品质管理质量认证ISO9001AwarenessTrainingforstaffs.ppt

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此处是大标题样稿字样十五 字以内 ADC Communications ShangHai ISO-国际标准化组织 ISO-International Organization for Standardization • 成立于1947年2月23日 • 总部设于瑞士日内瓦 推动和协调国际标准化工作 • 推动国际贸易的发展 • 120多个成员国组成，包括欧共体和欧盟的所有成员国，美 国、日本、中国、新加坡等 ADC Communications ShangHai 国际标准制定的过程 组织 文件 ISO（国际标准化组织） IS(国际标准) FDIS(最终~) DIS(国际标准草案) TC SC CD(委员会草案) WG(工作组) WD（工作组草案） TC—技术委员会 TC176：质量管理和质量保证技术委员会 成立于1980年 制定质量管理和质量保证标准 ISO9000族标准就是由ISO/TC176制定的所有国际标准 ADC Communications ShangHai Changes from ISO9000:1994 ISO9000:1994更改概要 ISO9001 ISO9002 ISO9003 ISO9001:2000- QMS requirements 質量管理系統要求 ISO9000:2000- Fundamentals & vocabulary 基本原理和術語 ISO8402 ISO9001-1 ISO9004-01 ISO9004:2000- Guidelines for performance improvement 業績改進指 ADC Communications ShangHai Changes from ISO9000:1994 ISO9000:1994更改概要 ISO10011 ISO14010 ISO14011 ISO14012 ISO 19011:2000 – Guidelines for environmental auditing 管理和環境審核指南 ADC Communications ShangHai ISO9000 Family of Standards ISO9000 標準家族 Four major standards 四個主要標準： • ISO9000 QMS — Fundamentals and vocabulary 質量管理系統— 基本原理和術語 • ISO9001 QMS — Requirements 質量管理系統— 要求 • ISO9004 QMS — Guidelines for Performance improvement 質量管理系統— 業績改進指南 • ISO 19011 Guidelines for management and environmental auditing 管理和環境審核指南 ADC Communications ShangHai ISO9000 QMS — Fundamentals & Vocabulary ISO9000 質量管理系統—基本原理和詞彙 • clause 8 quality management principles • 条款 八個質量管理的原則 • clause 2 Terms and definitions (Replace ISO 8402) • 條款2 術語和定義（取代ISO 8402 ） • clause 4 Fundamental of quality management system • 條款4 質量管理系統基本原理 ADC Communications ShangHai ISO9000:2000 Awareness Training ISO9000:2000 認識培訓 • Quality/Management Terminology • 質量/管理術語 ADC Communications ShangHai Quality/Management Terminology 質量/管理術語  Quality 質量  Management 管理  Organization 組織  Process and Product 過程與產 品  Characteristics 特性  Conformity 符合  Documentation 文件化  Examination 評核  Audit 審核  Quality assurance for measurement processes 測量過程的質量保 證 ADC Communications ShangHai ISO9000:2000 Awareness Training ISO9000:2000 認識培訓 8 Quality Management Principles 八項質量管理原則 ADC Communications ShangHai Quality Management Principle 質量管理原則 • Comprehensive and fundamental rule or belief, for leading and operating an organization, aimed at continually improving performance over the long term by focusing on customers while addressing the needs of all other stakeholders. • 全面和基礎的規則或信念，領導和運作一個組織， 以達致在考慮所有受益方（相關方）的需求的同時， 以顧客中心長期持續改進業績。【ISO/TC 176/WG 15 】 ADC Communications ShangHai 8 Quality Management Principles 八項質量管理原則 1. Customer focus 以顧客中心 2. Leadership 領導作用 3. Involvement of people 全員參與 4. Process approach 過程方法 5. System approach to management 以系統方法管理 6. Continual improvement 持續改進 7. Factual approach to decision making 基於事實的決策方法 8. Mutually beneficial supplier relationships 互利的供方關係 ADC Communications ShangHai ISO9000:2000 Awareness Training ISO9000:2000 認識培訓 QMS Model 質量管理模式 ADC Communications ShangHai ISO9001:1994 Structure ISO9001:1994 結構 ADC Communications ShangHai ISO9001:2000 — Process Approach ISO9001:2000 —流程導向 ADC Communications ShangHai Continual Improvement 持續改善 ADC Communications ShangHai ISO9000:2000 Awareness Training ISO9000:2000 認識培訓 ISO9001:2000 Requirements Interpretation • ISO9001:2000 條文剖 析 ADC Communications ShangHai ISO9001:2000 Structure ISO9001:2000 結構 0 Introduction 引言 1. Scope 範圍 2. Normative reference 引用標準 3. Terms and definitions 術語和定義 4. Quality management system 質量管理系統 5. Management responsibility 管理職責 6. Resources management 資源管理 7. Product realization 產品的實現 8. Measurement, analysis and improvement 測量、 分析和改進 ADC Communications ShangHai 0 Introduction 引言  General 總則  Specifies requirements for a QMS 規定質量管理系統要求  Assess the organization’s ability to meet customer and regulatory requirements 可用於評價組織滿足顧客和法規要求的能力  Not imply uniformity of the structure of QMS and documentation 目的並非統一質量管理系統結構和統一文件  Promote the adoption of process approach 鼓勵採用過程方 法  Consistent to ISO9004 and complement to each other 與 ISO9004 相符及互補  Compatibility with other management systems 與其他管理 系統相容 ADC Communications ShangHai 1 Scope 範圍  General 總則 • Provide product consistently that meets customer and applicable regulatory requirements 提供穩定產品，並符合顧客和法規的要求 • Enhance customer satisfaction 令顧客滿意 • Continual improvement 持續改進 • Assurance of conformity to customer and applicable regulatory requirements 保證符合顧客和法規的要求 ADC Communications ShangHai 2 Normative reference 引用標準  The normative document constitute provisions of this