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ilities and authorities of process owners過程所有者的職責和權限 6 Planning策劃 Actions to address risks and opportunities 風險和機遇的應對措施 Actions to address risks and opportunities Supplemental 風險和機遇的應對措施 補充 Contingency planning 應急計劃 Quality objectives and planning to achieve them 質量目標及其實施的策劃 Safety objectives 安全目標 Planning of changes 變更的策劃 Business planning 經營計劃 7 Support 支持 Resources 資源 General 總則 General Supplemental 總則 補充 People 人員 Infrastructure 基礎設施 Environment for the operation of processes 過程操作的環(huán)境 Monitoring and measuring resources監(jiān)視和測量資源 General 總則 Measurement traceability 測量的可追溯性 Monitoring and measuring resources Supplemental 監(jiān)視和測量資源 補充 Organizational knowledge 組織的知識 Organizational knowledge Supplemental 組織的知識 補充 Competence 能力 Competence Supplemental 能力 補充 Awareness 意識 Awareness Supplemental 意識 補充 Communication 溝通 Documented information 形成文件的信息 General 總則 Creating and updating 編制和更新 Control of documented information文件化信息的控制 Control of documented information Supplemental 文件化信息的控制 補充 8 Operation 運行 Operational planning and control運行的策劃和控制 Planning for the outsourcing or transfer of processes過程外包和轉包的策劃 Tender management 投標管理 Project management 項目管理 Project integration management項目整合管理 Project scope management 項目范圍管理 Project time management項目時間管理 Project cost management項目成本管理 Project quality management 項目質量管理 Project human resource management項目人力資源管理 Project munications management項目溝通管理 Project risk and opportunity management 項目風險和機遇管理 Project procurement management 項目采購管理 Configuration management 技術狀態(tài)管理 Change management 變更管理 Requirements for products and services 產品和服務的要求 Customer munication顧客溝通 Customer munication Supplemental 顧客溝通 補充 Determining the requirements related to products and services 產品和服務相關要求的確定 Determining the requirements related to products and services Supplemental. 產品和服務相關要求的確定 補充 Review of requirements related to products and services產品和服務相關要求的評審 Changes to requirements for products and services產品和服務相關要求的變更 Requirements for products and services Supplemental產品和服務相關要求 補充 Design and development of products and services 產品和符合的設計和開發(fā) General 總則 General Supplemental 總則 補充 Design and development planning 設計和開發(fā)策劃 Design and development planning Supplemental設計和開發(fā)策劃 補充 Design and development inputs 設計和開發(fā)的輸入 Design and development inputs Supplemental設計和開發(fā)的輸入 補充 Design and development controls 設計和開發(fā)的控制 Design and development controls – Supplemental設計和開發(fā)的控制 補充 Design reviews設計評審 Design verification設計驗證 Design validation設計確認 Design and development outputs 設計和開發(fā)的輸出 Design and development outputs Supplemental 設計和開發(fā)的輸出 補充 Design and development changes 設計和開發(fā)的變更 Control of externally provided processes, products and services 外部提供的過程、產品和服務的控制 General 總則 50 General Supplemental 總則 補充 Type and extent of control 控制的類型和程度 External provided products, process or service approval of release 外部提供的產品、過程或服務放行的批準 External provided products, process or service verification after release 外部提供的產品、過程或服務放行后的驗證 Monitoring of external provider performance, reevaluation and ranking外部供方的績效監(jiān)視、再評估和評級 Information for external providers 外部供方的信息 Information for external providers Supplemental 外部供方的信息 補充 Supply chain management 供應鏈管理 Production and service provision生產和服務的提供 Control of production and service provision 生產和服務提供的控制 Control of production and service provision Supplemental 生產和服務提供的控制 補充 Special processes 特殊過程 Production equipment 生產設備 Identification and traceability 標識和可追溯性 Identification and traceability – Supplemental標識和可追溯性 補充 Property belonging to customers or external providers顧客或外部供方所有的財產 Property belonging to customers or external providers Supplemental 顧客或外部供方所有的財產 補充 Preservation防護 Preservation Supplemental 防護 補充 Postdelivery activities交付后活動 Postdelivery activities Supplemental 交付后活動 補充 Control of changes 變更控制 Production scheduling 生產計劃 Release of products and services 產品和服務的放行 Release of products and services Supplemental 產品和服務的放行 補充 Control of nonconforming outputs 不合格輸出的控制 Control of nonconforming outputs Supplemental 不合格輸出的控制 補充 RAMS / LCC First article inspection 首件檢驗 Obsolescence management 廢棄管理 Innovation management 創(chuàng)新管理 9 Performance evaluation績效評價 Monitoring, measurement, analysis and evaluation 監(jiān)視、測量、分析和評價 General 總則 General Supplemental 總則 補充 Customer satisfaction 客戶滿意 Customer satisfaction Supplemental 客戶滿意 補充 Analysis and evaluation 分析和評價 Analysis and evaluation Supplemental 分析和評價 Internal audit 內部審核 Internal audit Supplemental 內部審核 補充 Audit programme 審核計劃 Auditors management 審核員管理 Management review 管理評審 General 總則 General Supplemental 總則 補充 Management review inputs 管理評審 輸入 Management review inputs Supplemental 管理評審輸入 補充 Management review outputs 管理評審輸出 Management review outputs Supplemental 管理評審輸出 補充 Process reviews 過程評審 10 Improvement改進 General 總則 Nonconformity and corrective action 不符合及糾正措施 Nonconformity and corrective action – Supplemental 不符合及糾正措施補充 Continual improvement 持續(xù)改進 11 Bibliography 參考書目 0 Introduction引言 General總則 ISO 9001:2023, Quality management systems — Requirements 質量管理體系 要求 General總則 The adoption of a quality management system is a strategic decision for an anization that can help to improve its overall performance and provide a sound basis for sustainable development initiatives. 采用質量管理體系是組織的戰(zhàn)略決策,可以幫助組織改進其整體績效,并且為積極進行可持續(xù)發(fā)展提供可靠基礎。 ? Whenever this Technical Spec