【正文】 tion and type of activities, 組織的規(guī)模及作業(yè)的型態(tài)； b) the plexity of processes and their interactions, and 流程的復(fù)雜性及其相 互作用； c) the petence of personnel. 人員的能力。 Quality manual 品質(zhì)手冊 The anization shall establish and maintain a quality manual that includes 組織應(yīng)建立和維持一份品質(zhì)手冊。 Control of documents 文件管制 Documents required by the quality management system shall be controlled. Records are special type of document and shall be controlled according to the requirements give in . 品質(zhì)管理系統(tǒng)所要求的文件應(yīng)予以管制。 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 5 g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose. 防止失效的文件被誤用，若為任何目的而保留的失效文件采取適當(dāng)?shù)蔫b別； Control of records 品質(zhì)記錄管制 Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records. 應(yīng)建立和維持品質(zhì)管理系統(tǒng)所要求的記錄，以提供品質(zhì)管理系統(tǒng)符合要求及有效作業(yè)之證據(jù)。應(yīng)建立一書面程序以鑒別、儲存、保護(hù)、調(diào)閱、保存期限及處置品質(zhì)記錄。 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。 Planning規(guī)劃 Quality objectives 品質(zhì)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 anization. The quality objectives shall be measurable and consistent with the quality policy. 高階管理階層應(yīng)確 保在組織內(nèi)相關(guān)功能部門及階層已建立包含產(chǎn)品（見 ）必須符合要求在內(nèi)之品質(zhì)目標(biāo)，品質(zhì)目標(biāo)應(yīng)可量測并與品質(zhì)政策一致。 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，品質(zhì)管理系統(tǒng)完整性仍加以維持。 Management representative 管理代表 Top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes 高階管理階層應(yīng)指定管理階層的一員作為管理代表，該代表不受其它職責(zé)影響，應(yīng)有的責(zé)任和權(quán)限，包括： 企業(yè) ()大量管理資料下載 7 a) ensuring that processes needed for the quality management system are established, implemented and maintained, 確保品質(zhì)管理系統(tǒng)所必須的流程已建立、實(shí)施及維持； b) reporting top management on the performance of the quality management system and any need for improvement, and 向高階管理階層報告品質(zhì)管理系統(tǒng)的績效和改善的需要； c) ensuring the promotion of awareness of customer requirements throughout the anization. 確保促進(jìn)組織全盤對顧客需求的認(rèn)知。 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鞒蹋τ嘘P(guān)于品質(zhì)管理系統(tǒng)的有效性加以溝通。此審查應(yīng)包括評鑒改善機(jī)會和包括品質(zhì)政策和目標(biāo)在內(nèi)的品質(zhì) 管理系統(tǒng)變更的需求。 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。 6 Resource management資源管理 Provision of resources 資源的提供 The anization shall determine and provide the resources needed 組織應(yīng)決定和提供所需要的資源： a) to implement and maintain the quality management system and continually improve its effectiveness, and 以實(shí)施和維持品質(zhì)管理系統(tǒng)和持續(xù)地改善其有效性；和 b) to enhance customer satisfaction by meeting customer requirements. 達(dá)成顧客滿意。 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 )?；A(chǔ)設(shè)施可能包括： a) buildings, workspace and associated utilities, 建物、工作空間和相關(guān)的設(shè)施； b) process equipment (both hardware and software), and 流程設(shè)備，包括硬件和軟件； c) support services (such as transport or munication). 支持服務(wù) (如運(yùn)輸、通信 )。 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。 In planning product realization, the anization shall determin