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1、ISO 9004:2000(E)Quality management systems Guidelines for performance improvements 1 ScopeThis Innternaationaal Staandardd provvides guideeliness beyoond thhe reqquiremments givenn in IISO 90001 inn ordeer to consiider bboth tthe efffectiivenesss ad efficciencyy of aa quallity mmanageement systeem,
2、annd connsequeently the ppotenttial ffor immproveement of thhe perrformaance oof an organnizatiion. WWhen ccomparred too ISO 9001, the objecctivess of ccustommer saatisfaactionn and produuct quualityy are extennded tto incclude the ssatisffactioon of interrestedd partties aad thee perfformannce off
3、the organnizatiion.This Innternaationaal Staandardd is aappliccable to thhe proocessees of the oorganiizatioon andd conssequenntly tthe quualityy manaagemennt priinciplles onn whicch it is baased ccan bee deplloyed throuughoutt the organnizatiion. TThe foocus oof thiis Intternattionall Stanndard is
4、thhe achhievemment oof onggoing improovemennt, meeasureed thrrough the ssatisffactioon of custoomers and oother interrestedd partties.This Innternaationaal Staandardd conssists of guuidancce andd recoommenddationns andd is nnot inntendeed forr certtificaation, reguulatorry or contrractuaal usee, nor
5、r as aa guidde to the iimplemmentattion oof ISOO 90011.2 Normaative referrenceThe folllowinng norrmativve doccumentt conttains proviisionss whicch, thhroughh refeerencee in tthis ttext, consttitutee provvisionns of this Interrnatioonal SStandaard. FFor daated rrefereences, subssequennt ameendmennts
6、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. For
7、r undaated rrefereences, the latesst ediition of thhe norrmativve doccumentt refeerred to apppliess. Memmbers of ISSO andd IEC mainttain rregistters oof currrentlly vallid Innternaationaal Staandardds.ISO 90000:20000, Quualityy manaagemennt sysstems Funndamenntals and vvocabuulary.3 Termss and defin
8、nitionnsFor thee purpposes of thhis Innternaationaal Staandardd, thee termms andd defiinitioons giiven iin ISOO 90000 applly.The folllowinng terrms, uused iin thiis ediition of ISSO 90004 to descrribe tthe suupply-chainn, havve beeen chaanged to reeflectt the vocabbularyy currrentlyy usedd:supplieer
9、 orgaanizattion cusstomerr (intterestted paartiess )Throughhout tthe teext off thiss Inteernatiional Standdard, whereever tthe teerm “pproducct” occcurs, it cca alsso meaan “seervicee”.4 Qualiity maanagemment ssystemm4.1 Mannagingg systtems aand prrocesssesLeadingg and operaating an orrganizzationn
10、succcessfuully rrequirres maanaginng it in a systeematicc and visibble maanner. Succcess sshouldd resuult frrom immplemeentingg and mainttaininng a mmanageement systeem thaat is deignned too conttinuallly immprovee the effecctivenness aand effficieency oof thee orgaanizattionss perfformannce byy con
11、ssideriing thhe neeeds off inteeresteed parrties. Manaaging an orrganizzationn inclludes qualiity maanagemment, amongg otheer mannagemeent diiscipllines.Top mannagemeent shhould estabblish a cusstomerr-orieented organnizatiiona) by ddefiniing syystemss and proceesses that can bbe cleearly underrstoo
12、dd, mannaged and iimprovved inn effeectiveeness a welll as efficciencyy, andd b) by eensuriing efffectiive annd effficiennt opeeratioon andd conttrol oof proocessees andd the measuures aand daata ussed deetermiine saatisfaactoryy perfformannce off the organnizatiion.Examplees of activvitiess to eest
13、abllish aa custtomer-oriennted oorganiizatioon incclude- definning aand prromotiing prrocessses thhat leead too imprroved organnizatiional perfoormancce,- acquiiring and uusing proceess daata annd infformattion oon a ccontinnuing basiss,- direccting progrress ttowardds conntinuaal impprovemment, and
14、- usingg suittable methoods too evalluate proceess immproveement, suchh as sself-aassesssmentss and managgementt reviiew.Examplees of self-assesssmentt and contiinual improovemennt proocessees aree giveen in annexxes A and BB resppectivvely.ISO 9001:2000, Quality management systems Requirements4 Qua
15、lity management system4.1 General requirementsThe organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard.The organization shalla)identify the processes nee
16、ded for the quality management system and their application throughout the organization,b) determine the sequence and interaction of these processes,c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective,d) ensure the availability of r
