【正文】 Customer property 顧客財(cái)產(chǎn) The anization shall exercise are with customer property while it is under the anization’s control or being used by the anization. The anization shall identify, verify, protect and safeguard customer property provided for use or incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use, this shall be reported to the customer and records maintained (see ). 當(dāng)顧客財(cái)產(chǎn) 被組織控管或正被使用時(shí)，組織應(yīng)給予妥善保管。 Identification and traceability 鑒別與追溯性 Where appropriate, the anization shall identify the product by suitable means throughout product realization. 適當(dāng)時(shí)，組織應(yīng)對產(chǎn)品藉由適當(dāng)?shù)姆椒?，于產(chǎn)品實(shí)現(xiàn)各階段予以鑒別。 Validation of processes for production and service provision 生產(chǎn)和服務(wù)運(yùn)作流程確認(rèn) The anization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This i ncludes any processes where deficiencies bee apparent only after the product is in use or the service has been delivered. 組織應(yīng)確認(rèn)其最終輸出不能由隨后的監(jiān)督和量測來查證的任何生產(chǎn)和服務(wù)供應(yīng)流程。 The anization shall ensure the adequacy of specified purchase requirements prior to their munication to the supplier. 組織應(yīng)確保在與供貨商溝通前對所訂要求之適切性。 The anization shall evaluate and select suppliers based on their ability to supply product in accordance with the anization’s requirements. Criteria for selection, evaluation and reevaluation shall be established. Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained (see ). 組織應(yīng)基于供應(yīng)與組織要求一致之產(chǎn)品的能力來評估和選擇供貨商。設(shè)計(jì)和開發(fā)變更應(yīng)包含評 估所構(gòu)成零組件和已交貨的產(chǎn)品因變更的影響。適當(dāng)時(shí)，確認(rèn)應(yīng)在產(chǎn)品交貨前或?qū)嵤┣巴瓿?。因?qū)彶槎岢龅膶彶榻Y(jié)果和措施應(yīng)予以記錄。 Design and development outputs 設(shè)計(jì)和開發(fā)輸出 The outputs of design and development shall be provided in a form that enables verification against the design and development input and shall be approved prior to release. 設(shè)計(jì)和開發(fā)流程的輸出應(yīng)提供以能對應(yīng)設(shè)計(jì)和開發(fā)輸入查證的型式，且發(fā)行前 應(yīng)予以核準(zhǔn)。 Design and development inputs 設(shè)計(jì)和開發(fā)輸入 Input relating to product requirements shall be determined and records maintained (). These inputs shall include 與產(chǎn)品要求有關(guān)的輸入應(yīng)加以決定與記錄 (見 )。 Design and development 設(shè)計(jì)和開發(fā) Design and development planning 設(shè)計(jì)和開發(fā)規(guī)劃 The anization shall plan and control the design and development of product. 組織應(yīng)規(guī)劃和管制產(chǎn)品的設(shè)計(jì)和開發(fā)。 Where product requirements are changed the anization shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements. 當(dāng)產(chǎn)品要求被改變，組織應(yīng)確保相關(guān)文件已被修訂，且相關(guān)人員已知會變更的要求。 d) any additional requirements determined by the anization. 任何由組織決定的額外要求。 NOTE 2 The anization may also apply the requirements given in to the development of product realization processes. 注 2：條文 。 建立流程和文件的需要，和產(chǎn)品所規(guī)定的資源； c) required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance。 7 Product realization產(chǎn)品實(shí)現(xiàn) Planning of product realization產(chǎn)品實(shí)現(xiàn)的規(guī)劃 The anization 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)規(guī)劃和發(fā)展為了產(chǎn)品實(shí)現(xiàn)所需的流程。 Competence, awareness and training能力、認(rèn)知和訓(xùn)練 The anization shall 組織應(yīng)： a) determine the necessary petence for personnel performing work affecting product quality, 鑒別執(zhí)行會影響品質(zhì)活動(dòng)之人員的能力需求； b) provide training or take other actions to satisfy these needs, 提供訓(xùn)練或采取其它措施以滿足這些需求； c) evaluate the effectiveness of the actions taken, 評估所采取措施的有效性； 企業(yè) ()大量管理資料下載 9 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 確保組織的人員認(rèn)知他們活動(dòng)的關(guān)聯(lián)及重要性和他們?nèi)绾螌τ谄焚|(zhì)目標(biāo)的達(dá)成有所貢獻(xiàn)； e) maintain appropriate records of education, training, skills and experience (see )) 維持教育、訓(xùn)練、技能和經(jīng)驗(yàn)的記錄 (見 )。 Review input審查輸入 The input to management review shall include information on 輸入到管理階層審查應(yīng)包括的信息，有關(guān)下列： a) results of audits, 稽核結(jié)果； b) customer feedback, 顧客回饋； c) process performance and product conformity, 流程績效與產(chǎn)品符合性； d) status of preventive and corrective actions, 預(yù)防和矯正措施的狀況； 企業(yè) ()大量管理資料下載 8 e) followup actions from previous management reviews, 上一次管理階層審查的跟催措施； f) changes that could affect the quality management system, and 可能影響品質(zhì)管理系統(tǒng)的所 規(guī)劃的變更； g) remendations for improvement 為了改善的推薦。 Internal munication內(nèi)部溝通 Top management shall ensure that appropriate munication processes are established within the anization and that munication takes place regarding the effectiveness of the quality management system. 高階管理階層應(yīng)確保在組織內(nèi)已建立適當(dāng)?shù)臏贤鞒?，并對有關(guān)于品質(zhì)管理系統(tǒng)的有效性加以溝通。 b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented. 當(dāng)規(guī)劃和執(zhí)行品質(zhì)管理系統(tǒng)而有所變更時(shí)，品質(zhì)管理系統(tǒng)完整性仍加以維持。 Customer focus 顧客焦點(diǎn) Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction (see and ). 高階管理階層應(yīng)確保顧客要求已被決定，以符合達(dá)成顧客滿意之目的。 A documented procedure shall be established to define the controls needed 應(yīng)建立一書面程序，使得： a) to approve documents for adequacy prior to issue, 文件發(fā)放前批準(zhǔn)其適切性； b) to review and update as necessary and reapprove documents, 審查，必要時(shí)更新并重新批準(zhǔn)文件； c) to ensure that changes and the current revision status of documents are identified, 確保文件改訂狀況及最新版次狀況已被鑒別； d) to ensure that relevant versions of applicable documents are available at points of use, 確保使用場所可取用相關(guān)版本的適用文件； e) to ensure that documents remain legible and readily identifiable, 確保文件保持易讀及容易辨識； f) to ensure that documents of external origin are identified and their distribution controlled, and 確保外來原始文件已被鑒別，和對其分發(fā)加以管制； 企業(yè) ()大量管理資料下載