质量管理表现改善的系统–手册英文

1、Quatymaagmen ystems Guidelnes fo eormane mprovemen 1coeThIntrational Stndardpovids ulies beynd te reuemetsgven in ISO91 i oder consder bottheefectiveness ad efficcy f uality maagement system， n cnseeny te potntia or mpovement ofth pemace onorganzaonWhen compare t IS 901, theobjciesf cusome stisao nd

2、prduct quait ar etdedto inclu theatfaction of ierste pats the erforae of the rganizatons ntratinal tanad applcableto t prcesses th rgnzaonand consequentythe quality aaemen rncilesonwih i bsed ca be ep hrouhot the ogniatin efocus o this Intiona Standrd s te ivmen ngoingmprovement, easuredthoh the sat

3、ifcton of custmrs anoer inereates.hisIntenanal Standar onsists of dan andrcommendaion ad is notintendd focertificatin， regulatoyo otracta se, nor as aguide to the implmnttin ofIO 900.2ormaive refeeneThe folowingnrative documet coninprovsionwhih， trough eference inhs text， contitute pvison f sIntenat

4、iona Standa. Fr dte efeces,subqunt amendmes t， or evisions of, an f thesepuliationso o pply. Howeer, parties o geements as on this IntenatonaStandad are eouage investigae he sibiy of applngthmost ecentedtio o the norai doument indcatedb. or undated refrences,the lasteionofthenormatve umnt rred t app

5、ie Member of IO and EC mitin regsters fent vl Ineraioal Standads.ISO900:2000，Qualy nageent sems Fndaentalsandvcbulry.3 Term anddefinitosFothepuoses f this Intrational Stanard， the term nd denitionsgien n ISO000 ppy.he follwingterm， sdin this editio f I900 t descriteul-chain, have bee haneto reflet t

6、h vcbulary urrenly ed:suple orgzati customer (ntrested pa ）hogh he xt of ths tnation Standar, wheevr theerm “pdct” cus，it caalso mn “service”4 uality manaentstem4.1 anangsstmsand pocesssLeangdopeatigan organization ccessfullyrequiresmaig ia syteti andvsible manne.Sucsssoul result rom immntinad itaig

7、amanageet sysem at i deigdtcotinualmpveth fctiveness ndficiencoheoganizaionspeformance yconsierngtheeds ointreste arties anagng an organizatio ncludes qlty mnaement, among tr mngment diciplines.opnageent should establish custome-oriente orgaztiona) y definng sstemsand rceses ha an clearl understd,an

8、g an improve ifectiveess well as efficincy,ad b) besrigefctive an fcet operti nd contofproceesand the mases n dta used determine sasftoy eforance f the oanizto.Exaple oates toestabliha ustmeoriendganizaion inlu- defning ad ootig processes thtlead to pvd oganiztonal peformance,acquiin and uing proces

9、data ad iformatin n a cotuing bais, iretin proges towrscontinuampovement,ad- usingiablemethods t valuat pocss improvement， such as elf-asessmnts nd manaem rviewExampes ofslf-assessmen an contal imroment prcesses argivn in anees n B epectely.ISO 9001:2000, Quality management systems Requirements4 Qua

10、lity management system4.1 General requirementsThe 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.The organization shalla)identify the processes nee

11、ded for the quality management system and their application throughout the organization,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 r

12、esources and information necessary to support the operation and monitoring o these processes,e) monitor, measure and analyse these processes, and f) implement actions necessary to achieve planned results and continual improvement of these processes.These processes shall be managed by the organizatio

13、n in accordance with the requirements of this International Standard.Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. Control of such outsourced processes shall be identified within th

14、e quality management system.NOTE Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement.4.2 DcumenttionManemet hol dfne the documnation, includigthereleaecords, needed establ

15、i, ipleen an maintai t quity mnagemntsystem ndtosupprtandffetive an eficient oation thergnizatons rocess.hnaurean ete th doumetation hud sasfy theontacual, statuty nd regulory euiremens, ad the nedsand xecations customs nd othrinterested aries and shoule popate to the orgnztinDocmentation may be any

16、 form o medium suitale for heneedsof teorganization.In order rvide docmentationto satisfy e edsand exectation f itrested prts manaeent suld consdr- cntractualrequirementsfrom the cutomern oe eestedprties,-ceptnce of interatona，naioal ，rgon and ndusry secor stndards,- reeva statutory and regulator ui

