Beruflich Dokumente
Kultur Dokumente
11212E.112thSt.N. Owasso,OK740554227
AS9100QualityManual Revision:I
AS9100QualityManual
OriginationDate:August14,2009 DocumentIdentifier: Date: DocumentStatus: DocumentLink:
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TABLEOFCONTENTS
Section1: Welcome5 Section2: CompanyVisionandGoverningPolicies.6 Section3: Scope,ExclusionandDefinitions..6 3.1 Scope...6 3.2 Exclusions.6 3.3 Definitions&Conventions.7 Section4: QualityManagementSystem...7 4.1 GeneralRequirements.7 4.2 Documentation.9 4.2.1 OverviewofDocumentation..9 4.2.2 QualityManualandProcedures.10 4.2.3 ControlofDocuments11 4.2.4 ControlofRecords..11 Section5: ManagementResponsibility....11 5.1 ManagementCommitment...11 5.2 CustomerFocus..12 5.3 QualityPolicy12 5.4 Planning12 5.4.1 QualityObjectives13 5.4.2 QualityManagementSystemPlanning.13 5.5 Responsibility,AuthorityandCommunication..13 5.5.1 ResponsibilityandAuthority..13 5.5.2 ManagementRepresentative.14 5.5.3 InternalCommunication..15 5.6 ManagementReview.15 5.6.1 General.15 5.6.2 ReviewInput.15 5.6.3 ReviewOutput.15 Section6: ResourceManagement.16 6.1 ProvisionofResources...16 6.2 HumanResources..16 6.2.1 General.16 6.2.2 Competence,TrainingandAwareness...16 6.3 Infrastructure17 6.4 WorkEnvironment.17
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Section7: ProductRealization..17 7.1 PlanningofProductRealization...17 7.1.1 ProjectManagement..18 7.1.2 RiskManagement..18 7.1.3 ConfigurationManagement19 7.1.4 ControlofWorkTransfers..20 7.2 CustomerRelatedProcesses..20 7.2.1 DeterminationofRequirements.20 7.2.2 ReviewofRequirements..20 7.2.3 CustomerCommunication..21 7.3 DesignandDevelopment..21 7.4 Purchasing...21 7.4.1 PurchasingProcess..21 7.4.2 PurchasingInformation....22 7.4.3 VerificationofPurchasedProduct.22 7.5 ProductionProvision.23 7.5.1 ControlofProductionProvision..23 7.5.1.1ProductionProcessVerification.24 7.5.1.2ControlofProductionProcessChanges..24 7.5.1.3ControlofProductionEquipment,Tools,andSoftwarePrograms24 7.5.1.4PostDeliverySupport...24 7.5.2 ValidationofProcessesforProduction(SpecialProcesses)...25 7.5.3 IdentificationandTraceability..25 7.5.4 CustomerProperty26 7.5.5 PreservationofProduct.26 7.6 ControlofMonitoringandMeasuringDevices..26 Section8: Measurement,Analysis,&Improvement.26 8.1 General26 8.2 MonitoringandMeasurement..27 8.2.1 CustomerSatisfaction...27 8.2.2 InternalAudits....27 8.2.3 MonitoringandMeasuringofProcesses..28 8.2.4 MonitoringandMeasuringofProduct28 8.3 ControlofNonconformingProduct29 8.4 AnalysisofData..29 8.5 Improvement.29
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8.5.1 ContinualImprovement...30 8.5.2 CorrectiveAction...30 8.5.3 PreventativeAction....30 AppendixA: AdvancedProcessesandApplicableAS9100Clauses..31 AppendixB: MasterProceduresList..32 AppendixC: OutsourcedProcesses...33 AppendixD: QualityObjectives.34 AppendixE: ProductionFlowChart...35 RevisionLog.36
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Section1:Welcome
AdvancedCompanies(Advanced)hasestablishedaQualityManagementSystem(QMS)and managesprocessesinaccordancewithAS9100C(Note:WhereAS9100isread,itistobe understoodAS9100C).AdvancedCompaniesincludesthreedifferentcompanies,colocatedat 11212E112thSt.N,OwassoOK74055.Thesecompaniesare: AdvancedPlastics,Inc. AdvancedPlastics,Inc.(API)isadistributorofengineeredplastics,andfabricatorof plasticsandmetalcomponents. AdvancedMachining&Fabricating,Inc. AdvancedMachining&Fabricating,Inc.(AMF)isaCNCmachineshopandproviderof precisioncomponents/parts(metalandplastic)andlightassemblies. AdvancedPlasticsCompositesMarketingGroup,Inc. AdvancedPlasticsCompositesMarketingGroup,Inc.(CMG)isadistributorofcomposite materials,andmanufacturersrepresentativeorganization. Advancedhasalwaysappliedhighqualitystandards toitsprocessesandoperations,andcontinuesits dedicationinmaintaininghighlevelsofqualityand integrityincommunicatingwithpeopleinsideand outsideofitsbusinessoperations. Weinviteyoutoreviewourqualitysysteminaction. Toarrangeavisit,contactusat: TheAdvancedCompanies 11212E112thSt.N. Owasso,OK74055 (800)3245410 Website:www.advcosinc.com
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Section2: AdvancedsPhilosophyandGoverningPolicies
COMPANYPHILOSOPHY Takingactiontocontinuallyimproveourselvespersonallyandprofessionally,ina corporateculturethataddsvaluetoourcustomers,families,communitiesandour country.Thisiswhatwedo,whywedoit,andwhoweare. QUALITYPOLICY Throughaculturebasedonteamworkandcontinuousimprovement,Advanced
providesmanufacturedanddistributedgoodswhilebringingmeasuredvaluetoour customersandmeetingrequirements.
