【正文】 shall be identified within the quality management system. Note: Process needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement. 針對組織所選擇的任何影響產(chǎn)品符合要求的外包過程 ,組織 應 確保對其實施控制 .對此類外包過程的控制 應 在質(zhì)量管理體系中加以識別 . 注 :上述質(zhì)量管理體系所需的過程應當包括與管理活動 ,資源提供 ,產(chǎn)品實現(xiàn)和測量有關(guān)的過程 . ? 4 Quality management system 4 質(zhì)量管理體系 General requirements Supplemental Ensuring control over outsourced processes shall not absolve the anization of the responsibility of conformity to all customers requirements. NOTE See also and 總則 補充 確?？刂仆獍^程 不應 免除組織對符合所有客戶要求的職責。實施 應 包括更新文件。 記錄的保持 記錄控制 應 滿足法規(guī)和客戶要求。 ? 5 Management responsibility 5 管理層職責 Quality management system planning Top management shall ensure that: a) the planning of the quality management system is carried out in order to meet the requirements given in , as well as the quality objectives, and b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented. 質(zhì)量管理體系策劃 最高管理者 應 確保 : a) 對質(zhì)量管理體系進行策劃 ,以滿足質(zhì)量目標以及 , b) 在對質(zhì)量管理體系的變更進行策劃和實施時 ,保持質(zhì)量管理體系的完整性 . ? 5 Management responsibility 5 管理層職責 Responsibility, authority and munication Responsibility and authority Top management shall ensure that the responsibilities and authorities are defined and municated within the anization. 職責 ,權(quán)限與溝通 職責和權(quán)限 最高管理者 應 確保組織內(nèi)的職責 ,權(quán)限得到規(guī)定和溝通 . ? 5 Management responsibility 5 管理層職責 Responsibility for Quality Managers with responsibility and authority for corrective action shall be promptly informed of products or processes which do not conform to requirements. Personnel responsible for product quality shall have the authority to stop production to correct quality problems. Production operations across all shifts shall be staffed with personnel in charge of, or delegated responsibility for， ensuring product quality. 質(zhì)量職責 對糾正措施賦有職責和權(quán)限的管理者 應被及時通知不符合要求的產(chǎn)品或過程。包括選擇特殊特性、建立質(zhì)量目標和相關(guān)的培訓、糾正和預防措施、產(chǎn)品設計和開發(fā)。 ? 5 Management responsibility 5 管理層職責 These results shall be recorded to provide, as a minimum, evidence of the achievement of: the quality objectives specified in the business plan, and customer satisfaction with product supplied. 這些結(jié)果 應 被記錄，至少可提供作為證據(jù)達到： 業(yè)務計劃中規(guī)定的質(zhì)量目標，和 客戶對產(chǎn)品提供的滿意度。 ? 6 Resource managem 6 資源管理 Training The anization shall establish and maintain documented procedures for identifying training needs and achieving petence of all personnel performing activities affecting product quality. Personnel performing specific assigned tasks shall be qualified， as required with particular attention to the satisfaction of customer requirements. 培訓 組織 應 建立和保持文件化程序以識別培訓需求和影響產(chǎn)品質(zhì)量的所有員工具備能力。 ? 6 Resource managem 6 資源管理 在職培訓 組織 應 向員工，包括合同或中介人員提供關(guān)于影響產(chǎn)品質(zhì)量的新的或修改過的作業(yè)的在職培訓。 Employee motivation and empowerment The anization shall have a process to motivate employees to achieve quality objectives, to make continual improvements, and to create an environment to promote innovation. The process shall include the promotion of quality and technological awareness throughout the whole anization. ? 6 Resource managem 6 資源管理 員工的積極性和推動 組織 應 具備一測量過程以保證其人員了解他們活動的恰當性和重要性及他們?nèi)绾斡兄谶_到質(zhì)量目標 (見 d)。 Plant, facility and equipment planning The anization shall use a multidisciplinary approach (see ) for developing plant, facility and equipment plans. Plant layouts shall optimize material travel, handling and valueadded use of floor space, and shall facilitate synchronous material flow. Methods shall be developed and implemented to evaluate and monitor the effectiveness of existing operations. ? 6 Resource managem 6 資源管理 工廠，設施和設備策劃 注 這些要求應該關(guān)注于精益生產(chǎn)原則及與質(zhì)量管理體系有效性的連系。 7 Product Realization 產(chǎn)品實現(xiàn) ? 7 product realization 7 產(chǎn)品實現(xiàn) Planning of product realization 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 ). a) quality objectives and requirements for the product。先期質(zhì)量策劃是在多方論證方式的基礎上，體現(xiàn)了錯誤預防和持續(xù)改進的概念，而并非錯誤檢測。 (見 ) ? 7 product realization 7 產(chǎn)品實現(xiàn) Confidentiality The anization shall ensure the confidentiality of customer contracted products and projects under development, and related product information. 保密性 組織 應 確?？蛻艏s定的產(chǎn)品，開發(fā)的項目和相關(guān)產(chǎn)品信息的保密性。 ? 7 product realization 7 產(chǎn)品實現(xiàn) Acceptance criteria Acceptance criteria shall be defined by the anization and， where required, approved by the customer. For attribute data sampling，acceptance level shall be zero defects. (see ) 接受準則 接受準則 應 由組織規(guī)定，在需要時，由客戶審批。 c) required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance。 ? 6 Resource management 6 資源管理 Work environment The anization shall determine and manage the work environment needed to achieve conformity to product requirements. 工作環(huán)境 組織 應 確定并管理為達到產(chǎn)品符合要求所需的工作環(huán)境 . ? 6 Resource management 6 資源管理 Personnel safety to achieve product quality Product safety and means to minimize potential risks to employees shall be addressed by the anization,