【正文】 nagement responsibility 5 管理層職責(zé) Customer representative Top management shall designate personnel with responsibility and authority to ensure the customer requirements are addressed. This includes selection of special characteristics, setting quality objectives and related training, corrective and preventive actions, product design and development. 客戶代表 最高管理層 應(yīng) 指派人員擁有職責(zé)和權(quán)限以確保滿足客戶要求。 適用的工具和技巧 應(yīng) 被組織識(shí)別 。這個(gè)過程 應(yīng) 包括整個(gè)組織對(duì)質(zhì)量和技術(shù)意識(shí)的提升。 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(yīng) 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(jìn)行適當(dāng)?shù)木S護(hù)。計(jì)數(shù)值抽樣的接受水準(zhǔn) 應(yīng) 為零缺陷。 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(shí)現(xiàn)的策劃 組織 應(yīng) 策劃和開發(fā)產(chǎn)品實(shí)現(xiàn)所需的過程 .產(chǎn)品實(shí)現(xiàn)的策劃 應(yīng) 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(biāo)和要求 b) 針對(duì)產(chǎn)品確定過程 ,文件和資源的需求 c) 產(chǎn)品所要求的驗(yàn)證 ,確認(rèn) ,監(jiān)視 ,檢驗(yàn)和試驗(yàn)活動(dòng) ,以及產(chǎn)品接收準(zhǔn)則 d) 為實(shí)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(yīng) 適用于組織的運(yùn)作方式 . 58 ? 7 product realization 7 產(chǎn)品實(shí)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(shí)現(xiàn)的策劃 注 1: 對(duì)應(yīng)用于特定產(chǎn)品 ,項(xiàng)目或合同的質(zhì)量管理體系的過程(包括產(chǎn)品實(shí)現(xiàn)過程 )和資源作出規(guī)定的文件可稱之為質(zhì)量計(jì)劃 . 注 2: 組織也可將 用于產(chǎn)品實(shí)現(xiàn)過程的開發(fā) 59 ? 7 product realization 7 產(chǎn)品實(shí)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(xiàng)目管理或先期產(chǎn)品質(zhì)量策劃作為產(chǎn)品實(shí)現(xiàn)手段。應(yīng) 開發(fā)和實(shí)施方法來評(píng)估和監(jiān)控現(xiàn)有運(yùn)作的有效性。 注 2 客戶特殊要求的一個(gè)例子是數(shù)字?jǐn)?shù)據(jù)的應(yīng)用。 管理評(píng)審的其中部分 應(yīng) 是質(zhì)量目標(biāo)的監(jiān)控，定期報(bào)告和評(píng)價(jià)不良質(zhì)量成本。 注：質(zhì)量目標(biāo)中應(yīng)該注明客戶的期望，并在所定期限內(nèi)可以達(dá)到。 組織 應(yīng) 保持在生產(chǎn)中的每一個(gè)更改實(shí)施日期的記錄。 ISO/TS 16949:2023 標(biāo)準(zhǔn)講解 （中英文對(duì)照版） 因涉及 ISO的版權(quán)問題，故僅限家園范圍使用。實(shí)施 應(yīng) 包括更新文件。 27 ? 5 Management responsibility 5 管理層職責(zé) 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(yīng) 確保 : a) 對(duì)質(zhì)量管理體系進(jìn)行策劃 ,以滿足質(zhì)量目標(biāo)以及 , b) 在對(duì)質(zhì)量管理體系的變更進(jìn)行策劃和實(shí)施時(shí) ,保持質(zhì)量管理體系的完整性 . 28 ? 5 Management responsibility 5 管理層職責(zé) 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(zé) ,權(quán)限與溝通 職責(zé)和權(quán)限 最高管理者 應(yīng) 確保組織內(nèi)的職責(zé) ,權(quán)限得到規(guī)定和溝通 . 29 ? 5 Management responsibility 5 管理層職責(zé) 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(zé) 對(duì)糾正措施賦有職責(zé)和權(quán)限的管理者 應(yīng)被及時(shí)通知不符合要求的產(chǎn)品或過程。 35 ? 5 Management responsibility 5 管理層職責(zé) 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(yīng) 被記錄，至少可提供作為證據(jù)達(dá)到： 業(yè)務(wù)計(jì)劃中規(guī)定的質(zhì)量目標(biāo)，和 客戶對(duì)產(chǎn)品提供的滿意度。 46 ? 6 Resource managem 6 資源管理 在職培訓(xùn) 組織 應(yīng) 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(xùn)。 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(shè)施和設(shè)備策劃 注 這些要求應(yīng)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。先期質(zhì)量策劃是在多方論證方式的基礎(chǔ)上，體現(xiàn)了錯(cuò)誤預(yù)防和持續(xù)改進(jìn)的概念，而并非錯(cuò)誤檢測(cè)。 61 ? 7 product realization 7 產(chǎn)品實(shí)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(zhǔn)則 接受準(zhǔn)則 應(yīng) 由組織規(guī)定，在需要時(shí)，由客戶審批。 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(yīng) 確定并管理為達(dá)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 pro