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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質(zhì)量管理體系汽車(chē)生產(chǎn)件及相關(guān)維修零件組織應(yīng)用GB/T19001- 2000的特別要求Foreword ISO 前言ISO (the International Organization for Standardization) is a worldwide federation of nati

2、onal standards 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. Internat

3、ional organizations, governmental and non-governmental, 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.國(guó)際標(biāo)準(zhǔn)化組織(ISO)是由國(guó)際標(biāo)準(zhǔn)化團(tuán)體(ISO成員團(tuán)體)組成的世界生的聯(lián)合會(huì)。制定國(guó)際標(biāo)準(zhǔn)的工作通常由ISO的技術(shù)委員會(huì)

4、完成。各成員團(tuán)體若對(duì)某技術(shù)委員會(huì)確定的項(xiàng)目感興趣,均有權(quán)參加委員會(huì)(IEC)在電工技術(shù)標(biāo)準(zhǔn)化方面保持緊密的合作關(guān)系。International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.國(guó)際標(biāo)準(zhǔn)的制定符合ISO/IEC導(dǎo)則第3部分的有關(guān)規(guī)定。The main task of technical committees is to prepare International Standards. Draft International Standards ad

5、opted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.技術(shù)委員會(huì)的主要任務(wù)是制定國(guó)際標(biāo)準(zhǔn)。由技術(shù)委員會(huì)通過(guò)的國(guó)際標(biāo)準(zhǔn)草案提交各成員團(tuán)體投票表決。國(guó)際標(biāo)準(zhǔn)草案需取得至少75%參加表決成員團(tuán)體的同意,才能作為國(guó)際標(biāo)準(zhǔn)正式發(fā)布。In other circumstances

6、, 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 technical experts in an ISO working group and is accepted f

7、or 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 publication if it is approved by 2/3 of the members of the comm

8、ittee casting a vote.其它情況下,特別是市場(chǎng)對(duì)這樣的文件有緊迫需求時(shí),技術(shù)委員會(huì)可決定出版其它形式的標(biāo)準(zhǔn)化文件: ISO 公開(kāi)規(guī)范(ISO/PAS)表明一個(gè)ISO 工作組內(nèi)技術(shù)專(zhuān)家間已達(dá)成一致,如果上一級(jí)委員會(huì)的成員50%投票同意則可被接受出版。 ISO 技術(shù)規(guī)范(ISO/TS),表明技術(shù)委員會(huì)成員間已達(dá)成一致,如果委員會(huì)2/3的成員投票同意則可被接受出版。An ISO/PAS or ISO/TS is reviewed after three years with a view to deciding whether it should be confirmed for

9、a further three years, revised to become an International Standard, or withdrawn. In the case of a confirmed ISO/PAS or ISO/TS, it is reviewed again after six years at which time it has to be either transposed into an International Standard or withdrawn.對(duì)ISO/PAS或ISO/TS,三年后要進(jìn)行一次評(píng)審,以決定是否應(yīng)當(dāng)在下一個(gè)三年內(nèi)獲得確認(rèn),

10、修改為國(guó)際標(biāo)準(zhǔn)或撤消。在ISO/PAS或ISO/TS獲得確認(rèn)的情況下,六年后重新評(píng)審,最終確定為國(guó)際標(biāo)準(zhǔn)或撤消。ISO/TS 16949:2002 was prepared by the International Automotive Task Force (IATF) and Japan Automobile Manufacturers Association, Inc. (JAMA), with support from ISO/TC 176, Quality management and quality assurance.ISO/TS16949:2002 由國(guó)際汽車(chē)特別工作組(IAT

11、F)和日本汽車(chē)制造商協(xié)會(huì)(JAMA)在ISO/TC176質(zhì)量管理和質(zhì)量保證委員會(huì)的支持下共同制定。This second edition of ISO/TS 16949 cancels and replaces the first edition (ISO/TS 16949:1999), which has been technically revised.通過(guò)技術(shù)修訂,取消第一版的ISO/TS16949:1999,并由第二版ISO/TS16949替代。Boxed text is original ISO 9001:2000 text. The sector-specific suppleme

12、ntal requirements are outside the boxes.方框內(nèi)的文字是ISO9001:2000原文。方框外的部分是行業(yè)特殊補(bǔ)充要求。In this Technical Specification, the word “shall” indicates a requirement. The word “should” indicates a recommendation. Paragraphs marked “NOTE” are for guidance in understanding or clarifying the associated requirement.在

