质量管理系统–根本性和词汇量(1)dbzz.docx
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1、Evaluation Warning: The document was created with Spire.Doc for .NET.ISO9000:2000(E)Quality management systems Fundamentals and vocabulary1 ScopeeThis Innternaationaal Staandardd desccribess funddamenttals oof quaality managgementt systtems, whichh formm the subjeect off the ISO 99000 ffamilyy, andd
2、 defiines rrelateed terrms.This Innternaationaal Staandardd is aappliccable to thhe folllowinng:a) orgaanizattions seekiing addvantaage thhroughh the impleementaation of a qualiity maanagemment ssystemm;b) orgaanizattions seekiing coonfideence ffrom ttheir supplliers that theirr prodduct rrequirreme
3、ntts willl be satissfied;c) userrs of the pproduccts;d) thosse conncerneed witth a mmutuall undeerstannding of thhe terrminollogy uused iin quaality managgementt (e.gg. suppplierrs, cuustomeers, rregulaators);e) thosse intternall or eexternnal too the organnizatiion whho asssess tthe quualityy manaa
4、gemennt sysstem oor auddit itt for confoormityy withh the requiiremennts off ISO 9001 (e.g. audiitors, reguulatorrs, ceertifiicatioon/reggistraation bodiees);f) thosse intternall or eexternnal too the organnizatiion whho givve advvice oor traainingg on tthe quualityy manaagemennt sysstem aapproppria
5、tee to tthat oorganiizatioon;g) deveeloperrs of relatted sttandarrds.2 Fundaamentaals off quallity mmanageement systeems2.1 Rattionalle forr quallity mmanageement systeemsQualityy manaagemennt sysstems can aassistt orgaanizattions in ennhanciing cuustomeer sattisfacction.Customeers reequiree prodduc
6、ts with charaacteriisticss thatt satiisfy ttheir needss and expecctatioons. TThese needss and expecctatioons arre exppresseed in produuct sppecifiicatioons annd colllectiively referrred tto as custoomer rrequirrementts. Cuustomeer reqquiremments may bbe speecifieed conntracttuallyy by tthe cuustomee
7、r or may bbe detterminned byy the organnizatiion ittself. In eeitherr casee, thee custtomer ultimmatelyy deteerminees thee acceeptabiility of thhe prooduct. Becaause ccustommer neeeds aand exxpectaationss are changging, and bbecausse of compeetitivve preessurees andd techhnicall advaances, orgaaniza
8、ttions are ddrivenn to iimprovve conntinuaally ttheir produucts aand prrocessses.The quaality managgementt systtem appproacch enccouragges orrganizzationns to analyyse cuustomeer reqquiremments, defiine thhe proocessees thaat conntribuute too the achieevemennt of a prooduct whichh is aaccepttable to
9、 thhe cusstomerr, andd keepp thesse proocessees undder coontroll. A qqualitty mannagemeent syystem can pprovidde thee frammeworkk for contiinual improovemennt to increease tthe prrobabiility of ennhanciing cuustomeer sattisfacction and tthe saatisfaactionn of oother interrestedd partties. It prrovid
10、ees connfidennce too the organnizatiion annd itss custtomerss thatt it iis ablle to proviide prroductts thaat connsisteently fulfiill reequireementss.2.2 Reqquiremments of quualityy manaagemennt sysstems and rrequirrementts forr prodductsThe ISOO 90000 famiily diistingguishees bettween requiiremennt
11、s foor quaality managgementt systtems aand reequireementss for produucts.Requireementss for qualiity maanagemment ssystemms aree speccifiedd in IISO 90001. RRequirrementts forr quallity mmanageement systeems arre genneric and aappliccable to orrganizzationns in any iindusttry orr econnomic sectoor r
12、eggardleess off the offerred prroductt cateegory. ISO 9001 itsellf doees nott estaablishh requuiremeents ffor prroductts.Requireementss for produucts ccan bee speccifiedd by ccustommers oor by the oorganiizatioon in anticcipatiion off custtomer requiiremennts, oor by regullationn. Thee requuiremeent
