【正文】 the importance of meeting customer / regulatory/legal requirements 對內(nèi)傳達(dá)符合客戶 /法規(guī) 要求 之重要性 ?Establishing the quality policy objectives 建立質(zhì)量方針和目標(biāo) ?Performing management reviews 實(shí)施管理評審 ?Ensuring the availability of resources 確保資源獲取 Management Commitment 管理層承諾 DNV SZ20231018 23 INTEGRATED QUALITY SERVIEC ASSOCIATION ?Customer satisfaction 客戶滿意 ?Customer needs and expectations are determined converted into requirement 確定客戶的需求和期望轉(zhuǎn)化成要求，并予以滿足 注：在確定顧客的需要和期望時(shí)考慮與產(chǎn)品有關(guān)的義務(wù)，包括法律和法規(guī)的要求 (見 ) Customer focus以客戶為中心 DNV SZ20231018 24 INTEGRATED QUALITY SERVIEC ASSOCIATION ? Appropriate to purpose of the anization 適合 組織的宗旨 ? Commitment to meeting requirements continual improvement 承諾滿足要求和持續(xù)改進(jìn) ? As a framework for establishing and reviewing quality objectives 為建立和評審質(zhì)量目標(biāo)建立框架結(jié)構(gòu) ? Communicated understood within the anisation 溝通并被理解 ? Reviewed for suitability 評審方針的持續(xù)適宜性 Quality Policy 質(zhì)量方針 DNV SZ20231018 25 INTEGRATED QUALITY SERVIEC ASSOCIATION Quality Objectives 質(zhì)量目標(biāo) ?at relevant functions levels 不同部門和層次 ?measurable 可量度 ?consistent with quality policy 與 質(zhì)量方針一致 ?continual improvement 持續(xù)改進(jìn) ?meet requirement of product 達(dá)到產(chǎn)品的要求 .見 Planning 策劃 DNV SZ20231018 26 INTEGRATED QUALITY SERVIEC ASSOCIATION Q M S Planning 質(zhì)量管理體系策劃 最高管理者應(yīng)確保： A. 對質(zhì)量體系進(jìn)行策劃，以滿足質(zhì)量目標(biāo)以及 條款 B. 在對質(zhì)量體系的更改進(jìn)行策劃和實(shí)施時(shí)， 保持質(zhì)量體系的完整性。 Planning 策劃 DNV SZ20231018 27 INTEGRATED QUALITY SERVIEC ASSOCIATION 職責(zé)權(quán)限與溝通 Responsibility and authority 職責(zé)與權(quán)限 ? Management representative 管理者代表 ? Internal munication 內(nèi)部溝通 DNV SZ20231018 28 INTEGRATED QUALITY SERVIEC ASSOCIATION 最高管理者應(yīng)確保： ?Responsibility authority職責(zé)與權(quán) 限 ?Interrelation 相 互間關(guān)系 are defined and municated within the anisation. 應(yīng)被規(guī)定及溝通 Responsibility and authority 職責(zé)與權(quán)限 DNV SZ20231018 29 INTEGRATED QUALITY SERVIEC ASSOCIATION ? Member of the management 管理層的成員 ? Implementation/maintenance of the QMS 實(shí)施和維護(hù)質(zhì)量管理體系 ? Reporting to top management on 向最高管理層報(bào)告 performance of the quality management system 質(zhì)量管理系統(tǒng)的表現(xiàn) needs for improvement 改進(jìn)的需要 ? Promote awareness of customer requirements 促進(jìn)客戶要求意識(shí)的形成 注：包括與 QM有關(guān)事宜的外部聯(lián)絡(luò) Mgt representative 管理者代表 DNV SZ20231018 30 INTEGRATED QUALITY SERVIEC ASSOCIATION Communication between the various levels and functions regarding 不同層次和部門之間溝通涉及 : ?the process QMS 質(zhì)量管理體系的過程 ?and its effectiveness 其有效性 Internal munication 內(nèi)部溝通 DNV SZ20231018 31 INTEGRATED QUALITY SERVIEC ASSOCIATION General 總則 ?Planned interval 計(jì)劃的間隔 ?Review QMSs 評審質(zhì)量管理體系的 適用性 /充足性 /有效性 評審質(zhì)量管理體系 /質(zhì)量方針 /質(zhì)量目標(biāo)改進(jìn)和變化的需要 ?