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QAPPvsISO17025
MichelleBognerMichiganDepartmentofAgriculture
andRuralDevelopment
TheQAProjectPlanintegratesalltechnicalandqualityaspectsofaproject,includingplanning,implementaHon,andassessment.ThepurposeoftheQAProjectPlanistodocumentplanningresultsforenvironmentaldataoperaHonsandtoprovideaproject-specific“blueprint”forobtainingthetypeandqualityofenvironmentaldataneededforaspecificdecisionoruse.
hOp://www.epa.gov/quality
WhatisaQAPP?
EPAPOLICYAllworkfundedbyEPAthatinvolvestheacquisiHonofenvironmentaldatageneratedfromdirectmeasurementacHviHes,collectedfromothersources,orcompiledfromcomputerizeddatabasesandinformaHonsystemsshallbeimplementedinaccordancewithanapprovedQAProjectPlan.TheQAProjectPlanwillbedevelopedusingasystemaHcplanningprocessbasedonthegradedapproach.NoworkcoveredbythisrequirementshallbeimplementedwithoutanapprovedQAProjectPlanavailablepriortothestartoftheworkexceptundercircumstancesrequiringimmediateacHontoprotecthumanhealthandtheenvironmentoroperaHonsconductedunderpolicepowers.
WhydowehavetowriteaQAPP?
v EPAheadquartershasleZituptoeachRegiontodeterminewhetherornottheywillacceptISO17025accreditaHoninlieuofaQAPP
v RegardlessofRegion,inordertouseISO17025accreditaHoninlieuofaQAPP,thescopeoftheaccreditaHonmustincludetheFIFRAwork.
v AnyFIFRAworkthatisnotwithinthescopeoftheISO17025accreditaHonmusthaveaQAPP.
CanISO17025AccreditaHonbeUsedinPlaceofaQAPP?
v EachoftheEPAregionsissetupaseitheracentralizedgrouporade-centralizedgroup.
v CentralizedregionshaveseveralspecialistsandanyoneofthemcanbeassignedaprojectandtheQAPPassociatedwithitforreviewandassessment.
v DecentralizedregionshaveoneQAspecialistwhodoesalloftheQAPPreviewsandassessmentsfortheregion.
v Region5isdecentralized.v RegionsconsultwitheachotheronQAmaOers
WhointheEPAReviewstheQAPP?
FourQAPPSecHons
A–ProgramManagementAddressesthebasicareaofprojectmanagement,includingtheprojecthistoryandobjecHves,rolesandresponsibiliHesoftheparHcipants,etc.toensurethattheprojecthasadefinedgoal,thattheparHcipantsunderstandthegoalandtheapproachtobeused,andthattheplanningoutputshavebeendocumented.B–Measurement/DataAcquisiHonAddressesallaspectsofprojectdesignandimplementaHon.ImplementaHonoftheseelementsensurethatappropriatemethodsforsampling,measurementandanalysis,datacollecHonorgeneraHon,datahandling,andQCacHviHesareemployedandareproperlydocumented.
FourQAPPSecHons
C–AssessmentandOversightAddressestheacHviHesforassessingtheeffecHvenessoftheimplementaHonoftheprojectandassociatedQAandQCacHviHes.ThepurposeofassessmentistoensurethattheQAProjectPlanisimplementedasprescribed.D–DataValidaHonandUsabilityAddressestheQAacHviHesthatoccuraZerthedatacollecHonorgeneraHonphaseoftheprojectiscompleted.ImplementaHonoftheseelementsensuresthatthedataconformtothespecifiedcriteria,thusachievingtheprojectobjecHves.
