ISO-FDIS-9001：2015(英文版)

©ISO2015Qualitymanagementsystems—RequirementsSystèmesdemanagementdelaqualité—ExigencesReferencenumberISO/FDIS9001:2015(E)INTERNATIONALSTANDARDISO/FDIS9001FINALDRAFTRECIPIENTSOFTHISDRAFTAREINVITEDTOSUBMIT,WITHTHEIRCOMMENTS,NOTIFICATIONOFANYRELEVANTPATENTRIGHTSOFWHICHTHEYAREAWAREANDTOPROVIDESUPPORTINGDOCUMENTATION.INADDITIONTOTHEIREVALUATIONASBEINGACCEPTABLEFORINDUSTRIAL,TECHNO­LOGICAL,COMMERCIALANDUSERPURPOSES,DRAFTINTERNATIONALSTANDARDSMAYONOCCASIONHAVETOBECONSIDEREDINTHELIGHTOFTHEIRPOTENTIALTOBECOMESTAN­DARDSTOWHICHREFERENCEMAYBEMADEINNATIONALREGULATIONS.ISO/TC176/SC2Secretariat:BSIVotingbeginson:2015­07­09Votingterminateson:2015­09­09PleaseseetheadministrativenotesonpageiiiISO/FDIS9001:2015(E)ISO/CENPARALLELPROCESSINGThisfinaldrafthasbeendevelopedwithintheInternationalOrganizationforStandardization(ISO),andpro­cessedundertheISO-leadmodeofcollaborationasdefinedintheViennaAgreement.Thefinaldraftwasestablishedonthebasisofcommentsreceivedduringaparallelenquiryonthedraft.ThisfinaldraftisherebysubmittedtotheISOmemberbodiesandtotheCENmemberbodiesforaparalleltwo-monthapprovalvoteinISOandformalvoteinCEN.Positivevotesshallnotbeaccompaniedbycomments.Negativevotesshallbeaccompaniedbytherelevanttechnicalreasons.ii©ISO2015–AllrightsreservedCOPYRIGHTPROTECTEDDOCUMENT©ISO2015,PublishedinSwitzerlandAllrightsreserved.Unlessotherwisespecified,nopartofthispublicationmaybereproducedorutilizedotherwiseinanyformorbyanymeans,electronicormechanical,includingphotocopying,orpostingontheinternetoranintranet,withoutpriorwrittenpermission.PermissioncanberequestedfromeitherISOattheaddressbeloworISO’smemberbodyinthecountryoftherequester.ISOcopyrightofficeCh.deBlandonnet8•CP401CH-1214Vernier,Geneva,[e-mail]:2015(E)Foreword..........................................................................................................................................................................................................................................vIntroduction................................................................................................................................................................................................................................vi1Scope.................................................................................................................................................................................................................................12Normativereferences......................................................................................................................................................................................13 Terms and definitions.....................................................................................................................................................................................14Contextoftheorganization.......................................................................................................................................................................14.1Understandingtheorganizationanditscontext.......................................................................................................14.2Understandingtheneedsandexpectationsofinterestedparties..............................................................24.3Determiningthescopeofthequalitymanagementsystem.............................................................................24.4Qualitymanagementsystemanditsprocesses..........................................................................................................25Leadership..................................................................................................................................................................................................................35.1Leadershipandcommitment.....................................................................................................................................................35.1.1General......................................................................................................................................................................................35.1.2Customerfocus..................................................................................................................................................................35.2Policy...............................................................................................................................................................................................................45.2.1Developingthequalitypolicy...............................................................................................................................45.2.2Communicatingthequalitypolicy....................................................................................................................45.3Organizationalroles,responsibilitiesandauthorities