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1、Section 4 Quality management system第四章 质量管管理体系4.1 Genneral requiiremennts一般要求4.2 Doccumenttationn requuiremeents文件要求4.2.1 GGeneraal总则4.2.2 QQualitty mannual质量手册4.2.3 CControol of documments文件控制4.2.3.CC.1 Coontroll of CCustommer-Suupplieed Doccumentts andd Dataa The organnizatiion shhall eestabllish
2、aand mainttain aa docuumenteed proocedurre(s) to coontroll all custoomer-ssuppliied doocumennts annd datta (e.g., nnetworrk archiitectuure, ttopoloogy, ccapaciity, iinstalllatioon terrminattion aassignnmentss, andd dataabase) if tthese documments and ddata iinflueence tthe deesign, veriificattion, v
3、aliddationn, insspectiion annd tessting, or sserviccing tthe prroductt.客户提供文件及及数据控制 组织将建立立并且维护文文件化程序以以控制所有客客户提供的文文件和数据（例例如，网络体体系结构，布布局，容量，安安装结束任务务及数据库）如如果这些文件件和数据影响响设计，验证证，确认，检检查及测试，或或服务于产品品。4.2.4 CControol of recorrds记录控制Sectionn 5 Maanagemment rresponnsibillity第五章管理职职责5.1 Mannagemeent coommitmment
4、管理承诺5.2 Cusstomerr focuus 以顾客客为关注焦点点5.2.C.11 Custtomer Relattionshhip Deeveloppment Topp manaagemennt shaall deemonsttrate activve invvolvemmentin estaablishhing aand maaintaiining mutuaally-bbenefiicial relattionshhips bbetweeen thee orgaanizattion aand ittscustomeers. 4发展顾客关系最高管理者者应积极参与与建立并维护护组织与顾
5、客客之间的相互互受益的关系系。5.2.C.22 Custtomer Commuunicattion PProceddures Thee orgaanizattion sshall estabblish and mmaintaain adocumennted pproceddure(ss) forr commmunicaating with seleccted ccustommers. The ddocumeented proceedure(s) shalll incllude:顾客沟通程序组织应建立立并维护文件件化的程序以以确保与特定定顾客之间的的沟通。该程程序文件应包包括：a) a sttr
6、ateggy andd critteria for ccustommer seelectiion,选择顾客的策略略及标准b) a meethod for tthe orrganizzationn and its ccustommers tto shaare jooint eexpecttationns andd imprrove tthe quualityy of produucts, and组织和顾客共同同参与策划及及提高产品质质量的方法，和和c) a jooint rrevieww withh the custoomer aat deffined interrvals coverring
7、tthe sttatus of shhared expecctatioons annd incluuding a metthod tto traack thhe ressolutiion off issuues. 4会同顾客安既定定的时间间隔隔评审期望目目标的状况，并并且应有可以以追踪决定流流转的方法。5.2.C.22-NOTEE 1: IIt is recoggnizedd thatt it iis nott posssible for aan orgganizaation to prrovidee the same levell of commuunicattion wwith aall
8、itts cusstomerrs. Thhe levvel prrovideed mayy depeend onn the amounnt of businness wwith tthe custoomer, the hhistorry of probllems, custoomer eexpecttationns, annd othher faactorss (seee Appeendix F, “GGuidannce for CCommunnicatiion wiith Cuustomeers”).注解1：众所周周知，组织不不可能对所有有顾客提供同同样级别的沟沟通。所提供供的级别应依依据与
9、顾客的的生意数量、历历史问题、顾顾客期望值，以以及其它因素素（参见附录录F，“顾客沟通指指导”）5.3 Quaality policcy质量方针5.4 Plaanningg策划5.4.1 QQualitty objjectivves质量目标5.4.1.CC.1 Quualityy Objeectivees OObjecttives for qqualitty shaall inncludee targgets ffor thhe TL 9000 measuuremennts definned inn the TL 90000 Quualityy Manaagemennt Sysstem MMe