13、本技術(shù)規(guī)范中“應(yīng)”(shall)表示要求。“應(yīng)當(dāng)”(should)表示建議。標(biāo)有“注”(NOTE)的段落是對(duì)理解和解釋的關(guān)要求的指南。Where the term “such as” is used, any suggestions given are for guidance only.凡使用“例如”(such as)一詞處,任何給出的建議僅起指導(dǎo)作用。Annex A forms a normative part of this Technical Specification.附錄A是標(biāo)準(zhǔn)的附錄,構(gòu)成本標(biāo)準(zhǔn)的一部分。Remarks for certificationThe certifica

14、tion to this Technical Specification, including customer-specific requirements if any, is recognized by the customer members of IATF when achieved according to the IATF certification scheme (see the “Rules for achieving IATF recognition”).Details can be obtained at the addresses of the local oversig

15、ht bodies of IATF cited below:Associazione Nazionale Fra Industrie Automobilistiche (ANFIA) Web site: www.anfia.it e-mail: anfiaanfia.itInternational Automotive Oversight Bureau (IAOB) Web site: e-mail: Fédération des Industries des Équipements pour Vé

16、hicules (FIEV)Comité des Constructeurs Français d'Automobiles (CCFA) Web site: www.iatf- e-mail: iatfiatf-FSociety of Motor Manufacturers and Traders Ltd. (SMMT Ltd.) Web site: www.smmt.co.uk e-mail: qualitysmmt.co.ukVerband der Automobilindustrie Qualitätsmanagement Center (VDA-Q

17、MC) Web site: www.vda-qmc.de e-mail: infovda-qmc.de關(guān)于認(rèn)證的說(shuō)明 按照IATF的認(rèn)證方案獲得本技術(shù)規(guī)范的認(rèn)證,包括顧客特殊要求(若存在),將獲得IATF顧客成員的承認(rèn)(見(jiàn)獲得IATF承認(rèn)的規(guī)則)。 詳細(xì)資料可從以下IATF在各區(qū)域下設(shè)的監(jiān)督機(jī)構(gòu)得到。Associazione Nazionle Fra Industie Automobilistiche(ANFIA) Web site :www.anfia.it e-mail: anfiaanfia.itInternational Automotive Oversight Bureau (IAO

18、B) Web site: e-mail:Federation des Industries des Equipements Pour Vehicules(FIEV)Comite des Constructeurs Francais dAutomobiles(CCFA)Web site: www.iatf- e-mail:iatfiatf-FSociety of Motor Manufacturers and Traders Ltd.(SMMT Ltd.)Web site: www.smmt.co.uk e-mail:qualitysmmt

19、.co.ukVerband der Autombilindustrie Qualitatmanagement Center(VDA、QMC)Web site:www.vda-qmc.de e-mail:infovda-qmc.deIntroduction引 言0.1 General0.1總則ISO 9001:2000, Quality management systems RequirementsIntroduction0.1 GeneralThe adoption of a quality management system should be a strategic decision of

20、 an organization. The design and implementation of an organization's quality management system is influenced 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 Standard

21、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 complementary to requirements for products. Information marked “NOTE” is for guidance in understanding or clarifyi

22、ng the associated requirement.This International Standard can be used by internal and external parties, including certification bodies, to assess the organization's ability to meet customer, regulatory and the organization's own requirements.The quality management principles stated in ISO 90

23、00 and ISO 9004 have been taken into consideration during the development of this International Standard.GB/T 19001:2000,質(zhì)量管理體系要求引言0.1總則 采用質(zhì)量管理體系應(yīng)當(dāng)是組織的一項(xiàng)戰(zhàn)略性決策。一個(gè)組織質(zhì)量管理體系的設(shè)計(jì)和實(shí)施受各種需求、具體目標(biāo)、所提供的產(chǎn)品、所采用的過(guò)程以及該組織的規(guī)模和結(jié)構(gòu)的影響。統(tǒng)一質(zhì)量管理體系的結(jié)構(gòu)或文件不是本標(biāo)準(zhǔn)的目的。 本標(biāo)準(zhǔn)所規(guī)定的質(zhì)量管理體系要求是對(duì)產(chǎn)品要求的補(bǔ)充。“注”是理解和說(shuō)明有關(guān)要求的指南。本標(biāo)準(zhǔn)能力于內(nèi)部和外部(包括認(rèn)證機(jī)構(gòu))評(píng)