Section3: TermsandDefinitions
3.1 Scope
3.2
Exclusions
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3.3
Definitions
Section4: QualityManagementSystem
4.1 GeneralRequirements
Advancedhasestablished,documented,implemented,andmaintainsaqualitymanagement systemandcontinuallyimprovesitseffectivenessinaccordancewiththerequirementsof AS9100.Furthermore,AdvancedsQMSaddressescustomerandapplicablestatutoryand regulatoryqualitymanagementsystemrequirements. Advancedhas; a. determinedtheprocessesneededforthequalitymanagementsystemandtheir applicationsthroughouttheorganization,seefigure1 b. determinedthesequenceandinteractionoftheseprocesses,seefigure1 c. determinedcriteriaandmethodsneededtoensurethatboththeoperationandcontrol oftheseprocessesareeffective, d. ensuredtheavailabilityofresourcesandinformationnecessarytosupportthe operationandmonitoringoftheseprocesses, e. monitored,measured,whereapplicable,andanalyzedtheseprocesses, f. implementedactionsnecessarytoachieveplannedresultsandcontinualimprovement oftheseprocesses. Theseprocesses,theirsequenceandinteraction(includinganyoutsourcedprocesses)are showninFigure1.
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4.2 Documentation
4.2.1 OverviewofDocumentation Advancedmaintainsallrequireddocumentationtoeffectivelysustainitsqualitymanagement system.Managementisresponsibleforimplementationofproceduresandrecordsintheir areasasrequiredbythequalitymanagementsystem. Thequalitysystemdocumentationiscomprisedofahierarchyofdocumentsthatflowfrom AS9100andthisqualitymanual.Proceduressupportandenhancetheprimarymandatesof Advancedscompanyphilosophyandqualitypolicyasdefinedinsection2.QualityObjectives maybefoundinAppendixDofthisdocument.
HierarchyofDocuments
WorkInstructions
Records
Forms
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Advancedmaintainsasecureintranetthatallowsauthorizeduserstoaccessdocumentsas neededthroughoutAdvancedsfacilities.Obsoletedocumentsareidentifiedassuchandstored separatelytopreventunintendeduse. Documentsandrecordsdeterminedtobenecessaryforeffectiveplanning,operation,and controlofprocesses,unlessotherwisedirectedbycustomerrequirementsareasfollows: CustomerContract/PurchaseOrder EngineeringData AdvancedsShopTraveler InspectionRecords Governmentspecifications Vendor/Sellerspecifications TheextentoftheQMSdocumentationisappropriateforthesizeoftheAdvancedorganization, itsactivities,thecomplexity,andinteractionofthequalityprocesses. 4.2.2 QualityManualandProcedures TheprimarypurposeofthequalitymanualandQMSproceduresistodescribeanddocument thequalitymanagementsysteminplaceatAdvancedandtodefinealltheQMSprocessesin usewithinAdvanced.Thismanualisissuedundertheauthorityofthetopmanagement. Copiesofthemanualarecontrolledbymeansasdescribedbelow.Uncontrolledcopiesmaybe distributedasrequestedandareidentifiedasUncontrolled.Itismeanttobeusedby employeesastheprimarysourceofofficialAdvancedqualitypolicies.Thismanualisaccessible tocustomers,regulatoryauthoritiesandthirdpartiesthatwishtoverifyAdvancedsquality managementsystem.Externallydistributedcopieswillbeuncontrolledandnotsubjectto revisionnotificationunlessotherwiseagreed. Additionalproceduresandworkinstructionshavebeendevelopedtofurtherclarifyspecific instructionsfortheexecutionoftheseprocedures.Wheresubordinatedocumentsare referenced,theyareshowninbolditalics. TheManagementRepresentativeisresponsibleforcontrolanddistributionofthismanualand allothercontrolleddocumentationwithinthequalitymanagementsystem.Thelatestrevision ofthisdocumentislocatedontheAdvancedintranet.Usersshallverifythelatestrevision beforeuse.ContacttheManagementRepresentativeforquestionsrelatedtothismanual.
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Minorcorrections(typographicalerrorsandclarifications)arenotconsideredachange; therefore,changeinrevisionstatusisnotrequired. DocumentedproceduresestablishedfortheQMSmaybefoundinAppendixB:Master ProceduresList InteractionbetweenprocessesoftheQMSmaybefoundinAppendixA:AdvancedProcesses andApplicableAS9100Clauses Detailsforexclusionsandjustificationseesection3.2ofthismanual. 4.2.3 ControlofDocuments Documentsarecontrolledsothattheinformationonthemisaccessible,legibleandsuitably maintained.Documentsarereviewedandapprovedpriortoreleaseandonlythelatest revisionsareavailabletousers.Previousrevisionsaresegregatedandretainedelectronicallyin afolderlabeledobsolete. ThecontrolsfordocumentsaredefinedintheADVCOS1201DocumentControl. 4.2.4 ControlofRecords Recordsarecontrolledtoprovideevidenceofconformitytorequirements.Recordsthatare subjecttocontrolaremaintainedaccordingtotheADVCOS1202RecordsControland AdvancedsPurchaseOrderTermsandConditions.