10、asurrementts Hanndbookk.质量目标质量量目标应包括括在TL90000 质量量管理体系计计算手册中为为TL90000定义的对对象。5.4.2 QQualitty mannagemeent syystem plannning质量管理体系策策划5.4.2.CC.1 Loong- aand Shhort-TTerm QQualitty Plaanningg Thhe orgganizaations quaality plannning aactiviities shalll incluude loong- aand shhort-tterm pplans with goalss
11、for improoving qualiity annd cusstomerr satiisfacttion.长期和短期质量量策划组织织的质量策划划行为应包括括以提高质量量和顾客满意意度为目标的的长期策划和和短期策划。Performmance to thhese ggoals shalll be mmonitoored aand reeporteed. Thhese pplans shalll addrress:实现这些目标需需要监控和汇汇报。这些策策划应注明：a) cyclle timme, 循环时间间b) custtomer serviice, 顾客服服务c) traiining, 培训d
12、) costt, 成本e) deliivery commiitmentts, annd 交货承承诺，等f) prodduct rreliabbilityy. 产品可靠靠性5.4.2.CC.1-NOOTE 1: Top Managgementt shouuld deemonsttrate theirr actiive innvolveement in loong- aand shhort-tterm qualiity pllanninng.注解1：最高管管理者应积极极参与到长期期和短期质量量策划中。5.4.2.CC.2 Cuustomeer Inpput The oorganiizatioon
13、shaall immplemeent meethodss for soliccitingg and consiiderinng custoomer iinput for qqualitty plaanningg actiivitiees. Thhe orgganizaation shoulld esttablissh joiint quualityy imprrovemeent progrrams wwith ccustommers. 4顾客输入 组组织应将顾客客输入纳入质质量策划中。组组织应会同顾顾客建立质量量改进程序。5.4.2.CC.3 Suupplieer Inpput The oor
14、ganiizatioon shaall immplemeent meethodss for soliccitingg and usingg suppplier inputt for qualiity pllanninng acttivitiies. 4供应商输入组组织应将供应应商输入纳入入质量策划中中。5.5 Ressponsiibilitty, auuthoriity annd commmuniccationn职责、权限与沟沟通5.5.1 RResponnsibillity aand auuthoriity职责和权限5.5.2 MManageement repreesentaative管理者
15、代表5.5.3 IInternnal coommuniicatioon内部沟通5.5.3.CC.1 Orrganizzationn Perfformannce Feeedbacck TThe orrganizzationn shalll infform eemployyees oof itss quallity perfoormancce andd the levell of ccustommer saatisfaactionn. 4组织成绩反馈组织应通知知其员工关于于质量成绩以以及顾客满意意程度。5.6 Mannagemeent reeview管理评审5.6.1 GGeneraal总则5.6
16、.2 RRevieww inpuut评审输入5.6.3 RRevieww outpput评审输出Sectionn 6 Reesourcce mannagemeent第六章 资源管管理6.1 Proovisioon of resouurces资源提供6.2 Humman reesourcces人力资源6.2.1 GGeneraal 总则6.2.2 CCompettence, awarrenesss and trainning能力、意识和培培训6.2.2.CC.1 Innternaal Couurse DDeveloopmentt Whhen thhe orgganizaation devello
17、ps iinternnal trraininng couurses, it shalll estaablishh and mainttain aa proccess ffor pllanninng, deevelopping, and iimplemmentinng theese cooursess. 4内部课程开展当组织开展展内部培训课课程时应当建建立并维护一一个程序以确确保课程的计计划、开展及及实现。446.2.2.CC.2 Quualityy Imprrovemeent Coonceptts TThose emplooyees that have a dirrect iimpactt o
18、n tthe quualityy of the pproducct, inncludiing toop mannagemeent, sshall be trrainedd in tthe fuundameental conceepts oof conntinuaal improovemennt, prroblemm solvving, and ccustommer saatisfaactionn. 4质量改进观念包括最高管管理者在内的的所有对产品品质量有直接接影响的员工工应当接受持持续改进、解解决问题及顾顾客满意等基基本观念的培培训。46.2.2.CC.3 Trraininng Reqquir