GroupA:ProjectManagementElements
v A1TitleandApprovalSheetv A2TableofContentsv A3DistribuHonListv A4Project/TaskOrganizaHonv A5ProblemDefiniHon/Backgroundv A6Project/TaskDescripHonv A7QualityObjecHvesandCriteriav A8SpecialTraining/CerHficaHonv A9DocumentsandRecords
GroupB:DataGenera=onandAcquisi=onElements
v B1SamplingProcessDesign(ExperimentalDesign)v B2SamplingMethodsv B3SampleHandlingandCustodyv B4AnalyHcalMethodsv B5QualityControlv B6Instrument/EquipmentTesHng,InspecHon,and
Maintenancev B7Instrument/EquipmentCalibraHonand
Frequencyv B8InspecHon/AcceptanceofSuppliesand
Consumablesv B9Non-directMeasurementsv B10DataManagement
GroupC:AssessmentandOversightElements
v C1AssessmentsandResponseAcHonsv C2ReportstoManagement
GroupD:DataValida=onandUsability
Elements
v D1DataReview,VerificaHon,andValidaHonv D2VerificaHonandValidaHonMethodsv D3ReconciliaHonwithUserRequirements
ISO17025
v SecHon4:ManagementRequirementsv SecHon5:TechnicalRequirements
ManagementRequirements
v OrganizaHonv ManagementSystemv DocumentControlv ReviewofRequests,TendersandContractsv SubcontracHngofTestsandCalibraHonsv PurchasingServicesandSuppliesv ServicetotheCustomerv Complaintsv ControlofNonconformingTesHngand/orCalibraHonWorkv Improvementv ControlofRecordsv InternalAuditsv ManagementReviews
TechnicalRequirements
v Generalv Personnelv AccommodaHonandEnvironmentalCondiHonsv TestandCalibraHonMethodsandMethodValidaHonv Equipmentv MeasurementTraceabilityv Samplingv HandlingofTestandCalibraHonItemsv EnsuringtheQualityofTestandCalibraHonResultsv ReporHngtheResults
QAPPvsISO17025v ISO17025requiresa“QualityManual”perse,aQAPPisaquality
manual.v BoththeQAPPandISO17025aretryingtoaccomplishthesamething,
documenthowthelaboratoryfulfills“goodlaboratorypracHces”inconducHnglaboratoryanalyses.
v TheQAPPworksthroughthesepracHcesasitfollowstheorderofcompleHngaproject:theplanning,thesampling,theanalysis,thedatareducHonandreporHng.WhereasISO17025usestheapproachofsystemaHcallycoveringrequirementsthatmaytouchalltheseareasofaproject.
v NotallISO17025secHonsrequiredocumentaHonoutsideofbeingaddressedinyourQualityManualandthereforewouldnotshowupasdocumentaHonforQAPP,althoughtherearesomethathavebeenincludedinthefollowingslides.
QAPPvsISO17025v ManyQAPPsecHonsaredescripHveoftheprojectortaskandtherefore
donotapplytoISO17025requirementseg.,manyoftheSecHonBsubsecHonsstartwithasubsecHon“Purpose/Background.”
v YoumayfindotherconnecHonsthatImissed,pleasefeelfreetobringthesetoeveryone’saOenHon–thisisbasedoncomparingMichigan’sQAPPandA2LAAssessor’sChecklist.
v ThereisalotofoverlapfromonesecHontoanotherintheQAPPsuchthatoneSOPcouldcovermanysecHonsandmanysecHonsofISO17025touchthosesamerequirements.
QAPPvsISO17025–GeneralAlignmentQAPP ISO17025 QAPP ISO17025 QAPP ISO17025
A1-A3 NA B1 5.1,5.4,5.7 B9 4.13,5.4,5.6
A4 4.1,4.2,4.4,5.2 B2 4.8,4.9,4.11,4.12,5.3,5.4,5.5,5.7,5.8
B10 4.11,4.13,5.4,5.6,5.10
A5-A6 NA B3 5.3,5.4,5.8 C1 4.2,4.8,4.12,4.14,4.15
A7 5.9 B4 5.4,5.7 C2 4.2,4.15
