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1、ISO/TS 16949:ISO/TS 16949:20022002 * * * * L L* * * * L L* * * * 中国大陆地区中国大陆地区 TS16949 TS16949产品经理产品经理nQS-9000QS-9000:1998 1998 主任审核员主任审核员nISO/TS 16949ISO/TS 16949:2002 2002 主任审核员主任审核员1ISO/TS16949:2002新时代汽车产业QMS标准AgendaAgendaModule 1Module 1汽车产业标准变革汽车产业标准变革Module 2Module 2ISO/TS 16949ISO/TS 16949:200
2、2:2002 认证资格指南认证资格指南Module 3 ISO/TS 16949:2002Module 3 ISO/TS 16949:2002 流程导向观念流程导向观念介绍介绍Module 4Module 4ISO/TS 16949:2002ISO/TS 16949:2002体系体系导入与实施导入与实施Module 5Module 5ISO/TS 16949:2002ISO/TS 16949:2002认证规定认证规定 3Module 1Module 1汽车产业标准变革汽车产业标准变革汽车产业标准变革汽车产业标准变革19791979BS 5750BS 5750英国国家标准英国国家标准198119
3、81Q 101Q 101福特汽车品质体系标准福特汽车品质体系标准( (Quality System Standard)Quality System Standard) 19831983Chrysler SQAM Chrysler SQAM 克莱斯勒品质保证克莱斯勒品质保证 ( (Supplier Quality Assurance Manual)Supplier Quality Assurance Manual)19871987ISO 9000ISO 9000国际标准国际标准 GM TFE GM TFE 通用汽车通用汽车( (Targets for Excellence)Targets for
4、 Excellence)19941994ISO 9000ISO 9000修正之国际标准修正之国际标准 QS-9000QS-9000 第一版第一版19951995QS-9000QS-9000 第二版第二版19981998QS-9000QS-9000 第三版第三版19991999ISO/TS 16949ISO/TS 16949依依 ISO 9001:1994ISO 9001:1994架构之技术规范架构之技术规范( (Version 1)Version 1)20002000ISO RevisionISO RevisionISO9001:2000 ISO9001:2000 20022002ISO/TS
5、 16949ISO/TS 16949依依ISO 9001:2000ISO 9001:2000架构之技术规范架构之技术规范 (Version 2)(Version 2)5ISO/TS 16949:ISO/TS 16949:20022002ISO/TS 16949:ISO/TS 16949:20022002是由下列单位起草是由下列单位起草: : 国际汽车行动小组国际汽车行动小组 ( (IATF)IATF) 日本车辆制造者协会日本车辆制造者协会( (JAMA)JAMA) ISO/TC 176, ISO/TC 176, 所支持所支持 取代初版取代初版 1999 1999 ISO/TS 16949:IS
6、O/TS 16949:20022002 整合整合 所有所有 ISO9001:2000ISO9001:2000之要求之要求6ISO/TS 16949 ed 2BS 5750ISO 9000VDA6QS-9000AVSQEAQFISO/TS 16949 ed 1ISO 9001:2000nMembership of the IATFMembership of the IATF n(International Automotive Task Force);(International Automotive Task Force);Registrar scheme administered by IA
7、TF.Certification delegated to National Trade associations;8其他汽车标准怎么走?其他汽车标准怎么走?QS-9000, VDA 6.1, EAQF 94 and AVSQ 94 QS-9000, VDA 6.1, EAQF 94 and AVSQ 94 to to 没有升级成没有升级成 ISO 9001:2000 ISO 9001:2000 版本的计划版本的计划 QS-9000 QS-9000 将在将在 20062006年年1212月终止月终止德国德国VDA 6.1 VDA 6.1 目前没有明确终止日期目前没有明确终止日期 法国法国EAQ
8、F 94EAQF 94将在将在20032003年年1212月终止月终止意大利意大利AVSQ 94AVSQ 94将在将在20032003年年1212月终止月终止此将驱使转向此将驱使转向 ISO/TS 16949:ISO/TS 16949:200220029现有的汽车业标准会被现有的汽车业标准会被 ISO/TS 16949:ISO/TS 16949:20022002取代吗取代吗? ?不会不会! ! QS-9000 QS-9000 仍被三大所认可仍被三大所认可到到2006-12-152006-12-15 : : VDA 6.1 (German)VDA 6.1 (German)與與ISO9001:2K
9、 ISO9001:2K 並行並行AVSQ (Italian)AVSQ (Italian)EAQF (French)EAQF (French)10ISO/TS 16949:ISO/TS 16949:20022002 会会被视为现有标准的增加部分吗?被视为现有标准的增加部分吗?是的是的. . 循客户之特定要求循客户之特定要求, , ISO/TS 16949 ISO/TS 16949 被被视等同于视等同于: :QS-9000 (America)QS-9000 (America)VDA 6.1 (Germany)VDA 6.1 (Germany)AVSQ (Italy)AVSQ (Italy)EAQF
10、 (France)EAQF (France)JAMA (Japan)JAMA (Japan)11哪些汽车制造者接受哪些汽车制造者接受 ISO/TS 16949:ISO/TS 16949:20022002? ?nFord, GM, Daimler Chrysler, PSA Ford, GM, Daimler Chrysler, PSA Peugeot-Citroen, Renault, Fiat, BMW, Peugeot-Citroen, Renault, Fiat, BMW, Daimler Benz, Volkswagen,Daimler Benz, Volkswagen,日本及南韩汽日