19、emments and AAwarenness Traainingg requuiremeents sshall be deefinedd for all posittions that have a dirrect iimpactt on tthe quualityy of pproduccts. EEmployyees sshall be maade awware oof traainingg opporrtunitties. 4培训需求和意识识培训需求求应针对所有有对产品质量量有直接影响响的职位。员员工应该知晓晓培训的机会会。6.2.2.CC.4 ESSD Traainingg Alll
20、 empployeees witth funnctionns thaat invvolve any hhandliing, sstoragge, paackagiing,preservvationn, or delivvery oof ESDD-senssitivee prodducts shalll receeive ttrainiing inn elecctrosttatic dischharge (ESD) proteectionn prioor to perfoormingg theiir jobbs.ESD 培训所有包括操操作、仓储、包包装、保存及及运输ESDD敏感产品的的员工都应接
21、接受静电放电电培训，以确确保他们开展展工作。6.2.2.CC.5 Addvanceed Quaality Trainning The organnizatiion shhall ooffer approopriatte levvels oof advvancedd qualiity trraininng. Exxamplees of advannced qqualitty traainingg may incluude sttatisttical technniquess, proocess capabbilityy, staatistiical ssampliing, ddata ccoll
22、ecction and aanalyssis, pprobleem ideentifiicatioon, prroblemm anallysis, and correectivee and preveentivee actiion. 5高级质量培训组织应体统统适当更高层层次的质量培培训。高级质质量培训可以以包括统计技技术、过程能能力、统计取取样、数据收收集及分析、问问题判断、问问题分析积极极纠正预防措措施等。556.2.2.CC.6 Trraininng Conntent Wheere thhe pottentiaal forr hazaardouss condditionns exiists
23、, trainning ccontennt shoouldincludee the folloowing:培训内容有潜潜在危险的地地方，培训内内容应包括：a) taskk execcutionn, 作业执行b) perssonal safetty, 个人安全c) awarrenesss of hhazarddous eenviroonmentt, andd 危险意识，等等d) equiipmentt prottectioon. 设备保护6.2.2.HHV.1 OOperattor Quualifiicatioon TThe orrganizzationn shalll esttablissh
24、opeeratorr quallificaation andrequaliificattion rrequirrementts forr all appliicablee proccessess. Theese reequireementss, at a minnimum, shalll addreess emmployeee eduucatioon, exxperieence, trainning, and ddemonsstrateed skiills. The oorganiizatioon shaall commuunicatte thiis infformattion tto all
25、l affeected emplooyees. 4HV.1 操作作员资格组组织应当为所所有必要过程程建立操作员员资格及要求求条件。这些些要求应注明明员工教育背背景、工作经经历、培训及及技能。组织织应将该信息息通知所有相相关职工。6.3 Inffrastrructurre基础设施6.4 Worrk envvironmment工作环境6.4.C.11 Workk Areaas AAreas used for hhandliing, sstoragge, annd pacckaginng of produucts sshall be cllean, safe, and oorganiized tto
26、 enssure tthat tthey ddo nott adveerselyy affeect quualityy or ppersonnnel pperforrmancee. 56.4.C.11 工作区用于操作、储储存及包装产产品的区域应应保持干净、安安全并且有序序，以确保不不会对质量或或个人造成负负面影响。Sectionn 7 Prroductt reallizatiion第七章 产品实实现7.1 Plaanningg of pproducct reaalizattion 产品品实现的策划划7.1.C.11 Lifee Cyclle Moddel The oorganiizatioon
27、 shaall esstabliish annd maiintainn an iintegrrated set oof guiidelinnes that coverrs thee lifee cyclle of its pproduccts. TThis fframewwork sshall contaain, aas apppropriiate, the pprocessses, activvitiess, andd taskks invvolvedd in tthe coonceptt, deffinitiion, ddeveloopmentt, prooductiion, oopera
