ASC标准中英双Word格式.docx

1、NOTE1InthisInternationalStandard,theterm“product”onlyappliestoa）productintendedfor,orrequiredby,acustomer,b）anyintendedoutputresultingfromtheproductrealizationprocesses.NOTE2Statutoryandregulatoryrequirementsmaybeexpressedaslegalrequirements.1.2 ApplicationAllrequirementsofthisInternationalStandarda

2、regenericandareintendedtobeapplicabletoallorganizations,regardlessoftype,sizeandproductprovided.Whereanyrequirement（s）ofthisInternationalStandardcannotbeappliedduetothenatureofanorganizationanditsproduct,thiscanbeconsideredforexclusion.Whereexclusionsaremade,claimsofconformitytothisInternationalStan

3、dardarenotacceptableunlesstheseexclusionsarelimitedtorequirementswithinclause7,andsuchexclusionsdonotaffecttheorganizationsability,orresponsibility,toprovideproductthatmeetscustomerandapplicablestatutoryandregulatoryrequirements.Thisstandardisintendedforusebyorganizationsthatdesign,developand/orprod

4、uceaviation,spaceanddefenseproducts;andbyorganizationsprovidingpost-deliverysupport,includingtheprovisionofmaintenance,sparepartsormaterialsfortheirownproducts.Organizationswhoseprimarybusinessisprovidingmaintenance,repairandoverhaulservicesforaviationcommercialandmilitaryproducts;andoriginalequipme

5、ntmanufacturerswithmaintenance,repairandoverhauloperationsthatoperateautonomously,orthataresubstantiallydifferentfromtheirmanufacturing/productionoperations;shouldusetheIAQG-developed9110standard（seeBibliography）.Organizationsthatprocureparts,materialsandassembliesandreselltheseproductstoacustomerin

6、theaviation,spaceanddefenseindustries,includingorganizationsthatprocureproductsandsplitthemintosmallerquantitiesforresale,shouldusetheIAQG-developed9120standard（seeBibliography）.2. NormativereferencesThefollowingreferenceddocumentsareindispensablefortheapplicationofthisdocument.Fordatedreferences,on

7、lytheeditioncitedapplies.Forundatedreferences,thelatesteditionofthereferenceddocument（includinganyamendments）applies.ISO9000:2005,QualitymanagementsystemsFundamentalsandvocabulary.3.TermsanddefinitionsForthepurposesofthisdocument,thetermsanddefinitionsgiveninISO9000apply.ThroughoutthetextofthisInter

8、nationalStandard,wherevertheterm“product”occurs,itcanalsomean“service”.3.1RiskAnundesirablesituationorcircumstancethathasbothalikelihoodofoccurringandapotentiallynegativeconsequence.3.2SpecialrequirementsThoserequirementsidentifiedbythecustomer,ordeterminedbytheorganization,whichhavehighriskstobeing

9、achieved,thusrequiringtheirinclusionintheriskmanagementprocess.Factorsusedinthedeterminationofspecialrequirementsincludeproductorprocesscomplexity,pastexperienceandproductorprocessmaturity.ExamplesofspecialrequirementsincludeperformancerequirementsImposedbythecustomerthatareatthelimitoftheindustrysc

10、apability,orrequirementsdeterminedbytheorganizationtobeatthelimitofitstechnicalorprocesscapabilities.3.3CriticalitemsThoseitems（e.g.,functions,parts,software,characteristics,processes）havingsignificanteffectontheproductrealizationanduseoftheproduct;includingsafety,performance,form,fit,function,produ

11、cibility,servicelife,etc.;thatrequirespecificactionstoensuretheyareadequatelymanaged.Examplesofcriticalitemsincludesafetycriticalitems,fracturecriticalitems,missioncriticalitems,keycharacteristics,etc.3.4KeyCharacteristicAnattributeorfeaturewhosevariationhasasignificanteffectonproductfit,form,functi

12、on,performance,servicelifeorproducibility,thatrequiresspecificactionsforthepurposeofcontrollingvariation.NOTESpecialrequirementsandcriticalitemsarenewtermsand,alongwithkeycharacteristics,areinterrelated.Specialrequirementsareidentifiedwhendeterminingandreviewingrequirementsrelatedtotheproduct（see7.2

13、.1 andDesignoutput（see7.3.3）canincludeidentificationofcriticalitemsthatrequirespecificactionstoensuretheyareadequatelymanaged.Somecriticalitemswillbefurtherclassifiedaskeycharacteristicsbecausetheirvariationneedstobecontrolled.4Qualitymanagementsystem4.1GeneralrequirementsTheorganizationshallestabli

14、sh,document,implementandmaintainaqualitymanagementsystemandcontinuallyimproveitseffectivenessinaccordancewiththerequirementsofthisInternationalStandard.Theorganizationsqualitymanagementsystemshallalsoaddresscustomerandapplicablestatutoryandregulatoryqualitymanagementsystemrequirements.Theorganizatio

15、nshalla）determinetheprocessesneededforthequalitymanagementsystemandtheirapplicationthroughouttheorganization（see1.2）,b）determinethesequenceandinteractionoftheseprocesses,c）determinecriteriaandmethodsneededtoensurethatboththeoperationandcontroloftheseprocessesareeffective,d）ensuretheavailabilityofres

