品质管理系统要求

1、ISO 9001:20002000.12.15 PAGE 68 ITA英特美國際驗證股份有限公司TEL:02-27866726FAX:02-27866753E-Mail : inter_am嘉特國際驗證股份有限公司 電話：02-22789822 傳真：02-22789823 Email：ursasiaQualityy manaagemennt sysstems Reqquiremments1 Scopee1.1 GenneralThis Innternaationaal Staandardd speccifiess requuiremeents ffor a qualiity maanagem

2、ment ssystemm wherre an organnizatiion a) needds to demonnstratte itss abillity tto connsisteently proviide prroductt thatt meetts cusstomerr and appliicablee reguulatorry reqquiremments, and b) aimss to eenhancce cusstomerr satiisfacttion tthrouggh thee effeectivee appllicatiion off the systeem, in

3、ncludiing prrocessses foor conntinuaal impprovemment oof thee systtem annd thee assuurancee of cconforrmity to cuustomeer andd appllicablle reggulatoory reequireementss.NOTE IIn thiis Intternattionall Stanndard, the term “prodduct” appliies too the produuct inntendeed forr, or requiired bby, a custo

4、omer. 1.2 AppplicattionAll reqquiremments of thhis Innternaationaal Staandardd are generric annd aree inteended to bee appllicablle to all oorganiizatioons, rregarddless of tyype, ssize aand prroductt provvided.Were anny reqquiremment(ss) of this interrnatioonal SStandaard caannot be apppliedd due t

5、o thhe natture oof an organnizatiion annd itss prodduct, this can bbe connsiderred foor excclusioon.Where eexclussions are mmade, claimms of confoormityy to tthis IInternnationnal Sttandarrd aree not accepptablee unllessaccceptaable uunlesss thesse excclusioons arre limmited to reequireementss withh

6、in cllause 7, annd succh excclusioons doo not affecct thee orgaanizattionss abillity, or reesponssibiliity, tto proovide produuct thhat meeets ccustommer annd appplicabble reegulattory rrequirrementts. 2 Normaative referrenceThe folllowinng norrmativve doccumentt conttains proviisionss whicch, thhro

7、ughh refeerencee in tthis ttext, consttitutee provvisionns of this Interrnatioonal SStandaard. FFor daated rrefereences, subssequennt ameendmennts too, or revissions of, aany off thesse pubblicattions do noot appply. HHoweveer, paartiess to aagreemments basedd on tthis IInternnationnal Sttandarrd ar

8、ee encoourageed to invesstigatte thee posssibiliity off appllying the mmost rrecentt edittion oof thee normmativee docuument indiccated beloww. Forr undaated rrefereences, the latesst ediition of thhe norrmativve doocumennt refferredd to aappliees. Meemberss of IISO annd IECC mainntain regissters of

9、 cuurrenttly vaalid IInternnationnal Sttandarrds.ISO 90000:20000, Quualityy manaagemennt sysstems Funndamenntals and vvocabuulary.3 Termss and definnitionnsFor thee purpposes of thhis Innternaationaal Staandardd, thee termms andd defiinitioons giiven iin ISOO 90000 applly.The folllowinng iteems, uus

10、ed iin thiis ediition of ISSO 90001 to descrribe tthe suupply chainn, havve beeen chaanged to reeflectt the vocabbularyy currrentlyy usedd:supplieer organnizatiion custoomerThe terrm “orrganizzationn” repplacess the term “suppplier” used in ISSO 90001:19994, annd reffers tto thee unitt to whichh thi

11、ss Inteernatiional Standdard aappliees. Allso, tthe teerm “ssuppliier” nnow reeplacees thee termm “subbcontrractorr”. Throughhout tthe teext off thiss Inteernatiional Standdard, whereever tthe teerm “pproducct” occcurs, it ccan allso meean “sservicce”.4 Qualiity maanagemment ssystemm4.1 Genneral req

12、uiiremenntsThe orgganizaation shalll estaablishh, doccumentt, impplemennt andd mainntain a quaality managgementt systtem annd conntinuaally iimprovve itss effeectiveeness in acccordaance wwith tthe reequireementss of tthis IInternnationnal Sttandarrd.The orgganizaation shalllidentiffy thee proccesse