Section5: ManagementResponsibility
5.1 ManagementCommitment
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EMPOWERMENT:Allemployeesareempoweredtosubmitrequestsforcorrectiveor preventiveactiontoaffectchangeandimproveAdvancedanditsprocessesandtheir ownexperienceatAdvanced(see8.5).Allemployeesareempoweredtostop productionwhennonconformitiesareencountered(see8.3). INTELLIGENTMANAGEMENT:Advancedaimstoensurethatmanagementmakes decisionsbasedonfacts,dataandevidence.Todothis,managementhasestablished qualityobjectives(see5.4.1).Theinternalauditprocessreliesontherecordingof verifiabledataasameansofdrivingcorrectiveandpreventiveactionsaswellas improvementefforts(see8.2.2,8.5.2,8.5.3).Byconductingperiodicmanagement reviewsofthequalitysystem,managementensurestheoveralleffectivenessofthe qualitysystem(see5.6).TheADVCOS1206CorrectiveActionprocedureensuresthat actionistakenifplannedresultsarenotachieved. WORKPLACEEXCELLENCE:Advancedensurestheworkenvironment,facilitiesand atmospherearesatisfactorytoemployeesthroughmanagementsunderstandingand reviewofresourcerequirements(see5.6)andthroughongoingcommunicationwith employeesregardingtheworkplace(see5.5.3).
5.2CustomerFocus
Topmanagementshallensurethatcustomerrequirementsaredeterminedandaremetwith theaimofenhancingcustomersatisfaction. Topmanagementshallensurethatproductconformityandontimedeliveryperformanceare measuredandthatappropriateactionistakenifplannedresultsarenot,orwillnotbe, achieved.
5.3QualityPolicy
ThequalitypolicyhasbeendevelopedandapprovedbytheManagementRepresentative.This policyandrelevantproceduresisavailabletoallemployees.Thepolicyisauditedregularlyto ensureitsdistributionandtheongoingoverallawarenessofitbyemployees.During managementreview,thequalitypolicyisreviewedforcontinuingsuitability.Thequalitypolicy iscontainedinsidethequalitymanualthatiscontrolledaccordingtotheADVCOS1201 DocumentControl.Thequalitypolicymayalsobeissuedasastandalonedocument;inthis occurrenceitisuncontrolledifprinted.
5.4Planning
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5.4.1QualityObjectives Topmanagementhasestablishedthequalityobjectivesfortheentireorganizationof Advanced;theseobjectivesapplywithineachofthethreecompanies. AppendixDdefinesallthequalityobjectivescurrentlyinplace. 5.4.2QualityManagementSystemPlanning Thisqualitysystemwasplanned.Itsdocumentedpoliciesandprocedureswerereviewedprior toimplementation.ManagementensurestheQMSismaintainedwhenchangestotheQMSare plannedandimplemented.Subsequentmajorchangesthatmayaffecttheperformance,quality orreliabilityoftheproductwillbeidentified,reviewedandapprovedandtheQMS documentationwillbeupdated. TheQMSdocumentationactsastheoverallqualityplanforAdvanced.Asrequired,specific qualityprocessesmaybedevelopedforindividualproducts;theseplansincludethe informationgivenabove.Insuchcases,theappropriatedepartmentmanager(withsupport fromtheQualityManager)hasoverallresponsibilityforthedevelopmentofqualityplans.
5.5Responsibility,AuthorityandCommunication
5.5.1ResponsibilityandAuthority TheorganizationalchartbelowdefinesthebasicmanagementstructureofAdvanced.Inall cases,theappropriatepersonhasbeengrantedboththeresponsibilityandauthorityfortheir position'sduties,whicharefurtherdefinedwithinpositionspecificjobdescriptions.
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COO
QualityManager
Inspection
President
ValueStreamManagers
Shipping/Receiving
VPManufacturing
TopManagement
ChainofCommand Additionallinesofcommunication
5.5.2ManagementRepresentative TheQualityManagerhasbeenassignedtheroleofManagementRepresentative.As ManagementRepresentative,theQualityManagerisresponsibleforensuringtheproper implementationofthequalitymanagementsystem,aswellas,foroverseeingthemaintenance ofthesystem,reportingonitseffectivenessduringmanagementreview,anddiscussionof mattersrelatingtothequalitymanagementsystemwithcustomers,registrarsandother concernedparties. TheManagementRepresentativeisresponsibleforfacilitationofthesepoliciesandprocedures. TheManagementRepresentativehastheresponsibilityandauthoritytoresolvematters relativetoqualityinproducts,processesandservicesfrominternalandexternalsources. Qualitymaysuspendinternalandexternalprocessesand/orshipmentsthatdonotmeet
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5.6ManagementReview
5.6.1General TopmanagementshallreviewtheQMS,atquarterlyintervals,toensureitscontinuing suitability,adequacyandeffectiveness.Thisreviewshallincludeassessingopportunitiesfor improvementandtheneedforchangestotheQMS,includingthequalitypolicyandobjectives. Records(managementreviewmeetingminutes)aremaintained. 5.6.2ReviewInput Itemsthatwillappearontheagendainclude: a. b. c. d. e. f. g. h. i. resultsofinternal,customerandregulatoryaudits, customerfeedback, processperformanceandproductconformity, statusofpreventiveandcorrectiveactions, followupactionsfrompreviousmanagementreviews, recommendationsforimprovement, reviewofqualityobjectivesandqualitypolicy, workenvironmentreview, changesthatcouldaffectthequalitymanagementsystem.
5.6.3ReviewOutput Thefollowingitemswillappearinthemeetingminutes:
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Section6:ResourceManagement
6.1ProvisionofResources
Duringmanagementreview,Advanced'smanagementdeterminesandprovidestheresources neededtoimplementandmaintainthequalitymanagementsystemandcontinuallyimproveits effectiveness.Resourcesneededtoenhancecustomersatisfactionbymeetingcustomer requirementsarealsodeterminedandprovided.
