TS16949標(biāo)準(zhǔn)中英文對照

.0TECHNICALISO/TSSPECIFICATION 16949Second Edition20020301質(zhì)量管理體系汽車行業(yè)生產(chǎn)件和相關(guān)服務(wù)件的組織實施ISO 9001:2000的特殊要求Quality management systems Particular requirements for the application of ISO 9001:2000 for automotive production and relevant service part organizationsInternational Automotive Task ForceReference numberISO/TS 16949:2002 (B). ISO 2002All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISOs member body in the country of the requester.The content inside the boxed text of this document is ISO 9001:2000 text and is protected by the above copyright statement.The text outside the boxes has been originated by the International Automotive Task Force. Copyright for this text is held by ANFIA, CCFA/FIEV, SMMT, VDA (see below) and the car manufacturers DaimIerChrysler, Ford Motor Company, General Motors Corp. Neither this Technical Specification nor any extract from it may be reproduced in a retrieval system or transmitted in any form or by any means, electronic, photocopying, recording or otherwise without prior written permission being secured.Requests for permission to reproduce and/or translate nonboxed text should be addressed to one of the addresses below:International Automotive Oversight Bureau (IAOB/USA)Associazione Nazionale Fra Industrie Automobilistiche (ANFIA/Italy)Comite des Constructeurs Franais dAutomobiles (CCFA/France)Fdration des Industries des Equipements pour Vhicules (FIEV/France)Society of Motor Manufacturers and Traders (SMMT/UK)Verband der Automobilindustrie Qualitatsmanagement Center (VDAOMC/Germany).ContentsPageForeword前言Remarks for certification有關(guān)認(rèn)證的說明Introduction引言0.1 General總則0.2 Process approach過程方法0.3 Relationship with ISO 9004 與ISO 9004的關(guān)系0.3.1 IATF Guidance to ISO/TS 16949:2002 IATF關(guān)于ISO/TS 16949:2002的指南0.4 Compatibility with other management systems與其他管理體系的相容性0.5 Goal of this Technical Specification本技術(shù)規(guī)范的目的1 Scope范圍1.1 General總則1.2 Application應(yīng)用2 Normative reference引用標(biāo)準(zhǔn)3 Terms and definitions術(shù)語和定義3.1Terms and definitions for the automotive industry汽車行業(yè)的術(shù)語和定義4 Quality management system4.1 General requirements4.1.1 General requirements - Supplemental4.2 Documentation requirements4.2.1 General4.2.2 Quality manual4.2.3 Control of documents Engineering specifications4.2.4 Control of records Records retention5 Management responsibility5.1 Management commitment5.1.1 Process efficiency5.2 Customer focus5.3 Quality policy5.4 Planning5.4.1 Quality objectives Quality objectives Supplemental5.4.2 Quality management system planning5.5 Responsibility, authority and communication5.5.1 Responsibility and authority Responsibility for quality5.5.2 Management representative5.5.2 1 Customer representative5.5.3 Internal communication5.6 Management review5.6.1 General Quality management system performance5.6.2 Review input Review input Supplemental5.6.3 Review output6 Resource management6.1 Provision of resources6.2 Human resources6.2.1 General6.2.2 Competence, awareness and training Product design skills Training Training on the job Employee motivation and empowerment6.3 Infrastructure6.3.1 Plant, facility and equipment planning6.3.2 Contingency plans6.4 Work environment6.4.1 Personnel safety to achieve product quality6.4.2 Cleanliness of premises7 Product realization7.1 Planning of product realization7.1.1 Planning of product realization Supplemental7.1.2 Acceptance criteria7.1.3 Confidentiality7.1.4 Change control7.2 Customerrelated processes7.2.1 Determination of requirements related to the product Customerdesignated special characteristics7.2.2 Review of requirements related to the product Review of requirements related to the product Supplemental Organization manufacturing feasibility7.2.3 Customer communication Customer communication Supplemental7.3 Design and development7.3.1 Design and development planning Multidisciplinary approach7.3.2 Design and development inputs Product design input Manufacturing process design input Special characteristics7.3 3 Design and development outputs Product design outputs Supplemental Manufacturing process design output7.3.4 Design and development review Monitoring7.3.5Design and development verification7.3.6 Design and development validation Design and development validation Supplemental Prototype programme Product approval process7.3.7 Control of design and development changes7.4 Purchasing7.4.1 Purchasing process Regulatory conformity Supplier quality management system development Customerapproved sources7.4.2 Purchasing information7.4.3 Verification of purchased product Incoming product