13、ss needded foor thee quallity mmanageement systeem andd theiir appplicattion tthrougghout the oorganiizatioon (seee 1.22),determiine thhe seqquencee and interractioon of thesee proccessess,determiine crriteriia andd methhods nneededd to eensuree thatt bothh the operaation and ccontrool of thesee pro

14、ccessess are effecctive,ensure the aavailaabilitty of resouurces and iinformmationn neceessaryy to ssupporrt thee operrationn and monittoringg of tthese proceesses,monitorr, meaasure and aanalysseanallyze tthese proceesses, andimplemeent acctionss neceessaryy to aachievve plaanned resullts annd conn

15、tinuaal impprovemment oof theese prrocessses.These pprocessses sshall be maanagedd by tthe orrganizzationn in aaccorddance with the rrequirrementts of this Interrnatioonal SStandaard.Where aan orgganizaation choosses too outssourcee any proceess thhat afffectss prodduct cconforrmity with requiiremen

16、nts, tthe orrganizzationn shalll enssure ccontrool oveer succh proocessees. Coontroll of ssuch ooutsouurced proceesses shalll be iidentiified withiin thee quallity mmanageement systeem.NOTE Prrocessses neeeded for tthe quualityy manaagemennt sysstem rreferrred too abovve shoould iincludde prrocessse

17、s foor mannagemeent acctivitties, proviision of reesourcces, pproducct reaalizattion aand meeasureement.4.2 Doccumenttationn requuiremeents4.2.1 GGeneraalThe quaality managgementt systtem doocumenntatioon shaall inncludeedocumennted sstatemments of a qualiity poolicy and qqualitty objjectivves,a qua

18、liity maanual,documennted pproceddures requiired bby thiis Intternattionall Stanndard,documennts neeeded by thhe orgganizaation to ennsure the eeffecttive pplanniing, ooperattion aand coontroll of iits prrocessses, aandrecordss requuired by thhis Innternaationaal Staandardd (seee 4.2.4)NOTE 1 Wheree

19、 the term “docuumenteed proocedurre” apppearss withhin thhis Innternaationaal Staandardd, thiis meaans thhat thhe proocedurre is estabblisheed, doocumennted, impleementeed andd mainntaineed.NOTE 2 The eextentt of tthe quualityy manaagemennt sysstem ddocumeentatiion caan difffer ffrom oone orrganizza

20、tionn to aanotheer duee tothe sizze of the oorganiizatioon andd typee of aactiviities,the commplexiity off proccessess and theirr inteeractiions, and the commpetenncies of peersonnnel.NOTE 3 The ddocumeentatiion caan be in anny forrm or type of meedium.4.2.2 QQualitty mannualThe orgganizaation shall

21、l estaablishh and mainttain aa quallity mmanuall thatt inclludesthe scoope off the qualiity maanagemment ssystemm, inccludinng dettails of annd jusstificcationn for any eexclussions (see11.2.),the doccumentted prroceduures eestabllishedd for the qqualitty mannagemeent syystem, or rrefereence tto the

22、em, annda descrriptioon of the iinteraactionn betwween tthe prrocessses off the qualiity maanagemment ssystemm.4.2.3 CControol of docummentsDocumennts reequireed by the qqualitty mannagemeent syystem shalll be ccontroolled. Recoords aare a speciial tyype off docuument and sshall be coontrollled aacc

23、ordding tto thee requuiremeents ggiven in 4.2.4.A docummentedd procceduree shalll be estabblisheed to definne thee conttrols needeed to apprrove ddocumeents ffor addequaccy priior too issuue,to reviiew annd upddate aas neccessarry andd re-aapprovve doccumentts,to ensuure thhat chhangess and the ccur

24、rennt verrsion statuus of documments are iidentiified,to ensuure thhat reelevannt verrsionss of aappliccable documments are aavailaable aat poiints oof usee,to ensuure thhat doocumennts reemain legibble annd reaadily identtifiabble,to ensuure thhat doocumennts off exteernal origiin aree idenntifieed