6.2HumanResources
6.2.1General AllAdvancedemployeesshallbecompetentonthebasisofappropriateeducation,training skills,andexperience. 6.2.2Competence,TrainingandAwareness Forfulltime,parttime,andtemporaryemployees,Advanced a. hasdeterminedthenecessarycompetenceforpersonnelperformingworkaffecting conformitytoproductrequirements, b. whereapplicable,providestrainingortakesotheractionstoachievethenecessary competence, c. evaluatestheeffectivenessofthistraining, d. ensurespersonnelareawareoftherelevanceandimportanceoftheiractivitiesand howtheycontributetotheachievementofthequalityobjectives,and, e. maintainsappropriaterecordsofeducation,training,skillsandexperience(see 4.2.4). Advancedsmanagementregularlyreviewstheknowledge,capabilitiesandskillneedsofthe organizationagainstthoseavailable.Inanyinstancewherethereisagapbetweenneedsand capability,thefunctionalmanagerwilltakethenecessarystepstoacquireneededknowledge,
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6.3Infrastructure
Advancedhasdeterminedandprovidesandmaintainsthebasicinfrastructureneededto achieveconformitytoproductrequirements.Infrastructurerequirementsareregularly reviewedduringmanagementreviewandincludeareviewof: buildings,workspace,andassociatedutilities, processequipment(bothhardwareandsoftware),and supportingservices(suchastransportation,communicationorinformationsystems).
6.4WorkEnvironment
Advancedhasdeterminedandmanagestheworkenvironment,includingnoise,temperature, humidity,andlighting,neededtoachieveconformitytoproductrequirements.Thework environmentisperiodicallyreviewedduringinternalauditsandworkenvironmentrelated resourcerequirementsareregularlyreviewedduringmanagementreview.
Section7:ProductRealization
7.1PlanningofProductRealization
Inplanningtheprocessesforproductrealization,managementhasensuredthattheprocesses areconsistentwiththerequirementsoftheotherprocesseswithinthequalitysystem.
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Planningincludesthefollowing: A. Qualityobjectivesandrequirementsfortheproduct; B. Theneedtoestablishprocessesanddocuments,andtoprovideresourcesspecifictothe product; C. Requiredverification,validation,monitoring,measurement,inspection,andtest activitiesspecifictotheproductandthecriteriaforproductacceptance; D. Recordsneededtoprovideevidencethattherealizationprocessesandresulting productmeetrequirements; E. Configurationmanagementappropriatetotheproduct; F. Resourcestosupporttheuseandmaintenanceoftheproduct. Theoutputoftheplanningistheshoptraveler,relateddrawings,inspectionpackages,operator checksheets,andspecificationsthatshowdimensions,characteristics,tolerances,andanykey characteristicsidentifiedbyAdvancedorthecustomer.Likewise,theseinstructionsdefineany processes,documentsorresourcerequirementsspecifictotheproduct.Inspection,testingand othermonitoringstepswillalsobedefinedintheshoptraveler. 7.1.1ProjectManagement Projectmanagementisaprocessdesignedtoensurecustomerrequirementsaremet.During projectmanagement,managersplanandmanageproductrealizationinastructuredand controlledmanner.Resourceneedsandscheduleconstraintsareconsideredandadjustedas needed.Appropriateactionsaretakentomitigaterisksastheyaredetermined.These processesarefurtherdefinedinsections7.1.2,7.1.3,7.2,and7.5. 7.1.2RiskManagement Riskmanagementisessentialinmeetingcustomerrequirements.Managers,ortheirdelegates, communicatewithcustomers,obtaininginformationthatmaynotbestatedincontractsor purchaseorders.Theinformationobtainedisusedinriskmanagement. Managementisresponsibleforriskmanagementandtakingactiontomitigaterisks.Factors suchaslabor,equipment,material,scheduling,andoutsideprocessingareidentified throughoutcontractreview,purchasing,planning,production,andinspectionprocesses. Documentsarecreatedorrevised,andmeetingsareheldasneededtoaddressand communicaterisksthathavebeenidentified.Internalpreventiveandcorrectiveactionisclosely integratedintoriskmanagement.Asrisksareidentifiedtheseactionsmaybeusedtomitigate/ resolverisks.See8.5.2and8.5.3.
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Priortoacceptanceofcontractorpurchaseorder,relevantriskcriteriaareassessedtoidentify riskanddeterminefeasibility.Criteriamayincludebutarenotlimitedto: Engineeringdata(e.g.,drawings,models,specifications,etc.)aremadeavailable, Customersuppliedqualityrequirementsand/orvendormanual, Configurationplan, Quantityanddeliveryschedule, Requirementforcustomerapprovedsuppliers, Leadtimeandcostforrawmaterialand/orhardwareitems, Leadtimeandcostofoutsideprocessing(e.g.,heattreat,plating,etc.), Costofanynonrecurringchanges,ifany, Laborhoursandskill, Equipment(e.g.,tooling,fixtures,andresources), Inspectionandtestplans, Anyspecialrequirementsandexpectationsnotstatedinrequest.
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Configurationiscontrolledthroughverificationduringmanufacturing.Evidenceofverificationis recordedonshoptravelersandinspectionrecordsasdefinedinsection8.2.4. 7.1.4ControlofWorkTransfers WhenplanningtotemporarilytransferworkAdvanceddefinestheprocesstocontroland validatethequalityofworkperthecustomerrequirementsand/orthevendorchecksheet. A. Theoutsourcedserviceprovidermustbeanapproved,evaluatedsupplieraccordingto therequirementsofsection7.4 B. ThesupplierisrequiredtonotifyAdvancedofanyprocesschanges,anynonconformity, orotherissues. C. Thesupplierwillbesubjecttothecorrectiveactionsystem,asdefinedinsection8.5.2. D. Workmustbeconductedonthearticle(s)accordingtoanyspecificationslistedonthe purchaseorder. Thisprocessiscontrolledthroughpurchasingandresultantreceivingdocumentation.Product andqualityrequirementsarefloweddowninpurchaseordersasdescribedinsection7.4.2.
