1. <dl id="v8qpt"></dl>
      <menuitem id="v8qpt"><bdo id="v8qpt"><td id="v8qpt"></td></bdo></menuitem>

            <dl id="v8qpt"></dl><dl id="v8qpt"><ins id="v8qpt"></ins></dl>

            <li id="v8qpt"><ins id="v8qpt"><strong id="v8qpt"></strong></ins></li>

            1. <li id="v8qpt"><ins id="v8qpt"><strong id="v8qpt"></strong></ins></li>

                  <output id="v8qpt"><font id="v8qpt"></font></output>
                  <output id="v8qpt"><ins id="v8qpt"></ins></output>
                1. <li id="v8qpt"><s id="v8qpt"></s></li>

                2. <li id="v8qpt"></li>
                3. <menuitem id="v8qpt"><font id="v8qpt"><td id="v8qpt"></td></font></menuitem>

                  熱線電話:188 *******

                  北京ISO認證公司,北京ISO9000,北京ISO9001認證,ts16949認證,社會責任體系

                  聯系我們

                  深圳市宏儒企業管理咨詢有限公司北京分公司www.hede.tw
                  所在地區:
                  北京市 北京市
                  企業官網:
                  電話號碼:
                  400-*******
                  傳真號碼:
                  1889*******
                  聯系人:
                  王治力
                  移動電話:
                  1889*******
                  電子郵箱:
                  ***[email protected]

                  北京海淀區iso/ts16949標準下載,最新中英文對照版

                  發布時間:2015-12-11 19:15    來源:www.hede.tw
                  [摘要] 北京海淀區iso/ts16949標準下載,最新中英文對照版 以下ISO/TS1694:2009標準由北京宏儒http://beijing.hr9000.com/發布僅供參考,不作為標準依據。? 質量管理體系— 汽車生產件及相關服務件組織應用ISO9001:2008的特殊要求

                  北京海淀區iso/ts16949標準下載,組織應如何建立符合標準要求的基本體系

                  以下ISO/TS1694:2009標準由北京宏儒http://beijing.hr9000.com/發布僅供參考,不作為標準依據。

                  質量管理體系—

                  汽車生產件及相關服務件組織應用ISO9001:2008的特殊要求  
                  技術規范                ISO/TS

                  TECHNICAL   16949 SPECIFICATION    
                     
                                                                                         T hird edition  
                                                                                            第三版 
                                                                                         2009- 06- 15 
                   
                  Quality management systems  — 
                   
                  Particular requirements for the application of ISO 9 001:200 8 for automotive production and relevant service part organizations  
                   
                  Systèmes de management de la qualité--- 
                   
                  Exigences particulières pour l'application de l'ISO 9001:2008 pour la production de série et de pièces de rechange dans l'industrie automobile 

                  Reference number 
                    ISO/ITS 16949:200 9 (E) 
                   

                  目錄  Contents 
                    前言 
                   有關認證的說明 
                  Foreword…………………………………………………. ………………………………………………………………………7 
                   引言 
                  Remarks for certification ………………………………………………………………………………………9 
                  0.1 總則 General
                  Introduction…………………………………………………………………………………………………………………..10 
                  0.2 過程方法 Process approach …………………………………………………………..………………………………………11  
                  ……………. ……………………………. ……………………………………………………………………….10 
                  0.3 與ISO 9004 的關系 Relationship with ISO 9004 ……………………………………………………………………….. 13  
                  0.4 與其他管理體系的相容性 
                  0.5  本技術規范的目的 
                  Compatibility with other management systems …………………………………………..14  
                  1 范圍  Scope  …………………………………………………………………………………………………………………………..16 
                  Goal of  this Technical Specification…………………………………………………………..15  
                  1.1 總則 General …………………………………………………………………………………………………………………… 16  
                  1.2 應用 Application ……………………………………………………………………………………………………………..17 
                  2 引用標準 
                  3 術語和定義 
                  Normative reference  …………………………………………………………………………………………………..17  
                  3.1 汽車行業術語和定義 
                  Terms and definitions ……………………………………………………………………………………………. 18  
                  4 質量管理體系 
                  Terms and definitions for the automotive industry ………………………………………. 18  
                  4.1 總要求 
                  Quality management system ……………………………………………………………………………………..20 
                  4.1.1 總要求-補充 
                  General requirements …………………………………………………………………………………………………20  
                  4.2 文件要求  Documentation requirements……………………………………………………………………………………21 
                  General requirements – Supplemental ……………………………………………………………..21 
                  4.2.1 總則  General…………………………………………………………………………………………………………….21 
                  4.2.2 質量手冊   Quality manual……………………………………………………………………………………………..22 
                  4.2.3 文件控制   Control of documents………..…………………………………………………………………………..22 
                  4.2.3.1 工程規范  Engineering specifications  ………………………………………………………………………….23 
                  4 .2.4  記錄控制  Control of records
                  4.2.4.1 記錄保存  Records retention……………………………………………………………………………………...24 
                  ……………………………………………………………………………………...23 
                  5   管理職責   Management responsibility
                  5.1   管理承諾  
                    ……………………………………………………………………………………….24 
                  Management commitment
                  5.1.1   過程效率 Process efficiency ……………………………………………………………………………………….. 24 
                  ………………………………………………………………………………………..24 
                  5.2   以顧客為關注焦點  Customer focus
                  5.3   質量方針   Quality policy  ………………………………………………………………………………………………..25 
                  ……………………………………………………………………………………….24 
                  5.4   策劃   Planning…………………………………………………………………………………………………………….. 25 
                  5.4.1   質量目標  Quality objectives …………………………………………………………………………………….  25 
                  5.4.1.1   質量目標-補充  Quality objectives – Supplemental ………………………………………………………..25 
                  5.4.2   質量管理體系的策劃  Quality management system planning
                  5.5   職責,權限與溝通  
                  ………………………………………………..…..26  
                  5.5.1   職責和權限  Responsibility and authority
                  Responsibility, authority and communication ………………………………………………..26  
                  5.5.1.1   質量職責  Responsibility for quality 
                  ………………………………………………………. ……………..26  
                  5.5.2   管理者代表  
                  ………………………………………………………. ……………..26  
                  5.5.2.1   顧客代表  Customer representative
                  Management representative  ……………………. …………………………………. ……………..27  
                  5.5.3   內部溝通  Internal communication ………………………………………………………………………………..27 
                  ……………………..……………………………………. ……………..27  
                  5.6   管理評審   Management review ……………………………………………………………………………………………  27  
                  5.6.1   總則  General ………………………………………………………………………………………………………….27 
                  5.6.1.1   質量管理體系績效  
                  5.6.2   評審輸入  Review input ……………………………………………………………………………………………….28 
                  Quality management system performance………………………………………………..28 
                  5.6.2.1   評審輸入-補充  Review input – Supplemental………………………………………………………………….28 
                  5.6.3   評審輸出  Review output……………………………………………………………………………………………..29 
                  6   資源管理   Resource management ………………………………………………………………………………………………..29 
                  6.1   資源提供   Provision of resources  ……………………………………………………………………………………..29 
                  6.2   人力資源   Human resou rces ……………………………………………………………………………………………….29 
                  6.2.1   總則  General…………………………………………………………………………………………… …………….30 
                  6.2.2   能力, 培訓和意識  Competence, training and awareness  
                  6.2.2.1 產品設計技能  Product design skills …………………………………………………………… …………….30 
                  ……………………………………… …………….30 
                  6.2.2.2 培訓  Training   ……………………………………………………………………………………… …………….31 
                  6.2.2.3 崗位培訓 ……………………………………………………………………………………………………………….31 
                  6.2.2.4   員工的激勵  Employee motivation and empowerment  
                  6.3   基礎設施   Infrastructure…………………………………………………. ……………………………………………. 31  
                  ………………………………………… …………….31 
                  6.3.1   工廠, 設施和設備策劃  Plant, facility and equipment planning  …………………………………………..32  
                  6.3.2   應急計劃  Contingency plans………………………………………………………………………………………..32 
                  6.4   工作環境   Work environment ……………………………………………………………………………………………….32 
                  6.4.1   為達成產品要求符合性的人員安全  Personnel safety to achieve conformity product requirements ...32 
                  6.4.2   生產現場的清潔  
                  7   產品實現   Product realization ......................................................................... 33  
                  Cleanliness of premises ……………………………………………………………………… .32 
                  7.1   產品實現的策劃   Planning of product realization ...................................................33 
                  7.1.1   產品實現的策劃—補充 Planning of product realization  –  Supplemental............................34  
                  7.1.2   接收準則  Acceptance criteria..................................................................34 
                  7.1.3   保密性  Confidentiality....................................................................... 34  
                  7.1.4   更改控制  Change control.......................................................................34 
                  7.2   與顧客有關的過程  Customer-related processes  ......................................................34  
                  7.2.1   與產品有關的要求的確定  
                  7.2.1.1   顧客指定的特殊特性  
                  Determination of requirements related to the product....................35 
                  7.2.2 與產品有關的要求的評審  
                  Customer-designated special characteristics ..............................35  
                  7.2.2.1 與產品有關的要求的評審——補充  Review of requirements related to the product  – Supplemental...36 
                  Review of requirements related to the product...........................35 
                  7.2.2.2 組織制造可行性  Organization manufacturing feasibility.........................................36 
                  7.2.3   顧客溝通  Customer communication...............................................................36 
                  7.2.3.1   顧客溝通—補充  Customer communication – Supplemental........................................37  
                  7.3   設計和開發  
                  7.3.1   設計和開發策劃  
                  Design and d evelopment ................................................................37  
                  7.3.1.1   多方論證方法   Multidisciplinary approach  ...................................................37  
                  Design and development planning ...............................................37 
                  7.3.2   設計和開發輸入  Design and development inputs..................................................38 
                  7.3.2.1   產品設計輸入  Product design input ...........................................................38 
                  7.3.2.2   制造過程設計輸入  Manufacturing process design input.........................................39 
                  7.3.2.3   特殊特性  Special characteristics……………………………………………………………………………..39 
                  7.3.3  設計和開發輸出  Design and development outputs..................................................39  
                  7.3.3.1 產品設計輸出—補充  Product design outputs –  Supplemental.................................. ...40  
                  7.3.3.2 制造過程設計輸出  
                  7.3.4  設計和開發評審  Design and development review..................................................41 
                  Manufacturing process design output…………………………………………………… .40 
                  7.3.4.1 監視  Monitoring ..............................................................................41 
                  7.3.5   設計和開發驗證  
                  7.3.6   設計和開發確認  
                  Design and development verification............................................42 
                  7.3.6.1 設計和開發確認—補充  
                  Design and development validation…………………………………………………………..42 
                  Design and development validation – Supplemental
                  7.3.6.2 樣件計劃  Prototype programme .................................................................42  
                    .....................42 
                  7.3.6.3 產品批準過程   Product approval process………………………………………………………………………..43 
                  7.3.7  設計和開發更改的控制  
                  7.4   采購   Purchasing............................................................................. .....43 
                  Control of design and development changes...............................43  
                  7.4.1 采購過程  
                  7.4.1.1 法規符合性   Regulatory conformity…………………………………………………………………………… ….44 
                  Purchasing process............................................................... .....44 
                  7.4.1.2 供方質量管理體系開發  
                  7.4.1.3 顧客批準的供方   Customer- approved sources............................................... ......44  
                  Supplier quality management system development ...........................44 
                  7.4.2 采購信息  Purchasing information …………………………………………………………………………… ………45  
                  7.4.3 采購產品的驗證  Verification of purchased product ……………………………………………………… ……..45  
                  7.4.3.1 進貨產品對要求的符合性  Incoming product conformity to requirements………………………… ……….45 
                  7.4.3.2 對供方監視  Supplier monitoring ………………………………………………………………………………….46 
                  7.5 生產和服務提供   Production and service provision ............................................. .....46 
                  7.5.1 生產和服務提供的控制  
                  7.5.1.1 控制計劃   Control plan………………………………………………………………………………………………47 
                  Control of production and service provision.......................... .....46 
                  7.5.1.2 作業指導書  Work instructions …………………………………………………………………………………. .47 
                  7.5.1.3 作業準備驗證  
                  7.5.1.4 預防性和預見性維護   P reventive and predictive maintenance.....................................48  
                  Verification of job set -ups.....................................................47  
                  7.5.1.5 生產工裝的管理  
                  7.5.1.6 生產計劃  
                  Management of production tooling…………………………………………………………..48 
                  7.5.1.7 服務信息反饋  
                  Production scheduling ………………………………………………………………………………….49 
                  7.5.1.8 與顧客的服務協議  Service agreement with customer..............................................49 
                  Feedback of informati on from service ............................................49 
                    7.5.2 生產和服務提供過程的確認  
                  7.5.2.1 生產和服務提供過程的確認—補充  Validation of processes for production and service provision  – 
                  Supplemental…………..50  
                  Validation of processes for production and service provision …………..49  
                  7.5.3 標識和可追溯性  Identification and traceability..................................................50 
                  7.5.3.1 標識和可追溯性—補充  
                  7.5.4 顧客財產  
                  Identification and traceability –  Supplemental..........................50 
                  7.5.4.1 顧客所有的工裝   Customer- owned production tooling.............................................51  
                  Customer property…………………………………………………………………………………………. 51  
                  7.5.5.產品防護  
                  7.5.5.1 貯存和庫存  Storage and inventory............................................................. 51 
                  Preservation of product...............................................................51 
                  7.6 監視和測量設備的控制  Control of monitoring and measuring  equipment ...................................52 
                  7.6.1 測量系統分析  Measurement system analysis........................................................53 
                  7.6.2 校準/驗證記錄  Calibration/verification records …………………………………………………………………53  
                  7.6.3 實驗室要求   Laboratory requirements………………………………………………………………………………..53  
                  7.6.3.1 內部實驗室   Internal laboratory................................................................53  
                  7.6.3.2 外部實驗室   External laboratory............................................................... 54  
                  8   測量, 分析和改進   Measurement, analysis and improvement ................................................54 
                  8.1   總則   General ………………………………………………………………………. ……………………………………… 55  
                  8.1.1 統計工具的確定  Identification of statistical tools .............................................55  
                  8.1.2 基礎統計概念知識  Knowledge of basic statistical concepts........................................55  
                  8.2 監視和測量  Monitoring and measurement ………………………………………………………………………… ……..55 
                  8.2.1 顧客滿意  Customer satisfaction……………………………………………………………………………………. 55  
                  8.2.1.1 顧客滿意—補充   Customer satisfaction –  Supplemental………………………………………………  ……. 56  
                  8.2.2  內部審核  Internal audit ……………………………………………………………………………………………56 
                  8.2.2.1 質量管理體系審核  Quality management system audit ……………………………………………………… …..57  
                  8.2.2.2 制造過程審核  Manufacturing process audit ……………………………………………………………………. 57 
                  8.2.2.3 產品審核  Product audit …………………………………………………………………………………………….57 
                  8.2.2.4 內部審核計劃  Internal audit plans……………………………………………………………………………..57 
                  8.2.2.5 內審員資格   Internal auditor qualification………………………………………………………………….57 
                  8.2.3 過程的監視和測量  
                  8.2.3.1 制造過程的監視和測量  Monitoring and measurement of m anufacturing processes……. ………………  58  
                  Monitoring and measurement of processes …………………………………………………  58 
                  8.2.4 產品的監視和測量   Monitoring and measurement of product …………………………………………………….59 
                  8.2.4.1 全尺寸檢驗和功能試驗  
                  8.2.4.2 外觀項目   Appearance items…………………………………………………………………………………………60 
                  Layout inspection and functional testing…………………………………………59 
                  8.3 不合格品控制  
                  8.3.1 不合格品控制—補充 Control of nonconforming product  – Supplemental……………………………………. 61 
                  Control of nonconforming product……………………………………………………………………  60  
                  8.3.2 返工產品的控制  Control of reworked product………………………………………………………………………61 
                  8.3.3 顧客通知  
                  8.3.4 顧客特許  Customer waiver …………………………………………………………………  …………………………61 
                  Customer information………………………………………………………………………………………61 
                  8.4 數據分析  
                  8.4.1 數據分析和使用  
                  Analysis of data………………………………………………………………………………………………..61 
                  8.5 改進  Improvement ……………………………………………………………  ……………………………………………..62 
                  Analysis and use of data  ………………………………………………………………………. 62 
                  8.5.1 持續改進  
                  8.5.1.1 組織的持續改進  
                  Continual improvement ………………………………………………………………………………….  62 
                  8.5.1.2 制造過程的改進   Manufacturing process improvement ………………………………………………………….62 
                  Continual improvement of the organization ……………………………………………….62 
                  8.5.2 糾正措施  Corrective action ………………………………………………………………………………………….63 
                  8.5.2.1 解決問題的方法  
                  8.5.2.2 防錯  Error- proofing   ……………………………………………………………………………………………….63 
                  Problem solving ………………………………………………………………  …………………63 
                  8.5.2.3 糾正措施影響   Corrective action impact………………………………………………………………………..63 
                  8.5.2.4 拒收產品的試驗/分析  
                  8.5.3 預防措施  
                  Rejected product test/analysis……………………………………………………….63 
                  附錄A   
                  Preventive action…………………………………………………………………………………………. 64  
                  A1  控制計劃的階段   Phases of the control plan……………………………………………………………………………… 65  
                  Annex A  (normative)  Control plan  ……………………………………………………………………………. ……. 65 
                  A2  控制計劃的要素   Elements of the control plan …………………………………………………………………………… 65  
                  參考文獻Bibliography ……………………………………………………………………………………………………………….67 
                  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 technical committee has been established has the right to be represented on that committee. Internationa l 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. 
                  本國際標準是依照 ISO/IEC 導則第 2 部分中的規則制定的。 
                  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 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范文件: 
                  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:  
                       —ISO 公布的可獲得規范(ISO/PAS )代表一項在一個 IS O 工作小組內的技術專家達成的協議,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行。 
                  —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; 
                       —ISO 技術規范(ISO/TS),是技術委員會成員之間達成的協議,在委員會成員所投票中有2/3 投票贊
                  成后就可以出版發行。 
                  —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.  
                  ISO/TS 16949 是由國際汽車工業特別行動小組(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 (IATF) with support from ISO/TC  176, Quality 
                  management and quality   assurance . 
                  通過根據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 9001:2008.   
                  方框內的文本是 ISO 9001:2008的原文內容,方框外是行業特殊補充的要求。 
                  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 requirement. 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 是本技術規范的引用文件,構成技術規范的一部分。 
                  Annex A forms a normative part of this Technical Specification.  
                   