11、本及南韩汽车制造者均支持车制造者均支持 ISO/TS 16949:ISO/TS 16949:20022002n组织应向其客户征询是否接受组织应向其客户征询是否接受ISO/TS ISO/TS 16949:16949:2002200212发展趋势发展趋势TimeLicensesQS-9000TS 16949:200228,000Sept 2004300 issuedby Jul 2003 ISO/TS 16949:ISO/TS 16949:20022002之目的之目的品质管理系统之发展以品质管理系统之发展以持续不断改善之提供持续不断改善之提供强调缺失预防强调缺失预防 减少供应链内之变异与浪费减少供
12、应链内之变异与浪费 附加可能之客户特定要求附加可能之客户特定要求 定义基本的品质管理系统要求定义基本的品质管理系统要求 避免多重的认证审核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提供共通之汽车业品质管理系统方法 14Module 2Module 2ISO/TS16949:ISO/TS16949:20022002 认证资格指南认证资格指南 2003-1 2003-1 更新版更新版Eligibility for Eligibility for ISO/TS16949:ISO/TS16949:20022002Applicability of TS16949:2002 Certificati
13、onApplicability of TS16949:2002 Certification : :Any organisation in the automotive supply chain meeting the Any organisation in the automotive supply chain meeting the eligibility criteria can obtain certificationeligibility 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任何汽车供应链内组织均符合本规范所
14、指具认证资格 Any motor-powered vehicle can be considered as automotiveAny 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, Therefore, suppliers in the Heavy Truck, Motorcycle, Construction Vehicle supply cha
15、ins can obtain certification Construction Vehicle supply chains can obtain certification to TS16949:2002to TS16949:2002 因此重车因此重车, ,摩托车与营建车辆之供应链内之供货商均可取得摩托车与营建车辆之供应链内之供货商均可取得TS16949:2002TS16949:2002认证认证 16Eligibility for Eligibility for ISO/TS16949:ISO/TS16949:20022002Eligibility requirements for TS1
16、6949:Eligibility requirements for TS16949:20022002 Certification :Certification :Relevant to automotive-related products onlyRelevant to automotive-related products only 汽车相关之零件汽车相关之零件 Applicable only to sites where production or service parts are Applicable only to sites where production or service
17、 parts are manufacturedmanufactured 适用于生产或服务零件制造场所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 Site is defined as a location at which value added manufacturing processes occurprocesses occur 场所的定义为增值制造流程产生的地点场所的定义为增值制造流程产生的地点 Manufacturing is defined as the process
18、 of making production Manufacturing is defined as the process of making production materials, parts or assemblies, or heat treating, painting, materials, parts or assemblies, or heat treating, painting, plating servicesplating services 制造的定义为制作生产原料制造的定义为制作生产原料, ,零件或组装零件或组装, ,或热处理或热处理, ,涂装与电镀服务涂装与电镀服
19、务 17Eligibility for Eligibility for ISO/TS16949:ISO/TS16949:20022002Note that this eligibility criteria for means that some Note that this eligibility criteria for means that some organisations currently certified to QS-9000 will not be organisations currently certified to QS-9000 will not be eligib
20、le for TS16949:2002 registrationeligible for TS16949:2002 registration 此意味目前某些已认证此意味目前某些已认证QS-9000 QS-9000 的组织企业将不能适用于的组织企业将不能适用于TS16949:TS16949:20022002 For example, Stockists For example, Stockists 如仓储物流业如仓储物流业 18Eligibility for Eligibility for ISO/TS16949:ISO/TS16949:20022002Any organisation who
