BS EN ISO 9001-2008 Quality management systems – R

raisingstandardsworldwide™NOCOPYINGWITHOUTBSIPERMISSIONEXCEPTASPERMITTEDBYCOPYRIGHTLAWBSIBritishStandardsQualitymanagementsystems–RequirementsBSENISO9001:2008BSENISO9001:2008BrItIShStaNdardNationalforewordthisBritishStandardistheUKimplementationofENISO9001:2008.ItsupersedesBSENISO9001:2000whichiswithdrawn.theUKparticipationinitspreparationwasentrustedtotechnicalCommitteeQS/1,Qualitymanagementandqualityassuranceprocedures.alistoforganizationsrepresentedonthiscommitteecanbeobtainedonrequesttoitssecretary.thispublicationdoesnotpurporttoincludeallthenecessaryprovisionsofacontract.Usersareresponsibleforitscorrectapplication.©BSI2008ISBN9780580594717ICS03.120.10CompliancewithaBritishStandardcannotconferimmunityfromlegalobligations.thisBritishStandardwaspublishedundertheauthorityoftheStandardsPolicyandStrategyCommitteeon30November2008.AmendmentsissuedsincepublicationAmd.No.DateTextaffectedEUROPEANSTANDARDNORMEEUROPÉENNEEUROPÄISCHENORMENISO9001November2008ICS03.120.10SupersedesENISO9001:2000EnglishVersionQualitymanagementsystems-Requirements(ISO9001:2008)Systèmesdemanagementdelaqualité-Exigences(ISO9001:2008)Qualitätsmanagementsysteme-Anforderungen(ISO9001:2008)ThisEuropeanStandardwasapprovedbyCENon8November2008.CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEuropeanStandardthestatusofanationalstandardwithoutanyalteration.Up-to-datelistsandbibliographicalreferencesconcerningsuchnationalstandardsmaybeobtainedonapplicationtotheCENManagementCentreortoanyCENmember.ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).AversioninanyotherlanguagemadebytranslationundertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheCENManagementCentrehasthesamestatusastheofficialversions.CENmembersarethenationalstandardsbodiesofAustria,Belgium,Bulgaria,Cyprus,CzechRepublic,Denmark,Estonia,Finland,France,Germany,Greece,Hungary,Iceland,Ireland,Italy,Latvia,Lithuania,Luxembourg,Malta,Netherlands,Norway,Poland,Portugal,Romania,Slovakia,Slovenia,Spain,Sweden,SwitzerlandandUnitedKingdom.EUROPEANCOMMITTEEFORSTANDARDIZATIONCOMITÉEUROPÉENDENORMALISATIONEUROPÄISCHESKOMITEEFÜRNORMUNGManagementCentre:ruedeStassart,36B-1050Brussels©2008CENAllrightsofexploitationinanyformandbyanymeansreservedworldwideforCENnationalMembers.Ref.No.ENISO9001:2008:EForewordThisdocument(ENISO9001:2008)hasbeenpreparedbyTechnicalCommitteeISO/TC176Qualitymanagementandqualityassurance.ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherbypublicationofanidenticaltextorbyendorsement,atthelatestbyMay2009,andconflictingnationalstandardsshallbewithdrawnatthelatestbyMay2009.Attentionisdrawntothepossibilitythatsomeoftheelementsofthisdocumentmaybethesubjectofpatentrights.CENshallnotbeheldresponsibleforidentifyinganyorallsuchpatentrights.ThisdocumentsupersedesENISO9001:2000.AccordingtotheCEN/CENELECInternalRegulations,thenationalstandardsorganizationsofthefollowingcountriesareboundtoimplementthisEuropeanStandard:Austria,Belgium,Bulgaria,Cyprus,CzechRepublic,Denmark,Estonia,Finland,France,Germany,Greece,Hungary,Iceland,Ireland,Italy,Latvia,Lithuania,Luxembourg,Malta,Netherlands,Norway,Poland,Portugal,Romania,Slovakia,Slovenia,Spain,Sweden,SwitzerlandandtheUnitedKingdom.EndorsementnoticeThetextofISO9001:2008hasbeenapprovedbyCENasENISO9001:2008withoutanymodification.BBBBSENISO9001:2008INTERNATIONALSTANDARDISO9001Fourthedition2008-11-15ReferencenumberISO9001:2008(E)Qualitymanagementsystems—RequirementsSystèmesdemanagementdelaqualité—ExigencesBBBBSENISO9001:2008iiBSENISO9001:2008iiiContentsPage1Scope....................................................................................................................................................11.1General.................................................................................................................................................11.2Application...........................................................................................................................................12Normativereferences..........................................................................................................................13Termsanddefinitions..........................................................................................................................14Qualitymanagementsystem..............................................................................................................24.1Generalrequirements.........................................................................................................................24.2Documentationrequirements............................................................................................................25Managementresponsibility................................................................................................................35.1Managementcommitment...............................................................................................