7.2CustomerRelatedProcesses
7.2.1DeterminationofRequirements Advancedcapturesallcontractualandspecialrequirements,monitoringandmeasurement requirements,applicablestatutoryorregulatoryrequirements,and/oranynecessary,unstated requirementsaspartofthecontractreviewprocess. 7.2.2ReviewofRequirements Oncecontractualandspecialrequirementsarecaptured,andrisksdetermined,theyare reviewedagainstpreviouscontractororderrequirementsanddifferencesareresolved. Relevantdocumentsarechangedasrequirementschange,asdefinedinSection7.1.3. Advanceddeterminestheircapabilitytomeetcustomerrequirementsbeforeacceptanceofthe order. OrderentryintoE2isarecordofreview.Recordsofactionsarisingfromthereviewshall becomepartoftheworkpackage.
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Wherethecustomerprovidesnodocumentedstatementofrequirement,thecustomer requirementsshallbeconfirmedbyrequestingcustomerapprovalofquoteorbyfeedback throughelectroniccommunicationsorphone(orphoneisfornonaerospacepartsonly). Whereproductrequirementsarechangedafterworkhasbegun,Advancedshallensurethat relevantdocumentsareamendedandthatrelevantpersonnelaremadeawareofthechanges. 7.2.3CustomerCommunication Advanceddeterminesandimplementseffectivearrangementsforcommunicatingwith customersinrelationto a. productinformation, b. inquiries,contractsororderhandling,includingamendments,and c. customerfeedback,includingcustomercomplaints.
7.3DesignandDevelopment
AdvancedtakesexclusiontodesignanddevelopmentfromthescopeofitsQMSperparagraph 3.2.
7.4Purchasing
7.4.1PurchasingProcess Advancedensurespurchasedproductsorservicesconformtospecifiedpurchaserequirements asdefinedinthepurchaseorderandreferenceddocuments.Thecontrolsappliedtothe supplierandtothepurchasedproductorservicevary,dependentontheeffectofthe purchasedproductorserviceonAdvancedproduct. PurchasingisaprocesswithintheAdvancedQMS.Advancedacceptsresponsibilityforthe conformityofproductsthatarepurchasedfromsuppliersincludingproductfromsources definedbythecustomer.Advanceddoesnotusecustomerverificationasevidenceofeffective controlofqualitybytheSupplier. SupplierselectionandevaluationisdefinedinADVCOS1211,SupplierSelection&Evaluation. ThepurchasingprocessensuresAdvancedmanagesriskwhenselectingandusingsuppliersand onlypurchasesmaterialsandservicesfromsuppliersandsubcontractorsthathaveundergone evaluationandapproval.
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7.4.2PurchasingInformation PurchaseordersareusedtotransmitAdvanced'srequirementstosuppliers. Purchaseordersshallinclude,whereappropriate requirementsforapprovalofproduct,procedures,processesandequipment, requirementsforqualificationofpersonnel, qualitymanagementsystemrequirements, thedrawingand/orspecification(s)(orothertechnicaldata)andapplicablerevision, requirementsfordesign,test,examination,inspection,andrelatedinstructionsfor acceptance, f. requirementsfortestspecimens,designapproval,inspection/verification,investigation orauditing, g. requirementsforsuppliernotificationtoAdvancedofnonconformingproduct, requirementsforthesuppliertonotifyAdvancedofchangesinproductand/orprocess definitionand,whererequired,obtainorganizationalapprovalfornonconforming productdisposition,requirementsforthesuppliertoflowdownapplicable requirements, h. recordsretentionrequirements, i. rightofaccessbytheorganization,theircustomer,andregulatoryauthoritiestoall facilitiesinvolvedintheorderandtoallapplicablerecords,and Advancedshallensureadequacyofspecifiedpurchaserequirementsbeforecommunicating themtosupplier. 7.4.3VerificationofPurchasedProduct Advancedhasestablishedreceivinginspectionandotheractivitiesnecessarytoensure purchasedproductmeetsspecifiedpurchaserequirements. Receivinginspectionusescertificatesofconformity,testreports,and/orvisualanddimensional inspectiontoverifyproductconformity. Withoutexception,purchasedproductshallnotbeusedorprocesseduntilithaspassed receivinginspection. Advanceddoesnotdelegateinspectiontosuppliers. a. b. c. d. e.
