質(zhì)量管理系統(tǒng)–根本性和詞匯量

ISO900０：（Ｅ)Qｕalityｍaｎａgｅmentｓyｓｔｅms–Funｄamentalsａｎdvocabuｌary1ScoｐeThｉsＩｎｔerｎatioｎａlStaｎdarddｅscｒiｂｅｓfunｄａmｅntalsｏfqualiｔymanａｇementsystemｓ,wｈｉcｈｆormtheｓｕbｊecｔoftheＩSＯ９000fａｍilｙ,ａｎddefinesrｅlateｄｔeｒｍｓ.ThｉｓInternaｔiｏｎａlＳtandａrｄisappｌicaｂlｅtotheｆollowｉng:ａ)orｇａnizationssｅe(cuò)kiｎｇadvantagｅthｒoughｔhｅiｍpleｍｅｎtationｏｆaqｕalitymanagementｓystem;b)orｇanｉzatioｎssｅe(cuò)kingｃonfｉｄencefromtheirｓupplｉersｔhaｔtheiｒprodｕcｔrｅquｉrｅmentｓwillbesaｔisfiｅd;c)ｕsersoftheｐroducts;d)thoｓｅｃｏncｅｒnｅdｗiｔhamutuａlunderstaｎdiｎgｏfｔhetｅrminoloｇyｕsedinqｕａlｉtｙmａnagｅment（e.g.sｕpplieｒs，customers，reguｌators);e)thｏｓeｉｎｔeｒｎalorexｔernaltotheｏrｇaｎizａt(yī)ionwｈoasseｓｓｔheｑualitymanaｇemeｎtｓｙstemｏｒauｄitｉtfｏrcoｎfoｒmitｙwｉththerequｉｒeｍｅntsｏfISＯ900１（e.g.auditorｓ,reguｌators,certifiｃation／ｒegiｓtｒationbodiｅs);f)thoseinteｒnalorｅxterｎaltｏtｈｅorgａnizatｉoｎwhogiｖｅadviｃeoｒｔraｉninｇｏntheｑｕａｌitｙmanagｅｍｅntｓysｔｅmappropriaｔeｔｏthaｔoｒganiｚatｉｏn;ｇ)ｄｅｖelｏperｓofrｅlateｄsｔandards.２Fuｎｄamentalsofqualitｙｍanaｇemｅntsｙｓteｍs2．１ＲａｔionaleforqｕalitymanagementsysｔｅmｓQuaｌitｙmａnａgemｅｎｔsysｔemscaｎaｓｓisｔorganiｚａt(yī)ｉoｎsinenhanciｎｇcuｓtomeｒsatisｆａctiｏn.Cusｔoｍerｓrequｉreprodｕctswithcｈarａｃｔｅriｓtｉcstｈaｔsａt(yī)isｆythｅirneedsａndｅxpｅcｔatｉons.Theｓeneｅｄsandexpectaｔionsａreｅxpressedinprｏductspｅcifｉcatioｎｓanｄcolｌｅｃtiｖeｌyreferredtｏascｕｓtｏmerrｅｑuiｒｅmｅnts.Ｃuｓｔomｅrｒeｑuiｒeｍentｓmayｂespeciｆiｅdcontraｃｔuａllybytｈecuｓtoｍeｒormaybedeteｒｍinedbyｔhｅorgａnizatiｏnitｓeｌｆ.Iｎeiｔhercase,thecuｓtomeｒultimａt(yī)elydetｅrmｉnesthｅaccｅptabiｌityofthｅproｄuct.Becausecusｔｏmeｒｎeedｓandexpectａｔionsaｒechａnginｇ,andbｅｃaｕseofcompetiｔｉｖepreｓｓurｅsandtechｎicａladvaｎces,orgaｎiｚatiｏnｓaredrivｅntoimprovecontinuallyｔheirpｒoｄuctsanｄprocesses.Thequａlitymaｎagementsyｓtemapｐroacｈｅnｃouragesorｇaｎizａt(yī)ｉonstｏanalysecustomｅｒreｑuiremeｎｔs,defineｔhｅpｒocesｓesthaｔｃontriｂutｅtotheａchｉevemenｔofａprｏductwhicｈisａｃｃｅptabletothｅｃｕｓtoｍeｒ，ａndkeeptheｓｅpｒocｅsｓesｕnｄerconｔｒｏｌ.Aqｕaｌitymanaｇｅmｅntｓystemcanproviｄethefraｍｅｗorｋfoｒconｔｉnuaｌiｍprovemenｔｔoiｎcrｅａsetheproｂabｉlityofｅｎhanｃｉngｃustoｍerｓatisfactioｎaｎdthesatisｆactionofoｔherｉnｔeｒestedparties.Iｔprｏviｄesconfiｄenｃｅtoｔhｅorｇanizatiｏnanditｓcustoｍersthatｉtisablｅtｏproｖｉｄuctsthatcoｎsiｓteｎtlyfulｆilｌreqｕiｒeｍents.2．2RｅｑuiremｅnｔｓofquａｌitymanagementsystemsandrequirementsｆｏrproducｔsTｈeＩSO９０00fａmｉlydiｓｔinｇuiｓhesbetwｅe(cuò)nreｑｕirementsｆorqualiｔymanageｍenｔsｙsｔｅmsandrequiｒementsｆorｐroduｃtｓ．ReqｕirementsfｏrｑualityｍａnagemｅntｓystemｓarespeｃifiｅdｉnＩSO９０01.Ｒｅqｕiｒeｍｅｎtsforquaｌiｔymanagｅmentsｙstemsaｒegenericanｄapｐlicabletooｒganiｚationsｉnanyｉｎdusｔryｏreconomｉcｓecｔｏｒregarｄlessoftheofferedpｒｏdｕctcategoｒy.ISＯ９０01itsｅlｆｄoｅsｎｏtｅstabｌｉｓhrequiremeｎtsfｏrｐrｏductｓ.Ｒequiｒｅｍｅnｔsｆorproductｓcanbespecifiedbycｕstoｍｅrsoｒｂytheoｒganizatioｎinａnticipatｉonofcｕsｔｏmeｒrequireｍents,oｒbyｒegulation.Theｒequｉｒeｍｅｎｔsｆｏrｐrodｕctsａnｄiｎsomecasｅｓａsｓociａceｓsesｃanbeｃontainediｎ,forｅxampｌe,ｔechｎicalsｐｅciｆicatｉoｎs,prｏｄuctstandａrdｓ，procｅssstandaｒds，ｃontracｔｕaｌagｒeemｅntsaｎｄｒeguｌatｏrｙrｅquｉrｅmｅnts.２．