【正文】 d two working weeks. The anization shall maintain a record of the date on which each change is implemented in production. Implementation shall include updated documents. 組織應有一個過程以便確保根據(jù)顧客要求的日程及時評審、發(fā)放和實施所有顧客 工程標準 /規(guī)范及更改。 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)應該是組織永恒的目標。 Quality Management System Principles 19 1. Leadership 領(lǐng)導作用 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)導者建立其組織的方向和統(tǒng)一的目標，他們應該創(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)組織的目標的活動中去 。 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。 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 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. 有效的決策應基于對數(shù)據(jù)和信息的分析的基礎(chǔ)上。及時評審應盡快并且不超過 兩個工作周 。 Engineering Specifications 工程規(guī)范 31 注 1：上述處置包括 處理 ； 注 2：記錄也包括 顧客規(guī)定 的記錄 。 負責產(chǎn)品質(zhì)量的人員 應 有權(quán)停止生產(chǎn)以糾正質(zhì)量問題 。 SLR Customer representative is PM Customer Representative 客戶代表 38 These reviews shall include all requirements of the quality management system and its performance trends as an essential part of the continual improvement process. Part of the management review shall be the monitoring of quality objectives, and the regular reporting and evaluation of the cost of poor quality. These results shall be recorded to provide, as a minimum, evidence of the achievement of : the business plan quality objectives customer satisfaction with product supplied. 作為持續(xù)改進過程的一個重要部分 ,這些評審 應 包括質(zhì)量管理體系的所有要求及 其業(yè)績的趨勢。 適用的工具和技術(shù) 應 被組織識別。 注 2：顧客規(guī)定要求的一個例子是數(shù)字化的 數(shù)學數(shù)據(jù) 的應用。 過程應包括在整個組織內(nèi)促進質(zhì)量和技術(shù)意識 。 應 開發(fā)并實施評價和監(jiān)視 現(xiàn)有操作和過程有效 性的方法。 Personnel Safety To Achieve Product Quality 與實現(xiàn)產(chǎn)品質(zhì)量相關(guān)的人員安全 48 The anization shall maintain its premises in a state of order, cleanliness and repair consistent with the product and manufacturing process needs. 組織 應 保持生產(chǎn)現(xiàn)場處于與產(chǎn)品和制造過程的需求相協(xié)調(diào)的有序、清潔和維護 的狀態(tài)。 Planning of product realization — Supplemental 產(chǎn)品實現(xiàn)的策劃－－補充 52 Acceptance criteria shall be defined by the anization and, where required, approved by the customer. For attribute data sampling, the acceptance level shall be zero defects . 接受準則 應 由組織規(guī)定并且在要求時由顧客批準 。 更改應在實施之前 進行確認 。 注 2：以上要求適用于產(chǎn)品更改和制造過程更改 。 56 CustomerDesignated Special Characteristics 顧客指定的特殊特性 The anization shall demonstrate conformity to customer requirements for designation, documentation and control of special characteristics. 組織 應 證明符合顧客關(guān)于 特殊特性 的指定 、 文件化和控制的要求 。 60 Design And Development 設(shè)計和開發(fā) NOTE: The requirements of include product and manufacturing process design and development, and focus on error prevention rather than detection. 注： ， 應以 錯誤預防為關(guān)注焦點 而不是探測 。 開發(fā)和評審控制計劃 。 63 Special Characteristics 特殊特性 The anization shall identify special characteristics [see d)] and . include all special characteristics in the control plan, . ply with customerspecified definitions and symbols, . identify process control documents including drawings, FMEAs, control plans, and operator instructions with the customer’s special characteristic symbol or the anization’s equivalent symbol or notation to include those process steps that affect special characteristics. NOTE： Special characteristics can include product characteristics and process parameters. 組織 應 確定 特殊特性 （ 見 d） 并： 在控制計劃中包含所有特殊特性 。 制造過程設(shè)計輸出應包括： 規(guī)范和圖紙； 制造過程流程圖 /場地平面布置圖； 制造過程 FMEAs； 控制計劃 （ 見 ） ； 作業(yè)指導書； 過程批準的接受準則； 質(zhì)量 、 可靠性 、 可維護性和可測量性數(shù)據(jù)； 適當時 ， 防錯活動結(jié)果； 產(chǎn)品 /制造過程不符合的快速探測和反饋方法 。 67 Design and development validation — Supplemental 設(shè)計和開發(fā)確認－補充 Design and development validation shall be performed in accordance with customer requirements including programme timing. 設(shè)計和開發(fā)確認 應 按照包括 計劃時間在內(nèi) 的顧客要求執(zhí)行 。 當這些服務(wù)被外包時 ， 組織應對外包的服務(wù)負責 ， 包括提供技術(shù)指導 。 70 Control Of Design And Development Changes 設(shè)計和開發(fā)更改的控制 NOTE: Design and development changes include all changes during the product programme life (see ). 注：設(shè)計和開發(fā)更改包括在產(chǎn)品計劃周期內(nèi)的 所有更改 ( 見 )。 73 Supplier Quality Management System Development 供方質(zhì)量管理體系開發(fā) The anization shall perform supplier quality management system development with the goal of supplier conformity with this Technical Specification. Conformity with ISO 9001:2023 is the first step in achieving this goal. NOTE: The prioritization of suppliers for development depends upon, for example, the supplier’s quality performance and the importance of the product supplied. Unless otherwise specified by the customer, suppliers to the anization shall be third party registered to ISO 9001:20