24、定組織滿(mǎn)足顧客、法律法規(guī)和組織自身要求的能力。本標(biāo)準(zhǔn)的制定已經(jīng)考慮了GB/T 19000和GB/T 19004中所闡明的質(zhì)量管理原則。0.2 Process approach0.2 過(guò)程方法ISO 9001:2000, Quality management systems Requirements0.2 Process approachThis International Standard promotes the adoption of a process approach when developing, implementing and improving the effectivene

25、ss of a quality management system, to enhance customer satisfaction by meeting customer requirements.For an organization to function effectively, it has to identify and manage numerous linked activities. An activity using resources, and managed in order to enable the transformation of inputs into ou

26、tputs, can be considered as a process. Often the output from one process directly forms the input to the next.The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management, can be referred to as the “proces

27、s approach”.An 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, such an approach emphasizes the i

28、mportance 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 process-based quality management sys

29、tem 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 customer perception as to whet

30、her 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-Act” (PDCA) can be applied to all processes. PDCA

31、can be briefly described as follows.Plan: establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organization's policies.Do: implement the processes.Check: monitor and measure processes and product against policies, objectives and req

32、uirements for the product and report the results.Act: take actions to continually improve process performance.GB/T 19001:2000,質(zhì)量管理體系要求0.2 過(guò)程方法本標(biāo)準(zhǔn)鼓勵(lì)在建立、實(shí)施質(zhì)量管理體系以及改進(jìn)其有效性時(shí)采用過(guò)程方法,通過(guò)滿(mǎn)足顧客要求,增強(qiáng)顧客滿(mǎn)意。為使組織有效運(yùn)作,必須識(shí)別和管理體系眾多相互關(guān)聯(lián)的活動(dòng)。通過(guò)使用資源和管理,將輸入轉(zhuǎn)化為輸出的活動(dòng)可視為過(guò)程。通常,一個(gè)過(guò)程的輸出直接形成下一個(gè)過(guò)程的輸入。組織內(nèi)諸過(guò)程的系統(tǒng)的應(yīng)用,連同這些過(guò)程的識(shí)別和相互作用及其管理

33、,可稱(chēng)之為“過(guò)程方法”。過(guò)程方法的優(yōu)點(diǎn)是對(duì)諸過(guò)程的系統(tǒng)中單個(gè)過(guò)程之間的聯(lián)系以及過(guò)程的組合和相互作用進(jìn)行連續(xù)的控制。過(guò)程方法在質(zhì)量管理體系中應(yīng)用時(shí),強(qiáng)調(diào)以下方面的重要性:a) 理解并滿(mǎn)足要求;b) 需要從增值的角度考慮過(guò)程;c) 獲得過(guò)程業(yè)績(jī)和有效性的結(jié)果;d) 基于客觀的測(cè)量,持續(xù)改進(jìn)過(guò)程。圖1所反映的過(guò)程為基礎(chǔ)的質(zhì)量管理體系模式展示了48章中所提出的過(guò)程聯(lián)系。這種展示反映了在規(guī)定輸入要求時(shí),顧客起著重要作用。對(duì)顧客滿(mǎn)意的監(jiān)視要求對(duì)顧客有關(guān)組織是否已滿(mǎn)足其要求的感受的信息進(jìn)行評(píng)價(jià)。該模式雖覆蓋了本標(biāo)準(zhǔn)的所有要求,但卻未詳細(xì)地反映各過(guò)程。 注:此外,稱(chēng)之為“PDCA”的方法可適用于所有過(guò)程。PD

34、CA模式可簡(jiǎn)述如下: P策劃:根據(jù)顧客的要求和組織的方針,為提供結(jié)果建立必要的目標(biāo)和過(guò)程; D實(shí)施:實(shí)施過(guò)程; C檢查:根據(jù)方針、目標(biāo)和產(chǎn)品要求,對(duì)過(guò)程和產(chǎn)品進(jìn)行監(jiān)視和測(cè)量,并報(bào)告結(jié)果; A處理:采取措施,以持續(xù)改進(jìn)過(guò)程業(yè)績(jī)。0.3 Relationship with ISO 90040.3 與GB/T 19004 的關(guān)系ISO 9001:2000, Quality management systems Requirements0.3 Relationship with ISO 9004The present editions of ISO 9001 and ISO 9004 have bee

35、n 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 similar structures in order to assist their application as a consist

36、ent 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 requirements.ISO 9004 gives gui

37、dance on a wider range of objectives of a quality management system than does 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 whose top management wish