3ＱｕａlitｙmanagemｅｎtsysｔｅmsapｐrｏacｈＡnａｐproachｔoｄeveloｐiｎganｄimｐlｅmentingaquaｌitymanaｇeｍentsyｓｔeｍｃonsistｓofｓeveraｌsｔepsｉｎcluｄiｎgtｈｅfollowing：determiningtheｎeedsaｎdｅｘpectａt(yī)ｉonsofｃustｏmersandinteｒeｓtedｐarｔies；establｉshingthequａｌitypoｌiｃｙandqualityobjectiｖesoｆtｈeｏrｇaniｚａt(yī)ioｎ;deteｒmｉｎingtheｐrocｅssesandｒeｓｐonｓibilitiｅsｎｅｃｅssａrytｏaｔtaiｎthｅquaｌｉtyobjectives;ｄeterminingandｐroviｄiｎｇｔheresoｕｒcesｅstablishｉｎgmｅthodｓtomeａｓureｔheeｆfｅctiｖeｎessａｎdｅffｉｃienｃｙｏfeacｈpｒoceｓs;ａｐplyiｎｇtｈesemeaｓurestodeterｍｉneｔheeffｅcｔivenessaｎｄeｆfｉｃiencyｏfeacｈproｃess；determiｎingmｅａnｓoｆprevenｔiｎｇnonconformitｉeｓaｎｄeｌimｉnatiｎgtheircauseｓ;establishingａｎdappｌyingaｐrocessfｏrcｏｎtｉnualimproveｍenｔoftｈeqｕaliｔymanａｇeｍentsyｓteｍ.Ｓuchanappｒｏacｈisａlsｏapplicablｅtomaiｎtaininｇandimpｒovingaｎdexisｔiｎgｑuaｌitｙｍａｎagｅmentsystem.Anｏrｇanizatiｏnthatａｄopｔｓtｈeabｏｖｅapproachcrｅatｅｓｃonfidenｃeinｔhecａpabilityofｉtsprocesseｓandthequalｉtyｏｆitspｒoducｔｓ，anｄproviｄｅｓabasｉsｆorcontｉｎualｉｍprｏvｅmeｎｔ.Thisｃanlｅａdtoｉnｃreａｓedsａｔisfaｃtiｏnofｃuｓｔｏmerｓaｎdｏｔherintｅrestedpartiesａnｄｔoｔhｅsｕcｃｅssｏftheorganiｚation．2.4TｈｃessapprｏachAnyａctivｉtｙ，orsｅｔofacｔivities,ｔhatusｅsresourｃｅstotｒaｎsfoｒminputsｔooutputscanｂeｃｏｎsideｒedasａprｏcess.Fororｇaｎｉｚatｉonstofunctioｎeffectively，theyｈａvetoidentｉｆｙandｍaｎagｅｎumerousinｔｅｒrelatedandｉnteractｉnｇproceｓseｓ.Oftｅｎ，theoutｐutfroｍoｎｅpｒｏcｅsswilldirectlyforｍthｅinｐｕtｉnｔｏｔhecess．Thesｙsteｍａt(yī)iｃｉdenｔifｉcａｔiｏｎａndmaｎaｇemenｔｏｆthｅｐrｏｃｅssｅsemｐloyedwithiｎanorｇａｎizａt(yī)ionanｄｐartｉｃuｌaｒｌｙｔhｅinteracｔionsbｅtweenｓuchpｒocｅsseｓiｓｒeferｒedtoａsthe“proceｓsａppｒoacｈ．”TheiｎtentｏfthisＩntｅrnationalSｔanｄaｒdistoencouｒａgeｔｈeadoｐtionｏftｈeprｏcessapｐｒoaｃhtｏmanaｇeaｎorganizaｔion.Figｕｒe１illustrateｓｔhｅprocess-ｂａｓedｑualｉtyｍaｎａｇeｍentｓysｔｅmdescribedtheISO9000fａｍilystaｎdards．Thisｉllustraｔｉonｓhowsthaｔinｔeresｔｅdpａrtiesplayａsｉgnificａntrｏleｉnprovidｉnginputstotｈeorｇaｎization.Moｎitｏrinｇthｅsａt(yī)ｉsfａｃｔionｏfｉnｔerｅｓｔedｐａｒｔｉesrｅquｉreｓｔheevalｕationrmatiｏｎreｌaｔingtotｈeperceptioｎofinteｒestｅｄpartｉeｓａstｏthｅe(cuò)xtenttowhichthｅiｒneedｓandexpecｔaｔioｎshavebeenmet.ThemodelshoｗｎｉnＦigｕre１ｄoeｓｎｏtshowpｒｏcessｅsａｔadetailedlevel.２.5QualｉtｙpｏｌicyandｑuａlityobjectivesQualitypoliｃｙandqualiｔｙobjectivesareestａｂlishｅｄｔoproｖideaｆocustodiｒecttheorganizaｔion.Bothdetermineｔｈedｅsirｅｄresuｌｔｓaｎdassisｔtｈeｏrｇａnizatiｏnｔoapplyitsｒesourｃestoachieveｔhesｅresults.Tｈequaｌitypolicｙprovidesａframｅwoｒkforestａｂlishinganｄrｅviewingquａliｔyobjectｉves.Thequalityobｊectivesnｅe(cuò)dtｏbeconｓｉｓteｎtwithｔhｅqｕalitｙpolicyandthecommiｔmentｔｏcoｎtｉnｕaliｍpｒovement,ａndtheirａchiｅvemenｔｎeeｄsｔobemeasurabｌe.Ｔheachiｅvｅmentｏfquaｌityobjecｔivesｃanhaｖｅaｐosiｔｉveimpaｃtｏｎprｏducｔquality，opｅrationａlefｆecｔｉveneｓsanｄfinaｎcialpｅｒfｏrｍanceandtｈｕｓonthesaｔisfaｃtionａndcoｎfidenｃeerｅｓｔedpartｉes.ＮOTEStaｔemｅntsinpａｒenｔｈｅsｅｓdｏnotapplｙtoＩＳO9001.Figure1–Mｏdｅｌoｆaprocｅss-ｂasedquａlitｙmanagｅmeｎｔｓystem2.６RoleoftｏpｍａnaｇeｍentwitｈｉnｔhequａlitymａnaｇementsｙstemＴhroughleａdershｉpａnｄaｃｔｉons,ｔopmａnagementcaｎcrｅatｅaｎenvｉronmeｎtwｈerepｅoｐlearefullyinvoｌvedａｎdinｗｈichａｑuａlitｙｍanageｍentｓystemcanｏｐeｒａｔeeffectｉｖely.Tｈeｑｕalitymanａｇementprinｃipｌes(see0.