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1、quality management systems particular requirements for the application of iso 9001:2000 for automotive production and relevant service part organizations质量管理体系汽车生产件及相关维修零件组织应用gb/t19001- 2000的特别要求forewordiso (the international organization for standardization) is a worldwide federation of national st

2、andards bodies (iso member bodies). the work of preparing international standards is normally carried out through iso technical committees each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. international or

3、ganizations, governmental and non-governmenial, in liaison with iso, also take part in the work. iso collaborates closely with the international electrotechnical commission (iec) on all matters of electrotechnical standardization.international standards are drafted in accordance with the rules given

4、 in the iso/iec directives, part 3.the main task of technical committees is to prepare international standards draft international standards adopted by the technical committees are circulated to the member bodies for voting. publication as an international standard requires approval by at least 75 %

5、 of the member bodies casting a votein other circumstances, particularly when there is an urgent market requirement for such documents, a technical committee may decide to publish other types of normative document:- an iso publicly available specification (iso/pas) represents an agreement between te

6、chnical experts in an iso working group and is accepted for publication if it is approved by more than 50 % of the members of the parent committee casting a vote;-an iso technical specification (iso/ts) represents an agreement between the members of a technical committee and is accepted for publicat

7、ion if it is approved by 2/3 of the members of the committee casting a votean iso/pas or iso/ts is reviewed after three years with a view to deciding whether it should be confirmed for a further three years, revised to become an international standard, or withdrawn. in the case of a confirmed iso/pa

8、s or iso/ts, it is reviewed again after six years at which time it has to be either transposed into an international standard or withdrawniso前言国际标准化组织(iso)是由国际标准化团体(iso成 员团体)组成的世界生的联合会。制定国际标准的工作 通常由iso的技术委员会完成。各成员团体若对某技术 委员会确定的项日感兴趣,均有权参加委员会(iec) 在电工技术标准化方面保持紧密的合作关系。国际标准的制定符合iso/iec导则第3部分的有关规 定。技术委员

9、会的主要任务是制定国际标准。由技术委员会 通过的国际标准草案提交各成员团休投票表决。国 际标准草案需取得至少75%参加表决成员团体的同 意,才能作为国际标准正式发布。其它情况下,特别是市场对这样的文件有紧迫需求时, 技术委员会可决定出版其它形式的标准化文件:iso公开规范(iso/pas)表明一个iso工作组 内技术专家间己达成一致,如果上一级委员会的成员 50%投票同意则可被接受出版。iso技术规范(iso/ts),表明技术委员会成员 间己达成一致,如果委员会2/3的成员投票同意则可被 接受出版。对iso/pas或iso/ts,三年后要进行一次评审,以决定 是否应当在下一个三年内获得确认,修

10、改为国际标 准或撤消。在iso/pas或iso/ts获得确认的情况下, 六年后重新评审,最终确定为国际标准或撤消。iso/ts 16949:2002 was prepared by the international automotivetask force (1atf) and japan automobile manufacturers association, inc. (jama), with support from iso/tc 176, quality management and quality assurancethis second edition of iso/ts 16

11、949 cancels and replaces the first edition (iso/ts 16949:1999), which has been technically revised.boxed text is original iso 9001:2000 text. the sector-specific supplemental requirements are outside the boxesin this technical specification, the word "shall" indicates a requirement. the wo

12、rd "should5" indicates a recommendation. paragraphs marked "note'、 are for guidance in understanding or clarifying the associated requirement.where the term “such as" is used, any suggestions given are for guidance only.annex a forms a normative part of this technical specifi

13、cation.remarks for certificationthe certification to this technical specification, includingiso/ts 16949: 2002由国际汽车特别工作组(iatf)和 日本汽车制造商协会(jama)在iso/tc176质量管理 和质量保证委员会的支持下共同制定。通过技术修订,取消第一版的iso/ts 16949: 1999,并 由第二版iso/ts 16949替代。方框内的文字是is09001: 2000原文。方框外的部分是 行业特殊补充要求。在木技术规范中“应”(shall)表示要求。“应当”(shoul

14、d) 表示建议。标有“注”(note)的段落是对理解和解释 的关要求的指南。凡使用“例如” (suchas)词处,任何给出的建议仅 起指导作用。附录a是标准的附录,构成本标准的一部分。关于认证的说明按照iatf的认证方案获得木技术规范的认证,包括customer-specific requirements if any, is recognized by the customer 顾客特殊要求(若存在),将获得 iatf 顾客成员的承认 members of iatf when achieved according to the iatf(见获得 iatf 承认的规则)。certificati

