ISOTS16949：2009質量管理體系中英文對照版

1、ISO/TS16949：2009標準ISO/TS16949：2009技術規(guī)范TECHNICAL SPECIFICATION質量管理體系 汽車生產(chǎn)件及相關服務件組織應用 ISO9001:2008的特殊要求Quality management systems Particular requirements for the application of ISO 9001:2008 for automotive production and relevant service part organizations目錄Contents 前言Foreword7 有關認證的說明Remarks for cert

2、ification9 引言Introduction10 0.1總則General10 0.2過程方法Process approach11 0.3與ISO 9004的關系Relationship with ISO 900413 0.4與其他管理體系的相容性Compatibility with other management systems14 0.5本技術規(guī)范的目的Goal of this Technical Specification15 1范圍Scope16 1.1總則General16 1.2應用Application17 2引用標準Normative reference17 3術語和定

3、義Terms and definitions18 3.1汽車行業(yè)術語和定義Terms and definitions for the automotive industry18 4質量管理體系Quality management system20 4.1總要求General requirements 20 4.1.1總要求補充General requirementsSupplemental21 4.2文件要求Documentation requirements21 4.2.1 總則General21 4.2.2 質量手冊Quality manual22 4.2.3文件控制Control of

4、documents22 工程規(guī)范Engineering specifications23 4.2.4記錄控制Control of records23 記錄保存Records retention 24 5管理職責Management responsibility24 5.1管理承諾Management commitment24 5.1.1過程效率Process efficiency24 5.2以顧客為關注焦點Customer focus24 5.3質量方針Quality policy 25 5.4策劃Planning25 5.4.1質量目標Quality object

5、ives25 質量目標補充Quality objectivesSupplemental25 5.4.2質量管理體系的策劃Quality management system planning26 5.5職責、權限與溝通Responsibility, authority and communication26 5.5.1職責和權限Responsibility and authority26 質量職責Responsibility for quality26 5.5.2管理者代表Management representative27 顧客代表Customer

6、representative27 5.5.3內部溝通Internal communication27 5.6管理評審Management review27 5.6.1總則General27 質量管理體系績效Quality management system performance28 5.6.2評審輸入Review input28 評審輸入補充Review inputSupplemental28 5.6.3評審輸出Review output29 6資源管理Resource management29 6.1資源提供Provision of resources29 6.

7、2人力資源Human resources29 6.2.1總則General30 6.2.2能力、培訓和意識Competence, training and awareness30 產(chǎn)品設計技能Product design skills30 培訓Training31 崗位培訓31 員工的激勵Employee motivation and empowerment31 6.3基礎設施Infrastructure31 6.3.1工廠、設施和設備策劃Plant, facility and equipment planning32 6.3.2應急計劃

8、Contingency plans32 6.4工作環(huán)境Work environment32 6.4.1為達成產(chǎn)品要求符合性的人員安全Personnel safety to achieve conformity product requirements32 6.4.2生產(chǎn)現(xiàn)場的清潔Cleanliness of premises32 7產(chǎn)品實現(xiàn)Product realization33 7.1產(chǎn)品實現(xiàn)的策劃Planning of product realization33 7.1.1產(chǎn)品實現(xiàn)的策劃補充Planning of product realizationSupplemental34 7.1

9、.2接收準則Acceptance criteria34 7.1.3保密性Confidentiality34 7.1.4更改控制Change control34 7.2與顧客有關的過程Customer-related processes34 7.2.1與產(chǎn)品有關的要求的確Determination of requirements related to the product35 顧客指定的特殊特性Customer-designated special characteristics35 7.2.2與產(chǎn)品有關的要求的評審Review of requirements related t

10、o the product35 與產(chǎn)品有關的要求的評審補充Review of requirements related to the produc Supplemental36 組織制造可行性Organization manufacturing feasibility36 7.2.3顧客溝通Customer communication36 顧客溝通補充Customer communicationSupplemental37 7.3設計和開發(fā)Design and development37 7.3.1設計和開發(fā)策劃Design and developme

11、nt planning37 多方論證方法Multidisciplinary approach37 7.3.2設計和開發(fā)輸入Design and development inputs38 產(chǎn)品設計輸入Product design input38 制造過程設計輸入Manufacturing process design input39 特殊特性Special characteristics39 7.3.3設計和開發(fā)輸出Design and development outputs39 產(chǎn)品設計輸出補充Product design

