品质管理系统要求37789.docx

ISO 9001:20002000.12.15Qualityy manaagemennt sysstems Reqquiremments1 Scopee1.1 GenneralThis Innternaationaal Staandardd speccifiess requuiremeents ffor a qualiity maanagemment 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, inncludiing 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 custoomer. 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 to 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 withhin 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, thhroughh 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 aree 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 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, uused 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 thiss 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 requiiremenntsThe 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 shallla) identiffy thee proccessess needded foor thee quallity mmanageement systeem andd theiir appplicattion tthrougghout the oorganiizatioon (seee 1.22),b) determiine thhe seqquencee and interractioon of thesee proccessess,c) determiine crriteriia andd methhods nneededd to eensuree thatt bothh the operaation and ccontrool of thesee proccessess are effecctive,d) ensure the aavailaabilitty of resouurces and iinformmationn neceessaryy to ssupporrt thee operrationn and monittoringg of tthese proceesses,e) monitorr, meaasure and aanalysseanallyze tthese proceesses, andf) implemeent acctionss neceessaryy to aachievve plaanned resullts annd conntinuaal 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 requiiremennts, 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 prrocessses foor mannagemeent acctivitties, proviision of reesourcces, pproducct reaalizattion aand meeasureement.4.2 Doccumenttationn requuiremeents4.2.1 GGeneraalThe quaality managgementt systtem doocumenntatioon shaall inncludeea) documennted sstatemments of a qualiity poolicy and qqualitty objjectivves,b) a qualiity maanual,c) documennted pproceddures requiired bby thiis Intternattionall Stanndard,d) documennts neeeded by thhe orgganizaation to ennsure the eeffecttive pplanniing, ooperattion aand coontroll of iits prrocessses, aande) recordss requuired by thhis Innternaationaal Staandardd (seee 4.2.4)NOTE 1 Wheree 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 orrganizzationn to aanotheer duee toa) the sizze of the oorganiizatioon andd typee of aactiviities,b) the commplexiity off proccessess and theirr inteeractiions, and c) the commpetenncies of peersonnnel.NOTE 3 The ddocumeentatiion caan be in anny forrm or type of meedium.4.2.2 QQualitty mannualThe orgganizaation shalll estaablishh and mainttain aa quallity mmanuall thatt inclludesa) the scoope off the qualiity maanagemment ssystemm, inccludinng dettails of annd jusstificcationn for any eexclussions (see11.2.),b) the doccumentted prroceduures eestabllishedd for the qqualitty mannagemeent syystem, or rrefereence tto theem, anndc) a 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 aaccordding tto thee requuiremeents ggiven in 4.2.4.A docummentedd procceduree shalll be estabblisheed to definne thee conttrols needeed a) to apprrove ddocumeents ffor addequaccy priior too issuue,b) to reviiew annd upddate aas neccessarry andd re-aapprovve doccumentts,c) to ensuure thhat chhangess and the ccurrennt verrsion statuus of documments are iidentiified,d) to ensuure thhat reelevannt verrsionss of aappliccable documments are aavailaable aat poiints oof usee,e) to ensuure thhat doocumennts reemain legibble annd reaadily identtifiabble,f) to ensuure thhat doocumennts off exteernal origiin aree idenntifieed andd theiir disstribuution contrrolledd, anddg) to 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 evvidencce 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 ideentifiicatioon, 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 syystem and ccontinnuallyy imprrovingg its effecctivenness bbya) communiicatinng to the oorganiizatioon thee impoortancce of meetiing cuustomeer as well as sttatutoory annd reggulatoory reequireementss,b) establiishingg the qualiity poolicy,c) ensurinng thaat quaality objecctivess are estabblisheed,d) conductting mmanageement revieews, aande) ensurinng 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 mannagemeent shhall eensuree thatt the qualiity poolicya) is apprropriaate too the purpoose off the organnizatiion,b) includees a ccommittment to coomply with requiiremennts annd conntinuaally iimprovve thee effeectiveeness of thhe quaality managgementt systtem,c) providees a fframewwork ffor esstabliishingg and revieewing qualiity obbjectiives,d) is commmunicaated aand unndersttood wwithinn the organnizatiion, aande) is reviiewed for ccontinnuing suitaabilitty.5.4 Plaanningg5.4.1 QQualitty objjectivvesTop mannagemeent shhall eensuree thatt quallity oobjecttives, inclludingg thosse neeeded tto meeet reqquiremments 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 a) the 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 b) the inttegritty of the qqualitty mannagemeent syystem is maaintaiined wwhen cchangees to the qqualitty mannagemeent syystem are pplanneed 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 mannagemeent shhall aappoinnt a mmemberr of mmanageement who, irresspectiive off otheer ressponsiibilitties, shalll havee respponsibbilityy and authoority that incluudesa) ensurinng thaat proocessees neeeded ffor thhe quaality managgementt systtem arre esttablisshed, impleementeed andd mainntaineed,b) reportiing too top managgementt on tthe peerformmance of thhe quaality managgementt systtem annd anyy needd for improovemennt, annd c) ensurinng thee prommotionn of aawarenness oof cusstomerr requuiremeents tthrougghout the oorganiizatioon.NOTE Thhe ressponsiibilitty of a mannagemeent reepreseentatiive caan 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 takess 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 effecctivenness. 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 RRevieww inpuutThe inpput too manaagemennt revview sshall incluude innformaation ona) resultss of aauditss,b) customeer feeedbackk,c) processs perfformannce annd prooduct confoormityy,d) status of prreventtive aand coorrecttive aactionns,e) follow-up acctionss fromm prevvious managgementt reviiews,f) changess thatt coulld afffect tthe quualityy manaagemennt sysstem, andg) recommeendatiions ffor immproveement.5.6.3 RRevieww outpputThe outtput ffrom tthe maanagemment rrevieww shalll incclude any ddecisiions aand acctionss relaate tooa) improveement of thhe efffectivvenesss of tthe quualityy manaagemennt sysstem aand itts proocessees,b) improveement of prroductt relaated tto cusstomerr requuiremeents, andc) resourcce neeeds.6 Resouurce mmanageement6.1 Proovisioon of resouurcesThe orgganizaation shalll deteerminee and proviide thhe ressourcees neeededa) to impplemennt andd mainntain the qqualitty mannagemeent syystem and ccontinnuallyy imprrove iits efffectiivenesss, anndb) 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, skkills and eexperiience.6.2.2 CCompettence, awarrenesss and trainning The orgganizaation shallla) determiine thhe neccessarry commpetenncy foor perrsonneel perrformiing woork afffectiing prroductt quallity,b) providee traiining or taake otther aactionns to satissfy thhese nneeds,c) evaluatte thee effeectiveeness of thhe acttions takenn,d) 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, ande) maintaiin apppropriiate rrecordds of educaation, traiining, skillls annd expperiennce (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 aappliccablea) buildinng, woorkspaace annd asssociatted uttilitiies;b) processs equiipmentt (botth harrdwaree and softwware), and c) supportting sservicces (ssuch aas traansporrt or commuunicattion).6.4 Worrk envvironmmentThe orgganizaation shalll deteer