6. ISO/TS 16949 ed 2BS 5750ISO 9000VDA6QS-9000AVSQEAQFISO/TS 16949 ed 1ISO 9001:2000
7. Membership of the IATF
(International Automotive Task Force);Registrar scheme administered by IATF.
Certification delegated to National Trade associations;
8. 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
14. Eligibility for ISO/TS16949:2002Applicability 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
15. Eligibility for ISO/TS16949:2002Eligibility 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
16. Eligibility for ISO/TS16949:2002Note 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
17. Eligibility for ISO/TS16949:2002Any 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
18. Eligibility for ISO/TS16949:2002For 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. Continual improvement of the quality management systemCustomerCustomer
RequirementsSatisfactionManagement
responsibilityResource
ManagementMeasurement,
analysis and
improvementProduct
realizationProduct outputinputQUALITY MANAGEMENT PROCESS MODEL
21. 输入输出
活动
(加资源)Basic Process Model
22. OutIn76543281InInInInInInIn Out Out Out Out Out Out Out客戶要求报价客户拿到
『报价单』 ISO/TS 16949:2002客戶导向流程
23.
组织活动1
活动2
活动3…
支援过程输入输出客户InOut123客戶导向流程
24. 流程分析方法龟形图Process OutputInputWith what
用什么With Who
由谁做How
如何做What result
量度方法人机器,物料方法量测
32. 过程方法运用报价流程
Input:
Output:
With who:
With what:
How:
What result:
33. 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…
34. 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.
35. 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.
36. 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.
… …
37. Module 4ISO/TS 16949:2002
体系导入与实施
38. ISO/TS 16949:2002 structureCertificate QS-9000Certificate VDA 6.1Additional expenditure for a supplier with a QS-9000 and VDA 6.1 - certificatesCertificate ISO/TS 16949:2002ISO 9001ISO 9001Certificate ISO 9001Reduced expenditure for a supplier with QS-9000 and VDA 6.1 - Certificates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)
45. 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
46. 5.1.1流程效率(NEW against TS Edition 1 and QS-9000)
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
47. 5.4.1.1 品质目标-附加要求(TS Edition 1 clause 4.1.1.2, NEW against QS-9000)
最高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.
NOTE 质量目标应阐明客户的期望且能在规定时程内达成.
48. 5.5.1.1 品质责任(TS Edition 1 clauses 4.1.2.1.3 and 4.1.2.2.2, QS-9000 clause 4.1.2.5, plus note to 4.1.2.1.a - 3rd bullet NEW against QS-90000)
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.
质量负责人员应有权停止生产来矫正质量问题.
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.
50. 5.6.1.1 品质管理系統绩效(TS Edition 1 clauses 4.1.3.2 and 4.2.8, QS-9000 clause 4.1.3.1 - bullets 2 & 3 NEW against QS-9000)
这些评审应包括质量管理系统所有要素及其绩效趋势当作是持续改善流程的基本部分.
管理评审的一部份是质量目标的监督,及定期呈报与评估不良质量成本 (see 8.4.1 and 8.5.1).
这些评审结果应纪录并提供,最低要求为下列的达成证明:
业务计划中规定的目标
客户满意
51. 5.6.2.1 评审输入 – 附加要求(NEW against TS Edition 1 and QS-9000)
管理审查的输入应包括实际与潜在市场退回的分析及对质量,安全或环境的冲击.
Note: 七个输入与三个输出在 TS Edition 1 and QS-9000 均为新的要求
52. 6.2.2.产品设计技能(TS Edition 1 clause 4.4.2.2, QS-9000 clause 4.4.2.1 - bullet 2 NEW against TS Edition 1 and QS-9000)
组织应确保负有产品设计权责人员有资格与能力达成设计要求与熟悉应用相关工具与技术.
应用的工具与技术应被组织鉴别出.