２)cａnｂeuseｄbytopｍaｎageｍｅntasthebａsｉsofｉtsroｌe,whichisａsfollows:ａ)tｏeｓtaｂlｉｓｈandmaiｎｔａintheｑuaｌityｐoliｃｙandqｕalｉtｙｏbjectiｖｅｓoftheorgａｎizaｔion;b)ｔｏｐromｏteｔhequalitypｏｌicｙandｑualitｙobjectivesthｒoughouｔtheｏrｇanizaｔｉontoincｒeaseaｗaｒeness,motivatｉｏnａｎdinvolvemeｎt;c)toensurｅfｏcｕsonｃustｏｍｅrｒequｉrementsthrouｇhｏuｔtheorganization;d)ｔoensurethatａｐpｒoｐrｉａｔeprocesｓesaｒｅimｐlｅｍeｎteｄｔｏenabｌｅｒeｑuiremｅntｓofcｕstoｍｅrsandｏtherｉnterｅstedpａrtｉeｓtｏbｅfulfilｌｅdandqualityobjeｃｔｉvestobｅaｃｈieved；e)toensurethataｎeffectｉveandｅfficieｎtqualityｍaｎagemｅntsysｔemisestａblished,imｐlemｅntedａndmａintainedｔoachievethｅsequaｌityobjｅcｔives;f)toeｎｓuretheavailaｂilityｏfnｅｃｅｓsａrｙｒesources;ｇ)toreviｅｗthequaliｔｙmanagｅmentsｙｓtemperｉｏdicａlｌy；h)todeｃideoｎａctionsregardingｔｈｅquaｌｉtypｏlｉｃｙａndｑualiｔyobjｅｃｔivｅs.i)todeｃｉdeonａｃtｉonsforiｍprovｅmｅｎtoftheｑｕaliｔｙｍanaｇementsysteｍ.2．７Documentatioｎ2.７.1ValuｅofｄocumeｎｔaｔionDocumentatioｎenablescoｍmunｉcaｔionoｆintentaｎdｃonsistencyofacｔion.Itｓｕsecoｎｔｒibｕtesforachievemｅnｔofcｏnformitytocustomerreｑuiremeｎtsandqualityimprovement,prｏvisioｎofaｐpｒoｐriateｔｒaｉniｎg．reｐeatabilityandtracｅabiliｔy,proviｓioｎoobｊｅcｔiveeviｄence,aｎｄevａluａt(yī)ｉonoftｈeｅｆfeｃｔivｅｎessadcontinuingsuitabilityofthequalitymａnａｇｅmｅnｔsyｓtem.Geｎeｒａｔionoｆdocumeｎtaｔｉonｓｈoｕldnotｂeaneｎｄinitselfbuｔｓhoulｄbeａvalue-ａdｄiｎgａｃtｉvity.2.7.2TypeｓoｆdｏcｕmｅｎｔusedｉnｑualitｙmａnaｇemeｎｔsｙstｅmsTｈefolloｗｉngtypesofdocuｍeｎtareuseｄiｎｑｕalｉtymanagementsystems：a)dｏｃumｅntsthatprｏvidecｏnsiｓtenｔiｎfｏｒmation,bothｉntｅrnａllyandexternally,abｏutanｉzation’ｓqualitymanagｅｍentsｙstｅm；suｃhdｏｃumentsarｅrｅfｅrｒeｄtｏasqｕaliｔymａｎuａls;ｂ)doｃumentstｈａt(yī)descrｉbehowtｈequａlityｍａnageｍｅntsysteｍisappliedtoaspｅｃｉfｉcprodｕｃt,proｊeｃtorcｏｎtｒact;sｕchｄｏcuｍeｎtsarerefeｒredtoａsquaｌｉｔyplans;c)docｕmeｎｔｓｓtatｉngｒｅquiremenｔｓ；sucｈdocumentsaｒeｒｅｆeｒｒｅdtoaｓspｅcifｉcatiｏｎs;d)documeｎtsstatingｒecommendatｉｏnsorsuggｅsｔｉons;suｃhdｏcumｅｎtｓaｒerefeｒｒedtoaｓguidelines;ｅ)documentsthatpｒovｉdeinforｍatiｏnabouｔｈｏｗtｏperformactivitiｅsandｐrocｅssescｏnsistently;suｃhdocumentscａｎiｎcｌuｄｅdoｃumenｔeｄprｏcｅｄures,woｒkiｎstructｉonsaｎddrawｉngs;f)docuｍｅntsthatprovidｅobjeｃtiveeviｄenｃeｏｆａctｉvitiesperｆormｅｄorresultsacｈieveｄ;suchdｏcumentsarerｅferｒｅdtoａsreｃｏｒｄs.Eaｃanｉzatiｏndeｔeｒminestheｅxtentoｆdocuｍentａｔionｒeｑuiredadthemｅｄｉatoｂｅusｅｄ.Ｔhisdependｓonfａctｏrssuｃhasthetyｐｅaｎdｓｉzeofthｅorganｉzation,plexityandinteracｔｉonofｐroｃeｓses，theｃompｌｅｘityｏducts，custoｍerreｑｕiremｅntｓ,thｅapplｉcaｂｌeｒegulａt(yī)oryｒequirｅmentｓ，thｅｄｅmonstrａｔedabilityofpｅｒsonnel，aｎｄtheｅxｔeｎｔtｏｗhｉchｉtisnｅcessaｒytodemｏnsｔrａｔefｕｌfillmentofqｕalitymａnagｅmentｓystｅｍrｅquｉｒｅments.2.8Eｖaluatｉnｇｑｕaｌiｔｙmaｎaｇｅｍeｎtsｙｓｔems2．８．1EvaluatｉｎgprｏcesseswｉｔhintheｑｕaliｔymanagemenｔｓyｓtｅmWheｎevaｌuａt(yī)inｇquａliｔymanａgementsysteｍs,therearefourbasiｃquesｔiｏｎsｔhatsｈouldbeaskｅｄiｎｒｅlaｔiontoeｖeryprocessｂeinｇevaluateｄ.a)Ｉｓtｈeｐｒoｃessidenｔifiedanｄａpｐｒｏｐｒiaｔelydｅｆinｅｄ?ｂ)Ａreresｐonsibiｌitｉesａsｓiｇned?ｃ）Arethｅproceduresimｐlｅmenteｄandmaｉntaiｎed?d)Istheproｃｅｓseｆfecｔiveinａｃhieｖiｎgthｅrequiredｒesultｓ?Ｔhecｏｌlectiveanswerstｏthｅaboｖequestｉonscandetermｉnｅｔheresultofｔheevaluation.Evaｌuationoｆａqｕalｉtymanaｇemｅnｔsystemcａnvaｒyinｓcopｅandencompａsｓarａnｇeoｆactivｉtiｅs,ｓｕchaｓaｕdｉtingａnｄrｅviewingｔｈeｑuaｌitymａnａｇementsｙsｔｅm，andseｌｆ-asseｓsments.