應(yīng)保持管理評審的記錄 (見 ) Management review 管理評審 DNV SZ20231018 32 INTEGRATED QUALITY SERVIEC ASSOCIATION Inputs 管理評審輸入 ? results of audits 審核的結(jié)果 ? customer feedback 客戶反饋 ? process performance and product conformance 過程表現(xiàn)和產(chǎn)品符合性 ? preventive and corrective actions 預(yù)防及糾正行動(dòng)的狀況 ? followup actions from previous management reviews 上次管理評審決議的跟蹤 ? changes affecting QMS 影響 質(zhì)量管理體系的變化 ? Remendations for improvement 對改進(jìn)的建議 Management review 管理評審 DNV SZ20231018 33 INTEGRATED QUALITY SERVIEC ASSOCIATION Outputs 管理評審輸出 ? improvement of effectiveness of the QMS its processes 質(zhì)量管理體系和過程的改進(jìn) ? improvement of product related to customer requirements 與客戶要求有關(guān)的 產(chǎn)品的改進(jìn) ? resource needs 資源需求 Management review 管理評審 DNV SZ20231018 34 INTEGRATED QUALITY SERVIEC ASSOCIATION ? Provision of resources 提供資源 ? Human Resources 人力資源 ? Facilities 設(shè)施 ? Work environment 工作環(huán)境 6 Resource management 資源管理 DNV SZ20231018 35 INTEGRATED QUALITY SERVIEC ASSOCIATION Provision of Resource提供資源 The anisation shall determine and provide the resources needed to :組織應(yīng)確定并提供所需的資源，以： ?implement and maintain the QMS and continually improve its effectiveness 實(shí)施，保持 QMS并持續(xù)改進(jìn)其有效性 ?Address customer satisfaction 達(dá)到 客戶滿意 DNV SZ20231018 36 INTEGRATED QUALITY SERVIEC ASSOCIATION ? General Personnel performing work affecting product quality shall be petent on the basis of :appropriate education, training, skills and experience. 在適當(dāng)?shù)慕逃?，培?xùn)，技能和經(jīng)驗(yàn)的基礎(chǔ)上確保承擔(dān) QMS規(guī)定職責(zé)的人員能 勝任其工作 Human resources 人力資源 DNV SZ20231018 37 INTEGRATED QUALITY SERVIEC ASSOCIATION ? 培訓(xùn)，意識(shí)和能力 a) 確定能力需求 (資格 ) b) 提供培訓(xùn)或采取其他措施以滿足這些需求。 c) 評估所 采取措施 的有效性 d) 意識(shí)本身 工作活動(dòng)對質(zhì)量的 相 關(guān)性 ,重 要性及貢獻(xiàn) e) 保存教育 ,經(jīng)歷，培訓(xùn)和技能記錄 Human resources 人力資源 DNV SZ20231018 38 INTEGRATED QUALITY SERVIEC ASSOCIATION 組織應(yīng)識(shí)別，提供并維持為實(shí)現(xiàn)產(chǎn)品的符合性所需要的設(shè)施應(yīng)包括： Workspace and associated facilities 工作場所和相關(guān)設(shè)施 ? Process equipment, both hardware and software 過程設(shè)備，硬件，軟件 ? Supporting services (.,transport,munication ) 支持性服務(wù) (如運(yùn)輸，通訊 ) Facilities設(shè)施 DNV SZ20231018 39 INTEGRATED QUALITY SERVIEC ASSOCIATION The anisation shall Identify and manage the factors of the work environment needed to achieve conforming product. 組織應(yīng)識(shí)別和管理為實(shí)現(xiàn)產(chǎn)品的符合性所需的工作環(huán)境因素 human factors 人的因素 physical factors 物理因素 Work environment 工作環(huán)境 DNV SZ20231018 40 INTEGRATED QUALITY SERVIEC ASSOCIATION ? Planning of product realization 產(chǎn)品 實(shí)現(xiàn)的策劃 ? Customerrelated processes 與客戶相關(guān)過程 ? Design and development