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質(zhì)量方針 最高管理者 應(yīng) 確保質(zhì)量方針 : a) 與組織的宗旨相適應(yīng) , b) 包括對(duì)滿足要求和持續(xù)改進(jìn)質(zhì)量管理體系有效性的承諾 , c) 提供制定和評(píng)審質(zhì)量目標(biāo)的框架 , d) 在組織內(nèi)得到溝通和理解 e) 在持續(xù)適宜性方面得到評(píng)審 . 25 ) ? 5 Management responsibility 5 管理層職責(zé) Planning Quality objectives Top management shall ensure that quality objectives, including those needed to meet requirements for product (see ) are established at relevant functions and levels within the anization. The quality objectives shall be measurable and consistent with the quality policy. 策劃 質(zhì)量目標(biāo) 最高管理者 應(yīng) 確保在組織的相關(guān)職能和層次上建立質(zhì)量目標(biāo) ,質(zhì)量目標(biāo)包括滿足產(chǎn)品要求所需的內(nèi)容 (見(jiàn)).質(zhì)量目標(biāo) 應(yīng) 是可測(cè)量的 ,并與質(zhì)量方針保持一致 . 26 ) ? 5 Management responsibility 5 管理層職責(zé) Quality objectives supplemental Top management shall define quality objectives and measurements that shall be included in the business plan and used to deploy the quality policy. NOTE: Quality objectives should address customer expectations and be achievable within a defined time period. 質(zhì)量目標(biāo) 補(bǔ)充 最高管理層 應(yīng) 確定質(zhì)量目標(biāo)和度量指標(biāo),應(yīng) 包含于業(yè)務(wù)計(jì)劃和用來(lái)展開(kāi)質(zhì)量方針。 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。 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(guò)程。 賦有產(chǎn)品質(zhì)量職責(zé)的人員 應(yīng) 有權(quán)限停止生產(chǎn)以糾正質(zhì)量問(wèn)題。 所有班次的生產(chǎn)運(yùn)作 應(yīng) 有人員看管,或委派相關(guān)職責(zé)人員以確保產(chǎn)品質(zhì)量。 30 ) ? 5 Management responsibility 5 管理層職責(zé) Management representative Top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes: a) ensuring that processes needed for the quality management system are established, implemented and maintained, b) reporting to top management on the performance of the quality management system and any need for improvement, and c) ensuring the promotion of awareness of customer requirements throughout the anization. NOTE: The responsibility of a management representative can include liaison with external parties on matters relating to the quality management system. 管理者代表 最高管理者 應(yīng) 指定一名管理者 ,無(wú)論該成員在其它方面的職責(zé)如何 ,應(yīng) 具有以下方面的職責(zé)和權(quán)限 : a) 確保質(zhì)量管理體系所需的過(guò)程得到建立 ,實(shí)施和保持 , b) 向最高管理者報(bào)告質(zhì)量管理體系的業(yè)績(jī)和任何改進(jìn)的需求 , c) 確保在整個(gè)組織內(nèi)提高滿足顧客要求的意識(shí) . 注 : 管理者代表的職責(zé)可包括與質(zhì)量管理體系有關(guān)事宜的外部聯(lián)絡(luò) . 31 ) ? 5 Management 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。包括選擇特殊特性、建立質(zhì)量目標(biāo)和相關(guān)的培訓(xùn)、糾正和預(yù)防措施、產(chǎn)品設(shè)計(jì)和開(kāi)發(fā)。 32 ) ? 5 Management responsibility 5 管理層職責(zé) Internal munication Top management shall ensure that appropriate munication processes are established within the anization and that munication takes places regarding the effectiveness of the quality management system. 內(nèi)部溝通 最高管理者 應(yīng) 確保在組織內(nèi)建立適當(dāng)?shù)臏贤ㄟ^(guò)程 ,并確保對(duì)質(zhì)量管理體系的有效性進(jìn)行溝通 . 33 ) ? 5 Management responsibility 5 管理層職責(zé) Management review General Top management shall review the anization39。s quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives. Records from management reviews shall be maintained (see ) 管理評(píng)審 總則 最高管理者 應(yīng) 按策劃的時(shí)間間隔評(píng)審質(zhì)量管理體系 ,以確保其持續(xù)的適宜性 ,充分性和有效性 .評(píng)審 應(yīng) 包括評(píng)價(jià)質(zhì)量管理體系改進(jìn)的機(jī)會(huì)和變更的需要 ,包括質(zhì)量方針和質(zhì)量目標(biāo) .. 應(yīng) 保持管理評(píng)審的記錄 (見(jiàn) ). 34 ) ? 5 Management responsibility 5 管理層職責(zé) Quality management system performance These reviews shall include all requirements of the quality management system and its performance trends as an essential part of the continual improvement process. Part of the management review shall be the monitoring of quality objectives, and the regular reporting and evaluation of the cost of poor quality (see and ) 質(zhì)量管理體系績(jī)效 這些評(píng)審 應(yīng) 包括質(zhì)量管理體系的所有要求,并且將它的績(jī)效趨勢(shì)作為持續(xù)改進(jìn)過(guò)程的實(shí)質(zhì)部分。 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。 35 ) ? 5 Management responsibility 5 管理層職責(zé) These results shall be recorded to provide, as a minimum, evidence of