２．８.２AuｄｉｔｉｎgtｈeqｕａlitymanagｅmeｎtsystemＡｕｄiｔsareuseｄｔｏdｅｔermｉnetｈeｅxｔenｔtｏｗhiｃhｔhequaｌitymaｎａgeｍentsysｔｅmreqｕireｍentsareｆulfilleｄ.Audｉtfｉｎdｉnｇsareuｓedtoassesstheｅfｆｅctivenesｓｏfthequalitymａｎagｅｍentsyｓｔemandtoidentiｆyopportunｉtiｅsｆoｒiｍproｖemeｎt.Fｉrｓt-partyａｕditsａreconductｅｄby,oronbehａlfoｆ，theｏrganizａt(yī)ioniｔselffoｒintｅrnalpuｒposeｓandcanformthebasisfｏranorganizａt(yī)ｉon’sself－declarａt(yī)ioｎｏfconｆoｒmity.Sｅconｄ-partｙaｕdiｔsareconｄuctｅdｂｙｃuｓtｏmeｒsoｆtheoｒgaｎizａt(yī)ｉonorｂyotherpeｒｓonsonbehalfofthecustomer.Thiｒd-parｔｙauditsａｒｅcoｎｄucｔeｄbｙｅxterｎaｌｉndeｐｅndｅｎtｏrgaｎｉzations.Suchｏrganｉzations,usuａllyacｃreｄｉｔｅｄ,ｐrｏvidｅceｒtiｆiｃａt(yī)ｉonorｒegｉｓtｒaｔioｎｏfconfｏrmｉtywitｈrequireｍｅｎtssｕｃhａｓｔhoseoｆISO９001.ISO１90１１providesguidａｎｃｅoｎauｄitiｎg.2．8.３RｅviｅwｉngｔhequaｌiｔymanageｍentｓysteｍOneroｌeｏfｔｏｐmanageｍenｔiｓtoｃarｒyoutrｅgulaｒsystemａｔiｃevaｌuationsofthｅsuitａbility,ｅfｆｅctivenessａｎdeｆfｉciｅｎcyofｔhｅqualiｔyｍaｎagｅｍｅntsyｓtｅmｗithｒespeｃttothequａlitｙpolicyandqualityｏｂjｅctiveｓ.Thisrevｉewcaninｃludecoｎsｉderationoftheｅnｄtｏadaptthｅqｕaｌitypolicｙandｏbｊectiｖesiｎresｐonsetochangｉｎgneedsaｎｄｅｘｐeｃtａt(yī)ionsofｉnteｒestedpartｉｅs.Thｅrｅｖiewinclｕdｅsdeteｒmiｎａｔｉｏｎoｆthｅnｅe(cuò)ｄfoｒaｃtiｏns.Amongｓｔothersｏurcesoｆinｆoｒmatiｏｎ，auditｒeportｓarｅuseｄforrｅviewoftｈequａlitymａnagemeｎtｓｙｓtem．2．8.４Self－assessｍentAaｎｉｚation’ssｅｌf-assessｍｅntiｓacｏｍｐrehensivｅａndsystｅmatｉcreviewofｔｈａｎizａｔｉｏn’ｓactｉvitｉeｓandrｅsultsrefeｒencｅdａgａｉnstthequalitymａｎaｇｅmeｎtsystemoramodeloｆexcelｌｅncｅ.Self-assessmｅntcanprovｉdeanoveralｌviｅwｏｆtｈeperfｏｒmaｎceoｆｔｈanｉｚａt(yī)iｏnａndｔhedegreeofmaturityｏfthequａlｉtymanagｅｍｅntｓystem.Iｔcanalsohｅlptoｉdentifyａreaｓｒequiｒinｇimpｒｏｖemeｎtinｔｈeorｇａnizationaｎｄtｏdeterｍineprｉoritiｅs.2.9ConｔinｕalImprｏveｍentTheaｉmｏfconｔｉｎualimｐrovｅｍｅntoｆaqｕalｉtymanageｍentsystemiｓtoiｎｃreasetｈｅprobaｂiｌｉｔyofenhaｎcinｇtheｓatｉsfacｔionofcusｔｏmersａndotheriｎｔeｒesｔｅdpａrties.Actｉonsｆorimprovementinｃｌｕdeｔhefｏｌｌoｗing：a)anaｌｙsｉnganｄevaluａt(yī)ｉｎｇtheexｉstingsiｔuａt(yī)iontｏidｅntｉｆyａｒeａsfｏｒimｐｒｏvｅment；b)ｅｓtａbliｓｈiｎgｔheobｊecｔｉveｓforiｍproveｍｅnt;c)seａrｃｈｉｎgfoｒｐosｓiblｅsｏlutiｏnstoachｉevｅtheobjeｃｔives;d）ｅvaluatingthｅｓesoｌutioｎsandmａｋinｇaｓeｌection;e）ｉmplｅmｅntingｔhｅｓelectedsｏlution;f)measuring,veｒiｆying，anａlｙzingａｎdevａluaｔingresultsofｔheiｍpｌｅｍｅnｔationｔodeｔerminetｈａｔtheobjｅｃtｉveshavｅｂeenmet;g)foｒmaliｚiｎgchanges.Resultsarerevｉewed,asneｃesｓaｒy，toｄｅtｅrmiｎefurｔheｒｏpporｔunitｉesｆorimprｏvement.Inthiｓway,imｐrovemenｔisacoｎtinuａｌactｉｖiｔy．Feedbaｃkfｒomcusｔomersanｄｏtherｉnteresｔｅdpａrtieｓ,aｕdｉtsａnｄｒeｖieｗofthｅquａｌｉtymanagemenｔsystｅｍcanaｌｓobeusｅｄtｏｉdｅｎｔifyopｐoｒｔｕnｉtiesforimprovｅｍｅnt.2.10RｏlｅofstatisticａltecｈｎiquesTｈｅｕｓｅofｓｔatiｓｔicaltechniquesｃaｎheｌｐinｕnｄerstaｎｄinｇvariａbiｌitｙ,anｄtｈerｅｂyｃanhelｐorganizaｔiｏnｓtoｓolveproｂｌｅmsanｄimprｏveeffｅctiｖenessaｎdefficienｃy.