21、manufactures products which are Any organisation who manufactures products which are automotive-related, but are not currently within the automotive-related, but are not currently within the automotive supply chain may be accepted for automotive supply chain may be accepted for certification activit
22、ycertification 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链可能被接受认证活动 These situations are to be managed by the individual These situations are to be managed by the individual certification body, not by any IATF rulingcertification body, not by any IATF ruling 实况将由个别认证机构管理
23、非由实况将由个别认证机构管理非由IATFIATF管制管制 19Eligibility for Eligibility for ISO/TS16949:ISO/TS16949:20022002For organisations who manufacture “general” products (such For organisations who manufacture “general” products (such as bulk chemicals, paints or raw steel for example), which as bulk chemicals, paints or
24、 raw steel for example), which could be automotive or non-automotive, there must be evidence could be automotive or non-automotive, there must be evidence that they have at least one automotive customerthat they have at least one automotive customer 当组织生产制造一般产品如化学散材当组织生产制造一般产品如化学散材, ,涂料或钢铁原材时涂料或钢铁原材
25、时, ,有可能为汽车有可能为汽车用或非汽车用用或非汽车用, ,但必须有证据至少有一个汽车业客户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 The key issue is that the product is used in the automotive supply chain, even though the same product may be manufactured supply chain, even though the same product may be man
26、ufactured for a variety of sectorsfor a variety of sectors 关键点为其产品必须使用在汽车供应链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即使其产品可能有多种产业使用20Module 3 Module 3 ISO/TS16949:ISO/TS16949:20022002流程导向观念流程导向观念介绍介绍流程流程导导向向ISO/TS 16949:ISO/TS 16949:20022002提升流程导向的采用提升流程导向的采用 发展发展, ,实施及改善品质管理系统有效性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
27、客户满意藉由符合客户要求以强化客户满意有效运作基于有效运作基于: : 鉴别与管理数个相关联的活动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确保在当作要求之输入时, ,客户是重要的角色客户是重要的角色 规划规划, , 执行执行, , 查核查核, , 行动行动PDCA PDCA 应运用在所有流程应运用在所有流程22Continual improvement of the quality management systemCustomerCustomer RequirementsSatisfactionManagement r
28、esponsibilityResourceManagementMeasurement,analysis andimprovementProductrealizationProduct outputinputQUALITY MANAGEMENT QUALITY MANAGEMENT PROCESS MODELPROCESS MODEL23输入输入输出输出 活动活动 (加资源)(加资源)Basic Process ModelBasic Process Model24 OutIn76543281InInInInInInIn Out Out Out Out Out Out Out客戶要求报价客户拿到报
29、价单 ISO/TS 16949:2002ISO/TS 16949:2002客戶客戶导导向流程向流程25组织活动1活动2活动3支援过程输入输出客户InOut123客戶客戶导导向流程向流程26流程分析方法流程分析方法龟形图龟形图ProcessOutputInputWithwhat用什么WithWho由谁做How如何做Whatresult量度方法人机器,物料方法量测27ISO/TS16949:2002规范与龟形图ProductRealization(e)ManagementResponsibility(c)Resources(Equipment/Capital)(d)Resources(People
30、)(d)Outputs(b)Inputs(a)Measurement(f)活动持续改进4顾客要求顾客满意5687产品输入输出机,料方法人量测过程分析方法过程分析方法29顾客要求顾客满意品质管理体系的持续改进客户导向流程COP支援流程SP管理流程BP接口客户导向流程,客户导向流程,支援流程,支援流程,管理流程管理流程间相互关系间相互关系30TS16949:TS16949:20022002所指出基本流程所指出基本流程nCustomer Oriented Processes Customer Oriented Processes 客戶客戶导导向流程向流程nSupport Processes Supp
