ISO10007-2003+质量管理体系+技术状态管理指南(E

BRITISHSTANDARDBSISO10007:2003Qualitymanagementsystems—GuidelinesforconfigurationmanagementICS03.120.10����������� ����� ������������������������������� ������������� LicensedCopy:InstituteOfTechnologyTallaght,InstituteofTechnology,TueNov0712:24:43GMT+00:002006,UncontrolledCopy,(c)BSIBSISO10007:2003ThisBritishStandardwaspublishedundertheauthorityoftheStandardsPolicyandStrategyCommitteeon3July2003©BSI3July2003ISBN0580421694NationalforewordThisBritishStandardreproducesverbatimISO10007:2003andimplementsitastheUKnationalstandard.ItsupersedesBSENISO10007:1997whichiswithdrawn.TheUKparticipationinitspreparationwasentrustedtoTechnicalCommitteeMS/4,Designmanagementsystems,whichhastheresponsibilityto:Alistoforganizationsrepresentedonthiscommitteecanbeobtainedonrequesttoitssecretary.Cross-referencesTheBritishStandardswhichimplementinternationalpublicationsreferredtointhisdocumentmaybefoundintheBSICatalogueunderthesectionentitled“InternationalStandardsCorrespondenceIndex”,orbyusingthe“Search”facilityoftheBSIElectronicCatalogueorofBritishStandardsOnline.Thispublicationdoesnotpurporttoincludeallthenecessaryprovisionsofacontract.Usersareresponsibleforitscorrectapplication.CompliancewithaBritishStandarddoesnotofitselfconferimmunityfromlegalobligations.—aidenquirerstounderstandthetext;—presenttotheresponsibleinternational/Europeancommitteeanyenquiriesontheinterpretation,orproposalsforchange,andkeeptheUKinterestsinformed;—monitorrelatedinternationalandEuropeandevelopmentsandpromulgatethemintheUK.SummaryofpagesThisdocumentcomprisesafrontcover,aninsidefrontcover,theISOtitlepage,pagesiitov,ablankpage,pages1to10,aninsidebackcoverandabackcover.TheBSIcopyrightdatedisplayedinthisdocumentindicateswhenthedocumentwaslastissued.AmendmentsissuedsincepublicationAmd.No.DateCommentsLicensedCopy:InstituteOfTechnologyTallaght,InstituteofTechnology,TueNov0712:24:43GMT+00:002006,UncontrolledCopy,(c)BSIReferencenumberISO10007:2003(E)INTERNATIONALSTANDARDISO10007Secondedition2003-06-15Qualitymanagementsystems—GuidelinesforconfigurationmanagementSystèmesdemanagementdelaqualité—LignesdirectricespourlagestiondelaconfigurationBSISO10007:2003LicensedCopy:InstituteOfTechnologyTallaght,InstituteofTechnology,TueNov0712:24:43GMT+00:002006,UncontrolledCopy,(c)BSIiiBSISO10007:2003LicensedCopy:InstituteOfTechnologyTallaght,InstituteofTechnology,TueNov0712:24:43GMT+00:002006,UncontrolledCopy,(c)BSIiiiContentsPageForeword............................................................................................................................................................ivIntroduction........................................................................................................................................................v1Scope......................................................................................................................................................12Normativereferences...........................................................................................................................13Termsanddefinitions...........................................................................................................................14Configurationmanagementresponsibility.........................................................................................24.1Responsibilitiesandauthorities..........................................................................................................24.2Dispositioningauthority.......................................................................................................................25Configurationmanagementprocess..................................................................................................35.1General...................................................................................................................................................35.2Configurationmanagementplanning.................