Ｔhｅsetechniquｅsａlsofacilｉtatebetteruseｏfavaiｌabｌｅｄａt(yī)atoasｓistindｅcisiｏnmakinｇ.VaｒiabｉlｉtycanbｅoｂserveｄItｈｅｂｅhaviouraｎｄｏｕtcｏmeofｍanyactiviｔies，evenundeｒcondｉｔｉonｓofａpｐarｅｎtsｔaｂiliｔy.Suchvarｉabiｌitycanbeｏｂsｅrvedinmeaｓｕrａblecharacｔeristicsoｆｐroductsａdprｏcｅｓsｅｓ,ａｎdmａyｂeseentoeｘiｓtaｔvarioｕｓstａｇｅsovｅrtheliｆeｃycｌｅｏfproducｔsfromｍarkeｔｒesearcｈtocustomeｒsｅrvicｅadfinaldisｐｏsａl.Statisticalｔechnｉqueｓcanｈelpｔomｅasure,ｄescｒiｂe，analysｅ，inｔｅｒprｅtａnｄｍoｄelｓｕchvariａbｉliｔｙ,eｖenｗitharelatiｖｅlyliｍitｅdamouｎtｏfdaｔa.Statisticaｌａnaｌysiｓoｆｓｕchｄatacanｈｅlptoｐrｏｖｉdeabeｔtｅrundeｒstandingｏfｔhenａt(yī)uｒe,extentandcauseｓｏｆvａriabiliｔy,thushelpiｎgｔosolｖｅａdevｅｎpreventprｏbｌeｍｓtｈatmaｙｒesultfroｍｓucｈｖariabilｉty,aｎdtｏｐｒoｍｏtecontinualｉmproｖemｅnt.GuｉdａｎｃeｏnｓtaｔｉstｉcaltechｎiquesiｎａｑualｉtymanａgemｅｎtｓｙstemisgiveｎiｎＩSO/TR1001７.2．１1QualitｙmａnageｍenｔsysｔｅmsanｄｏtherｍａnaｇementｓystemfｏｃusesＴhequalitｙｍanagementsyｓｔemｉsthatpaｒｔｏftheoｒgaｎizａt(yī)iｏn’sｍａnａgｅmentsysteｍthａt(yī)focusｅｓontheachievementｏｆreｓulｔs，inrelａｔiｏｎｔｏthequalityoｂjｅctivｅs，ｔｏｓａt(yī)isfytｈｅneｅds，expectationｓandrｅｑuiｒemｅntsoｆiｎteｒesteｄｐarｔｉes,aｓaｐprｏpｒiaｔe．Theｑuaｌityｏbjectiｖｅscomplemｅntotheｒｏbjeｃtiveｓoｆtheorganizａt(yī)ｉｏnｓｕchasthosereｌａｔeｄtogｒoｗtｈ,ｆｕndinｇ,prｏfiｔabiｌｉty,theeｎvｉｒoｎmenｔandoccupaｔiｏnａｌhｅaｌｔhandsafety.Ｔhevaｒioｕspartsofanorganｉzａt(yī)ion’ｓmaｎaｇementsｙsｔemmightbeintegrated,ｔｏgethｅrwiｔhｔhｅqualｉｔｙmａｎagementsysteｍ,intoasinglemａnagementsyｓtemusiｎgｃoｍmｏnｅlemｅnｔs.Tｈｉｓｃanｆacilitatepｌａnniｎg，allocaｔｉonofreｓourｃes，defiｎitｉonｏfｃoｍplｅｍｅntaｒｙｏbjeｃtiveｓandevalｕationoftheoｖerallefｆｅｃtivｅnｅsｓofｔｈaｎiｚation．Ｔhｅｏｒganizatｉon’smanagemeｎtsyｓtemcａnｂｅａsｓｅssedagａiｎstｔｈeorganｉzatiｏｎ’smａnagｅmｅｎtsystemｒeｑｕiremｅnts.TｈemａnａgementsystemｃaｎａlsoｂｅauｄiｔedagaiｎstthｅrｅqｕｉrementsoｆIｎｔerｎａｔionalStaｎdardｓsuchasISO9００1ａndISＯ14001:199６.Thｅsｅｍａnagementsysｔeｍaudｉtｓcanbecarriedoutsepａratelyorincoｍbiｎatｉon.２．12Rｅlａt(yī)ｉonshipｂetweeｎquaｌitymanaｇeｍeｎtｓｙsｔｅｍsandeｘcelleｎcｅｍodeｌsＴｈeａppｒoａchesofqualｉtｙmaｎageｍentsysｔｅｍｓｇiveniｎｔhｅISO9００0famiｌyofstandaｒｄsａｎｄｉｎoｒｇaｎｉｚaｔionalｅxcｅｌlｅncemoｄｅlsarebaseｄｏncommonpriｎｃipｌes．Ｂothapprｏachesa)enａbｌeａnｏｒｇanizationtｏideｎtifyiｔｓｓｔｒengthsandweaknesseｓ，ｂ)cｏntａiｎpｒｏvｉsｉonfｏｒevａluaｔiｏｎagaiｎstgｅnerｉcmｏdｅls,ｃ)ｐｒovｉdｅａｂasisforｃｏntiｎｕaｌｉmprｏvement,andd)contａinprｏｖｉｓiｏnｆoｒeｘterｎaｌrecoｇｎｉtion.ＴｈｅdｉfｆｅrｅｎceｂeｔweentheaｐproacｈesofｔｈequalitymanageｍeｎtsyｓtemsinｔｈeISO90０0ｆamilyanｄtheexcellencemodｅlsliｅsinthｅirscopeoｆapplicaｔioｎ.ThｅISO9000familyofstandａrdspｒoｖidesrequiremeｎtsfｏrｑuaｌitymanaｇｅmeｎtｓystemsandｇｕidanceｆｏｒpｅrｆｏrmanｃeimprovement；evalｕａt(yī)ionｏfqualitymanaｇemenｔsyｓteｍsdeterｍinｅsfulfilｌｍentofｔhｏserｅqｕiｒemｅnts.Tｈeeｘcellｅncｅmodeｌscontaincritｅriathaｔｅｎablecomparativeevalｕatiｏnoforｇａnｉｚationａlｐerｆormanceaｎdtｈｉｓisappｌｉcａbletoallaｃtｉvitiesandallｉnｔereｓｔedpａrtｉesofaｎorganizatiｏn.Assessmｅnｔcriteriainexｃellencemodｅlsprｏｖideaｂasｉsforaｎｏrgaｎiｚａt(yī)ｉontocｏmｐareｉｔspeｒｆｏｒmanceｗiththｅｐerfoｒmａncｅｏｆotheroｒgａnizatｉons.３TｅrmsanｄｄeｆiｎitionsAterｍiｎadeｆinitionｏrnoｔewhｉｃhisdefinｅdelseｗｈereinthisclａuｓｅｉsindiｃateｄｂybｏlｄfａcefolｌowedbyitseｎtrynumbeｒiｎparenthｅｓeｓ.Suｃhaｂoldfaceｔermmaｙbereｐlacedｉｎｔhedefinitioｎbyitscoｍpletedefinitioｎ.Foｒexample:producｔ(3.4.2）isdefiｎｅdaｓ“rｅsultoｆaｐrocｅsｓ(３．４.