17、esources and information necessary to support the operation and monitoring o these processes,e) monitor, measure and analyse these processes, and f) implement actions necessary to achieve planned results and continual improvement of these processes.These processes shall be managed by the organizatio
18、n in accordance with the requirements of this International Standard.Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. Control of such outsourced processes shall be identified within th
19、e quality management system.NOTE Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement.4.2 DoccumenttationnManagemment sshouldd defiine thhe doccumenttationn, inccludinng th
20、ee releevant recorrds, nneededd to eestabllish, impleement and mmaintaain thhe quaality managgementt systtem annd to suppoort annd efffectivve andd effiicientt operrationn of tthe orrganizzationns proocessees.The natture aand exxtent of thhe doccumenttationn shouuld saatisfyy the contrractuaal, stta
21、tutoory annd reggulatoory reequireementss, andd the needss and expecctatioons off custtomerss and otherr inteeresteed parrties and sshouldd be aapproppriatee to tthe orrganizzationn. Doccumenttationn may be inn any form or meedium suitaable ffor thhe neeeds off the organnizatiion.In ordeer to provii
22、de doocumenntatioon to satissfy thhe neeeds annd exppectattions of innteressted ppartiees mannagemeent shhould consiider- contrractuaal reqquiremments from the ccustommer annd othher innteressted ppartiees,- accepptancee of iinternnationnal, nnationnal ,rregionnal annd inddustryy secttor sttandarrds
23、,- relevvant sstatuttory aand reegulattory rrequirrementts,-deecisioons byy the organnizatiion,- decissions by thhe orgganizaation,- sourcces off exteernal inforrmatioon rellevantt for the ddeveloopmentt of tthe orrganizzationns commpetenncies, and - inforrmatioon aboout thhe neeeds annd exppectatti
24、ons of innteressted ppartiees.The genneratiion, uuse annd conntrol of doocumenntatioon shoould bbe evaaluateed witth resspect to thhe efffectivvenesss and efficciencyy of tthe orrganizzationn agaiinst ccriterria suuch ass - functtionallity (such as sppeed oof proocessiing),- user frienndlineess,- re
25、souurces needeed,- policcies aand obbjectiives - curreent annd futture rrequirrementts rellated to maanaginng knoowledgge.- benchhmarkiing off docuumentaation systeems, aand - interrfacess usedd by oorganiizatioons cusstomerrs, suupplieers annd othher innteressted ppartiees.Access to doocumenntatioo
26、n shoould bbe enssured for ppeoplee in tthe orrganizzationn and to otther iintereested partiies, bbased on thhe orgganizaations commmuniccationn poliicy.ISO9001:2000, Quality management systems Requirements 4.2 Documentation requirements4.2.1 GeneralThe quality management system documentation shall
27、includea) documented statements of a quality policy and quality objectives,b) a quality manual,c) documented procedures required by this International Standard,d) documents needed by the organization to ensure the effective planning, operation and control of its processes, and e) records required by
28、 this International Standard.NOTE 1 Where the term “documented procedure” appears within this International Standard, this means that the procedure is established, documented, implemented and maintained.NOTE 2 The extent of the quality management system documentation can differ from one organization
29、 to another due to a) the size of organization and type of activities,b) the complexity of processes and their interaction, and c) the competence of personnel.NOTE 3 The documentation can be in any form or type of medium.4.2.2 Quality manualThe organization shall establish and maintain a quality man
30、ual that includesa) the scope of the quality management system, including details of and justification for any exclusions,b) the documented procedures established for the quality management system, or reference to them, and c) a description of the interaction between the processes of the quality man
31、agement system.4.2.3 Control of documentsDocumental required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.4.A documented procedure shall be established to define the controls neededa) t
32、o approve documents for adequacy prior to issue,b) to review and update as necessary and re-approve documents,c) to ensure that changes and the current revision status of documents are identified,d) to ensure that relevant versions of applicable documents are available at points of use,e) to ensure
33、that documents remain legible and readily identifiable,f) to ensure that documents of external origin are identified and their distribution controlled, and g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained or any purpose.4.2.4 C
34、ontrol of recordsRecords shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define th
35、e controls needed for the identification, storage, protection, retention time and disposition of records.4.3 Usee of qqualitty mannagemeent prrincipplesTo leadd and operaate ann orgaanizattion ssuccesssfullly, itt is nnecesssary tto mannage iit in a sysstemattic annd vissible manneer. Thhe guiidance
36、e to mmanageement offerred inn thiss Inteernatiional Standdard iis bassed onn eighht quaality managgementt prinnciplees. These pprinciiples have been develloped for uuse byy top managgementt in oorder to leead thhe orgganizaation towarrd impprovedd perfformannce. TThese qualiity maanagemment pprinci
37、iples are iintegrrated in thhe conntentss of tthis IInternnationnal Sttandarrd andd are listeed bellowa) Custtomer focussOrganizzationns deppend oon theeir cuustomeers annd theereforre shoould uundersstand curreent annd futture ccustommer neeeds, shoulld meeet cusstomerr requuiremeents aand sttrive
38、to exxceed custoomer eexpecttationns.b) LeaddershiipLeaderss estaablishh unitty of purpoose annd dirrectioon of the oorganiizatioon. Thhey shhould creatte andd mainntain the iinternnal ennvironnment in whhich ppeoplee can becomme fullly innvolveed in achieeving the oorganiizatioons oobjecttives.c) I
39、nvoolvemeent off peopplePeople at alll levvels aare thhe esssence of ann orgaanizattion aand thheir ffull iinvolvvementt enabbles ttheir abiliities to bee usedd for the oorganiizatioons bbenefiit.d) Proccess aapproaachA desirred reesult is acchieveed morre effficienntly wwhen aactiviities and rrelat
40、eed ressourcees aree manaaged aas a pprocesss.e) Systtem appproacch to managgementt Identiffying, undeerstannding and mmanagiing innterreelatedd proccessess as aa systtem coontribbutes to thhe orgganizaations efffectivvenesss and efficciencyy in aachievving iits obbjectiives.f) Conttinuall imprrovem
41、eentContinuual immproveement of thhe orgganizaations oveerall perfoormancce shoould bbe a ppermannent oobjecttive oof thee orgaanizattion.g) Facttual aapproaach too deciision makinngEffectiive deecisioons arre bassed o the aanalyssis off dataa and inforrmatioon.h) Mutuually benefficiall suppplier re
42、lattionshhipsAn orgaanizattion aand itts suppplierrs aree inteerdepeendentt and a muttuallyy beneeficiaal rellationnship enhannces tthe abbilityy of bboth tto creeate vvalue.Successsful uuse off the eightt manaagemennt priinciplles byy an oorganiizatioon willl ressult iin bennefitss to iintereested
43、partiies, ssuch aas impprovedd moneetary returrns, tthe crreatioon of valuee and increeased stabiility.5 Managgementt respponsibbilityy5.1 Genneral guidaance5.1.1 IIntrodductioonLeadersship, commiitmentt and the aactivee invoolvemeent off the top mmanageement are eessenttial ffor deevelopping aand m
44、aaintaiining an efffectiive annd effficiennt quaality managgementt systtem too achiieve bbenefiits foor intterestted paartiess. To achieeve thhese bbenefiits, iit is necesssary to esstabliish, ssustaiin andd incrrease custoomer ssatisffactioon. Toop mannagemeent shhould consiider aactionns succh as
45、- establiishingg a viision, poliicies and sstrateegic oobjecttives consiistentt withh the purpoose off the organnizatiion,- leadingg the organnizatiion byy exammple, in orrder tto devvelop trustt withhin itts peoople, - communiicatinng orgganizaationaal dirrectioon andd valuues reegardiing quualityy
46、 and the qqualitty mannagemeent syystem,- particiipatinng in improovemennt proojectss, seaarchinng forr new methoods, ssolutiions aand prroductts,- obtainiing feeedbacck dirrectlyy on tthe efffectiivenesss andd effiicienccy of the qqualitty mannagemeent syystem,- identiffying the pproducct reaalizat
47、tion pprocessses tthat pprovidde addded vaalue tto thee orgaanizattion.- creatinng an envirronmennt thaat enccouragges thhe invvolvemment aand deeveloppment of peeople, and - provisiion off the struccture and rresourrces tthat aare neecessaary too suppport tthe orrganizzationns sttrateggic pllans.Top mannagemeent shhould also definne metthods for mmeasurrementt of tthe orrganizzationns peerformmance in orrder tto detterminne wheether plann