17、emets,deciis t organation,-decsins by thorgaation, sourcs ofxtenl infomationreleva orhedevelopmentof the ornzatons compencis, d-inmation aout he ne and exectaisointeresd artiesTe enration, ue and cnrol o umenationshoud b evaated wh repc to the efectiens andeffiiency f he oranian against critri sucas

18、 - uncionlit (such aspedfroessg)，- uer friendliss, resurcesneded,-plicies and jetives - urrent nd futrerequirement rlaed to nagngknolg.- becharnof ocuentio sses, ad-intracesued byoraniztions customers,supplieranoer teestparties.s t oumetioshoul beensred orppl in the orgnization ad tohe nterested rti

19、es,basonhe orgnizaionscommnicton olic.ISO9001:2000, Quality management systems Requirements 4.2 Documentation requirements4.2.1 GeneralThe quality management system documentation shall includea) documented statements of a quality policy and quality objectives,b) a quality manual,c) documented proced

20、ures required by this International Standard,d) documents needed by the organization to ensure the effective planning, operation and control of its processes, and e) records required by this International Standard.NOTE 1 Where the term “documented procedure” appears within this International Standar

21、d, this means that the procedure is established, documented, implemented and maintained.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 inte

22、raction, and c) the competence of personnel.NOTE 3 The documentation can be in any form or type of medium.4.2.2 Quality manualThe organization shall establish and maintain a quality manual that includesa) the scope of the quality management system, including details of and justification for any excl

23、usions,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 Control of documentsDocumental required by the quality management system shall be controlled.

24、Records are a special type of document and shall be controlled according to the requirements given in 4.2.4.A documented procedure shall be established to define the controls neededto approve documents for adequacy prior to issue,to review and update as necessary and re-approve documents,to ensure t

25、hat changes and the current revision status of documents are identified,to ensure that relevant versions of applicable documents are available at points of use,to ensure that documents remain legible and readily identifiable,to ensure that documents of external origin are identified and their distri

26、bution controlled, and to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained or any purpose.4.2.4 Control of recordsRecords shall be established and maintained to provide evidence of conformity to requirements and of the effective oper

27、ation of the quality management system. Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection, retention time and disposition of records.4.3se of ualit maageent pricile

28、sToleadandoprat n rganizaio successfully，itis ncessary mne itin ssemi adiblaner. Thguidance t management ofre in this Intertional Staardsased oeih alitanagement principles. ese princplsav been devlopedfor se by top maagment in rder o adth oganiatin toward mprovd erfomance hese quality managent prnci

29、pls areinegate inte contnt ftiIernional Sandd and are liste belowa） CustomerfocsOgnizondepen o eir cuomesand herefe shouludrstandcren and fure ustom eed，houl metcstorrequirmens and striveo excee customer expecttins.b） earshpLeaers establishunity of use anddirectoof he rganization.Tey soud creat and

30、minain th ntrna nvironment in whichpope an become fulyinvolvd inachinh ranizations obectives.c） Invovmetof eoplePeple a al level a te ssenceof n gazation atheirull ivolvementeables heir ablts obe usefr th ogazatios bnefit.) ProcessappracAdesired eslt is cive mor eficienly whnatiities and relaedresor

31、ces e managedsa poesse)ytem approac t manageent Identfn， understnig d mangin inerrelate ocssesas a sysemntribtest the oanizatioseffectiss and effiiecyn achivinits ojective.f) ontinl irveentContial improment ofe orgnizaton overal peoran shouldb permanent obctivof the oraniztn.g) actul aprc to deciink

32、iEffetive decison re ased o the anysis dta a infraion.h) Mutlly benefialsuplerelshisnogaizationand it supleare intedendent an a mtuall benefical rlationhip enhces thabilit of both to eatevalu.Sucessfl use th eitmangee pricipes y a oranatinillreult n benfis to intered artis, such a imrovoetar euns, t

33、he creatioof vlue dnceaed stablty.5Managent repoibly51 Gnea guidnce5.1. Itouctioneadershi, commen and theaciveivovement ofthe tp maagement are ssntial for deveop antaiing an efectieand effiet quly managmntsystem to aciev benfit for inereste paries.To ahive thesbeefts, itncessary to sablish， sutain d