25、 andd theiir disstribuution contrrolledd, anddto prevvent tthe unnintennded uuse off obsoolete documments, and to appply ssuitabble iddentifficatiion too themm if tthey aare reetaineed forr any purpoose.4.2.4 CControol of recorrdsRecordss shalll be estabblisheed andd mainntaineed to proviide evviden

26、cce of confoormityy to rrequirrementts andd of tthe efffectiive opperatiion off the qualiity maanagemment ssystemm. Reccords shalll remaain leegiblee, reaadily identtifiabble annd rettrievaable. A doccumentted prroceduure shhall bbe esttablisshed tto deffine tthe coontrolls neeeded ffor thhe ideenti

27、fiicatioon, sttoragee, prootectiion, rretrieeval, retenntion time and ddispossitionn of rrecordds.5 Managgementt respponsibbilityy5.1 Mannagemeent coommitmmentTop mannagemeent shhall pprovidde eviidencee of iits coommitmment tto thee deveelopmeent annd impplemenntatioon of the qqualitty mannagemeent

28、 syystem and ccontinnuallyy imprrovingg its effecctivenness bbycommuniicatinng to the oorganiizatioon thee impoortancce of meetiing cuustomeer as well as sttatutoory annd reggulatoory reequireementss,establiishingg the qualiity poolicy,ensurinng thaat quaality objecctivess are estabblisheed,conductt

29、ing mmanageement revieews, aandensurinng thee avaiilabillity oof ressourcees.5.2 Cusstomerr focuusTop mannagemeent shhall eensuree thatt custtomer requiiremennts arre detterminned annd mett withh the aim oof enhhancinng cusstomerr satiisfacttion (see 77.2.1 and 88.2.1).5.3 Quaality policcyTop mannag

30、emeent shhall eensuree thatt the qualiity poolicyis apprropriaate too the purpoose off the organnizatiion,includees a ccommittment to coomply with requiiremennts annd conntinuaally iimprovve thee effeectiveeness of thhe quaality managgementt systtem,providees a fframewwork ffor esstabliishingg and r

31、evieewing qualiity obbjectiives,is commmunicaated aand unndersttood wwithinn the organnizatiion, aandis reviiewed for ccontinnuing suitaabilitty.5.4 Plaanningg5.4.1 QQualitty objjectivvesTop mannagemeent shhall eensuree thatt quallity oobjecttives, inclludingg thosse neeeded tto meeet reqquiremments

32、 for pproducct seee 7.11 a), are estabblisheed at relevvant ffunctiions aand leevels withiin thee orgaanizattion. The qqualitty objjectivves shhall bbe meaasurabble annd connsisteent wiith thhe quaality policcy.5.4.2 QQualitty mannagemeent syystem plannningTop mannagemeent shhall eensuree thatt the

33、plaanningg of tthe quualityy manaagemennt sysstem iis carrried out iin ordder too meett the requiiremennts giiven iin 4.11, as well as thhe quaality objecctivess, andd the inttegritty of the qqualitty mannagemeent syystem is maaintaiined wwhen cchangees to the qqualitty mannagemeent syystem are ppla

34、nneed andd impllementted.5.5 Ressponsiibilitty, auuthoriity annd commmuniccationn 5.5.1 RResponnsibillity aand auuthoriityTop mannagemeent shhall eensuree thatt the respoonsibiilitiees, auuthoriities are ddefineed andd commmunicaated wwithinn the organnizatiion.5.5.2 MManageement repreesentaativeTop

35、 mannagemeent shhall aappoinnt a mmemberr of mmanageement who, irresspectiive off otheer ressponsiibilitties, shalll havee respponsibbilityy and authoority that incluudesensurinng thaat proocessees neeeded ffor thhe quaality managgementt systtem arre esttablisshed, impleementeed andd mainntaineed,re

36、portiing too top managgementt on tthe peerformmance of thhe quaality managgementt systtem annd anyy needd for improovemennt, annd ensurinng thee prommotionn of aawarenness oof cusstomerr requuiremeents tthrougghout the oorganiizatioon.NOTE Thhe ressponsiibilitty of a mannagemeent reepreseentatiive c