12、outputsSupplemental40 制造過程設計輸出Manufacturing process design output40 7.3.4設計和開發(fā)評審Design and development review41 監(jiān)視Monitoring41 7.3.5設計和開發(fā)驗證Design and development verification42 7.3.6設計和開發(fā)確認Design and development validation42 設計和開發(fā)確認補充Design and development validationSupplemental

13、42 樣件計劃Prototype programme42 產(chǎn)品批準過程Product approval process43 7.3.7 設計和開發(fā)更改的控制Control of design and development changes43 7.4 采購Purchasing43 7.4.1采購過程Purchasing process44 法規(guī)符合性Regulatory conformity44 供方質量管理體系開發(fā)Supplier quality management system development44 顧客批準的供

14、方Customer-approved sources44 7.4.2采購信息Purchasing information45 7.4.3采購產(chǎn)品的驗證Verification of purchased product45 進貨產(chǎn)品對要求的符合性Incoming product conformity to requirements45 對供方監(jiān)視Supplier monitoring46 7.5 生產(chǎn)和服務提供Production and service provision46 7.5.1生產(chǎn)和服務提供的控制Control of production and serv

15、ice provision46 控制計劃Control plan47 作業(yè)指導書Work instructions47 作業(yè)準備驗證Verification of job setups47 預防性和預見性維護Preventive and predictive maintenance48 生產(chǎn)工裝的管理Management of production tooling48 生產(chǎn)計劃Production scheduling49 服務信息反饋Feedback of information from se

16、rvice49 與顧客的服務協(xié)議Service agreement with customer49 7.5.2生產(chǎn)和服務提供過程的確認Validation of processes for production and service provision49 生產(chǎn)和服務提供過程的確認補充Validation of processes for production and service provisionSupplemental50 7.5.3標識和可追溯性Identification and traceability50 標識和可追溯性補充Ident

17、ification and traceabilitySupplemental50 7.5.4顧客財產(chǎn)Customer property51 顧客所有的工裝Customer-owned production tooling51 7.5.5.產(chǎn)品防護Preservation of product51 貯存和庫存Storage and inventory51 7.6監(jiān)視和測量設備的控制Control of monitoring and measuring equipment52 7.6.1測量系統(tǒng)分析Measurement system analysis53 7.6.2校

18、準/驗證記錄Calibration/verification records53 7.6.3實驗室要求Laboratory requirements53 內部實驗室Internal laboratory53 外部實驗室External laboratory54 8測量、分析和改進Measurement, analysis and improvement54 8.1總則General55 8.1.1統(tǒng)計工具的確定Identification of statistical tools55 8.1.2基礎統(tǒng)計概念知識 Knowledge of basic statisti

19、cal concepts55 8.2 監(jiān)視和測量Monitoring and measurement55 8.2.1顧客滿意Customer satisfaction55 顧客滿意補充Customer satisfactionSupplemental56 8.2.2內部審核Internal audit56 質量管理體系審核Quality management system audit57 制造過程審核Manufacturing process audit57 產(chǎn)品審核Product audit57 內部審核計劃Interna

20、l audit plans57 內審員資格Internal auditor qualification57 8.2.3過程的監(jiān)視和測量Monitoring and measurement of processes58 制造過程的監(jiān)視和測量Monitoring and measurement of manufacturing processes 58 8.2.4產(chǎn)品的監(jiān)視和測量Monitoring and measurement of product59 全尺寸檢驗和功能試驗Layout inspection and functional testing

21、59 外觀項目Appearance items60 8.3不合格品控制Control of nonconforming product60 8.3.1不合格品控制補充Control of nonconforming productSupplemental61 8.3.2返工產(chǎn)品的控制Control of reworked product61 8.3.3顧客通知Customer information61 8.3.4顧客特許Customer waiver61 8.4數(shù)據(jù)分析Analysis of data61 8.4.1數(shù)據(jù)分析和使用Analysis and use of data

22、62 8.5改進Improvement62 8.5.1持續(xù)改進Continual improvement62 組織的持續(xù)改進Continual improvement of the organization62 制造過程的改進Manufacturing process improvement62 8.5.2糾正措施Corrective action63 解決問題的方法Problem solving63 防錯Error-proofing63 糾正措施影響Corrective action impact63 拒收產(chǎn)