53. 6.2.2.2 培训(TS Edition 1 clauses 4.18.1 and 4.18.2, QS-9000 clause 4.18 - notes NEW against QS-9000)
组织应创建并维持书面程序以鉴别其所运行之工作会影响产品质量之所有人员的训练需求与工作能力的达成.必须时,运行特定工作人员应以教育水平,培训,技能及/或工作经验来认定期资格. 应注意客户的特定要求.
NOTE 1 此要求是用到组织内影响质量的所有层级员工.
NOTE 2 客户特定要求的一个例子为数位化数学资料数据资料应用.
54. 6.2.2.3在职培训(TS Edition 1 clause 4.18.3, NEW against QS-9000)
组织应提供包括契约与外包人员在内的在职训练,在新的或更改的作业影响到产品质量时.影响产品质量人员应被告知其不符合客户质量要求时的后果
55. 6.2.2.4员工激励与强化 (TS Edition 1 clause 4.1.6, NEW against QS-9000)
组织应设有流程激励员工达成质量目标,从事持续改善,及创造鼓励创新的环境.此流程应包括组织全体上下对质量与技术认知的提升.
组织应设有流程衡量成员知悉活他们从事的活动之相关性与重要性的程度及他们如何对质量目标的达成作出贡献 (see 6.2.2 d).
56. 6.3.1厂房, 设施与设备规划(TS Edition 1 clause 4.2.5, QS-9000 clause 4.2.6.1 - note NEW against TS Edition 1 and QS-9000)
组织应使用跨功能组成方式来发展厂房,设施及设备的规划.厂房配置应最佳化原物料流动,搬运及楼版面积的加值使用及装置同步物流,评估与监督现有运作效果的方法应发展与实施
NOTE 这些要求应导向精实制造原则并连结到质量管理系统的有效性.
75. 7.3.2.1 产品设计输入(TS Edition 1 clauses 4.4.4.1, 4.4.4.2 and 4.4.4.3,QS-9000 clauses 4.4.4 and 4.4.1.1 - point 3 NEW against QS-9000)组织应鉴别,书面化与审查产品设计的输入要求包括, :
客户要求 (合约审查) 诸如特殊特性 (see 7.3.2.4),鉴别,追朔性与包装;
信息的运用:组织应设有流程展开由之前设计专案,竞争者分析,供应商回馈,内部输入,市场数据和其他来源获得之信息运用在现有及未来类似专案项目;
产品质量,寿命,可靠度,耐久性,可维修性, 时程,及成本之目标.
76. 7.3.2.2 制造流程的设计输入(TS Edition 1 clauses 4.2.4.9.2 and 4.2.4.5, NEW against QS-9000)组织应鉴别,书面化与审查制造流程的设计输入要求,包括
产品设计输出数据,
生产力,制程能力与成本的目标,
任何客户有的要求,及
之前开发的经验.
NOTE 制造流程的设计包括对问题的影响程度及所评估的风险等级所采取之防错方法.
102. 7.5.1.5 生产工模具之管理(TS Edition 1 clause 4.2.6, QS-9000 clause 4.2.6.2 - point 7 NEW against QS-9000)组织应提供资源予工模具和量规设计,制造和确认活动.
组织应创建与实施一套生产工模具之管理系统, 包括:
保养与修理设施与人员,
保存与撤消,
设置,
磨耗性工模具更换方案,
工模具更改书面化文档,包括工程变更等级版本,
工模具更改与版本和文档,
工模具鉴别, 状态订立,诸如生产,修理或清理.
103. 7.5.1.5生产工模具之管理(continued) (TS Edition 1 clause 4.2.6, QS-9000 clause 4.2.6.2 - note NEW against TS Edition 1 and QS-9000)
组织应实施一套系统以监督这些活动外包时.
NOTE 此要求一适用于车辆服务性零件之工具的可取得性 .