                  有關認證的說明 
                   
                  按照IATF 的認證方案(見《IATF 認可規則》)所獲取的本技術規范的認證,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地監督辦公室處獲得: 
                   
                       意大利汽車工業協會  (ANFIA) 
                  www.anfia.it 
                       美國國際汽車監督署(IAOB ) 
                  www.iaob.org 
                         IATF-France 
                       www.iatf -france.com  
                       英國汽車制造與貿易商謝(SMMT) 
                       www.smmt.co.uk 
                       德國汽車工業協會-質量管理中心  (VDA -QMC) 
                       www.vda -qmc.de 
                   
                  Remarks for certification  
                  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 obtained 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   
                  www.iaob.org  
                       Web site: www.iatf -france.com
                  Society of Motor Manufacturers and Traders Ltd. (SMMT Ltd.)   
                     
                       Web site: 
                  Verband der Automobilindustrie Qualit?tsmanagement Center (VDA- QMC)   
                  www.smmt.co.uk   
                       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略性決策。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) 組織的環境、該環境的變化或與該環境有關的風險; 
                  b) 組織不斷變化的需求; 
                  c) 組織的具體目標; 
                  d) 組織所提供的產品; 
                  e) 組織所采用的過程; 
                  f)  組織的規模和組織結構; 
                  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 
                  統一質量管理體系的結構或文件不是本標準的目的。 
                  It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation. 
                       本標準規定的質量管理體系要求是對產品要求的補充。“注”是理解和說明有關要求的指南。 
                  The quality management system requirements specified in this International Standard are complementary to requir ements 
                  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、適用于產品的法律法規要求和組織自
                  身要求的能力。 
                  This International Standard can be used by internal and external parties, including certification bodies, to assess the organization's ability to meet customer, regulatory and the organization's own requirements. 
                     本標準的制定已經考慮了 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 Standard. 

                  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 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 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. 
                       為了產生期望的結果,由過程組成的系統在組織內的應用,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 within 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”  
                       過程方法的一個優點是對過程系統中單個過程之間的聯系以及過程的組合和相互作用進行連續的控制. 
                  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.  
                       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,持續改進過程。 
                  When used within a quality management system, such an approach 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系。該圖反
                  映了在規定輸入要求時,顧客起著重要的作用。對顧客滿意的監視,要求對顧客有關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 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.  
                   
                        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: 
                       P -策劃:根據顧客的要求和組織的方針,為提供結果建立必要的目標和過程; 
                       D -實施:實施過程; 
                       C -檢查:根據方針、目標和產品要求,對過程和產品進行監視和測量,并報告結果; 
                       A -處置:采取措施,以持續改進過程業績。 
                  NOTE In addition, the methodology known as "Plan -Do-Check -Act" (PDCA) can be applied to all pr ocesses. PDCA 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 requirements for the product 
                    and report the results.  
                    Act: take actions to continually improve process performance. 
                   
                     Figure 1 —   Model of a process-based quality management system 
                    
                  測量, 分析, 改進 

                  顧客要求 
                  質量管理體系
                  的持續改進 
                  管理職責 
                  資源管理 
                  顧客 
                  滿意 
                  輸入 
                  輸出 
                  產品  產品實現 
                  圖釋 
                  增值活動 
                  信息流 
                  圖1  以過程為基礎的質量管理體系模式 
                    
                  0.3  與ISO9004 的關系   Relationship with ISO 9004 
                   
                  注:應當由最高管理者在組織內宣傳和貫徹ISO9000 :2005和ISO9004 中涉及的八項質量管理原則的知識及其應用。 
                  Note :The knowledge and use of the eight quality management principles referred to in the ISO 9000:2005  and ISO 9004 
                  should be demonstrated     and     cascaded    through the organization by top management. 

                  ISO9001:2008,質量管理體制體系   要求 
                  ISO 9001:2008,  Quality management systems — Requirements  
                   
                  0.3  與ISO9004 的關系    Relationship with ISO 9004  
                       ISO9001 和ISO9004 都是質量管理體系標準,這兩項標準相互補充,但也可單獨使用。 
                  ISO9001 and ISO9004 are quality management system standards which have been designed to complement each other,but can 
                  al so be used independently. 
                       ISO9001 規定了質量管理體系要求,可供組織內部使用,也可用于認證或合同目的。ISO9001 所關
                  注的是質量管理體系在滿足顧客要求方面的有效性。 
                  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. 
                  在本標準發布時,ISO 9004 處于修訂中。修訂后的 ISO 9004 將為組織在復雜、要求更高和不斷變
                  化的環境中獲得持續成功提供管理指南。與 ISO 9001 相比,ISO 9004關注質量管理的更寬范圍;通過
                  系統和持續改進組織的績效,滿足所有相關方的需求和期望。然而 ISO 9004 不擬于用于認證、法律法
                  規和合同的目的。 
                  At the time of publication of this International Standard, ISO 9004 is under revision. The revised edition of ISO 9004 will provide guidance to management for achieving sustained success for any organization in a complex, demanding, and   ever changing, environment. ISO 9004 provides a wider focus on quality management than ISO 9001; it addresses the needs and expectations of all interested parties and their satisfaction, by the systematic and continual improvement of the organization’s performance. However, it is not intended for certification,  regulatory or contractual use.  
                   
                  0.4  與其它管理體系的相容性    Compatibility wi th other management systems  
                   
                  ISO9001:2008   質量管理體制體系—要求 
                  ISO 9001:2008, Quality management systems  — Requirements 
                   
                  0.4  與其它管理體系的相容性 
                       為方便使用者,本標準在起草過程中適當的考慮了 ISO 4001-2004 標準的內容,以增強兩類標準的相
                  容性。附錄 A 表明了 ISO 9001-2008與ISO14001-2004之間的對應關系 
                  During the development of this   international standard,due consideration was given to the provision of ISO14001:2004 to enhance the compatibility of the two standards for benefit of the user community.Annex a shows the correspondence between ISO14001:2004. 
                       本國際標準不包括其它管理體系所規定的要求,例如環境管理,職業健康和安全管理,財務管理或風
                  險管理。然而本國際標準能夠使組織的質量管理體系與有關的管理體系要求相互結合或一體化。組織為了
                  建立符合本國際標準要求的質量管理體系,有可能會改變其現有的管理體系。 
                  This International Standard does not include requirements specific to other management systems, such 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 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 Standard。 
                   
                   0.5  ISO/TS16949 的目的    Goal of    this Technical Specification 
                       本技術規范的目標是在供應鏈中建立持續改進,強調缺陷預防,減少變差和浪費的質量管理體系。 
                  The goal of this Technical Specification is the development of a quality management system that provides for continual improvem ent, emphasizing defect prevention and the reduction of variation and waste in the supply chain. 
                       本技術規范與適當的顧客特殊要求相結合,規定了簽署本文件顧客的基本質量管理體系要求。 
                  This Technical Specification, coupled with applicable customer -specific requirements, defines the fundamental qua lity management system requirements for those subscribing to this Technical Specification。 
                       本技術規范旨在避免多重認證審核,并為汽車生產件及服務件的組織建立質量管理體系提供了一個通
                  用的方法。 
                  This 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.  
                   
                  質量管理體系  —— 
                  汽車行業生產件下相關服務件的組織實施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 
                  1    范圍   Scope  
                  1.1   總則   General 
                  ISO9001 :2008   質量管理體系—要求 
                  ISO 9001: 2008, Quality management systems — Requirements 
                       本標準為有下列需求的組織規定了質量管理體系要求; 
                  a)   需要證實其具有穩定地提供滿足顧客和適用的法律法規要求的產品的能力; 
                  b)   通過體系的有效應用,包括體系持續改進的
                  This International Standard specifies requirements for a quality management system where an organization 
                  過程的有效應用,以及保證符合顧客與適用的法律法規要求,
                  旨在增進顧客滿意。 
                  a)   needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and 
                  b)   aims to enhance customer satisfaction through the effective application of the system, including processes for 
                  continual improvement of the system and the assurance of conformity to customer and applicable regulatory 
                  requirements. 
                       注1 :在本標準中,術語”產品”僅適用于: 
                       a)     預期提供給顧客的或顧客所要求的產品;; 
                       b)    產品實現過程所產生的任何預期輸出; 
                       注2 :法律法規要求可稱作法定要求。 
                  NOTE 1:   In this In ternational Standard, the term “product”only applies to : 
                  a)   product intended for, or required by, a customer. 
                  b)   And intended output resulting from the product realization processes.  
                  Note2: Statutory and regulatory requirements can be expressed as legal requirements. 
                       本技術規范與 ISO9001 :2008 相結合,規定了質量管理體系要求,用于汽車相關產品的設計和開發、
                  生產,相關時,也適用于安裝和服務。 
                  This Technical Specification, in conjunction with ISO 9001: 2008, defines the quality management system requirements for the design and development, production and, when relevant, installation and service of automotive -related products.  
                       本技術規范適用于組織進行顧客指定產品和/或服務零件的制造現場。 
                  This Technical Specification is applicable to sites of the organization where customer-specified parts, for production and/or service, are manufactured. 
                       “ 支持功能”,無論其在現場或外部場所(如設計中心、公司總部及分銷中心),由于它們對現場其支持
                  性作而構成現場審核的一部分。但是,但不能獲得本技術規范的認證。 
                  Supporting functions whether on-site or remote (such as design centres, corporate headquart ers and distribution centres),  form part of the site audit  as they support the site ,  but cannot obtain stand-alone certification to this Technical Specification.  
                       本技術規范可適用于整個汽車供應鏈。 
                  This Technical Specification can be applied throughout the automotive supply chain.  
                  1.2    應用    Application 
                  ISO9001:2008     質量管理體制體系—要求 
                  ISO 9001: 2008, Quality management systems  — Requirements 
                   
                  1.2    應用  Applicatio n  
                       本標準規定的所有要求是通用的,旨在適用于各種類型、不同規模和提供不同產品的組織. 
                  All requirements of this International Standard are generic and are intended to be applicable to all organizations, 
                  regardless of type, size and product provided. 
                       當本標準的任何要求因組織及其產品的特點不適用時,可以考慮對其進行刪減。 
                  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. 
                       如果進行刪減,應僅限于本標準第 7 章的要求,并且這樣的刪減不影響組織提供滿足顧客要求和適用
                  法律法規要求的產品的能力或責任,  否則不能聲稱符合本標準。 
                  Where exclusions are made, claims of conformity to this International 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. 
                       本技術規范僅允許在組織在沒有產品設計和開發責任的情況下刪減與 7.3 有關的內容。 
                       不允許刪減制造過程設計。 
                  The only permitted exclusions for this Technical Specification relate to 7.3 where the organization is not responsible for product design and development.  
                  Permitted exclusions do not include manufacturing process design.   
                   
                  2    引用標準    Normative reference 
                  ISO9001:2008    質量管理體制體系—要求 
                  ISO 9001:2008, Quality management systems  — Requirements 
                   
                  ISO9001:2008    質量管理體制體系—要求 
                       下列文件的條款通過本標準的引用而成為本標準的條款。凡是注日期的引用文件,其隨后所有的修改
                  單(不包括勘誤的內容)或修訂版均不適用于本標準,然而,鼓勵根據本標準達成協議的各方研究是否可
                  使用這些文件的最新版本。凡是不注日期的引用文件,其最新版本適用于本標準。 
                       ISO 9000-200 5    質量管理體系    基礎和術語. 
                  The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applie s.  
                  ISO 9000:2005 , Quality management systems — Fundamentals and vocabulary. 

                  3    術語和定義   Terms and definitions 
                  ISO9000 :2008    質量管理體系—要求 
                  ISO 9001: 2008, Quality management systems  — Requirements 
                   
                       本標準采用 ISO9000 中所確立的術語和定義 
                  For the purposes of this  document the terms and definitions given in ISO 9000 apply.  
                       本標準中所有出現的術語“產品”之處,也可指“服務”。 
                  Throughout the text of this International Standard, wherever the term “product”  occurs, it can also mean “service” . 
                  3.1  汽車行業術語和定義  Terms and definitions for the automotive industry 
                       本文件應用了 ISO9001 :2005以及下列內容中所確立的術語和定義。 
                  For the purposes of this  document, the terms and definitions given in ISO 9000 :  2005 and the following apply. 
                  3.1.1.  控制計劃    control plan 
                  對控制產品所要求的系統和過程的形成文件的描述。 
                  注:見附錄A 
                  documented description of the systems and  processes required for controlling product .  
                  Note: see annex A 
                  3.1.2.  具有設計責任的組織   design responsible organization 
                  有權制定一個新的或更改現有的產品規范的組織。 
                  organization with authority to establish a new, or change an existing product specification .  
                  注:該職責包括在顧客指定的應用范圍內。試驗并驗證設計性能。 
                  NOTE  This responsibility includes testing and verification of design performance within the customer’s specified 
                  application. 
                  3.1.3  防錯   error proofing  
                  為防止制造不合格產品而進行的產品和制造過程的設計和開發。 
                  product and manufacturing process design and development to prevent man ufacture of non -conforming products. 
                  3.1.4實驗室   laboratory  
                  進行檢驗、試驗和校準的設施,其范圍包括但不限于化學、冶金、尺寸、物理、電性能或可靠性試驗。 
                  facility for inspection, test or calibration that may include, but is not limited to, chemical, metallurgical, dimensional, 
                  physical, electrical or reliability testing.  
                  3.1.5 實驗室范圍   laboratory scope  
                          受控文件包括: 
                          —  實驗室有資格進行的特定試驗,評價和校準, 
                          —  用來進行上述活動的設備清單,以及 
                          — 用來進行上述活動的方法和標準的清單。 
                  controlled document containing : 
                  o  specific tests, evaluations and calibrations that a laboratory is qualified to  perform,  
                  o  a  list of the equipment which it uses to perform the above, and  
                  o  a  list of methods and standards to which it performs the above.  

                  3.1.6  制造   manufacturing 
                  以下制作或加工的過程: 
                  —生產材料; 
                  —生產或服務件; 
                  —裝配,或 
                  —熱處理、焊接、噴漆、電鍍或其他表面處理。 
                  process of making or fabricating :  
                  o  production materials,  
                  o  production or service parts, 
                  o  assemblies, or 
                  o   heat treating, welding, painting, plating or other finishing services . 
                  3.1.7預測性維護    predictive maintenance 
                  基于針對通過預測可能的失效模式的過程數據而避免維護問題的活動。 
                  activities based on process data aimed at the avoidance o f maintenance problems by prediction of likely failure modes.  
                  3.1.8預防性維護   preventive maintenance 
                  為消除設備失效和生產的計劃外中斷的原因而策劃的措施,它是制造過程設計的一項輸出。 
                  planned action to eliminate causes of equipment failure and unscheduled interruptions to production,as an output of the manufacturing process design. 
                  3.1.9  額外運費   premium freight  
                  在合同約定的交付之外發生的超出成本或費用。 
                  注:可因方法、數量、未按計劃或延遲交付等原因引起。 
                  extra costs or charges incurred additional to contracted delivery. 
                  NOTE this can be caused by method,quanlity,unscheduled or late deliveries.ect. 
                  3.1.10   外部地點   remote location  
                  支持現場,且不存在生產過程的場所。 
                  location that supports sites and at which non -production processes occur . 
                  3.1.11   現場   site  
                  發生增值的制造過程的場所 
                  location at which value-added manufacturing processes occur . 
                  3.1.12   特殊特性   special characteristic 
                  產品特性或制造過程參數,可能影響產品的安全性或法規的符合性、配合、功能、性能或其后續過程
                  的產品特性或制造過程參數。 
                  product characteristic or manufacturing process parameter which may affect safety or compliance with 
                  regulations, fit, function, performance or subsequent processing of product. 

                  4    質量管理體系   Quality management system 
                  4.1  總要求    General requirements 
                  ISO9001 :2008  質量管理體系—要求 
                  ISO 9001: 2008 Quality management systems –  Requirements 
                   
                  4 質量管理體系    Quality management system 
                  4.1    總要求   General requirements 
                  組織應按本標準的要求建立質量管理體系,形成文件,加以實施和保持,并持續改進其有效性。 
                  The organization shall establish, document, implement and maintain a quality management system and continually 
                  improve its effectiveness in accordance with the requirements of this International Standard.  
                  組織應: 
                  a)   確定質量管理體系所需要的過程及其在整個組織中的應用(見 1.2) 
                  b)   確定這些過程的順序和相互作用; 
                  c) 確定所需的準則和方法,以確保這些過程的運作和控制有效; 
                  d )  確保可以獲得必要的資源和信息,以支持這些過程的有效運行和監視; 
                  e   監視、測量(適用時)和分析這些過程。 
                  f)    實施必要的措施,以實現對這些過程所策劃的結果和對這些過程的持續改進。 
                  The organization shall  
                  a)   determine  the processes needed for the quality management system and their application throughout the 
                  organization (see 1.2),  
                  b)   determine the sequence and interaction of these processes, 
                  c)   determine criteria and methods needed to ensure that both the operation and control of these processes are 
                  effective,  
                  d)   ensure the availability of resources and information necessary to support the operation and monitoring of these processes,  
                  e)   monitor, measure  where applicable and analyse these processes, and 
                  f)   implement actions necessary to achieve planned results and continual improvement of these processes. 
                  組織應按本標準的要求管理這些過程。 
                  These processes shall be managed by the organization in accordance with the requirements of this International Standard. 
                  組織如果選擇將影響產品符合要求的任何過程外包,應確保對這些過程的控制。對此類外包過程的控
                  制類型和程度應在質量管理體系中加以規定。 
                  注1 :上述質量管理體系所需的過程應當包括與管理活動、資源提供、產品實現和測量、分析和改進有關的過程。 
                  注2 :“外包過程”是為了質量管理體系的需要,由組織選擇,并由外部方實施的過程 
                  注3 :組織確保對外包過程的控制,并不免除其滿足所有顧客要求和法律法規要求的責任。對外包過程控制的類型和程
                  度可受諸如下列因素的影響 
                  a) 外包過程對組織提供滿足要求的產品的能力的潛在影響. 
                  b) 對外包過程控制的分擔程度. 
                  c) 通過應用7.4 條款實現所需控制的能力 

                  Where an organization chooses to outsource any process that affects product conformity with requirements, the 
                  organization shall ensure control over such processes.  The type and extent of control to be applied to these outsourced processes shall be defined within the quality management system. 
                  NOTE 1:   Processes needed for the quality management system referred to above should include processes for 
                  management activities, provision of resources, product realization and measurement.analysis and improvement.  
                  NOTE 2 An “outsourced process” is a process that the organization needs for its quality management system and which  the  organization chooses to have performed by an external party. 
                  NOTE 3 Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all  customer, statutory and regulatory requirements. The type and extent of control to be applied to the outsourced process can  be influenced by factors such as 
                  a) the potential impact of the outsourced process on the organization's capability to provide product that conforms to requirements, 
                  b) the degree to which the control for the process is shared, 
                  c) the capability of achieving the necessary control through the application of 7.4.  
                  4.1.1    General requirements — Supplemental 
                  4.1.1    總要求—補充 
                       確保外包過程的控制不能免除組織對符合所有顧客要求的職責。 
                       注:另見7.4.1和7.4.1.3 
                  Ensuring control over outsourced processes shall not absolve the organization of the responsibility of conformity to all customer requirements. 
                  NOTE See also 7.4.1 and 7.4.1.3. 
                   
