6667203-ISO-17025-Presentation

GeneralrequirementsforthecompetenceofTestingandCalibrationLaboratoriesPresentationbyB.SudarsanLeadAssessor-NABLContentsofISO/IEC17025:19991.Scope2.NormativeReferences3.TermsandDefinitions4.ManagementRequirements5.TechnicalRequirementsISO/IEC17025:19991.SCOPESpecifiesrequirementsapplicabletoTesting/CalibrationlaboratoriesNotesgiveninthestandardareforguidanceanddonotcontainrequirementsStandardismeantforusebylaboratories,clients,accreditationbodiesetc.CompliancewiththeregulatoryandsafetyrequirementsarenotcoveredbythestandardCompliancewiththisstandardensurescompliancewithISO9001/9002:1994ISO/IEC17025:19992.NORMATIVEREFERENCESISO9001:1994QualitySystems–ModelforQualityAssuranceinDesign,Development,Production,InstallationandServicingISO9002:1994QualitySystems–ModelforQualityAssuranceinProduction,InstallationandServicingISO/IECGuide2:GeneraltermsandtheirdefinitionsconcerningstandardizationVIM:InternationalVocabularyofbasicandgeneraltermsinmetrologyISO/IEC17025:19993.TERMSANDDEFINITIONSTermsgiveninISO/IECguide2andVIMareapplicableAlsotermsgivenISO8402:1994areapplicableforgeneraldefinitionsISO/IEC17025:19994.MANAGEMENTREQUIREMENTS4.1Organization4.2Qualitysystem4.3Documentcontrol4.4Reviewofrequests,tendersandcontracts4.5Subcontractingoftestsandcalibrations4.6Purchasingservicesandsupplies4.7Servicetoclient4.8ComplaintsISO/IEC17025:19994.MANAGEMENTREQUIREMENTS–contd.4.9Controlofnon-conformingtesting/calibration4.10Correctiveactions4.11Preventiveactions4.12Controlofrecords4.13Internalaudits4.14ManagementreviewsISO/IEC17025:19994.1ORGANIZATION4.1.1Laboratory/organizationshallbeanentitythatcanbeheldlegallyresponsible4.1.2Laboratorytocarryoutactivitiestomeettherequirementsofthisstandard,clients,regulatoryauthoritiesandorganizationsprovidingrecognition4.1.3Managementsystemtocoverpermanent,temporaryandmobilefacilities4.1.4Iflaboratoryispartofanorganizationhavingdifferentactivities,responsibilityofkeypersonnelshallbedefinedISO/IEC17025:19994.1.5Thelaboratoryshallhavea)Managerialandtechnicalpersonnelb)Policiesandprocedurestoensurepersonnelarefreefromunduepressuresc)Policiesandprocedurestoensureprotectionofclient’sconfidentialinformationd)Policiesandprocedurestoavoidinvolvementinanyactivitiesthatwoulddiminishconfidencee)Definedmanagementstructuref)Definedauthorityandresponsibilityandinter-relationshipofpersonnelg)Adequatesupervisionoftesting/calibrationstaffh)Technicalmanagementi)AppointmentofQualityMangerj)DeputiesforkeyManagementpersonnelISO/IEC17025:19994.2QUALITYSYSTEM4.2.1Establish,maintainandimplementQualitySystemappropriatetothescopeofactivities4.2.2QualitySystemPoliciesandObjectivesshallbedefinedinQualityManual.QualityPolicyshallbeissuedundertheauthorityofchiefexecutiveandshallContaina)Commitmenttogoodprofessionalpracticesb)Statementoflaboratory’sservicec)ObjectivesofQualitySystemd)RequirementthatpersonnelconcernedgetfamiliarizedwithQualitySysteme)CommitmenttocomplywithISO/IEC17025:1999ISO/IEC17025:19994.2.3QualityManualshallinclude/refertosupportingproceduresandoutlinestructureofQualitySystem4.2.4DefinedresponsibilityandauthorityoftechnicalmanagementandQualityManagerISO/IEC17025:19994.3DOCUMENTCONTROL4.3.1GENERALProcedureforDocumentControl,coveringdocumentsofinternalandexternalorigin4.3.2DOCUMENTAPPROVALANDISSUE4.3.2.1ApprovalofDocumentsbyauthorizedpersonnel.MaintenanceofMasterList4.3.2.2Theprocedureshallensurethata)Availabilityofauthorizedappropriatedocumentsb)Periodicreviewandrevisionasneededc)Removalofobsolete/invaliddocumentsd)Suitableidentificationofobsoletedocumentretainedforknowledge/legalpurposes4.3.2.3Uniqueidentification:date.Revisionstatus,pagenumberandnumberpagesISO/IEC17025:19994.3.3DOCUMENTCHANGES4.3.3.1Approvalofchangesbythesameagencyasoriginalissueorauthorizedotherwise4.3.3.2Identificationofchangeseitheronthedocumentoronattachments4.3.3.3Ifmanualcorrectionsarepermitteddefinethesameintheprocedure4.3.3.4IfdocumentsaremaintainedoncomputermemorydefinethecontrolsISO/IEC17025:19994.4REVIEWOFREQUESTS,TENDERSANDCONTRACTS4.4.1Establishandmaintaindocumentedprocedureforreviewofrequests,tendersandcontractsfortesting/calibration.Theprocedureshallcovera)Ensurethattherequirementsareadequatelydefined,documentedandunderstoodb)Laboratoryhasthecapabilityandresourcestomeettherequirementsc)Selectionofappropriatetest/calibrationmethod.Resolutionofdifferencesbetweencontractandtender,ifanyISO/IEC17025:19994.4.2Maintenanceofrecordsofreview4.4.3Reviewalsotocoversub-contractedwork4.4.4Clienttobeinformedanydeviation4.4.5AmendmentstoacontractshallalsotobereviewedandcommunicatedISO/IEC17025:19994.5SUBCONTRACTINGOFTESTSANDCALIBRATIONS4.5.1Iflaboratorysub-contractsthework,thisshallbedoneonsuitablesubcontractors:satisfyingtherequirementsofthisstandard4.5.2Informationtoclientonsucharrangement4.5.3Laboratoryshallberesponsibleforsubcontractor’swork4.5.4MaintenanceofregisterofsubcontractorsISO/IEC17025:19994.6PURCHASINGSERVICESANDSUPPLIES4.6.1Procedureforselectionandpurchasingofservicesandsuppliesthataffectqualityoftests/calibrati