38、es 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.GB/T 19001:2000, 質(zhì)量管理體系要求0.3 與GB/T 19004的關(guān)系GB/T 19001和GB/T 19004已制定為一對(duì)協(xié)調(diào)一致的質(zhì)量管理體系標(biāo)準(zhǔn),他們相互補(bǔ)充,但也可單獨(dú)使用,雖然這兩項(xiàng)標(biāo)準(zhǔn)具有不同的范圍,但卻具有相似的結(jié)構(gòu),以有

39、助于他們作為協(xié)調(diào)一致的一對(duì)標(biāo)準(zhǔn)的應(yīng)用。GB/T19001 規(guī)定了質(zhì)量管理體系要求,可供組織內(nèi)部使用,也可用于認(rèn)證或合同目的。在滿(mǎn)足顧客要求方面,GB/T 19001所關(guān)注的是質(zhì)量管理體系的有效性。與GB/T19001 相比, GB/T 19004為質(zhì)量管理體系更寬范圍的目標(biāo)提供了指南。除了有效性,該標(biāo)準(zhǔn)還特別關(guān)注持續(xù)改進(jìn)組織的總體業(yè)績(jī)與效率。對(duì)于最高管理者希望通過(guò)追求業(yè)績(jī)持續(xù)改進(jìn)而超越GB/T 19001 要求的那些組織,GB/T 19004推薦了指南。然而,用于認(rèn)證或合同不是GB/T19004的目的。NOTE The knowledge and use of the eight qualit

40、y management principles referred to in ISO 9000:2000 and ISO 9004:2000 should be demonstrated and cascaded through the organization by top management.注:應(yīng)當(dāng)由最高管理者在組織內(nèi)宣傳和貫徹GB/T190002000和GB/T190042000中提及的八項(xiàng)質(zhì)量管理原則的知識(shí)及其應(yīng)用。0.3.1 IATF Guidance to ISO/TS 16949:2000“IATF Guidance to ISO/TS 16949:2002” is a do

41、cument containing recommended automotive industry practices, examples, illustrations and explanations, and provides assistance in the application to conform to the requirements of this Technical Specification.This IATF Guidance document is not intended for certification or for contractual purposes0.

42、3.1 IATF關(guān)于ISO/ 16949:2002的指南 IATF關(guān)于ISO/TS 16949:2002的指南是一份包含了推薦性的汽車(chē)行業(yè)實(shí)踐、范例、圖解和解釋的文件,并對(duì)符合本標(biāo)準(zhǔn)要求的應(yīng)用提供幫助。 此IATF指南文件不擬用于認(rèn)證或合同的目的。0.4 Compatibility with other management systems0.4 與其它管理體系的兼容性ISO 9001:2000, Quality management systems Requirements0.4 Compatibility with other management systemsThis Internat

43、ional Standard has been aligned with ISO 14001:1996 in order to enhance the compatibility of the two standards for the benefit of the user community.This International Standard does not include requirements specific to other management systems, such as those particular to environmental management, o

44、ccupational 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 is possible for an organization to adapt its existin

45、g management system(s) in order to establish a quality management system that complies with the requirements of this International Standard.GB/T 19001:2000,質(zhì)量管理體系要求0.4 與其它管理體系的兼容性 為了使用者的利益,本標(biāo)準(zhǔn)與GB/T240011996相互趨近,以增強(qiáng)兩類(lèi)標(biāo)準(zhǔn)的兼容性。 本標(biāo)準(zhǔn)不包括針對(duì)其它管理體系的要求,如環(huán)境管理、職業(yè)衛(wèi)生與安全管理、財(cái)務(wù)管理或風(fēng)險(xiǎn)管理的特定要求。然而本標(biāo)準(zhǔn)使組織能夠?qū)⒆陨淼馁|(zhì)量管理體系與相關(guān)的管理體

46、系要求結(jié)合或整合。組織為了建立符合本標(biāo)準(zhǔn)的質(zhì)量管理體系,可能會(huì)改變現(xiàn)行的管理體系。0.5 Goal of this Technical SpecificationThe goal of this Technical Specification is the development of a quality management system that provides for continual improvement, emphasizing defect prevention and the reduction of variation and waste in the supply ch

47、ain.This Technical Specification, coupled with applicable customer-specific requirements, defines the fundamental quality management system requirements for those subscribing to this document.This Technical Specification is intended to avoid multiple certification audits and provide a common approac