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7.5Production
7.5.1ControlofProduction Advancedplansandcarriesoutproductionundercontrolledconditions.Controlledconditions include,asapplicable: a. b. c. d. e. f. g. theavailabilityofinformationthatdescribesthecharacteristicsoftheproduct, theavailabilityofworkinstructions,asnecessary, theuseofsuitableequipment, theavailabilityanduseofmonitoringandmeasuringequipment, theimplementationofmonitoringandmeasurement, theimplementationofproductreleaseanddelivery, accountabilityforallproductsduringproduction(e.g.,partsquantities,splitorders, nonconformingproduct) h. evidencethatallproductionandinspection/verificationoperationshavebeen completedasplanned,orasotherwisedocumentedandauthorized, i. provisionfortheprevention,detection,andremovalofforeignobjects, j. monitoringandcontrolofutilitiesandsuppliessuchaswater,compressedair,electricity andchemicalproductstotheextenttheyaffectconformitytoproductrequirements, and k. criteriaforworkmanship(e.g.,deburrorblendingsmoothingoutsteps),specifiedin theclearestpracticalway(e.g.,writtenstandards,representativesamples,or illustrations). Planningconsiders,asapplicable, a. establishing,implementingandmaintainingappropriateprocessestomanagecritical items,includingprocesscontrolswherekeycharacteristicshavebeenidentified, b. designing,manufacturingandusingtoolingtomeasurevariabledata,
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c. identifyinginprocessinspection/verificationpointswhenadequateverificationof conformancecannotbeperformedatlaterstagesofrealization,and d. specialprocesses(see7.5.2). 7.5.1.1ProductionProcessVerification Advancedprovidesfortheinspection,verificationanddocumentationofrepresentativeitem fromthefirstproductionrunofanewpartorassembly,orfollowinganysubsequentchange thatinvalidatesthepreviousfirstarticleinspectionresult. 7.5.1.2ControlofProductionProcessChanges COO,Programming/Planning,LeadMachineOperator,ProductionManager,VP Manufacturing,Quality,ShippingManager,orValueStreamManagershavetheauthorityto approvechangestoproductionprocesses. Toensureproductconformity,Advancedshallvalidateproductionprocesses;equipment,tools, setupandsoftwareprogramspriortoproductionorafterchangeshavebeenmadethrough firstpieceinspectionateachoperation. Softwareprograms,equipment,andprocesschangesshallbedocumentedonthejobtraveler. PermanentrevisionstothejobtravelershallbemadeinE2andthespecificchanges documentedinthecommentssection,sorevisionscanbetrackedthroughtheaudittrail feature.Temporaryrevisionsmaybehandwrittenonthejobtravelerandmustbeinitialed anddatedbysomeonewithapprovalauthority. 7.5.1.3ControlofProductionEquipment,ToolsandSoftwarePrograms Productionequipment,toolsandsoftwareprogramsusedtoautomateandcontrol/monitor productrealizationprocesses,willbevalidatedpriortoreleasetoproductionandwillbe maintained. Productionequipmentshallbemaintainedinaccordancewithestablishedpreventive maintenanceplansandmaintenanceshallbelogged. Holdingfixtures(vises,jaws,etc.),whennotinuse,shallbestoredindoors.Theyshallbe lubricatedandinspectedasnecessarybeforeuse. 7.5.1.4PostDeliverySupport Asofthisrevision,Advancedhasnocontractualrequirementsrelatingtopostdelivery support.Therefore,Advancedtakesexclusionfrom7.5.1.4;thisexclusiondoesnotaffectthe
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abilityorresponsibilityofAdvancedtoprovideproductthatmeetscustomerandapplicable regulatoryrequirements. 7.5.2ValidationofProcessesforProduction(SpecialProcesses) Validationdemonstratestheabilityoftheseprocessestoachieveplannedresults. Advancedshallspecifyarrangementsfortheseprocessesincluding,asapplicable a. b. c. d. e. definedcriteriaforreviewandapprovaloftheprocesses, approvalofequipmentandqualificationofpersonnel, useofspecificmethodsandprocedures, requirementsforrecords(see4.2.4),and revalidation
7.5.3IdentificationandTraceability Productisidentifiedbysuitablemeansthroughoutproductrealization. Advancedshallmaintaintheidentificationoftheconfigurationoftheproductinorderto identifyanydifferencesbetweentheactualconfigurationandtheagreedconfiguration. Productstatuswithrespecttomonitoringandmeasuringrequirementsisidentified; nonconformingpartsareidentified(andsegregated)inaccordancewithADVCOS1204,Control ofNonConformingProduct. InspectionstampsarecontrolledinaccordancewithADVCOS1212,StampControl Wheretraceabilityisarequirement,Advancedcontrolsandrecordstheuniqueidentificationof theproductaccordingtotheleveloftraceabilityrequiredbycontract,regulatory,orother establishedrequirements. Advancedsystemprovidesfor: a. identificationtobemaintainedthroughouttheproductlife; b. alltheproductsmanufacturedfromthesamebatchofrawmaterialorfromthesame manufacturingbatchtobetraced,aswellasthedestination(delivery,scrap)ofall productsofthesamebatch; c. foranassembly,theidentityofitscomponentsandthoseofthenexthigherassemblyto betraced; d. foragivenproduct,asequentialrecordofitsproduction(manufacture,assembly, inspection)toberetrieved.
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7.5.4CustomerProperty AdvancedexercisescarewithcustomerpropertywhileitisinAdvancedscontroloruse. Advancedshallidentify,verify,protectandsafeguardcustomerpropertyprovidedforuseor incorporationintotheproduct.Ifanycustomerpropertyislost,damagedorotherwisefoundto beunsuitableforuse,Advancedwillreportittothecustomerandrecordsmaintainedin accordancewithADVCOS1202,RecordsControl. Customerpropertymayincludeintellectualpropertyandpersonaldata. 7.5.5PreservationofProduct Advancedpreservestheproductduringinternalprocessinganddeliverytotheintended destinationinordertomaintainconformitytorequirements.Asapplicable,preservation includesidentification,handling,packaging,storageandprotection.Preservationalsoappliesto theconstituentpartsofaproduct. Preservationofproductalsoincludes,whereapplicableinaccordancewithproduct specificationsandapplicablestatutoryandregulatoryrequirementsprovisionsfor: a. b. c. d. e. f. cleaning, prevention,detectionandremovalofforeignobjects, specialhandlingforsensitiveproducts, markingandlabelingincludingsafetywarnings, shelflifecontrolandstockrotation, specialhandlingforhazardousmaterials.
7.6ControlofMonitoringandMeasuringEquipment
Advanceddeterminesthemonitoringandmeasurementtobeundertakenandthemonitoring andmeasuringequipmentneededtoprovideevidenceofconformityofproductinaccordance withADVCOS1210,ControlofMonitoringandMeasuringEquipment.
