【正文】 b) the availability of work instructions, as necessary, 必要時編制工作指導(dǎo)文件﹔c) the use of suitable equipment, 使用相應(yīng)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(shí)施規(guī)定的放行﹑交付和相應(yīng)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(dāng)組織或其客戶提出在供方貨源處進(jìn)行驗(yàn)証活動時﹐組織應(yīng)在采購資料中規(guī)定驗(yàn)証安排和產(chǎn)品放行方法。 Verification of purchased product 采購產(chǎn)品的驗(yàn)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(yīng)識別并實(shí)施對采購進(jìn)行驗(yàn)証或其他必須的活動﹐確保采購的產(chǎn)品符合采購需求。選擇標(biāo)準(zhǔn)對供方進(jìn)行定期的評估﹐評估結(jié)果和隨后的躍進(jìn)措施應(yīng)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(yīng)包含對所采購產(chǎn)品的適當(dāng)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(rèn)可條件。The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization39。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(jìn)措施應(yīng)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(yīng)確保采購的產(chǎn)品符合采購需求。確認(rèn)驗(yàn)証結(jié)果及隨后的跟進(jìn)措施應(yīng)予以記錄() Control of design and development changes 設(shè)計(jì)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(yīng)識別設(shè)計(jì)和開發(fā)變更并記錄其修訂。 Design and development verification 設(shè)計(jì)和開發(fā)驗(yàn)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(yīng)實(shí)施設(shè)計(jì)和開發(fā)驗(yàn)証以確保輸出符合設(shè)計(jì)和開發(fā)輸入要求。b) to identify any problems and propose necessary actions. 識別問題并建議解決方案。 Design and development review 設(shè)計(jì)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(dāng)階段﹐組織應(yīng)對設(shè)計(jì)和開發(fā)進(jìn)行系統(tǒng)的評審以確保與計(jì)劃安排的相一至。c) contain or reference product acceptance criteria, and 包括或引用設(shè)計(jì)或開發(fā)產(chǎn)品接受的標(biāo)準(zhǔn)。Design and development outputs shall設(shè)計(jì)和開發(fā)輸出應(yīng)﹕a) meet the input requirements for design and development, 符合設(shè)計(jì)和開發(fā)輸入的要求。These inputs shall be reviewed for adequacy. Requirements shall be plete, unambiguous and not in conflict with each other.應(yīng)對這些輸入的適用性進(jìn)行評審﹐所有的需求都應(yīng)滿足﹐表述清楚且各部分間接口清楚。c) where applicable, information derived from previous similar designs, and 以前類似設(shè)計(jì)開發(fā)之適用資訊。 Design and development inputs 設(shè)計(jì)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(xiàng)需求相關(guān)之輸入應(yīng)予定議和記錄()﹐其包括﹕a) functional and performance requirements, 功能與執(zhí)行的需求。The organization shall manage the interfaces between different groups involved in design and development to ensure effective munication and clear assignment of responsibility.組織應(yīng)對設(shè)計(jì)和開發(fā)各小組之間的接口進(jìn)行管理確保信息的有效傳達(dá)﹐并清楚的規(guī)定各部門職責(zé)。b) the review, verification and validation that are appropriate to each design and development stage, and 設(shè)計(jì)和開發(fā)的每個階段的評審﹑驗(yàn)証和確認(rèn)的活動。c) customer feedback, including customer plaints. 客戶反饋﹐包括客戶報(bào)怨。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(luò)銷售等每一訂單都進(jìn)行正式的評審是不現(xiàn)實(shí)的﹐可以審查相關(guān)的產(chǎn)品的信息如﹕型號﹑廣告材料等。當(dāng)顧客需求沒有提供書面陳述時﹐顧客要求應(yīng)在被接受前組織需予以確認(rèn)。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(yīng)被記錄。b) contract or order requirements differing from those previously expressed are resolved, and 解決合約或訂單內(nèi)容與先前所敘不同處。 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。c) statutory and regulatory requirements related to the product, and 與產(chǎn)品相關(guān)的法律﹑法規(guī)的要求。 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(xiàng)要求The organization shall determine組織應(yīng)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(yùn)送及郵寄之要求。NOTE 1 A document specifying the processes of the quality management system (including the product realization processes) and the resources to be applied to a specific product, project or contract, can be referred to as a quality plan.備注1﹕描述質(zhì)量管理體系過程如何在特定的產(chǎn)品﹑項(xiàng)目﹑或合同中實(shí)施的文件可以被看作為質(zhì)量計(jì)劃。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。c) required verification, validation, monitoring, inspection and test activities specific to the