１)”；pｒｏcessｉsdefｉnedａs“setｏfinterｒeｌａｔedorinｔeractｉnｇactivｉtiｅｓwｈｉcｈｔransforｍsinｐutsinｔooｕｔpuｔs．”Ifthetｅrm“procｅss”isｒeplａｃｅdbyitｓdefinｉｔiｏｎ，ａｓｆolloｗs:prodｕcｔthenbecomes“ｒesulｔofａseｔofinｔerrelaｔｅｄｏrinｔeｒactiｎgacｔivｉｔｉｅswhｉchtransｆormsinputsiｎtoｏutpｕtｓ.”Aconｃｅｐtliｍiｔedtoaspｅcialｍeａningiｎａｐartｉculａrcontｅxtｉsiｎdiｃatｅｄbydesｉgnatingthｅsubjectfｉｅldinaｎglｅｂraｃkｅts,<>，ｂefoｒethedeｆiniｔion,ｆoｒexａmｐle,teｃhnicaｌexｐert<ａudiｔ>(3．９.１1).３．1Termsrｅlaｔｉngｔoqｕaｌity3.1.1quaｌitydegreetｏwhiｃｈasetoｆinheｒentchaｒaｃtｅristics(３．5.1)ｆulfilsreｑuiｒｅmｅnts(3.1．２)NOＴE1Theterm“quａｌｉtｙ”caｎbeusedｗｉthadjecｔｉvessucｈaｓpｏｏr，ｇoodｏｒeｘcelleｎt．NＯTE2“Ｉnherent”,ａsｏppoｓｅdｔo“assignｅｄ”,ｍeanｓｅxｉstingｉｎsomeｔhiｎg,especiallｙasaｐｅｒｍａneｎｔcｈaracteristic．３.１.２ｒeｑuirementneedorｅｘpｅctaｔiｏnthatisstated,generaｌlyｉmpｌiｅｄｏroblｉgatｏｒｙＮOTE1“Generａｌlyimpｌｉed”meaｎstｈatiｔiscｕsｔomoｒcommonpｒaｃticeforthｅｏrganizａt(yī)ion(3.3.1),itｓcustomers(3.3.5)andotｈeｒｉnterｅstedpartieｓ(３．3．7),tｈaｔtｈeneedorｅxpｅｃｔａt(yī)ioｎｕnｄercoｎsiｄeraｔionｉsimpｌｉed:NOTＥ2Aqualiｆiercａnbeuseｄtodenｏｔｅａsｐeｃｉfiｃtyｐeofｒeqｕiremｅnt，e.g．ｐroductrequireｍent,quａliｔymanagemeｎtｒequｉrement，custoｍeｒrequｉrement.NOTE3Aspecifｉedrequｉｒｅmenｔisonewhichiｓｓtａｔeｄ,fｏrexample,ｉnadocument(３.7.２).ＮＯTE4Requirｅmｅntｓcaｎbegeｎｅratｅdbydiｆｆerentinterestｅｄparties.３.1.3grａｄecaｔｅgoryorｒankgiventodifｆerentqualityｒｅquirｅｍｅｎts(3．1．2)ｆorｐrodｕcｔｓ(3.4．2)ｐrｏcesｓｅｓ（3．４.1)oｒsystems（3．2.１）havingｔhesａmefunctｉoｎaluｓeＥＸAMPLEClaｓsｏfaｉｒlinetiｃketａｎdcａt(yī)ｅgoryofhｏtｅlinａhｏtｅlgｕｉde.NＯTE4Rｅｑuiｒemｅntｓcａnｂｅｇeｎeraｔedbydiｆｆerentinteｒesｔeｄpａｒｔｉes.3．1.4customeｒｓatｉsfａctｉoncustomer’spｅrceptionｏfｔhedegrｅe(cuò)tｏwhｉcｈthｅcustomer’srequｉremenｔs(3.1.2)ｈaveｂeenfulfiｌledNOTE1Cusｔomercｏmplａintsａreaｃomｍoｎindicatoｒoflｏwcusｔoｍｅｒｓａt(yī)ｉsfacｔioｎbｕttheｉrａbsencedoesnotneｃessariｌyimｐlｙhｉghcustomerｓatisfaction.NＯTE2Eｖeｎwhencustomｅrrequiremｅnｔshaｖebeenagreeｄwiththｅｃustomｅrandｆｕlfｉllｅd,tｈｉsdoｅsｎotnecessariｌyｅnｓurehｉgｈcustomeｒsatｉsfacｔion.?３.1.5caｐabｉlityaｂilitｙofａｎorgａｎizａt(yī)iｏn（3.3.1),sｙstem(3．2.1)orｐｒocess（3.４.1)toreaｌｉzeapｒoduct(3.4.2)thatwｉllfuｌfiｌlｔherｅｑｕiremeｎts(3.１．２）fortｈａt(yī)ｐrｏduｃtNOＴEProceｓｓcapaｂｉlityｔermsinthefｉelｄofsｔａt(yī)iｓtｉcsaｒｅdefｉnediｎＩSO3５34．2.３.2Termｓrelａt(yī)ingtomａnagement3.2．１sｙstｅmsetofinｔerrelatｅdoｒintｅractｉngｅlｅments3.2.2mａnageｍｅntsｙｓtemsystem(3.2.1)toeｓｔaｂlｉsｈpolicｙanｄobjectiｖesａndtoachievｅthoseobjecｔｉvesNOTEAｍａnａｇｅmeｎtｓysｔemofanoｒｇanｉzatioｎ(3.3.１)canincludｅdｉｆｆerｅntｍanagementsｙstｅｍ,suchasａｑｕalityｍａｎageｍｅntsysｔeｍ(3．2.3），aｆiｎａｎｃialmａnagｅmeｎtｓｙsteｍorａｎenvｉronｍｅntalmaｎagementsystem.3.2.3qｕaｌityｍaｎagementsｙsｔemmanageｍenｔsysｔｅm（３.2.２)toｄirectaｎdcontrolanｏｒｇanizaｔｉon（3.3.1)ｗithregａrdｔoqualiｔy(3.１.１)3.2.4ｑuaｌitｙpｏlicyoveraｌｌiｎtｅntｉoｎsanddｉrecｔｉonｏfaｎｏrganiｚaｔioｎ(3.3.１)ｒｅlａｔｅdtoquaｌｉtｙ(3.1．１)aｓfｏｒmａlｌyeｘpｒｅssedｂｙtopmaｎａgement(３.2．7)ＮOTE１Geneｒａllyｔheqｕalｉtypoｌiｃyisｃonsisｔeｎtwiththeoverallｐoｌiｃｙoftheorｇanizatｉonandｐrｏvidｅsaframeworkfoｒthesettｉngofquaｌｉtyｏbjｅcｔives(3.2.5)．NＯＴＥ2QuａliｔymaｎaｇｅmentprinciplesprｅsentedｉntｈiｓIntｅrnaｔionａｌStａndａｒｄｃａnｆormabasiｓｆｏrｔｈeestabliｓhｍentofaquaｌiｔypｏlicy.(See0．2.）３.2.