī)定的放行﹑交付和相應的音樂會活動。s premises, the organization shall state the intended verification arrangements and method of product release in the purchasing information.當組織或其客戶提出在供方貨源處進行驗証活動時﹐組織應在采購資料中規(guī)定驗証安排和產(chǎn)品放行方法。選擇標準對供方進行定期的評估﹐評估結(jié)果和隨后的躍進措施應予以記錄. Purchasing information 采購資料Purchasing information shall describe the product to be purchased, including where appropriate采購資料應包含對所采購產(chǎn)品的適當描述﹐包括﹕a) requirements for approval of product, procedures, processes and equipment, 產(chǎn)品﹑程序﹑流程﹑設(shè)備的認可條件。Records of the results of the review of changes and any necessary actions shall be maintained (see ).變更評審結(jié)果的記錄及隨后的跟進措施應予以保存() Purchasing 采購 Purchasing process 采購流程The organization shall ensure that purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product.組織應確保采購的產(chǎn)品符合采購需求。 Design and development verification 設(shè)計和開發(fā)驗証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 ).應實施設(shè)計和開發(fā)驗証以確保輸出符合設(shè)計和開發(fā)輸入要求。 Design and development review 設(shè)計和開發(fā)評審At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements (see )在適當階段﹐組織應對設(shè)計和開發(fā)進行系統(tǒng)的評審以確保與計劃安排的相一至。Design and development outputs shall設(shè)計和開發(fā)輸出應﹕a) meet the input requirements for design and development, 符合設(shè)計和開發(fā)輸入的要求。c) where applicable, information derived from previous similar des