15、on scheme (see the “rules for achieving iatf详细资料可从以下iatf在各区域下设的监督机构recognition).得到。details can be obtained at the addresses of the local oversight bodies associazione nazionle fra industie automobilistiche(anfia)of iatf cited below:associazione nazionale fra industrie automobilistiche (anfia)web sit

16、e : www.anfia.it e-mail: anfiaanfia.itweb site: www.anfia.ite-mail: anfiaanfia.itinternational automotive oversight bureau (iaob)web site: e-mail: federation des industries des equipements pour vehicules (fiev) comile des conslructeurs fran(;ais d'aulomobiles (ccfa)web

17、 site: www.iatf-e-mail:iatfiatf-fra society of motor manufacturers and traders ltd. (smmt ltd.)web site: www.smmt.co.uk e-mail: qualitysmmt.co.ukverband der automobilindustrie qualitatsmanagement center (vda-qmc)web site: www.vda-qmc.dee-mail:infovda-qmc.deinternational automotive oversight bureau (

18、iaob)web site: e-mail:federation des industries des equipements pourvehicules(fiev)comite des constructeurs francais d automobiles(ccfa)web site: www.iatf- e-mail:iatfiatf-fsociety of motor manufacturers and traders ltd.(smmtltd.)web site: www.smmt.co.uk e-mail:qualitysmm

19、t.co.ukverband der autombilindustrie qualitatmanagementcenter(vda qmc)web site: www.vda-qmc.de e-mail:infovda-qmc.deintroduction0.1 general引 言0.1总则iso 9001:2000, quality management systems requirementsintroduction0.1 generalthe adoption of a quality management system should be a strategic decision o

20、f an organization. the design and implementation of an organization's quality management system is influe need by varying needs, particular objectives, the products provided, the processes employed and the size and structure of the organization. it is not the intent of this international standar

21、d to imply uniformity in the structure of quality management systems or uniformity of documentation.the quality management system requirements specified in this international standard are complementa to requirements for products. in formation marked “note' is for guidance in understanding or cla

22、rifying the associated requirement.this international standard can be used by internal and external parties, including certification bodies, to assess the organization ability to meet customer, regulatory and the organization own requirementsthe quality management principles staled in iso 9000 and i

23、so 9004 have been taken into consideration during the development of this international standardgb/t 19001: 2000,质量管理体系一要求引言01总则采用质量管理体系应当是组织的一项战略性决策。一个组 织质量管理体系的设计和实施受各种需求、具体目标、所提 供的产品、所采用的过程以及该组织的规模和结构的影响。 统一质量管理体系的结构或文件不是本标准的冃的。本标准所规定的质量管理体系要求是对产品要求的补 充。“注”是理解和说明有关要求的指南。本标准能力于内部和外部(包括认证机构)评定组织满 足

24、顾客、法律法规和组织自身要求的直呂力。本标准的制定己经考虑了 gb/t 19000和gb/t 19004屮所阐 明的质量管理原则。0.2 process approach0.2过程方法iso 9001:2000, quality management systems requirements0.2 process approachgb/t 19001: 2000,质量管理体系一要求0.2过程方法this international standard promotes the adoption of a process approach when developing, implementing

25、 and improving the effectiveness of a quality management system, to enhance本标准鼓励在建立、实施质量管理体系以及改进其有效 性时采用过程方法,通过满足顾客要求,增强顾客满意。customer satisfaction by meeting customer requirements.for an organization to function effectively, it has to identify and manage numerous linked activities. an activity using

26、 resources, and managed in order to enable the transformation 为使组织有效运作,必须识別和管理体系众多相互关联 的活动。通过使用资源和管理,将输入转化为输出的活动可 视为过程。通常,一个过程的输出直接形成下一个过程的输of inputs into outputs, can be considered as a process often the 入。output from one process directly fomis the input to the next.the application of a system of p

27、rocesses within an organization, together with the identification and interactions组织内诸过程的系统的应用,连同这些过程的识别和相 互作用及其管理,可称z为“过程方法”。0.3 relationship with iso 90040.3与gb/t 19004的关系iso 9001:2000, quality management systems requirementsgb/t 19001: 2000,质量管理体系一要求of these processes, and their management, can b

28、e referred to as the "process approachan advantage of the process approach is the ongoing control that it provides over the linkage between the individual processes within the system of processes, as well as over their combination and interaction.when used within a quality management system, su

29、ch an approach emphasizes the importance of:a) understanding and meeting requirements,b) the need to consider processes in terms of added value,c) obtaining results of process performance and effectiveness, andd) continual improvement of processes based on objective measurement.the model of a proces

30、s-based quality management system shown in figure 1 illustrates the process linkages presented in clauses 4 to 8. this illustration shows that customers play a significant role in defining requirements as inputs. monitoring of customer satisfaction requires the evaluation of information relating to