５qｕalｉtyｏbjｅctivｅsomethinｇsｏught,oraimedfor,relatedtoquality(3.1.1）NOTE1Ｑualityobjｅｃｔiveｓaregenerallybasedontheｏrganizaｔion’ｓｑｕａliｔypoｌｉcy(3．2．4）.ＮＯＴＥ2Qｕaliｔｙobjectｉvesaregenerａllyｓｐecifiedｆｏrｒelevａntｆunctionsandleveｌｓｉntheoｒganizaｔiｏn(３.3.1）．３．2．６managｅmentcooｒdinatedａctivitiestodireｃtandｃｏntrolａanizatｉon(3.3.１)NＯＴEInＥnｇlish，theterm“management”sｏmeｔimｅsrｅfｅrｓtopeople,i.e.apｅｒｓoｎoｒｇｒouｐofpｅoplewiｔｈauthｏｒityandrｅsponsiｂｉｌｉtyｆortｈecｏｎdｕctａndcoｎtrolｏfａnoｒgａｎiｚation．When“maｎagｅment”isuｓediｎthissｅｎseiｔｓhouldａlwａyｓｂeusedwiｔhsomｅformoｆqｕａliｆiｅrｔoａvoidcｏnfusｉoｎwitｈthｅconｃｅpt“management”ｄefiｎedａboｖe.Foｒｅxａmple,“manａgemｅntｓhaｌl…”ｉsdｅpｒecatｅdwherｅａs“topmａｎagement（３．2.7）shall…”iｓacceptａble.３.２．7topmanageｍeｎtpeｒｓonｏrｇｒoｕpｏfpeoplｅｗhｏdiｒｅctａndｃoｎtｒolsanorgａniｚation(3.3.1)atthehigｈｅｓｔｌｅvel３.2．8qｕaliｔymａnagemeｎtcoｏｒdinatedactiviｔiestoｄirectanｄcｏntrolaｎoｒgaｎｉzaｔｉon（3.3.1)wｉthｒegaｒdtoquａlｉty(3.1.1）ＮOTEDｉrectiｏｎaｎdｃontｒｏlwithregａrdｔｏquａlitｙgeｎｅrallyincｌｕdeｓestablishｍentｏfthequalitypolicy(3．2．４)ａndｑuａlityobｊeｃtiｖes（3.2．5),ｑuａlitｙｐlanｎinｇ(３.2.9)qualitycontｒol(3.2.１0),qualityasｓurance(3.2.１１)ａndqualityimprovemｅnt(3.2.１２）.3.2.9quａｌitypｌannｉngpａrtofｑuaｌitｙmanａｇeｍent(3.２.8)focuseｄonsｅｔtingｑuaｌityobｊecｔｉves（3.2．５)anｄspecifｙingneｃessaryoｐeratｉonaｌproceｓses(3.4.1）anｄreｌａｔｅdresourceｓtofｕlｆilｌthｅqｕａliｔyobjｅctiｖesNOTEEsｔaｂｌｉｓｈingｑualiｔyplans(３.7.5)canbepartofqualityｐlaｎnｉng.3.２．10qualitycontrolparｔofquaｌitymaｎaｇeｍenｔ（3.2.8)focuｓeｄoｎfuｌｆillingquaｌityrｅqｕirｅmｅnts(３．1.2）3.２.11qualitｙassuｒancepartｏｆqualｉtymanaｇｅment(3．2.8)fｏcusedｏvidingｃonｆｉdencetｈａt(yī)qｕalｉtyｒequiremenｔs(3.1.2)ｗilｌｂefｕlfilled3.2.12ｑualｉｔyimprovemｅntｐａｒtｏｆｑｕaｌｉtｙmａnagｅmeｎt(3．２.8)focusedｏｎｉncreａsｉngｔheabilitｙtofulｆilｌqualitｙrequirements(3.1.２)NOＴＥTheｒｅquｉrｅmｅntscanbｅｒｅlaｔｅdtoａnyaspectsuchasefｆectiｖenｅss(3.２.1４)，effiｃｉｅncy(３.2...１5)oｒtraｃeability(3.5.4).３．2．13ｃoｎｔinuaｌimpｒoveｍeｎｔrecuｒrｉngａctivitytoiｎｃｒeasｅtheabilitytofulｆilｌrequｉreｍents(3．1.2)NOＴEＴheｐｒｏceｓs(3．4.1)oｆｅstａｂｌishingoｂjecｔivｅsandfinｄｉnｇｏpportunitieｓforimpｒｏｖeｍentisａcｏnｔinualpｒoｃｅｓstｈｒoughthｅuseofａudiｔfｉndingｓ(3．9.5)aｎdaｕdｉtconclｕsiｏｎs（3.9．6),anaｌysisｏfdata,managemenｔｒeｖiｅwｓ(3.8.7)orotheｒmeａｎsandgeneraｌlyleadstｏcoｒrectiveactioｎ（３.6.5)oｒpｒeventiveaｃtioｎ(3.6．4）.３．2.14effecｔiｖｅｎｅｓｓextｅnttowｈichplannedactｉｖitiesarereａlizｅdandplaｎnedreｓｕltｓacｈｉeｖｅd3．２．１５ｅfｆiciencｙｒelaｔionｓhipbｅtweｅｎtheresuｌtacｈievｅdandtheresourcesused3．3Teｒmｓｒｅlaｔinｇｔoorgaｎization3.3．１ｏrgaｎiｚatiｏnｇrｏupoｆpeoｐleａndfacilｉｔieswithａnａrrangementｏｆｒesｐonｓibiｌitｉｅs,ａuｔｈoriｔiesａnｄrelaｔｉoｎsｈｉｐsEXＡＭLEComｐany,corpｏratｉoｎ,ｆirm,enｔerpriｓe，iｎstituｔion,chａｒｉty，sｏletradｅｒ,asｓociａt(yī)ion,ｏrpartsｏrｃｏmbiｎatiｏnｔhｅreoｆ.NＯTE1Thearｒangemeｎtｉｓｇｅnerａllyoｒdeｒly.NOTE2Anｏrganizａｔioｎcａnｂｅpuｂｌiｃorprivate.NＯTE３Tｈisdefiniｔｉoniｓｖaliｄｆortheｐｕrｐoseｓofquａlｉtｙmanａｇemｅntsysteｍ(3.２.３)sｔａndａrｄｓ.Ｔheteｒｍ“ｏrganizａt(yī)ion”ｉsdefinedｄｉffｅrentlｙiｎI(lǐng)ＳＯ/ＩECGuidｅ２．3．３.２orgａnizationaｌsｔructurearrangｅｍentoｆｒesponsｉbｉliｔiｅs,authoritｉesandｒｅlatｉｏｎshｉpsｂetweeｎpeopleNOTＥ1Theａrrangｅmentisｇenｅralｌyordeｒlｙ.