【正文】 chieve conformity to product requirements. Infrastructure includes, as applicable a) buildings, workspace and associated utilities, b) process equipment, (both hardware and software), and c) supporting services (such as transport or munication). 基礎設施 組織 應 確定 ,提供并維護為達到產(chǎn)品符合要求所需的基礎設施 .適用時 ,基礎設施包括 : a) 建筑物 ,工作場所和相關(guān)的設施 b) 過程設備 (硬件和軟件 ) c) 支持性服務 (如運輸或通訊 ). 50 ? 6 Resource managem 6 資源管理 工廠，設施和設備策劃 組織 應 采用多方論證方式 (見) 以開發(fā)工廠，設施和設備的計劃。工廠的布局 應 優(yōu)化材料的運輸，搬運及增值使用空間，并 應 方便材料的同步流動。應 開發(fā)和實施方法來評估和監(jiān)控現(xiàn)有運作的有效性。 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. 51 ? 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。 Plant, facility and equipment planning NOTE These requirements should focus on lean manufacturing principles and the link to the effectiveness of the quality management system. 52 ? 6 Resource managem 6 資源管理 Contingency plans The anization shall prepare contingency plans to satisfy the customer requirements in the event of an emergency such as utility interruptions, labour shortages, key equipment failure, and field returns. 應急計劃 組織 應 準備應急計劃以在緊急情況下，諸如供應中斷，勞動力短缺，關(guān)鍵設備故障和市場退回時，滿足客戶要求。 53 ? 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 . 54 ? 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, especially in design and development process and in the manufacturing process activities. 人員安全以達到產(chǎn)品質(zhì)量 產(chǎn)品安全性和降低對員工的潛在風險的方法 應 由組織提出，尤其是設計和開發(fā)過程及生產(chǎn)過程活動。 55 ? 6 Resource managem 6 資源管理 Cleanliness of premises The anization shall maintain its premises in a state of order， cleanliness and repair consistent with the product and manufacturing process needs. 廠區(qū)的清潔 組織 應 保持廠區(qū)與產(chǎn)品一致的有序、清潔，并按產(chǎn)品和制造過程需求進行適當?shù)木S護。 56 7 Product Realization 產(chǎn)品實現(xiàn) 57 ? 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。 b) the need to establish processes, documents, and provide resources specific to the product。 c) required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance。 d) records needed to provide evidence that the realization processes and resulting product meet requirements (see ). The output of this planning shall be in a form suitable for the anization’ s method of operations. 產(chǎn)品實現(xiàn)的策劃 組織 應 策劃和開發(fā)產(chǎn)品實現(xiàn)所需的過程 .產(chǎn)品實現(xiàn)的策劃 應 與質(zhì)量管理體系其它過程的要求相一致 (見 ). a) 產(chǎn)品的質(zhì)量目標和要求 b) 針對產(chǎn)品確定過程 ,文件和資源的需求 c) 產(chǎn)品所要求的驗證 ,確認 ,監(jiān)視 ,檢驗和試驗活動 ,以及產(chǎn)品接收準則 d) 為實現(xiàn)過程及其產(chǎn)品滿足要求提供證據(jù)所需的記錄 (見 ) 策劃的輸出形式 應 適用于組織的運作方式 . 58 ? 7 product realization 7 產(chǎn)品實現(xiàn) Planning of product realization 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. NOTE 2: The anization may also apply the requirements given in to the development of product realization processes. 產(chǎn)品實現(xiàn)的策劃 注 1: 對應用于特定產(chǎn)品 ,項目或合同的質(zhì)量管理體系的過程(包括產(chǎn)品實現(xiàn)過程 )和資源作出規(guī)定的文件可稱之為質(zhì)量計劃 . 注 2: 組織也可將 用于產(chǎn)品實現(xiàn)過程的開發(fā) 59 ? 7 product realization 7 產(chǎn)品實現(xiàn) NOTE Some customers refer to project management or advanced product quality planning as a means to achieve product product quality planning embodies the concepts of error prevention and continual improvement as contrasted with error detection and is based on a multidisciplinary approach. 注 一些客戶借助項目管理或先期產(chǎn)品質(zhì)量策劃作為產(chǎn)品實現(xiàn)手段。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。 60 ? 7 product realization 7 產(chǎn)品實現(xiàn) Planning of product realizationsupplemental Customer requirements and references to its technical specifications shall be included in the planning of product realization as a ponent of the quality plan. 產(chǎn)品實現(xiàn)的策劃 補充 客戶要求和參考的技術(shù)規(guī)范 應 被包括在產(chǎn)品實現(xiàn)的策劃中作為質(zhì)量計劃的一部分。 61 ? 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。計數(shù)值抽樣的接受水準 應 為零缺陷。 (見 ) 62 ? 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 確保客戶約定的產(chǎn)品，開發(fā)的項目和相關(guān)產(chǎn)品信息的保密性。 63 ? 7 product realization 7 產(chǎn)品實現(xiàn) Change control The anization shall have a process to control and