XYZLABORATORY

ISO/IEC17025QUALITYMANUAL

REV.1 DATE:MM/DD/YY

XYZLaboratory

ISO/IEC17025 QUALITYMANUAL

Revision:01

Date:MM/DD/YY

UNCONTROLLEDCOPY

CONTROLLEDCOPY

Serial#_________

IssuedTo:___________________________Date:___________

SAMPLE

Note:Thissamplemanualonlycontainspartialtext,therefore,thenumberingisnotconsecutive

TableofContents

TOC\o"2-2"\h\z\t"Heading1,1,Title,1"

APPROVALS

4

REVISIONANDAPPROVALRECORD

5

1.0 General

6

1.1 Applicability

7

2.0 References

8

3.0 TermsandDefinitions

9

4.0 GeneralRequirements

10

4.1 Impartiality

10

4.2 Confidentiality

11

5.0 StructuralRequirements

12

5.1 AdministrativeandGeneralRequirements

12

5.2 OrganizationandManagement

13

XYZLaboratoryOrganizationalChart

15

6.0 ResourceRequirements

20

6.1 General

20

6.2 Personnel

20

6.3 FacilitiesandEnvironmentalConditions

23

6.4 Equipment

25

6.5 MetrologicalTraceability

29

6.6 ExternallyProvidedProductsandServices

31

7.0 ProcessRequirements

33

7.1 ReviewofRequests,Tenders,andContracts

33

7.2 Selection,Verification,andValidationofMethods

36

7.3 Sampling

40

7.4 HandlingofTestand/orCalibrationItems

41

7.5 TechnicalRecords

42

7.6 EvaluationofMeasurementUncertainty

42

7.7 EnsuringtheValidityofResults

44

7.8 ReportingofResults

46

7.9 Complaints

52

7.10 NonconformingWork

53

7.11 ControlofDataandInformationManagement

54

8.0 ManagementSYSTEMRequirements

56

8.1 Options

56

8.1.1 General

56

8.2 ManagementSystemDocumentation

57

8.3 ControlofManagementSystemDocuments

63

8.4 ControlofRecords

64

8.5 ActionstoAddressRisksandOpportunities

65

8.6 Improvement

66

8.7 CorrectiveAction

67

8.8 InternalAudits

68

8.9 ManagementReviews

70

APPROVALS

APPROVEDBY:

________________________________________ ____________

(Name),President Date

________________________________________ ____________

(Name),QualityManager Date

________________________________________ ____________

(Name),TechnicalManager Date

________________________________________ ____________

(Name),PurchasingManager Date

5.0StructuralRequirements

5.1 AdministrativeandGeneralRequirements

5.1.1 XYZLaboratoryholdslegalresponsibilityforitsoperation.

5.1.2 Calibration/testingactivitiesareperformedinsuchawayastomeettherequirementsoftheISO/IEC17025standard,aswellassatisfyingtheneedsofthecustomer,regulatoryauthorities,ororganizationsprovidingrecognition.

5.1.3 Themanagementsystemcoversworkcarriedoutinthelaboratory’spermanentfacilities,atsitesawayfromitspermanentfacilities,andinassociatedtemporaryormobilefacilitiesorcustomers’facilities.

5.1.4 XYZLaboratory’scalibration/testcapabilitiesaredocumented.See“ScopeofServices”and“ScopeofAccreditation”in1.0General.

6.0ResourceRequirements

6.1 General

XYZLaboratoryhasthenecessarypersonnel,accommodationandenvironmentalconditions,measuring/testequipment,informationsystem(s)andsupportservicestoperformitslaboratoryactivities.

6.2 Personnel

6.2.1 XYZLaboratorymanagementensuresthecompetencyofallwhooperatespecificequipment,whoperformtestsand/orcalibrations,evaluateresults,andsigntestreportsand/orcalibrationcertificates.Staffundergoingtrainingisadequatelyandappropriatelysupervised.Personnelperformingspecifictaskswithinthemanagementsystemthatmaydirectlyorindirectlyaffecttheconformanceoftheproducttoqualityrequirementsarequalifiedonthebasisofappropriateeducation,qualification,training,technicalknowledge,experience,and/ordemonstratedskills,asrequired.Allpersonnelunderstandthesignificanceof,andrespondto,deviationsfoundwithregardtothelaboratoryactivities.

6.2.2 XYZLaboratoryusespersonnelwhoarepermanentlyemployedby,orundercontractto,thelaboratory.TheTechnicalManagerensuresthatcontractual,additionaltechnicalemployeesandkeysupportpersonnelareadequatelysupervisedandworkinaccordancewiththelaboratory’smanagementsystem.

