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ISO17025AwarenessCourseGeneralrequirementsforthecompetenceoftestingandcalibrationlaboratoriesWELCOMECourseObjectivesToprovideconfidenceinthetestingprocessTounderstand:TheimpactofISO17025onourbusinessThemandatoryrequirementsatestlabneedstooperateHowtheserequirementsrelatetoourBMSHowyourindividualresponsibilitiesrelatetoISO:17025HistoryofISO17025ReplacesNAMASM10,EN45001&ISOGuide25PublishedasaBSinApril2000BSITSassessedbyUKASin2001ImplementationMarch2002ISOisacceptedinternationallywhereasM10wasaUKASowneddocumentStructuredmorelikeaqualitymanagementsystemstandardRequirementsoftenspeltoutindetailwithnotes.ScopeofISO17025Generalrequirementsforthecompetencetocarryouttestsand/orcalibrationsincludingsampling.Section4-ManagementrequirementsThereare14clausesinthissectionLinkedtoISO9000seriesSection5-TechnicalrequirementsThereare10clausesinthissectionTwoinformativeannexesChangeofEmphasisinISO17025Assessmentwillneedtoconsider:

Whetherthesystemworks,ratherthan,Doesitcontainspecificfeatures.ISO17025-ManagementRequirementsOrganisation-4.1Satisfyclient,regulatoryauthoritiesorthoseprovidingrecognitione.g.UKASDominantinfluencesQualitysystem-4.2GoodprofessionalpracticeStateobjectivesofthequalitysystemDocumentControl-4.3Re-issuehandamendeddocumentsChangecontrolofelectronicmediaReviewofrequests,tenders&contracts-4.4thelaboratoryhasthenecessarycapabilityandresourcestomeettherequirementstheappropriatemethodisselectedandiscapableofmeetingtheclients’requirementscontractreviewistobeconductedinapracticalandefficientmannerchangesagreedbybothparties(recorded)Salesisinvolvedatalltimes.

Subcontractingoftestsandcalibrations-4.5TheLaboratoryisresponsibleforsub-contractorswork

ISO17025-ManagementRequirementsPurchasingservicesandsuppliers-4.6TechnicalapprovalofpurchaseordersServicetotheclient-4.7Accesstotesting(confidentialitytoothers)Complaints-4.8Controlofnonconformingtestingand/orcalibrationwork-4.9Correctiveaction-4.10Preventiveaction-4.11Controlofrecords-4.12Internalaudits-4.13Managementreview-4.14ISO17025-ManagementRequirementsISO17025TechnicalrequirementsPersonnel-5.2GoalsforcompetenceProcedurestoidentifytrainingneedsAccommodationandenvironmentalconditions-5.3SegregationofincompatibleactivitiesMonitorandcontrolconditionsTestandcalibrationmethodsandmethodsofvalidation-5.47sub-clausesValidation5.4.5Uncertaintyfortesting5.4.6Equipment-5.5RecordsIncludingsoftwareAuthorisedpersonnel

Measurementtraceability-5.6CalibrationReferencestandards/materials

Sampling-5.7

Handlingoftestandcalibrationitems-5.8ISO17025TechnicalrequirementsAssuringthequalityoftestandcalibrationresults-5.9TrendanalysisStatisticaltechniquesReplicatingtests

Reportingtheresults-5.10CertificatesandreportsOpinionsandinterpretationsISO17025Technicalrequirements

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