6667203-ISO-17025-Presentation.ppt

ISO IEC17025 1999 GeneralrequirementsforthecompetenceofTestingandCalibrationLaboratories PresentationbyB SudarsanLeadAssessor NABL ContentsofISO IEC17025 1999ScopeNormativeReferencesTermsandDefinitionsManagementRequirementsTechnicalRequirements ISO IEC17025 1999 1 SCOPESpecifiesrequirementsapplicabletoTesting CalibrationlaboratoriesNotesgiveninthestandardareforguidanceanddonotcontainrequirementsStandardismeantforusebylaboratories clients accreditationbodiesetc CompliancewiththeregulatoryandsafetyrequirementsarenotcoveredbythestandardCompliancewiththisstandardensurescompliancewithISO9001 9002 1994 ISO IEC17025 1999 2 NORMATIVEREFERENCESISO9001 1994QualitySystems ModelforQualityAssuranceinDesign Development Production InstallationandServicingISO9002 1994QualitySystems ModelforQualityAssuranceinProduction InstallationandServicingISO IECGuide2 GeneraltermsandtheirdefinitionsconcerningstandardizationVIM InternationalVocabularyofbasicandgeneraltermsinmetrology ISO IEC17025 1999 3 TERMSANDDEFINITIONSTermsgiveninISO IECguide2andVIMareapplicableAlsotermsgivenISO8402 1994areapplicableforgeneraldefinitions ISO IEC17025 1999 4 MANAGEMENTREQUIREMENTS4 1Organization4 2Qualitysystem4 3Documentcontrol4 4Reviewofrequests tendersandcontracts4 5Subcontractingoftestsandcalibrations4 6Purchasingservicesandsupplies4 7Servicetoclient4 8Complaints ISO IEC17025 1999 4 MANAGEMENTREQUIREMENTS contd 4 9Controlofnon conformingtesting calibration4 10Correctiveactions4 11Preventiveactions4 12Controlofrecords4 13Internalaudits4 14Managementreviews ISO IEC17025 1999 4 1ORGANIZATION4 1 1Laboratory organizationshallbeanentitythatcanbeheldlegallyresponsible4 1 2Laboratorytocarryoutactivitiestomeettherequirementsofthisstandard clients regulatoryauthoritiesandorganizationsprovidingrecognition4 1 3Managementsystemtocoverpermanent temporaryandmobilefacilities4 1 4Iflaboratoryispartofanorganizationhavingdifferentactivities responsibilityofkeypersonnelshallbedefined ISO IEC17025 1999 4 1 5ThelaboratoryshallhaveManagerialandtechnicalpersonnelPoliciesandprocedurestoensurepersonnelarefreefromunduepressuresPoliciesandprocedurestoensureprotectionofclient sconfidentialinformationPoliciesandprocedurestoavoidinvolvementinanyactivitiesthatwoulddiminishconfidenceDefinedmanagementstructureDefinedauthorityandresponsibilityandinter relationshipofpersonnelAdequatesupervisionoftesting calibrationstaffTechnicalmanagementAppointmentofQualityMangerDeputiesforkeyManagementpersonnel ISO IEC17025 1999 4 2QUALITYSYSTEM4 2 1Establish maintainandimplementQualitySystemappropriatetothescopeofactivities4 2 2QualitySystemPoliciesandObjectivesshallbedefinedinQualityManual QualityPolicyshallbeissuedundertheauthorityofchiefexecutiveandshallContainCommitmenttogoodprofessionalpracticesStatementoflaboratory sserviceObjectivesofQualitySystemRequirementthatpersonnelconcernedgetfamiliarizedwithQualitySystemCommitmenttocomplywithISO IEC17025 1999 ISO IEC17025 1999 4 2 3QualityManualshallinclude refertosupportingproceduresandoutlinestructureofQualitySystem4 2 4DefinedresponsibilityandauthorityoftechnicalmanagementandQualityManager ISO IEC17025 1999 4 3DOCUMENTCONTROL4 3 1GENERALProcedureforDocumentControl coveringdocumentsofinternalandexternalorigin4 3 2DOCUMENTAPPROVALANDISSUE4 3 2 1ApprovalofDocumentsbyauthorizedpersonnel MaintenanceofMasterList4 3 2 2TheprocedureshallensurethatAvailabilityofauthorizedappropriatedocumentsPeriodicreviewandrevisionasneededRemovalofobsolete invaliddocumentsSuitableidentificationofobsoletedocumentretainedforknowledge