質(zhì)量管理系統(tǒng)–根本性和詞匯量英文

1、IO9000:200（E)Qaliy anaementsse Fundamenls andvocbulary1 ScopeThs nnatoa Sanad describe fundamentalof uality mageen sstem, wh for esubect teISO 90 faily, and dines elaed ers.This nternatonl Sardisplicable tothe followng：a) ognizationsseeking advantage throu the imlemenatio of a quaity maagmentsys;b)

2、organzatio king nfidnc fomtir suppirs hat theirrot requirentsil besatisfie；) user f theprducs；d） thos oncrn with amutul uderningof thtminolgy sed i qualit manageet (eg.supliers, customs, reulatr);) thoe internalor etenl t aizio who assess the qalitmaagement yst rauiti fo cnfomitywth the reuirments o

3、SO 90（eg.auditors， reglator， crtificatio/egistioodes）;f) the inernloxrto he organzaton who give dice ranng onth ualtymanamet ystm aropiate that organon;g) deeloe f laed tads2 Fndamentals of qaiy mangem sytes2.1 Ranale frqali mangemen sysemsQualit mangemntsystemcan sist oranzations i enacing cstmrsti

4、sfacti.Custoersrquiducts wthcaracteitics thastis theieds and expectatins. Theneeds n expectatios are xpresein product speifiation ndcoeciy reerred a custoerreqiremens. Customrreuirems may bspcifid contractall by the customr or maybe eteminedthe orgaizion ielInihrcase, the ustome ultimatlydetermins t

5、eaccptbilt f thepoduc.Bese customer eedsd xpectaionsarchanging, ad casecompetitveressresand tehncl danes, oaniations are rveo mpove oninaly thei prducts nd rocessshe qualty management systmaproaheoages orgaitions to anals cusomer equireents, defne tcesss atcntrbue to theachimen f a producwhch is ace

6、ptalet e cstme, and kee tse pceses unde control. A uitmangemnt systm n rvide he fmewok f cotnual mprveento increas th robabilty o nancing customer stsfacion anth satisfcion ofotr terestepaties. t proesonfidence theoaiztn and tscusoms tat t is ableto pride roductsthat consistentlfulfil requrements.2.

7、2 eqiremnt of qalitymngnt systems andrqumnts fr prducsTeIO 90 amily distiushs enriements for quaity magentsysemsand equrementsfor pduc.Reqireens o qualty anagee systemsre spefe nISO901. Rqiremens or qualit magement systems neic ad applicabe o oganizatin iany inustr o ecni stor egardles of the feed o

8、dut categry. S 1 telfdoes nt esali reqremnorpuctsequiremenfoproductsan peifed by ustoms or y the oraiaion n nticipationof customrequirmnt， r by regulation. Theuirmefor poducts nd nomecss associacesss nb contiedi, fr exmpe,technical speifictis， duc sandard, process stdrd,otractual agreemntsa regutory

9、 euirements.23 Qulity magen syems appraAnapproach to developinand impementig ualtymagementsystemcnsts of veal sepincludig the lowng：determni th neds and expectatin o custmrs and inretd paties；estalsingthe qualtpoicyad qulit objective f heoazatio;dterminin h prcssa resnibiliiesecessary to tainh quali

10、ty bjectivs;detemin d rovidg h rsoucs estbihingmetds o eaurethe etiveness and fcny of ech ress;applyn thseeaus todemine theefectienes ndeffcienc f ea proess;deerminingmeas of preventing nononformities nd eiminatn eir cues;estblisingan plyinga proes focontinual improveme f the qalitymanaementsystm.ch

11、 approc s asoappliable maintanngand mprvingan xistng quatmanagmnt syse.An orgnization ta aots he bove aproach rea confidece in the aabiliyofitspocesssandthe qali of idct, and rvie bass for ontinal ipvement Ticn lad to incrasd sifto csmers a othe inereserties and tothesccs o the orgaizaion2.4 Tprcss

12、apocAy activity,o et of actiies， tha ues esuresto tsfrm inputs to outpt can b coniderdas a proces. organizations touctn efivly, they hav tidentify and mnag merous interlted ainteractingprcese. ften, he outpu from one prcesswil drectly orm the nput into nexprocs. The systematic identificion nmanagemn

13、 of the proces employed ithnn rgantin ad partcarly th ierations between suh poceses sreferdto a th “pros approah.”The ntenof his Internainl Standar s to enoure the aoption of te procesapproc to nage an ornztion. gure 1 llustates the rocess-ased quaity maagement sstem descrb he S 000fmily standards.

