【正文】 Prepared By Chriss Zheng Site QA Jul. 2023 質(zhì)量管理體系 — 汽車生產(chǎn)和相關(guān)維修零件組織應(yīng)用 ISO9001： 2023的特別要求 1 Agenda ? History ? Quality System Basic Knowledge ? TS16949 Additional Requirements 2 ISO/TS 16949:2023 BS 5750 ISO 9000:1994 VDA6 QS9000 AVSQ EAQF ISO/TS 16949:1999 ISO 9001:2023 ISO/TS 16949: 2023 Roadmap 3 ISO/TS 16949:2023 Finalization ? ISO/TS 16949:2023是由下列單位起草 : ? 國際汽車行動小組 (IATF) ? 日本車輛制造者協(xié)會 (JAMA) ? ISO/TC 176, 所支持 ? 取代初版 1999 ? ISO/TS 16949:2023 整合 所有 ISO9001:2023之要求 4 Membership Of The IATF Registrar scheme administered by IATF. Certification delegated to National Trade associations。 5 QS9000 Difference Between ISO9001/TL9000/QS9000/TS16949 ISO/TS 16949 TL9000: ISO9001:2023 6 ISO/TS 16949:2023 Goal Continual improvement 持續(xù)改進 Emphasizing defect prevention 強調(diào)缺陷預(yù)防 The reduction of variation and waste 減少變差和浪費 Including customer specific requirements 7 ISO/TS 16949:2023 OEM Requirement 8 Eligibility for ISO/TS16949:2023 ? 任何汽車供應(yīng)鏈內(nèi)組織均符合本規(guī)范所指具認(rèn)證資格 ? 任何由發(fā)動機驅(qū)動之車輛均可考量視為汽車業(yè) ? 汽車相關(guān)之零件 ? 適用于生產(chǎn)或服務(wù)零件制造場所 ? 場所的定義為增值制造流程產(chǎn)生的地點 ? 制造的定義為制作生產(chǎn)原料 ,零件或組裝 ,或熱處理 ,涂裝與電鍍服務(wù) 9 Continual Improvement Of The Quality Management System Customer Customer Requirements Satisfaction Management responsibility Resource Management Measurement, analysis and improvement Product realization Product output input Quality Management Process Model 10 輸入 輸出 活動 （加資源） Basic Process Model 11 Output Input Resources (Equipment/ Capital) Resources (People) How 如何做 What result 量度方法 能力 /技能 /資格 機器 /設(shè)備 /裝置 方法 /程序 /指導(dǎo)書 /技術(shù) 測量 /評估 /績效 /指標(biāo) Process Model Analysis 龜形圖 Process 12 Process And Process Approach ? Customer Oriented Processes 客戶 導(dǎo)向過程 ? Support Oriented Processes 支 持性導(dǎo)向過 程 ? Management Oriented Processes 管理導(dǎo)向過程 13 ? Market Analysis/Customer Requirement ? Tender/Bid ? Order/Request ? Product and Process Design ? Product and Process Verification/Validation ? Product Manufacturing ? Delivery ? Payment ? Warranty/Service ? Post Sales/Customer Feedback Customer Oriented Processes 組織 活動 1 活動 2 活動 3? 支援過程 輸入 輸出 客戶 In Out 1 2 3 14 Out In 7 6 5 4 3 2 8 1 In In In In In In In Out Out Out Out Out Out Out 客戶要求 報價 客戶拿到 『報價單』 Customer Oriented Processes 章魚圖 15 ? Management review ? Customer focus ? Quality policy and objectives monitor ? Quality management system planning Management Oriented Processes 16 Certificate Process 創(chuàng)建體系并實施至少 12個月確認(rèn)所有客戶 要求已實施 向 IATF認(rèn)可之認(rèn)證 單位提出申請 全球只有 48家被認(rèn)可 到廠進行文 件 審查 三個月內(nèi)進行正式評鑒 (事先提報到 IATF) 文審后三個月內(nèi) 需正式評鑒 評估糾正措施 核發(fā)具 IATF序號 之認(rèn)證證書 依續(xù)審規(guī)定進行 延期不得超過一個月 第三年為重新評鑒 , 重新評估證書再發(fā) 17 