International Standard 引用的標準，構成規定內容  ISO9000:2000 Quality management systems — Fundamentals and vocabulary. ISO9000 : 2000 質量管理系統— 基本原理和字 彙 ADC Communications ShangHai 3 Terms and definitions 術語和定義  The terms and definitions given in ISO9000 apply to ISO9001:2000 於ISO9001:2000 中所用的術語定義  Supply-chain terminology 供應鏈術語： ISO9001:1994 ISO9001:2000 Customer 顧客 → Customer 顧客 Supplier 供方 → Organization 組織 Subcontractor 分承包方 → Supplier供方 ADC Communications ShangHai 4 Quality Management System 質量管理系統 General requirements 總要求 Documentation requirements 文件的總要求 ADC Communications ShangHai General requirements 總要求  Establish, document, implement, maintain and continually improve a QMS 建立建立，文件化，實施，保持，持續 改進一個質量管理系統 • Identify the processes needed for the QMS and their application throughout the organization 識別所需過程及其在組織中的應用 • Determine the sequence and interaction of these processes 確定順序和相互作用 • Determine criteria and methods needed to ensure the operation and control processes 確定運作和控制的準則和方法 ADC Communications ShangHai General requirements 總要求 • Acquire information to support the operation and monitoring of these processes 獲得資訊以運作和監控 • Monitor, measure and analyse these processes 測量，監控和分析 • Actions to achieve planned results and continual improvement of these processes 措施實現策劃結果和持續改進 ADC Communications ShangHai Documentation requirements文件的總要求 General 總則 Quality Manual 質量手冊 Control of documents 文件控制 Control of quality records 質量記錄的控制 ADC Communications ShangHai Documentation requirements文件的總要求 General 總則 • The quality management system documentation shall include : 質量管理文件系統應包括： • Quality manual and documented statements of a quality policy and quality objectives 質量手冊，質量政策及質量目標 • Documents needed by the organization to ensure the effective planning,operation and control of its processes 建立組織有效運作和控制過程所需的文件 • Documents and records required by the International Standard 建立標準要求的程式文件及記錄 ADC Communications ShangHai 质量体系文件与结构 质量 手册 程序文件 质量计划/作业指导书 表格、记录、文件簿、档案 表明意向及达到此目的的策略及方法 说明由谁负责执行什么及什么情况下执行程序 详细说明如何执行某些工作 证明以按文件执行工作的证据 ADC Communications ShangHai Documentation requirements文件的總要求  The extent of the QMS documentation is due to: 系統文件詳略程式取決於： • The size of organization and type of activities 組織的規模和類型 • The complexity of processes and their interactions 過程的複雜性和相互作用 • The competence of personnel 人員的技能和培訓 ADC Communications ShangHai Documentation requirements文件的總要求 • Where the term “documented procedure” appears, this means that the procedure is established, implemented and maintained 「文件化程序」是要求程序被建立、書面化、執行和 維持 • The documentation can be in any form or type of medium 可用任何種類的媒介或形式建立文件 ADC Communications ShangHai Documentation requirements文件的總要求 Quality Manual 質量手冊 • Establish and maintain a quality manual 編制和保持 質量手冊 • The scope of the QMS 系統的範圍 • Details of exclusions and justification 刪減部份的細節和合理性 • Documented procedures, or reference to them 文件化的程式或對其引用 • Description of the interaction between the processes 過程的順序和相互間作用 • Should be controlled 需受控 ADC Communications ShangHai Documentation requirements 文件的總要求 Control of documents 文件控制  Documents required by the quality management system shall be controlled 質量管理系統所要求的文件應被管制  Records are a special type of document and shall be controlled according to the requirements given in 記錄是一特別形式的文件，應根據的要求加以管制  A documented procedure shall be established to define the controls needed : 應建設文件化程序以管制： ADC Communications ShangHai Documentation requirements 文件的總要求 to approve documents for adequacy prior to issue 文件在發行之前應審核其適切性 to review and update as necessary and re-approve documents, 文件應 被審查、更新，並重新核准 to ensure that changes and the current revision status of documents are identified 能鑑別文件最新版本 to ensure that relevant versions of applicable documents are available at points of use, 確保使用處可取得相關版本之應用文件 ADC Communications ShangHai Documentation requirements文件的總要求 to ensure that documents remain legible and readily identifiable 確保文件易讀、容易辨識和回收 to ensure that documents of external origin are identified and their distribution controlled 確保能鑑別外來文件之原稿，和其發行的管制； to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose 為避免作廢文件被誤用，作廢文件因任何目的而 留存時應予以適當的鑑別文件當作是記錄時應加以 管制 ADC Communications ShangHai The ISO9001:2000 standard specifically required documents ISO9001:2000 标准特别要求的文件 • 1. Quality Manual 质量手册( b) • 2. Procedure for Control of Documents文件控制程序 () • 3. Procedure for Control of Records 记录的控制审核() • 4. Procedure for Internal Audits 内部审核程序() • 5. Procedure for Control of Nonconforming Product 不合格 产品的控制程序() • 6. Procedure for Corrective Action 纠正行动程序() • 7. Procedure for Preventive Action 预防行动程序() ADC Communications ShangHai Documentation requirements文件的總要求 Control of quality records質量記錄的控制 • Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. 