14、Tis llusrtio hows tha intete paries lay a igniicant rle in prvidng inputs to aization Mirng he atisction of intesed paries reuies the evaluatin ofirmatio relating to the perception f ntereste pties o te exten t hic hei ndsandexpctatn avebee e.The model sown Figur1 es notsow prcese at daie el.2. Qual

15、y policyand qalt objeciveslity picyandquait objectis aresablhe o pid a fo todic e oganatin thdetemne te desire rsuls and ssist he oraizan to appy itsresources t cieve hese rsuts. heqality piyprdes aframework sabsig ndreiing utbjectv.The ualit objectives need to be cnsisten wi he qultypolicy and the

16、comn to cotinua improven, an thir achievemen needs t e masurable. Theahievent of quity jecivs ca ave apstivempat o roducquit, oprtinaleffectives and finanil pformancan thu on the stisfactn adcfidece ointeeed arties.OTESeents in arenesesdo not appl o ISO 00.Fiure 1 Mode of a pross-bsequity mnagment y

17、ste2.Roleofop mnageent ihin the quaity manageent ysemTrougheadeship , top anaemnt can crete an nvionment where peopleare ullyinvld nd i whha quait maagmensste can opeate effectivey. Thequalitmangemnt principe （ee .) can e usdy topmaageen s the bsis f it rle,whichs allows:a) t establis nintan th quty

18、 policy an qlity jctieof the oraization；b) t rmote the qalit olic ad ualityobetis throuhout te organzation toincras aweness, motiatio ndnvolemen;c) tensurefcuson smer reqireents thoghout the organization;d) to ensure that apprprite pcesse are implented t enaleequirements of csomrs andthr inerestd pa

19、rtiestobe fulfilldad ual bjcives to be ahieved;e) tensu ht n effectiven efient qaltygement system is tablihed， mplementend mantadto achevetheeuality ojectives;f)o ensure the aailabiy f necesay resuces;g) t review thequaliy mangmentstem perdclly;h) to dcide on action regaig t quty oliy an qualyectve.

20、) to decide onaciosfor mprvemet of th qualit mnagement sstem2.7 Documenta27.1 Valuof documenttionDocumentai eabes communicain nt ad onsstency ofact.Is cnibtes for chieveet oconority o usomerequirmentand quait ioement,pvi o apoprte training.peatabiity nd traeility，pvio obectie eience, andvaion o the

21、effectivess ad ntinuing uiabilty of the qualiy maagmet sstem.Geeration f doentatn oldtbe end n itself but hoube avalueaddinactivty2.7.2 Tys of docmt ued inqit agementsystemsTfollowing typeof doumntar ued n quality manageent systs:a) oumentsthaprovid csient nfomaton， bo intnall ad exernall, abotthe r

22、gaizaos quaitmanametsysem； such docmntse efred to s aliyals;b) men tat descbe ow te quality anagemesystes pplied t pecfi rduct, ojector contrct; shdocments ae rfred to aqity plans;）documnttatin rqureens； uch docuents rereerred oas spiains；） documen stting recomenats r sgestins;scocmnts are eferredto

23、a gideins；) ocuments tat provide nformatibot h to perorm ivitiand prcsescnsientl； such documents an include ocument prdures, work nstructo and drawings;f) documentsth rovidbjective evienceofactivities perormdo sults achied;uchdouments e refere to arecordsoranization etermie th etent ofdocumentio req

24、ured ad h medi t be ued.his depends n fcts sch as theye d iz f e orgnzatio, thecoplexitan interactin o proesss, th cmlexit o products，cusme reement, thpplicl reulato rquirements， teemonsrated abilty of personel,ad he exteowih it inecessay odonstrate fuilent oqaliy managment sytem reiremets.2.8 Ealua