legalpurposes4 3 2 3Uniqueidentification date Revisionstatus pagenumberandnumberpages ISO IEC17025 1999 4 3 3DOCUMENTCHANGES4 3 3 1Approvalofchangesbythesameagencyasoriginalissueorauthorizedotherwise4 3 3 2Identificationofchangeseitheronthedocumentoronattachments4 3 3 3Ifmanualcorrectionsarepermitteddefinethesameintheprocedure4 3 3 4Ifdocumentsaremaintainedoncomputermemorydefinethecontrols ISO IEC17025 1999 4 4REVIEWOFREQUESTS TENDERSANDCONTRACTS4 4 1Establishandmaintaindocumentedprocedureforreviewofrequests tendersandcontractsfortesting calibration TheprocedureshallcoverEnsurethattherequirementsareadequatelydefined documentedandunderstoodb Laboratoryhasthecapabilityandresourcestomeettherequirementsc Selectionofappropriatetest calibrationmethod Resolutionofdifferencesbetweencontractandtender ifany ISO IEC17025 1999 4 4 2Maintenanceofrecordsofreview4 4 3Reviewalsotocoversub contractedwork4 4 4Clienttobeinformedanydeviation4 4 5Amendmentstoacontractshallalsotobereviewedandcommunicated ISO IEC17025 1999 4 5SUBCONTRACTINGOFTESTSANDCALIBRATIONS4 5 1Iflaboratorysub contractsthework thisshallbedoneonsuitablesubcontractors satisfyingtherequirementsofthisstandard4 5 2Informationtoclientonsucharrangement4 5 3Laboratoryshallberesponsibleforsubcontractor swork4 5 4Maintenanceofregisterofsubcontractors ISO IEC17025 1999 4 6PURCHASINGSERVICESANDSUPPLIES4 6 1Procedureforselectionandpurchasingofservicesandsuppliesthataffectqualityoftests calibration4 6 2Useofpurchasedmaterialsonlyafterinspection verification4 6 3Reviewandapprovalofpurchasedocumentsbeforerelease4 6 4Evaluationofsuppliersandmaintenanceofrecords forcriticalmaterials ISO IEC17025 1999 4 7SERVICETOCLIENTLaboratoryshallaffordclientcooperationtoclarifyclient srequestandmonitorperformanceoflaboratoryinrelationtoworkperformedandprotectconfidentialityofotherclients ISO IEC17025 1999 4 8COMPLAINTSProcedureforresolutionofcomplaintsfromclientsandotherpartiesMaintenanceofRecordsofComplaints ISO IEC17025 1999 4 9CONTROLOFNONCONFORMINGTESTING CALIBRATION4 9 1Procedurefordealingwithnonconformingtesting calibration TheprocedureshallensureAuthorityformanagementofnonconformingworktobedefinedb Evaluationofnonconformingworkc Notificationtoclient ifneededd Definedresponsibilityforresumptionofwork4 9 2Incaseofpossibilityofrecurrence initiationofsuitablecorrectiveaction ISO IEC17025 1999 4 10CORRECTIVEACTION4 10 1ProcedureforimplementingCorrectiveAction4 10 2CauseAnalysis Investigationofrootcause4 10 3SelectionandimplementationofCorrectiveActionSelectionandimplementationofmostsuitableCorrectiveActionDocumentandimplementanychangesasresultofCorrectiveAction4 10 4MonitoringofCorrectiveAction4 10 5AdditionalAudits whereneeded ISO IEC17025 1999 4 11PREVENTIVEACTION4 11 1IdentificationandimplementationofPreventiveActions4 11 2ProcedureforPreventiveActionshallincludeinitiationandcontrol ISO IEC17025 1999 4 12CONTROLOFRECORDS4 12 1GENERAL4 12 1 1ProcedureforQualityandTechnicalRecords identification collection indexing accessfiling storage maintenanceanddisposal 4 12 1 2Recordsshallbelegible4 12 1 3Securityofrecords4 12 1 4Procedureforprotectionandback up ISO IEC17025 1999 4 12 2TECHNICALREPORTS4 12 2 1Recordsoforiginalobservations deriveddataandpersonnelresponsibleforchecking4 12 2 2Observations dataandconclusionsshallbemadewhentheyaremade4 12 2 3Whenmistakesoccurthechangesareenteredaftercrossingtheoriginalobservation notbyerasing ISO IEC17025 1999 4 13INTERNALAUDITS4 13 1InternalAuditsasperpredeterminedscheduleandprocedure