qapp vs iso 17025 - · pdf filev b2 sampling methods v b3 sample handling and ... qapp vs iso...

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).