Customer Focus 以客戶為關(guān)注焦點 Quality Management System Principles Leadership 領(lǐng)導(dǎo)作用 Involvement Of People 全員參與 Process Approach 過程方法 System Approach To Management 系統(tǒng)化管理 Factual Approach To Decision Making 基于事實的決策方法 Mutually Beneficial Supplier Relationships與供方互利的關(guān)系 Continual Improvement 持續(xù)改進 18 ? Customer Focus 以客戶為關(guān)注焦點 Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations。 組織依賴于他們的客戶，因此應(yīng)該了解客戶當(dāng)前和未來的需求，應(yīng)該滿足客 戶的要求，并應(yīng)該致力于超越客戶的期望。 Quality Management System Principles 19 1. Leadership 領(lǐng)導(dǎo)作用 2. Leaders establish unity of purpose and direction of the anization. They 3. should create and maintain the internal environment in which people can 4. bee fully involved in achieving the anization’ s objective. 5. 領(lǐng)導(dǎo)者建立其組織的方向和統(tǒng)一的目標(biāo)，他們應(yīng)該創(chuàng)造并維護內(nèi)部環(huán)境以使 6. 組織中的人們能充分參與到實現(xiàn)組織的目標(biāo)的活動中去 。 Quality Management System Principles 20 ? Involvement of People 全員參與 People at all levels are the essence of an anization and their full involvement enables their abilities to be used for the anization’ s benefit. 組織中所有層次的員工是組織的基本，他們的充分參與能使他們的才能被用 于使組織的獲利。 Quality Management System Principles 21 ? Process Approach 過程方法 A desired result is achieved more efficiently when activities and related resources are managed as a process. 當(dāng)活動和有關(guān)資源被作為一個過程管理起來時，期望的結(jié)果能被更有效的實現(xiàn)。 Quality Management System Principles 22 ? System Approach To Management 系統(tǒng)化管理 Identifying, understanding and managing interrelated processes as a system contributes to the anization’ s effectiveness and efficiency in achieving its objectives. 作為一個系統(tǒng)識別、了解并管理相互關(guān)聯(lián)的過程，致力于組織的效益和效率 以實現(xiàn)組織的目標(biāo)。 Quality Management System Principles 23 ? Continual Improvement 持續(xù)改進 Continual improvement of the anization’ s overall performance should be a permanent objective of the anization. 持續(xù)改進組織的各個方面的表現(xiàn)應(yīng)該是組織永恒的目標(biāo)。 Quality Management System Principles 24 ? Factual Approach To Decision Making 基于事實的決策方法 Effective decisions are based on the analysis of data and information. 有效的決策應(yīng)基于對數(shù)據(jù)和信息的分析的基礎(chǔ)上。 Quality Management System Principles 25 ? Mutually Beneficial Supplier Relationships 與供方互利的關(guān)系 An anization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value. 組織及其供應(yīng)商之間應(yīng)是相互依賴的，并且互利的關(guān)系能提高兩者創(chuàng)造價值的 能力。 Quality Management System Principles 26 ISO/TS16949:2023 Document Procedure 七個需要文檔化的程序 ： ? 文檔管制 () ? 記錄管制 () ? 培訓(xùn) () ? 內(nèi)部稽核 () ? 不合格品控制 () ? 糾正措施 () ? 預(yù)防措施 () 27 七個必需的程序，但未必文檔化 ： ? 員工激勵與強化 () ? 變更管制 () ? 來料品質(zhì) () ? 服務(wù)信息的反饋 () ? 監(jiān)控與測量裝置的控制 () ? 內(nèi)部實驗室 () ? 持續(xù)