【正文】 適用時 ， 組織應使用 統(tǒng)計方 法 進行驗證 。 采用 顧客指定的貨源 不能免除組織確保采購產品的質量的責任 。 68 Prototype Programme 樣件項目 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. 當顧客要求時 ， 組織 應 有一個 原型樣件計劃和控制計劃 。 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。 對于 計數(shù)型 數(shù)據的抽樣 ， 接受準則應是 零缺陷 （ 見 ). Acceptance Criteria 接受準則 53 The anization shall ensure the confidentiality of customercontracted products and projects under development, and related product information. 組織 應 確保 顧客合同 中在開發(fā)的產品和項目以及相關產品信息的保密性 . 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 有一個過程對影響產品實現(xiàn)的更改進行控制和反應 。 Training 培訓 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 為包括合同工或代理在內的從事新的或更改的影響產品質量的工作的人 員提供 崗位培訓 。 Control Of Records 記錄控制 32 The control of records shall satisfy regulatory and customer requirement. 記錄的控制 應 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 Emphasizing defect prevention 強調缺陷預防 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 ? 任何汽車供應鏈內組織均符合本規(guī)范所指具認證資格 ? 任何由發(fā)動機驅動之車輛均可考量視為汽車業(yè) ? 汽車相關之零件 ? 適用于生產或服務零件制造場所 ? 場所的定義為增值制造流程產生的地點 ? 制造的定義為制作生產原料 ,零件或組裝 ,或熱處理 ,涂裝與電鍍服務 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 /設備 /裝置 方法 /程序 /指導書 /技術 測量 /評估 /績效 /指標 Process Model Analysis 龜形圖 Process 12 Process And Process Approach ? Customer Oriented Processes 客戶 導向過程 ? Support Oriented Processes 支 持性導向過 程 ? Management Oriented Processes 管理導向過程 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個月確認所有客戶 要求已實施 向 IATF認可之認證 單位提出申請 全球只有 48家被認可 到廠進行文 件 審查 三個月內進行正式評鑒 (事先提報到 IATF) 文審后三個月內 需正式評鑒 評估糾正措施 核發(fā)具 IATF序號 之認證證書 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 以客戶為關注焦點 Quality Management System Principles Leadership 領導作用 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與供方互利的關系 Continual Improvement 持續(xù)改進 18 ? Customer Focus 以客戶為關注焦點 Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations。實施應包括文件的更新。從事特殊指派任務的人員應被資格考核，如要求對顧客 要求的滿意程度予以特別關注。產品先期質量策劃包含著 防錯和持續(xù)改進的概念 ，與找出錯誤不同，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