AS9100C标准中英双版.docx
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AS9100C标准中英双版.docx
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AS9100C标准中英双版
QualityManagementSystems–RequirementsforAviation,SpaceandDefenseOrganizations
1.Scope
1.1General
ThisstandardincludesISO9001:
2008qualitymanagementsystemrequirementsandspecifiesadditionalaviation,spaceanddefenseindustryrequirements,definitionsandnotesasshowninbold,italictext.
Itisemphasizedthattherequirementsspecifiedinthisstandardarecomplementary(notalternative)tocontractualandapplicablestatutoryandregulatoryrequirements.Shouldtherebeaconflictbetweentherequirementsofthisstandardandapplicablestatutoryorregulatoryrequirements,thelattershalltakeprecedence.
ThisInternationalStandardspecifiesrequirementsforaqualitymanagementsystemwhereanorganization
a)needstodemonstrateitsabilitytoconsistentlyprovideproductthatmeetscustomerandapplicablestatutoryandregulatoryrequirements,and
b)aimstoenhancecustomersatisfactionthroughtheeffectiveapplicationofthesystem,includingprocessesforcontinualimprovementofthesystemandtheassuranceofconformitytocustomerandapplicablestatutoryandregulatoryrequirements.
NOTE1
InthisInternationalStandard,theterm“product”onlyappliesto
a)productintendedfor,orrequiredby,acustomer,
b)anyintendedoutputresultingfromtheproductrealizationprocesses.
NOTE2
Statutoryandregulatoryrequirementsmaybeexpressedaslegalrequirements.
1.2Application
AllrequirementsofthisInternationalStandardaregenericandareintendedtobeapplicabletoallorganizations,regardlessoftype,sizeandproductprovided.
Whereanyrequirement(s)ofthisInternationalStandardcannotbeappliedduetothenatureofanorganizationanditsproduct,thiscanbeconsideredforexclusion.
Whereexclusionsaremade,claimsofconformitytothisInternationalStandardarenotacceptableunlesstheseexclusionsarelimitedtorequirementswithinclause7,andsuchexclusionsdonotaffecttheorganizationsability,orresponsibility,toprovideproductthatmeetscustomerandapplicablestatutoryandregulatoryrequirements.
Thisstandardisintendedforusebyorganizationsthatdesign,developand/orproduceaviation,spaceanddefenseproducts;andbyorganizationsprovidingpost-deliverysupport,includingtheprovisionofmaintenance,sparepartsormaterialsfortheirownproducts.
Organizationswhoseprimarybusinessisprovidingmaintenance,repairandoverhaulservicesforaviationcommercialandmilitaryproducts;andoriginalequipmentmanufacturerswithmaintenance,repairandoverhauloperationsthatoperateautonomously,orthatare
substantiallydifferentfromtheirmanufacturing/productionoperations;shouldusetheIAQG-developed9110standard(seeBibliography).
Organizationsthatprocureparts,materialsandassembliesandreselltheseproductstoacustomerintheaviation,spaceanddefenseindustries,includingorganizationsthatprocureproductsandsplitthemintosmallerquantitiesforresale,shouldusetheIAQG-developed9120standard(seeBibliography).
2.Normativereferences
Thefollowingreferenceddocumentsareindispensablefortheapplicationofthisdocument.Fordatedreferences,onlytheeditioncitedapplies.Forundatedreferences,thelatesteditionofthereferenceddocument(includinganyamendments)applies.
ISO9000:
2005,Qualitymanagementsystems—Fundamentalsandvocabulary.
3.Termsanddefinitions
Forthepurposesofthisdocument,thetermsanddefinitionsgiveninISO9000apply.
ThroughoutthetextofthisInternationalStandard,wherevertheterm“product”occurs,itcanalsomean“service”.
3.1Risk
Anundesirablesituationorcircumstancethathasbothalikelihoodofoccurringandapotentiallynegativeconsequence.
3.2Specialrequirements
Thoserequirementsidentifiedbythecustomer,ordeterminedbytheorganization,whichhavehighriskstobeingachieved,thusrequiringtheirinclusionintheriskmanagementprocess.Factorsusedinthedeterminationofspecialrequirementsincludeproductorprocesscomplexity,pastexperienceandproductorprocessmaturity.ExamplesofspecialrequirementsincludeperformancerequirementsImposedbythecustomerthatareatthelimitoftheindustry’scapability,orrequirementsdeterminedbytheorganizationtobeatthelimitofitstechnicalorprocesscapabilities.
3.3Criticalitems
Thoseitems(e.g.,functions,parts,software,characteristics,processes)havingsignificanteffectontheproductrealizationanduseoftheproduct;includingsafety,performance,form,fit,function,producibility,servicelife,etc.;thatrequirespecificactionstoensuretheyare
adequatelymanaged.Examplesofcriticalitemsincludesafetycriticalitems,fracturecriticalitems,missioncriticalitems,keycharacteristics,etc.