28、ttion, mainttenancce, and (if reequireed) diisposaal of produucts, spannning tthe liife off the produucts. 10生命循环模式组织应当建建立并维护一一套覆盖产品品生命循环的的完整的指导导手册。该框框架应尽可能能包括国过程程、功能、以以及观念、定定义、发展、产产品、操作、维维护，以及产产品的处理（如如果必要），跨跨度产品的生生命周期。7.1.C.22 New Produuct Inntroduuctionn Thhe orgganizaation shalll estaablishh and
29、mainttain aa docummentedd proceedure(s) foor inttroduccing nnew prroductts forr Geneeral AAvailaabilitty.新产品介绍组组织应建立并并维护一套文文件化的程序序用以介绍新新产品的一般般性能。7.1.C.22-NOTEE 1: TThe neew prooduct introoductiion prrogramm shouuld inncludee provvisionns forr suchh proggrams as: qualiity annd relliabillity ppredicct
30、ion studiies, ppilot produuctionn, demmand aand caapacitty stuudies, salees andd servvice persoonnel trainning, and nnew prroductt postt-intrroducttion eevaluaationss.注解1新产品品介绍程序应应包括以下程程序：质量及及可靠性预测测计划，试制制产品，需求求及产量计划划，销售及服服务人员培训训，新产品定定位估计。7.1.C.33 Disaaster Recovvery The organnizatiion shhall eestabl
31、lish aand maaintaiin metthods for ddisastterrecoverry to ensurre thee orgaanizattionss abillity tto reccreatee and serviice thhe prooduct throuughoutt its life cycle. 10事故处理组织织应建立并维维护事故处理理的方法以确确保组织有能能力在生命周周期内进行维维修和服务。7.1.C.44 End of Liife Pllanninng TThe orrganizzationn shalll esttablissh andd mainn
32、tain a doccumenttedproceduure(s) for the ddisconntinuaance oof mannufactturingg and/or suupportt of aa prodduct bby thee operrationn and serviice orrganizzationns. Thhe doccumentted prroceduure(s) shouuld inncludee:最终策划组织织应为保质期期和服务组织织终止生产或或支持产品建建立并维护一一套文件化的的程序。该程程序文件应包包括：a) cesssationn of ffull oor
33、parrtial suppoort affter aa certtain pperiodd of ttime, 一定时时间后停止全全部或部分支支持，b) archhivingg prodduct ddocumeentatiion annd sofftwaree, 保存产产品文档及软软件，c) respponsibbilityy for any ffuturee resiidual suppoort isssues, 对任何何残留问题支支持的责任，d) trannsitioon to the nnew prroductt, if appliicablee, andd 如果适适用，转化为为新产品，
34、等等e) acceessibiility of arrchivee copiies off dataa. 100 数据拷拷贝存档的可可达性7.1.HS.1 Confiigurattion MManageement Plan Thee orgaanizattion sshall estabblish and mmaintaain a confiigurattion mmanageement plan, whicch shoould iincludde: 配置管管理策划组组织应建立并并维护一配置置管理策划，其其内容应包括括：a) idenntificcationn and scopee of tt
35、he coonfiguuratioon mannagemeent acctivitties, 配置置管理活动的的定义及范围围b) scheedule for pperforrming thesee actiivitiees, 执行这这些活动的进进度表c) conffiguraation managgementt toolls, 配置管管理工具d) conffiguraation managgementt methhods aand doocumennted pproceddure(ss), 配置管管理方法及程程序文件e) orgaanizattions and rresponnsibillit
36、iess assiigned to thhem, 组织及及分派给它的的责任，f) leveel of requiired ccontrool forr eachh conffiguraation item, and 每个配配置项目需要要控制的级别别g) poinnt at whichh itemms aree brouught uunder confiigurattion mmanageement. 10指明哪些条款置置于配置管理理的管辖范围围。107.1.HS.1-NOTTE 1: Generral woork innstrucctionss defiining generral coonf
37、iguuratioon mannagemeent taasks aand respoonsibiilitiees neeed nott be rrepliccated as paart off a sppecifiic doccumentted coonfiguuratioon mannagemeent pllan.注解1：总的工工作指令规定定总的配置管管理任务并且且责任不必转转述为配置管管理策划的部部分文件。7.1.S.11 Estiimatioon TThe orrganizzationn shalll esttablissh andd mainntain a metthod ffor e