質量管理系統所要求的記錄應予以管制，這些記錄應留 存以證明符合質量管理系統規定的要求及有效運作 • Records shall remain legible, readily identifiable and retrievable 記錄應保持清晰、容易辨認及方便提取的狀態 ADC Communications ShangHai Documentation requirements文件的總要求  A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records. 應制定書面程序以鑑別、保存、蒐集、保護，規定保存 期限和處置記錄 ADC Communications ShangHai 5 Management responsibility 管理職責 Management commitment 管理承諾 Customer focus 以顧客中心 Quality policy 質量方針 Planning策劃 Responsibility, authority and communication 職責、權力和溝通 Management review 管理評審 ADC Communications ShangHai Management commitment管理承諾  Top management shall commit最高管理層需承諾  development and implement of the QMS and 建立及執行質量管理系統和  continually improving its effectiveness 持續改進其有效性 • communicating to the organization the importance of meeting customer and statutory and regulatory requirements 對內傳達符合顧客和法律，法規要求 之重要性 • establishing the quality policy建立質量方針和目標 • conducting management reviews 實施管理評審 • ensuring the availability of resources 確保資源獲取 ADC Communications ShangHai Customer Focus 以顧客中心  Top management shall ensure customer requirements are 最高管理需保證顧客的要求  determined 確定  fulfilled 符合  with the aim of enhancing customer satisfaction  並以加強顧客滿意目標 ADC Communications ShangHai Quality policy 質量方針  Top management shall ensure the quality policy is 最高管理需保證質量方針  appropriate to the purpose of the organization 適合組織公司本身之目標  committed to comply with requirements and continually improve the effectiveness of the QMS 承諾符合要求和持續改進質量管理系統的有效性  providing a framework for establishing and reviewing quality objectives 建立和評審質量目標提供框架 ADC Communications ShangHai ADC Quality Policy ADC is committed to being a high quality provider of communication network products and services, striving to exceed customer expectations. ADC accomplishes this through continual improvement in customer satisfaction, supplier relationships and our business management system. We succeed by focusing on: – Customer – Quality – Innovation – Teamwork – Integrity The combination of these efforts allows us to satisfy our customers, shareholders, fellow employees, suppliers and our communities by giving them what they have a right to expect and, in their eyes, doing it better than anyone else. ADC Communications ShangHai ADC 质量方针 ADC致力于成为高质量通讯网络产品和服务的供 应商、不断努力以超越客户的期望。ADC通过持 续改进客户满意度、供应链和业务管理体系， 以实现这个目标。 我们的成功在于我们专注于： – 客户 – 质量 – 创新 – 团队合作 – 诚信 上述行为的结合，让我们能够满足顾客、股东、 雇员、供应商和各个社会团体的期望。在他们 眼里，ADC做得比别的公司更好。 ADC Communications ShangHai Quality policy 質量方針  communicated and understood within the organization 各層次溝通和理解  reviewed for continuing suitability 評審方針的持續適宜性  controlled 需受控 ADC Communications ShangHai Planning 策劃 Quality objectives 質量目標  Top management shall ensure 最高管理需保證  meet requirements for product 滿足產品要求  established at relevant functions and levels within the organization 在相關職能和組織內各層次建立  measurable 可量度  consistent with the quality policy 與質量方針一致 ADC Communications ShangHai Planning 策劃 QMS planning 質量管理系統策劃 Top management shall ensure the planning of the QMS is 最高管理需保證質量管理系統策劃  carried out to meet 落實以滿足 • requirements given in 質量管理系統總則()的要求 • requirements of quality objectives 質量目標的要求  the integrity of the QMS is maintained when changes to the QMS 更改時，質量管理系統的完整性得以保持 ADC Communications ShangHai Responsibility, authority and communication 職責、權力和溝通 Responsibility and authority 職責與權力 • Ensure that responsibilities and authorities are defined and communicated within the organization 組織應對功能及其相互關係，包括責任和權限應 加以定義及被構通過，以達成有效的質量管理 Management representative管理者代表 • Top management shall appoint a member of management who shall have responsibility and authority that includes : 最高管理層需委派一管理層成員負責： ADC Communications ShangHai Responsibility, authority and communication 職責、權力和溝通  Ensuring the processes needed for the QMS are established implemented and maintained 確定系統需要的流程已被建立、執行及維持  Reporting to top management any need for improvement 向最高管理層報告改進的需要  Promote of awareness of customer requirements 促進對顧客要求的意識 ADC Communications ShangHai Responsibility, authority and communication 職責、權力和溝通 Internal communication 內部溝通 • Communication processes are established 建立溝通的過程 • Communication takes place regarding to the effectiveness of the QMS 質量管理系統的有效性得以溝通 ADC Communications ShangHai Management review 管理評審 General 總則 • Include requirements in ISO9001:1994 