104. 7.5.1.6 生产排程(TS Edition 1 clause 4.15.6.3, NEW against QS-9000)生产应安排排程以便符合客户要求,诸如 由一套信息系统可允许进入流程关键阶段之生产信息所支持的及时供应(JIT)与订单驱动.
ISO 9001:2000 requirement - 7.5.1f) the implementation of release, delivery and post-delivery activities.
105. 7.5.1.6 生产排程(TS Edition 1 clause 4.15.6.3, NEW against QS-9000)精益生产方式之排程
-拉动式(Pull)控制
-看板管理
-长期 ,中期 ,短期计划
106. 7.5.1.6 生产排程(TS Edition 1 clause 4.15.6.3, NEW against QS-9000)
客户业务计划与需求
114. 7.5.5.1 保存与库存(TS Edition 1 clauses 4.15.3.1 and 4.15.3.2, QS-9000 clauses 4.15.3 and 4.15.3.1 -final point NEW against QS-9000)为察知变质状况,库存产品状况应在适当规划周期作评核.
组织应运用一套库存管理系统以佳化库存周转时间与确保库存流动,诸如“先进先出" (FIFO).
过期产品应以管制不合格品方式管制.
132. 8.2.2.5 内部审核员资格(TS Edition 1 clause 4.17.3, NEW against QS-9000)
组织应有内部审核人员具资格审核本技术规范之要求 ( see 6.2.2.2).
课堂说明
GM ISO19011-2->2/4
Ford Direct supplier-AIAG certified
133. 8.2.3.1 制造流程之监督与量测TS Edition 1 clause 4.2.4.5, NEW against QS-9000)
组织应对所有新流程 (包括组装或后续加工)进行流程研究以确认其制程能力及提供流程控制之附加输入.流程研究的结果应应以文档化规范呈现,可行时, 含生产方法,量测与测试,及维护指导等.这些文档应包括制造制程能力,可靠度,维护性及可用性与允收准则之目标.Continued >>>
154. Create specificationDevelop solutionTest with marketManufactureMarket and sell“Bringing new products to market”新产品导入市场Typical Process典型的流程
Processes typically cut across organisational functionsResearch
market市场行销单位开发与行销单位设计开发单位业务行销单位制造生产单位业务销售单位
165. ISO/TS 16949:20021. ISO/TS16949 Quality management systems, 2002-03-01
2. IATF Guidance to ISO/TS16949: 2002, edition 1
3. Quality system assessment checklist to ISO/TS16949: 2002, ed 1
4. Automotive certification scheme for ISO/TS16949, 2002-3-19
5. ISO9004: 2000, Guidelines for performance improvements
6. ISO19011, Guidelines on quality and/or environmental managements auditing
7. ISO10012-1: 1992, Quality Assurance requirements for measuring equipment-part 1: Metrologic confirmation system for measuring equipment
8. ISO10012-2: 1997, Quality Assurance for measuring equipment-part 2: Guidelines for control of measurement processes
9. ISO/IEC 17025: 1999, General requirements for the competence of testing and calibration laboratories
167. ISO/TS 16949:2002 OEM RequirementDaimler-Chrysler require certification to ISO/TS16949:2002 by all suppliers by 2004-7-1.
Ford & GM require certification to ISO/TS16949:2002 by 2006-12-15 .
PSA Peugeot-Citroen require certification to ISO/TS16949:2002 by 2004-7-1.
Renault require certification to ISO/TS16949:2002 by 2003-12-15.
Fiat require certification to ISO/TS16949:1999 or ISO/TS16949:2002 from now.
Volkswagen require certification to either ISO/TS16949:2002 or VDA6.1.
BMW require compliance to either ISO/TS16949:2002.
Nissan, because of their link with Renault, require compliance to ISO/TS16949:2002.
Other Japanese manufacturers don’t require ISO/TS16949:2002 as a supplier approval process, but may reduce second party audits if an supplier is ISO/TS16949:2002 certified.