23、品的試驗/分析Rejected product test/analysis63 8.5.3預防措施Preventive action64 附錄A控制計劃Annex A (normative) Control plan65 參考文獻Bibliography67前言 Foreword 國際標準化組織(ISO)是由各國標準化機構（ISO成員機構）組成的世界性聯(lián)合會。國際標準的擬定由ISO技術委員會負責。各成員機構若對某技術委員會所選定的主題感興趣，均有權參加該委員會的工作。與ISO保持聯(lián)系的各國組織(官方的或非官方的)也可參加該項工作。ISO與國際電器委員會（IEC）在電工技術標準化方面保持密切合作

24、的關系。ISO (the International Organization for Standardization) is a worldwide federation of national 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 techni

25、cal committee has been established has the right to be represented on that committee. International 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 e

26、lectrotechnical standardization. 本國際標準是依照ISO/IEC導則第2部分中的規(guī)則制定的。 International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. 技術委員會的主要任務是制定國際標準。本國際技術標準草案已由技術委員會通過，并傳閱各成員機構一共投票表決。國際標準的公布需要至少75%的參加投票的成員團體批準。 The main task of technical committees is to prepare

27、 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% of the member bodies casting a vote. 在其它情況下，特別是在市場急需某個文件時，技術委員會可以決定出版其他形式的規(guī)范文件： In ot

28、her circumstances, particularly when there is an urgent market requirement for such documents, a technical committee may decide to publish other types of normative document: ISO公布的可獲得規(guī)范（ISO/PAS）代表一項在一個ISO工作小組內的技術專家達成的協(xié)議，在相應委員會的成員的投票中有50%投票贊成后就可以出版發(fā)行； an ISO Publicly Available Specification (ISO/PAS)

29、 represents an agreement between technical experts in an ISO working group and is accepted for publication if it is approved by 50 % of the members of the parent committee casting a vote; ISO技術規(guī)范（ISO/TS），是技術委員會成員之間達成的協(xié)議，在委員會成員所投票中有2/3投票贊成后就可以出版發(fā)行。 an ISO Technical Specification (ISO/TS) represents a

30、n 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 committee casting a vote. ISO/TS 16949是由國際汽車工業(yè)特別行動小組（IATF），在ISO/TC176 質量管理和質量保證技術委員會支持下制定的。 ISO/TS 16949 was prepared by the International Automotive Task Force (IA

31、TF) with support from ISO/TC 176, Quality management and quality assurance. 通過根據(jù)ISO9001 :2008所作的技術修訂，第三版的ISO/TS16949取消并替代了第二版(ISO/TS 16949:2002) This third edition of ISO/TS 16949 cancels and replaces the second edition (ISO/TS 16949:2002), which has been technically amended according to ISO 9001:20

32、08. 方框內的文本是ISO 9001：2008的原文內容，方框外是行業(yè)特殊補充的要求。 Boxed text is original ISO 9001:2008 text. The sector-specific supplemental requirements are outside the boxes. 在本技術規(guī)范中，“應”（shall）表示要求，“應當”（should）表示建議。標示有“注”（NOTE）的段落是對理解或澄清相關要求的指南。 In this Technical Specification, the word “shall” indicates a requiremen

33、t. The word “should” indicates a recommendation. Paragraphs marked “NOTE” are for guidance in understanding or clarifying the associated requirement. 所有用“例如”引出的建議都只具有指導性作用. Where the term “such as” is used, any suggestions given are for guidance only. 附錄A是本技術規(guī)范的引用文件，構成技術規(guī)范的一部分。 Annex A forms a norma

34、tive part of this Technical Specification. 有關認證的說明Remarks for certification按照IATF的認證方案（見IATF認可規(guī)則）所獲取的本技術規(guī)范的認證，包括任何的顧客特殊要求（如果有），將獲得IATF的顧客成員的認可。 詳細情況可以從以下的國際汽車推動小組的當?shù)乇O(jiān)督辦公室處獲得： 意大利汽車工業(yè)協(xié)會 (ANFIA) www.anfia.it 美國國際汽車監(jiān)督署(IAOB) IATF-France www.iatf- 英國汽車制造與貿易商謝(SMMT) www.smmt.co.uk 德國汽車工業(yè)協(xié)會-質

35、量管理中心 (VDA-QMC) www.vda-qmc.de The certification 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 o

36、btained at the addresses of the local oversight offices of IATF cited below: Associazione Nazionale Fra Industrie Automobilistiche (ANFIA) Web site: www.anfia.it International Automotive Oversight Bureau (IAOB) Web site: IATF-France Web site: www.iatf- Society of Motor Manufacturers and