包括ISO9001:1994 的要求 • Assessing opportunities for improvement 評價改進的機會 ADC Communications ShangHai Management review管理評審 Review input 評審輸入 • Results of audits 審核結果 • Customer feedback (. complaints, satisfaction) 顧客反饋(如設拆、滿意度) • Process performance and product conformity 過程表現和產品符合性 ADC Communications ShangHai Management review管理評審  Status of preventive and corrective actions 預防及糾正措施的狀況  Follow-up actions from previous management reviews 上次管理評審決議的跟蹤措施  Planned changes that could affect the QMS 可能影響質量管理系統的有計劃的變化  Recommendations for improvement 改進的建議 ADC Communications ShangHai Management review 管理評審 Review output 評審輸出  Related decisions and actions 相關措施  improvement of the effectiveness of the QMS and its processes 質量管理系統和過程的改進  improvement of product 產品的改進  resource needs 資源需求  Results of management review should be recorded 管理評審結果應予記錄 ADC Communications ShangHai 6 Resource management 資源管理 Provision of resources 資源的提供 Human resources 人力資源 Infrastructure 基礎建設 Work environment 工作環境 ADC Communications ShangHai Provision of resources 資源的提供  Determine and provide the resources needed to 確定及提供資源  implement the QMS 實施質量管理系統  continually improve the effectiveness of the QMS 持續改進系統的有效性  enhance customer satisfaction by meeting customer requirements 符合顧客要求以加強顧客滿意 ADC Communications ShangHai Human resources 人力資源 General 總則 • Personnel performing work affecting product quality shall be competent 執行會影響產品質量的工作的人員應是有能力  Ability to justify 能力的判斷  Education 教育  Training 培訓  Skill 技能  Experience 經驗 ADC Communications ShangHai Human resources 人力資源 Competence, Awareness and Training 能力、意識和培訓 • Determine the necessary competence確定能力需求 • Provide training or other actions 提供培訓或其它活動 • Evaluate the effectiveness of the actions taken 評價措施的有效性  Ensure personnel are aware of the achievement of the quality objectives 確保員工意識從事活動對於質量目標的  Relevance 相關性  Importance 重要性  How they contribute 如何作出貢獻  Maintain appropriate records 保存合適的記錄 ADC Communications ShangHai Infrastructure 基礎建設  Determine, provide and maintain the infrastructure needed to achieve conformity to product requirements 識別、提供和維護所需的基礎建設以達致符合產品要求  Buildings, workspace and associated utilities 建築物，工作場所和相關設施  Process equipment, both hardware and software 過程設備，包括硬體及軟件  Supporting services such as transport or communication 支援性服務，如交通或通訊 ADC Communications ShangHai Work environment 工作環境  Determine and manage the work environment needed to achieve conformity to product requirements 確定和管理工作環境以達致符合產品要求 ADC Communications ShangHai 7 Product realization 產品實現 Planning of product realization 實現產品的策劃 Customer-related processes 與顧客相關的過程 Design and development 設計和開發 Purchasing 採購 Production and service provision 生产和服務的提供 Control of monitoring and measuring devices 測量和監 控裝置的控制 ADC Communications ShangHai Planning of product realization 實現產品的策劃  Plan and develop the processes needed for product realization 策劃和發展實現產品所需的過程  Determine 確定  objectives and requirements 目標和要求  required processes, documents and resources 所需的過程、文件和資源  required verification, monitoring, inspection and test 所需的驗證、確認、監控、檢驗和測試  required records — evidence of processes and product fulfils 所 需的記錄— 過程和產品符合性的證據  Shall be documented and suitable for the organization’s method of operations 應以適用於組織運作的方式形成文件 ADC Communications ShangHai Customer-related processes 與顧客相關的過程 Determination of requirements related to the product 確定與產品有關的要求  Requirements specified by the customer 顧客規定的要求  delivery and post-delivery requirements 交付和交付後的要求  Requirements not stated by customer but necessary 顧客未規定但 需要的要求  specific use or known and intended use 規定用途，或已知和預期用 途 ADC Communications ShangHai Customer-related processes 與顧客相關的過程  Statutory and regulatory requirements related to the product 產品的法律和法規要求  Any additional requirements determined by the organization 任何由組織確定的附加要求 ADC Communications ShangHai Customer-related processes 與顧客相關的過程 Review of requirements related to the product 產品要求的評審 • Review should be conducted prior to the commitment to supply a product to the customer 審查應在承諾向客戶供應產品前完成 • Product requirements are defined 對產品的需求已被定義 • Contract or order requirements differing from the previous are resolved 與先前不一致的要求已經得到解決 • Capable to meet the defined requirements 有能力滿足客戶的要 求 ADC Communications ShangHai Customer-related processes 與顧客相關的過 程  ‹Maintain records of the review and actions arising from the review 保存評審或因評審引起的活動的記錄  Customer provides no documented statement of requirement, the organization should confirm customer requirements before