25、tin qualy magemnt ystem281 vauaing processes withn te qualt magemetsystemWhn ealuatngqualiyanemetsystms，ere are four basicquestnsha soul b akedn relationce eingeluate）I h rocess ienifed ad apprratel dfined?b) Ar responsibilitie assigned？） Arehe procdues imlemented an aained？d) Is the ocess ffectiv i

26、n achievin he equirerests?Thecllciveaswerstte above quesions a determieth eult of th eluation.Evaluain f a qalit maaement yseman vary i sopeand enompas a ang o activiies,suhs auditig a rewn qulit manaement sytem,and sefasesets.8.2Audingthe qualt magn sysmAut re uso dermn te extent to whic the quali

27、mangemn stem requieetare ulfilled. Audit findings ae used to sess h fctiveess of t quit maagement stmand to dentif ootunte for imprvet.is-arty auit re conucted ，r n behalof, t orgniaio itself or inernalpres ndcn forhe bss or an orgaains sfdeclaraon o onformity.Scond-prty uare cnducted y ustoers ofte

28、 oraization o by othe pesons on bhalfof hecusomrhird-party auits are conducted by extrnlnependn orazons. uch ogaiatios, usull accredied, provide cerificatin o egistaton o onrity withrquirement uh a those ofIS 901.IS911 rovides ginc on aditing.283Reieing the qulmanagemen ytemOne olef to magement i o

29、cary out reulasematc evluatin f the suitabilit, effectienssand fficiency oftheqali manaemnt system whsec to he ultypolicandulty obctves. his eview ca inclue osideaion o te no dapt te quality pcand bjective in esn to cngingeed ad expctatins of intese paties.Th rw incesermnatio ofhe ne fo ction.Aost h

30、esurs of inormation, adit reporsareusd for evi o the qali anaemn syse2.8.4 SelfasssmetAorganztios self-asesst is a compensiveadsysematieie othe orizati ctivitie a uls referencd agaist he quity manent system or a model of xceence. Self-assessent a povide an overal view of te peormance of te ognizaton

31、 a h dege of muritf the uality anagement stemIt can lshe to idnti arserin povemet in he rganian and dermepriorits2.9 ontinual mprovementThe ai f continu mpoeent of uaty managent sym is to increas th rbabilityf enhancing e sston ofcustmes ndother nteretdparte. Actnfr impremnt nclde hefollowing:a) aly

32、singan vluating theexsting sittion o enfrea for improent；b) establisig the bjtive r mprovement;) seaching for poible oltns taievehe ojecives;d) valting tes olins aaking a selcto;e) ilementing the seleted solto;) measuring,ifyig,analyig and evauang resls of the implemetint determita te objtive have b

33、een me;g) formalizng chag.Reults are rview, s ecessay，to detmin furte pportunitesr improvement Ithi y, imprement sacontnu acivity. Feda fom ustmr and otherespatis， ts ad revew of the qlitymaneent sysem cn alo b used to identify portunie for imrovent.10 Rl ofsatitical technqueThse of stitial eciqecan

34、 hin undrstandn varablty, and hereby help orgition to sorlems nmove fctivenssandefficieny. Testehns alolitte bettere of aalabldata toassist i deision maing.Variabiliy cn e obserd I he baviouandoutcome of man aiie， evenndrcotions f apparentstblity. Such varbilit can be observed in measurable caraeris

35、ticsof roduts ad processes,ad ay esee existatvais sae r he liecycle of poductsfrom mrk researho ustomer serviced inal dipoa.Sttisticl techniqu cn help to meaure,scibe，aay, ierreandmelsuh ariabily,ee with reatiely limid ountof dt. Satistical analyssof sch daa cn helpto pridebettrunrtin o the atue,ten

36、t and cusesofvariability， ts heling sol een pevent roblems tha may reult fom such riail,and mot continualmprvement.Guan on statitcal techniques ualit magemet stem giv inO/101.11 ualty anaement sstems ad other mnmenysem foesTh qulity anaemet ystem is tat pat of te orgaitios mnaemet stm tha ocuses on

37、the acievent ofreults， nreatont he qualiy bjectie, o atisy the neds，execttos n reqireen inested pries, asapproprte Teuaity objectiv comlementother obectves of the rganizatinsch as se rated to rowth, funding， profaility,th iromnt ancupainal heath adsafty.Th vrios parsof n rgnizaions magemen ytm might

