【正文】 Input to management review shall include an analysis of actual and potential fieldfailures impact on quality, safety, or the environment. 管理評(píng)審輸入應(yīng)包括實(shí)際和潛在 外部 失效 ,以及它們對(duì)質(zhì)量 、 安全或環(huán)境的影 響的分析 。 Responsibility For Quality 質(zhì)量職責(zé) 37 Top management shall designate personnel with responsibility and authority to ensure the customer requirements are addressed. This includes selection of special characteristics, setting quality objectives and related training, corrective and preventive actions, product design and development. 最高管理者 應(yīng) 指派人員有職責(zé)和權(quán)限確保顧客要求被闡述 。 Records Retention 記錄保存 33 5Management responsibility 34 Top management shall review the product realization processes and the support processes to assure the effectiveness and efficiency. 最高管理者 應(yīng) 評(píng)審產(chǎn)品實(shí)現(xiàn)過程和其支持過程以確保它們的 有效性和效率 。實(shí)施應(yīng)包括文件的更新。 Quality Management System Principles 26 ISO/TS16949:2023 Document Procedure 七個(gè)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(gè)必需的程序，但未必文檔化 ： ? 員工激勵(lì)與強(qiáng)化 () ? 變更管制 () ? 來料品質(zhì) () ? 服務(wù)信息的反饋 () ? 監(jiān)控與測(cè)量裝置的控制 () ? 內(nèi)部實(shí)驗(yàn)室 () ? 持續(xù)改進(jìn) () ISO/TS16949:2023 Document Procedure 28 4Quality Management System 29 Ensuring control over outsourced processes shall not absolve the anization of the responsibility of conformity to all customer requirements. 確保對(duì) 外包過程 的控制不能免除組織符合所有顧客要求的責(zé)任。 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(gè)系統(tǒng)識(shí)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(shí)現(xiàn)組織的目標(biāo)。 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。 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(jìn) Emphasizing defect prevention 強(qiáng)調(diào)缺陷預(yù)防 The reduction of variation and waste 減少變差和浪費(fèi) 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(dòng)機(jī)驅(qū)動(dòng)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(chǎng)所 ? 場(chǎng)所的定義為增值制造流程產(chǎn)生的地點(diǎn) ? 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(dòng) （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(jī)器 /設(shè)備 /裝置 方法 /程序 /指導(dǎo)書 /技術(shù) 測(cè)量 /評(píng)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(dòng) 1 活動(dòng) 2 活動(dòng) 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(bào)價(jià) 客戶拿到 『報(bào)價(jià)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(shí)施至少 12個(gè)月確認(rèn)所有客戶 要求已實(shí)施 向 IATF認(rèn)可之認(rèn)證 單位提出申請(qǐng) 全球只有 48家被認(rèn)可 到廠進(jìn)行文 件 審查 三個(gè)月內(nèi)進(jìn)行正式評(píng)鑒 (事先提報(bào)到 IATF) 文審后三個(gè)月內(nèi) 需正式評(píng)鑒 評(píng)估糾正措施 核發(fā)具 IATF序號(hào) 之認(rèn)證證書 依續(xù)審規(guī)定進(jìn)行 延期不得超過一個(gè)月 第三年為重新評(píng)鑒 , 重新評(píng)估證書再發(fā) 17 Customer Focus 以客戶為關(guān)注焦點(diǎn) 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(shí)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(jìn) 18 ? Customer Focus 以客戶為關(guān)注焦點(diǎn) Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations。 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(dòng)和有關(guān)資源被作為一個(gè)過程管理起來時(shí)，期望的結(jié)果能被更有效的實(shí)現(xiàn)。 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(jià)值的 能力。 組織應(yīng)保存每項(xiàng)更改在生產(chǎn)中實(shí)施日期的 記錄 。 Control Of Records 記錄控制 32 The control of records shall satisfy regulatory and customer requirement. 記錄的控制 應(yīng) 滿足 法律和顧客要求 。 跨 所有班次 的生產(chǎn)操作 應(yīng) 配備人員負(fù)責(zé)或指派職責(zé) ， 以確保產(chǎn)品質(zhì)量 。 管理評(píng)審的部分內(nèi)容 應(yīng) 是 質(zhì)量目標(biāo)的監(jiān)視和不良質(zhì)量成本 （見 ） 的定期報(bào)告和評(píng)估。 Product Design Skills 產(chǎn)品設(shè)計(jì)技能 42 The anization shall establish and maintain documented procedures for identifying training needs and achieving petence of all personnel performing specific assigned tasks shall be qualified, as required with particular attention to the satisfaction of customer requirements. 組織 應(yīng) 建