A8 5.2 B5 4.8,4.9,4.11,4.12,5.4,5.5,
5.9
D1 5.4,5.5,5.6,5.7,5.8,5.9
A9 4.1,4.3,4.13 B6 5.3,5.4,5.5,5.6 D2 4.11,5.4,5.9
B7 5.3,5.4,5.5,5.6 D3 4.9,5.4,5.9
B8 4.6,5.5,5.6
ISO17025vsQAPP–GeneralAlignmentISO17025 QAPP ISO17025 QAPP ISO17025 QAPP
4.1 A4,A9 4.10 N/A 5.3 B2,B3,B6,B7
4.2 A4,C1,C2 4.11 B2,B5,B10,D2
5.4 B1,B2,B3,B4,B5,B6,B7,B9,B10,D1,
D2,D3
4.3 A9 4.12 B2,B5,C1
5.5 B2,B5,B6,B7,B8,D1
4.4 A4 4.13 A9,B9,B10
5.6 B6,B7,B8,B9,B10,D1
4.5 N/A 4.14 C1 5.7 B1,B2,B4,D1
4.6 B8 4.15 C1,C2 5.8 B2,B3,D1
4.7 N/A 5.1 B1 5.9 A7,B5,D1,D2,D3
4.8 B2,B5,C1 5.2 A4,A8 5.10 B10
4.9 B2,B5,D3
QAPPSecHonA(ProgramManagement)vsISO17025–SpecificAlignment
QAPP ISO17025 SOP/Documenta=on
A1throughA3,A5,A6 TableofContents
A4.1Program/TaskOrganizaHonandPlanningDocumentaHon
4.1.4,4.2.2,4.4.1,5.2.3,5.2.5
OrganizaHonalchartsSOPonreviewofrequests,tendersandcontractsQualitypolicystatement
A7QualityObjecHvesandCriteriaforMeasurementData
5.9.1 SOPQCcriteria
A8SpecialTraining/CerHficaHon
5.2.2,5.2.4 SOPontrainingTrainingdocumentsPosiHondescripHonsCurriculumvitae
A9DocumentsandRecords 4.1.5.c,4.3.1,4.3.3.3,4.3.3.4,4.13.1.1,4.13.1.4
SOPsonwriHngSOPs,documentcontrol,recordcontrolandstorage,reporHngresults,dataarchivalRetenHonschedules
QAPPSecHonB1(SamplingProcessDesign)vsISO17025–SpecificAlignment
QAPP ISO17025 SOP/Documenta=on
B1.1–B1.3,B1.5 NA
B1.4SamplingMethodologyandRaHonale
5.4.1,5.7.1,5.7.2 SOPsonhomogenizaHonandsamplealiquots(oZenwithinmethodSOPs)
B1.6ClassificaHonofMeasures(CriHcal/NoncriHcal)
5.1,5.4.6.1 SOPonmeasurementuncertainty
B1.7ValidaHonofAnyNonstandardMethods
5.4.3,5.4.5.2 SOPonmethodvalidaHon
QAPPSecHonB2(SamplingMethodsRequirements)vsISO17025–SpecificAlignment
QAPP ISO17025 SOP/Documenta=on
B2.1,2.6 NA
B2.2SampleCollecHon,PreparaHon,andDecontaminaHon
5.3.3,5.3.5,5.7.1,5.7.2 SOPsonhomogenizaHonandsamplealiquots
B2.3SupportFaciliHesforSamplingMethods
5.3,5.7.1,5.7.2 SOPsonhomogenizaHonandsamplealiquots
B2.4Sampling/MeasurementSystemFailureResponseandCorrecHveAcHonProcess
4.8,4.9.1,4.11.1,4.12.1,4.12.2
SOPsoncomplaints,correcHveacHons,prevenHveacHons,controlcharHng,QCcriteria
B2.5SamplingEquipment,PreservaHon,andHoldingTimeRequirements
5.4.1,5.5.1,5.5.2,5.5.7,5.5.8,5.5.9,5.5.12,5.7.1,5.7.2,5.8.1,5.8.2,5.8.4
SOPsonmethods;equipment;samplealiquots;samplelabeling,handlingandstorage
QAPPSecHonB3(SampleHandlingandCustodyRequirements)andB4(AnalyHcalMethodsRequirements)vsISO17025–SpecificAlignment
QAPP ISO17025 SOP/Documenta=on
B3.1,B4.3 NA
B3.2SampleCustodyandSampleShippingProcedures
5.4.1 SOPonsamplechainofcustody
B3.3SamplePreservaHonandStorage
5.3,5.8.1,5.8.2,5.8.4 SOPsonhandlingandstorageofsamples
B4.1SelecHonofAnalyHcalMethods
5.4.1,5.4.3 SOPsonmethodsandmethodvalidaHon
B4.2ValidaHonofAnyNonstandardMethods
5.4.3,5.4.5.2 SOPonmethodvalidaHon
B4.4Subsamplings 5.7.1,5.7.2 SOPonsamplealiquots
B4.5PreparaHonofSamples 5.7.1,5.7.2 SOPsonhomogenizaHonandsamplealiquots
