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ISO/TS 16949: 2002

ISO/TS 16949: 2002. 刘俊霖 WTA 深圳地区 TS16949 高级顾问师 QS-9000：1998 主任审核员 培训 ISO/TS 16949：2002 审核员 培训. ISO/TS16949:2002 新 时代汽车产业 QMS 标准. Agenda. Module 1 汽车产业标准变革 Module 2 ISO/TS 16949 :2002 认证资格指南 Module 3 ISO/TS 16949:2002 流程导向观念 介绍

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ISO/TS 16949: 2002

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  1. ISO/TS 16949:2002 刘俊霖 WTA深圳地区 TS16949高级顾问师 • QS-9000：1998 主任审核员培训 • ISO/TS 16949：2002 审核员培训 1

  2. ISO/TS16949:2002 • 新时代汽车产业QMS标准

  3. Agenda Module 1 汽车产业标准变革 Module 2 ISO/TS 16949:2002 认证资格指南 Module 3 ISO/TS 16949:2002 流程导向观念介绍 Module 4 ISO/TS 16949:2002 体系导入与实施 Module 5 ISO/TS 16949:2002 认证规定 3

  4. Module 1 汽车产业标准变革

  5. 汽车产业标准变革 1979 BS 5750 英国国家标准 1981 Q 101 福特汽车品质体系标准(Quality System Standard) 1983 Chrysler SQAM 克莱斯勒品质保证 (Supplier Quality Assurance Manual) 1987 ISO 9000 国际标准 GM TFE 通用汽车(Targets for Excellence) 1994 ISO 9000 修正之国际标准 QS-9000 第一版 1995 QS-9000 第二版 1998 QS-9000 第三版 1999 ISO/TS 16949 依 ISO 9001:1994架构之技术规范(Version 1) 2000 ISO Revision ISO9001:2000 2002 ISO/TS 16949 依ISO 9001:2000架构之技术规范(Version 2) 5

  6. ISO/TS 16949:2002 • ISO/TS 16949:2002是由下列单位起草: • 国际汽车行动小组 (IATF) • 日本车辆制造者协会(JAMA) • ISO/TC 176, 所支持 • 取代初版1999 • ISO/TS 16949:2002整合 所有 ISO9001:2000之要求 6

  7. ISO/TS 16949 ed 2 ISO 9001:2000 ISO/TS 16949 ed 1 VDA6 AVSQ QS-9000 EAQF ISO 9000 BS 5750

  8. Registrar scheme administered by IATF. Certification delegated to National Trade associations; • Membership of the IATF • (International Automotive Task Force); 8

  9. 其他汽车标准怎么走？ • QS-9000, VDA 6.1, EAQF 94 and AVSQ 94 to 没有升级成ISO 9001:2000 版本的计划 • QS-9000 将在2006年12月终止 • 德国VDA 6.1 目前没有明确终止日期 • 法国EAQF 94将在2003年12月终止 • 意大利AVSQ 94将在2003年12月终止 • 此将驱使转向ISO/TS 16949:2002 9

  10. 现有的汽车业标准会被ISO/TS 16949:2002取代吗? 不会! • QS-9000 仍被三大所认可到2006-12-15: • VDA 6.1 (German)與ISO9001:2K 並行 • AVSQ (Italian) • EAQF (French) 10

  11. ISO/TS 16949:2002会被视为现有标准的增加部分吗？ 是的. 循客户之特定要求, ISO/TS 16949 被视等同于: • QS-9000 (America) • VDA 6.1 (Germany) • AVSQ (Italy) • EAQF (France) • JAMA (Japan) 11

  12. 哪些汽车制造者接受ISO/TS 16949:2002? • Ford, GM, Daimler Chrysler, PSA Peugeot-Citroen, Renault, Fiat, BMW, Daimler Benz, Volkswagen,日本及南韩汽车制造者均支持ISO/TS 16949:2002 • 组织应向其客户征询是否接受ISO/TS 16949:2002 12

  13. Licenses QS-9000 28,000 TS 16949:2002 Time Sept 2004 • 发展趋势 300 issued by Jul 2003

  14. ISO/TS 16949:2002之目的 品质管理系统之发展以 持续不断改善之提供 强调缺失预防 减少供应链内之变异与浪费 附加可能之客户特定要求 定义基本的品质管理系统要求 避免多重的认证审核 提供共通之汽车业品质管理系统方法 14