48、h to a quality management system for automotive production, and relevant service part organizations.0.5 本標(biāo)準(zhǔn)的目標(biāo) 本標(biāo)準(zhǔn)的目標(biāo)是在供應(yīng)鏈中建立持續(xù)改進(jìn),強(qiáng)調(diào)缺陷預(yù)防,減少變差和浪費(fèi)的質(zhì)量管理體系。 本標(biāo)準(zhǔn)與適用的顧客特殊要求相結(jié)合,規(guī)定了簽署本文件顧客的基本質(zhì)量管理體系要求。 本標(biāo)準(zhǔn)旨在避免多重的認(rèn)證審核,并為汽車(chē)生產(chǎn)件和相關(guān)維修零件組織建立質(zhì)量管理體系提供一個(gè)通用的方法。Quality management systems - Particular requirements for t

49、he application of ISO 9001:2000 for automotive production and relevant service part organizations質(zhì)量管理體系汽車(chē)生產(chǎn)件及相關(guān)維修零件組織應(yīng)用GB/T19001- 2000的特別要求1 Scope1.1 General1范圍1.1總則ISO 9001:2000, Quality management systems Requirements1 Scope1.1 GeneralThis International Standard specifies requirements for a qualit

50、y 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 impr

51、ovement of the system and the assurance of conformity to customer and applicable regulatory requirements.NOTE In this International Standard, the term “product” applies only to the product intended for, or required by, a customer.GB/T 19001:2000,質(zhì)量管理體系要求1. 范圍1.1 總則本標(biāo)準(zhǔn)為有下列需求的組織規(guī)定了質(zhì)量管理體系要求:a) 需求證實(shí)其有能力

52、穩(wěn)定地提供滿(mǎn)足顧客和適用的法律法規(guī)要求的產(chǎn)品;b) 通過(guò)體系的有效應(yīng)用,包括體系持續(xù)改進(jìn)的過(guò)程以及保證符合顧客與適用的法律法規(guī)要求,旨在增強(qiáng)顧客滿(mǎn)意。 注:在本標(biāo)準(zhǔn)中,術(shù)語(yǔ)“產(chǎn)品”僅適用于預(yù)期提供給顧客或顧客要求的產(chǎn)品。This Technical Specification, in conjunction with ISO 9001:2000, defines the quality management system requirements for the design and development, production and, when relevant, installatio

53、n and service of automotive-related products.This Technical Specification is applicable to sites of the organization where customer-specified parts, for production and/or service, are manufactured. Supporting functions, whether on-site or remote (such as design centres, corporate headquarters and di

54、stribution centres), form part of the site audit as they support the site, but cannot obtain stand-alone certification to this Technical Specification.This Technical Specification can be applied throughout the automotive supply chain.本標(biāo)準(zhǔn)與GB/T19001-2000相結(jié)合,規(guī)定了質(zhì)量管理體系要求,用于汽車(chē)相關(guān)產(chǎn)品的設(shè)計(jì)和開(kāi)發(fā)、生產(chǎn); 相關(guān)時(shí),也適用于安裝和服務(wù)

55、。 本標(biāo)準(zhǔn)適用于組織進(jìn)行顧客規(guī)定的生產(chǎn)件和/或維修零件制造的現(xiàn)場(chǎng)。 支持職能,無(wú)論其在現(xiàn)場(chǎng)或在外部(如設(shè)計(jì)中心,公司總部及分銷(xiāo)中心),由于它們對(duì)現(xiàn)場(chǎng)起支持性作用而構(gòu)成現(xiàn)場(chǎng)審核的一部分,但不能單獨(dú)獲得本標(biāo)準(zhǔn)的認(rèn)證。 本標(biāo)準(zhǔn)可適用于整個(gè)汽車(chē)供應(yīng)鏈。1.2 Application1.2 應(yīng)用ISO 9001:2000, Quality management systems Requirements1.2 ApplicationAll requirements of this International Standard are generic and are intended to be appli

56、cable to all organizations, regardless of type, size and product provided.Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.Where exclusions are made, claims of conformity to this Inter

57、national Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable regulatory requirements.GB/T 19001:2000,質(zhì)量管理體系要求1.2 應(yīng)用 本標(biāo)準(zhǔn)規(guī)定的所有要求是通用的,旨在適用于各種類(lèi)型、不同規(guī)模和提供不同產(chǎn)品的組織。 當(dāng)本標(biāo)準(zhǔn)的任何要求因組織及其產(chǎn)品的特點(diǎn)而不適用時(shí),可以考慮對(duì)其進(jìn)行刪減。 除非刪減僅限于本標(biāo)準(zhǔn)第7章中那些不影響組織提供滿(mǎn)足顧客和適用法律法規(guī)要求的產(chǎn)品的能力或責(zé)任的要求,否則不能聲稱(chēng)符合本標(biāo)準(zhǔn)。The on

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