31、customer perception as to whether the organization has met the customer requirements. the model shown in figure 1 covers all the requirements of this international standard, but does not show processes at a detailed level.note in addition, the methodology known as "plan-do-check-acf(pdca) can b

32、e applied to all processes. pdca can be briefly described as followsplan: establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organization's policies.do: implement the processescheck: monitor and measure processes and product again

33、st policies, objectives and requirements for the product and report the results.act: take actions to continually improve process performance 过程方法的优点是对诸过程的系统中单个过程z间的 联系以及过程的组合和相互作用进行连续的控制。过程方法在质量管理体系中应用时,强调以下方面的重 要性:a)理解并满足要求;b)需耍从增值的角度考虑过程;c)获得过程业绩和有效性的结果;d)棊于客观的测量,持续改进过程。图1所反映的过程为基础的质量管理体系模式展示了48章中

34、所提出的过程联系。这种展示反映了在规定输 入要求时,顾客起着重要作用。对顾客满意的监视要求 对顾客冇关组织是否己满足其耍求的感受的信息进行 评价。该模式虽覆盖了本标准的所有耍求,但却未详细 地反映各过程。注:此外,称之为“pdca”的方法可适用于所有过程。pdca模式可简述如下:p策划:根据顾客的要求和组织的方针,为提供结果建立必要的目标和过程;d实施:实施过程;c检查:根据方针、目标和产品要求,对过程和产品进行监视和测量,并报告结果;a-处理:采取措施,以持续改进过程业纟贞。0.3 relationship with iso 9004the present editions of iso 9

35、001 and iso 9004 have been developed as a consistent pair of quality management system standards which have been designed to complement each other, but can also be used independently.although the two international standards have different scopes, they have simikir structures in order to assist their

36、 application as a consistent pair.iso 9001 specifies requirements for a quality management system that can be used for internal application by organizations, or for certification, or for contractual purposes it focuses on the effectiveness of the quality management system in meeting customer require

37、mentsiso 9004 gives guidance on a wider range of objectives of a quality management system than docs iso 9001, particularly for the continual improvement of an organization's overall performance and efficiency, as well as its effectiveness iso 9004 is recommended as a guide for organizations who

38、se top management wishes to move beyond the requirements of iso 9001, in pursuit of continual improvement of performance however, it is not intended for certification or for contractual purposes note the knowledge and use of the eight quality management principles referred to in iso 9000:2000 and is

39、o 9004:2000 should be demonstrated and cascaded through the organization by top management.0.3.1 iatf guidance to iso/ts 16949:2000“iatf guidance to iso/ts 16949:2002" is a document containing recommended automotive industry practices, examples, illustrations and explanations, and provides assi

40、stance in the application to conform to the requirements of this technical specification.0.3 与gb/t 19004的关系gb/t 19001和gb/t 19004己制定为一对协调一致的质 量管理体系标准,他们相互补充,但也可单独使用,虽然这 两项标准具有不同的范围,但却具有相似的结构,以有助于他 们作为协调一致的一对标准的应用。gb/t19001规定了质量管理体系耍求,可供组织内部 使用,也可用于认证或合同冃的。在满足顾客要求方面,gb/t 19001所关注的是质量管理体系的有效性。与gb/t1900

41、1相比,gb/t 19004为质量管理体系更宽范围 的目标提供了指南。除了有效性,该标准还特别关注持 续改进组织的总体业绩与效率。对于最高管理者希望通 过追求业绩持续改进而超越gb/t 19001要求的那些组 织,gb/t 19004推荐了指南。然而,用于认证或合同不 是gb/t19004的日的。注:应当由最高管理者在组织内宣传和贯彻gb/t 19000-2000 和gb/t190042000中提及的八项质量管理原则的知识及其 应用。0.3.1 iatf 关于 iso/ 16949: 2002 的指南iatf关于iso/ts 16949: 2002的指南是一份包含了 推荐性的汽车行业实践、范例

42、、图解和解释的文件,并 对符合本标准要求的应用提供帮助。this iatf guidance document is not intended for 此iatf指南文件不拟用于认证或合同的目的。certification or for contractual purposes04 compatibility with other management systems0.4与其它管理体系的兼容性iso 9001:2000, quality management systems requirements0.4 compatibility with other management systems

43、gb/t 19001: 2000,质量管理体系一要求0.4与其它管理体系的兼容性this intemational standard has been aligned with iso 14001:1996 in order to enhance the compatibility of the two standiirds for the benefit of the user communitythis international standard docs not include requirements specific to other management systems, suc

44、h as those particular to environmental management, occupational health and safety management, financial management or risk management. however, this international standard enables an organization to align or integrate its own quality management system with related management system requirements. it