AllelementsofQualitySystemshallbecoveredQualityManagertoensureconductingaudits Auditsbyqualifiedandtrainedpersonnel ifpossibleindependentoftheareabeingauditedCycletimeforauditsisusually1year4 13 2Timelycorrectiveactionandnotificationtoclient ifneeded4 13 3RecordsofInternalAudits4 13 4Followupaudittoverifyeffectivenessofcorrectiveactions ISO IEC17025 1999 4 14MANAGEMENTREVIEWS4 14 1PredeterminedprocedureandscheduleforManagementreview ThereviewshallcoverSuitabilityofpoliciesandproceduresReportsfromManagementandsupervisorsOutcomeofInternalAuditsCorrectiveandPreventiveactionsAssessmentbyexternalagenciesInter laboratorycomparisons proficiencytestingChangesinvolumeandtypeofworkClientfeedback complaints4 14 2RecordsofManagementReviewandfollowupforactions ISO IEC17025 1999 5 TECHNICALREQUIREMENTS5 1General5 2Personnel5 3Accommodationandenvironmentalconditions5 4Testandcalibrationmethodsandmethodvalidation5 5Equipment5 6Measurementtraceability5 7Sampling5 8Handlingoftestandcalibrationitems5 9Assuringqualityoftestandcalibrationresults5 10Reportingtheresults ISO IEC17025 1999 5 1GENERAL5 1 1Factorsaffectingcalibration Testresults5 1 2Alltheseshallbetakenintoaccountwhiledevelopingprocedures selectionofequipmentandtrainingofpersonnel ISO IEC17025 1999 5 2PERSONNEL5 2 1Personnelperformingspecifictasksshallbequalifiedonthebasisofeducation training experienceandskills5 2 2Policyandprocedureforidentifyingtrainingneedsandprovidingtraining5 2 3Ensurethatcontractedpersonnelworkinaccordancewithlaboratory sQualitySystem5 2 4Maintenanceofjobdescriptionoftechnical managerialandkeypersonnel5 2 5Authorizationforsampling testing Calibration Issueofcertificates interpretations opinions operationofparticularequipmentMaintenanceofRecordsofqualifications trainingandskillsofpersonnel ISO IEC17025 1999 ISO IEC17025 1999 5 3ACCOMMODATIONANDENVIRONMENTALCONDITIONS5 3 1Technicalrequirementsofaccommodationandenvironmentalconditionsaffectingtesting calibrationshallbedocumentedandcontrolled5 3 2Monitor controlandrecordenvironmentalconditions5 3 3Effectiveseparationbetweenneighboringareas5 3 4Controlledaccesstotesting calibrationareas5 3 5Goodhousekeeping ISO IEC17025 1999 5 4TESTANDCALIBRATIONMETHODSANDMETHODVALIDATION5 4 1GENERALUseofappropriatemethodsfortests calibrationTheseincludesampling transport storage estimationofuncertaintyetc Availabilityofuptodateinstructions standards manualsanddataatworkplaces5 4 2SELECTIONOFMETHODSUseofpublishedmethods proceduresUseofvalidatedlaboratorydevelopedmethodsInformationtoclientwhenclientsuggestedmethodisinappropriate ISO IEC17025 1999 5 4 3LABORATORYDEVELOPEDMETHODSPlanfordevelopmentoftest calibrationmethodsAssignmentofactivitytoqualifiedpersonnelUpdatingofplanasthedevelopmentproceeds5 4 4NON STANDARDMETHODSUseofnon standardmethodissubjecttoagreementbyclientValidationofsuchmethodsbeforeuse ISO IEC17025 1999 5 4 5VALIDATIONOFMETHODS5 4 5 1Validationistheconfirmationbyexaminationandprovisionofobjectiveevidenceforsuitability5 4 5 2Validationofnon standard laboratorydevelopedmethods Maintenanceofrecordsofvalidation5 4 5 3Rangeandaccuracyobtainablefromvalidationmethodstosuitclient sneeds ISO IEC17025 1999 5 4 6ESTIMATIONOFUNCERTAINTYOFMEASUREMENT5 4 6 1Procedureforestimationofuncertaintyofmeasurementinallcalibrations5 4 6 2Procedureforestimationofuncertaintyofmeasurementintesting totheextentpossibleusingstatisticalmethods5 4 6 3Considerationtoallcomponentsinuncertaintyestimation5 4 7CONTROLOFDATA5 4 7 1Checksoncalculationsanddatatransfers5 4 7 