acceptance 顧客沒有以文件形式提出要求，接受前要確認要求  Aware of the changed requirements 變更的管理 ADC Communications ShangHai Customer-related processes 與顧客相關的過程 Customer communication 與顧客溝通  Determine and implement effective arrangements for communicating with customers 需確認和執行與顧客有效溝 通的安排  Product information 產品資訊  Enquiries, contracts or order handling and amendment 合同/訂 單的處置及修改  Customer feedback, including complaints 顧客反饋，包括投訴 ADC Communications ShangHai Design and development 設計和開發 Design and development planning 設計和開發策劃 – Determine the design and development stages 決定設計和/或開 發過程的各階段 – Determine the review, verification and validation that are appropriate to each stage 決定在每一設計和/或開發階段必要 的審查、驗證和確認活動 – Determine the responsibilities and authorities決定設計和/或開 發活動的權責 ADC Communications ShangHai Design and development 設計和開發  Manage the interfaces between different groups involved to ensure effective communication and clear assignment of responsibility 參予設計和/或開發的不同群組間的介面須加以管理，以確 保有效的溝通和責任的澄清 ADC Communications ShangHai Design and development 設計和開發  Inputs relating to product requirements shall be determined and records maintained 產品要求的輸入須加以定義和文件化，這些應包括  functional and performance requirements 功能和績效的要求  applicable statutory and regulatory requirements 適用的規章和法律的要求  information derived from previous similar design 以前設計的適用資訊 ADC Communications ShangHai Design and development 設計和開發  other essential requirements其他任何設計和/或開發的基本要 求  Inputs shall be reviewed for adequacy. Requirements shall be complete,unambiguous and not in conflict with each other. 應對這些輸入的適切性加以檢討，任何不完整、不明確及有 矛盾的要求應加以解決 ADC Communications ShangHai Design and development 設計和開發 Design and development outputs 設計和開發輸出 • Outputs shall be provided in a form that enables verification against the input and shall be approved prior to release. 設計和/或開發過程的輸出必須以能和設計輸入相驗證的方 式提供，並於發放前批樸  meet the input requirements 符合設計和/或開發輸入的要求  provide appropriate information for purchasing, production and for service provision 為生產和服務作業提供適當的資訊 ADC Communications ShangHai Design and development 設計和開發  contain or reference product acceptance criteria 包括或引用產品之允收標準  specify the characteristics of the product that are essential for its safe and proper use 界定產品的安全和正常使用的基本特性 ADC Communications ShangHai Design and development 設計和開發  Systematic reviews shall be performed in accordance with planned arrangements (see ) 在設計和/或開發過程的適當階段應執行系統性的審查  Evaluate the results of design and development to meet requirements, 評估滿足要求的能力  Identify any problems and propose necessary actions 確定問題和提出後續跟催行動 ADC Communications ShangHai Design and development 設計和開發  Participants in the reviews shall include representatives of functions concerned with the design and development stage(s) being reviewed 參予這類審查的人員應包括與被審查的設計和/或開發階段 有關的部門代表  Records of the results of the reviews and any necessary actions shall be maintained (see ) 設計和/或開發審查的結果和後續的跟催行動應予以記錄 ADC Communications ShangHai Design and development 設計和開發 Design and development verification 設計和開發驗證 • Verification shall be performed in accordance with planned arrangements (see ) 應有計劃執行設計和/或開發驗 • Ensure that the design and development outputs have met the design and development input requirements 確保輸出滿足設計和/或開發輸入要求 • Records of the results of the verification and any necessary actions shall be maintained (see ). 證驗證的結果和後續的跟催行動應予以記錄 ADC Communications ShangHai Design and development 設計和開發 Design and development validation 設計和開發確認 • Design and development validation shall be performed in accordance with planned arrangements (see ) • 應執行設計和/或開發確認  ensure that the resulting product is capable of meeting the requirements for the specified application or intended use 確認最終產品能夠滿足預期的使用要求  validation shall be completed prior to the delivery or implementation of the product 應在交貨或完成產品前完成確認  " Records of the results of validation and any necessary actions shall be maintained (see ) 確認的結果和後續的跟催行動應予以記錄 ADC Communications ShangHai Design and development 設計和開發  Changes shall be identified, reviewed, verified, validated and approved before implementation 設計和/或開發的變更應予以鑑別、評審、驗證和確認，並 於執行前核准  Include evaluation of the effect of the changes on constituent parts and product already delivered 這包括評估零組件和已交貨的產品因變更而產生的影響  Records of the review of changes and any necessary actions shall be maintained (see ) 變更審查的結果和後續的跟催行動應予以記錄. ADC Communications ShangHai Purchasing 採購 Purchasing process 採購控制 • Conforms to specified purchase requirements 符合特定採購要 求 • Type and extent of purchasing process shall be dependent upon the effect