38、 itegratd, toter wih the alitymanemen ystem,int a single anaement sse sing omon lemnts.his cn facilitaeplannig,allatin of esources, defiitionf complementry jecives and valationoftheoverall effecienes o hrganizaton.he organzats manaemet syseanbe asessed agnt the ognzatonsmagementst rquen. Theagement

39、ysem can so be uited ginst terequens of nerntional Standad su as ISO901 d ISO 40:1996. Thes mageent syste audits an bcarred out seatel orin obination.2.12Retonship bewen qual nmensyst andexcellence oeshepproaches f alit managemet sems gien int ISO900 ly of standrds and in orgaiaial exellenc modes ab

40、asedon common pinipls. Boh proaches a) nbe an oranizationto entiy i tengs a weknesses,b) contain proviion fo evauato agintgenerc mols,） rovide a basis focntinual imrovemet, nd d) cntai pvison fo xernalecognition. edifernce betweenhe approacheo he ulity nagemnt systmsn he IO000 familand the exeencemd

41、els ies in tei scope of appicatinTO 9000 amilyof standadproids rquirmtsfoqualitymaagemt systs nd guidnce f erforace impoement;evauaton of qualit manamnt ysemsdetemnesfufillmet of hose rquiementsTh celenc modls continriterathat enbl comparative evuaiono orgaiztional erforman d ts is applcbet alativit

42、ie an al ineested partie of an orgnitio. Asessent rteria n ecllencevid abais for an orgnzton mpare its perome wih he prformanco other oranizatin.3emsafinitnsA trmin adefinition ornote wh is define seeit clusei diated b bodc ollwed its ntrynub inarentss. Such bodfaeterm m be relace nthe efinition y c

43、mlte defniin. Fr eampe：rot(34.2） i defnd “resltf ce (.4.1）”;prcesis efieds “set o intereted or itecti actviies wch anorm nts io outts.”I the trm “prss” is repaced by ts enitin, as fllo:prouct then comes “reult of aset oirlated r intrctng activitis whichtanfor iputs intoutts” concept limied tospeciae

44、aing in apartular contextisidicedby egntngthe subject fe inangebrakts, ， efre th defiitn, for exe,ehncaleert （3.9.1）.3.1 Trms elating to qualty.qulitydege to hicha et o inherencharacteristis(.5.1）ulfil ruimet (3.1.2)N 1 The te “qualiy” an be ud wth adjtves such as poor, goo rexlnt.NOE 2 “Iherent”, s

45、 oppoed to“assigned”, means exstig smhing, eseciallys pemanentaacteristic.2 reuiremennee orexpetatin tat s satd, genaly impied or obligatryNOT1“enrally implied”means hat t iscustom orcmmon actce otheoranation (3.), its csoers (3.） a the terested parties（3.3.7）， tha he nd expetation under onsideaion

46、s iplied:Oqualifier a b used todenote a spcifc tye o reuirement, .g. prouct reqiremt， quality mngemet reuirement, usoer reuiremeT A spcified reuirentis one wichissated,for examle,na doent （3.7.2).T4 euirents can be generate by diffet intereste parie.1.3grdeceory rankgivn o differn quality requiremen

47、ts （.12） fo produt （3.4.2) pocesses （34.1) or tems (3.1) hainte sam fuctionl useEXAMPLE Cls of alie tick and cagory of hotelin ht guide.NOE Ruiremts can be generated ydfent ntersed partes.3.14cuoer sisfcticutomers perception of the degre to hic the custoers reqirements （.2)haveen ffldNOTE1 Cstoer om

48、ais are acmmon idiatoof low customeratisfaction but eirabsece des nonecesrilyimply hig cstomr safactionOTE2Eenhencustme reuirementsave been reed witthecsomr and fuflld, thi doe ot neessailyenue highcser satsfactin.15 capabiliybiliof nrganton (33), sstem (3.2.1) opress (3.4.1)tralizapuct (32) thatwil

49、fulfile rqirment(31.）fr ctEPres pblt er hfild osttistics are dfined nSO 353.32 ermseltig to mnagee.2.1 systemset o ntrrelat or interacting ements.2 anagement ystem syse (3.) to etablh polc d objetives d tchieve thse objectieNOT Amaagemen syste o an oganizaion (.3.) cn ncdedferent nagement syt, uch a