6.2.3 TheQualityManagermaintainscurrentjobdescriptionsformanagerial,technical,andkeysupportpersonnelinvolvedintests/calibrationsandlaboratoryoperations.Thisincludesduties,responsibilitiesandauthorities.

6.2.4 XYZLaboratoryhasadocumentedprocessfor,selecting,training;supervising;authorizing;andongoingmonitoringofpersonnelcompetencyinvolvedinlaboratoryactivities.Fordetails,refertotheTrainingProcedure.

7.0ProcessRequirements

7.1ReviewofRequests,Tenders,andContracts

7.1.1 TheContractReviewProcedureoutlinestheprocessesforreviewofrequests,tenders,orcontracts.Thisprocedureensuresthat:

therequirements,includingthemethodstobeused,areadequatelydefined,documented,andunderstood;

thelaboratoryhasthecapabilityandresourcestomeettherequirements,andwhereexternalprovidersarenecessary,therequirementsofclause6.6.2aresatisfied;

theappropriatetestand/orcalibrationmethodisselectedandcapableofmeetingthecustomer’srequirements

XYZlaboratoryinformsthecustomerwhenthemethodrequestedbythecustomerisdeterminedtobeinappropriateorobsolete.

7.1.2 Anydifferencesbetweentherequestortenderandthecontractareresolvedbeforeanyworkcommences.Eachcontractmustbeacceptabletoboththelaboratoryandthecustomer.Deviationsrequestedbythecustomermustnotjeopardizetheintegrityofthelaboratoryortheresults.

7.1.3 Therequest,tender,andcontractreviewisconductedinapracticalandefficientmanner,andtheeffectoffinancial,legal,andtimescheduleaspectsaretakenintoaccount.

7.1.4 XYZLaboratoryensuresthatlaboratoryactivitieswhichareexternallyprovidedmeetthecustomer’srequirementsandwhereapplicable,therelevantrequirementsoftheISO/IEC17025standard.

7.1.5 Recordsofreviews,includinganysignificantchanges,aremaintained.Thisincludespertinentdiscussionswithacustomerrelatingtothecustomer'srequirementsortheresultsofthework.

7.2Selection,Verification,andValidationofMethods

7.2.1 XYZLaboratoryusesappropriatemethodsandproceduresforalltestsand/orcalibrationswithinitsscopeincludingsampling,handling,transport,storage,andpreparationofitemstobetestedand/orcalibrated,andwhereappropriate,anestimationofthemeasurementuncertaintyaswellasstatisticaltechniquesforanalysisoftestand/orcalibrationdata.

TheXYZLaboratorymaintainsinstructionsontheuseandoperationofallrelevantequipment,andonthehandlingandpreparationofitemsfortestingand/orcalibration,orbothwheretheabsenceofsuchinstructionscouldjeopardizetheresultsoftestsand/orcalibrations.Allinstructions,standards,manuals,andreferencedatarelevanttotheworkofthelaboratoryaremaintainedcurrentandaremadereadilyavailabletopersonnel.Deviationfromtestandcalibrationmethodsoccuronlyifthedeviationisdocumented,technicallyjustified,authorized,andacceptedbythecustomer.

7.2.2 Methodsfortestand/orcalibration,includingmethodsforsampling,areselectedandusedtomeettheneedsofthecustomerandareappropriateforthetestsand/orcalibrationsundertaken.Methodspublishedasinternational,regional,ornationalstandardsareusedwheneverpossible.Thelatestvalideditionofastandardisusedunlessitisnotappropriateorpossibletodoso.Whennecessary,thestandardsaresupplementedwithadditionaldetailstoensureconsistentapplication.

7.2.3 ValidationofMethods

7.2.3.1 Validationofmethodsconfirmsthatparticularrequirementsforaspecificintendedusearefulfilled.

7.2.3.2 Allstandardandnon-standardtestmethodsandprocedures,andstandardmethodsusedoutsidetheirintendedscope(modifiedstandardsmethods),includingthosedevelopedbythelaboratoryarevalidatedtoensurethatsuchmethodsandproceduresarefitfortheintendeduseandarerelevanttotherequirementsofISO/IEC17025,aswellas,thecustomer.Validationisasextensiveasisnecessarytomeettheneedsofthegivenapplicationorfieldofapplication.

Ifchangesaremadetovalidatednon-standardmethods,theinfluenceofsuchchangesisdocumentedand,ifappropriate,anewvalidationiscarriedout.

Theresultsofsuchvalidationarerecordedtogetherwiththeprocedureutilizedandanyotherrelevantinformation.Therecordstateswhetherthemethodorprocedureisfitfortheintendeduse.