31、ort Processes 支支持持流程流程nManagement Processes Management Processes 管理流程管理流程31Customer Oriented Customer Oriented ProcessesProcesses客戶客戶导导向流程向流程市场调查市场调查生产制造生产制造投标投标交付交付业务行销业务行销付款付款设计开发设计开发保证保证/服务服务验证验证/确认确认售后售后/客户反馈客户反馈其它其它32Support ProcessesSupport Processes支支持持流程流程Document contrDocument contrololCont
32、rol of recordsControl of recordsCustomer satisfactionCustomer satisfactionInternal auditInternal auditPurchasingPurchasingTrainingTrainingEtc.Etc.33Management ProcessesManagement Processes管理流程管理流程Management commitmentManagement commitmentCustomer focusCustomer focusQuality policy Quality policy EtcE
33、tc其他其他34过程方法运用报价流程报价流程Input:Input:Output:Output:With who:With who:With what:With what:How:How:What result:What result:35过程方法运用Input: Input: Customer requirement, Regulation, Business Customer requirement, Regulation, Business plan, Previous experience, Customer Replan, Previous experience, Customer
34、ReOutput: Output: Quotation report Quotation report With what: With what: BOM, Spec, FMEA, Material price listBOM, Spec, FMEA, Material price listHow: How: SOP, Risk analysis method, cost analysis WI SOP, Risk analysis method, cost analysis WI With who: mWith who: management, Purchasing, Engineering
35、, QA, anagement, Purchasing, Engineering, QA, Financial, CustomerFinancial, CustomerWhat result: What result: Response cycle, error rate, Conversion rate Response cycle, error rate, Conversion rate with good profit, Quotation casewith good profit, Quotation case36过程量度指标举例 Sales: Sales: Quotation tur
36、n over, quotation case, sales Quotation turn over, quotation case, sales volume, Profit, customer satisfaction rating, volume, Profit, customer satisfaction rating, service response timeservice response time. . Customer complaint: Customer complaint: Response time, reject rate, repeated problem Resp
37、onse time, reject rate, repeated problem casecase. . Production: Production: Production efficiency, poor quality cost, Production efficiency, poor quality cost, Kaizen cases, OJT achievement, CPK/PPKKaizen cases, OJT achievement, CPK/PPK. .37过程量度指标举例nQuality Assurance:Quality Assurance: Customer com
38、plaint cases, poor quality cost, Customer complaint cases, poor quality cost, defect rate, lead time for problem solving, defect rate, lead time for problem solving, operation costoperation cost. .nTraining: Training: Training accomplishment, pass rate for Training accomplishment, pass rate for eval
39、uation, Human error cases in defect.evaluation, Human error cases in defect. nEmployee motivation: Employee motivation: Quit rate, absenteeism, Quality objective Quit rate, absenteeism, Quality objective achievement in each section, employee achievement in each section, employee satisfaction surveys
40、atisfaction survey, , kaizen cases,5S rating.kaizen cases,5S rating.38过程量度指标举例nPurchasing: Purchasing: Supplier quality/delivery performance, cost Supplier quality/delivery performance, cost down, development achievement,premium freightdown, development achievement,premium freightnR&D: R&D: Cost, le