on the subsequent product realization or the final product 控制採購過程方式和程度取決於對隨後實現過程及其輸出的 影響 • Evaluate and select suppliers in accordance with the organization’s requirements 根據組織要求評審及選取供應商 ADC Communications ShangHai Purchasing 採購  Establish criteria for evaluation and re-evaluation shall be established 規定評價和定期評價的準則  Records of the results of evaluations and actions arising from the evaluation shall be maintained 記錄評價的結果和跟蹤措 施 ADC Communications ShangHai Purchasing 採購 Purchasing information 採購資訊  Describe the product to be purchased 包含用以描述採購產品 的資訊  Requirements for approval of product, procedures, processes and equipment 對產品、程序、過程、設備作審批的要求  Requirements for qualification of personnel 人員的資格評定  Quality management system requirements 質量管理系統的要求  Ensure the adequacy of specified purchase requirements prior communicate to the supplier 與供應商溝通前應確保規定的採 購要求的適宜性 ADC Communications ShangHai Purchasing 採購 Verification of purchased product 採購產品的驗證 • Implement inspection or other activities for ensuring purchased product meets specified purchase requirements 實施檢驗或其他活動以確保採購的產品滿足規定的採購要求 • Define the verification arrangements and method of product release when perform verification at the supplier’s premises 在供方處進行驗證活動時，規定驗證安排和放行的方式 ADC Communications ShangHai Production and service provision 生產和服務 的提供 Control of production and service provision 生产和服務的提供的控制 Validation of processes for production and service provision 過程確認 Identification and traceability 標識和可追溯性 Customer property 顧客的財产 Preservation of product 產品防護 ADC Communications ShangHai Production and service provision 生產和服務 的提供 Control of production and service provision 生產和服務的提 供的控制  Carry out production and service provision under controlled conditions 需在控制狀態下進行生產和服務的提供  the availability of information that describes the characteristics of the product, and the availability of work instructions 規定產 品特性的資訊和作業指導書的可獲得性  the use of suitable equipment 使用合適的設備 ADC Communications ShangHai Production and service provision 生產和服務 的提供  the availability and use of monitoring and measurement devices 合適的測量和監控裝置的可獲得性監控活動  defined release, delivery and post-delivery activities 規定的放 行，交付和交付後活動 過程確認  Validate any processes for production provision where the resulting output cannot be verified by subsequent monitoring or measurement 當輸出不能被隨後的檢查或監控驗證時，需進 行確認以展示有關過程能達致計劃的結果 ADC Communications ShangHai Production and service provision 生產和服務 的提供 Identification and traceability 標識和可追溯性 • Where appropriate, identify the product by suitable means throughout product realization 必要時，在各作業過程中以適 當方式標識產品 • Identify the product status with respect to monitoring and measurement requirements 針對測量和監控要求，標識產品 的狀態 • Control and record the unique identification of the product, where traceability is a requirement (see ). 當有追溯性要 求時，組織應管制和記錄產品獨特的鑑別方式 ADC Communications ShangHai Production and service provision 生產和服務 的提供 Customer property 顧客的財產 • Customer property shall be cared while it is under organization’s control or being used by the organization 當客 戶財產被組織監管或使用時，組織應給予妥善保管 • Identify, verify, protect and safeguard customer property provided for use or incorporation into the product 組織應確認 提供作為使用或組裝或產品的客戶財產與以標識、驗證、 保存和維護.對於遺失、損壞任何客戶財產、或不適當使用 • Report to the customer about any lost, damage or unsuitable use 記錄並向顧客報告丟失、損壞或發現不適用的情況‹Note : can include intellectual property 備註：可包括知識�權(保密 ) ADC Communications ShangHai Production and service provision 生產和服務的提供 產品防護  Preservation of product) Preserve the conformity of product during internal processing and delivery 在內部處理和交付的 期間，對產品的符合性進行防護  Labelling, handling, packaging, storage and protection 標識、搬 運、包裝、貯存和保護  Apply to the constituent parts of a product 適用於產品的組成 部分 ADC Communications ShangHai Control of monitoring and measuring devices 測量和監控裝置控制  Determine monitoring and measuring devices needed to provide evidence of conformity of product (see ). 組織應鑑定完成 量測及所需的量測和監督設備，以確認產品符合特定要求  Establish processes to ensure monitoring and measurement can be carried out 設立程序使量測及監督得以進行  Consistent with the monitoring and measurement requirements 符合量測的要求 ADC Communications ShangHai Control of monitoring and measuring devices 測量和監控裝置控制  Measuring equipment shall量測和監督設備應  Calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards 依規定的 周期或在使用前校正和調整，此項作業應可追溯至國 際或國家標準  If there is no such standards exist, the basis used for calibration or verification shall be recorded 如無此類標 準存在時，應書面記載校所使用之基率  Adjusted or re-adjusted as necessary 按需要調較或再調 較 ADC Communications ShangHai Control of monitoring and measuring devices 測量和監控裝置控制  Identified to enable the calibration status; and be safeguarded from adjustments that would invalidate the measurement result 妥善防護以免因調整不當而使其校正失效  Protected from damage and deterioration during handling, maintenance and storage 在搬運、維護、和儲存時應加以保 護以避色損傷和變質 ADC Communications ShangHai Control of monitoring and measuring devices 測量和監控裝置控制  Assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements (see ). 