                  4.2     文件要求   Documentation requirements  
                  4.2.1   總則   General                       
                  ISO9001:2008   質量管理體系—要求 
                  ISO 9001:2008, Quality management systems  –  Requirements 
                   
                       質量管理體系文件應包括: 
                       a)   形成文件的質量方針和質量目標 
                       b)   質量手冊 
                       c) 本國際標準所要求的程序文件和記錄; 
                       d)   組織為確保其過程有效策劃、運行和得到控制所需要的文件,包括記錄; 
                  The quality management system documentation shall include 
                  a) documented statements of a quality policy and quality objectives,  
                  b)   a quality manual, 
                  c)   documented procedures required by this International Standard,,and  
                  d)   documents, including records, determined by the organization to be necessary to ensure the effe ctive   
                     planning, operation and control of its processes. 
                  注1 :本標準出現“形成文件的程序”之處,即要求建立程序,形成文件,并加以實施和保持;一個文件可包括對一個或
                  多個程序的要求。一個形成文件的程序的要求可以被包含在多個文件中。 
                   
                  NOTE 1 Where the term ?documented procedure? appears within this International Standard, this means that the procedure is established, documented, implemented and maintained.  A single document may address the requirements for one or more procedures. A requirement for a documented procedure may be covered by more than one document. 
                       注2 :不同組織的質量管理體系文件的多少與詳略程度可以不同,取決于: 
                       a)   組織的規模和活動類型; 
                       b)   過程及其相互作用的復雜程度; 
                       c) 人員的能力 
                  NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to 
                  a)   the size of organization and type of activities,  
                  b)   the complexity of processes and their interactions, and 
                  c)   the competence of personnel. 
                       注3 :文件可采用任何形式或類型的媒體 
                  NOTE 3 The documentation can be in any form or type of medium. 
                   
                  4.2.2   質量手冊   Quality manual                                              
                  ISO9001 :2008  質量管理體系—要求 
                  ISO 9001:2008, Quality management systems  –  Requirements 
                   
                  組織應編制和保持質量手冊,質量手冊包括: 
                  a)   質量管理體系的范圍,包括任何刪減的細節和正當的理由(見 1.2); 
                  b)   為質量管理體系而建立的形成文件的程序或對其引用; 
                  c) 質量管理體系過程之間相的互作用的描述。 
                  The organization shall establish and maintain a quality manual that includes 
                  a)   the scope of the quality management system, including details of and justification for any  exclusions (see 1.2), 
                  b)   the documented procedures established for the quality management system, or reference to them, and  
                  c)   a description of the interaction between the processes of the quality management system 
                   
                  4.2.3   文件控制   Control of documents          
                  ISO 9001:2008   質量管理體系—要求 
                  ISO 9001:2008, Quality management systems  –  Requirements 
                   
                  4.2.3   文件控制   Control of documents 
                  質量管理體系所要求的文件應予以控制。記錄是一種特殊類型的文件,應根據 4.2.4的要求進行控制。 
                  Documents required by the quality management system shall be controlled.  Records are a special  type of document and shall be controlled according to the requirements given in 4.2.4. 
                  應編制形成文件的程序,以規定以下方面所需的控制: 
                       a)   為使文件是充分與適宜的,文件發布前得到批準。 
                       b)   必要時對文件進行評審與更新,并再次批準; 
                        c) 確保文件的更改和現行修訂狀態得到識別; 
                       d)   確保在使用處可獲得適用文件的有關版本; 
                       e)   確保文件保持清晰、易于識別; 
                       f)   確保組織所規定的策劃和運行質量管理體系所需的外來文件得到識別;  并控制其分發; 
                       g)   防止作廢文件的非預期使用,若因任何原因而保留作廢文件時,對這些文件進行適當的標識。 
                  A documented procedure shall be established to define the controls needed 
                  a)   to approve documents for adequacy prior to issue, 
                  b)   to review and update as necessary and re -approve documents, 
                  c)   to ensure that changes and the current revision status of documents are identified,  
                  d)   to ensure that relevant versions of applicable documents are available at points of use, 
                  e)   to ensure that documents remain legible and readily identifiable, 
                  f)   to   ensure that documents of external origin are  determined by the organization to be necessary for the planning and operation of the quality management system are identified and their distribution controlled, and  
                  g)   to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose. 
                  4.2.3.1工程規范   Engineering specifications 
                  組織應有一個過程,以保證按顧客要求的時間安排及時評審、發放和實施所有顧客工程標準/規范及其
                  更改。及時評審應當盡快進行,不應超過兩個工作周。 
                  組織應保存每項更改在生產中實施日期的記錄。實施應包括對文件的更新。 
                  The organization shall have a process to assure the timely review, distribution and implementation of all customer 
                  engineering standards/specifications and changes based on customer required schedule. Timely review should be as soon as possible.   and shall not exceed two working weeks. 
                  The organization shall maintain a record of the date on which each change is implemented in production. Implementation shall include updated documents.  
                  注:當設計記錄引用了這些規范或這些規范影響生產件批準過程的文件,例如:控制計劃,FMEA s 等時,這些標準/ 規
                  范的更改要求對顧客的生產件批準記錄進行更新。 
                  NOTE  A change in these standards/specifications requires an updated record of customer production part approval when  these specifications are referenced on the design record or i f they affect documents of production part approval process, such as control plan, FMEAs, etc.  
                   
                  4.2.4    記錄的控制   Control of records                   
                  ISO9001 :2008   質量管理體系—要求 
                  ISO 9001:2008, Quality management systems  –  Requirements 
                   
                  4.2.4    記錄的控制   Control of records            
                  為提供符合要求和質量管理體系有效運行的證據而建立的記錄,應得到控制。 
                  組織應編制形成文件的程序,以規定記錄的標識、貯存、保護、檢索、保存期限和處置所需的控制。 
                       記錄應保持清晰、易于識別和檢索。 
                  Records established to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be controlled.  
                  The organization shall establish a documented procedure to define the controls needed for the identificationstorage, protection, retrieval, retention and disposition of records.  
                  Records shall remain legible, readily identifiable and retrievable.  
                  注1 :以上“處置”包括廢棄。 
                  注2 :“記錄”還包括顧客指定的記錄。 
                  NOTE 1    "Disposition" above includes disposal. 
                  NOTE 2    "Records" also include customer-specified records.  
                  4.2.4.1 記錄保存   Records retention  
                       記錄控制應滿足滿足法規和顧客的要求。 
                  The control of records shall satisfy regulatory and customer requirements. 
                   
                  5      管理職責   Management responsibility 
                  5.1    管理承諾   Management commitment       
                  ISO9001 :2008   質量管理體系—要求 
                  ISO 9001:2008, Quality management systems  –  Requirements 
                   
                  最高管理者應通過以下活動,對其建立、實施質量管理體系并持續改進其有效性的承諾提供證據: 
                  a)   向組織傳達滿足顧客和法律、法規要求的重要性; 
                  b)   制定質量方針; 
                  c) 確保質量目標的制定; 
                  d)   進行管理評審; 
                  e)   確保資源的獲得。 
                  T op management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by 
                  a)   communicating to the organization the importan ce of meeting customer as well as statutory and regulatory 
                  requirements, 
                  b)   establishing the quality policy, 
                  c)   ensuring that quality objectives are established, 
                  d)   conducting management reviews, and  
                  e)   ensuring the availability of resources. 
                  5.1.1  過程績效   Process efficiency  
                  最高管理應評審產品實現過程和支持過程,以確保它們的有效性和效率。 
                  Top management shall review the product realization processes and the support processes to assure their effectiveness and efficiency. 
                   
                  5.2  以顧客為關注焦點  Customer focus  
                  ISO9001 :2008   質量管理體系—要求 
                  ISO 9001:2008, Quality management systems  –  Requirement 

                  5.2  以顧客為關注焦點  Customer focu 
                  最高管理者應以增進顧客滿意為目的,確保顧客的要求得到確定并予以滿足。(見 7.2.1和8.2.1) 
                  Top management shall ensure that customer requirements are determined and fulfilled with the aim of enhancing 
                  customer satisfaction (see 7.2.1 and 8.2.1 ). 
                   
                  5.3  質量方針  Quality policy                           
                  ISO9001 :2008   質量管理體系—要求 
                  ISO 9001:2008, Quality management systems  –  Requirements 
                   
                  5.3  質量方針  Quality policy    
                  最高管理者應確保質量方針: 
                  a)   與組織的宗旨相適應; 
                  b)   包括對滿足要求和持續改進質量管理體系有效性的承諾; 
                  c) 提供制定和評審質量目標的框架; 
                  d)   在組織的得到溝通和理解; 
                  e)   在持續適宜性方面得到評審。 
                  Top management shall ensure that the quality policy 
                  a)   is appropriate to the purpose of the organization,  
                  b)   includes a commitment to comply with requirements and continually improve the effectiveness of the quality 
                  management system, 
                  c)   provides a framework for establishing and reviewing quality objectives, 
                  d)   is communicated and understood within the organization, and 
                  e)   is reviewed for continuing suitability.  
                   
                  5.4  策劃Planning  
                  5.4.1   質量目標   Quality objectives                                 
                  ISO9001 :2008   質量管理體系—要求 
                  ISO 9001:2008, Quality management systems  –  Requirements 
                   
                  5.4  策劃Planning 
                  5.4.1   質量目標   Quality objectives  
                  最高管理者應確保在組織的相關職能和層次上建立質量目標,質量目標包括滿足產品要求所需的內容
                  (見7.1 a ))。質量目標應是可測量的,并與質量方針保持一致。  
                  Top management shall ensure that quality objectives, including those needed to meet requirements for product (see 7.1) are established at relevant functions and levels within the organization.    The quality objectives shall be measurable and consistent with the quality policy 
                  5.4.1.1   質量目標—補充 Quality objectives –  Supplemental 
                  最高管理者應確定質量目標及測量要求,并應包含在經營計劃中,用于質量方針的展開。 
                        注:質量目標應體現顧客期望并在規定的時間內是可以實現的。 
                  Top management shall define quality objectives and measurements that shall be included in the business plan and used to deploy the quality policy.  
                  NOTE  Quality objectives should address customer expectations and be achievable within a defined time period.  
                   
                  5 .4.2    質量管理體系策劃     Quality management system planning        
                  ISO9001 :2008   質量管理體系—要求 
                  ISO 9001:2008    Quality management systems — Requirements 
                   
                  5.4.2    質量管理體系策劃 Quality management system planning 
                  最高管理者應確保: 
                  a)   對質量管理體系進行策劃,以滿足質量目標以及 4.1的要求; 
                  b)   在對質量管理體系的變更進行策劃和實施時,保持質量管理體系的完整性; 
                  Top management shall ensure that 
                  a)   the planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the quality objectives, and 
                  b)   the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.  
                   
                  5 .5    職責、權限和溝通   Responsibility, authority and communication 
                  5.5.1  職責與權限    Responsibility and authority                
                  ISO9001 :2008  質量管理體系—要求   
                  ISO 9001:2008, Quality management systems  — Requirements 
                   
                  5.5  職責、權限和溝通 Responsibility, authority and communication 
                  5.5.1  職責與權限      Responsibility and authority 
                  最高管理者應確保組織內的職責、權限得到規定和溝通。 
                  Top management shall ensure that the responsibilities and authorities are defined and communicated within the 
                  organization.  
                  5.5.1.1 質量職責   Responsibility for quality  
                  不符合要求的產品或過程應立即通知給負有糾正措施職責和權限的管理者。 
                  負責產品要求符合性的
                  所有班次的生產作業,應安排有負責確保產品要求符合性的人員,或指定其代理人員。 
                  人員,應有權停止生產,以糾正質量問題。 
                  Managers with responsibility and authority for corrective action shall be promptly informed of products or processes which do not conform to requirements. 
                  Personnel responsible for  conformity to product requirement  shall have the authority to stop production to correct quality problems. 
                  Production operations across all shifts shall be staffed with personnel in charge of, or delegated responsibility for, ensuring conformity to product requiremnen. 
                   
                   5.5.2   管理代表    Management representative          
                  ISO9001 :2008   質量管理體系—要求 
                  ISO 9001:2008, Quality management systems  — Requirements 
                   
                  5.5.2   管理代表    Management representative 
                       最高管理者應在本組織管理層中指定一名管理者,無論該成員在其他方面的職責如何,應具有以下方
                  面的職責和權限: 
                     a)   確保質量管理體系所需的過程得到建立、實施和保持; 
                     b)   向最高管理者報告質量管理體系的業績和任何改進的需求; 
                     c) 確保在整個組織內提高滿足顧客要求的意識。 
                       注:管理者代表的職責可包括與質量管理體系有關事宜的外部聯絡。 
                  Top management shall appoint a member of  the organization’s  management who, irrespective of other responsibilities, shall have responsibility and authority that includes 
                  a)   ensuring that processes needed for the quality management system are established, implemented and maintained,  
                  b)   reporting to top management on the performance of the quality management system and any need for improvement, and  
                  c)   ensuring the promotion of awareness of customer requirements throughout the organization.  
                  NOTE The responsibility of a management representative can include liaison with external parties on matters relating to the quality management system.  
                    5.5.2.1 顧客代表  Customer representative  
                       最高管理者應指定人員,賦予其職責和權限,以確保顧客要求得到體現,包括特殊特性的選擇、制定
                  質量目標和相關的培訓、糾正和預防措施、產品設計和開發。 
                  Top management shall designate personnel with responsibility and authority to ensure the customer requirements are addressed This includes selection of  special characteristics, setting quality objectives and related training, corrective and preventive actions, product design and development. 
                  5.5.3   內部溝通    Internal communication  
                  ISO9001 :2008   質量管理體系—要求 
                  ISO 9001:2008, Quality management systems  — Requireme nts 
                   
                  5.5.3內部溝通Internal communication 
                  最高管理者應確保在組織內建立適當的溝通過程,并確保對質量管理體系的有效性進行溝通。 
                  Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system.   
                   
                  5.6  管理評審    Management review  
                  5.6.1總則    General      
                  ISO9001 :2008   質量管理體系—要求 
                  ISO 9001:2008, Quality management systems  — Requirements 
                   
                  5.6  管理評審Management review  
                  5.6.1總則General 
                  最高管理者應按策劃的時間間隔評審質量管理體系,以確保其持續的適宜性、充分性和有效性。評審
                  應包括評價質量管理體系的改進機會和變更的需要,包括質量方針和質量目標。 
                       應保持管理評審的記錄(見 4.2.4)。 
                  Top management shall review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives 
                  Records from management reviews shall be maintained (see 4.2.4) 
                  5.6.1.1   質量管理體系績效   Quality management system performance 
                  作為持續改進過程的必不可少的部分。這些評審應包括對質量管理體系的所有要求及其績效趨勢的評
                  審。   
                  對質量目標進行監視及對不良質量成本的定期報告和評價應是管理評審的一部分內容(見8.4.1 和
                  8.5.1  )。 
                  這些結果應予以記錄,至少能為以下方面的成績提供證據: 
                  a)   經營計劃中規定的質量目標; 
                  b)   顧客對提供產品的滿意度。 
                  These reviews shall include all requirements of the quality management system and its performance trends as an 
                  essential part of the continual improvement process. 
                  Part of the management review shall be the monitoring of quality objectives, and the regular reporting and evaluation of the cost of poor quality (see 8.4.1 and 8.5.1).  
                  These results sha ll be recorded to provide, as a minimum, evidence of the achievement of  
                  a)   the quality objectives specified in the business plan, and  
                  b)   customer satisfaction with product supplied. 
                   
                  5.6.2   評審輸入   Review input 
                  ISO9001 :2008   質量管理體系—要求 
                  ISO 9001:2008, Quality management systems  — Requirements 
                   
                  5.6.2評審輸入Review input 
                  管理評審的輸入應包括以下方面的信息: 
                  a)   審核結果; 
                  b)   顧客反饋; 
                  c)  過程表現和產品符合性; 
                  d)   預防和糾正措施的狀況; 
                  e)   以往管理評審的跟蹤措施; 
                  f)   可能影響質量管理體系的變更; 
                  g)   改進建議。 
                  The input to management review shall include information on  
                   a)   results of audits, 
                  b)   customer feedback,  
                  c)   process performance and product conformity, 
                  d)   status of preventive and corrective actions,  
                  e)   follow -up actions from previous management reviews,  
                  f)   changes that could affect the quality management system, and  
                  g)   recommendations for improvement.  
                  5.6.2.1  評審輸入--- 補充    Review input –  Supplemental 
                  管理評審的輸入應包括實際的和潛在的使用現場失效以及他們對質量、安全或環境的影響分析。 
                  Input to management review shall include an analysis of actual and potential field -failures and their impact on quality, safety, or the environment.  
                   
                  5.6.3   評審輸出    Review out put 
                  ISO9001 :2008   質量管理體系—要求 
                  ISO 9001:2008, Quality management systems  — Requirements 
                   
                  5.6.3評審輸出Review output 
                       管理評審的輸出應包括與以下方面有關的任何決定和措施: 
                       a)   質量管理體系有效性及其過程有效性的改進; 
                       b)   與顧客要求有關的產品改進 
                       c) 資源需求 
                  The output from the management review shall include any decisions and actions related to  
                  a)   improvement of the effectiveness of the quality management system and its processes,  
                  b)   improvement of product related to customer requirements, and  
                  c)   resource needs  
                   
                  6.   資源管理    Resource management 
                  6.1    資源的提供     Provision of resou rces                          
                  ISO9001 :2008   質量管理體系—要求 
                  ISO 9001:2008, Quality management systems  — Requirements 
                   
                  6 資源管理    Resource management 
                  6.1 資源的提供 Provision of resources  
                       組織應確定并提供以下方面所需資源,以: 
                       a)   實施、保持質量管理體系并持續改進其有效性; 
                       b)   通過滿足顧客要求,增強顧客滿意。 
                  The organization shall determine and provide the resources needed  
                  a)   to implement and maintain the quality management system and continually improve its effectiveness, and  
                  b)   to enhance customer satisfaction by meeting customer requirements.  
                   