  15. Module 2 ISO/TS16949:2002 认证资格指南 2003-1 更新版

  16. Eligibility for ISO/TS16949:2002 • Applicability of TS16949:2002 Certification : • Any organisation in the automotive supply chain meeting the eligibility criteria can obtain certification 任何汽车供应链内组织均符合本规范所指具认证资格 • Any motor-powered vehicle can be considered as automotive 任何由发动机驱动之车辆均可考量视为汽车业 • Therefore, suppliers in the Heavy Truck, Motorcycle, Construction Vehicle supply chains can obtain certification to TS16949:2002 因此重车,摩托车与营建车辆之供应链内之供货商均可取得TS16949:2002认证 16

  17. Eligibility for ISO/TS16949:2002 • Eligibility requirements for TS16949:2002 Certification : • Relevant to automotive-related products only 汽车相关之零件 • Applicable only to sites where production or service parts are manufactured 适用于生产或服务零件制造场所 • Site is defined as a location at which value added manufacturing processes occur 场所的定义为增值制造流程产生的地点 • Manufacturing is defined as the process of making production materials, parts or assemblies, or heat treating, painting, plating services 制造的定义为制作生产原料,零件或组装,或热处理,涂装与电镀服务 17

  18. Eligibility for ISO/TS16949:2002 • Note that this eligibility criteria for means that some organisations currently certified to QS-9000 will not be eligible for TS16949:2002 registration 此意味目前某些已认证QS-9000 的组织企业将不能适用于TS16949:2002 For example, Stockists 如仓储物流业 18

  19. Eligibility for ISO/TS16949:2002 • Any organisation who manufactures products which are automotive-related, but are not currently within the automotive supply chain may be accepted for certification activity 任何组织其所制造生产产品为汽车相关但现在不是汽车供应链可能被接受认证活动 • These situations are to be managed by the individual certification body, not by any IATF ruling 实况将由个别认证机构管理非由IATF管制 19

  20. Eligibility for ISO/TS16949:2002 • For organisations who manufacture “general” products (such as bulk chemicals, paints or raw steel for example), which could be automotive or non-automotive, there must be evidence that they have at least one automotive customer 当组织生产制造一般产品如化学散材,涂料或钢铁原材时,有可能为汽车用或非汽车用,但必须有证据至少有一个汽车业客户 • The key issue is that the product is used in the automotive supply chain, even though the same product may be manufactured for a variety of sectors 关键点为其产品必须使用在汽车供应链,即使其产品可能有多种产业使用 20

  21. Module 3 ISO/TS16949:2002 流程导向观念介绍

  22. 流程导向 ISO/TS 16949:2002 提升流程导向的采用 • •     发展,实施及改善品质管理系统有效性 • •    藉由符合客户要求以强化客户满意 有效运作基于: • •     鉴别与管理数个相关联的活动 • •     阐述品质管理系统内流程之交互作用 • •     确保在当作要求之输入时,客户是重要的角色 规划, 执行, 查核, 行动PDCA 应运用在所有流程 22

  23. QUALITY MANAGEMENT PROCESS MODEL Continual improvement of the quality management system Management responsibility Customer Customer Measurement, analysis and improvement Satisfaction Resource Management Requirements output input Product realization Product 23

  24. Basic Process Model 活动 （加资源） 输入 输出 24

  25. ISO/TS 16949:2002客戶导向流程 Out In In Out Out In 客户拿到 『报价单』 8 In 7 1 Out 6 2 Out 5 3 In 4 In Out 客戶要求报价 Out In In Out 25

  26. 客戶导向流程 输出 In Out 1 2 3 客户 组织 输入 活动1 活动2 活动3… 支援过程 26

  27. 流程分析方法龟形图 机器，物料 人 Process With what 用什么 With Who 由谁做 Input Output How 如何做 What result 量度方法 方法 量测 27

  28. Measurement (f) Management Responsibility (c) Inputs (a) Product Realization (e) Outputs (b) Resources (Equipment/ Capital) (d) Resources (People) (d) • ISO/TS16949:2002规范与龟形图

  29. 过程分析方法 机，料 人 输 入 活动 输 出 方法 量测 持续改进 4 顾客 要求 顾客 满意 5 6 8 7 产品 29

  30. 客户导向流程，支援流程，管理流程 间相互关系 品质管理体系的持续改进 顾客 要求 顾客 满意 客户导向流程 COP支援流程 SP 管理流程 BP 接口 30