當發現校正失效時，應評估之前的結果並採取 適當的措施  The ability of any computer software used in the monitoring and measurement of specified requirements shall be confirmed prior to initial use to satisfy the intended application. This shall be undertaken and reconfirmed as necessary. 為特定要求而使 用在量測和監督的軟體在使用前應予以確認.  NOTE See ISO 10012-1 and ISO 10012-2 for guidance. 備註: 參閱ISO 10012指引 ADC Communications ShangHai 8 Measurement, analysis and improvement 測量、 分析和改進 General 總則 Monitoring and measurement測量和監控 Control of nonconforming product 不合格控制 Analysis of data 資料分析 Improvement 改進 ADC Communications ShangHai General 總則  Define, plan and implement measurement and monitoring processes 確定、計劃和實施測量及監控過程  Demonstrate conformity of the product 保證產品的符合性  Ensure the conformity of the QMS 保證質量管理系統的符合 性  Continually improve the effectiveness of the QMS 持續改進質 量管理系統的有效性  Determine and use applicable methods, include statistical techniques, and the extent of their use 鑒別和使用合適方法， 包括統計工具，及其使用的內容 ADC Communications ShangHai Monitoring and measurement 測量及監控 Customer satisfaction 顧客滿 Internal audit 內部審核 Monitoring and measurement of processes 測量及監控過程 Monitoring and measurement of product 測量及監控產品 ADC Communications ShangHai Monitoring and measurement 測量及監控  Measurement of the performance of the QMS 質量管理系統表 現的一個測量‹Monitor customer perception whether the organization has fulfilled customer requirements 監控顧客對 於組織已否滿足客戶要求的看法  Determine methods for obtaining and using this information 規 定收集及應用資訊的方法 ADC Communications ShangHai Monitoring and measurement 測量及監控  Conduct internal audits at planned intervals to determine whether the quality management system 組織應執行定期性的 內部審核，以判斷質量管理系統：  Conforms to the planned arrangements (see ), to the requirements of this International Standard and to the quality management system requirements 符合本國際標準的要求  Effectively implemented and maintained 已有效地運作和維持 ADC Communications ShangHai Monitoring and measurement 測量及監控  An audit program shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits 組織應制定審 核計劃，該計劃將依活動的狀況和重要性、被審核的範圍 和以往審核結果列作考慮‹The audit criteria, scope, frequency and methods shall be defined 審核範圍、頻率和方法應作界 定‹Auditors shall not audit their own work 審核應由與受審方 之工作無直接關係的人員執行  The responsibilities and requirements for planning and conducting audits, and for reporting results shall be defined 審 核的策劃、執行及報告等責任及要求應作界定 ADC Communications ShangHai Monitoring and measurement 測量及監控  Follow-up activities shall include the verification of the actions taken and the reporting of verification results (see ) 後續 跟催活動應包括驗證糾正措施並記錄驗證結果  The management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes 管理階層應確定對 審核期間所發現之缺失所採取的糾正措施在在限期前執行  NOTE See ISO 10011-1, ISO 10011-2 and ISO 10011-3 for guidance. 備註: 參閱ISO 10011-1, ISO 10011-2和ISO 10011- 3指引 ADC Communications ShangHai Monitoring and measurement 測量及監控 Monitoring and measurement of processes 測量及監控過程 • Apply suitable methods for monitoring and measurement 組織 應採用適當量測和監督方法 • Demonstrate the ability of the processes to achieve planned results 方法需展示過程可達致計劃結果的能力 • Correction and corrective action shall be taken if not achieve in order to ensure conformity of the product 若不能達致，需採 取糾正和糾正措施以確保產品的符合性 ADC Communications ShangHai Monitoring and measurement 測量及監控 Monitoring and measurement of product 測量及監控產品 • Monitor and measure the characteristics of the product to verify that product requirements are satisfied 組織應量測和監督產品的特性，以驗證產品符合要求 • Carry out at appropriate stages of the product realization process in accordance with the planned arrangements (see ) 這些監督和量測應架構在產品實現流程的適當階段 • Evidence of conformity with the acceptance criteria shall be maintained. 符合允收標準的證據應予以文件化 • Records shall indicate the person(s) authorizing release of product (). • 記錄應能顯示負責產品放行的權責人員 ADC Communications ShangHai Monitoring and measurement 測量及監控  Product release and service delivery shall not proceed until the planned arrangements (see ) have been satisfactorily completed. Otherwise it should be approved by a relevant authority or the customer. 只有在所有規定的活動都已圓滿完成後，產品才能放行和服 務才能交付，不然應取得客戶的核准.  