【正文】 文件和資料控制”﹔ “顧客的財(cái)產(chǎn)”取代了 “顧客提供的產(chǎn)品”﹔﹕ “承包方供方顧客” 改為﹕ “供方組織顧客”﹔ “最高管理者”取代 “負(fù)有執(zhí)行職責(zé)的管理者”。b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements. 目的在于通過(guò)系統(tǒng)的有效運(yùn)作以達(dá)到客戶的滿意﹐包括持續(xù)改善系統(tǒng)的流程和確保符合客戶滿及適用 法規(guī)的需求。然而﹐使用本國(guó)際標(biāo)準(zhǔn)的各方應(yīng)探討使用下列相關(guān)國(guó)際標(biāo)準(zhǔn)之最新版本的可能性。b) determine the sequence and interaction of these processes, 確定這些流程之順序及相互關(guān)系。 Documentation requirements 文件需求 General 一般要求The quality management system documentation shall include質(zhì)量管理體系文件應(yīng)包括﹕a) documented statements of a quality policy and quality objectives, 文件化的質(zhì)量方針和質(zhì)量目標(biāo)。c) the petence of personnel. 人員的能力。c) to ensure that changes and the current revision status of documents are identified, 確保對(duì)文件修訂及修訂狀態(tài)進(jìn)行標(biāo)識(shí)。5 Management responsibility 管理職責(zé) Management mitment 管理承諾Top management shall provide evidence of its mitment to the development and implementation of the quality management system and continually improving its effectiveness by最高管理層應(yīng)提供以下証據(jù)﹐以顯示品質(zhì)管理系統(tǒng)的發(fā)展與實(shí)施并進(jìn)行有效的改善的承諾。 Planning 策劃 Quality objectives 質(zhì)量目標(biāo)Top management shall ensure that quality objectives, including those needed to meet requirements for product [see a]], are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy.最高管理層應(yīng)確保在組織的各級(jí)相關(guān)職能部門(mén)都建立質(zhì)量目標(biāo)﹐質(zhì)量目標(biāo)應(yīng)可被測(cè)量﹐并與質(zhì)量方針及持續(xù)改進(jìn)的承諾相一至。NOTE The responsibility of a management representative can include liaison with external parties on matters relating to the quality management system.備注﹕管理者代表的職責(zé)還包括與質(zhì)量管理體系有關(guān)的外部聯(lián)絡(luò)。e) followup actions from previous management reviews, 上一次管理評(píng)審的跟蹤情況。b) provide training or take other actions to satisfy these needs, 提供培訓(xùn)或其他方式以滿足這些需求。7 Product realization 產(chǎn)品的實(shí)現(xiàn) Planning of product realization 產(chǎn)品實(shí)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(yīng)建立和實(shí)施產(chǎn)品實(shí)現(xiàn)所需的計(jì)劃和發(fā)展程序。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。 Review of requirements related to the product 與產(chǎn)品相關(guān)要求的評(píng)審The organization shall review the requirements related to the product. This review shall be conducted prior to the organization39。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(xiāo)售等每一訂單都進(jìn)行正式的評(píng)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(hào)﹑廣告材料等。 Design and development inputs 設(shè)計(jì)和開(kāi)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。c) contain or reference product acceptance criteria, and 包括或引用設(shè)計(jì)或開(kāi)發(fā)產(chǎn)品接受的標(biāo)準(zhǔn)。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(kāi)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(shí)別設(shè)計(jì)和開(kāi)發(fā)變更并記錄其修訂。 Verification of purchased product 采購(gòu)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(shí)別并實(shí)施對(duì)采購(gòu)進(jìn)行驗(yàn)証或其他必須的活動(dòng)﹐確保采購(gòu)的產(chǎn)品符合采購(gòu)需求。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(dòng)時(shí)﹐組織應(yīng)在采購(gòu)資料中規(guī)定驗(yàn)証安排和產(chǎn)品放行方法。Records of the results of the review of changes and any necessary actions shall be maintained (see ).變更評(píng)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(gòu) Purchasing process 采購(gòu)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(gòu)的產(chǎn)品符合采購(gòu)需求。 Design and development review 設(shè)計(jì)和開(kāi)發(fā)評(píng)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(duì)設(shè)計(jì)和開(kāi)發(fā)進(jìn)行系統(tǒng)的評(píng)審以確保與計(jì)劃安排的相一至。c) where applicable, information derived from previous similar designs, and 以前類(lèi)似設(shè)計(jì)開(kāi)發(fā)之適用資訊。c) customer feedback, including customer plaints. 客戶反饋﹐包括客戶報(bào)怨。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。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(guò)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。In planning product realization, the organization shall determine the following, as appropriate:在計(jì)劃產(chǎn)品實(shí)現(xiàn)時(shí)組織應(yīng)適當(dāng)?shù)臎Q定如下各項(xiàng)﹕a) quality objectives and requirements for the product。d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and 確保其員工能意識(shí)到他們活動(dòng)的關(guān)聯(lián)性和重要性以及他們對(duì)達(dá)到品質(zhì)目標(biāo)的貢獻(xiàn)。g) remendations for improveme