Section8:Measurement,Analysis,&Improvement
8.1General
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8.2MonitoringandMeasurement
8.2.1CustomerSatisfaction Asoneofthemeasurementsoftheperformanceofthequalitymanagementsystem,Advanced monitorsinformationrelatingtocustomerperceptionastowhethertheorganizationhasmet customerrequirements.Themethodsforobtainingandusingthisinformationaredetermined. Advancedcollectsfeedbackfromcustomersusingoneormoreofthefollowingmethodsto monitorandmeasurecustomersatisfaction: correctiveactionrequests customercomplaints customerprovidedperformancedata onTimedelivery productconformity Advancedhasdevelopedandimplementsaplanforcustomersatisfactionimprovementthat addressesdeficienciesidentifiedbytheaboveevaluations,andassessestheeffectivenessof theresults.See5.6ManagementReview. 8.2.2InternalAudit Advancedconductsinternalauditsatplannedintervalstodeterminewhetherthequality managementsystem: a. conformstotheplannedarrangements,totherequirementsofAS9100andtothe qualitymanagementsystemrequirementsestablishedbyAdvancedand b. iseffectivelyimplementedandmaintained. a. b. c. d. e.
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InternalauditsareperformedinaccordancewithADVCOS1205,InternalAudits. Advancedmaintainstheauthoritytooutsourcetheinternalauditingprocesstoacertifiedthird partyauditor.SeeappendixCInternalAuditing. 8.2.3MonitoringandMeasurementofProcesses Advancedshallapplysuitablemethodsformonitoringand,whereapplicable,measurementof thequalitymanagementsystemprocesses. Thesemethodsdemonstratetheabilityoftheprocessestoachieveplannedresults.When plannedresultsarenotachieved,correctionandcorrectiveactionistaken,asappropriate. Intheeventofprocessnonconformity,Advanced a. takesappropriateactiontocorrectthenonconformingprocess, b. evaluateswhethertheprocessnonconformityhasresultedinproductnonconformity, c. determinesiftheprocessnonconformityislimitedtoaspecificcaseorwhetheritcould haveaffectedotherprocessesorproducts,and d. identifiesandcontrolsanynonconformingproduct. 8.2.4MonitoringandMeasurementofProduct Advancedmonitorsandmeasuresthecharacteristicsoftheproducttoverifythatproduct requirementsaremet.Thisiscarriedoutatappropriatestagesoftheproductrealization processinaccordancewiththeplannedarrangements.Evidenceofconformitywiththe acceptancecriteriawillbemaintained. Measurementrequirementswillinclude: a. criteriaforacceptanceand/orrejection, b. whereinthesequencemeasurementandtestingoperationareperformed, c. requiredrecordsofthemeasurementresultsandatminimumindicationofacceptance orrejection,and d. anyspecificmeasurementinstrumentsrequiredandanyspecificinstructionsassociated withtheiruse. Whencriticalitems,includingkeycharacteristics,havebeenidentifiedAdvancedensuresthey aremonitoredandcontrolledinaccordancewithestablishedprocesses.
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WhenAdvancedusessamplinginspectionasameansofproductacceptance,thesamplingplan isjustifiedonthebasisofrecognizedstatisticalprinciplesandappropriateforuse. Productisnottobereleaseduntilithasbeeninspectedorotherwiseverifiedasconformingto specifiedrequirements. Recordsindicatetheperson(s)authorizingreleaseofproductfordeliverytocustomer. WhererequiredtodemonstrateproductqualificationAdvancedensuresthatrecordsprovide evidencethattheproductmeetsthedefinedrequirements. Productreleaseanddeliverywillnotproceeduntilalltheplannedarrangementshavebeen satisfactorilycompleted,unlessotherwiseapprovedbyarelevantauthority,andwhere applicablebythecustomer. Advancedensuresthatalldocumentsrequiredbythecontract/ordertoaccompanytheproduct arepresentatdeliveryandareprotectedagainstlossanddeterioration.
8.3ControlofNonconformingProduct
Advancedensuresthatproductwhichdoesnotconformtoproductrequirementsisidentified andcontrolledtopreventitsunintendeduseordelivery.Theresponsibilities,authorities,and controlsforcontrollingnonconformingproductaredefinedinADVCOS1204,Controlof NonconformingProduct.
8.4AnalysisofData
Advanceddetermines,collectsandanalyzesappropriatedatatodemonstratethesuitability andeffectivenessofthequalitymanagementsystemandtoevaluatewherecontinual improvementoftheeffectivenessofqualitymanagementsystemcanbemade.Thisincludes datageneratedasaresultofmonitoringandmeasurementandfromotherrelevantsources. Theanalysisofdataprovidesinformationrelatingto: a. customersatisfaction(see8.2.1), b. conformitytoproductrequirements(see8.2.4), c. characteristicsandtrendsofprocessesandproductsincludingopportunitiesfor preventiveaction(see8.2.3and8.2.4),and d. suppliers(see7.4).
8.5Improvement
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8.5.1ContinualImprovement Advancedcontinuallyimprovestheeffectivenessofthequalitymanagementsystemthrough theuseofthequalitypolicy,qualityobjectives,auditresults,analysisofdata,correctiveand preventiveactionsandmanagementreview. Advancedmonitorstheimplementationofimprovementactivitiesandevaluatesthe effectivenessoftheresults. 8.5.2CorrectiveAction Advancedtakesactiontoeliminatethecause(s)ofnonconformitiesinordertoprevent recurrenceinaccordancewithADVCOS1206,CorrectiveAction.Correctiveactionsare appropriatetotheeffectsofthenonconformitiesencountered. 8.5.3PreventiveAction Advanceddeterminesactiontoeliminatethecausesofpotentialnonconformitiesinorderto preventtheiroccurrenceinaccordancewithADVCOS1207,PreventiveAction.Preventive actionsareappropriatetotheeffectsofthepotentialproblems.