37、aan incclude liaisson wiith exxternaal parrties on maatterss relaating to thhe quaality managgementt systtem.5.5.3 IInternnal coommuniicatioonTop mannagemeent shhall eensuree thatt apprropriaate coommuniicatioon proocessees aree estaablishhed wiithin the oorganiizatioon andd thatt commmunicaation ta

38、kess placce reggardinng thee effeectiveeness of thhe quaality managgementt systtem. 5.6 Mannagemeent reeview5.6.1 GGeneraalTop mannagemeent shhall rrevieww the organnizatiions qualiity maanagemment ssystemm, at plannned inntervaals, tto enssure iits coontinuuing ssuitabbilityy, adeequacyy and effecc

39、tivenness. This revieew shaall inncludee asseessingg oppoortuniities for iimprovvementt and the nneed ffor chhangess to tthe quualityy manaagemennt sysstem, incluuding the qqualitty pollicy aand quualityy objeectivees.Recordss fromm manaagemennt revview sshall be maaintaiined (see 44.2.4).5.6.2 RRev

40、ieww inpuutThe inpput too manaagemennt revview sshall incluude innformaation onresultss of aauditss,customeer feeedbackk,processs perfformannce annd prooduct confoormityy,status of prreventtive aand coorrecttive aactionns,follow-up acctionss fromm prevvious managgementt reviiews,changess thatt coull

41、d afffect tthe quualityy manaagemennt sysstem, andrecommeendatiions ffor immproveement.5.6.3 RRevieww outpputThe outtput ffrom tthe maanagemment rrevieww shalll incclude any ddecisiions aand acctionss relaate tooimproveement of thhe efffectivvenesss of tthe quualityy manaagemennt sysstem aand itts p

42、roocessees,improveement of prroductt relaated tto cusstomerr requuiremeents, andresourcce neeeds.6 Resouurce mmanageement6.1 Proovisioon of resouurcesThe orgganizaation shalll deteerminee and proviide thhe ressourcees neeeded to impplemennt andd mainntain the qqualitty mannagemeent syystem and ccont

43、innuallyy imprrove iits efffectiivenesss, annd to enhhance custoomer ssatisffactioon by meetiing cuustomeer reqquiremments.6.2 Humman reesourcces6.2.1 GGeneraalPersonnnel peerformming wwork aaffectting pproducct quaality shalll be ccompettent oon thee basiis of approopriatte eduucatioon, trraininng,

44、 skkills and eexperiience.6.2.2 CCompettence, awarrenesss and trainning The orgganizaation shallldetermiine thhe neccessarry commpetenncy foor perrsonneel perrformiing woork afffectiing prroductt quallity,providee traiining or taake otther aactionns to satissfy thhese nneeds,evaluatte thee effeectiv

45、eeness of thhe acttions takenn,ensure that its ppersonnnel aare awware oof thee releevancee and imporrtancee of ttheir activvitiess and how tthey ccontriibute to thhe achhievemment oof thee quallity oobjecttives, andmaintaiin apppropriiate rrecordds of educaation, traiining, skillls annd expperiennc

46、e (ssee 4.2.4).6.3 InffrastrructurreThe orgganizaation shalll deteerminee, proovide and mmaintaain thhe inffrastrructurre neeeded tto achhieve confoormityy to pproducct reqquiremments. Infrrastruucturee inclludes, as aappliccablebuildinng, woorkspaace annd asssociatted uttilitiies;processs equiipmen

47、tt (botth harrdwaree and softwware), and supportting sservicces (ssuch aas traansporrt or commuunicattion).6.4 Worrk envvironmmentThe orgganizaation shalll deteerminee and managge thee the work envirronmennt neeeded tto achhieve confoormityy to pproducct reqquiremments.7 Produuct reealizaation7.1 Pl

48、aanningg of pproducct reaalizattionThe orgganizaation shalll plann and devellop thhe proocessees neeeded ffor prroductt reallizatiion. PPlanniing off prodduct rrealizzationn shalll be consiistentt withh the requiiremennts off the otherr proccessess of tthe quualityy manaagemennt sysstem (see 44.1).I

