AS9100C标准.docx

AS9100C标准.docx

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AS9100C标准

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”.

Risk

Anundesirablesituationorcircumstancethathasbothalikelihoodofoccurringandapotentiallynegativeconsequence.

Specialrequirements

Thoserequirementsidentifiedbythecustomer,ordeterminedbytheorganization,whichhavehighriskstobeingachieved,thusrequiringtheirinclusionintheriskmanagementprocess.Factorsusedinthedeterminationofspecialrequirementsincludeproductorprocesscomplexity,pastexperienceandproductorprocessmaturity.ExamplesofspecialrequirementsincludeperformancerequirementsImposedbythecustomerthatareatthelimitoftheindustry’scapability,orrequirementsdeterminedbytheorganizationtobeatthelimitofitstechnicalorprocesscapabilities.

Criticalitems

Thoseitems.,functions,parts,software,characteristics,processes）havingsignificanteffectontheproductrealizationanduseoftheproduct;includingsafety,performance,form,fit,function,producibility,servicelife,etc.;thatrequirespecificactionstoensuretheyare

adequatelymanaged.Examplesofcriticalitemsincludesafetycriticalitems,fracturecriticalitems,missioncriticalitems,keycharacteristics,etc.

KeyCharacteristic

Anattributeorfeaturewhosevariationhasasignificanteffectonproductfit,form,function,performance,servicelifeorproducibility,thatrequiresspecificactionsforthepurposeofcontrollingvariation.

NOTESpecialrequirementsandcriticalitemsarenewtermsand,alongwithkeycharacteristics,areinterrelated.Specialrequirementsareidentifiedwhendeterminingandreviewingrequirementsrelatedtotheproduct（see7.2.1andSpecialrequirementscanrequiretheidentificationofcriticalitems.Designoutput（see7.3.3）canincludeidentificationofcriticalitemsthatrequirespecificactionstoensuretheyareadequatelymanaged.Somecriticalitemswillbefurtherclassifiedaskeycharacteristicsbecausetheirvariationneedstobecontrolled.

4Qualitymanagementsystem

Generalrequirements

Theorganizationshallestablish,document,implementandmaintainaqualitymanagementsystemandcontinuallyimproveitseffectivenessinaccordancewiththerequirementsofthisInternationalStandard.

Theorganization’squalitymanagementsystemshallalsoaddresscustomerandapplicablestatutoryandregulatoryqualitymanagementsystemrequirements.

Theorganizationshall

a）determinetheprocessesneededforthequalitymanagementsystemandtheirapplicationthroughouttheorganization（see,

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）thecapabilityofachievingthenecessarycontrolthroughtheapplicationof.

Documentationrequirements

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（see,

b）thedocumentedproceduresestablishedforthequality

managementsystem,orreferencetothem,and

c）adescriptionoftheinteractionbetweentheprocessesofthequalitymanagementsystem.

4.2.3Controlofdocuments

Documentsrequiredbythequalitymanagementsystemshallbecontrolled.Recordsareaspecialtypeofdocumentandshallbecontrolledaccordingtotherequirementsgivenin4.2.4.

Adocumentedprocedu