37、 Traders Ltd. (SMMT Ltd.) Web site: www.smmt.co.uk Verband der Automobilindustrie Qualit?tsmanagement Center (VDA-QMC) Web site: www.vda-qmc.de 引言 Introduction 0.1 總則 General ISO9001:2008 質量管理體系要求 ISO 9001:2008 Quality management systems Requirements 引言 Introduction 0.1 總則 General 采納質量管理體系是組織的一項戰(zhàn)略性決

38、策。一個組織的質量管理體系的設計和實施受下列因素的影響： The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organization's quality management system is influenced by: a) 組織的環(huán)境、該環(huán)境的變化或與該環(huán)境有關的風險； b) 組織不斷變化的需求； c) 組織的具體目標； d) 組織所提供的產(chǎn)品； e) 組織所采用的過程

39、； f) 組織的規(guī)模和組織結構。 a) Its organizational environment, changes in that environment, and the risks associated with that environment; b) Its varying needs; c) Its particular objectives; d) The products it provides; e) The processes it employs; f) Its size and organizational structure. 統(tǒng)一質量管理體系的結構或文件不是本標準

40、的目的。 It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation. 本標準規(guī)定的質量管理體系要求是對產(chǎn)品要求的補充?！白ⅰ笔抢斫夂驼f明有關要求的指南。 The quality management system requirements specified in this International Standard are complementary

41、to requirements for products. Information marked. “NOTE” is for guidance in understanding or clarifying the associated requirement. 本標準能用于內部和外部（包括認證機構）評價組織滿足顧客、適用于產(chǎn)品的法律法規(guī)要求和組織自身要求的能力。 This International Standard can be used by internal and external parties, including certification bodies, to assess

42、the organization's ability to meet customer, regulatory and the organization's own requirements. 本標準的制定已經(jīng)考慮了GB/T 19000和GB/T 19004中所闡明的質量管理原則。 The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration during the development of this International Stan

43、dard. 0.2 過程方法 Process approach ISO9001:2008 質量管理體制體系要求 ISO 9001:2008 Quality management systems Requirements 本標準鼓勵在建立、實施質量管理體系以及在改進其有效性時采用過程方法，通過滿足顧客要求，增強顧客滿意度。 This International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a

44、 quality management system, to enhance customer satisfaction by meeting customer requirements. 為了使組織有效運行，應確定和管理許多相互聯(lián)系的活動。通過使用資源和管理，將輸入轉換為輸出的一項或一組活動，可視為一個過程，通常，一個過程的輸出直接形成下一個過程的輸入。 For an organization to function effectively, it has to determine and manage numerous linked activities. An activity usin

45、g resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process. Often the output from one process directly forms the input to the next. 為了產(chǎn)生期望的結果，由過程組成的系統(tǒng)在組織內的應用，連同這些過程的識別和相互作用，以及對這些過程的管理，可稱之為“過程方法”。The application of a system of processes withi

46、n an organization, together with the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the “process approach”. 過程方法的一個優(yōu)點是對過程系統(tǒng)中單個過程之間的聯(lián)系以及過程的組合和相互作用進行連續(xù)的控制。 An advantage of the process approach is the ongoing control that i

47、t provides over the linkage between the individual processes within the system of processes, as well as over their combination and interaction. 在質量管理體系應用過程方法時，強調以下方面的重要性： a) 理解和滿足要求； b) 需要從增值的角度考慮過程； c) 獲得過程績效和有效性的結果； d) 在客觀測量的基礎上，持續(xù)改進過程。 When used within a quality management system, such an approac

48、h emphasizes the importance of: a) Understanding and fulfilling requirements; b) The need to consider processes in terms of added value; c) Obtaining results of process performance and effectiveness; and d) Continual improvement of processes based on objective measurement. 圖1所反映的以過程為基礎的質量管理體系模式展示了第4章至第8章中所提出的過程聯(lián)系。該圖反映了在規(guī)定輸入要求時，顧客起著重要的作用。對顧客滿意的監(jiān)視，要求組織對顧客關于組織是否已滿足其要求的感受信息進行評價。該模式雖覆蓋了本標準的所有要求，但卻未詳細地反映各過程。 The model of a process-based quality management system shown in Figure 1 illustrates the process linkages presented in clauses 4 to 8. This illustration shows that cus