理解和实施ISO9001过程方法的完全指引（英文）

OxebridgeQualityResources,Inc.TheCompleteGuidetoUnderstanding&ImplementingISO9001’sProcessManagementRequirementsv3ByChristopherParisVPOperationsOxebridgeQualityResources,Inc.©2003Allrightsreserved.Forreprintorinternationaltranslationrights,[e-mail]y2003on’sProcessManagementRequirementsOxebridgeQualityResources,Inc.:registeredcompanieslookingtoupdatetheirsystems,companieslookingtoregistertoISO9001forthefirsttime,consultantsaimingtoteachthenewstandard'srequirements,andeventheregistrarsthemselves.InternationalaccreditationbodiessuchasRABhavenowbecomealerttothisissue,andaretighteningregistrarrequirementstoensureregistrantcompanieshavefullyimplementedtheprocessapproach.Tosummarize,ISO9K2Krequiresthatyourprocessesbeidentified,controlled,analyzed,auditedandreviewed.Thisfour-partguidewilltakeyouthroughallthosestepstohelpyourcompanyensurecompliancewiththenewstandardwhileeliminatingunnecessaryworkanddocumentation.Portionsofthestandardthatarenotprocess-relatedarenotdiscussedhere,sothisisnotmeanttobeaguideonfulltransitiontoISO9001:2000,butratheracompleteguideonadoptingtheprocessapproach.Specifically,thisguidewillshowyouhowto:•Understandwhataprocessis,andwhatitisn't•AdopttheprocessapproachbyeasilyidentifyingyourprocessesinfullcompliancetoISO9001•Easilymappingyourprocesses'sequenceandinteraction•Assigningqualityobjectivestoyourprocesses•Auditingprocesses,whiletreatingauditingitselfasaprocessAsalways,Oxebridgeaimsatmakingthisaffairsimpleandintuitive.Besuretoprovideusfeedbackonthisarticleifyouhaveanyquestions;thiswaywecanupdatetheseriestohelpotherswithsimilarproblems.TheCompleteGuidetoUnderstanding&ImplementingISO9001’sProcessManagementRequirementsOxebridgeQualityResources,Inc.:UNDERSTANDINGTHEPROCESSAPPROACHInadditiontoClause4.1,themethodsofutilizingaprocessapproachareelaboratedinClause0.2which,althoughnotauditable,definesthebasicexpectationsofaprocessmodel.TheClausealsopresentsanoverallprocessdiagramwhichIwouldstronglyrecommendcompaniesignorecompletelyuntiltheyhaveimplementedtheirownprocessmodels.ThereasonforthisisthatthediagrampresentedwithinthetextofISO9001:2000isagenericmodeltakingarathermacrolookattherelationshipbetweencompanyandcustomer.ManycompaniesfeelthatbyincludingsomeversionofthisdiagramintheirQualityManualtheyhavemettherequirementsoftheprocessapproach,onlytofindoutthattheyhavefailedtomeettheother,morespecificrequirements.Instead,auniquesystemmustbedevelopedforeachcompany,dependentonitsownprocesses.Theendresultmaybeadiagramthatlookssimilarto,ornothinglike,thediagramofferedinClause0.2.Or,assomecompaniesarenowdiscovering,themodelmaynotbeadiagramatall.ANATOMYOFAPROCESSTostart,letusdefinewhataprocessisnot.Aprocessisnotaprocedure;thetwoarevastlydifferentconcepts,yeteventothisdaymanyconsultantsconfusethetwo.Aprocedureisawrittendescriptionofaprocess,butaprocessexistswhetheritiswrittendownornot.Aprocessisnotadiagram,ormap.Whilethedefiningofaprocessmaytaketheformofamap,simplydrawingaflowchartdoesnotconvertaprocedureintoaprocess,nordoesitmakeanintangibleactivityintoanISO-styleprocess.Again,aprocessexistswhetheritismappedornot.Whatisaprocess,then?Simplyput,aprocessisanactivity;moreaccurately,itisanactivitythatconvertsathingintosomethingelse.ISO9000:2000,thevocabularyguidancedocument,definesprocessasasetofinterrelatedorinteractingactivitieswhichtransformsinputsintooutputs.Iwouldargue,however,thataprocessmaystillbeasingleactivity,notsolelyaset.Breathingisaprocess.Webreatheinair(theinput)andconvertittooxygenatedbloodandcarbondioxideexhalant(theoutputs.)Likewise,activitiessuchaswalking,reading,driving,typingandmanagingareallprocesses,withinputsandoutputs.Thisreallyisn'tTheCompleteGuidetoUnderstanding&ImplementingISO9001’sProcessManagementRequirementsOxebridgeQualityResources,Inc.:Variousinputsarefedintoaprocess,whichresultinoneormoreoutputs;thesethenmayfeedotherprocesses.Processesmayalsobenested,asintheexamplebelow.Hereeachprocess(red)maybemadeofnumeroussub-processes(tan).Thepermutationsarebasedonthecomplexityofyouroperations.Thenextillustrationpresentsamoredetailedlookataprocess(inthiscase,painting)a