7.6EvaluationofMeasurementUncertainty

7.6.1 TheEstimationofUncertaintyofMeasurementProcedureisappliedtoallinhousecalibrations(includingthelaboratory’sownequipment).Theuncertaintyofmeasurementisavailableonthecertificateofanalysisorcalibrationcertificatefromasubcontractor.

7.6.2 TheEstimationofUncertaintyofMeasurementProcedureisappliedtoestimatinguncertaintyofallsamplingactivitiesandmeasurementintests,exceptwhenthetestmethodsmayprecluderigorouscalculations.Incertaincasesitisnotpossibletoundertakemetrologicallyandstatisticallyvalidestimationsofuncertaintyofmeasurement.Inthesecasesthelaboratoryattemptstoidentifyallthecomponentsofuncertaintyandmakethebestpossibleestimation,andensurethattheformofreportingdoesnotgiveanexaggeratedimpressionofaccuracy.Reasonableestimationisbasedonknowledgeoftheperformanceofthemethodandonthemeasurementscope,andmakesuseofpreviousexperience,qualitycontrolandvalidationdata.

7.10NonconformingWork

7.10.1 XYZLaboratoryhasestablishedandmaintainsaControlofNonconformingProduct/WorkProcedurethatisimplementedwhenanyaspectofitstestingand/orcalibrationwork,ortheresultsofthiswork,donotconformtoitsownproceduresortheagreedrequirementsofthecustomer.

Thepolicyandprocedureensuresthat:

theresponsibilitiesandauthoritiesforthemanagementofnonconformingworkaredefined;

actions,includinghaltingworkandwithholdingtestreportsandcalibrationcertificates,asnecessaryaredefinedandtakenwhennonconformingworkisidentified;

anevaluationismadeofthesignificanceofthenonconformingwork,includinganimpactanalysisonpreviousresults;

correctiveactionsaretakenimmediately,togetherwithanydecisionabouttheacceptabilityofthenonconformingwork;

wherenecessary,thecustomerisnotifiedandworkisrecalled;

theresponsibilityforauthorizingtheresumptionofworkisdefined;

nonconformingworkandactionsrequiredasspecifiedarerecorded

7.10.2 Identificationofnonconformingworkorproblemswiththemanagementsystemorwithtestingand/orcalibrationactivitiescanoccuratvariouspointswithinthemanagementsystemandtechnicaloperationssuchascustomercomplaints,qualitycontrol,instrumentcalibration,checkingofconsumablematerials,staffobservationsorsupervision,testreportandcalibrationcertificatechecking,managementreviews,andinternalorexternalaudits.

7.10.3 Wheretheevaluationindicatesthatthenonconformingworkcouldrecurorthatthereisdoubtaboutthecomplianceofthelaboratory'soperationswithitsownpoliciesandprocedures,theCorrectiveandPreventiveActionProcedureispromptlyfollowedtoidentifytherootcause(s)oftheproblemandtoeliminatethis(these)cause(s).

8.0ManagementRequirements

8.2ManagementSystemDocumentation

8.2.1 TheQualityManualistheprincipaldocumentthatdefinesthemanagementsystematXYZLaboratory.

TheXYZLaboratorymanagementsystemistailoredtoouroperations/processes,includingallcustomer,andapplicablestatutoryandregulatoryrequirements.Managementsystempolicies,objectives,procedures,instructions,andrecordsaredocumentedtoestablishandmaintaincontinuityofeachactivityorfunctionaffectingquality.QualityManagementensuresthatqualitydocumentationiscommunicatedto,understoodby,andreadilyavailabletoappropriatepersonnelforreferenceandimplementation.

XYZLaboratory‘smanagementsystem:

determinestheprocessesneededforthemanagementsystemandtheirapplicationthroughouttheorganization;

determinesthesequenceandinteractionoftheseprocesses(seeTable1);

determinescriteriaandmethodsrequiredtoensuretheeffectiveoperationandcontroloftheseprocesses;

ensurestheavailabilityofresourcesandinformationnecessarytosupporttheoperationandmonitoringoftheseprocesses;

monitors,measures,andanalyzestheseprocesses,andimplementsactionsnecessarytoachieveplannedresultsandcontinualimprovement

8.2.2 Managementsystempoliciesandobjectivesaredefinedinthisqualitymanualandtheoverallobjectivesofthelaboratoryaredocumentedinthequalitypolicy.

TheobjectivesareestablishedviatheManagementReviewProcedureandcommunicatedtoalllevelsoftheorg