                  6.2    人力資源   Human resources  
                  6 .2.1 總則   General   
                  ISO9001 :2008   質量管理體系—要求 
                  ISO 9001:2008, Quality management systems  — Requirements 
                   
                  6.2 人力資源Human resources  
                  6.2.1總則General 
                  基于適當的教育、培訓、技能和經驗,從事影響產品要求符合性工作的人員應是能夠勝任的。 
                  Personnel performing work affecting  conformity to product requirements   shall be competent on the basis of appropriate education, training, skills and experience 
                  NOTE Conformity to product requirements can be affected directly or indirectly by personnel performing any task within the quality 
                  management system。 
                    注:在質量管理體系中承擔任何任務的人員都可能直接或間接地影響產品要求符合性。 
                   
                  6.2.2  能力、培訓和意識   Competence, training and awareness  
                  ISO9001 :2008   質量管理體系—要求 
                  ISO 9001:2008, Quality management systems  — Requirements 
                   
                  6.2.2  能力、培訓和意識 Competence, training and awareness 
                  組織應: 
                  a)   確定從事影響產品要求符合性的工作的人員的必要的能力; 
                  b)   適用時,提供培訓或采取其他措施以滿足這些需求; 
                  c) 評價采取措施的有效性; 
                  d)   確保員工意識到所從事活動的相關性和重要性,以及如何為實現質量目標做出貢獻; 
                  e)   保持教育、培訓、技能和經驗的適當記錄。 
                  The organization shall  
                  a)   determine the necessary competence for personnel performing work affecting  conformity to product    requirements . 
                  b)   where applicable,   provide training or take other actions achieve the necessary competence.  
                  c)   evaluate the effectiveness of the actions taken,  
                  d)   ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality object ives, and  
                  e)   maintain appropriate records of education, training, skills and experience (see 4.2.4)    
                   
                  6.2.2.1  產品設計技能  Product design skills 
                  組織應確保具有產品設計責任人員有達到設計要求的能力,并熟練地掌握適用的工具和技術。 
                  組織應識別適用工具和技術。 
                  The organization shall ensure that personnel with product design responsibility are competent to achieve design 
                  requirements and are skilled in applicable tools and techni ques. 
                   Applicable tools and techniques shall be identified by the organization. 
                  6.2.2.2 培訓  Training 
                  組織應建立并保持形成文件的程序,識別培訓需求并使所有從事對產品要求符合性有影響的人員具備
                  能力。承擔特定任務的人員應按要求進行資格認可,在滿足顧客要求方面給予特別的關注。 
                  注1 :本要求適用于組織各層次內所有影響質量的員工。 
                  注2 :顧客特殊要求的范例之一是使用數字化的數學數據。 
                  The organization shall establish and maintain documented procedures for identifying training needs and achieving 
                  competence of all personnel performing acti vities affecting  conformity to product requirement. Personnel performing specific assigned tasks shall be qualified, as   required with particular attention to the satisfaction of customer requirements. 
                  NOTE 1    This applies to all employees having an effect on quality at all levels of the organization.  
                  NOTE 2    An example of the customer specific requirements is the application of digitized mathematically based data. 
                  6.2.2.3   崗位培訓Training on the job 
                  對影響產品要求符合性的崗位,組織應對新的或調整工作崗位的人員提供崗位培訓。包括合同工和代
                  理工作人員。應將不符合要求給顧客帶來的后果告知對質量有影響的人員。 
                  The organization shall provide on -the -job training for personnel in any new or modified job affecting conformity to  product requirements ,   including contract or agency personnel. Personnel whose work can affect quality shall be informed about the consequences to the customer of nonconformity to quality requirements  
                  6.2.2.4 員工的鼓勵    Employee motivation and em powerment  
                  組織應建立一個激勵員工實現質量目標、進行持續改進和建立促進創新的環境的過程。該過程應促進
                  提高整個組織對質量和技術的認知。 
                  組織應有一個過程,以測量員工對于所從事活動的相關性和重要性,以及如何為實現質量目標作出貢
                  獻(見 6.2.2.d)的認知程度。 
                  The organization shall have a process  to motivate employees to achieve quality objectives, to make continual 
                  improvements,  and to create an environment to promote innovation. The process shall include the promotion of quality and technological awareness throughout the whole organization.  
                  The organization shall have a process  to measure the extent to which its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives (see 6.2.2 d).  
                   
                  6.3   基礎設施       Infrastructure                                          
                  ISO9001 :2008   質量管理體系—要求 
                  ISO 9001:2008, Quality management systems  — Requirements 
                   
                  6.3    基礎設施    Infrastructure  
                  組織應確定、提供并維護為達到產品符合要求所需的基礎設施。適用時,基礎設施包括: 
                  a) 建筑物、工作場所和相應的設施; 
                    b)    過程設備(硬件和軟件); 
                    c)  支持性服務(如運輸和通訊或信息系統)。 
                  The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable  
                  a)   buildings, workspace and associated utilities,  
                  b)   process equipment,( both hardware and software ), and 
                  c)   supporting services ( such as transport or communication or information systems ). 
                  6.3.1   工廠、設施和設備策劃    Plant, facility and equipment planning 
                  組織應采用多方論證的方法(見7.3.1.1)  來開發工廠、設施和設備的計劃。工廠的布局應最大限度地減
                  少材料地交轉和搬運,以及最大限度地增值使用場地空間,便于材料的同步流動。應開發并實施對現有操
                  作有效性進行評價和監視方法。 
                  注:這些要求應著重于精益制造原則,并與質量管理體系的有效性相關聯。 
                  The organization shall use a multidisciplinary approach (see 7.3.1.1) for developing plant, facility and equipment plans. 
                  Plant layouts shall optimize material travel, handling and value-added use of   floor space, and shall facilitate synchronous material flow. Methods shall be developed and implemented to evaluate and monitor the effectiveness of existing operations.  
                  NOTE  These requirements should focus on lean manufacturing principles and the link to the effectiveness of the 
                  quality management system.  
                  6.3.2   應急計劃    Contingency plans 
                  組織應準備應急計劃,以在緊急事件下滿足顧客的要求,例如:公用事業供應中斷、勞動力短缺,關
                  鍵設備故障和使用現場退貨等。 
                  The organization shall prepare contingency plans to satisfy customer requirements in the event of an emergency such as utility interruptions, labour shortages, key equipment failure and field returns . 
                   
                  6.4   工作環境   Work environment                      
                  ISO9001:2008   質量管理體系—要求 
                  ISO 9001:2008, Quality management systems  — Requirements 
                   
                  6.4 工作環境    Work environment 
                  組織應確定和管理為達到產品符合要求所需的工作環境。 
                  注: 術語工作環境是指工作時所處的條件,包括物理的、環境的和其他因素,如噪聲、溫度、濕度、照明或天氣等。 
                  The organization shall determine and manage the work environment needed to achieve conformity to product 
                  requirements. 
                  NOTE The term “work environment” relates to those conditions under which work is performed including physical, 
                  environmental and other factors (such as noise, temperature, humidity, lighting or weather). 
                  6.4.1為達到產品要求符合性的人員安全   Personnel safety to achieve conformity to product requirement 
                  組織應落實產品安全性和方法以使員工潛在風險降至最低,特別是在設計和開發以及制造過程活動中。 
                  Product safety and means to minimize potential risks to employees shall be addressed by the organization, especially in the design and development process and in manufacturing process activities. 
                  6.4.2  生產現場的清潔    Cleanliness of premises 
                  組織應保持生產現場處于與產品和制造過程的需求相協調的有序、清潔和維護狀態。 
                  The organization shall maintain its premises in a state of order, cleanliness and repair consistent with the    product and manufacturing process needs. 
                   
                  7    產品實現  Product realization 
                  7.1  產品實現的策劃    Planning of product realization 
                  ISO9001 :2008  質量管理體系—要求 
                  ISO 9001:2008, Quality management sy stems — Requirements 
                   
                  7    產品實現Product realization 
                  7.1  產品實現的策劃 Planning of product realization 
                  組織應策劃和建立產品實現所需的過程,產品實現的策劃應與質量管理體系其他過程的要求相一致。
                  (見4.1) 
                  The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system (see 4.1).  
                  在策劃產品實現的過程中,組織應確定以下方面的適用內容: 
                  a)   產品的質量目標和要求; 
                  b)   針對產品確定過程、文件和資源的需求; 
                  c) 產品所要求的驗證、確認、監視、檢驗和試驗活動,以及產品接收準則; 
                  d)   為實現過程及其產品滿足要求提供證據所需的記錄(見 4.2.4)。 
                  In planning product realization, the organization shall determine the following, as appropriate: 
                  a)   quality objectives and requirements for the product;  
                  b)   the need to establish processes, documents, and provide resources specific to the product; 
                  c)   required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance; 
                  d)   records needed to provide evidence that the realization processes and resulting product meet requirements (see 
                  4.2.4).  
                       策劃的輸出形式應適于組織的運作方式。 
                  The output of this planning shall be in a form suitable for the organization's method of operations.  
                  注1 :對應用于特定產品、項目或合同的質量管理體系的過程(包括產品實現過程)和資源作出規定的文件可稱之為質
                  量計劃。 
                  注2 :組織也可將7.3的要求應用于產品實現過程的開發。 
                  NOTE 1 A document specifying the processes of the quality management system (including the product realization processes) and the resources to be applied to a specific product, project or contract, can be referred to as a quality plan. 
                  NOTE 2 The organization may also apply the requirements given in 7.3 to  the development of product realization 
                  processes.  
                  注:有些顧客把項目管理或產品質量策劃作為一種產品實現的方法。產品質量先期策劃包括防錯和持續改進的概念,與
                  錯誤探測不同,并且基于多方論證的方法。 
                  NOTE  Some customers refer to project management or advanced product quality planning as a means to achieve 
                  product realization. Advanced product quality planning embodies the concepts   of error prevention and continual 
                  improvement as contrasted with error detection and is based on a multidisciplinary approach. 
                  7.1.1    產品實現的策劃——補充   Planning of product realization –  Supplemental 
                  作為質量計劃的一部分,產品實現的策劃應包括顧客要求和對其技術規范的引用。 
                  Customer requirements and references to its technical specifications shall be included in the planning of  product 
                  realization as a component of the quality plan. 
                  7.1.2  接收準則  Acceptance criteria 
                  接收準則應由組織定義,要求時,應由顧客批準。 
                  對于計數型數據抽樣,接收水平應是零缺陷(見 8.2.3.1)。 
                  Acceptance criteria shall be defined by  the organization and, where required, approved by the customer.  
                  For attribute data sampling, acceptance level shall be zero defects (see 8.2.3.1). 
                  7.1.3   保密Confidentiality 
                  組織應確保顧客合同產品、正在開發的項目和有關產品信息的保密。 
                  The organization shall ensure the confidentiality of  customer-contracted products and projects under development, and related product information. 
                  7.1.4    變更控制Change control  
                  組織應建立一個過程,對影響產品實現的更改進行控制和反應。任何更改的影響,包括由任何供方引
                  起的更改,都應進行評估,并且驗證和確認活動應得以規定,以確保和顧客要求相一致。變更在實施前應
                  予以作確認。 
                  具有專利權的設計,影響外形、配合和功能(包括性能,和/或耐久性)的更改,應與顧客一同評審,
                  以便所有的影響都能得到適當的評價。 
                       注1 :任何影響顧客要求的產品實現的更改都要通知顧客,并征得顧客同意。 
                  注2 :以上要求適用于產品和制造過程更改。 
                  The organization shall have a process to control and react to changes that impact product realization. The effects of any change, including those changes caused by any supplier, shall be assessed, and verification and validation activities shall be defined, to ensure compliance with customer requirements. Changes shall be validated before implementation. 
                  For proprietary designs, impact on form, fit and function (including performance, and/or durability) shall be reviewed with the customer so that all effects can be properly evaluated.  
                  When required by the customer, additional verification/identification requirements, such as those required for new product introduction, shall   be met. 
                  NOTE 1    Any product realization change affecting customer requirements requires notification to, and agreement from, the customer. 
                  NOTE 2    The above requirement applies to product and manufacturing process changes.  
                   
                  7.2   與顧客有關的過程  Customer-related  processes 
                  7.2.1   與產品相關要求的確定   Determination of requirements related to the product 
                  ISO9001:2008   質量管理體系—要求 
                  ISO 9001:2008, Quality management systems  — Requirements 
                   
                  7.2   與顧客有關的過程 Customer-related processes  
                  7.2.1   與產品相關要求的確定 Determination of requirements related to the product  
                  組織應確定: 
                  a)   顧客規定的要求,包括對交付和交付后活動的要求; 
                  b)   顧客雖然沒有明示,但規定的用途或已知的預期用途所必需的要求; 
                  c) 與產品有關的法律法規要求; 
                  d)   組織確定的任何附加要求。 
                  The organization shall determine 
                  a)   requirements specified by the customer, including the requirements for delivery and post -delivery activ ities, 
                  b)   requirements not stated by the customer but necessary for specified or intended use, where known,  
                  c)   statutory and regulatory requirements related to the product, and  
                  d)   any additional requirements determined by the organization. 
                  NOTE Post-delivery activi ties include, for example, actions under warranty provisions, contractual obligations such as ,  maintenance 
                  services, and supplementary services such as recycling or final disposal.  
                  注  :交付后活動包括諸如擔保條款規定的措施、合同義務(例如,維護服務)、附件服務(例如,回收和最終處理)等。 
                  注1 :交付后的活動包括作為顧客合同和采購訂單一部分的任何售后產品服務。 
                  注2 :本要求包括回收再利用、對環境的影響,以及根據組織對產品和制造過程度的認知知識識別的特性(見7.3.2.3) 
                  注3 :條款 c )的符合性包括所有適用的政府、安全和環境法規,適用于材料的獲得、貯存、搬運、再利用、銷毀或廢棄。 
                  NOTE 1  Post-delivery activities include any after-sales product service provided as part of the customer contract or purchase order.  
                  NOTE 2    This requirement includes recycling, environmental impact and characteristics identified as a result of the organization’s knowledge of the product and manufacturing processes ( see 7.3.2.3). 
                  NOTE 3    Compliance to item c) includes all applicable government, safety and environmental regulations, applied to acquisition, storage, handling, recycling, elimination or disposal of materials.  
                  7.2.1.1   顧客指定的特殊特性 Customer-designated special characteristics  
                       組織應證實在特殊特性的指定、形成文件和控制方面符合顧客的要求。 
                  The organization shall demonstrate conformity to customer requirements for designation, documentation and control of special characteristics. 
                  7.2.2    與產品相關要求的評審     Revi ew of requirements related to the product   
                  ISO9001:2008   質量管理體系—要求 
                  ISO 9001:2008, Quality management systems  — Requirements 
                   
                  7.2.2與產品有關要求的評審 Review of requirements related to the product 
                  組織應評審與產品有關的要求。評審應在組織向顧客作出提供產品的承諾(如:在投標、接受合同或
                  訂單,接受合同或訂單的變更)之前進行,并應確保: 
                  a )  產品要求已得到規定; 
                  b)   與以前表述不一致的合同或訂單的要求已得到解決; 
                  c) 組織有能力滿足規定的要求。 
                  The organization shall review the requirements related to the product. This review shall be conducted prior to the 
                  organization's commitment to supply a product to the customer (e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and shall ensure that 
                   a)   product requirements are defined,  
                  b)   contract or order requirements differing from those previously expressed are resolved, and  
                  c)   the organization has  the ability to meet the defined requirements.  
                  評審結果及評審所引起的措施的記錄應予保持(見 4.2.4)。 
                  若顧客提供的要求沒有形成文件,組織在接收顧客要求前應對顧客要求進行確認; 
                  若產品要求發生變更,組織應確保相關文件得到修改,并確保相關人員知道已變更的要求。 
                  Records of the results of the review and actions arising from the review shall be maintained (see 4.2.4). 
                  Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the organization before acceptance.  
                  Where product requirements are changed, the organization shall ensure that relevant documents are amended and that relevant personnel are made awa re of the changed requirements. 
                  注:在某些情況中,如網上銷售,對每一個訂單進行正式的評審可能是不實際的。而代之對有關的產品信息,如產品目
                  錄、產品廣告內容等進行評審。 
                  NOTE In some situations, such as internet sales, a formal review is impractical for each order. Instead the review can cover relevant product information such as catalogues or advertizing material.  
                  7.2.2.1 與產品有關的要求的評審——補充Review of requirements related to the product -  Supplemental 
                  對7.2.2中所說明的正式評審(參見注)要求的棄權,應要求顧客授權。 
                  Waiving the requirement stated in 7.2.2 for a formal review (see note) shall require customer authorization 
                   
                  7.2.2.2 組織制造可行性   Organization manufacturing feasibility 
                       組織應在合同評審過程中,對所涉及產品的制造可行性進行研究、確認并形成文件,包括進行風險分
                  析。 
                  The organization shall investigate, confirm and document the manufacturing feasibility of the proposed products in the contract review process, including risk analysis. 
                   
                  7.2.3   顧客溝通    Customer communication              
                  ISO9001:2008   質量管理體系—要求 
                  ISO 9001:2008, Quality management systems  — Requirements 
                   
                  7.2.3    顧客溝通  Customer communication 
                  組織應對以下有關方面確定并實施與顧客溝通的有效安排: 
                  a)     產品信息 
                  b)     問詢、合同或訂單的處理,包括對其的修改; 
                  c)    顧客反饋,包括顧客抱怨。 
                  The organization shall determine and implement effective arrangements for communicating with customers in relation to  
                  a)   product information,  
                  b)   enquiries, contracts or order handling, including amendments, and 
                  c)   customer feedback, including customer complaints.  
                   
                  7.2.3.1 顧客溝通——補充  Customer communication -  Supplemental 
                  組織應有能力按顧客規定的語言和方式來溝通必要的信息,包括數據(例如:計算機輔助設計數據、
                  電子數據交換等)。 
                  The organization shall have the ability to communicate necessary information, including data, in a customer -specified language and format (e.g. computer -aided  design data, electronic data exchange). 
                   
