______________________________________________________________________________________________________

Form# Issued:11/05 Rev.1.4

LF562k5 Revised:10/07 Page 1 of 52
ISO/IEC17025:2005
WORKINGDOCUMENT
NOTES:
1. ThisworkingdocumentisintendedasachecklistfortheassessorwhenconductingTestingandCalibration
LaboratoryAccreditationAssessmentsaccordingtoISO/IEC17025:2005.Thisstandardincorporatesall
elementsofISO9001/9002relevanttotestingandcalibrationlaboratories.
2. Pleasenoteinthe Comments columnanydeficienciesinthelaboratorysmanagementsystemidentifiedduringthe
assessment(seeitem#3).Theseobservationsmaybeusefulwhenpreparingtheassessmentreportandindicateto
thereviewerthatathoroughassessmentwasconducted.Itisalsoimperativetonoteevidenceofcompliance,
makingreferencetoprocedures/workinstructions,dates,andotherspecificobservations.
3. Donotrecommendspecificsolutionstodeficiencies,asthiswouldconstituteaconflictofinterest.
4. Assessthesystemonlytotherelevantstandardandtotherequestedscopeofaccreditation.Donotbeconcerned
withsystemrequirementsstemmingfrom:
Company orfacilityimposedpolicies
Regulatorybodies
Subcontractors
Othersources
5. Ifadditionalquestionsariseduringtheassessment,indicatethem(andtheappropriateresponses)eitherinthe
blankworkingdocumentpagesattheendofthisdocumentorintheemptyrowsincludedinsomeofthesections.
6. Pleasereadthequestionscarefully,asthepreferredanswerinsomecasesmaybenoornot
applicable.
7. If,atanytime,theassessmentteamrequiresassistanceintheinterpretationoftherequirementsof
ISO/IEC17025:2005,contactthePJLAofficeimmediately.
AssessmentNumber:_________________________Date(s):________________
Client:
Address:
Contact/ManagementRep.:
LeadAssessor:
AssessmentTeam:
(IncludeRAB/IRCAcertificatenumbers)
______________________________________________________________________________________________________
Form# Issued:11/05 Rev.1.4
LF562k5 Revised:10/07 Page 2 of 52
ISO
Req.
Characteristic Yes No
Commentsregarding
deficiencies/effectiveness
(ifapplicable)
MANAGEMENT REQUIREMENTS
4.1 Organization
4.1.1 Isthelaboratoryortheorganizationof
whichitispartanentitythatcanbeheld
legallyresponsible?
4.1.2 Doesthelaboratoryupholditsresponsibility
tocarryoutitstestingandcalibration
activitiesinsuchawayastomeetthe
requirementsofthisstandard?
Doesthelaboratorycarryoutitstestingand
calibrationactivitiesinsuchawayasto
meettherequirementsofthecustomer,the
regulatoryauthoritiesororganizations
providingrecognition?
4.1.3 Doesthemanagementsystemcoverwork
carriedoutinthelaboratoryspermanent
facilities,atsitesawayfromitspermanent
facilities,orinassociatedtemporaryor
mobilefacilities?
4.1.4 Ifthelaboratoryispartofanorganization
performingactivitiesotherthantesting
and/orcalibration,aretheresponsibilitiesof
keypersonnelintheorganizationthathave
aninvolvementorinfluenceonthetesting
and/orcalibrationactivitiesdefinedinorder
toidentifypotentialconflictsofinterest?
4.1.5 Doesthelaboratory(aj):
a) havemanagerialandtechnicalpersonnel
withtheauthorityandresourcesneeded
to:
performtheirduties?
identifydeparturesfromthe
managementsystemorfromthe
proceduresforperformingtestsand/or
calibrations?
initiateactionstopreventorminimize
suchdepartures?
implement,maintainandimprovethe
managementsystemirrespectiveof
otherresponsibilities?
______________________________________________________________________________________________________
Form# Issued:11/05 Rev.1.4
LF562k5 Revised:10/07 Page 3 of 52
ISO
Req.
Characteristic Yes No
Commentsregarding
deficiencies/effectiveness
(ifapplicable)
4.1.5 b) havearrangementstoensurethatits
management&personnelarefreefrom
anyundueinternalandexternal
commercial,financialandotherpressures
thatmayadverselyaffectthequalityof
theirwork?
4.1.5 c) havepoliciesandprocedurestoensurethe
protectionofitscustomersconfidential
informationandproprietaryrights,
includingproceduresforprotectingthe
electronicstorageandtransmissionof
results?
4.1.5 d) havepoliciesandprocedurestoavoid
involvementinanyactivitiesthatwould
diminishconfidenceinitscompetence,
impartiality,judgmentoroperational
integrity?
4.1.5 e) definetheorganizationandmanagement
structureofthelaboratory,itsplaceinany
parentorganization,andtherelationships
betweenqualitymanagement,technical
operationsandsupportservices?
4.1.5 f) specifytheresponsibility,authority,and
interrelationofallpersonnelwhomanage,
performorverifyworkaffectingthe
qualityoftestsand/orcalibrations?
4.1.5 g) provideadequatesupervisionoftesting
andcalibrationstaff,includingtrainees,by
personsfamiliarwith methodsand
procedures,thepurposeofeachtestand/or
calibrationandtheassessmentofthe
results?
4.1.5 h) havetechnicalmanagementwithoverall
responsibilityforthetechnicaloperations
andtheprovisionofresourcesneededto
ensuretherequiredqualityoflaboratory
operations?
______________________________________________________________________________________________________
Form# Issued:11/05 Rev.1.4
LF562k5 Revised:10/07 Page 4 of 52
ISO
Req.