16、ourcesandinformationnecessarytosupporttheoperationandmonitoringoftheseprocesses,e）monitor,measurewhereapplicable,andanalysetheseprocesses,andf） implementactionsnecessarytoachieveplannedresultsandcontinualimprovementoftheseprocesses.Theseprocessesshallbemanagedbytheorganizationinaccordancewiththerequ

17、irementsofthisInternationalStandard.Whereanorganizationchoosestooutsourceanyprocessthataffectsproductconformitytorequirements,theorganizationshallensurecontroloversuchprocesses.Thetypeandextentofcontroltobeappliedtotheseoutsourcedprocessesshallbedefinedwithinthequalitymanagementsystem.NOTE1Processes

18、neededforthequalitymanagementsystemreferredtoaboveincludeprocessesformanagementactivities,provisionofresources,productrealization,measurement,analysisandimprovement.NOTE2An“outsourcedprocess”isaprocessthattheorganizationneedsforitsqualitymanagementsystemandwhichtheorganizationchoosestohaveperformedb

19、yanexternalparty.NOTE3Ensuringcontroloveroutsourcedprocessesdoesnotabsolvetheorganizationoftheresponsibilityofconformitytoallcustomer,statutoryandregulatoryrequirements.Thetypeandextentofcontroltobeappliedtotheoutsourcedprocesscanbeinfluencedbyfactorssuchasa）thepotentialimpactoftheoutsourcedprocesso

20、ntheorganizationscapabilitytoprovideproductthatconformstorequirements,b）thedegreetowhichthecontrolfortheprocessisshared,c）thecapabilityofachievingthenecessarycontrolthroughtheapplicationof7.4.4.2Documentationrequirements4.2.1GeneralThequalitymanagementsystemdocumentationshallincludea）documentedstate

21、mentsofaqualitypolicyandqualityobjectives,b）aqualitymanual,c）documentedproceduresandrecordsrequiredbythisInternationalStandard,andd）documents,includingrecords,determinedbytheorganizationtobenecessarytoensuretheeffectiveplanning,operationandcontrolofitsprocesses.Theorganizationshallensurethatpersonne

22、lhaveaccessto,andareawareof,relevantqualitymanagementsystemdocumentationandchanges.NOTE1Wheretheterm“documentedprocedure”appearswithinthisInternationalStandard,thismeansthattheprocedureisestablished,documented,implementedandmaintained.Asingledocumentmayaddresstherequirementsforoneormoreprocedures.Ar

23、equirementforadocumentedproceduremaybecoveredbymorethanonedocument.NOTE2Theextentofthequalitymanagementsystemdocumentationcandifferfromoneorganizationtoanotherduetoa）thesizeoforganizationandtypeofactivities,b）thecomplexityofprocessesandtheirinteractions,andc）thecompetenceofpersonnel.NOTE3Thedocument

24、ationcanbeinanyformortypeofmedium.4.2.2QualitymanualTheorganizationshallestablishandmaintainaqualitymanualthatincludesa）thescopeofthequalitymanagementsystem,includingdetailsofandjustificationforanyexclusions（see1.2）,b）thedocumentedproceduresestablishedforthequalitymanagementsystem,orreferencetothem,

25、andc）adescriptionoftheinteractionbetweentheprocessesofthequalitymanagementsystem.4.2.3ControlofdocumentsDocumentsrequiredbythequalitymanagementsystemshallbecontrolled.Recordsareaspecialtypeofdocumentandshallbecontrolledaccordingtotherequirementsgivenin4.2.4.Adocumentedprocedureshallbeestablishedtode

26、finethecontrolsneededa）toapprovedocumentsforadequacypriortoissue,b）toreviewandupdateasnecessaryandre-approvedocuments,c）toensurethatchangesandthecurrentrevisionstatusofdocumentsareidentified,d）toensurethatrelevantversionsofapplicabledocumentsareavailableatpointsofuse,e）toensurethatdocumentsremainleg

27、ibleandreadilyidentifiable,f）toensurethatdocumentsofexternalorigindeterminedbytheorganizationtobenecessaryfortheplanningandoperationofthequalitymanagementsystemareidentifiedandtheirdistributioncontrolled,andg）topreventtheunintendeduseofobsoletedocuments,andtoapplysuitableidentificationtothemiftheyar

28、eretainedforanypurpose.4.2.4ControlofrecordsRecordsestablishedtoprovideevidenceofconformitytorequirementsandoftheeffectiveoperationofthequalitymanagementsystemshallbecontrolled.Theorganizationshallestablishadocumentedproceduretodefinethecontrolsneededfortheidentification,storage,protection,retrieval

29、,retentionanddispositionofrecords.Thedocumentedprocedureshalldefinethemethodforcontrollingrecordsthatarecreatedbyand/orretainedbysuppliers.Recordsshallremainlegible,readilyidentifiableandretrievable.5Managementresponsibility5.1ManagementcommitmentTopmanagementshallprovideevidenceofitscommitmenttothedevelopmentandimplementationofthequalitymanagementsystemandcontinuallyimprovingitseffectivenessbya）comm