                  7.3    設計和開發Design and development  
                       注:7.3 的要求包括產品和制造過程的設計與開發,并注重防錯,而不是探測。 
                  NOTE    The requirements of clause 7.3 include product and manufacturing process design and development, and focus on error prevention rather than  detection. 
                  7.3.1    設計和開發策劃   Design and development planning 
                  ISO9001 :2008   質量管理體系—要求 
                  ISO 9001:2008, Quality management systems  — Requirements 
                   
                  7.3    設計和開發Design and development 
                  7.3.1  設計和開發策劃Design and development planning 
                       組織應對產品的設計和開發進行策劃和控制。 
                       在進行設計和開發的策劃時,組織應確定: 
                       a) 設計和開發的階段; 
                       b)   適于每個設計和開發階段的評審、驗證和確認活動; 
                       c) 設計和開發的職責和權限。 
                  組織應對參與設計和開發的不同小組之間的接口實施管理,以確保有效的溝通,并明確職責分工。 
                  隨設計和開發的進展,在適當時,策劃的輸出應予以更新。 
                       注:設計和開發的評審、驗證和確認具有不同的目的,根據產品和組織的具體情況,可單獨或以任意組合的方式進行并記錄.  
                   
                  The organization shall plan and control the  design and development of product.  
                  During the design and development planning, the organization shall determine 
                  a)   the design and development stages  
                  b)   the review, verification and validation that are appropriate to each design and development stage, an d 
                  c)   the responsibilities and authorities for design and development  
                  The organization shall manage the interfaces between different groups involved in design and development to ensu re effective communication and clear assignment of responsibility . 
                  Planning output shall be updated, as appropriate, as the design and development progresses . 
                  NOTE Design and development review, verification and validation have distinct purposes. They can be conducted and recorded  separately or in any combination, as suitable fo r the product and the organization . 
                  7.3.1.1   多方論證的方法 Multidisciplinary approach 
                       組織應采用多方論證的方法進行產品實現的準備工作,包括: 
                     —特殊特性的開發/最終確定和監視; 
                     —潛在失效模式及后果分析(FMEAs)的開發和評審,包括采取降低潛在風險的措施。 
                     — 控制計劃的開發和評審。 
                     注:多方論證方法通常包括組織的設計、制造、工程、質量、生產和其他適當的人員。 
                  The organization shall use a multidisciplinary approach to prepare for product realization, including 
                  ?  development/ finalization and monitoring of special characteristics, 
                  ?  development and review of FMEAs including actions to reduce potential risks, and 
                  ?  development and review of control plans. 
                  NOTE  A multidisciplinary approach typically includes the organization's design, manufacturing, engineering, quality, 
                  production and other appropriate personnel. 
                   
                  7.3.2   設計和開發的輸入  Design and development inputs    
                  ISO9001:2008   質量管理體系—要求 
                  ISO 9001:2008, Quality management systems  — Requirements 
                   
                  7.3.2    設計和開發的輸入 Design and development inputs  
                     應確定與產品要求有關的輸入,并保持記錄(4.2.4)。 
                  Inputs relating to product requirements shall be determined and records maintained (see 4.2.4). 
                       這些輸入應包括: 
                       a)   功能和性能要求; 
                       b)   適用的法律和法規要求; 
                       c) 適當時,以前類似設計提供的信息; 
                       d)   設計和開發所必需的其他要求。 
                  These inputs shall include 
                  a)   functional and performance requirements,  
                  b)   applicable statutory and regulatory requirements,  
                  c)   where  applicable, information derived from previous similar designs, and 
                  d)   other requirements essential for design and development. 
                  應對這些輸入的充分性與適宜性進行評審。要求應完整、清楚,并且不能自相矛盾。 
                  These inputs shall be reviewed for adequacy. Requirements shall be complete, unambiguous and not in conflict with each other. 
                  注:特殊特性(見7.2.1.1)包括在這此要求中。 
                  NOTE    Special characteristics (see 7.2.1.1) are included in this requirement. 
                   
                  7.3.2.1產品設計輸入  Product design input 
                       組織應識別產品設計輸入要求,形成文件并進行評審,包括: 
                    — 顧客要求(合同評審),如:特殊特性(見7.3.2.3)、標識、可追溯性和包裝; 
                    — 信息的使用:組織應有一個過程,將從以往設計項目、競爭對手分析、供方反饋、內部輸入、使用
                  現場數據及其它相關來源獲得的信息推廣應用于當前或未來有相似性質的項目。 
                    — 產品質量、壽命、可靠性、耐久性、可維修性、時間性和成本的目標。 
                  The organization shall identify, document and review the product design inputs requirements including  the following  
                  ?  customer requirements (contract review) such as special characteristics (see 7.3.2.3), identification, traceability 
                  and packaging;  
                  ?  use of information; the organization shall have a process to deploy information gained from previous design 
                  projects, competitor analysis, supplier feedback, in ternal input, field data, and other relevant sources, for 
                  current and future projects of a similar nature; 
                  ?  targets for product quality, life, reliability, durability, maintainability, timing      and cost.  
                  7.3.2.2制造過程設計輸入Manufacturing process design input 
                       組織應識別制造過程設計輸入的要求,形成文件并進行評審,包括: 
                       —產品設計輸出數據; 
                       —生產率、過程能力和成本的目標; 
                       —顧客要求,如果有,和: 
                  —以往的開發經驗。 
                  制造過程設計包括采用放錯方法,其程度與問題的重要性和所存在風險的程度相適應。 
                  The organization shall identify, document and review the manufacturing process design input requirements, including 
                  ?  product design output data, 
                  ?  targets for productivity, process capability and cost,  
                  ?  customers requirements, if any, and  
                  ?  experience from previous developments. 
                  NOTE  The manufacturing process design includes the use of   error- proofing methods to a degree appropriate to the magnitude of the problems and commensurate with the risks encountered.  
                  7.3.2.3   特殊特性Special characteristics  
                       組織應識別特殊特性(見 7.3.3d ),并且   
                       —在控制計劃中包含所有特殊特性;   
                       —與顧客規定的定義和符號相一致,和 
                       —識別過程控制文件,包括圖樣、FMEAs、控制計劃及作業指導書,它們都應標明顧客的特殊特性符
                  號或組織的等效符號或記號,以包括對特殊特性有影響的過程步驟。 
                       注:特殊特性可包括產品特性和過程參數。 
                  The organization shall identify special characteristics (see 7.3.3 d) and   
                  ?  include all special characteristics in the control plan,  
                  ?  comply with customer specified definitions and symbols, and  
                  ?  identify process control documents including drawings, FMEAs, control plans, and operator instructions with the 
                  customer’s special characteristic symbol or the organization’s equivalent symbol or notation to include those 
                  process steps that affect special characteristics. 
                  NOTE    Special characteristics can include product characteristics and process parameters. 
                   
                  7.3.3   設計和開發輸出      Design and development outputs 
                  ISO9001:2008   質量管理體系—要求 
                  ISO 9001:2008, Quality management systems  — Requirements 
                   
                  7.3.3   設計和開發輸出      Design and development outputs 
                        設計和開發的輸出應以能夠針對設計和開發的輸入進行驗證的方式提出,  并應在放行前得到批準。 
                       設計和開發輸出應: 
                       a)   滿足設計和開發輸入的要求; 
                       b)   給出采購、生產和服務提供的適當信息; 
                       c) 包含或引用產品接收準則; 
                       d)   規定對產品的安全和正常使用所必需的產品特性。 
                        注  :生產和服務提供的信息可能包括產品防護的細節。 
                  The outputs  of design and development shall be provided in a form that enables verification against the design and development input and shall be approved prior to release. 
                  The outputs of design and development shall be provided in a form that enables verification ag ainst the design and development input and shall be approved prior to release. 
                  Design and development outputs shall 
                  a) meet the input requirements for design and development 
                  b) provide appropriate information for purchasing, production and for service prov ision 
                  c) contain or reference product acceptance criteria, an d 
                  d) specify the characteristics of the product that are essential for its safe and proper use  
                  NOTE Information for production and service provision can include details for the preservation of pr oduct 
                  7.3.3.1   產品設計輸出—補充    Product design outputs -  Supplemental 
                       產品設計輸出應以能根據產品設計輸入的要求,進行驗證和確認的方式來表示。產品設計輸出應包括: 
                       —設計FMEA 、可靠性結果 
                       —產品特殊特性和規范 
                       —適當的產品防錯 
                       —產品定義,包括圖紙和數學數據; 
                       —產品設計評審結果,以及 
                       —在適用時的診斷指南。 
                  The product design output shall be expressed in terms that can be verified and validated against product design input requirements. The product design output shall include  
                  ?  design FMEA, reliability results,  
                  ?  product special characteristics, specifications, 
                  ?  product error -proofing, as appropriate,  
                  ?  pr oduct definition including drawings or mathematically based data,  
                  ?  product design reviews results, and  
                  ?  diagnostic guidelines,   where applicable.  
                  7.3.3.2   制造過程設計輸出    Manufacturing process design output 
                  制造過程設計輸出應以能夠對照制造過程設計輸入的要求進行驗證和確認的方式來表示。制造過程設
                  計輸出應包括: 
                  —規范和圖樣 
                  —制造過程流程圖/制造過程平面布置圖 
                   —制造過程 FMEAs 
                  —控制計劃 
                  —作業指導書(見 7.5.1.1) 
                  —過程批準接受準則 
                  —有關質量、可靠性、可維修性和可量測性的數據 
                  —適當時,防錯活動的結果,和 
                  —產品/制造過程不合格的快速探測和反饋方法。 
                  The manufacturing process design output shall be expressed in terms that can be verified against manufacturing process design input  requirements and validated. The manufacturing process design output shall include  
                  ?  specifications and drawings, 
                  ?  manufacturing process flow chart / layout, 
                  ?  manufacturing process FMEAs,  
                  ?  control plan ( see 7.5.1.1.),  
                  ?  work instructions,  
                  ?  process approval accep tance criteria, 
                  ?  data for quality, reliability, maintainability and measurability, 
                  ?  results of error -proofing activities, as appropriate, and  
                  ?  methods of rapid detection and feedback of product/manufacturing process nonconformities. 
                   
                  7.3.4   設計和開發評審     Design and development review 
                   
                  ISO9001:2008   質量管理體系—要求 
                  ISO 9001:2008, Quality management systems  — Requirements 
                   
                  7.3.4   設計和開發評審     Design and development review 
                       應依據所策劃的安排(見 7.3.1 )在適宜的階段對設計和開發進行系統的評審,以便: 
                  a)   評價設計和開發的結果滿足要求的能力; 
                  b)   識別任何問題并提出必要的措施。 
                  評審的參加者應包括與所評審的設計和開發階段有關的職能的代表。評審結果及任何必要措施的記錄
                  應予保持(見 4.2.4) 
                  At suitable stages, systematic reviews of design and development shall be performed in accordance with planned 
                  arrangements    (see 7.3.1 ) 
                  a)   to evaluate the ability of the results of design and development to fulfil requirements, an d 
                  b)   to identify any problems and propose necessary actions  
                  Participants in such reviews shall include representatives of functions concerned with the design and development 
                  stage(s) being reviewed. Records of the results of the reviews and any necessary actions shall be maintained (see 4.2.4). 
                  注:這些評審通常與設計階段相協調,包括制造過程設計和開發。 
                  NOTE    These reviews are normally coordinated with the design phases and include manufacturing process design 
                  and development.  
                  7.3.4.1    監視Monitoring 
                  應對設計和開發特定階段的測量加以規定、分析,并對匯總結果進行報告,作為管理評審的輸入。 
                  注:在適當的情況下,這些測量包括質量風險、成本、提前期、關鍵路徑和其它事項。 
                  Measurements at specified stages of design and development shall be defined, analysed and reported with summary results as an input to management review.  
                  NOTE    These measurements include quality  risks, costs, lead -times, critical paths and others, as appropriate.  
                   
                  7.3.5  設計和開發的驗證    Design and development verification 
                  ISO9001:2008   質量管理體系—要求 
                  ISO 9001:2008, Quality management systems  — Requirements 
                   
                  7.3.5設計和開發的驗證    Design and development verification 
                  為確保設計和開發輸出滿足輸入的要求,應依據所策劃的安排(見 7.3.1 )對設計和開發進行驗證。驗
                  證結果及任何必要措施的記錄應予保持(見 4.2.4)。 
                  Verification shall be performed in accordance with planned arrangements  (see 7.3.1 ) to ensure that the design and development outputs have satisfied the design and development input requirements. Records of the results of the verification and any necessary actions shall be maintained (see 4.2.4)  
                   
                  7.3.6   設計和開發確認     Design and development validation 
                  ISO9001:2008   質量管理體系—要求 
                  ISO 9001:2008, Quality management systems  — Requirements 
                   
                  7.3.6  設計和開發確認  Design and development validation 
                  為確保產品能夠滿足規定的使用要求或已知的預期用途的要求,應依據所策劃的安排(見 7.3.1 )對設
                  計和開發進行確認。只要可行,確認應在產品交付或實施之前完成。確認結果及任何必要措施的記錄應予
                  保持(見 4.2.4)。 
                  Design and development validation shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known. Wherever practicable, validation shall be completed prior to the delivery or implementation of the product. Records of the results of validation and any necessary actions shall be maintained (see 4.2.4).  
                  注1 :確認過程通常包括類似產品在使用現場報告的分析。 
                  注2 :上述要求7.3.5和7.3.6的要求適用于產品和制造過程。 
                  NOTE 1    The validation process normally includes an analysis of field reports for similar products. 
                  NOTE 2    The requirements of 7.3.5 and 7.3.6 above apply to both product and manufacturing processes.  
                  7.3.6.1   設計和開發確認—補充Design and development validation  –  Supplemental 
                  設計和開發確認應與顧客要求一致,包括項目時間。 
                  Design and development validation shall be performed in accordance with customer requirements including programme timing.  
                  7.3.6.2    樣件計劃  Prototype programme 
                  當顧客要求時,組織應制定樣件計劃和控制計劃。只要可能,組織就應使用與正式生產相同的供方、
                   工裝和制造過程。 
                  應監視所有的性能試驗活動,以便及時完成并符合要求。 
                  當這些服務被外包時,組織應對外包服務負責,包括提供技術指導。 
                  When required by the customer, the organization shall have a prototype programme and control plan. The organization shall use, wherever possible, the same suppliers, tooling and manufacturing processes as will be used in production.  
                  All performance-testing activities shall be monitored for timely completion and con form ity  to requirements. 
                  While services may be outsourced, the organization shall be responsible for the outsourced services, including technical leadership.  
                  7.3.6.3   產品批準過程    Product approval process 
                  組織應符合顧客認可的產品和制造過程的批準程序。 
                  注:產品批準應當在制造過程驗證之后進行。 
                  該產品和制造過程批準程序也應適用于供方。 
                  The organization shall conform to a product and process approval procedure recognized by the customer.  
                  NOTE    Product approval should be subsequent to the verification of the manufacturing process. 
                  This product and manufacturing process approval procedure shall also be applied to suppliers. 
                   
                  7.3.7    設計和開發變更的控制     Control of design and development changes 
                  ISO9001:2008   質量管理體系—要求 
                  ISO 9001:2008, Quality management systems  — Requirements   
                   
                  7.3.7設計和開發變更的控制    Control of design and development changes 
                  應識別設計和開發的更改,并保持記錄。在適當時,應對設計和開發的更改進行評審、驗證和確認,
                  并在實施前得到批準。設計和開發更改的評審應包括評價更改對產品組成部分和已交付產品的影響。 
                  更改評審結果及任何必要措施的記錄應予保持(見 4.2.4)。 
                  Design and development changes shall be identified and records maintained. The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and already delivered product. 
                  Records of the results of the review of changes and any necessary actions   shall be maintained (see 4.2.4).  
                  注:設計和開發的更改包括產品項目生命周期內的所有更改(見7.1.4)。 
                  NOTE    Design and development changes include all changes during the product programme life (see 7.1.4) 
                   
                  7.4   采購   Purchasing 
                  7.4.1   采購過程      Purchasing process  
                  ISO9001:2008   質量管理體系—要求 
                  ISO 9 001:2008, Quality management systems — Requirements 
                   
                  7.4    采購Purchasing  
                  7.4.1    采購過程Purchasing process  
                  組織應確保采購的產品符合規定的采購要求。對供方及采購的產品控制的類型和程度應取決于采購的
                  產品對隨后的產品實現或最終產品的影響。 
                  The organization shall ensure that purchased product conforms to specified purchase require ments. The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product.  
                  組織應根據供方按組織的要求提供產品的能力評價和選擇供方。應制定選擇、評價和重新評價的準則。
                  評價結果及評價所引起的任何必要措施的記錄應予保持(見 4.2.4) 
                  The organization shall evaluate and select suppliers based on their ability to supply products in accordance with the organization’s requirements. Criteria for selection, evaluation, and re -evaluation shall be established. Records   of the results of evaluations and any necessary actions arising from the evaluation shall be maintained (see 4.2.4)  
                  注1 :上述采購產品包括所有影響顧客要求的產品和服務,例如:分裝、排序、分選、返工和校準服務。 
                  注2 :當發生與供方相關的兼并、收購或從屬關系時,組織應當驗證供方質量管理體系的延續性和有效性。 
                  NOTE 1  Purchased products above include all   products and services that affect customer requirements such as 
                  sub -assembly, sequencing, sorting, rework and calibration services.  
                  NOTE 2    When there are mergers, acquisitions or affiliations associated with suppliers, the organization should verify the continuity of the supplier’s quality management system and its effectiveness.  
                  7.4.1.1   法規的符合性Regulatory conformity 
                  用于產品而采購的所有產品或材料應符合適用的法規要求。 
                  All purchased products or materials used in product shall conform to applicable regulatory requirements. 
                  7.4.1.2   供方質量管理體系的開發 Supplier quality management system development 
                  組織應以供方符合本技術規范為目的,進行供方質量管理體系的開發。符合 ISO9001 :2008 是達到這
                  一目的的第一步。 
                  The organization shall perform supplier quality management system development with the goal of supplier conformity with this Technical Speci fication.   Conformity with ISO 9001  : 2008   is the first step of achieving this goal.  
                  注:供方開發的優先順序由供方的質量績效和所供應產品的重要性決定。 
                       除非顧客另有規定,否則組織的供方應通過經認可的第三方認證機構的 ISO9001 :2008第三方認證。 
                  NOTE    The prioritization of suppliers for development depends upon, for example, the supplier’s quality performance and the importance of the product supplied. 
                  Unless otherwise specified by the customer, suppliers to the organization shall be third party registered to ISO 9001 :  2008 by an accredited third party certification body. 
                  7.4.1.3   顧客批準的供方 Customer-approved sources  
                       若合同(如顧客工程圖紙、規范)中有規定,組織應從經顧客批準的供方處采購產品、材料和服務。 
                  Where specified by the contract (e.g. customer engineering drawing, specification), the organization shall purchase products, materials or services from approved sources. 
                       采用顧客指定的供方(包括工裝和量具供方)并不免除組織確保采購的零件、材料和服務質量的責任。 
                  The use of customer-designated sources, including tool/gauge suppliers, does not relieve the organization of the 
                  responsibility for ensuring the quality of purchased    products. 

