1,葵花寶典:品質管理系統/QMS (e.g. ISO 9001/9004:2000 , QS-9000 , ISO/IEC 17025 , ISO/TS 16949等) 之推行 & 稽核 (Conceptual Application & Assessor Handbook) Presented by Rock Chang Country Manager Underwriters Laboratories Inc. (Taiwan) Issued: May 28, 2001 Revised: October 15, 2002 (簡),2,Course Objectives 也算是知識管理( Knowledge Management) 當中的 一種知識呈現/ 知識成文化(Knowledge Representation): 將內隱知識(Implicit Knowledge)成文化、外化，成 為外顯知識(Explicit Knowledge) , 再和大家分享 (Knowledge Sharing)! 企業知識乃指能有效解決問題的方法及資訊，又可分 為外顯知識及內隱知識。,3,說明:外顯知識是指可以有系統的語言來表示的知識 (e.g. 企業的內部 ISO 文件&記錄等)， 內隱知識 則指無法以正式的方法表達 及溝通的知識。(e.g.隱藏在個別員工腦袋裡的專門技術或經驗)。由於外顯知識才能被傳播、擷取和再使用，因此如何將內隱知識 轉化成外顯知識是企業或個人知識管理的重要課題之一，尤其是對一些知識型產業，知識型工作者，高附加價值製造業。,4,知識管理之終極目的是知識創新創值:實施知識管理所倚重的不是資訊科技，而是一套鼓勵員工不斷創新創值的制度與文化，如讓基層員工參與研發，允許工作人員犯錯(但不可第二次犯相同的錯)，其對員工的尊重，使得該公司能得以從知識管理進入知識創造的境界，自然能不斷的創新。組織不陷入僵化的做法，就是在創新的精神下創造一個環境，讓企業內能發生創造性的摩擦和建設性的對立，如此則可有良性循環產生，企業有源源不絕的創新觀念和行動，使企業永遠具有競爭力。而創新是必須注意到人文面，才是成功。,5,ISO/TS 16949:2002 6.2.2.4之 :Employee motivation and empowerment (員工激勵與授/賦權)The organization shall have a process to motivate employees to achieve quality objectives, to make continual improvements, and to create an environment to promote innovation. The process shall include the promotion of quality and technological awareness throughout the whole organization. (組織必須有一流程來激勵員工 , 以達成品質目標 , 進行持續改善 , 以及建立一個能鼓勵創新之環境。此流程需包括將品質及科技意識推廣至整個組織內 。),6,Data (8.4) Information Knowledge (is power):ISO 9004:2000 Management should treat data ( 8.4 Analysis of data) as a fundamental resource for conversion to information and the continual development of an organizations knowledge , which is essential for making factual decisions(7th Quality Management Principle - Factual approach to decision making /Management by (quality) Objective /CI/CA/PA) and can stimulate innovation(知識創新e.g. 7.3 Design & Development)。,7,創新: 並非指技術研發和知識本身，而是指取得和應用知識和技術能將其轉變為市場價值的能力( i.e. 市場價值之創造)。這種市場價值乃經由市場競爭比較而來 , 而其最後之抉擇則在於滿足顧客需要的能力( i.e. 目前政府大力推動之Innovalue 創新價值 )。郭台銘說，對於一家公司而言，創新指的是速度、彈性、價格與品質的更佳化。,8,企業要靠什麼來創造價值?行銷( 即了解與掌握顧客的需求 Input)與 創新(即為顧客提出有效的解決方法 Output): Process approach!個人覺得 Learning Organization (或Organizational Learning)的真正精神是 Double-loop Learning: Tactical (Operational), Strategic Feedback & Learning!e.g. CAR, ECN, SWOT, FMEA, BSC,9,為何有新版 ISO 9001:2000? 目的? 應付(更適合)小公司 (Small Businesses) 小而美 (ISO 9001: 1994不太適用小公司) 更適合各行各業 (ISO 9001:1994 年版傾向於製造業之用) 更簡單易懂 1994年版20個條文之問題: ISO 9001:1994auditor-friendly (easy to audit but difficult for org.)vs. ISO 9001:2000 organization-friendly 和 ISO 14001 相容 品質管理系統 (QMS) 和作業流程 (Business Processes) 相結合: 新版ISO 9001 focuses on “how to manage a business to achieve planned/desired results (i.e. effectiveness), not on individual clauses” vs. 舊版20個條文: “The supplier shall.”,10,更強調 持續改善 和 客戶滿意 幾乎是向 QS-9000 靠攏強調高階管理階層之參與 (Emphasis on Top Management ): 條文5強調一張証書涵蓋總公司/旗下多廠之認証模式 (Emphasis on Corporate Registration/Certification): 更cost & QMS effective! UL不會為了多一些income而故意隱瞞此點! Beyond certification towards performance improvement.,11,New structure of the standards should not oblige organizations to change their system documentation to match the structure of the standards.System documentation is unique to each organization.Requirements from the old ISO 9001:1994 have been either:Maintained (Example-purchasing)Simplified (Example-calibration)Eliminated (Example-documentation),Structure changes,12,Features of ISO 9001:2000,Most requirements come from either:8 Quality Management Principles1994 version of ISO 9001ISO 14001:1996QS-9000 (Automotive industry),13,Single requirements standard (no more ISO 9002/3) Need for clear scope statementsClause 1.2 “Application” (ISO/TC 176 Guidance Document + IAF Communique)Special significance of “Design & Development”Process approach and PDCAComparison (Maybe a little unfair on ISO 9001:1994!)ISO 9001:1994 “Documented procedures evidenced by records”ISO 9001:2000 “Defined and managed processes evidenced by results”,14,新版 ISO 9001:2000 稽核方式 (AssessmentPhilosophy) 有那些變更?,文件化要求大幅減少 只剩九項強制要求和公司自覺有必要之文件: 書面化之品質政策 , 品質目標品質手冊, 文件管制, 記錄管制, 內部稽核, 不良品管制, 矯正措施和預防措施 。,15,註:Procedure (ISO 9000:2000 3.4.5)Specified way to carry out an activity or a process NOTE 1 procedures can be documented or not.NOTE 2 When a procedure is documented, the term “written procedure” or “documented procedure” is frequently used. The document that contains a procedure can be called a “procedure document”.判定是否符合規定 : 彈性更大 ! QMS driven by quality policy, quality objectives and continuous improvement targets (由品質政策, 品質目標及持續改善目標來驅動品質管理系統!),16,TL 9000 4.1.1 Quality Objectives - Objectives for quality shall include targets for the TL 9000 metrics defined in the TL 9000 Quality System Metrics handbook.註: QMS代表 Quality Management System (品質管理系統)。,