QAPPSecHonB5(QCRequirements)andB6(Instrument/EquipmentTesHngInspecHonandMaintenance)vsISO17025–SpecificAlignment
QAPP ISO17025 SOP/Documenta=on
B5.1QualityControlProcedures
4.11.1,5.4.6.1,5.4.6.2,5.5.10,5.5.11,5.9
SOPsonQCcriteria,controlcharHng,measurementuncertainty
B5.2CorrecHveAcHon 4.8,4.9.1,4.11.2,4.12.1,4.12.2
SOPsoncorrecHveacHonandprevenHveacHon
B6InstrumentaHon/EquipmentTesHngInspecHonandMaintenance
5.3.1,5.4.1,5.5.3,5.5.10,5.5.11,5.6.1,5.6.3.1,5.6.3.3,5.6.3.4
SOPsonequipmentcalibraHon/verificaHonandinstrumentmaintenance
QAPPSecHonB7(InstrumentCalibraHonandFrequency)vsISO17025–SpecificAlignment
QAPP ISO17025 SOP/Documenta=on
B7.1,B7.6 NA
B7.2InstrumentaHonRequiringCalibraHon
5.3.1,5.5.2,5.5.10,5.5.11,5.6.1,5.6.3.1,5.6.3.3,5.6.3.4
EquipmentmatrixSOPsonequipmentcalibraHon/verificaHonandinstrumentmaintenance
B7.3CalibraHonMethodUsedforEachInstrument
5.3.1,5.4.1,5.5.2,5.5.3,5.5.10,5.5.11
SOPsonequipmentcalibraHon/verificaHonandinstrumentmaintenance
B7.4CalibraHonStandard 5.5.10,5.5.11,5.6.1,5.6.3.1,5.6.3.3,5.6.3.4
SOPonacquisiHonandmakingofstandardsChemicalHygieneandBiosafetyPlan
B7.5CalibraHonandFrequency
5.3.1,5.4.1,5.5.2,5.5.3,5.5.10,5.5.11,5.6.3.3
SOPsonequipmentcalibraHon/verificaHonandinstrumentmaintenance,andacquisiHonandmakingofstandards
QAPPSecHonB8(InspecHon/AcceptanceRequirementsforSuppliesandConsumables)andB9(DataAcquisiHonRequirements{Non-DirectMeasurements}
vsISO17025–SpecificAlignment
QAPP ISO17025 SOP/Documenta=on
B8.1-8.3,B9.1 NA
B8.4TrackingandQualityVerificaHonofSuppliesandConsumables
4.6.1,5.5.2,5.5.4,5.5.7,5.5.8,5.5.9,5.5.12,5.6.1,5.6.3.2
SOPsonselecHonandevaluaHonofsuppliers,purchasing,reagenttesHngandtracking
B9.2AcquisiHonofNon-directMeasurementData
4.13.1.1,4.13.1.2,4.13.2,5.4.7,5.6
SOPsonlogbooks,fillingoutrecords,recordcontrol
QAPPSecHonB10(DataManagement)vsISO17025–SpecificAlignment
QAPP ISO17025 SOP/Documenta=on
B10.1DataRecording 4.13.1.1,4.13.1.2,4.13.2,5.4.7,5.6,5.10.1
SOPsonlogbooks,fillingoutrecords,recordcontrol
B10.2DataValidaHon 4.11.1 SOPonQCcriteria
B10.3DataTransformaHon 5.4.7.2.b SOPonrecordcontrol
B10.4DataTransmiOal 5.4.7.2.b SOPonrecordcontrol
B10.5DataReducHon 5.4.7.2.b SOPondatareducHon
B10.6DataAnalysis 5.4.7.2.b SOPonrecordcontrolanddatareducHon
B10.7DataTracking 4.13.1.1,5.10.9 SOPonrecordcontrolanddatareducHon
B10.8DataStorageandRetrieval
4.13.1.1,4.13.1.4 SOPonrecordcontrolanddataarchivalRetenHonschedules
QAPPSecHonC1(AssessmentsandResponseAcHons)vsISO17025–SpecificAlignment
QAPP ISO17025 SOP/Documenta=on
C1.1 NA
C1.2AssessmentAcHviHesandProgramPlanning
4.2.2,4.12.1,4.12.2,4.14.1,4.15.1
SOPsonreviewofrequest,tendersandcontracts;managementreview;correcHveacHons;prevenHveacHons;audiHng
C1.3DocumentaHonofAssessments
4.8,4.14.1 SOPonaudiHng
C1.4AssessorAuthority,QualificaHonsandReporHngRequirements
4.2.6,4.15.1 SOPsonaudiHngandmanagementreviewsPosiHondescripHons
QAPPSecHonC2(ReportstoManagement)vsISO17025–SpecificAlignment
QAPP ISO17025 SOP/Documenta=on
C2.1 NA