38、sstimatting aand trrackinng projeect faactorss duriing prrojectt plannning, execcutionn, andd channge maanagemment. 11评估组织应建建立并维护一一种方法用以以在方案策划划、实施及更更改过程中评评估和跟踪方方案因素7.1.S.11-NOTEE 1: PProjecct facctors shoulld incclude produuct siize, ccompleexity, effoort, sstaffiing, sscheduules, cost, qualiity, rr
39、eliabbilityy, andd prodductivvity.注解1：方案因因素应包括产产品尺寸，复复杂性，成就就，员工，进进度，成本，质质量，可靠性性及生产能力力。7.1.S.22 Compputer Resouurces Thee orgaanizattion sshall estabblish and mmaintaain meethodss for estimmatingg and ttrackiing crriticaal commputerr resoourcess for the ttargett compputer, the compuuter oon whiich th
40、he sofftwaree is intennded tto opeerate. Exammples of thhese rresourrces aare uttilizaation of meemory, throoughpuut, reeal tiime perfoormancce, annd I/OO channnels. 11计算机资源组组织应建立并并维护一种方方法用以评估估和追踪目标标计算机的重重要资源，计计算机中的软软件是否预期期运行。这些些资源包括存存储器的效用用、吞吐量、适适时执行以及及I/O通道。1117.1.S.33 Suppport SSoftwaare annd Too
41、ols Maanagemment The organnizatiion shhall eensuree thatt inteernallly develloped suppoort sooftwarre andd toolls useed in the pproducct liffe cyccle arre subbject to thhe apppropriiate qqualitty methood(s). Toolls to be coonsideered iincludde: deesign and ddeveloopmentt toolls, teestingg toolls, co
42、onfiguuratioon managgementt toolls, annd doccumenttationn toolls. 111支持软件及工具具管理组织织应该保证用用在产品中的的内部开发的的支持软件及及工具在整个个产品生命周周期中的质量量。应当考虑虑的工具包括括：设计开发发工具、测试试工具、配置置管理工具，以以及文件工具具。117.1.V.11 Servvice DDeliveery Pllan Supplliers that are rresponnsiblee for the ddeliveery orr impllementtationn of aa serviice, aan
43、d arre nott respponsibble foor thee desiign annd devvelopmment oof thaat serrvice, shalll commply wwith tthe Projeect Pllan reequireementss of 77.3.1.C.1.服务交付策划 厂商有责任任交货或提供供服务，但是是对服务的设设计及发展不不负责任，应应符合7.3.1.CC.1条方案案策划要求。7.2 Cusstomerr-relaated pprocessses与顾客有关的过过程7.2.1 DDetermminatiion off requuiremee
44、nts rrelateed to the pproducct 与产产品有关的要要求的确定7.2.2 RRevieww of rrequirrementts rellated to thhe prooduct与产品有关的要要求的评审7.2.2.CC-NOTEE 1: TThe coontracct revview pprocesss shoould iincludde:注解1：合同评评审过程应包包括：a) prodduct aaccepttance plannning aand reeview, 产品验收策策划和评审b) handdling of prroblemms dettectedd af
45、teer prooduct accepptancee, inccludinng cusstomerr compplaintts andd claiims, and 产品验收后后发现问题的的处理，包括括客户投诉及及要求，等c) respponsibbilityy of rremovaal andd/or ccorrecction of noonconfformitties aafter appliicablee warrranty periood or durinng prooduct mainttenancce conntractt periiod. 9在保证期或维修修合约有效期期间有责任删删除和/或修正不符符合项目。97.2.2.CC-NOTEE 2: TThe prroductt acceeptancce plaan shoould iincludde as approopriatte:注解2：产品验验收策划应当当包括以下内内容作为补充充：a) acceeptancce revview pprocesss, 验收评评审过程，b) acceeptancce criiteriaa, 验收标标准c) docuumenteed tesst proocedurre(s), 文件化化的检测程序序d) testt