ＮOTE2Aｆormａlｅｘpressiｏｎoftｈeorganiｚationalstructureiｓoftｅｎprovｉdedinaｑuａｌｉtymanual(３．7.4)oraquａlｉtyplaｎ(3.7.5)foｒaproject(3．4.３）.NOTＥ３Tｈｅscopeofanorganｉｚationalsｔruｃturｅcaｉncluderｅlevantiｎterfacｅstｏeｘteｒnａloｒｇanizaｔionｓ(３.3.1）.3．3.3infrａstｒｕcｔｕre<oｒｇaniｚａt(yī)ion＞ｓystemofｆaciｌiｔies,equiｐmentanｄserviｃesｎeeｄedfoｒｔheoperａt(yī)ｉｏnofａnoｒgａniｚaｔion（3.3．1）3．3．4wｏrｋenvｉronmentｓetofcoｎｄｉtionsunｄerｗhｉchworkｉsperｆorｍedNOTECｏndiｔｉoｎｓｉｎcludephysiｃal,ｓociａl,ｐsychologｉｃalａｎdenvirｏnmｅnｔalfactors（sｕchａstempeｒａｔｕre，rｅｃogniｔionscheｍeｓ,eｒgoｎｏmｉcsａndatmｏspｈericｃｏmpoｓitiｏn).３.3.５custｏｍerorｇａｎｉzation(３.3.1)orｐersoｎｔhatｒeceｉｖeｓaprｏduｃt（3.4．2)EXAＭＰLECoｎsｕmeｒ，cｌｉent，end-user，rｅｔａｉleｒ,benefｉｃiａryaｎdpｕｒchaser.NＯTEAcuｓtomeｒｃanbeinternaloreｘｔｅrnalｔotheorganizatiｏn.３.3.6supplieroｒgaｎｉｚatiｏn(３.3.１）orperｓontｈatｐroviｄesaｐroｄｕct（３.4.2)ＥＸAMPLEProducer,distｒｉbutor，retａilｅrorｖeｎdoroｆduｃt,ｏrproviderofaｓerviｃeｏrｉｎformatｉoｎ.ＮＯTＥ1Ａsuppliercanｂeｉｎternalorｅxｔernaｌｔａnizａｔion.NOTE2Iｎacontｒactualｓituatiｏnａsuppｌierissomeｔｉmｅscalｌed“cｏntractor.”3.3．７ｉntｅrｅstedpａrtyｐｅrsonorｇrouphａｖｉngａniｎｔereｓtｉnthepｅrfoｒmａnceoｒsucceｓsoｆanorganiｚａt(yī)iｏn（３.3.1）EXAMPLECustｏmerｓ（３.3.5),ownerｓ,peoplｅiｎａｎorｇaｎiｚation,suｐｐｌｉeｒs(3.3．6),bankers,unioｎs,pａrtｎｅrsorsocieｔy．NOTEAｇrouｐｃａｎｃomｐriseａnｏrｇａnizatiｏn，apaｒｔthｅreｏf,oｒmorｅtｈａnaｎization.３.4TermsｒｅｌatingtoｐrocessandprodｕcｔprocesssｅtofinｔerrｅlaｔedorｉntｅractingactivitieｓwhｉcｈｔranｓfｏrmｓinpuｔsintｏｏutｐutsNOTE1Inputｓｔoａprocｅsｓaｒegeneｒallyｏｕtpｕtsｏｆotｈeｒpｒoｃesｓes．NOTＥ2Processesinaｎｏrgaｎiｚatioｎ（3．３.1）ａｒｅgeneralｌypｌａnneｄandｃａrｒｉeｄoutｕnderconｔｒolｌedconｄｉｔionｓtoaddｖａｌｕe.NＯＴE3Ａｐｒocesswhereｔhｅcｏｎformitｙ(３．6.1)oftheｒesulｔingproｄuct(３.4．2)canｎｏtbｅrｅadilｙｏrｅｃonomｉcallyｖｅrifiediｓｆrequｅntlyｒｅfｅrｒedtｏａsａ“spｅcialｐroｃｅsｓ.”3.４.2ｐroducｔresultofcess(３．4.1）ＮOTE1Ｔhereａｒefourgｅnericproduｃtcａt(yī)eｇorieｓ,asfolloｗs：serviｃes(e.g.tｒanｓｐort);sｏfｔｗarｅ（e.ｇ.cｏmputeｒprogｒam,ｄictｉｏnary);ｈarｄwａre(e.g.ｅnginemｅcｈanｉcalpart）;ｐroｃｅsｓeｄmaterials(ｅ.g.lｕbｒicant).Manyｐroｄｕctscoｍｐriｓｅｅlｅmentsｂelｏngiｎgtｏdiｆfｅrｅｎtｇenｅｒｉcproｄｕctcaｔｅgories.Whetheｒthepｒoductｉsthenｃaｌlｅdｓerviｃｅ,softwarｅ，haｒｄwａreｏrproceｓseｄmateriａldependsontｈedomｉｎantelemeｎt．Foｒexamｐlethｅoｆｆeｒedｐrｏdｕｃt“ａutomobｉle”consisｔsoｆhardwａrｅ(e．g.tyres),procesｓｅdmaｔeriaｌs(e.g.ｆｕel,coｏliｎgliｑuid）,ｓｏfｔware(e．ｇ.ｅngｉneconｔrolsofｔｗare,ｄriver’ｓｍaｎual),andsｅrｖiｃe(ｅ.g.opｅratiｎgｅｘｐlaｎａt(yī)ionsgiｖenbytｈesaleｓｍａｎ）.ＮＯTE2Serｖiceiｓtｈeresultofatleastoｎeaｃtｉvityneｃesｓａrｉlｙperfoｒmedaｔtheｉnterfaceｂｅtweentｈｅsuppliｅｒ（3.3.6）andcustｏmer(3．3.5)ａnｄisｇｅnerallyintaｎｇibｌe.Ｐrovｉsｉonoｆaｓerｖiｃecanｉnvｏｌｖｅ,forexａmple,tｈefollowinｇ:anacｔｉｖｉtyｐｅrfoｒｍｅdonacuｓtoｍer-suppliedtaｎｇiｂleprｏduct(e.g．a(chǎn)utoｍｏbｉｌｅｔoberｅpaｉreｄ);anactiｖityｐeｒfｏrｍedａｎgｉbleｐｒoducｔ(e．g.theiｎcｏｍｅstateｍｅntneｅｄeｄtoｐreｐareａt(yī)axｒｅｔurｎ);ｔheｄeｌiｖｅrｙofａnintangiblｅproduct(e.g.thｅｄeｌiｖeryｏfinｆｏrmａt(yī)ioninｔhecontｅｘtofknowｌedｇetraｎｓmission）;thecｒｅaｔioｎoｆambiｅｎｃｅfoｒｔhecustomｅr(e.g.ｉnhoｔeｌｓanｄrestａuｒａnts）.Soｆtwａrecｏｎsistｓｏfｉnｆormaｔionandisgenerallｙintangｉbleａｎdcanｂeｉnｔhefｏrｍｏfapproacｈes,