【正文】 最高管理層承諾建立及改善品保系統(tǒng) ： ?Communicating the importance of meeting customer / regulatory/legal requirements 對(duì)內(nèi)傳達(dá)符合客戶 /法規(guī) 要求 之重要性 ?Establishing the quality policy amp。 objectives 建立質(zhì)量方針和目標(biāo) ?Performing management reviews 實(shí)施管理評(píng)審 ?Ensuring the availability of resources 確保資源獲取 Management Commitment 管理層承諾 INTEGRATED QUALITY SERVIEC ASSOCIATION DNV SZ20201018 24 ?Customer satisfaction 客戶滿意 ?Customer needs and expectations are determined amp。 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 INTEGRATED QUALITY SERVIEC ASSOCIATION DNV SZ20201018 25 ? Appropriate to purpose of the anization 適合 組織的宗旨 ? Commitment to meeting requirements amp。 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(píng)審質(zhì)量目標(biāo)建立框架結(jié)構(gòu) ? Communicated amp。 understood within the anisation 溝通并被理解 ? Reviewed for suitability 評(píng)審方針的持續(xù)適宜性 Quality Policy 質(zhì)量方針 INTEGRATED QUALITY SERVIEC ASSOCIATION DNV SZ20201018 26 Quality Objectives 質(zhì)量目標(biāo) ?at relevant functions amp。 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 INTEGRATED QUALITY SERVIEC ASSOCIATION DNV SZ20201018 27 Q M S Planning 質(zhì)量管理體系策劃 最高管理者應(yīng)確保： A. 對(duì)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(duì)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 INTEGRATED QUALITY SERVIEC ASSOCIATION DNV SZ20201018 28 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 INTEGRATED QUALITY SERVIEC ASSOCIATION DNV SZ20201018 29 最高管理者應(yīng)確保： ?Responsibility amp。 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 INTEGRATED QUALITY SERVIEC ASSOCIATION DNV SZ20201018 30 ? 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 INTEGRATED QUALITY SERVIEC ASSOCIATION DNV SZ20201018 31 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 INTEGRATED QUALITY SERVIEC ASSOCIATION DNV SZ20201018 32 General 總則 ?Planned interval 計(jì)劃的間隔 ?Review QMSs 評(píng)審質(zhì)量管理體系的 適用性 /充足性 /有效性 評(píng)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(píng)審的記錄 (見 ) Management review 管理評(píng)審 INTEGRATED QUALITY SERVIEC ASSOCIATION DNV SZ20201018 33 Inputs 管理評(píng)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(píng)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(duì)改進(jìn)的建議 Management review 管理評(píng)審 INTEGRATED QUALITY SERVIEC ASSOCIATION DNV SZ20201018 34 Outputs 管理評(píng)審輸出 ? improvement of effectiveness of the QMS amp。 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(píng)審 INTEGRATED QUALITY SERVIEC ASSOCIATION DNV SZ20201018 35 ? 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 INTEGRATED QUALITY SERVIEC ASSOCIATION DNV SZ20201018 36 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 INTEGRATED QUALITY SERVIEC ASSOCIATION DNV SZ20201018 37 ? 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 INTEGRATED QUALITY SERVIEC ASSOCIATION DNV SZ20201018 38 ? 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(píng)估所 采取措施 的有效性 d) 意識(shí)本身 工作活動(dòng)對(duì)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 INTEGRATED QUALITY SERVIEC ASSOCIATION DNV SZ20201018 39 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(chǎng)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 INTEGRATED QUALITY SERVIEC ASSOCIATION DNV SZ20201018 40 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 INTEGRATED QUALITY SERVIEC ASSOCIATION DNV SZ20201018 41 ? Planning of product rea