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ISO17025AwarenessCourse,Generalrequirementsforthecompetenceoftestingandcalibrationlaboratories,WELCOME,CourseObjectives,Toprovideconfidenceinthetestingprocess,Tounderstand:TheimpactofISO17025onourbusinessThemandatoryrequirementsatestlabneedstooperateHowtheserequirementsrelatetoourBMSHowyourindividualresponsibilitiesrelatetoISO:17025,HistoryofISO17025,ReplacesNAMASM10,EN45001&ISOGuide25PublishedasaBSinApril2000BSITSassessedbyUKASin2001ImplementationMarch2002ISOisacceptedinternationallywhereasM10wasaUKASowneddocumentStructuredmorelikeaqualitymanagementsystemstandardRequirementsoftenspeltoutindetailwithnotes.,ScopeofISO17025,Generalrequirementsforthecompetencetocarryouttestsand/orcalibrationsincludingsampling.Section4-ManagementrequirementsThereare14clausesinthissectionLinkedtoISO9000seriesSection5-TechnicalrequirementsThereare10clausesinthissectionTwoinformativeannexes,ChangeofEmphasisinISO17025,Assessmentwillneedtoconsider:Whetherthesystemworks,ratherthan,Doesitcontainspecificfeatures.,ISO17025-ManagementRequirements,Organisation-4.1Satisfyclient,regulatoryauthoritiesorthoseprovidingrecognitione.g.UKASDominantinfluencesQualitysystem-4.2GoodprofessionalpracticeStateobjectivesofthequalitysystemDocumentControl-4.3Re-issuehandamendeddocumentsChangecontrolofelectronicmedia,Reviewofrequests,tenders&contracts-4.4thelaboratoryhasthenecessarycapabilityandresourcestomeettherequirementstheappropriatemethodisselectedandiscapableofmeetingtheclientsrequirementscontractreviewistobeconductedinapracticalandefficientmannerchangesagreedbybothparties(recorded)Salesisinvolvedatalltimes.Subcontractingoftestsandcalibrations-4.5TheLaboratoryisresponsibleforsub-contractorswork,ISO17025-ManagementRequirements,Purchasingservicesandsuppliers-4.6TechnicalapprovalofpurchaseordersServicetotheclient-4.7Accesstotesting(confidentialitytoothers)Complaints-4.8Controlofnonconformingtestingand/orcalibrationwork-4.9Correctiveaction-4.10Preventiveaction-4.11Controlofrecords-4.12Internalaudits-4.13Managementreview-4.14,ISO17025-ManagementRequirements,ISO17025Technicalrequirements,Personnel-5.2GoalsforcompetenceProcedurestoidentifytrainingneedsAccommodationandenvironmentalconditions-5.3SegregationofincompatibleactivitiesMonitorandcontrolconditionsTestandcalibrationmethodsandmethodsofvalidation-5.47sub-clausesValidation5.4.5Uncertaintyfortesting5.4.6,Equipment-5.5RecordsIncludingsoftwareAuthorisedpersonnelMeasurementtraceability-5.6CalibrationReferencestandards/materialsSampling-5.7Handlingoftestandcalibrationitems-5.8,ISO17025Technicalrequirements,Assuringthequalityoftestandcalibrationresults-5.9TrendanalysisStatisticaltechniquesReplicatingtestsReportingtheresults-5.10CertificatesandreportsOpinionsandinterpretations,ISO17025Technicalrequirements,Su
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