45、is possible for an organization to adapt its existing management system(s) in order to establish a quality management system that complies with the requirements of this international standard0.5 goal of this technical specificationthe goal of this technical specification is the development of a qual

46、ity management system that provides for continual improvement, emphasizing defect prevention and the reduction of variation and waste in the supply chain.为了使用者的利益,本标准与gb/t240011996相互趋 近,以增强两类标准的兼容性。本标准不包括针对其它管理体系的耍求,如环境管理、职 业卫生与安全管理、财务管理或风险管理的特定要求。然而 本标准使组织能够将口身的质量管理体系与相关的管理体系 耍求结合或整合。组织为了建立符合本标准的质量

47、管理体系, 可能会改变现行的管理体系。0.5本标准的目标木标准的冃标是在供应链中建立持续改进,强调缺陷 预防,减少变差和浪费的质量管理体系。this technical specification, coupled with applicable customer-specific requirements, defines the fundamental木标准与适用的顾客特殊要求相结合,规定了签署本 文件顾客的基木质量管理体系要求。quality management system requirements for those subscribing to this document.thi

48、s technical specification is intended to avoid multiple certification audits and provide a common approach to a quality management system for automotive production, and relevant service part organizations.木标准旨在避免多重的认证审核,并为汽车牛产件和相 关维修零件组织建立质量管理体系提供一个通用的方 法。quality management systemsparticular require

49、ments for the application of iso 9001:2000 for automotive production and relevant service part organizations质量管理体系汽车生产件及相关维修零件组织 应用gb/t19001- 2000的特别要求1 scope1.1 generaliso 9001:2000, quality management systems requirements1 scope1.1 generalthis international standard specifies requirements for a qu

50、ality management system where an organizationa) needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, andb) aims to enhance customer satisfaction through the effective application of the system, including processes for continual

51、improvement of the system and the assurance of confomiity to customer and applicable regulatory requirementsnote in this international standard, the term"product applies only to the product intended for, or required by, a customer.this technical specification, in conjunction with iso 9001:2000,

52、 defines the quality management system requirements for the design and development, production and, when relevant, installation and service of automotivc-rclatcd products this technical specification is applicable to sites of the organization where customcr-spccificd parts, for production and/or ser

53、vice, arc manufactured.1范围1.1总则gb/t 19001: 2000,质量管理体系一要求1. 范围1.1总则本标准为有下列需求的组织规定了质量管理体系要求:a)需求证实其有能力稳定地提供满足顾客和适用的法 律法规要求的产品;b)通过体系的有效应用,包括体系持续改进的过程以 及保证符合顾客与适用的法律法规要求,旨在增强 顾客满意。注:在木标准中,术语“产品”仅适用于预期提供给顾客或 顾客要求的产品。本标准与gb/t19001-2000相结合,规定了质量管理体系 要求,用于汽车相关产品的设计和开发、生产;相关时, 也适用于安装和服务。本标准适用于组织进行顾客规定的生产件和

54、/或维修零 件制造的现场。supporting functions, whether on-sitc or remote (such as design centres, corporate headquarters and distribution centres), form part of the site audit as they support the site, but cannot obtain stand-alone certification to this technical spccificatio n.this technical specification can

55、be applied throughoutthe automotive supply chain.支持职能,无论其在现场或在外部(如设计屮心,公司 总部及分销中心),由于它们对现场起支持性作用而构 成现场审核的一部分,但不能单独获得本标准的认证。本标准可适用于整个汽车供应链。iso 9001:2000, quality management systems requirements1.2 applicationall requirements of this international standard are generic and are intended to be applicable

56、 to all organizations, regardless of type, size and product providedwhere any rcquircmcnt(s) of this international standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusionwhere exclusions are made, claims of conformity to this internationa

57、l standard are not acceptable unless these exclusions arc limited to requirements within clause 7, and such exclusions do not affect the organization ability, or responsibility, to provide product that meets customer and applicable regulatory requirementsgb/t 19001: 2000,质量管理体系一要求1.2应用本标准规定的所有耍求是通用的

58、,旨在适用于各种类型、 不同规模和捉供不同产品的组织。当本标准的任何耍求因组织及其产品的特点而不适用 时,可以考虑对其进行删减。除非删减仅限于本标准第7章屮那些不影响组织提供满 足顾客和适用法律法规耍求的产品的能力或责任的耍求,否 则不能声称符合本标准。the only permitted exclusions for this technical specification本标准仅允许在组织没有产品设计和开发责任的情况 relate to 7.3 where the organization is not responsible for 下删减与 7.3 有关的内容。 product design and development.permitted exclusions do not include manufacturing不允许删减制造过程的设计。process

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