C2.2Frequency,ContentandDistribuHon
4.15.1 SOPonmanagementreviews
C2.3IdenHfyResponsibleOrganizaHons
4.2.6 OrganizaHonalchartPosiHondescripHonsSOPsonhandlingofaccreditaHonlogos,proficiencytesHng
QAPPSecHonD1(DataReview,ValidaHon,andVerificaHonRequirements)vsISO17025–SpecificAlignment
QAPP ISO17025 SOP/Documenta=on
D1.1–1.2 NA
D1.3SampleCollecHonProcedures
5.4.1,5.7.1,5.7.2,5.8.1,5.8.2,5.8.4
SOPsonhomogenizaHonandsamplealiquots
D1.4SampleHandling 5.4.1,5.7.1,5.7.2,5.8.1,5.8.2,5.8.4
SOPsonhomogenizaHonandsamplealiquots
D1.5AnalyHcalProcedures 5.5.10,5.5.11,5.9.1 SOPsonQCcriteriaanddatareducHon
D1.6QualityControl 5.4.6.1,5.4.6.2,5.5.10 SOPsonQCcriteriaandmeasurementuncertainty
D1.7CalibraHon 5.4.1,5.5.10,5.5.11,5.6.1,5.6.3.1,5.6.3.3,5.6.3.4
SOPonequipmentcalibraHon/verificaHon
D1.8DataReducHonandProcessing
5.4.7.2.b SOPsonrecordcontrolanddatareducHon
QAPPSecHonD2(ValidaHonandVerificaHonMethods)andD3(ReconciliaHonswithDataQualityObjecHves)vsISO17025–SpecificAlignment
QAPP ISO17025 SOP/Documenta=on
D2.1,D3.1 NA
D2.2DescribetheProcessforValidaHonandVerifyingData
4.11.1,5.4.1,5.4.3,5.4.5.2,5.9.1
SOPsonQCcriteria,controlcharHng,methodvalidaHon,anddatareviews
D3.2ReconcilingResultswithDQOs
5.4.6.1,5.4.6.2,5.9.1 SOPonmeasurementuncertainty
TheCenterhasprocedurestoinventoryandmaintainallequipment.(RefertoBP-30).Eachinstrumentshallhaveinstrumentmaintenancelogbookwithallthemaintenancedocumented.(RefertoBP-24.)Equipmenttobetransportedand/orstoredshallbehandledinaccordancewithmanufacturers’instrucHon.AZerequipmenthasbeenmovedortakenoutofstorage,calibraHonshallbeverifiedpriortouse.StaffcannotindependentlyoperateanalyHcalequipmentwithoutauthorizaHonfromtheirsupervisor.TheauthorizaHonisgivenbasedondocumentedproofoftrainingandiniHaldemonstraHonofcompetency.(RefertoBP-10)
QAPPExamples–Equipment#1
AllinstrumentsshallbecalibratedaccordingtotheapplicablestandardoperaHngprocedure,method,orstandardattheintervalsspecifiedintheprotocol.-GoodifSOPsfortheprotocolsareaOached,shortandsweet.
QAPPExamples–Equipment#2
LaboratoryandfieldpersonnelareresponsiblefortheirrespecHveequipmentmaintenance.HDOAmaintainseitherservicecontractsorin-housecapabiliHesandresponsibiliHesforequipmentmaintenance.SchedulesforpreventaHveand/orcorrecHvemaintenancearedeterminedandcarriedoutthroughservicecontractsorin-housecapabiliHes.SamplingequipmentunderthecareoftheStateFIFRAPesHcideProgramwillbeoperated,calibrated,andmaintainedaccordingtothemanufacturer’sinstrucHonsand/orprogramSOPs.MaintenancelogswillbekeptintheStateoffice.Eachpieceofequipmentwillhaveitsownmaintenancelog.Thelogwilldocumentanymaintenanceandserviceoftheequipment.AlogentrywillincludethefollowinginformaHon:
Nameofpersonmaintainingtheinstrument/equipmentDateanddescripHonofthemaintenanceprocedureDateanddescripHonofanyinstrument/equipmentproblem(s)DateanddescripHonofacHontocorrectproblem(s)Listoffollow-upacHviHesaZermaintenance(i.e.,system
checks)Similarly,verysuccinctandworksifthereareSOPsaOached.