................................................................................35.3Configurationidentification.................................................................................................................35.4Changecontrol......................................................................................................................................45.5Configurationstatusaccounting.........................................................................................................65.6Configurationaudit...............................................................................................................................7AnnexA(informative)Structureandcontentofaconfigurationmanagementplan...................................8Bibliography.....................................................................................................................................................10BSISO10007:2003LicensedCopy:InstituteOfTechnologyTallaght,InstituteofTechnology,TueNov0712:24:43GMT+00:002006,UncontrolledCopy,(c)BSIivForewordISO(theInternationalOrganizationforStandardization)isaworldwidefederationofnationalstandardsbodies(ISOmemberbodies).TheworkofpreparingInternationalStandardsisnormallycarriedoutthroughISOtechnicalcommittees.Eachmemberbodyinterestedinasubjectforwhichatechnicalcommitteehasbeenestablishedhastherighttoberepresentedonthatcommittee.Internationalorganizations,governmentalandnon-governmental,inliaisonwithISO,alsotakepartinthework.ISOcollaboratescloselywiththeInternationalElectrotechnicalCommission(IEC)onallmattersofelectrotechnicalstandardization.InternationalStandardsaredraftedinaccordancewiththerulesgivenintheISO/IECDirectives,Part2.ThemaintaskoftechnicalcommitteesistoprepareInternationalStandards.DraftInternationalStandardsadoptedbythetechnicalcommitteesarecirculatedtothememberbodiesforvoting.PublicationasanInternationalStandardrequiresapprovalbyatleast75%ofthememberbodiescastingavote.Attentionisdrawntothepossibilitythatsomeoftheelementsofthisdocumentmaybethesubjectofpatentrights.ISOshallnotbeheldresponsibleforidentifyinganyorallsuchpatentrights.ISO10007waspreparedbyTechnicalCommitteeISO/TC176,Qualitymanagementandqualityassurance,SubcommitteeSC2,Qualitysystems.Thissecondeditioncancelsandreplacesthefirstedition(ISO10007:1995),whichhasbeentechnicallyrevised.ThiseditionhassoughttoimprovethealignmentofISO10007withtheISO9000familyofInternationalStandardsandtosimplifythestructureofthedocument.BSISO10007:2003LicensedCopy:InstituteOfTechnologyTallaght,InstituteofTechnology,TueNov0712:24:43GMT+00:002006,UncontrolledCopy,(c)BSIvIntroductionThepurposeofthisInternationalStandardistoenhancecommonunderstandingofthesubject,topromotetheuseofconfigurationmanagement,andtoassistorganizationsapplyingconfigurationmanagementtoimprovetheirperformance.Configurationmanagementisamanagementactivitythatappliestechnicalandadministrativedirectionoverthelifecycleofaproduct,itsconfigurationitems,andrelatedproductconfigurationinformation.Configurationmanagementdocumentstheproduct’sconfiguration.Itprovidesidentificationandtraceability,thestatusofachievementofitsphysicalandfunctionalrequirements,andaccesstoaccurateinformationinallphasesofthelifecycle.Configurationmanagementcanbeimplementedbasedonthesizeoftheorganizationandthecomplexityandnatureoftheproduct.ConfigurationmanagementcanbeusedtomeettheproductidentificationandtraceabilityrequirementsspecifiedinISO9001.BSISO10007:2003LicensedCopy:InstituteOfTechnologyTallaght,InstituteofTechnology,TueNov0712:24:43GMT+00:002006,UncontrolledCopy,(c)BSIblankLicensedCopy:InstituteOfTechnologyTallaght,InstituteofTechnology,TueNov0712:24:43GMT+00:002006,UncontrolledCopy,(c)BSIINTENRATIONALTSANDADRIS:70001O3002(E)I©SO—3002Allirhgtsseredevr1Qualitymanagementsystems—Guidelinesforconfigurationmanagement1ScopeThisInternationalStandardgivesguidanceontheuseofconfigurationmanagementwithinanorganization.Itisapplicabletothesupportofproductsfromconcepttodisposal.Itfirstoutlinestheresponsibilitiesandauthoritiesbeforedescribingtheconfigurationmanagementprocessthatincludesconfigurationmanagementplanning,configurationidentification,changecontrol,configurationstatusaccountingandconfigurationaudit.SincethisInternationalStandardisaguidancedocument,itisnotintendedtobeusedforcertification/registrationpurposes.2NormativereferencesThefollowingreferenceddocumentsareindispensablefortheapplicationofthisdocument.Fordatedreferences,onlytheeditioncitedapplies.Forundatedreferences,thelatesteditionofthereferenceddocument(includinganyamendments)applies.ISO9000:2000,Qualitymanagementsystems—Fundamentalsandvocabulary3TermsanddefinitionsForthepurposesofthisdocument,thedefinitionsgiveninISO9000andthefollowingapply.3.1changecontrolactivitiesforcontroloftheproductafterformalapprovalofitsproductconfigurationinformation(3.9)3.2concessionpermissiontouseorreleaseaproductthatdoesnotconformtospecifiedrequirementsNOTE1Aconcessionisgenerallylimitedtothedeliveryoftheproductthathasnonconformingcharacteristicswithinspecifiedlimitsforanagreedtimeorquantityofthatproduct.[ISO9000:2000,definition3.6.11]NOTE2Concessionsdonotaffecttheconfigurationbaseline(3.4)andincludepermissiontoproduceaproductthatdoesnotconformtospecifiedrequirements.NOTE3Someorganizationsusetermssuchas“waivers”or“deviations”insteadof“concession”.3.3configurationinterrelatedfunctionalandphysicalcharacteristicsofaproductdefinedinproductconfigurationinformation(3.9)BSISO10007:20031LicensedCopy:InstituteOfTechnologyTallaght,InstituteofTechnology,TueNov0712:24:43GMT+00:002006,UncontrolledCopy,(c)BSIISO10007:2003(E)2I©SO—3002Allirhgtsseredevr3.4configurationbaselineapprovedproductconfigurationinformation(3.9)thatestablishesthecharacteristicsofaproductatapointintimethatservesasreferenceforactivitiesthroughoutthelifecycleoftheproduct3.5configurationitementitywithinaconfiguration(3.3)thatsatisfiesanendusefunction3.6configurationmanagementcoordinatedactivitiestodirectandcontrolconfigurationNOTEConfigurationmanagementgenerallyconcentratesontechnicalandorganizationalactivitiesthatestablishandmaintaincontrolofaproductanditsproductconfigurationinformation(3.9)throughoutthelifecycleoftheproduct.3.7configurationstatusaccountingformalizedrecordingandreportingofproductconfigurationinformation(3.9),thestatusofproposedchangesandthestatusoftheimplementationofapprovedchanges3.8dispositioningauthoritypersonoragroupofpersonsassignedresponsibilityandauthoritytomakedecisionsontheconfiguration(3.3)NOTE1Dispositioningauthoritycanalsobecalleda“configurationcontrolboard”.NOTE2Relevantinterestedpartieswithinandoutsidetheorganizationshouldberepresentedonthedispositioningauthority.3.9productconfigurationinformationrequirementsforproductdesign,realization,verification,operationandsupport4Configurationmanagementresponsibility4.1ResponsibilitiesandauthoritiesTheorganizationshouldidentifyanddescriberesponsibilitiesandauthoritiesrelatedtotheimplementationandverificationoftheconfigurationmanagementprocess.Thefollowingshouldbeconsidered:thecomplexityandnatureoftheproduct;theneedsofthedifferentproductlifecyclestages;theinterfacesbetweenactivitiesdirectlyinvolvedintheconfigurationmanagementprocess;theotherrelevantinterestedpartiesthatmaybeinvolved,withinandoutsidetheorganization;theidentificationoftheresponsibleauthorityforverifyingimplementationactivities;theidentificationofthedispositioningauthority.4.2DispositioningauthorityPriortoapprovalofachange,thedispositioningauthorityshouldverifythattheproposedchangeisnecessary,andtheconsequenceswouldbeacceptable,BSISO10007:20032LicensedCopy:InstituteOfTechnologyTallaght,InstituteofTechnology,TueNov0712:24:43GMT+00:002006,UncontrolledCopy,(c)BSIISO10007:2003(E)I©SO—3002Allirhgtsseredevr3thechangehasbeenproperlydocumentedandcategorized,andtheplannedactivitiesfortheimplementationofthechangeintodocuments,hardwareand/orsoftwarearesatisfactory.5Configurationmanagementprocess5.1GeneralTheactivitiesthatareperformedwithintheconfigurationmanagementprocessaredescribedbelow.Itisessentialthattheseactivitiesbecoordinatedforthisprocesstobeeffective.Theconfigurationmanagementprocessshouldfocusoncustomerrequirementsfortheproductandshouldtakeintoaccountthecontextinwhichitwillbeperformed.Theconfigurationmanagementprocessshouldbedetailedinaconfigurationmanagementplan.Thisshoulddescribeanyproject-specificproceduresandtheextentoftheirapplicationduringthelifecycleoftheproduct.5.2ConfigurationmanagementplanningConfigurationmanagementplanningisthefoundationfortheconfigurationmanagementprocess.Effectiveplanningcoordinatesconfigurationmanagementactivitiesinaspecificcontextovertheproductlifecycle.Theoutputofconfigurationmanagementplanningistheconfigurationmanagementplan.Theconfigurationmanagementplanforaspecificproductshouldbedocumentedandapproved,becontrolled,identifytheconfigurationmanagementprocedurestobeused,makereferencetorelevantproceduresoftheorganizationwhereverpossible,anddescribetheresponsibilitiesandauthoritiesforcarryingoutconfigurationmanagementthroughoutthelifecycleoftheproduct.Theconfigurationmanagementplanmaybeastand-alonedocument,orapartofanotherdocument,orcomposedofseveraldocuments.Insomesituations,theorganizationwillneedtorequireasuppliertoprovideaconfigurationmanagementplan.Theorganizationmaywishtoretainsuchplanseitherasstand-alonedocumentsortoincorporatethemintoitsownconfigurationmanagementplan.AnnexAdescribesapotentialstructureandcontentforaconfigurationmanagementplan.5.3Configurationidentification5.3.1ProductstructureandselectionofconfigurationitemsTheselectionofconfigurationitemsandtheirinter-relationshipsshoulddescribetheproductstructure.Configurationitemsshouldbeidentifiedusingestablishedselectioncriteria.Configurationitemsshouldbeselectedwhosefunctionalandphysicalcharacteristicscanbemanagedseparatelytoachievetheoverallend-useperformanceoftheitem.Selectioncriteriashouldconsiderstatutoryandregulatoryrequirements,BSISO10007:20033LicensedCopy:InstituteOfTechnologyTallaght,InstituteofTechnology,TueNov0712:24:43GMT+00:002006,UncontrolledCopy,(c)BSIISO10007:2003(E)4I©SO—3002Allirhgtsseredevrcriticalityintermsofrisksandsafety,newormodifiedtechnology,designordevelopment,interfaceswithotherconfigurationitems,procurementconditions,andsupportandservice.Thenumberofconfigurationitemsselectedshouldoptimizetheabilitytocontroltheproduct.Theselectionofconfigurationitemsshouldbeinitiatedasearlyaspossibleintheproductlifecycle.Theconfigurationitemsshouldbereviewedastheproductevolves.5.3.2ProductconfigurationinformationProductconfigurationinformationcomprisesbothproductdefinitionandproductoperationalinformation.Thistypicallyincludesrequirements,specifications,designdrawings,partslists,softwaredocumentsandlistings,models,testspecifications,maintenanceandoperatinghandbooks.Productconfigurationinformationshouldberelevantandtraceable.Numberingconventionsshouldbeestablishedthatareuniqueandensurepropercontrolofconfigurationitems.Theseshouldtakeintoconsiderationtheexistingnumberingconventionsoftheorganizationandthechangecontrolinformation,suchasrevisionstatus.5.3.3ConfigurationbaselinesAconfigurationbaselineconsistsoftheapprovedproductconfigurationinformationthatrepresentsthedefinitionoftheproduct.Configurationbaselines,plusapprovedchangestothosebaselines,representthecurrentapprovedconfiguration.Configurationbaselinesshouldbeestablishedwheneveritisnecessaryintheproductlifecycletodefineareferenceforfurtheractivities.Thelevelofdetailtowhichtheproductisdefinedinaconfigurationbaselinedependsonthedegreeofcontrolrequired.5.4Changecontrol5.4.1GeneralAftertheinitialreleaseofproductconfigurationinformation,allchangesshouldbecontrolled.Thepotentialimpactofachange,customerrequirementsandtheconfigurationbaselinewillaffectthedegreeofcontrolneededtoprocessaproposedchangeorconcession.Theprocessforcontrollingthechangeshouldbedocumented,andshouldincludethefollowing:adescriptionof,justificationfor,andrecordof,thechange;acategorizationofthechange,intermsofcomplexity,resourcesandscheduling;anevaluationoftheconsequencesofthechange;detailsofhowthechangeshouldbedispositioned;detailsofhowthechangeshouldbeimplementedandverified.BSISO10007:20034LicensedCopy:InstituteOfTechnologyTallaght,InstituteofTechnology,TueNov0712:24:43GMT+00:002006,UncontrolledCopy,(c)BSIISO10007:2003(E)I©SO—3002Allirhgtsseredevr55.4.2Initiation,identificationanddocumentationoftheneedforchangeAchangemaybeinitiatedbytheorganization,byacustomer,orbyasupplier.Priortosubmissionforevaluationtothedispositioningauthority(see4.2),allchangeproposalsshouldbeidentifiedanddocumented.Changeproposalsshouldtypicallyincludethefollowinginformation:configurationitem(s)andrelatedinformationtobechanged,includingdetailsoftheirtitle(s)andcurrentrevisionstatus;adescriptionoftheproposedchange;detailsofotherconfigurationitemsorinformationthatmaybeaffectedbythechange;theinterestedpartypreparingtheproposal,andthedateitwasprepared;thereasonforthechange;thecategoryofthechange.Thestatusofchangeprocessing,therelateddecisionsandthedispositionsshouldbedocumented.Atypicalmethodfordocumentingchangemaybetheuseofastandardformthatisgivenauniqueidentificationnumberforeaseofidentificationandtraceability.5.4.3Evaluationofchange5.4.3.1Evaluationsconcerningtheproposedchangeshouldbeperformedanddocumented.Theextentofanyevaluationshouldbebasedonthecomplexityoftheproduct,thecategoryofthechange,andshouldincludethefollowing:thetechnicalmeritsoftheproposedchange;therisksassociatedwiththechange;thepotentialimpactoncontract,scheduleandcosts.5.4.3.2Indeterminingtheimpact,thefollowingfactorsshouldalsobeconsidered:therelevantstatutoryandregulatoryrequirements;theinterchangeabilityofconfigurationitemsandtheneedfortheirre-identification;theinterfacesbetweenconfigurationitems;themanufacturing,testandinspectionmethods;inventoryandpurchases;deliveryactivities;customersupportrequirements.5.4.4DispositionofchangeAprocessshouldbeestablishedforthedispositionofchangethatidentifiesthedispositioningauthority(see4.2)foreachproposedchange.Thisshouldtakeintoaccountthecategoryoftheproposedchange.BSISO10007:20035LicensedCopy:InstituteOfTechnologyTallaght,InstituteofTechnology,TueNov0712:24:43GMT+00:002006,UncontrolledCopy,(c)BSIISO10007:2003(E)6I©SO—3002AllirhgtsseredevrAfteraproposedchangehasbeenevaluated,thedispositioningauthorityshouldreviewtheevaluationandshoulddecideuponthedispositionofthechange.Thedispositionshouldberecorded.Noticeofthedispositionshouldbecirculatedtorelevantinterestedpartieswithinandoutsidetheorganization.5.4.5ImplementationandverificationofchangeTheimplementationofanapprovedchangenormallyincludeschangestotheproductconfigurationinformationbeingreleasedtorelevantinterestedparties,andactionsbeingtakenbyrelevantinterestedparties(bothwithinandoutsidetheorganization)thatareaffectedbythechange.Afterimplementation,compliancewiththeapprovedchangeshouldbeverified.Thisverificationshouldberecordedtoallowtraceability.5.5Configurationstatusaccounting5.5.1GeneralTheconfigurationstatusaccountingactivityresultsinrecordsandreportsthatrelatetoaproductanditsproductconfigurationinformation.Theorganizationshouldperformconfigurationstatusaccountingactivitiesthroughoutthelifecycleoftheproductinordertosupportandenableanefficientconfigurationmanagementprocess.5.5.2Records5.5.2.1Duringtheconfigurationidentificationandchangecontrolactivities,configurationstatusaccountingrecordswillbecreated.Theserecordsallowforvisibilityandtraceabilityandfortheefficientmanagementoftheevolvingconfiguration.Theytypicallyincludedetailsoftheproductconfigurationinformation(suchasidentificationnumber,title,effectivedates,revisionstatus,changehistoryanditsinclusioninanybaseline),theproduct’sconfiguration(suchaspartnumbers,productdesignorbuildstatus),thestatusofreleaseofnewproductconfigurationinformation,andtheprocessingofchanges.5.5.2.2Theevolvingproductconfigurationinformationshouldberecordedinamannerthatide