                  7.4.2   采購信息    Purchasing information  
                  ISO9001 :2008   質量管理體系—要求 
                  ISO 9001:2008, Quality management systems  — Requirements 
                   
                  7.4.2    采購信息Purchasing information 
                       采購信息應描述擬采購的產品,適當時包括: 
                       a)   產品、程序、過程和設備批準要求; 
                       b)   人員資格的要求; 
                       c) 質量管理體系的要求。 
                       在與供方溝通前,組織應確保規定的采購要求是充分與適宜的。 
                  Purchasing information shall describe the product to be purchased, including where appropriate 
                  a)   requirements for approval of product, procedures, processes and equipment  
                  b)   requirements for qualification of personnel, and 
                  c)   quality management system requirements 
                  The   organization shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier. 
                   
                  7.4.3   采購產品的驗證   Verification of purchased product 
                  ISO9001:2008   質量管理體系—要求 
                  ISO 9001:2008, Quality management systems  — Requirements 
                   
                  7 .4.3   采購產品的驗證 Verification of purchased product 
                       組織應確定并實施檢驗或其他必要的活動,以確保采購的產品滿足規定的采購要求。 
                       當組織或其顧客擬在供方的現場實施驗證時,組織應在采購信息中對擬驗證的安排和產品放行的方法
                  作出規定。 
                  The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements.   
                  Where the organization or its customer intends to perform verification at the supplier's premises, the organization shall state the intended verification arrangements and method of product release in the purchasing information.  
                  7.4.3.1  進貨產品對要求的符合性  Incoming product  conformity to requirement 
                       組織應有一過程來保證采購產品的質量(見 7.4.3),可以采用下面一種或多種方法: 
                       —組織收集統計數據,并對其進行評價; 
                       —接收檢驗和/或試驗,如基于績效的抽樣; 
                       —結合已交付產品對要求的符合性的可接受的記錄,由第二方或第三方機構對供方現場進行評估或審
                  核; 
                       —由指定的實驗室進行的零件評價; 
                       —顧客同意的其他方法。 
                  The organization shall have a process to assure the quality of purchased product (see 7.4.3) utilizing one or more of the following methods: 
                   ?  receipt of, and evaluation of, statistical data by the organization; 
                  ?  receiving inspection and/or testing such as sampling based on performance;  
                  ?  second or third party assessments or audits of supplier sites, when coupled with records of acceptable 
                  delivered product conformity the requirememnt.  
                  ?  part evaluation by a designated laboratory;  
                  ?  another method agreed with the customer.  
                  7.4.3.2對供方監視   Supplier monitoring 
                       應通過以下指標,對供方績效進行監視: 
                       —已交付產品對要求的符合性; 
                       —對顧客造成的干擾,包括市場的退貨; 
                       —按計劃交付的績效(包括發生的超額運費); 
                       —與質量或交付有關的特殊狀態顧客通知。 
                       組織應促進供方對其制造過程績效的監視。 
                  Supplier performance shall be monitored through the following  indicators  : 
                  ?  delivered product conformity the requirememnt , 
                  ?  customer disruptions including field returns, 
                  ?  delivery schedule performance (including incidents of premium freight), 
                  ?  special status customer notifications related to quality or delivery issues.  
                  The organization shall promote supplier monitoring of the performance of their manufacturing processes.  
                  7.5   生產和服務提供  Production and service provision 
                  7.5.1    生產和服務提供的控制    Control of production and service provision  
                  ISO9001:2008   質量管理體系—要求 
                  ISO 9001:2008, Qual ity management systems  — Requirements 
                   
                  7.5 生產和服務提供 Production and service provision 
                  7.5.1生產和服務提供的控制 Control of production and service provision  
                       組織應策劃并在受控條件下進行生產和服務提供。適用時,受控條件應包括: 
                     a)   獲得表述產品特性的信息; 
                     b)   必要時,獲得作業指導書; 
                     c) 使用適宜的設備; 
                     d)   獲得和使用監視和測量裝置; 
                     e)   實施監視和測量; 
                     f)   放行、交付和交付后活動的實施。 
                  The organization shall plan and carry out production and service provision under controlled conditions. Controlled 
                  conditions shall include, as applicable  
                  a)   the availability of information that describes the characteristics of the  product,  
                  b)   the availability of work instructions, as necessary,  
                  c)   the use of suitable equipment,  
                  d)   the availability and use of monitoring and measuring devices, 
                  e)   the implementation of monitoring and measurement, and 
                  f)   the implementation of release, delivery and po st -delivery activities.  
                  7.5.1.2   控制計劃  Control plan 
                  組織應: 
                  —針對所提供的產品在系統、子系統、部件和/或材料各層次上開發控制計劃(見附錄 A),包括散裝材
                  料及零件的生產過程,和 
                  —考慮了設計 FEMA 和制造過程 FEMA 輸出的試生產和生產控制計劃; 
                  控制計劃應: 
                  —列出用于制造過程控制的控制方法。 
                  —包括對由顧客和組織共同定義的特殊性控制(見 7.3.2.3)監視的方法; 
                  —若有,包括任何顧客要求的信息,以及 
                  —當過程變得不穩定或統計能力不足時,啟動規定的反應計劃(見 8.2.3.1)。 
                  The organization shall  
                  ?  develop control plans (see Annex A) at the system, subsystem, component and/or material level, for the 
                  product supplied, including those for processes producing bulk materials as well as parts, and 
                  ?  have a control plan for pre-launch and production that takes into account the design FMEA and manufacturing 
                  process FMEA outputs, 
                  The control plan shall   
                  ?  list the controls used for the manufacturing process control ,  
                  ?  include methods for monitoring of control exercised over special characteristics (see 7.3.2.3) defined by both 
                  the customer and the organization,  
                  ?  include the customer required information, if any, and  
                  ?  initiate the specified reaction plan (see 8.2.3.1) when the process becomes unstable or not statistically capable. 
                  當任何影響產品、制造過程、測量、物流、供應貨源或 FEMA (見 7.1.4)的更改發生時,應評審并更
                  新控制計劃。 
                  Control plans shall be reviewed and updated when any change occurs affecting product, manufacturing process, 
                  measurement, logistics, supply sources or FMEA (see 7.1.4).  
                  注:評審或更新后的控制計劃可能要有顧客批準。 
                  NOTE  Customer approval may be required after review or update of the control plan. 
                  7.5.1.2    作業指導書  Work instructions 
                       組織應為所有負責影響產品要求符合性的過程操作的人員提供文件化的作業指導書。這些指導書應在
                  工作崗位易于得到。 
                       這些指導書應來源于適當的文件,如質量計劃、控制計劃和產品實現過程。 
                  The organization shall prepare documented work instructions for all employees having responsibilities for the operation of processes that impact product conformity to requirement. These instructions shall be accessible for use at the work station. 
                  These instructions shall be derived from sources such as the quality plan, the control plan and the product realization process.  
                  7.5.1.3   作業準備的驗證  Verification of job set-ups  
                  無論何時進行作業準備,如作業的初次運行、材料的更換、作業更改,均應進行作業準備的驗證。作
                  業準備人員應能得到作業指導書。適用時,組織應使用統計方法進行驗證。 
                       注:推薦采用末件比較的方法。 
                  Job set-ups shall be verified whenever performed, such as an initial run of a job, material changeover, job change.   Work instructions shall be available for set -up personnel. The organization shall use statistical methods of verification where applicable.  
                  NOTE  Last-off-part comparisons are recommended. 
                  7.5.1.4   預防性和預見性維護   Preventive and predictive maintenance 
                  組織應標識關鍵過程設備,為機器/設備的維護提供資源,并建立有效的、有計劃的全面預防性維護系
                  統。這個系統至少應包括: 
                  —有計劃地維護活動 
                  —設備、工裝和量具的包裝和防護; 
                  —關鍵生產設備備件的可獲得性; 
                  —將維護目標形成文件并予以評價和改進 
                  組織應使用預見性維護方法,以持續改進生產設備的有效性和效率。 
                  The organization shall identify key process equipment and provide resources for machine/equipment maintenance and develop an effective planned total preventive maintenance system . As a minimum, this system shall include the following : 
                  ?  planned maintenance activities,  
                  ?  packaging and preservation of equipment, tooling and gauging,  
                  ?  availability of replacement parts for key manufacturing equipment, 
                  ?  documenting, evaluating and improving maintenance objectives. 
                  The organization shall utilize predictive maintenance methods to continually improve the effectiveness and the efficiency of production equipment.  
                  7.5.1.5   生產工裝的管理  Management of production tooling 
                       組織應為工裝和量具的設計、制造和驗證活動提供資源。 
                       組織應建立并實施生產工裝的管理系統,包括: 
                     —維護和修理的設施與人員; 
                     —貯存和修復; 
                     —工裝準備; 
                     —易損工具的更換計劃; 
                     —工裝設計的修改的文件,包括工程更改等級; 
                     —工裝的修改和文件的修訂; 
                     —工裝標識,明確其狀態,如在用、修理或廢棄。 
                     如果其中任何一項工作被外包,組織應實施監視這些活動的系統。 
                       注:該要求也適用于車輛服務零件的工裝。 
                  The organization shall provide resources for tool and gauge design, fabrication and verification activities. 
                  The organization shall establish and implement a system for production   tooling management  including :  
                  ?  maintenance and repair facilities and personnel, 
                  ?  storage and recovery,  
                  ?  set-up, 
                  ?  tool -change programmes for perishable tools, 
                   ?  tool design modification documentation, including engineering change level,  
                  ?  tool modification and re vision to documentation,  
                  ?  tool identification, defining the status, such as production, repair or disposal.  
                  The organization shall implement a system to monitor these activities if any work is outsourced. 
                  NOTE    This requirement also applies to the availability of tools for vehicle service parts. 
                  7.5.1.6     生產計劃  Production scheduling  
                  應有滿足顧客要求的生產計劃,如由信息系統支持的“準時”  計劃,該信息系統允許在過程的關鍵階
                  段獲得生產信息并且是訂單驅動的。 
                  Production shall be scheduled in order to meet customer requirements, such as just -in -time supported by an informati on system that permits access to production information at key stages of the process and is order drive 
                  7.5.1.7   服務信息反饋  Feedback of information from service 
                       應建立并保持與制造、工程和設計部門溝通服務問題的過程。 
                        注:將“服務問題”增加到本條款,其目的是為了保證組織了解其外部發生的不合格。 
                  A process for communication of information on service concerns to manufacturing, engineering and design activities shall be established and maintained.  
                  NOTE  The intent of the addition of "service concerns" to this clause is to ensure that the organization is aware of 
                  nonconformities that occur external to its organization.  
                  7.5.1.8與顧客的服務協議  Service agreement with customer  
                  當與顧客達成服務協議時,組織應驗證下列項目的有效性: 
                  —組織的任何一個服務中心 
                  —任何專用工具或測量設備,和 
                  —服務人員的培訓 
                  When there is a service agreement with the customer, the organization shall verify the effectiveness of  
                  ?  any organization service centres,  
                  ?  any special purpose tools or measurement equipment, and 
                  ?  the training of service personnel.  
                   
                  7.5.2  生產和服務提供過程的確認 Validation of processes for production and service provision 
                  ISO9001:2008   質量管理體系—要求 
                  ISO 9001:2008, Quality management systems  — Requirements 
                   
                  7.5.2生產和服務提供過程的確認  Validation of processes for production and service provision 
                       當生產和服務提供過程的輸出不能由后續的監視或測量加以驗證時,組織應對任何這樣的過程實施確
                  認。這包括僅在產品使用或服務已交付之后問題才顯現的過程。 
                  The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. as a consequence,   deficiencies become apparent only after the product is in use or the service has been delivered. 
                       確認應證實這些過程實現所策劃的結果的能力。 
                  Valida tion shall demonstrate the ability of these processes to achieve planned results. 
                       組織應規定確認這些過程的安排,適用時包括: 
                         a)   為過程的評審和批準所規定的準則; 
                         b)   設備的認可和人員資格的鑒定; 
                       c) 使用特定的方法和程序; 
                       d) 記錄的要求(見 4.2.4); 
                         e) 再確認。 
                  The organization shall establish arrangements for   these processes including, as applicable . 
                  a) defined criteria for review and approval of the processes , 
                  b) approval of equipment and qualification of personnel, 
                  c) use of specific methods and procedures , 
                  d) requirements for records (see 4.2.4), an d 
                  e) revalidation . 
                  7.5.2.1   生產和服務提供過程的確認——補充 
                  Validation of processes for production and service provision  –  Supplemental 
                       7.5.2的要求應適用于所有生產和服務提供過程。 
                  The requirements of 7.5.2 shall apply to all processes for production and service provision. 
                   
                  7.5.3    標識和可追溯性    Ide ntification and traceability 
                  ISO9001:2008   質量管理體系—要求 
                  ISO 9001:2008, Quality management systems  — Requirements 
                      
                  7.5.3  標識和可追溯性 Identification and traceability  
                  適當時,組織應在產品實現的全過程中使用適宜的方法識別產品。 
                  組織應針對監視和測量要求識別產品的狀態。 
                  在有可追溯性要求時,組織應控制和記錄產品的唯一標識,并保持紀錄(見 4.2.4) 
                  注:在某些行業,技術狀態管理是保持標識和可追溯性的一種方法。 
                  Where appropriate, the organization shall identify the product by suitable means throughout product realization. 
                  The organization shall identify the product status with respect to monitoring and measurement requirements.  
                  Where traceability is a requirement, the organization shall control  the unique identification of the product and maintain records (see 4.2.4).    
                  NOTE In some industry sectors, configuration management is a means by which identification and traceability are 
                  maintained. 
                  注:在生產流程中產品所處的位置并不能表明其檢驗、試驗狀態,除非產品本身狀態明顯,如:自動化生產流程過程中
                  的材料。如果狀態能清楚的識別、形成了文件且達到了預定的目標,也可以采用替代的方法。 
                  NOTE  Inspection and test status is not indicated by the location of product in the production flow unless inherently obvious,  such as material in an automated production transfer process. Alternatives are permitted, if the status is clearly identified, documented, and achieves the designated purpose.  
                  7.5.3.1標識和可追溯性——補充  Identification and traceability  -  Supplemental 
                       以上7.5.3中的“適當時”不適用。 
                  The words "Where appropriate" in 7.5.3 above, shall not apply.  
                   7.5.4  顧客財產    Customer property 
                  ISO9001:2008   質量管理體系—要求 
                  ISO 9001:2008, Quality management systems  — Requirements 
                   
                         組織應愛護在組織控制下或組織使用的顧客財產。組織應識別、驗證、保護和維護供其使用或構成產
                  品一部分的顧客財產。若顧客財產發生丟失、損壞或發現不適用的情況時,應報告顧客,并保持記錄(見
                  4.2.4)。 
                  The   organization shall exercise care with customer property while it is under the organization's control or being used by the organization. The organization shall identify, verify, protect and safeguard customer property provided for use or incorporation into   the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use, this shall be reported to the customer and records maintained (see 4.2.4).  
                       注:顧客財產可包括知識產權和個人信息。 
                  NOTE Customer property can include intellectual property  and personal data.. 
                       注:這個條款包括顧客所有的可重復使用的包裝。 
                       NOTE  Customer-owned returnable packaging is included in this  sub clause. 
                  7.5.4.1顧客所有的生產工裝  Customer-owned production tooling 
                  顧客所有的工具以及制造、試驗、檢驗的工裝和設備應予以永久性標識,以使每一工裝設備的權屬關
                  系清晰可見并可以確定。 
                  Customer-owned tools, manufacturing, test, inspection tooling and equipment shall be permanently marked so that the ownership of each item is visible, and can be determined. 
                   
                  7.5.5   產品防護     Preservation of product 
                  ISO9001:2008   質量管理體系—要求 
                  ISO 9001:2008, Quality management systems  — Requirements 
                  在內部處理和交付到預定的地點期間,組織應針對產品的符合性提供防護,這種防護應包括標識、搬
                  運、包裝、貯存和保護。防護也應適用于產品的組成部分。 
                  The organization shall preserve the conformity of product during internal processing and delivery to the intended 
                  destination   in  order to maintain conformity to requirements. As applicable,  preservation shall include identification, handling, packaging, storage and protection. Preservation shall also apply to the constituent parts of a product.  
                   
                  7.5.5.1 貯存和庫存 Storage and inventory  
                  應按策劃的適宜的時間間隔檢查庫存品狀況,以便及時發現變質情況。 
                  組織應使用一種庫存管理系統,以優化庫存周轉期,確保貨物周轉,如“ 先進先出(FIFO)” 。應以對
                  待不合格品的類似方法控制過期產品。 
                  In order to detect deterioration, the condition of product in stock shall be assessed at appropriate planned intervals.  
                  The organization shall use an inventory management system to optimize inventory turns over time and assure stock rotation, such as "first-in -first -out" (FIFO). Obsolete product shall be controlled in a similar manner to nonconforming product.  