QAPPExamples–Equipment#3
AllcalibraHonworkisdocumentedinlaboratorynotebooksoroncalibraHonsheets(retainedbytheQAOfficerorLaboratories)forin-housecalibraHons.CalibraHoncerHficatesaremaintainedbytheQAOfficerforcalibraHonsdonebythirdparHes.CerHficatesareobtainedforbalances,weights,automatedHtratorsystemsandvariousotherpiecesofequipment.BalancesrequiringcalibraHonarecalibratedandverifiedasrequiredthroughalinearrangeappropriateforthebalance.Phmetersarecalibratedbeforeuse.Refrigerators,freezersandincubatorsareconHnuouslymonitored.Thechartrecordersthatmonitortheseunitsarecalibratedyearly.Thetemperaturechartsarechangedweekly(whenpossible)bylaboratorypersonnelandreviewedbytheQAOfficer.ThesereviewsarerecordedbytheQAOfficerinthe“Temp.Charts-OISC”Logbook.
QAPPExamples–Equipment#4
Instrument/EquipmentManagementAllinstrumentaHonandequipmentaremaintainedfollowingmanufacturer’sguidelines.Whenaffordable,servicecontractsareusedforyearlyinspecHonandmaintenance,otherwiseallinspecHonsandmaintenanceareperformedbyanalyHcalstaff.MaintenancelogsarekeptonmajorinstrumentaHonandequipment.InspecHon/AcceptanceofSuppliesLaboratorysuppliesarereceivedintheOperaHonssecHonofthelaboratory.TheOperaHonssecHonwilldeliverthesuppliestothelaboratorysecHon,wheretheanalystwhoorderedtheitemwillcheckthattheitemreceivediscorrect.Thepackingslipissignedthattheorderiscorrect.ThisslipisreturnedtotheOperaHon’ssecHon.PurchasinginformaHon
QAPPExamples–Equipment#5
B7.1Purpose/BackgroundMatchestheoutlineoftheQAPPintheguidelinesmakingiteasierfortheEPAQApersonneltoseehowyouareaddressingeachrequirementAnalyHcalinstrumentsinthePesHcideSecHonarecalibratedasoZenasnecessarytoprovideaccuratedataasdeterminedthroughtheirQAmeasurementsperPesHcideSecHonSOPPBEQB,“ProcedurefortheCalibraHon/VerificaHonofPesHcideEquipmentB7.2InstrumentaHonRequiringCalibraHonTheinstrumentsinthePesHcideSecHonthatrequirecalibraHonand/orverificaHonofcalibraHonarethefollowing:Somestateshadverydetailedlistsofequipment
GCswithmassspectrometers.HPLCswithmassselecHvedetectors.AnalyHcalbalancespHmetersAutopipeOesRefrigeratorsFreezersAirflowcontrolsforhoodsThermometers/thermocouples
QAPPExamples–Equipment#6
Summaryv Region5isagreeabletousingaccreditaHoninlieuoftheQAPPbyreferencing
thequalitysystemintheQAPP,however,rememberthatanyaspectofyourFIFRAprogramthatisnotonyourscopeneedstobeinaQAPP
v FormoreinformaHononQAPPsandEPApolicygotohOp://www.epa.gov/quality
v ISO17025requirementscanbepurchaseddirectlyfromtheISOorganizaHonhOp://www.iso.org/iso/catalogue_detail.htm?csnumber=39883orfromAOACInternaHonalhOp://www.aoac.org/imis15_prod/AOAC/PublicaHons/ALACC/About_ALACC/AOAC_Member/PublicaHons/ALACC_Info/AOAC_ALACC_Main.aspx?hkey=a125f5af-653c-4aa5-afff-f2fafc126059alongwiththeiraddiHonalrequirementsforfoodtesHngorfromothersourcesthatwillincludekitsoftemplatesforyourmanual,SOPs,etc.
v YouneedtofamiliarizeyourselfwithboththeQAPPrequirementsandISO17025requirements
Summaryv ThereareacoupleofwaystowriteaQAPP,ifneeded,thatuHlizewhatmay
alreadybewriOenforISO17025v Cutandpastev ReferencesandincludecopiesofQualityManualand/orSOPsas
aOachmentstotheQAPPv WritetheQAPPasyourQualityManualandmenHonwhichoftheISO
17025requirementsaremetaspartofthedocumentorviceversawriHngyourQualityManualandgivecrossreferencetotheQAPPrequirements
v ThereisalotofoverlapfromonesecHontoanotherintheQAPPsuchthatoneSOPcouldcovermanysecHonsandmanysecHonsofISO17025touchthosesamerequirements.
v YourqualitysystemmaybesetuptomirrorQAPPoritmaybesetuptomirrorISO17025oritmaynotmirroreither(thiscouldbeparHcularlydifficultforassessorstofinddocumentaHonoffulfillmentofrequirements).