quality Supplier monitoring7.5 Production and service provision7.5.1 Control of production and service provision Control plan Work instructions Verification of job setups Preventive and Predictive maintenance Management of production tooling Production scheduling Feedback of information from service Servicing agreement with customer7.5.2 Validation of processes for production and service provision Validation of processes for production and service provision Supplemental7.5.3 Identification and traceability Identification and traceability Supplemental7.5.4 Customer property Customerowned production tooling7.5.5 Preservation of product Storage and inventory7.6 Control of monitoring and measuring devices7.6.1 Measurement system analysis7.6.2 Calibration/Verification records7.6.3 Laboratory requirements Internal laboratory External laboratory8 Measurement, analysis and improvement8.1 General8.1.1 Identification of statistical tools8.1.2 Knowledge of basic statistical concepts8.2 Monitoring and measurement8.2.1 Customer satisfaction Customer satisfaction Supplemental8.2.2 Internal audit Quality management system audit Manufacturing process audit Product audit Internal audit plans Internal auditor qualification8.2.3 Monitoring and measurement of processes Monitoring and measurement of manufacturing processes8.2.4 Monitoring and measurement of product Layout inspection and functional testing Appearance items8.3 Control of nonconforming product8.3.1 Control of nonconforming product Supplemental8.3.2 Control of reworked product8.3.3 Customer information8.3.4 Customer waiver8.4 Analysis of data8.4.1 Analysis and use of data8.5 Improvement8.5.1 Continual improvement Continual improvement of the organization Manufacturing process improvement8.5.2 Corrective action Problem solving Errorproofing Corrective action impact Rejected product test/analysis8.5.3 Preventive actionAnnex A (normative) Control Plan附錄A (標(biāo)準(zhǔn)的) 控制計劃A.1 Phases of the control plan/控制計劃的階段A.2 Elements of the control plan/控制計劃的要素Bibliography/引用文獻(xiàn)NOTE In this table of contents, ISO 9001:2000 headings are normal type face, IATF headings are in italics.注：在本目錄中，ISO 9001:2000的標(biāo)題是正體字，IATF的標(biāo)題是斜體字。.Foreword前言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 technical committee has been established has the right to be represented on that committee. International organizations, governmental and nongovernmental, 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.國際標(biāo)準(zhǔn)化組織（ISO）是由各國標(biāo)準(zhǔn)化團(tuán)體（ISO成員團(tuán)體）組成的世界性的聯(lián)合會。制定國際標(biāo)準(zhǔn)工作通常由ISO的技術(shù)委員會完成。各成員團(tuán)體若對某技術(shù)委員會確定的項目感興趣，均有權(quán)參加該委員會的工作。與ISO保持聯(lián)系的各國際組織（官方的或非官方的）也可參加有關(guān)工作。ISO與國際電工委員會（IEC）在電工技術(shù)標(biāo)準(zhǔn)化方面保持密切合作的關(guān)系。International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.,國際標(biāo)準(zhǔn)遵照ISO/IEC導(dǎo)則第3部分的規(guī)則起草。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% of the member bodies casting a vote.由技術(shù)委員會通過的國際標(biāo)準(zhǔn)草案提交各成員團(tuán)體投票表決，需取得了至少75%參加表決的成員團(tuán)體的同意，才能作為國際標(biāo)準(zhǔn)正式發(fā)布。In 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 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;- 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 committee casting a vote.An 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/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. 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/TS 16949:2002是由國際汽車推動小組(IATF)和日本汽車制造商協(xié)會(JAMA)，在ISO/TC 176，質(zhì)量管理和質(zhì)量保證技術(shù)委員會的支持下共同制定的。This second edition of ISO/TS 16949 cancels and replace the first edition (ISO/TS 16949:1999), which has been technically revised.本第二版ISO/TS 16949取代經(jīng)技術(shù)性修訂的第一版ISO/TS 16949 (ISO/TS 16949:1999)。Boxed text is original ISO 9001:2000 text. The sectorspecific supplemental requirements are outside the boxes.方框內(nèi)的文字是ISO 9001:2000原文。方框外的文字是行業(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. 在本技術(shù)規(guī)范中，“必須”(shall)表示要求?！皯?yīng)該”(should)表示推薦。標(biāo)有“注”(NOTE)的段落是理解或澄清相關(guān)要求的指導(dǎo)性解釋。Where the term such as is used, any suggestions given are for guidance only.所有用“如”(such as)引出的建議僅具有指導(dǎo)性作用。Annex A forms a normative part of this Technical Specification. 附錄A構(gòu)成本技術(shù)規(guī)范的一部分。Remarks for certification/有關(guān)認(rèn)證的說明The certification to this Technical Specification, including customerspecific 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).按照IATF的認(rèn)證安排獲得本技術(shù)規(guī)范的認(rèn)證，包括顧客特殊要求（如果有），將獲得IATF顧客成員的承認(rèn)。參見“獲得IATF認(rèn)可的規(guī)則”。