13、s ffor prroductts andd in ssome ccases assocciatedd proccessess can be coontainned inn, forr exammple, technnical speciificattions, prodduct sstandaards, proceess sttandarrds, ccontraactuall agreeementts andd reguulatorry reqquiremments.2.3 Quaality managgementt systtems aapproaachAn apprroach to de
14、evelopping aand immplemeentingg a quualityy manaagemennt sysstem cconsissts off seveeral ssteps incluuding the ffollowwing:a) determiining the nneeds and eexpecttationns of custoomers and iintereested partiies;b) establiishingg the qualiity poolicy and qqualitty objjectivves off the organnizatiion;c
15、) determiining the pprocessses aand reesponssibiliities necesssary to atttain the qqualitty objjectivves;d) determiining and pprovidding tthe reesourcces e) establiishingg methhods tto meaasure the eeffecttiveneess annd effficienncy off eachh proccess;f) applyinng theese meeasurees to deterrmine the
16、 eeffecttiveneess annd effficienncy off eachh proccess;g) determiining meanss of pprevennting noncoonformmitiess and elimiinatinng theeir caauses;h) establiishingg and applyying aa proccess ffor coontinuual immproveement of thhe quaality managgementt systtem.Such ann apprroach is allso appplicaable
17、tto maiintainning aand immproviing annd exiistingg quallity mmanageement systeem.An orgaanizattion tthat aadoptss the abovee apprroach creattes coonfideence iin thee capaabilitty of its pprocessses aand thhe quaality of itts prooductss, andd provvides a bassis foor conntinuaal impprovemment. This ca
18、n llead tto inccreaseed sattisfacction of cuustomeers annd othher innteressted ppartiees andd to tthe suuccesss of tthe orrganizzationn.2.4 Thee proccess aapproaachAny acttivityy, or set oof acttivitiies, tthat uuses rresourrces tto traansforrm inpputs tto outtputs can bbe connsiderred ass a prroces
19、ss.For orgganizaationss to ffunctiion efffectiively, theyy havee to iidentiify annd mannage nnumeroous innterreelatedd and interractinng proocessees. Offten, the ooutputt fromm one proceess wiill diirectlly forrm thee inpuut intto thee nextt proccess. The ssystemmatic identtificaation and mmanageeme
20、nt of thhe proocessees empployedd withhin ann orgaanizattion aand paarticuularlyy the interractioons beetweenn suchh proccessess is rreferrred too as tthe “pprocesss appproachh.”The inttent oof thiis Intternattionall Stanndard is too encoouragee the adopttion oof thee proccess aapproaach too manaage
21、 ann orgaanizattion. Figure 1 illlustraates tthe prrocesss-baseed quaality managgementt systtem deescribbed thhe ISOO 90000 famiily sttandarrds. TThis iillusttratioon shoows thhat innteressted ppartiees plaay a ssignifficantt rolee in pprovidding iinputss to tthe orrganizzationn. Monnitoriing thhe s
22、attisfacction of innteressted ppartiees reqquiress the evaluuationn of iinformmationn relaating to thhe perrceptiion off inteeresteed parrties as too the extennt to whichh theiir neeeds annd exppectattions have been met. The mmodel shownn in FFiguree 1 dooes noot shoow proocessees at a dettailedd le
23、veel.2.5 Quaality policcy andd quallity oobjecttivesQualityy poliicy annd quaality objecctivess are estabblisheed to proviide a focuss to ddirectt the organnizatiion. BBoth ddetermmine tthe deesiredd resuults aand asssist the oorganiizatioon to applyy its resouurces to acchievee thesse ressults. The
24、 qualiity poolicy proviides aa frammeworkk for estabblishiing annd revviewinng quaality objecctivess. Thee quallity oobjecttives need to bee conssistennt witth thee quallity ppolicyy and the ccommittment to coontinuual immproveement, and theirr achiievemeent neeeds tto be measuurablee. Thee achiieve
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