                  7.6  監控和測量設備的控制     Control of monitoring and measuring  equipment  
                  ISO9001:2008   質量管理體系—要求 
                  ISO 9001:2008, Quality management systems  — Requirements 
                   
                  7.6  監控和測量設備的控制     Control of monitoring and measuring equipment 
                     組織應確定需實施的監視和測量以及所需的監視和測量裝置,為產品符合確定的要求(見7.2.1 )提供證
                  據。 
                  The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring equipment   needed to provide evidence of conformity of product to determined requirements (see 7.2.1).  
                       組織應建立過程,以確保監視和測量活動可行并以與監視和測量的要求相一致的方式實施。 
                  The organization shall establish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements. 
                       當有必要確保結果有效的場合時,測量設備應: 
                       a)   對照能溯源到國際或國家標準的測量標準,按照規定的時間間隔或在使用前進行校準或檢定。當不
                  存在上述標準時,應記錄校準或檢定的依據; 
                       b)   必要時進行調整或再調整; 
                       c)  得到識別,以確定其校準狀態; 
                       d)   防止可能使測量結果失效的調整; 
                       e)   在搬運、維護和貯存期間防止損壞或失效。 
                  Where necessary to ensure valid results, measuring equipment shall 
                  a)   be calibrated or verified ,  or both,  at specified intervals, or prior to use, against measurement standards traceable to international or   national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded(see 4.2.4); ; 
                  b)   be adjusted or re-adjusted as necessary; 
                  c)   have identification on order to determine its calibration status . 
                  d)   be safeguarded from adjustments that would invalidate the measurement result; 
                  e)   be protected from damage and deterioration during handling, maintenance and storage.  
                       此外,當發現設備不符合要求時,組織應對以往測量結果的有效性進行評價和記錄。組織應對該設備
                  和任何受影響的產品采取適當的措施。校準和驗證結果的記錄應予保持(見 4.2.4)。 
                       當計算機軟件用于規定要求的監視和測量時,應確認其滿足預期用途的能力。確認應在初次使用前進
                  行,并在必要時予以重新確認。 
                          注:確認計算機軟件滿足預期用途能力的典型方法包括驗證和保持其適用性的配置管理.  
                  In addition, the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. The organization shall take appropriate action on the equipment and any product affected.  
                  Records of the results of calibration and verification shall be maintained (see 4.2.4).  
                  When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application shall be confirmed. This shall be undertaken prior to initial use and reconfirmed as necessary.  NOTE Confirmation of the ability of computer software to satisfy the intended application would   typically include its verification   and configuration management to maintain its suitability for use. 
                       注:可追溯到設備校準記錄的編號或其他標識滿足本要求c )的意圖。 
                  NOTE    A number or other identifier traceable to the device calibration record meets the intent of requirement c) above. 
                  7.6.1   測量系統分析Measurement system analysis 
                       為分析各種測量和試驗設備系統得出的結果中出現的變差,應進行統計研究。此要求應適用于控制計
                  劃中提及的測量系統。所用的分析方法及接受準則應符合顧客關于測量系統分析的參考手冊的要求。如果
                  得到顧客的批準,也可使用其他分析方法和接受準則。 
                  Statistical studies shall be conducted to analyse the variation present in the results of each  type of measuring and test equipment system. This requirement shall apply to measurement systems referenced in the control plan. The analytical methods and acceptance criteria used shall conform to those in customer reference manuals on measurement systems analysis. Other analytical methods and acceptance criteria may be used if approved by the customer.  
                  7.6.2   校準/驗證記錄Calibration/verification record s 
                       對所有量具、測量和試驗設備,包括員工和顧客所有的設備,都應提供校準/驗證活動記錄,用以提供
                  符合確定的產品要求的證據。記錄應包括: 
                       —設備標識,包括校準設備所依據的測量標準; 
                       —由工程更改所引發的修訂; 
                       —在校準/驗證時獲得的任何超出規范的讀數; 
                       —超出規范條件下影響的評估; 
                       —在校準/驗證后,有關符合規范的說明; 
                       —在可疑產品或材料已發運的情況下,給顧客的通知。 
                  Records of the calibration/verification activity for all gauges, measuring and test equipment, needed to provide evidence of conformity of product to determined requirements, including employee -  and customer-owned equipment, shall include  
                  ?  equipment identification, including the measurement standard against which the equipment is calibrated, 
                  ?  revisions following engineering changes,  
                  ?  any out-of -specificatio n readings as received for calibration/verification,  
                  ?  an assessment of the impact of out-of -specification condition, 
                  ?  statements of conformance to specification after calibration/verification, and 
                  ?  notification to the customer if suspect product or material h as been shipped.  
                  7.6.3   試驗室要求  Laboratory requirements  
                  7.6.3.1   內部實驗室  Internal laboratory 
                  組織的內部實驗室設施應有一個確定的范圍,包括進行要求的檢驗、試驗或校準服務的能力。實驗室
                  范圍應包括在質量管理體系文件中。實驗室至少應規定并實施以下方面的技術要求: 
                  — 實驗室程序的充分性 
                  — 實驗室人員的能力 
                  — 產品試驗 
                  — 正確的進行這些服務,可追溯到相關的過程標準(如 ASTM ,EN等)的能力,以及 
                  — 對相關記錄的評審。 
                       注:通過ISO /IEC 17025資格認可可以證明組織內部實驗室符合這一要求,但不是強制的。 
                  An organization’s internal laboratory facility shall have a defined scope that includes its capability to perform the required inspection, test or calibration services. This laboratory scope shall be included in the quality management system documentation. The laboratory shall specify and implement , as a minimum, technical requirements for   
                  ?  adequacy of the laboratory procedures, 
                  ?  competency of the laboratory personnel,  
                  ?  testing of the product ,  
                  ?  capability to perform th ese services correctly, traceable to the relevant proc ess standard (such as ASTM, 
                  EN,etc. ), and    
                  ?  review of the related records.  
                  NOTE    Accreditation to ISO/IEC 17025 may be used to demonstrate supplier in-house laboratory conformity to this requirement but is not mandatory.  
                  7.6.3.2   外部實驗室  External laboratory 
                  組織用于檢驗、試驗或校準服務的外部/商業/獨立的實驗室設施應有一個確定的范圍,包括進行要求的
                  檢驗、試驗或校準服務的能力,并且: 
                  — 應有證據表明外部實驗室對顧客是可接受的,或 
                  — 實驗室應通過 ISO/IEC17025 或同等的國家標準的認可 
                  External/commercial/independent laboratory facilities used for inspection, test or calibration services by the organization shall have a defined laboratory scope that includes the capability to perform the required inspection, test or calibration, and either 
                  ?  there shall be evidence that the external laboratory is acceptable to the customer,  or  
                  ?  the laboratory shall be accredited to ISO/IEC 17025 or national equivalent.  
                       注1 :顧客的評定或顧客批準的第二方評定等方式可作為證明實驗室滿足 ISO/IEC17025 標準或相應國家標準意圖的證
                  據。 
                       注2 :對于某一設備,黨沒有具有資格的實驗室時,校準服務可以由原設備制造廠家進行。這種情況下,組織應當確保
                  上述7.6.3.1要求已得到滿足。 
                  NOTE 1  Such evidence may be demonstrated by customer assessment, for example, or by customer  -a pproved 
                  secondparty assessment that the laboratory meets the intent of ISO/IEC   17025 or national equivalent.  
                  NOTE 2  When a qualified laboratory is not available for a given piece of equipment, calibration services may be 
                  performed by the equipment manufacturer. In such cases, the organization should ensure that the requirements listed in 
                  7.6.3.1 have been met. 
                   
                  8  測量、分析和改進 Measurement, analysis and improvement   
                  8.1   總則   General 
                  ISO9001:2008   質量管理體系—要求 
                  ISO 9001:2008, Quality management systems  — Requirements 
                  8 .  測量、分析和改進  Measurement, analysis and improvement 
                  8.1 總則  General 
                       組織應策劃并實施以下方面所需的監視、測量、分析和改進過程: 
                    a)   證實產品的符合性; 
                       b)   確保質量管理體系的符合性; 
                       c) 持續改進質量管理體系的有效性。 
                       這應包括對統計技術在內的適用方法及其應用程度的確定。 
                  The organization shall plan and implement the monitoring, measurement, analysis and improvement processes needed  
                  a)   to demonstrate conformity of the product   requirements, 
                  b)   to ensure conformity of the quality management system, and  
                  c)   to continually improve the effectiveness of the quality management system  
                  This shall include determination of applicable methods, including statistical techniques, and the extent of their use. 
                  8.1.1   統計工具的確定    Identification of statistical tools  
                       在質量先期策劃中應確定每一過程適用的統計工具,并應包括在控制計劃中。 
                  Appropri ate statistical tools for each process shall be determined during advance quality planning and included in the control plan. 
                  8.1.2   基礎統計概念知識  Knowledge of basic statistical concepts 
                       整個組織應了解和使用基本的統計概念,如變差、控制(穩定性)、過程能力和過度調整。 
                  Basic statistical concepts, su ch as variation, control (stability), process capability and over-adjustment shall be understood and utilized throughout the organization.  
                   
                  8.2  監視和測量 Monitoring and measurement  
                  8.2.1  顧客滿意   Customer satisfaction 
                  ISO9001:2008   質量管理體系—要求 
                  ISO 9001:2008, Quality   management systems — Requirements 
                   
                  8.2  監視和測量   Monitoring and measurement  
                  8.2.1  顧客滿意Customer satisfaction 
                    作為對質量管理體系業績的一種測量,組織應監視顧客關于組織是否滿足其要求的感受的相關信息,
                  并確定獲取和利用這種信息的方法。 
                     注:監視顧客感受可以包括從諸如顧客滿意度調查、來自顧客關于已交付產品質量方面數據、用戶意見調查、流失業務
                  分析、顧客贊揚、索賠和經銷商報告之類的來源活的輸入。 
                  As one of the measurements of the performance of the quality management system, the organization shall monitor information relating to customer perception as to whether the organization has met customer requirements. The methods for obtaining and using this information shall be determined.  
                  NOTE Monitoring customer perception can include obtaining input from sources such as customer satisfaction surveys, customer data on delivered product quality, user opinion surveys, lost business analysis, compliments, warranty c laims and   dealer reports. 
                       注:對內部和外部顧客均應當加以考慮。 
                  NOTE    Consideration should be given to both internal and external customers. 
                  8.2.1.1     顧客滿意—補充 Customer satisfaction  -  Supplemental 
                       顧客對組織的滿意應通過對(產品)實現過程績效的持續評價進行監視。績效指標應基于客觀數據,
                  包括但不限于: 
                       —交付零件的質量績效; 
                       — 對顧客造成的干擾,包括外部退貨; 
                       —按計劃交付的績效(包括超額運費的情況);以及 
                       —與質量或交付問題有關的顧客通知。 
                       組織應監視制造過程的績效以證明符合顧客對產品質量和過程效率的要求。 
                  Customer satisfaction with the organization shall be monitored through continual evaluation of performance of the 
                  realization processes. Performance  indicators shall be based on objective data and include, but not be limited to  : 
                  ?  delivered part quality performance, 
                  ?  customer disruptions including field returns, 
                  ?  delivery schedule performance (including incidents of premium freight),and  
                  ?  customer notifications related to quality or delivery issues.  
                  The organization shall monitor the performance of manufacturing processes to demonstrate compliance with customer requirements for product quality and efficiency of the process.   
                   
                  8.2.2    內部審核  I nternal audit 
                  ISO90 01:2008   質量管理體系—要求 
                  ISO 9001:2008, Quality management systems  — Requirements 
                   
                  8.2.2  內部審核Internal audit  
                  組織應按策劃的時間間隔進行內部審核,以確定質量管理體系是否: 
                  a)   符合策劃的安排(見 7.1)、本標準的要求以及組織所確定的質量管理體系的要求; 
                  b)   得到有效實施與保持。 
                  The organization shall conduct internal audits at planned intervals  to determine whether the quality management system  
                  a)   conforms to the planned arrangements (see 7.1), to the requirements of this International Standard and to the quality management system requirements established by the organization, and 
                  b)   is effectively imp lemented and maintained.  
                       組織應策劃審核方案,策劃時應考慮擬審核的過程和區域的狀況和重要性以及以往審核的結果,應規
                  定審核的準則、范圍、頻次和方法。審核員的選擇和審核的實施應確保審核過程的客觀性和公正性。審核
                  員不應審核自己的工作。 
                  An audit program shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods shall be defined. 
                  Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall no t audit their own  work. 
                         策劃和實施審核以及報告結果和保持記錄(見 4.2.4)的職責和要求應在形成文件的程序中作出規定。 
                  負責受審區域的管理者應確保及時采取必要的糾正和糾正措施,以消除所發現的不合格及其原因。跟
                  蹤活動應包括對所采取措施的驗證和驗證結果的報告(見 8.5.2 ) 
                  注:作為指南,參見GB/T19011  
                  A documented procedure shall be established to define the responsibilities and requirements for plann ing and conducting audits, establishing records and reporting results.  
                  Records of the audits and their results shall be maintained (see 4.2.4). 
                  The management responsible for the area being audited shall ensure that any necessary corrections and corrective actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up activities shall include the verification of the actions taken and the reporting of verification results (see 8.5.2).  
                  NOTE See ISO 19011 for guidance.  
                  8.2.2.1  質量管理體系審核 Quality management system audit 
                  組織應審核質量管理體系,以驗證與本技術規范和任何附加的質量管理體系要求的符合性。 
                  The organization shall audit its quality management system to verify compliance with this Technical Specification and any additional quality management system requirements. 
                  8.2.2.2   制造過程審核 Manufacturing process audit 
                  組織應對每一個制造過程進行審核以確定其有效性。 
                  The organization shall audit each manufacturing process to determine its effectiveness. 
                  8.2.2.3   產品審核Product audit  
                  組織應以確定的頻次,在生產和交付的適當階段對產品進行審核,以驗證符合所有規定的要求,如產
                  品的尺寸、功能、包裝和標簽等。 
                  The organization shall audit products at appropriate stages of production and delivery to verify conformance to all specified requirements, such as product dimensions, functionality, packaging, labelling, at a defined frequency.  
                  8.2.2.4   內部審核計劃Internal audit plan s 
                  內部審核應覆蓋所有與質量管理有關的過程、活動和班次,且應按年度計劃進行日程安排。 
                  當內部/外部不符合或顧客抱怨發生時,應適當增加審核頻次。 
                       注:每類審核應該使用規定的檢查表。 
                  Internal audits shall cover all quality management related processes, activities and shifts, and shall be scheduled 
                  according to an annual plan. 
                  When internal/external nonconformities or customer complaints occur, the audit frequency shall be appropriately 
                  increased.  
                  NOTE    Specific checklists should be used for each audit. 
                  8.2.2.5   內部審核員資格 Internal auditor qualification 
                  組織應具有有資格審核本技術規范要求的內部審核員(見 6.2.2.2)。 
                  The organization shall have internal auditors who are qualified to audit the requirements of  this Technical 
                  Specification( see 6.2.2.2).  
                   
                  8.2.3   過程的監視和測量    Monitoring and measurement of processes  
                  ISO9001:2008   質量管理體系—要求 
                  ISO 9001:2008, Quality management systems  — Requirements  
                   組織應采用適宜的方法對質量管理體系過程進行監視,并在適用時進行測量。這些方法應證實過程實
                  現所策劃的結果的能力。當未能達到所策劃的結果時,應采取適當的糾正和糾正措施,以確保產品的符合
                  性。 
                  The organization shall apply suitable methods for monitoring and, where applicable, measurement of the quality 
                  management system processes. These methods  shall demonstrate the ability of the processes to achieve planned results. 
                  When planned results are not achieved, correction and corrective action shall be taken, as appropriate.  
                  NOTE When determining suitable methods, it is advisable that the organization consider the type and extent of monitoring or   measurement appropriate to each of its processes in relation to their impact on the conformity to product requirements and on  the effectiveness of the quality management system. 
                  8.2.3.1制造過程的監視和測量 Monitoring and measurement of manufacturing processes 
                       組織應對所有新的制造過程(包括裝配和定序)進行過程研究,以驗證其過程能力并為過程控制提供
                  附加的輸入。過程研究的結果應形成文件,適用時,包括生產、測量和試驗方法的規范及維護指導書等。
                  這些文件應包括制造過程能力、可靠性、可維修性和可用性的目標及其接受準則。 
                  The organization shall perform process studies on all new manufacturing (including assembly or sequencing) processes to verify process capability and to provide additional input for process control. The results of process studies shall be documented with specifications, where applicable, for means of production, measurement and test, and maintenance instructions. These documents shall include objectives for manufacturing process capability, reliability, maintainability and availability, as well as acceptance criteria. 
                       組織應保持顧客生產件批準要求中規定的制造過程能力或性能。組織應確保實施控制計劃和過程流程
                  圖,包括符合規定的: 
                  ——測量技術 
                  ——抽樣計劃 
                  ——接收標準,和 
                  ——當未滿足接收準則時的反應計劃 
                       The organization shall maintain manufacturing process capability or performance as specified by the customer part approval process requirements. The organization shall ensure that the control plan and process flow diagram are implemented, including adherence to the specified 
                  ?  measurement techniques, 
                  ?  sampling plans,  
                  ?  acceptance criteria, and  
                  ?  reaction plans when acceptance criteria are not met. 
                       應記錄重要的過程事件,如更換工裝或修理機器等。 
                       組織應對統計能力不足或不穩定的特性啟動控制計劃中的反應計劃。適當時,反應計劃應包括對產品
                  的遏制和 100%檢驗。為保證過程變得穩定和有能力,組織隨后應完成明確進度和責任要求的糾正措施計劃。
                  要求時,此計劃應與顧客共同評審并經顧客批準。 
                       組織應保存過程更改生效日期的記錄。 
                  Significant process events  , such as tool change or machine repair ,  shall be recorded.  
                   The organization shall initiate a reaction plan from the control plan for characteristics that are either not statistically capable or are unstable.   These reaction plans shall include containment of product and 100% inspection as appropriate. A corrective action plan shall then be completed by the organization, indicating specific timing and assigned responsibilities to assure that the process becomes stable and capable. The plans shall be reviewed with and approved by the customer when so required.  
                  The organization shall maintain records of effective dates of process changes. 
                  8.2.4  產品的監視和測量     Monitoring and measurement of product 
                  ISO9001:2008   質量管理體系—要求 
                  ISO 9001:2008, Quality management systems  — Requirements 
                   
                  8.2.4  產品的監視和測量 Monitoring and measurement of product 
                       組織應對產品的特性進行監視和測量,以驗證產品要求已得到滿足。這種監視和測量應依據所策劃的
                  安排(見 7.1),在產品實現過程的適當階段進行。 
                       應保持符合接收準則的證據。記錄應指明有權放行產品的人員(見 4.2.4) 
                         除非得到有關授權人員的批準,適用時得到顧客的批準,否則在策劃的安排(見7.1)已圓滿完成之前,
                  不能放行產品和交付服務。 
                  The organization shall monitor and measure the characteristics of the product to verify that product requirements have been met. This shall be carried out at appropriate stages of the product realization process in accordance with the planned arrangements (see 7.1).  
                  Evidence of conformity with the acceptance criteria shall be maintained.   
                  Records shall indicate the person(s) authorizing release of product for deli very to the customer  (see 4.2.4). 
                  The release of  Product  and delivery of  service  shall not proceed until all the planned arrangements (see 7.1) have been satisfactorily completed, unless otherwise approved by a relevant authority, and where applicable by the customer. 
                       注:當選擇產品參數以監視與規定的內部和外部要求的符合性時,組織確定產品特性的類型,并得出: 
                       —測量的類型; 
                       —適當地測量方法,和 
                       —要求的能力和技術。 
                  NOTE    When selecting product parameters to monitor compliance to specified internal and external requirements, the 
                  organization determines the types of product characteristics, leading to 
                  ?  the types of measurement,  
                  ?  suitable measurement means, and 
                  ?  the capability and skills required.  
                  8.2.4.1   全尺寸檢驗和功能試驗 Layout inspection and functional testing 
                       應根據適用的顧客工程材料及性能標準,按控制計劃的規定,對每一種產品進行全尺寸檢驗和功能驗
                  證。其結果應可供顧客評審。 
                       注:全尺寸檢驗是對設計記錄上顯示的所有產品尺寸進行完整的測量。 
                  A layout inspection and a functional verification to applicable customer engineering material and performance standards shall be performed for each product as specified in the control plans. Results shall be available for customer review. 
                  NOTE    Layout inspection is a complete measurement of all product dimensions shown on the design records.  