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AppendixA:AdvancedProcessesandApplicableAS9100Clauses
Process
Corrective&PreventiveAction DesignandDevelopment InternalAuditing
ApplicableAS9100Clause
8.5.2CorrectiveAction 8.5.3PreventiveAction Excluded 8.2.2InternalAudits 4.1QMSGeneralRequirements 4.2DocumentationRequirements 5.1ManagementCommitment 5.2CustomerFocus 5.3QualityPolicy 5.4Planning 5.5.1Responsibility&Authority 5.5.2ManagementRepresentative 5.5.3InternalCommunication 5.6ManagementReview 6.1ProvisionofResources 6.2HumanResources 6.3Infrastructure 6.4WorkEnvironment 7.1.2RiskManagement 7.1.3ConfigurationManagement 7.2.3CustomerSatisfaction 7.5.1ControlofProductionProvision 7.6ControlofMonitoring&MeasurementEquipment 8.1Measurement,Analysis&Improvement:General 8.2.1CustomerSatisfaction 8.2.3Monitoring&MeasurementofProcesses 8.4AnalysisofData 8.5.1ContinualImprovement 7.1PlanningofProductRealization 7.5.1.1ProductionDocumentation 7.5.1.2ControlofProductionProcessChanges 7.5.1.3ControlofProductionEquipment 7.5.1.4PostDeliverySupport 7.5.3Identification&Traceability 7.5.4CustomerProperty 7.5.5Preservation 8.2.4Monitoring&MeasurementofProduct 8.3ControlofNonconformingProduct 7.2.1DeterminationofRequirements 7.2.2ReviewofRequirements 7.4.1PurchasingProcess 7.4.2PurchasingInformation 7.4.3VerificationofPurchasedProduct 7.5.3Identification&Traceability 7.5.4CustomerProperty 7.5.5Preservation 8.2.4Monitoring&MeasurementofProduct 8.3ControlofNonconformingProduct 7.5.3Identification&Traceability 7.5.5Preservation 8.3ControlofNonconformingProduct
Management
Manufacturing
ContractReview Purchasing
Receiving
Shipping
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AppendixB:MasterProceduresList
ADVCOSNo. 1201 1202 1204 1205 1206 1207 1210 1211 1212 Procedure DocumentControl RecordsControl ControlofNonconformingProduct InternalAudit CorrectiveAction PreventiveAction ControlofMonitoring&Measurement Equipment SupplierSelection StampControl AS9100Reference All 4.2.3 8.3 8.2.2 8.5.2 8.5.3 7.6 7.4.1 7.5.3
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AppendixC:OutsourcedProcesses
Thefollowingprocessesareoutsourcedandcontrolledasindicated: AcceptanceTesting:Onlyapprovedlabsareused.Alllabresultsmustbeaccompaniedbyacertificateor testresultthatisreviewedbyQC.Whereapplicable,testsmustbeconductedaccordingtospecifications referencedonthePurchaseOrder. Calibration:OnlyapprovedcalibrationlabsareusedaccordingtoADVCOS1210ControlofMonitoring& MeasurementEquipment.CertificatesmustprovideevidenceofstandardstraceabilitytoNISTandmust meetalltherequirementsofsection7.6ofthisqualitymanual. InternalAuditing:Contractinternalauditorsshallprovideevidenceofhavingattended,ataminimum,a 16hourASQ,RABQSA,orIRCAcertificationorequivalentcourse;furthermore,theserviceprovideris subjecttoallothervendorevaluationandmonitoringandmustfollowinternalauditingproceduresas required. Plating MaterialConversions SubContractMachining SilkScreening Grinding,etc.
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AppendixD:QualityObjectives
Objective
IncreaseOnTime Delivery IncreaseSales ReduceScrap ReduceReturns
ObjectiveTarget
98% Goal 2%ofSales 5/monthand31/year
MeasurementMethod
Percentofdeliveriesmadewithinagreed window Percentoftotalsalesinrelationto predeterminedgoal Percentofscrap(atfinishedproductvalue)in relationtooverallsales Monthlyandannualtotals
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AppendixE:ProductionFlowChart
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REVISIONLOG
Revision A Date
08/14/09
Changes
RevisedAS9100toSAEAS9100:2004(Revision B).Correctedgrammarissues.Revisedorgchart tohighlighttopmanagementmembers.Added communicationexamples. Removedtextfrompar.7.4.1andmadereference toprocedure1211SupplierSelectionand Evaluation ChangedInCompliancetoCertifiedtoon coverpage Removedreferencetowithdrawnprocedure1209 andrevisedthetitleofprocedure1208toProcess ChangesandValidation RevisedtextinSection7.4.3ReceivingInspection. WasReceivingInspectionusescertificatesof conformityandtestreportscoupledwithvisual anddimensionalinspectiontoverifyproduct.Is ReceivingInspectionusescertificatesof conformity,testreports,and/orvisualand dimensionalinspectiontoverifyproduct. ALLAfullrewriteoftheQualityManualand QualitySystemtoAS9100RevC. ALLRevisedtomakemoreconcise.Contexthas notchanged.
B C D E
09/16/09
05/10/10 07/26/10
05/13/11
F G H
Addedi.changesthatcouldaffectthequality managementsystem.At5.6.2
Section7.5.1.3,revisedallmaintenance (preventiveandnot)toreadmaintenanceshall belogged.
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