ISO9001-94英文版

风风风靡靡靡全全全球球球的的的GGGLLLOOOBBBAAALLLAAACCCCCCEEEPPPTTTEEEDDDMMMAAANNNAAAGGGEEEMMMEEENNNTTTSSSTTTAAANNNDDDAAARRRDDD——ISO9001：1994ENGLISHVERSION管理标准ISO9001：1994StandardQualitysysteems—Modelforqualityassuranceindesign,development,production,installationandservicing1ScopeThisInternationalStandardspecifiesqualitysystemrequirementsforusewhereasupplier’scapabilitytodesignandsupplyconformingproductneedstobedemonstrated.Therequirementsspecifiedareaimedprimarilyatachievingcustomersatisfactionbypreventnonconformityatallstagesfromdesignthroughtoservicing.ThisInternationalStandardisapplicableinsituationswhendesignisrequiredandtheproductrequirementsarestatedprincipallyinperformanceterms,ortheyneedtobeestablished,andconfidenceinproductconformancecanbeattainedbyadequatedemonstrationofasupplier’scapabilitiesindesign,development,production,installationandservicing.NOTE1Forinformativereferences,seeannexA.NormativereferenceThefollowingstandardcontainsprovisionswhich,throughreferenceinthistext,constituteprovisionsofthisInternationalStandard.Atthetimeofpublication,theeditionindicatedwasvalid.Allstandardsaresubjecttorevision,andpartiestoagreementsbasedonthisInternationalStandardareencouragedtoinvestigatethepossibilityofapplyingthemostrecenteditionofthestandardindicatedbelow.MembersofIECandISOmaintainregistersofcurrentlyvalidInternationalStandards.ISO8402:1994,Qualitymanagementandqualityassurance—Vocabulary.DefinitionsForthepurposesofthisInternationalStandard,thedefinitionsgiveninISO8402andthefollowingdefinitionsapply.product:Resultofactivitiesorprocesses.NOTESAproductmayincludeservice,hardware,processedmaterials,softwareoracombinationthereof.Aproductcanbetangible(e.g.assembliesorprocessedmaterials)orintangible(e.g.knowledgeorconcepts),oracombinationthereof.ForthepurposesofthisInternationalStandard,theterm“product”appliestotheintendedproductofferingonlyandnottounintended“by-products”affectingtheenvironment.ThisdiffersfromthedefinitiongiveninISO8402.tender:Offermadebyasupplierinresponsetoaninvitationtosatisfyacontractawardtoprovideproduct.3.3contract:Agreedrequirementsbetweenasupplierandcustomertransmittedbyanymeans.4Qualitysystemrequirements4.1Managementresponsibility4.1.1QualitypolicyThesupplier’smanagementwithexecutiveresponsibilityshalldefineanddocumentitspolicyforqualityincludingobjectivesforandcommitmenttoquality.Thequalitypolicyshallberelevanttothesupplier’sorganizationalgoalsandtheexpectationsandneedsofitscustomers.Thesuppliershallensurethatthepolicyisunderstood,implementedandmaintainedatalllevelsoftheorganization.4.1.2Organization4.1.2.1ResponsibilityandauthorityTheresponsibility,authorityandtheinterrelationofpersonnelwhomanage,performandverifyworkaffectingqualityshallbedefinedanddocumented,particularlyforpersonnelwhoneedtheorganizationalfreedomandauthorityto:a)initiateactiontopreventtheoccurrenceofanynonconformitiesrelatingtotheproduct,processandqualitysystem;b)identifyandrecordanyproblemsrelatingtotheproduct,processandqualitysystem;c)initiate,recommendorprovidesolutionsthroughdesignatedchannels;d)verifytheimplementationofsolutions;e)controlfurtherprocessing,deliveryorinstallationofnonconformingproductuntilthedeficiencyorunsatisfactoryconditionhasbeencorrected.4.1.2.2ResourcesThesuppliershallidentifyresourcerequirementsandprovidedadequateresources,includingtheassignmentoftrainedpersonnelformanagement,performanceofworkandverificationactivitiesincludinginternalqualityaudits.4.1.2.3ManagementrepresentativeThesupplier’smanagementwithexecutiveresponsibilityshallappointamemberofthesupplier’sownmanagementwhoirrespectiveofotherresponsibilities,shallhavedefinedauthorityfor:a)ensuringthequalitysystemisestablished,implementedandmaintainedinaccordancewiththeappropriatestandard,andb)reportingontheperformanceofthequalitysystemtothesupplier’smanagementforreviewandasabasisforimprovementofthequalitysystem.NOTE5Theresponsibilityofamanagementrepresentativemayalsoincludeliaisonwithexternalpartiesonmattersrelatingtothesupplier’squalitysystem.4.1.3ManagementreviewThesupplier’smanagementwithexecutiveresponsibilityreviewsthequalitysystematdefinedintervalssufficienttoensureitscontinuingsuitabilityandeffectivenessinsatisfyingtherequirementsoftheappropriatestandardandthesupplier’sstatedqualitypolicyandobjectives.Recordsofsuchreviewsshallbemaintained.4.2Qualitysystem4.2.1GeneralThesuppliershallestablish,documentandmaintainaqualitysystemasameansofensuringthatproductconformstospecifiedrequirements.Thesuppliershallprepareaqualitymanualcoveringtherequirementsoftheappropriatestandard.Thequalitymanualincludesormakesreferencetothequalitysystemproceduresandoutlinesthestructureofthedocumentationused.4.2.2QualitysystemproceduresThesuppliershall:a)preparedocumentedproceduresconsistentwiththerequirementsoftheappropriatestandardandthesuppliersstatedqualitypolicy,andb)effectivelyimplementethequalitysystemanditsdocumentedprocedures.4.2.3QualityplanningThesuppliershalldefineanddocumenthowtherequirementsforqualitywillbemet.Qualityplanningisconsistentwithallotherrequire