2Suitablecontrolswhendataisacquiredandprocessedthroughcomputersorautomatedequipment 5 5EQUIPMENT5 5 1Availabilityofnecessaryequipment5 5 2Equipmentandsoftwareshallbesuitableforachievingtherequiredaccuracy Establishmentofcalibrationprogramme5 5 3Operationbyauthorizedpersonnelusinguptodateinstructions5 5 4Uniqueidentificationofeachitemofequipment5 5 5Maintenanceofrecordsofequipment5 5 6Proceduresforsafehandling transport storage useandplannedmaintenance ISO IEC17025 1999 ISO IEC17025 1999 5 5 7Removalfromservicesubjectedtooverloading mishandling Useofsuchequipmentonlyaftercheckingorcalibrationafterrepair5 5 8Indicationofcalibrationstatusontheequipment5 5 9Whenanequipmentgoesoutsidethecontrolofthelaboratory checkingcalibrationvaliditybeforereuse5 5 10Intermediatechecksasperdefinedprocedure5 5 11Proceduretoensureapplicationofcorrectionfactorswhereneeded5 5 12Safeguardingequipmentagainstunintentionaladjustments ISO IEC17025 1999 5 6MEASUREMENTTRACEABILITY5 6 1GENERALCalibrationofequipmentbeforeuseAprogrammeforcalibration5 6 2SPECIFICREQUIREMENTS5 6 2 1Calibration5 6 2 1 1CalibrationstraceabletoInternationalSystemofUnits SIUnits 5 6 2 1 2WherethereisnopossibilityofuseofSIunits establishmentofmeasurementtraceabilitythroughUseofcertifiedmaterialsandspecifiedmethodsInter laboratorycomparisons ISO IEC17025 1999 5 6 3REFERENCESTANDARDSANDMATERIALS5 6 3 1ReferenceStandardsProgrammeforcalibrationofreferenceStandardsUseonlyforcalibrationsCalibrationbeforeafteradjustments ifany5 6 3 2ReferenceMaterialsReferenceMaterialstraceabletoSIunits whereverpossible5 6 3 3IntermediateChecksIntermediatechecksasperdefinedproceduresandschedules5 6 3 4TransportandStorageProceduresforsafehandlingofreferencematerials referencestandards ISO IEC17025 1999 5 7SAMPLING5 7 1SamplingPlan procedureforsamplingwhereneeded Thisshallbebasedonappropriatestatisticaltechniques wherepossible5 7 2Whereclientwantsdeviationtotheprocedurenecessarydetailsshallbeincludedinalldocumentsrelatedtotesting calibration5 7 3Proceduresforrecordingrelevantdataonsamplingcarriedout ISO IEC17025 1999 5 8HANDLINGOFTESTANDCALIBRATIONITEMS5 8 1Procedurefortransportation receipt handling protection storage retentionanddisposalofitemsreceivedfortesting calibration5 8 2Asystem procedureforidentificationoftest calibrationitems5 8 3Recordingabnormalitiesofitems ifanyandconsultationwiththeclientfornecessaryfurtherinstructions action5 8 4Procedureforavoidingdeteriorationduringhandling storageandpreparation ISO IEC17025 1999 5 9ASSURINGTHEQUALITYOFTESTANDCALIBRATIONRESULTSUseofqualitycontrolproceduresformonitoringthevalidityoftest calibrationsMonitoringmayinclude butnotlimitedtoUseofcertifiedmaterialsParticipationininter laboratorycomparisons proficiencytestingReplicatetestingRe testing re calibrationofretaineditemsCorrelationofresultsfordifferentcharacteristics ISO IEC17025 1999 5 10REPORTINGTHERESULTS5 10 1GENERALReportingtheresultsclearlyandobjectivelyinaTest CalibrationReportformIncaseofinternalclientorspecialagreementwithclienttheresultsmaybereportedinasimplifiedway howevercompleteinformation listedin5 10 2 5 10 4 shallbemaintainedbythelaboratory ISO IEC17025 1999 5 10 2TESTANDCALIBRATIONCERTIFICATESTestReport CalibrationCertificateshallcontainTitle TestReport CalibrationCertificate Name addressofthelaboratoryUniqueidentification likeserialnumber Name addressoftheclientIdentificationofTestMethodCondition identificationofTest CalibrationitemDateofreceipt dateoftest calibrationReferencetosamplingplan ifanyTest calibrationresultsName designationofpersonsauthorizingreportAstatementtoth