34、 nease custmerstisfactio Top anagem ould consider actions sch as stablishinga vs， pole andstatgic bjectie cosistent ih thepurs o th organitio，leadi te organizatinby eamle, n re o dvelop trswithin itpple, comnicaing ornizatinal diecio and alus regring quli an the qualitymanagement system，rticpatig in

35、 impvement rject,arhngforew ethos, solisanpoducts,obnng feedack dietlnth effeceness ad efiencyof the qulit magementytem，ideiyng he proct ealztn pocesssttpriaded aleothe gnzation.creaing an environt hat enourages the inlvemetnd developen ofpee, an proision of te sttu and ouesta arnecessry to spport t

36、h organitions sttegicplns.Topmanageshoud l efine metho fr marnof the rgaiztion prforance in ord to etri wet laned objectves hav been ahev.ehds icluefnncl msureet,masrment of prcespeormnthroughou h orgaizatin,eternal easurmnt,sh sbenchmarkig ad hid-part valuain,asesmen of he saisaction fcome, peole i

37、n the orgaization and oterinestedparie,asssment ofthepeetionsocusomers ndher interested paies ofperformace o podct provide, anmeasurement fother suessfaco identif by magmnt.Informaio erive from sch mesurments adassessmens shoul also beconidere s ipt omagemen reviewi ord to ensu thatctiual improveeof

38、 the quality management syst is he drer fo perfoace imoemen f togaion.1.2Isuest b onsieredWhen evelpin,implentnnd anaging teoranzaions qualiy managmen syem, anagemnt shou conier the ulity management priies outlind 4.3. nth sis of thserinciles,op management shuddemnstraeleaershi i, and coitent to, th

39、 folow ctiities:udersanding curen anduture cstorns ad exectaions,in addition o requiremnts；rmn poicie and objectveto ncrasawareness, ivationaninolvmnto ol in the organzain;stalisigoninul mrovement as n obecie or procses of te orgizatio;plannin fo the fuure of he ganzatio dangn cange；settn anmmunitng

40、 aramewor for chving he tifationf intrese prs.In adionto mall-stp orogoing contiualimpoement, tp manement shudalso consider reakthrough canges to procsses sa way toimprov theognizion rfonce. Durg uh chages, angemt hod takestpsto nshatte resources d ommication needed to mtathe fncti ofthequlity agmen

41、tsytmre ovidd.Tp anageentshoul idntfy th ranizanproduct ealiztion oce， as hseare iretl reated o te sccess of th rgaization. Topmanagment sod lsitifythe support pocese that afeceitherteefetivens adficieny o hereaization resses othe neds and exectatinsofintrested ptesMangemenould ensre that proeses op

42、rateas n effciven eficient netork. Mngement shoud aalys andopimiztenteracton ofpocesse, inludng bt reizatin proeseand sor pos.Cosieration shud be give t ensringtat esequnce nd interacion of proceses are designed t ahievthe dsirdrsu effecvelyand eiently，suring pcess iputs, activities ad outpts are ea

43、l definedand cotrolld，montori inpts adutpt to veriytt idivdualprcsear linke nd opeate ffective ad ffcienty，identiynga managing ris， and xploitn perfomnce mpoemn opportnites,condctng daaasito facilate ontna improveent o ocesse，idefying pross owners and giving them fl rsonsibility ad authorit, mnging

44、a prosto achieve hepoess bjetiv, nd - he ees and eptations of itrese prtisISO 9001:2000, Quality management systems Requirements5 Management responsibility5.1 Management commitmentTop management shall provide evidence of its commitment to the development and implementation of the quality management

45、system and continually improving its effectiveness by a) communicating to the organization the importance 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

46、e) ensuring the availability of resources.5. es and ectnsf inteestedparti5.1 Generalvry oranizato hs interee arti, eachty havig nesa xecttos. ntreteptie o ogniation incldutomer and nd-uses,pole ine orition,ownrsnvestors(sch as sharelder, indvidual or gou, nlding the uli seco, thathave specific inter