                  8.2.4.2   外觀項目Appearance items 
                       若組織生產的零件被顧客指定為“外觀項目”,則組織應提供: 
                       — 適當的資源,包括評價用的照明; 
                       —適當時,顏色、紋理、光澤、金屬亮度、結構、鮮映度(DOI )的標準樣品; 
                       —外觀標準樣品及評價設備的維護和控制; 
                       —對從事外觀評價人員的能力和資格的驗證。 
                  For organizations manufacturing parts designated by the customer as "appearance items", the organization shall provide 
                  ?  appropriate resources including lighting for evaluation,  
                  ?  masters for colour, grain, gloss, metallic brilliance, texture, distinctness of image (DOI) as appropriate, 
                  ?  maintenance and control of appearance masters and evaluation equipment, and 
                  ?  verification that personnel making appearance evaluations are competent and qualified to do so.  
                   
                  8.3   不合格產品的控制    Control of nonconforming product  
                  ISO9001:2008   質量管理體系—要求 
                  ISO 9001:2008, Quality management systems  — Requirements 
                   
                  8.3 不合格產品的控制 Control of nonconforming product  
                       組織應確保不符合產品要求的產品得到識別和控制,以防止其非預期的使用或交付。不合格品控制以
                  及不合格品處置的有關職責和權限應在形成文件的程序中作出規定。 
                  The organization shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. A documented procedure shall be established to define the controls and related responsibilities and authorities   for dealing with nonconforming product   
                  Where applicable, the organization shall deal with nonconforming product by one or more of the following ways: 
                     組織應通過下列一種或幾種途徑,處置不合格品: 
                       a)   采取措施,消除發現的不合格; 
                       b)   經有關授權人員批準,適用時經顧客批準,讓步使用、放行或接收不合格品; 
                       c) 采取措施,防止其原預期的使用或應用。 
                       d)當在交付或開始使用后發現產品不合格時,組織應采取與不合格的影響或潛在影響的程度相適應的
                  措施。 
                  The organization shall deal with nonconforming product by one or more of the following ways: 
                  a)   by taking action to eliminate the detected nonconformity;  
                  b)   by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer; 
                  c)   by taking action to preclude its original intended use or application. 
                  d) by taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming   product is detected after delivery or use has started. 
                  When nonconforming product is corrected it shall be subject to re-verification to demonstrate conformity to 
                  therequirements.  
                       應保持不合格的性質以及隨后所采取的任何措施的記錄,包括所批準的讓步的記錄(見 4.2.4)。 
                      應對糾正后的產品再次進行驗證,以證實符合要求。 
                  Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, shall be maintained (see 4.2.4). 
                  8.3.1  不合格品的控制——補充Control of nonconforming product –  Supplemental 
                       狀態未經標識或可疑的產品,應歸類為不合格品(見 7.5.3)。 
                  Product with unidentified or suspect status shall be classified as nonconforming product (see 7.5.3). 
                  8.3.2   返工產品的控制  Control of reworked product 
                       返工指導書,包括重新檢驗要求,應易于被適當的人員得到并使用。 
                  Instructions for rework, including re -inspection requirements, shall be accessible to and utilized by the appropriate 
                  personnel.  
                  8.3.3   顧客通知Customer information 
                       一旦發生不合格品被發運,應立即通知顧客。 
                  Customers shall be informed promptly in the event that nonconforming product has been shipped. 
                  8.3.4     顧客特許Customer waiver 
                  無論何時,只要產品或制造過程與當前的批準不同,在繼續生產之前,組織應獲得顧客的讓步或偏離
                  許可。 
                  組織應保持授權的有效期限或數量方面的記錄。當授權期滿時,組織還應確保符合原有的或替代的規
                  范和要求。被授權的材料裝運時,應在每一集裝箱上作適當的標識。 
                       此規定同樣適用于采購產品。在提交給顧客前,組織應與供方就其提出的任何要求達成一致。 
                  The organization shall obtain customer concession or deviation permit prior to further processing whenever the  product or manufacturing process is different from that which is currently approved.  
                  The organization shall maintain a record of the expiration date or quantity authorized. The organization shall also ensure compliance with the original or superseding specifications and requirements when the authorization expires. Material shipped on an authorization shall be properly identified on each shipping container.  
                  This applies equally to purchased product. The organization shall agree with any requests from suppliers before 
                  submission to the customer. 
                  8.4    數據分析  Analysis of data 
                  ISO9001:2008   質量管理體系—要求 
                  ISO 9001:2008, Quality management systems  — Requirements 
                   
                  8.4 數據分析Analysis of data 
                     組織應確定、收集和分析適當的數據,以證實質量管理體系的適宜性和有效性,并評價在何處可以持續
                  改進質量管理體系的有效性。這應包括來自監視和測量的結果以及其他有關來源的數據。 
                       數據分析應提供有關以下方面的信息: 
                    a)   顧客滿意(見 8.2.1); 
                    b)   與產品要求的符合性(見 7.2.1); 
                    c)  過程和產品的特性及趨勢,包括采取預防措施的機會; 
                    d)   供方。 
                  The organization shall determine, collect and analyse appropriate data to demonstrate the suitability and effectiveness of the quality management system  and to evaluate where continual improvement of the effectiveness of the quality management system can be made. This shall include data generated as a result of monitoring and measurement and from  other relevant sources. 
                  The analysis of data shall provide information relating to  
                  a)   customer satisfaction (see 8.2.1) 
                  b)   conformity to product requirements (see 8.2.4) 
                  c)   characteristics and trends of processes and products including opportunities for preventive action   (see 8.2.3 and 8.2.4), , and 
                  d)   suppliers.  (see 7.4). 
                   
                  8 .4.1  數據的分析和使用 Analysis and use of data  
                  質量和運行績效的趨勢應與實現目標的進展進行比較,并形成措施以支持: 
                  a)   確定迅速解決與顧客相關問題的優先順序; 
                  b)   確定與顧客相關的關鍵趨勢和相相互關系以支持狀況評審、決策和長期策劃; 
                  c) 及時報告產品使用信息的信息系統; 
                  注:應當將數據與競爭對手和/ 或適用的基準加以比較。 
                  Trends in quality and operational performance shall be compared with progress  toward objectives and lead to action to support the following :  
                  -  development of priorities for prompt solutions to customer-related problems,  
                  -  determination of key customer-related trends and correlation for status review, decision making and longer term 
                  planning, 
                  -  an information system for the timely reporting of product information arising from usage.  
                  NOTE    Data should be compared with those of competitors and/or appropriate benchmarks. 
                   
                  8.5   改進Improvement  
                  8.5.1     持續改進    Continual improvement 
                  ISO9001:2008    質量管理體系—要求 
                  ISO 9001:2008, Quality management systems  — Requirements 
                   
                  8.5 改進Improvement  
                  8.5 1持續改進Continual improvement 
                  組織應利用質量方針、質量目標、審核結果、數據分析、糾正和預防措施以及管理評審,持續改進質
                  量管理體系的有效性。 
                  The organization shall continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.  
                  8.5.1.1   組織的持續改進 Continual improvement of the organization 
                  組織應確定一個持續改進的過程 
                  The organization shall d efine a process for continual improvement . 
                  8.5.1.2      制造過程的改進 Manufacturing process improvement 
                       制造過改進應持續地關注于產品特性及制造過程參數變差的控制和減少。 
                  注1 :在控制計劃中將受控特性形成文件。 
                  注2 :持續改進是當制造過程有能力且穩定或當產品特性可預測并滿足顧客要求時實施的。 
                  Manufacturing process improvement shall continually focus upon  control and reduction of variation in products 
                  characteristics and manufacturing process parameters. 
                  NOTE 1    Controlled characteristics are documented in the control plan.  
                   NOTE 2    Continual improvement is implemented once manufacturing processes are capable and stable or product characteristics are predictable and meet customer requirements. 
                   
                  8.5.2   糾正措施    Corrective action 
                  ISO9001:2008   質量管理體系—要求 
                  ISO 9001:2008, Quality management systems  — Requirements 
                   
                  8.5.2糾正措施Corrective action 
                  組織應采取措施,以消除不合格的原因,防止不合格的再發生。糾正措施應與所遇到不合格的影響程
                  度相適應。 
                  應編制形成文件的程序,以規定以下方面的要求: 
                  a)   評審不合格(包括顧客抱怨); 
                  b)   確定不合格的原因; 
                  c) 評價確保不合格不再發生的措施的需求; 
                  d)   確定和實施所需的措施; 
                  e)   記錄所采取措施的結果(見 4.2.4); 
                  f)   評審所采取的糾正措施的有效性。 
                  The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence.  
                  Corrective actions shall be appropriate to the effects of the nonconformities encountered. 
                  A documented procedure shall be established to define requirements for  
                  a)   reviewing nonconformities (including customer complaints), 
                  b)   determining the causes of nonconformities , 
                  c)   evaluating the need for action to ensure that nonconformities do not recur,  
                  d)   determining and implementing action needed, 
                  e)   records of the results of action taken (see 4.2.4), and  
                  f)   reviewing  the effectiveness of  corrective action taken. 
                   
                  8.5.2.1     解決問題的方法 Problem solving 
                       組織應有一個確定的過程用于解決問題,使根本原因得到識別并消除。 
                       若顧客有規定解決問題的方式,則組織應采用此方式。 
                  The organization shall have a defined process for problem solving leading to root cause identification and elimination.  
                  If a customer -prescribed problem solving format exists, the organization shall use the prescribed format. 
                  8.5.2.2   防錯Error-proofing  
                       組織應在糾正措施的過程中采用防錯方法。 
                  The organization shall use error-proofing methods in their corrective action process.  
                  8.5.2.3   糾正措施影響 Corrective action impact 
                  組織應將糾正措施和實施的控制應用于其它類似的過程和產品,以消除不合格原因。 
                  The organization shall apply to other similar processes and products the corrective action, and controls implemented, to 
                  eliminate the cause of a nonconformity. 
                  8.5.2.4     拒收產品的試驗 /分析  Rejected product test/analysis 
                  組織應對顧客的制造廠、工程部門及經銷商退回的產品進行分析,組織應盡可能縮短該過程的短周期。
                  應保存分析的記錄,而且在要求時,可以提供。組織應進行分析,并采取糾正措施,以防止再發生。 

                       注:有關退回產品的分析周期,應當與確定根本原因、糾正措施和實施有效性監視相一致。 
                  The organization shall analyse parts rejected by the customer's manufacturing plants, engineering facilities and 
                  dealerships. The organization shall minimize the cycle time of this process. Records of these analyses shall be kept and made available upon request. The organization shall perform analysis and, initiate corrective action to prevent recurrence. 
                  NOTE  Cycle time related to rejected product analysis should be consistent with determination of root cause, 
                  corrective action and monitoring the effectiveness of implementation. 
                   
                  8.5.3    預防措施     Preventive action 
                  ISO9001:2008   質量管理體系—要求 
                  ISO 9001:2008, Quality management systems  — Requirements 
                   
                  8.5.3  預防措施Preventive action 
                  組織應確定措施,以消除潛在不合格的原因,防止不合格的發生。預防措施應與潛在問題的影響程度
                  相適應。 
                  The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions shall be appropriate to the  effects of the potential problems. 
                  應編制形成文件的程序,以規定以下方面的要求: 
                  a)   確定潛在不合格及其原因; 
                  b)   評價防止不合格發生的措施的需求; 
                  c) 確定并實施所需的措施; 
                  d)   記錄所采取措施的結果(見 4.2.4); 
                  e)   評審所采取的預防措施的有效性。 
                  A documented procedure shall be established to define requirements for  
                  a)   determining potential nonconformities and their causes  
                  b)   evaluating the need for action to prevent occurrence of nonconformities,  
                  c)   determining and implementing action needed  
                  d)   records of results of action taken (see 4.2.4), and  
                  e)   reviewing  the effectiveness of    preventive action taken. 
                   
                   附  錄  A   Annex A 
                  (規范性附錄)(normative) 
                  控制計劃Control plan  
                  A. 1 控制計劃的階段 
                  適當時,控制計劃應覆蓋三個不同的階段: 
                  a) 樣件:對樣件制造中將進行的尺寸測量、材料和性能試驗的描述。如果顧客要求,組織 
                  應有樣件控制計劃。 
                  b) 試生產:對樣件制造后,全面生產前將進行的尺寸測量、材料和性能試驗的描述。試生 
                  產被定義為在產品實現過程中樣件制造后可能要求的一個生產階段。 
                  c) 生產:在批量生產中,對產品/過程特性、過程控制、試驗和測量系統的形成文件的描述。 
                  每個零件應有一個控制計劃,但是在很多情況下,系列控制計劃可以覆蓋采用能通用過 
                  程生產的多個相似零件。控制計劃是質量策劃的一項輸出。 
                  A.1 Phases of the control plan 
                  The control plan shall cover three distinct phases as appropriate.  
                  a) Prototype: a description of the dimensional measurements, material and performance tests that will occur during  
                  building of the prototype. The organization shall have a prototype control plan if required by the customer.  
                  b) Pre -launch: a description of the dimensional measurements, material and performance tests that occur after   prototype and before full production. Pre-launch is defined as a production phase in the process of product   realization which may be required after prototype build. 
                  c) Production: documentation of product/process characteristics, process controls, tests and easurement 
                  syst ems that occur during mass production. 
                  Each part shall have a control plan but, in many cases, family control plans may cover a number of similar parts  produced using a common process. Control plans are an output of the quality plan. 
                   
                  A.2  控制計劃的要素 
                  組織應制定至少包括以下內容的控制計劃; 
                  A.2 Elements of the control plan 
                  The organization shall develop a control plan that includes, as a minimum, the following contents.  
                  a) 基本數據 
                  — 控制計劃編號; 
                  — 發布日期和修訂日期(若存在); 
                  — 顧客信息(見顧客要求); 
                  — 組織名稱/指定的現場; 
                  — 零件編號; 
                  — 零件名稱/描述; 
                  — 工程更改等級; 
                  — 覆蓋的階段(樣件、試生產、生產); 
                  — 主要聯系人; 
                  — 零件/過程步驟編號; 
                  — 過程名稱/作業描述。 
                  a) General data 
                  ?   control plan number, 
                  ?   issue date, and revision date, if any,  
                  ?   customer information (see customer requirements),  
                  ?   organization's name/site designation, 
                  ?   part number(s),  
                  ?   part name/description,  
                  ?   eng ineering change level,  
                  ?   phase covered (prototype, pre-launch, production),  
                  ?   key contact, 
                  ?   part/process step number,  
                  ?   process name/operation description. 
                  b) 產品控制 
                  — 與產品有關的特殊特性; 
                  — 其它要控制的特性(編號、產品或過程); 
                  — 規范/公差 
                  b) Product control  
                  ?   product-related special ch aracteristics,  
                  ?   other characteristics for control (number, product or process), 
                  ?   specification/tolerance. 
                  c)過程控制 
                  — 過程參數; 
                  — 與過程有關的特殊特性; 
                  — 制造用機器、卡具、夾具、工具。 
                  c) Process control  
                  ?   process parameters, 
                  ?   process-related special characteristics,  
                  ?   machines, jigs, fixtures, tools for manufacturing. 
                  d) 方法 
                  — 評價測量技術; 
                  — 防錯; 
                  — 樣本容量和頻次; 
                  — 控制方法; 
                  d) Methods 
                  ?   evaluation measurement technique,  
                  ?  error- proofing,  
                  ?   sample size and frequency, 
                  ?   control method.  
                  e) 反應計劃和糾正措施 
                  — 反應計劃(包括或引用); 
                  — 糾正措施。 
                  e) Reaction plan and corrective   actions 
                  ?   reaction plan (include or reference),  
                  ?   corrective action.  
                  參考文獻Bibliography 
                  [1]    ISO9001:2008 Quality management system -Requirement 
                  [2]     ISO 9004: —1) ,  Managing for the sustained success of an organization — A quality management approach 
                  [3 ]  ISO 10001:2007,  Quality management — Customer satisfaction  — Guidelines for codes of conduct for 
                  organizations  
                  [4 ] ISO 10002:2004,  Quality management — Customer satisfaction  — Guidelines for complaints handling in 
                  organizations  
                  [5 ] ISO 10003:2007,  Quality management — Customer satisfaction  — Guidelines for dispute resolution external to 
                  organizations  
                  [6 ] ISO 10005:2005,  Quality management systems — Guidelines for quality plans  
                  [7 ] ISO 10006:2003,  Quality management systems — Guidelines for quality management in projects 
                  [8 ] ISO 10007:2003,  Quality management systems — Guidelines for configuration management 
                  [9 ] ISO 10012:2003,  Measurement management systems — Requirements for measurement processes and  
                  measuring equipment 
                  [ 10] ISO/TR 10013:2001, Guidelines fo r quality management system documentation  
                  [1 1 ] ISO 10014:2006,  Quality management — Guidelines for realizing financial and economic benefits 
                  [1 2 ] ISO 10015:1999,  Quality management — Guidelines for training 
                  [1 3 ] ISO/TR 10017:2003, Guidance on statistical techniques for ISO 9001:2008 
                  [1 4 ] ISO 10019:2005,  Guidelines for the selection of quality management system consultants and use of their 
                  services  
                  [1 5 ] ISO 14001:2004,  Environmental management systems  — Requirements with guidance for use  
                  [1 6 ]ISO 19011:2002, Guidelines for quality and/or environmental management systems auditing  
                  [1 7 ] IEC 60300-1:2003,  Dependability management — Part 1: Dependability programme management. systems 
                  [1 8 ] IEC 61160:2006,  Design review 
                  [1 9]   ISO/IEC 90003:2004,  Software engineering  — Guidelines for the application of ISO 9001: 2008  to computer 
                  software  
                  [ 20]  Quality management principles 2) , ISO, 2001 
                  [2 1 ]  ISO Management Systems 3)  
                  [22] ISO  9001 for small business  –  What to do; Advice from ISO/TC176 , ISO, 2002 
                  [23]  ISO Management System  4)  
                  [2 4 ] Reference websites:  
                   
                  http://www.iso.org  
                  http://www.tc176.org 
                  http://www.iso.org/tc176/sc2 
                  http://www.iso.org/tc176/ISO9001AuditingPracticesGroup 
                   

                  本頁面資訊網址:http://www.hede.tw/detail/129561.html

                  11选5彩票软件