ISO9001-94英文版Word下载.doc

ISO9001-94英文版Word下载.doc

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1Scope

ThisInternationalStandardspecifiesqualitysystemrequirementsforusewhereasupplier’scapabilitytodesignandsupplyconformingproductneedstobedemonstrated.

Therequirementsspecifiedareaimedprimarilyatachievingcustomersatisfactionbypreventnonconformityatallstagesfromdesignthroughtoservicing.

ThisInternationalStandardisapplicableinsituationswhendesignisrequiredandtheproductrequirementsarestatedprincipallyinperformanceterms,ortheyneedtobeestablished,andconfidenceinproductconformancecanbeattainedbyadequatedemonstrationofasupplier’scapabilitiesindesign,development,production,installationandservicing.

NOTE1Forinformativereferences,seeannexA.

Normativereference

Thefollowingstandardcontainsprovisionswhich,throughreferenceinthistext,constituteprovisionsofthisInternationalStandard.Atthetimeofpublication,theeditionindicatedwasvalid.Allstandardsaresubjecttorevision,andpartiestoagreementsbasedonthisInternationalStandardareencouragedtoinvestigatethepossibilityofapplyingthemostrecenteditionofthestandardindicatedbelow.MembersofIECandISOmaintainregistersofcurrentlyvalidInternationalStandards.

ISO8402:

1994,Qualitymanagementandqualityassurance—Vocabulary.

Definitions

ForthepurposesofthisInternationalStandard,thedefinitionsgiveninISO8402andthefollowingdefinitionsapply.

product:

Resultofactivitiesorprocesses.

NOTES

Aproductmayincludeservice,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.

4Qualitysystemrequirements

4.1 Managementresponsibility

4.1.1 Qualitypolicy

Thesupplier’smanagementwithexecutiveresponsibilityshalldefineanddocumentitspolicyforqualityincludingobjectivesforandcommitmenttoquality.Thequalitypolicyshallberelevanttothesupplier’sorganizationalgoalsandtheexpectationsandneedsofitscustomers.

Thesuppliershallensurethatthepolicyisunderstood,implementedandmaintainedatalllevelsoftheorganization.

4.1.2 Organization

4.1.2.1 Responsibilityandauthority

Theresponsibility,authorityandtheinterrelationofpersonnelwhomanage,performandverifyworkaffectingqualityshallbedefinedanddocumented,particularlyforpersonnelwhoneedtheorganizationalfreedomandauthorityto:

a）initiateactiontopreventtheoccurrenceofanynonconformitiesrelatingtotheproduct,processandqualitysystem;

b）identifyandrecordanyproblemsrelatingtotheproduct,processandqualitysystem;

c）initiate,recommendorprovidesolutionsthroughdesignatedchannels;

d）verifytheimplementationofsolutions;

e）controlfurtherprocessing,deliveryorinstallationofnonconformingproductuntilthedeficiencyorunsatisfactoryconditionhasbeencorrected.

4.1.2.2 Resources

Thesuppliershallidentifyresourcerequirementsandprovidedadequateresources,includingtheassignmentoftrainedpersonnelformanagement,performanceofworkandverificationactivitiesincludinginternalqualityaudits.

4.1.2.3 Managementrepresentative

Thesupplier’smanagementwithexecutiveresponsibilityshallappointamemberofthesupplier’sownmanagementwhoirrespectiveofotherresponsibilities,shallhavedefinedauthorityfor:

a）ensuringthequalitysystemisestablished,implementedandmaintainedinaccordancewiththeappropriatestandard,and

b）reportingontheperformanceofthequalitysystemtothesupplier’smanagementforreviewandasabasisforimprovementofthequalitysystem.

NOTE5Theresponsibilityofamanagementrepresentativemayalsoincludeliaisonwithexternalpartiesonmattersrelatingtothesupplier’squalitysystem.

4.1.3 Managementreview

Thesupplier’smanagementwithexecutiveresponsibilityreviewsthequalitysystematdefinedintervalssufficienttoensureitscontinuingsuitabilityandeffectivenessinsatisfyingtherequirementsoftheappropriatestandardandthesupplier’sstatedqualitypolicyandobjectives.

Recordsofsuchreviewsshallbemaintained.

4.2 Qualitysystem

4.2.1 General

Thesuppliershallestablish,documentandmaintainaqualitysystemasameansofensuringthat