50、 qulityanagmetsyste (.2), finacil nagement sstem or annvronmentl angmt ste.3.3uaitynage systemmaagemesyte (32) to irt and contro a oganizain （3.1） it eard to qaity(31.1)3.2 quaty polcyoveall intetins and dirionof an orgaiztion(3.31) eatd to qualiy （.11) as frall xpressed b omanagemet (327)NOTE1 Gene

51、ll th quality olicy s osisnt withhe oeral polcyof aization d ovid a faework fr thesettin quali obecivs (3.5）.NT Quaity magment pinciles prsentednthisIntrnaonalStandard an form abasis frthe stishent of a qualty oliy (S 0.2)32.5 ulity objectvsoethngsought， raie for, elated to quality (3.1)NOTE Qualiyj

52、ctivesae geerally based onthe ognizatnsquay poic(34).NTE Qualtojectves re geerally speiied for rlvat unctsdeve in th ganizaion （3.31)32.6memetcoordnate atitio diect an contrlan orgnizaio (3.3.1)NOTE In English, term“managment” meims eferopeple, i.e. a eon r oupof peope it auhor resposibiity for he c

53、ndutand ontol f aniation. Whe“mnament” isus n this ense it should alwasbe sd with some frm f qualifier to avidnfusoith h cocept “anagent”dind above. Forexame, “mangmenthal” i depecatd wres“top manageen (3.2)shll ” i ceptabl.3.7top manaementeson o goo people whoirect nd onoan oanization (31)t the ghe

54、t levl3.8qualit mnamecoordinaed acivitie todirta cotol an ganzati (3.3.1)with regardt qait (3.1）NOTEDirectin d conrol with regrd toquality enrally ncludes estahment oft qualty pl (3.4）and qulit ojeves (3.2.), qualty aning (3.9） qualit control (.0)， quality assranc (3.2.1） and qualty mroemen (3.2.2).

55、2.qualty lningpart ofquiy manaemnt (.2.8)ocsed stin uality bjectives(3.2.5) and spiying ncesaoeriona proesses (34.1) ndreltdresoure tofulfilthe qualtybjctivesOTE Estbshngqaliy ans (.7.5） cn be prtof quaity planning3.2.10uty controlprt o qaitymanagement（2.8） fcuedonfulfiling qualit requirent (.1）3.1q

56、uality asunceprtof qua managent (3.2) focused on pviding ofience tat qualityeqireents (3.1.2) will be uille3.2qaityimprovmetpatof quaity mangent (.2） focsedon inreasing the abiliy o fulfll qualty reuireet (3.12）OTE Theruirenscn elated to y aspetsucsffectivens(3.1）,eficiey (3.2.1） tracabilit (.5.4）.3

57、.213ntnul impovemnturin actityto incr he abily to fufill euiremets (3.1.2)NTThe proces (3.4.1） of establisin cives an iningoppotuties for imroent isa otinual process through eus o adtfidin(.95)and audt conclusio(.9.6）， anlysis f daa, naent ree (.8) other means an gnrally ea to coretiveactio (3.) o p

58、rventve an (.6.4).2.14fctivenesextentohich pland atvities ae realied adplaned reusache3.15efiiecyretonship btweente reslt ahievedand thrsouce used33 Terms lag to oraization3.1oganizatin grouof peoeadfaciliteswit n arngment espoibiltes, ate and reltioshipsXML Coan， coorati， firm, eterprse， initution,

59、 chaty, sole trer, asiaion, orpts r coiatioereof.NOE Thearangme is genally orde.NOTE 2A organzation canbe ublicr riat.NOE 3 hs einti iid forh urposes ofuality mangentsystem(.2.3) nards Theterm “rgniaton” i efined difertl i I/IEGue2. .32 gnizatinal sttuearanemet of repoiblities，atoitie andrelinship b

60、etween pepleNE 1h arrangeent s enrly odry.NOE2A fra xprssion of tninaltrctue iten ovided in ualityanual(.7.）o a qality lan (37.5) fora projec(3.4.3).OE The coef an organatia structure ca iudrelevan neraces to extrnl gzaon (33.1).3.33infastrcture sstemo faciities， equimen andservies neededor the opat