41、ad time, critical path, quality risk, Cost, lead time, critical path, quality risk, operation cost, complaint due to R&D, VA/VE operation cost, complaint due to R&D, VA/VE casescasesnShipping: Shipping: On-time delivery, premium freight On-time delivery, premium freight. . 39Module 4Module 4ISO/TS 1
42、6949:ISO/TS 16949:20022002 体系导入与实施体系导入与实施40ISO/TS16949:2002structureCertificate ISO/TS 16949:2002ISO9001ISO 9001Certificate ISO 9001條文將涵蓋條文將涵蓋QS-9000, EAQF94, AVSQ94QS-9000, EAQF94, AVSQ94及及VDA6.1VDA6.1等等各國汽車工業標準各國汽車工業標準 ( (非百分之百涵蓋非百分之百涵蓋) )41ISO/TS16949:2002ISO/TS16949:2002Requirement Introduction
43、1.2 1.2 ApplicationApplicationn当组织非负责产品设计与开发责任时当组织非负责产品设计与开发责任时, ,只允只允许将许将7.37.3要求排除要求排除. .n 排除条款不包括制造流程的设计排除条款不包括制造流程的设计 43 3.13.1汽车产业术语与定义汽车产业术语与定义 n 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 44Clause 4Clause 4Quality management system 4.1.1 4.1.1 一般要求一般要求 附加要附加要求求 46 4
44、.2.2 4.2.2 品质手册品质手册 NOTENOTE(TS Edition 1 clause 4.2.2.2, NEW against QS-(TS Edition 1 clause 4.2.2.2, NEW against QS-9000)9000)n组织应建立与维持品质手册包括组织应建立与维持品质手册包括 47 4.2.3.1 4.2.3.1 工程工程规范规范( (TS Edition 1 clause 4.5.2.2, QS-9000 clause TS Edition 1 clause 4.5.2.2, QS-9000 clause 4.5.2.1)4.5.2.1)n组织应设有流程
45、基于客户要求时程的及时审查组织应设有流程基于客户要求时程的及时审查,分发分发与实施所有客户工程标准与实施所有客户工程标准/规范及变更规范及变更.组织应维持组织应维持每一变更生产实施日期的纪录每一变更生产实施日期的纪录.实施应包括文件的更实施应包括文件的更新新.n及时审查应尽快及时审查应尽快,不超过两个工作周不超过两个工作周.nNOTE NOTE 当变更相关于设计记录或影响到当变更相关于设计记录或影响到PPAPPPAP文件文件, ,如管制计划如管制计划, ,FMEAsFMEAs等时等时, ,此些标准此些标准/ /规范变更需更新规范变更需更新客户量产产品核准流程客户量产产品核准流程 48 4.2.
46、4 4.2.4 & 4.2.4.1 & 4.2.4.1 记录控制记录控制( (TS Edition 1 clause 4.16.1, note 1, NEW TS Edition 1 clause 4.16.1, note 1, NEW against QS-9000)against QS-9000)n需创建与维持需创建与维持记记录以佐证符合要求并有效运作体系要求录以佐证符合要求并有效运作体系要求. .记记录需保持可判读录需保持可判读, , 及时鉴别与调阅及时鉴别与调阅. .需创建书面化程序需创建书面化程序 以规定以规定 identification, storage, identificat
47、ion, storage, protection, retrieval, retention time and protection, retrieval, retention time and disposition of records.disposition of records.n记记录录控制控制需满足法规与客户要求需满足法规与客户要求nNOTE 1 “NOTE 1 “处置处置” ” 包括清理包括清理. .nNOTE 2 “NOTE 2 “质量质量记记录录” ” 包括客户规定之包括客户规定之记记录录 49Clause 5Clause 5 Management responsibilit
48、y管理責任管理責任 5.1.15.1.1流程效率流程效率( (NEW against TS Edition 1 and QS-9000)NEW against TS Edition 1 and QS-9000)n最高管理阶层应监督产品实现流程及其相关支持流程确保其效果与效率51 5.4.1.1 5.4.1.1 品质目标品质目标- -附加要附加要求求(TS Edition 1 clause 4.1.1.2, NEW against QS-(TS Edition 1 clause 4.1.1.2, NEW against QS-9000)9000)n最高管理阶层应定义质量目标与衡量并包括在经营最高
49、管理阶层应定义质量目标与衡量并包括在经营计划中且用来展开质量政策计划中且用来展开质量政策. .nNOTE NOTE 质量目标应阐明客户的期望且能在规定时程质量目标应阐明客户的期望且能在规定时程内达成内达成. .52 5.5.1.1 5.5.1.1 品质责任品质责任(TS Edition 1 clauses 4.1.2.1.3 and (TS Edition 1 clauses 4.1.2.1.3 and 4.1.2.2.2, 4.1.2.2.2, QS-9000 clause 4.1.2.5, plus note to QS-9000 clause 4.1.2.5, plus note to
50、4.1.2.1.a - 3rd bullet NEW against QS-90000) 4.1.2.1.a - 3rd bullet NEW against QS-90000) n管理阶层中负有矫正措施权责者在产品或流程不符合要求时,应及时被通知.n质量负责人员应有权停止生产来矫正质量问题.n生产营运之所有班别应有负责或代理责任者来确保产品质量.53 5.5.2 1 5.5.2 1 客客户户代表代表(TS Edition 1 clause 4.1.2.1.2, QS-9000 clause (TS Edition 1 clause 4.1.2.1.2, QS-9000 clause 4.1.