  31. TS16949:2002所指出基本流程 • Customer Oriented Processes 客戶导向流程 • Support Processes 支持流程 • Management Processes 管理流程 31

  32. Customer Oriented Processes客戶导向流程 • 市场调查 生产制造 • 投标 交付 • 业务行销 付款 • 设计开发 保证/服务 • 验证/确认 售后/客户反馈 • 其它 32

  33. Support Processes支持流程 • Document control • Control of records • Customer satisfaction • Internal audit • Purchasing • Training • Etc. 33

  34. Management Processes管理流程 • Management commitment • Customer focus • Quality policy • Etc其他 34

  35. 过程方法运用 报价流程 Input: Output: With who: With what: How: What result: 35

  36. 过程方法运用 Input: Customer requirement, Regulation, Business plan,, Previous experience, Customer Re Output: Quotation report With what: BOM, Spec, FMEA, Material price list… How: SOP, Risk analysis method, cost analysis WI… With who: management, Purchasing, Engineering, QA, Financial, Customer… What result: Response cycle, error rate, Conversion rate with good profit, Quotation case… 36

  37. 过程量度指标举例 Sales: Quotation turn over, quotation case, sales volume, Profit, customer satisfaction rating, service response time. Customer complaint: Response time, reject rate, repeated problem case. Production: Production efficiency, poor quality cost, Kaizen cases, OJT achievement, CPK/PPK. 37

  38. 过程量度指标举例 • Quality Assurance: Customer complaint cases, poor quality cost, defect rate, lead time for problem solving, operation cost. • Training: Training accomplishment, pass rate for evaluation, Human error cases in defect. • Employee motivation: Quit rate, absenteeism, Quality objective achievement in each section, employee satisfaction survey, kaizen cases,5S rating. 38

  39. 过程量度指标举例 • Purchasing: Supplier quality/delivery performance, cost down, development achievement,premium freight • R&D: Cost, lead time, critical path, quality risk, operation cost, complaint due to R&D, VA/VE cases • Shipping: On-time delivery, premium freight. …… 39

  40. Module 4 ISO/TS 16949:2002 体系导入与实施 40

  41. ISO/TS 16949:2002 structure Additional expenditure for a supplier with a QS-9000 and VDA 6.1 - certificates Reduced expenditure for a supplier with QS-9000 and VDA 6.1 - Certificates ISO 9001 ISO 9001 Certificate ISO 9001 Certificate VDA 6.1 Certificate QS-9000 Certificate ISO/TS 16949：2002 條文將涵蓋QS-9000, EAQF94, AVSQ94及VDA6.1等 各國汽車工業標準 (非百分之百涵蓋) 41

  42. ISO/TS16949:2002 Requirement Introduction

  43. 1.2 Application • 当组织非负责产品设计与开发责任时,只允许将7.3要求排除. • 排除条款不包括制造流程的设计 43

  44. 3.1汽车产业术语与定义 • ISO 9000:2000 的术语与定义适用于本规范.但当ISO 9000:2000 的定义与用语与本规范不同时,以本技术规范的定义为适用 44

  45. Clause 4 Quality management system

  46. 4.1.1 一般要求–附加要求 • 外包流程的管制确认不能免除组织符合客户要求的责任 46

  47. 4.2.2 品质手册NOTE(TS Edition 1 clause 4.2.2.2, NEW against QS-9000) • 组织应建立与维持品质手册包括… 47

  48. 4.2.3.1 工程规范(TS Edition 1 clause 4.5.2.2, QS-9000 clause 4.5.2.1) • 组织应设有流程基于客户要求时程的及时审查,分发与实施所有客户工程标准/规范及变更.组织应维持每一变更生产实施日期的纪录.实施应包括文件的更新. • 及时审查应尽快,不超过两个工作周. • NOTE 当变更相关于设计记录或影响到PPAP文件,如管制计划,FMEAs等时,此些标准/规范变更需更新客户量产产品核准流程 48

  49. 4.2.4 & 4.2.4.1 记录控制(TS Edition 1 clause 4.16.1, note 1, NEW against QS-9000) • 需创建与维持记录以佐证符合要求并有效运作体系要求.记录需保持可判读, 及时鉴别与调阅.需创建书面化程序 以规定 identification, storage, protection, retrieval, retention time and disposition of records. • 记录控制需满足法规与客户要求 • NOTE 1 “处置” 包括清理. • NOTE 2 “质量记录” 包括客户规定之记录 49

  50. Clause 5 Management responsibility 管理責任

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