49、n plannning produuct reealizaation, the organnizatiion shhall ddetermmine tthe foollowiing, aas apppropriiate:qualityy objeectivees andd requuiremeents ffor thhe prooduct;the neeed to estabblish proceesses, docuumentss, andd provvide rresourrces sspeciffic too the produuct;requireed verrificaation,

50、valiidatioon, moonitorring, inspeectionn and test activvitiess speccific to thhe prooduct and tthe crriteriia forr prodduct aaccepttance;recordss needded too provvide eevidennce thhat thhe reaalizattion pprocessses aand reesultiing prroductt meett requuiremeents (see 44.2.4).The outtput oof thiis pl

51、aanningg shalll be in a form suitaable ffor thhe orgganizaations metthod oof opeeratioons.NOTE 1 A doccumentt speccifyinng thee proccessess of tthe quualityy manaagemennt sysstem (incluuding the pproducct reaalizattion pprocessses) and tthe reesourcces too be aapplieed to a speecificc prodduct, proj

52、eect orr conttract, can be reeferreed to as a qualiity pllan.NOTE 2 The oorganiizatioon mayy alsoo applly thee requuiremeent giiven iin 7.33 to tthe deeveloppment of prroductt reallizatiion prrocessses.7.2 Cusstomerr-relaated pprocessses7.2.1 DDetermminatiion off requuiremeents rrelateed to the ppro

53、ducctThe orgganizaation shalll deteerminee requireementss speccifiedd by tthe cuustomeer, inncludiing thhe reqquiremments for ddeliveery annd posst-delliveryy actiivitiees,requireementss not stateed by the ccustommer buut neccessarry forr speccifiedd or iintendded usse, whhere kknown,statutoory annd

54、 reggulatoory reequireementss relaated tto prooduct, andd) any addittionall requuiremeents ddetermmined by thhe orgganizaation.7.2.2 RRevieww of rrequirrementts rellated to thhe prooductThe orgganizaation shalll reviiew thhe reqquiremments relatted too the produuct. TThis rrevieww shalll be conduuct

55、ed priorr to tthe orrganizzationns coommitmment tto suppply aa prodduct tto thee custtomer (e.g. submmissioon of tendeers, aaccepttance of coontraccts orr ordeers, aaccepttance of chhangess to ccontraacts oor ordders) and sshall ensurre thaatproductt requuiremeents aare deefinedd,contracct or orderr

56、 requuiremeents ddifferring ffrom tthose previiouslyy exprressedd are resollved, andthe orgganizaation has tthe abbilityy to mmeet tthe deefinedd requuiremeents.Recordss of tthe reesultss of tthe reeview and aactionns ariising from the rrevieww shalll be mainttainedd (seee 4.2.4).Where tthe cuustome

57、er proovidess no ddocumeented stateement of reequireement, the custoomer rrequirrementts shaall bee conffirmedd by tthe orrganizzationn befoore accceptaance.Where pproducct reqquiremments are cchangeed, thhe orgganizaation shalll ensuure thhat reelevannt doccumentts aree amennded aand thhat reelevan

58、nt perrsonneel aree madee awarre of the cchangeed reqquiremments.NOTE: IIn somme sittuatioons, ssuch aas in interrnet ssales, a foormal revieew is impraacticaal forr eachh ordeer. Innsteadd the revieew cann coveer rellevantt prodduct iinformmationn suchh as ccataloogues or addvertiising materrial.7.

59、2.3 CCustommer coommuniicatioonThe orgganizaation shalll deteerminee and impleement effecctive arranngemennts foor commmuniccatingg withh custtomerss in rrelatiion too:productt infoormatiion,enquiriies, ccontraacts oor ordder haandlinng, inncludiing ammendmeents, andcustomeer feeedbackk, inccludinng

60、 cusstomerr compplaintts.7.3 Dessign aand deeveloppment7.3.1 DDesignn and devellopmennt plaanninggThe orgganizaation shalll plann and contrrol deesign and ddeveloopmentt of pproducct.During the ddesignn and devellopmennt plaanningg, thee orgaanizattion sshall deterrminethe dessign aand deeveloppment