【正文】 適用時(shí) ， 組織應(yīng)使用 統(tǒng)計(jì)方 法 進(jìn)行驗(yàn)證 。 采用 顧客指定的貨源 不能免除組織確保采購(gòu)產(chǎn)品的質(zhì)量的責(zé)任 。 68 Prototype Programme 樣件項(xiàng)目 When required by the customer, the anization shall have a prototype programme and control plan. The anization shall use, wherever possible, the same suppliers, tooling and manufacturing processes as will be used in production. All performancetesting activities shall be monitored for timely pletion and conformity to requirements. While services may be outsourced, the anization shall be responsible for the outsourced services, including technical leadership. 當(dāng)顧客要求時(shí) ， 組織 應(yīng) 有一個(gè) 原型樣件計(jì)劃和控制計(jì)劃 。 61 Multidisciplinary Approach 多方論證方式 The anization shall use a multidisciplinary approach to prepare for product realization, including . development/finalization and monitoring of special characteristics, . development and review of FMEAs, including actions to reduce potential risks, . development and review of control plans. NOTE: A multidisciplinary approach typically includes the anization39。 對(duì)于 計(jì)數(shù)型 數(shù)據(jù)的抽樣 ， 接受準(zhǔn)則應(yīng)是 零缺陷 （ 見(jiàn) ). Acceptance Criteria 接受準(zhǔn)則 53 The anization shall ensure the confidentiality of customercontracted products and projects under development, and related product information. 組織 應(yīng) 確保 顧客合同 中在開(kāi)發(fā)的產(chǎn)品和項(xiàng)目以及相關(guān)產(chǎn)品信息的保密性 . Confidentiality 保密 54 Change Control 更改控制 The anization shall have a process to control and react to changes that impact product realization. The effects of any change, including those changes caused by any supplier, shall be assessed, and verification and validation activities shall be defined, to ensure pliance with customer requirements. Changes shall be validated before implementation. For proprietary designs, impact on form, fit and function (including performance and/or durability) shall be reviewed with the customer so that all effects can be properly evaluated. When required by the customer, additional verification/identification requirements, such as those required for new product introduction, shall be met. 組織 應(yīng) 有一個(gè)過(guò)程對(duì)影響產(chǎn)品實(shí)現(xiàn)的更改進(jìn)行控制和反應(yīng) 。 Training 培訓(xùn) 43 The anization shall provide onthejob training for personnel in any new or modified job affecting product quality including contract or agency personnel. Personnel whose work can affect quality shall be informed about the consequences to the customer of nonconformity to quality requirements. 組織 應(yīng) 為包括合同工或代理在內(nèi)的從事新的或更改的影響產(chǎn)品質(zhì)量的工作的人 員提供 崗位培訓(xùn) 。 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 。 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(jī)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(guò)程 ? Support Oriented Processes 支 持性導(dǎo)向過(guò) 程 ? Management Oriented Processes 管理導(dǎo)向過(guò)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(guò)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(guò)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(guò)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。實(shí)施應(yīng)包括文件的更新。從事特殊指派任務(wù)的人員應(yīng)被資格考核，如要求對(duì)顧客 要求的滿意程度予以特別關(guān)注。產(chǎn)品先期質(zhì)量策劃包含著 防錯(cuò)和持續(xù)改進(jìn)的概念 ，與找出錯(cuò)誤不同，而且是基于 多方論證 的方法。 58 Organization Manufacturing Feasibility 組織制造可行性 The anization shall investigate, confirm and document the manufacturing feasibility of the proposed products in the contract review process, including risk analysi