ISO90002000GapanalysisCheck

ISO9000:2000AuditChecklistComplianceCommentNo.RequirementN/ASatisMinorMajorPage1of226/19/03L.Benson4Qualitymanagementsystem4.1GeneralrequirementsTheorganizationshallestablish,document,implementandmaintainaqualitymanagementsystemandcontinuallyimproveitseffectivenessinaccordancewiththerequirementsofthisInternationalStandard.Theorganizationshalla)identifytheprocessesneededforthequalitymanagementsystemandtheirapplicationthroughouttheorganization(see1.2),b)determinethesequenceandinteractionoftheseprocesses,c)determinecriteriaandmethodsneededtoensurethatboththeoperationandcontroloftheseprocessesareeffective,d)ensuretheavailabilityofresourcesandinformationnecessarytosupporttheoperationandmonitoringoftheseprocesses,e)monitor,measureandanalyzetheseprocesses,andf)implementactionsnecessarytoachieveplannedresultsandcontinualimprovementoftheseprocesses.TheseprocessesshallbemanagedbytheorganizationinaccordancewiththerequirementsofthisInternationalStandard.NOTEProcessesneededforthequalitymanagementsystemreferredtoaboveshouldincludeprocessesformanagementactivities,provisionofresources,productrealizationandmeasurement.Whereanorganizationchoosestooutsourceanyprocessthataffectsproductconformitywithrequirements,theorganizationshallensurecontroloversuchprocesses.Controlofsuchoutsourcedprocessesshallbeidentifiedwithinthequalitymanagementsystem.ISO9000:2000AuditChecklistComplianceCommentNo.RequirementN/ASatisMinorMajor4.24.2DocumentationrequirementsThequalitymanagementsystemdocumentationshallinclude:documentedstatementsofaqualitypolicyandqualityobjectives,aqualitymanual,documentedproceduresrequiredbythisInternationalStandard,documentsneededbytheorganizationtoensuretheeffectiveplanning,operationandcontrolofitsprocesses,andqualityrecordsrequiredbythisInternationalStandard(see4.2.4).NOTE1Wheretheterm“documentedprocedure”appearswithinthisInternationalStandard,thismeansthattheprocedureisestablished,documented,implementedandmaintained.NOTE2Theextentofthequalitymanagementsystemdocumentationcandifferfromoneorganizationtoanotherduetoa)thesizeoforganizationandtypeofactivities,b)thecomplexityofprocessesandtheirinteractions,andc)thecompetenceofpersonnel.NOTE3Thedocumentationcanbeinanyformortypeofmedium.4.2.2QualitymanualTheorganizationshallestablishandmaintainaqualitymanualthatincludesa)thescopeofthequalitymanagementsystem,includingdetailsofandjustificationforanyexclusions(see1.2),b)thedocumentedproceduresestablishedforthequalitymanagementsystem,orreferencetothem,andc)adescriptionoftheinteractionbetweentheprocessesofthequalitymanagementsystem.Page2of226/19/03L.BensonISO9000:2000AuditChecklistComplianceCommentNo.RequirementN/ASatisMinorMajor4.2.3ControlofdocumentsDocumentsrequiredbythequalitymanagementsystemshallbecontrolled.Qualityrecordsareaspecialtypeofdocumentandshallbecontrolledaccordingtotherequirementsgivenin4.2.4.Adocumentedprocedureshallbeestablishedtodefinethecontrolsneededa)toapprovedocumentsforadequacypriortoissue,b)toreviewandupdateasnecessaryandre-approvedocuments,c)toensurethatchangesandthecurrentrevisionstatusofdocumentsareidentified,d)toensurethatrelevantversionsofapplicabledocumentsareavailableatpointsofuse,e)toensurethatdocumentsremainlegibleandreadilyidentifiable,toensurethatdocumentsofexternaloriginareidentifiedandtheirdistributioncontrolled,andg)topreventtheunintendeduseofobsoletedocuments,andtoapplysuitableidentificationtothemiftheyareretainedforanypurpose.4.2.4ControlofqualityrecordsQualityrecordsshallbeestablishedandmaintainedtoprovideevidenceofconformitytorequirementsandoftheeffectiveoperationofthequalitymanagementsystem.Qualityrecordsshallremainlegible,readilyidentifiableandretrievable.Page3of226/19/03L.BensonISO9000:2000AuditChecklistComplianceCommentNo.RequirementN/ASatisMinorMajorAdocumentedprocedureshallbeestablishedtodefinethecontrolsneededfortheidentification,storage,protection,retrieval,retentiontimeanddispositionofqualityrecords.5Managementresponsibility5.1ManagementcommitmentTopmanagementshallprovideevidenceofitscommitmenttothedevelopmentandimplementationofthequalitymanagementsystemandcontinuallyimprovingitseffectivenessbya)communicatingtotheorganizationtheimportanceofmeetingcustomeraswellasstatutoryandregulatoryrequirements,b)establishingthequalitypolicy,c)ensuringthatqualityobjectivesareestablished,d)conductingmanagementreviews,ande)ensuringtheavailabilityofresources.5.2CustomerfocusTopmanagementshallensurethatcustomerrequirementsaredeterminedandfulfilledwiththeaimofenhancingcustomersatisfaction(see7.2.1and8.2.1).5.3QualitypolicyTopmanagementshallensurethatthequalitypolicya)isappropriatetothepurposeoftheorganization,b)includesacommitmenttocomplywithrequirementsandcontinuallyimprovetheeffectivenessofthequalityPage4of226/19/03L.BensonISO9000:2000AuditChecklistComplianceCommentNo.RequirementN/ASatisMinorMajormanagementsystem,c)providesaframeworkforestablishingandreviewingqualityobjectives,d)iscommunicatedandunderstoodwithintheorganization,ande)isreviewedforcontinuingsuitability.5.4.1Planning:QualityObjective