3.4KeyCharacteristic
Anattributeorfeaturewhosevariationhasasignificanteffectonproductfit,form,function,performance,servicelifeorproducibility,thatrequiresspecificactionsforthepurposeofcontrollingvariation.
NOTESpecialrequirementsandcriticalitemsarenewtermsand,alongwithkeycharacteristics,areinterrelated.Specialrequirementsareidentifiedwhendeterminingandreviewingrequirementsrelatedtotheproduct(see7.2.1and7.2.2).Specialrequirementscanrequiretheidentificationofcriticalitems.Designoutput(see7.3.3)canincludeidentificationofcriticalitemsthatrequirespecificactionstoensuretheyareadequatelymanaged.Somecriticalitemswillbefurtherclassifiedaskeycharacteristicsbecausetheirvariationneedstobecontrolled.
4Qualitymanagementsystem
4.1Generalrequirements
Theorganizationshallestablish,document,implementandmaintainaqualitymanagementsystemandcontinuallyimproveitseffectivenessinaccordancewiththerequirementsofthisInternationalStandard.
Theorganization’squalitymanagementsystemshallalsoaddresscustomerandapplicablestatutoryandregulatoryqualitymanagementsystemrequirements.
Theorganizationshall
a)determinetheprocessesneededforthequalitymanagementsystemandtheirapplicationthroughouttheorganization(see1.2),
b)determinethesequenceandinteractionoftheseprocesses,
c)determinecriteriaandmethodsneededtoensurethatboththeoperationandcontroloftheseprocessesareeffective,
d)ensuretheavailabilityofresourcesandinformationnecessarytosupporttheoperationandmonitoringoftheseprocesses,
e)monitor,measurewhereapplicable,andanalysetheseprocesses,and
f)implementactionsnecessarytoachieveplannedresultsandcontinualimprovementoftheseprocesses.
TheseprocessesshallbemanagedbytheorganizationinaccordancewiththerequirementsofthisInternationalStandard.
Whereanorganizationchoosestooutsourceanyprocessthataffectsproductconformitytorequirements,theorganizationshallensurecontroloversuchprocesses.
Thetypeandextentofcontroltobeappliedtotheseoutsourcedprocessesshallbedefinedwithinthequalitymanagementsystem.
NOTE1Processesneededforthequalitymanagementsystemreferredtoaboveincludeprocessesformanagementactivities,provisionofresources,productrealization,measurement,analysisandimprovement.
NOTE2An“outsourcedprocess”isaprocessthattheorganizationneedsforitsqualitymanagementsystemandwhichtheorganizationchoosestohaveperformedbyanexternalparty.
NOTE3Ensuringcontroloveroutsourcedprocessesdoesnotabsolvetheorganizationoftheresponsibilityofconformitytoallcustomer,statutoryandregulatoryrequirements.Thetypeandextentofcontroltobeappliedtotheoutsourcedprocesscanbeinfluencedbyfactorssuchas
a)thepotentialimpactoftheoutsourcedprocessontheorganization’scapabilitytoprovideproductthatconformstorequirements,
b)thedegreetowhichthecontrolfortheprocessisshared,
c)thecapabilityofachievingthenecessarycontrolthroughtheapplicationof7.4.
4.2Documentationrequirements
4.2.1General
Thequalitymanagementsystemdocumentationshallinclude
a)documentedstatementsofaqualitypolicyandqualityobjectives,
b)aqualitymanual,
c)documentedproceduresandrecordsrequiredbythisInternationalStandard,and
d)documents,includingrecords,determinedbytheorganizationtobenecessarytoensuretheeffectiveplanning,operationandcontrolofitsprocesses.
Theorganizationshallensurethatpersonnelhaveaccessto,andareawareof,relevantqualitymanagementsystemdocumentationandchanges.
NOTE1Wheretheterm“documentedprocedure”appearswithinthisInternationalStandard,thismeansthattheprocedureisestablished,documented,implementedandmaintained.Asingledocumentmayaddresstherequirementsforoneormoreprocedures.Arequirementforadocumentedproceduremaybecoveredbymorethanonedocument.
NOTE2Theextentofthequalitymanagementsystemdocumentationcandifferfromoneorganizationtoanotherdueto
a)thesizeoforganizationandtypeofactivities,
b)thecomplexityofprocessesandtheirinteractions,and
c)thecompetenceofpersonnel.
NOTE3Thedocumentationcanbeinanyformortypeofmedium.
4.2.2Qualitymanual
Theorganizationshallestablishandmaintainaqualitymanualthatincludes
a)thescopeofthequalitymanagementsystem,includingdetailsofandjustificationforanyexclusions(see1.2),
b)thedocumentedproceduresestablishedforthequality
managementsystem,orreferencetothem,and
c)adescriptionoftheinteractionbetweentheprocessesofthequalitymanagementsystem.
4.2.3Controlofdocuments
Documentsrequiredbythequalitymanagementsystemshallbecontrolled.Recordsareaspecialtypeofdocumentandshallbecontrolledaccordingtotherequirement
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