No clear regulation on receive, process and final inspection of product 沒有明確規定進貨，過程和最終檢驗 ADC Communications ShangHai Control of nonconforming product 不合格控 制  Ensure product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery 組織應確保不合格的產品予以鑑別和管制，以防止無意的使 用或交貨  The controls and related responsibilities and authorities for shall be defined in a documented procedure 這些活動應於書面程序內界定 ADC Communications ShangHai Control of nonconforming product 不合格控 制  The organization shall: 組織應：  by taking action to eliminate the detected nonconformity 不合格產品應改正並於改正後重新查驗以顯示其符合性  by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer 當有所要求時，不合格產品的使用應向客戶、實際使用 者、驗證團體或其它團體報告取得特准  by taking action to preclude its original intended use or application 採取措施防止最初的用途或應用 ADC Communications ShangHai Control of nonconforming product 不合格控 制  Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, shall be maintained (see ) 保存不合格產品的性質及相應措施的記錄  Take appropriate actions to the effects or potential of the nonconformity 在交付後或開始使用後方查出，需針對影響或潛在影響採取 適當措施  When nonconforming product is corrected it shall be subject to reverification to demonstrate conformity to the requirements 改正後的產品需要再驗證以顯示已符合要求 ADC Communications ShangHai Control of nonconforming product 不合格控 制  If nonconforming product is detected after delivery or use has started, the organization shall take action appropriate to the effects, or potential effects, of the nonconformity 當不合格產品是在交貨後或開始使用後才被發覺，組織應視 不符合狀況採取適當的措施 ADC Communications ShangHai Analysis of data 數字分析  Determine the suitability and effectiveness of the QMS system 確定質量管理  系統的適用性和有效性  Identify improvement 識別改進  Information include 資料包括：  Customer satisfaction 顧客滿意/不滿意  Conformance to product requirements 與顧客要求符合性  Characteristics and trends of processes and products 過程及產品特性和趨勢  Suppliers 供方  Source : Monitoring and measurement activities or other related source 來源：測量和監控活動及其他相關來源 ADC Communications ShangHai Improvement 改進 Continual improvement 策劃持續改進  Continually improve the effectiveness of the QMS through the use of 需持續改進質量管理系統的有效性  Quality policy 質量方針  Quality objectives 質量目標  Results 審核結果  Analysis of data 資料分析  Corrective and preventive actions 糾正和預防措施  Management review 管理評審 ADC Communications ShangHai Improvement 改進 Corrective action 糾正措施 Corrective actions shall be token action to eliminate the cause of nonconformities in order to prevent recurrence 組織應採取糾正措施以清除不合格的原因並防止再次發生  Corrective actions shall be appropriate to the effects of the nonconformities encountered 糾正措施應與所遭遇問題的衝擊相符 ADC Communications ShangHai Improvement 改進  A documented procedure shall be established to define requirements for 糾正措施程序應包括：  Reviewing nonconformities (including customer complaints) 不符合格的鑑別（包括客戶投訴）  Determining the causes of nonconformities 確定不符合 的原因  Evaluating the need for action to ensure that nonconformities do not recur 評估為確保不符合不再發生所需的措施  Determining and implementing action needed 確定和實施所需的糾正措施  Records of the results of action taken (see ) 記錄措施實施的結果  reviewing corrective action taken 審查所採取的糾正措 施 ADC Communications ShangHai Improvement 改進 Preventive action 預防措施 • Determine preventive action to eliminate the causes of potential nonconformities in order to prevent their occurrence 組織應確定預防預防措施以消除潛在不符合的原因以避免其 發生 • Preventive actions shall be appropriate to the effects of the potential problems. 預防措施與所遭遇問題的大小和衝擊相符 ADC Communications ShangHai Improvement 改進  A documented procedure shall be established to define requirements for 預防措施程序應包括:  Determining potential nonconformities and their causes 鑑別潛在的不符合  Evaluating the need for action to prevent occurrence of nonconformities 評估預防措施的需要性  Determining and implementing action needed 確定和確認所需的預防措施執行狀況  Records of results of action taken (see ) 記錄預防措施的結果  Reviewing preventive action taken 審查所採取的預防措 施 ADC Communications ShangHai Conclusions 總結 Additional requirements 新增的要求： • Continual improvement 持續改進 • More emphasis on the role of top management 更強調最高管理層的角色 • Consider regulatory and statutory requirements 考慮法律和法規的要求 • Establish measurable index on related function and level 在相關職能和各層次建立可量度的目標 • Monitor information of customer satisfaction and dissatisfaction in order to evaluate system performance 監控顧客滿意及不滿意資訊以評估系統的表現 ADC Communications ShangHai Conclusions 總結  More concern on the readiness of resources 更關注資源的備用性  Decide the effectiveness of training 決定培訓的有效性  Extend measurement to system, processes and products 擴展至系統、過程和產品的測量  Analysis collected data to evaluate the QMS performance 對質量管理系統表現所收集的資料的分析 THANKS