Details can be obtained at the addresses of the local oversight bodies of IATF cited below:Associazione Nazionale Fra Industrie Automobilistiche (ANFIA)Web site: www.anfia.itemail: anfiaanfia.itInternational Automotive Oversight Bureau (IAOB)Web site: email: Federation des Industries des Equipements pour Vehicules (FIEV)Comite des Constructeurs Francais dAutomobiles (CCFA)Web site: email: iatfiatfFSociety of Motor Manufacturers and Traders Ltd. (SMMT Ltd.)Web site: www.smmt.co.ukemail: qualitysmmt.co.ukVerband der Automobilindustrie (VDA) Qualitatsmanagement Center (QMC)Web site: www.vdaqmc.deemail: infovdaqmc.deIntroduction引言0.1 General總則ISO 9001:2000, Quality management systems RequirementsIntroduction引言0.1 General總則The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organizations 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 to imply uniformity in the structure of quality management systems or uniformity of documentation.采用質(zhì)量管理體系應(yīng)當(dāng)是組織的一項戰(zhàn)略性決策。一個組織質(zhì)量管理體系的設(shè)計和實施受各種需求、具體目標(biāo)、所提供的產(chǎn)品、所采用的過程以及該組織的規(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。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 clarifying the associated requirement.本標(biāo)準(zhǔn)所規(guī)定的質(zhì)量管理體系要求是對產(chǎn)品要求的補(bǔ)充?！白ⅰ笔抢斫夂驼f明有關(guān)要求的指南。This International Standard can be used by internal and external parties, including certification bodies, to assess the organizations ability to meet customer, regulatory and the organizations own requirements.本標(biāo)準(zhǔn)能用于內(nèi)部和外部（包括認(rèn)證機(jī)構(gòu)）評定組織滿足顧客、法律法規(guī)和組織自身要求的能力。The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration during the development of this International Standard.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 approach過程方法ISO 9001:2000, Quality management systems Requirements0.2 Process approach過程方法This International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements.本標(biāo)準(zhǔn)鼓勵在建立、實施質(zhì)量管理體系以及改進(jìn)其有效性時采用過程方法，通過滿足顧客要求，增強(qiáng)顧客滿意。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 outputs, can be considered as a process. Often the output from one process directly forms the input to the next.為使組織有效運作，必須識別和管理眾多相互關(guān)聯(lián)的活動。通過使用資源和管理，將輸入轉(zhuǎn)化為輸出的活動可視為過程。通常，一個過程的輸出直接形成下一個過程的輸入。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 “process approach”.組織內(nèi)諸過程的系統(tǒng)的應(yīng)用，連同這些過程的識別和相互作用及其管理，可稱之為“過程方法”。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.過程方法的優(yōu)點是對諸過程的系統(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(jìn)行連續(xù)的控制。When used within a quality management system, such an approach emphasizes the importance of過程方法在質(zhì)量管理體系中應(yīng)用時，強(qiáng)調(diào)以下方面的重要性：a) understanding and fulfilling requirements,a）理解并滿足要求；b) the need to consider processes in terms of added value,b）需要從增值的角度考慮過程；c) obtaining results of process performance and effectiveness, andc）獲得過程業(yè)績和有效性的結(jié)果；d) continual improvement of processes based on objective measurement.d）基于客觀的測量，持續(xù)改進(jìn)過程。The model of a processbased 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 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.圖1所反映的以過程為基礎(chǔ)的質(zhì)量管理體系模式展示了48章中所提出的過程聯(lián)系。這種展示反映了在規(guī)定輸入要求時，顧客起著重要作用。對顧客滿意的監(jiān)視要求對顧客有關(guān)組織是否已滿足其要求的感受的信息進(jìn)行評價。該模式雖覆蓋了本標(biāo)準(zhǔn)的所有要求，但卻未詳細(xì)地反映各過程。NOTE In addition, the methodology known as PlanDoCheckAct (PDCA) can be applied to all processes. PDCA can be briefly described as follows.注：此外，稱之為“PDCA”的方法可適用于所有過程。PDCA模式可簡述如下：Plan: establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organizations policies.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)和過程；Do: implement the processes.D實施：實施過程；Check: monitor and measure processes and product against policies, objectives and requirements for the product and report the results.C檢查：根據(jù)方針、目標(biāo)和產(chǎn)品要求，對過程和產(chǎn)品進(jìn)行監(jiān)視和測量，并報告結(jié)果；Act: take actions to continually improve process performance.A處置：采取措施，以持續(xù)改進(jìn)過程業(yè)績。Key圖釋Value-adding activities增值活動Information flow信息流Figure 1 Model of a processbased quality management system/圖1 以過程為基礎(chǔ)的質(zhì)量管理模式0.3 Relationship with ISO 9004 與GB/T 19004的關(guān)系ISO 9001:2000, Quality management systems Requirements0.3 Relationship with ISO 9004 與GB/T 19004的關(guān)系The present editions of ISO 9001 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.GB/T 19001和GB/T 19004已制定為一對協(xié)調(diào)一致的質(zhì)量管理體系標(biāo)準(zhǔn)，他們相互補(bǔ)充，但也可單獨使用。Although the two International Standards have different scopes, they have similar structures in order to assist their application as a consistent pair.雖然這兩項標(biāo)準(zhǔn)具有不同的范圍，但卻具有相似的結(jié)構(gòu)，以有助于他們作為協(xié)調(diào)一致的一對標(biāo)準(zhǔn)的應(yīng)用。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.GB/T 19