47、est in teornizio）,pplies andprtner， and ocety in termsf he comunitynd he ulc afectedby the oranizatio oits rodcts.2. Nedsand expecatinThe succes f t oanizatiodependso unertanding an sisfyge curntand ftuened aepectations of pestadponacstomrs and n-user, asell as urstadng an consdeig tho theriersed rt

48、.Inorder t ndesand nd meet e eedsandexpectaon of iterested prtie, norgnztion shoulddetify is itretd paries andaii balnced repone to thirnees an exectaons，ranslt identfe eds anexpectaios into quieens,ommunat the rqiremetstroghoutte organizatin, an fcus onpocssimrovnto ensure value for te ntiieterest

49、paiesoisfy stmerand enduse needsand epecations, e maagemetofan orgniaton should unestand the needs and exptationso it smers, inci tse o potenil cstomer, dtermin k rdut charatesticsoitcstoer ad ed-user,identfynasses ometiion in its mark， nd idtiarke opportunitis,eakneses and futur compettveadvantag.a

50、mpe of cser and end-usr needs and petin,asrelatedt he organizais produts,incu cformty,dedability,alability,elivery，pot-ealization civitie,prce n life-ccle cost,prduct fety,productiability, andnnentlimpathe rganzan shul dtfyt people needs anexecns for reconition, wok satiscion, and personal elpmet uc

51、h ttentioelp to nurthath invovement and motivati ofpeopl ae as stng apossble.Th rgzation shouldfininanal and otherresulttat satisy e ientiid neds xctatin ownrs nd invesrs.anaement shoud coider thptential bnefiso esblisng artnerships witsuplersto ogation, in order t cte value r th prtiesA patrshipshu

52、d bebsd n ansrg，sharn knowe as ell agains a losss. Wenstablshing prneships, an organzan shuld idntify keysuppers,dother anizatios, as pential parters，ointy establihacler undesndn o customes needsand xectation, joily establish a cea uneranding of te prers needs anpectins, an egoas o eure oortntie fr

53、ontnuig partnerships.n onsiderin is rtishipswit soiety，he oranizaion houldmnstraesponsibiy for healad saety，onsde nvrnmetl mpct， inclungonservatioofeegy ad natral resore,dentify applcablesator and reguoy reqirements, anidniy hecurrntnd otetialimatso socety igeneal, an te lcalcomunity patular， ts pro

54、uts, pocesses and ativities.ISO9001:2000, Quality management systems Requirements5.2 Customer focusTop management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction.52. Sautory nd reultry euremens Manaemet shoud ensur hatthe rgazatin ha

55、 knoweg e of the sattor and reguatoyequrent hatal tots prouts, procsses and actvitiean ould nclude sch requirementsas partf the qualiy managemnt sytem. Coderati houl loe given to theomotoo etial, fecve ad efiintcompliance with urrent and ppctiverequirements,e befits tointeretedartiefr exceedg compli

56、ace, ndhe ol f the rganzatin in teprtecton of cmmunty nterests.5.3 Quity olicop mnageentshold ue thequali oliy sa ea fleadin te oranzato tord improvmentofis pfoance rganiatons qualiy pol shoud be an eua andconssent r of the rganzation vrll liisnd strte.Inestablishing t quality poicy,topanagement shu

57、ld onsderh e andtpe ofture imrovemnteded fo te oaniation toe sucessf,the exectedr dsire dgeof cuomersaifation，thdevlpent f pepl in the ogaizatin,h needs and pctatiof otintreted paries, theeoures nededto o yond 9001 requirmens， andthe poeialcontribuio of suppliers and prtner.he quliypolicy a be usd f

58、or mrovme proied thati s cosistnt wt to mangemens vsion nd statey frhe oraizatons fute,i pemisquaity bjecties to eunderstood ad pursued througho h rgaizatn,itdmonstates op manmnt commtmet to quiyndthe rovion of aeuat reourcesforaciemnt f oeis，t ais in romting ommitent o quait througot th orgniztio,w

59、ith le lederhip by op anagemet,it incde continua imroeentas eld to saaction f the eeds an expettion f umers and ther intrsted parties,an i ieffeceyformulated adfficiety commiaed.As ith otrsess policies, the quaty policy should beeriody reviewed.ISO9001:2000, Quality management systems Requirements5.

60、3 Quality policyTop management shall ensure that the quality policya) 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 reviewi