Characteristic Yes No
Commentsregarding
deficiencies/effectiveness
(ifapplicable)
4.1.5 i) appointamemberofstaffasquality
manager(howevernamed)?
doesthisqualitymanagerhavedefined
responsibilityandauthorityforensuring
thatthemanagementsystemis
implementedandfollowedatalltimes?
doesthisqualitymanagerhavedirect
accesstothehighestlevelof
managementatwhichdecisionsare
madeonlaboratorypolicyorresources?
4.1.5 j) appointdeputiesforkeymanagerial
personnel?
4.1.5 k) ensurethatpersonnelareawareofthe
relevanceandimportanceoftheir
activitiesandhowtheycontributeto
overallmanagementsystemgoals?
4.1.6 Doestopmanagementensurethat
communicationprocessesareestablished
andthatcommunicationregardingthe
effectivenessofthemanagementsystem
takesplace?
4.2 Managementsystem
4.2.1 Appropriatetothescopeofitsactivities,has
thelaboratory:
established
implemented
maintained
amanagementsystem?
Arethepolicies,systems,programs,
proceduresandinstructionsofthissystem
documentedtotheextentnecessaryto
assurethequalityofthetestand/or
calibrationresults?
Isthesystemdocumentationcommunicated
to, understoodby,availableto,and
implementedbytheappropriatepersonnel?
4.2.2 Arethelabsmanagementsystempolicies
andobjectivesdefinedinaqualitymanual
(howevernamed)?
______________________________________________________________________________________________________
Form# Issued:11/05 Rev.1.4
LF562k5 Revised:10/07 Page 5 of 52
ISO
Req.
Characteristic Yes No
Commentsregarding
deficiencies/effectiveness
(ifapplicable)
4.2.2 Aretheobjectivesestablishedandreviewed
duringmanagementreview?
4.2.2 Aretheoverallobjectivesdocumentedina
qualitypolicystatement?
4.2.2 Hasthequalitypolicystatementbeenissued
undertheauthorityoftopmanagement?
4.2.2 Doesthequalitypolicystatementincludeat
leastthefollowing(ae):
a) thelaboratorymanagements
commitmenttogoodprofessional
practiceandtothequalityofitstesting
andcalibrationinservicingits
customers?
4.2.2 b) themanagementsstatementofthe
laboratorysstandardofservice?
4.2.2 c) thepurposeofthemanagementsystem
relatedtoquality?
4.2.2 d) arequirementthatallpersonnel
concernedwithtestingandcalibration
activitieswithin thelabfamiliarize
themselveswiththequality
documentationandimplementthe
policiesandproceduresintheirwork?
4.2.2 e) thelaboratorymanagements
commitmenttocompliancewiththis
standardandtocontinuallyimprovethe
effectivenessofthe management
system?
4.2.2 NOTE:Thequalitypolicystatementshould
beconciseandmayincludetherequirement
thattestsand/orcalibrationsshallalwaysbe
carriedoutinaccordancewithstated
methodsandcustomersrequirements.
4.2.3 Hastopmanagementprovidedevidenceof
commitmenttothedevelopmentand
implementationofthemanagementsystem
andtocontinuallyimprovingits
effectiveness?
______________________________________________________________________________________________________
Form# Issued:11/05 Rev.1.4
LF562k5 Revised:10/07 Page 6 of 52
ISO
Req.
Characteristic Yes No
Commentsregarding
deficiencies/effectiveness
(ifapplicable)
4.2.4 Hastopmanagementcommunicatedtothe
organizationtheimportanceofmeeting
customer,statutoryandregulatory
requirements?
4.2.5 Doesthequalitymanualincludeormake
referencetosupportingandtechnical
proceduresanddoesitoutlinethestructure
ofthedocumentationusedinthe
managementsystem?
4.2.6 Doesthequalitymanualdefinetherolesand
responsibilitiesofthetechnicalandquality
managers,includingtheroleswhichensure
compliancewiththisstandard?
4.2.7 HasTopManagementensuredthatthe
integrityofthemanagementsystemis
maintainedwhenchangesareplannedand
implemented?
4.3 DocumentControl
4.3.1 Hasthelaboratoryestablishedproceduresto
controlalldocumentsthatformpartofits
managementsystem (internallygeneratedor
fromexternalsources)suchasregulations,
standards,othernormativedocuments,test
and/orcalibrationmethods,aswellas
drawings,software,specifications,
instructionsandmanuals?
Doesthelaboratorymaintainproceduresto
controltheabovedocuments?
4.3.2.1 Arealldocumentsissuedtolaboratory
personnelaspartofthemanagementsystem
reviewedandapprovedforusedby
authorizedpersonnelpriortoissue?
4.3.2.1 Isthereamasterlist(orequivalent
procedure) identifyingthecurrentrevision
statusanddistributionofdocumentsinthe
managementsystem?
Isthismasterlistreadilyavailableto
precludetheusedofinvalidand/orobsolete
documents?
______________________________________________________________________________________________________
Form# Issued:11/05 Rev.1.4
LF562k5 Revised:10/07 Page 7 of 52
ISO
Req.
Characteristic Yes No
Commentsregarding
deficiencies/effectiveness
(ifapplicable)
4.3.2.2 Doestheadoptedprocedureensurethat
(ad):
a) authorizededitionsofappropriate
documentsareavailableatalllocations
whereoperationsessentialtothe
effectivefunctioningofthelaboratory
areperformed?
4.3.2.2 b) documentsareperiodicallyreviewedand
wherenecessary,revisedtoensure
continuingsuitabilityandcompliance
withapplicablerequirements?
4.3.2.2 c) invalidorobsoletedocumentsare
promptlyremovedfromallpointsof
issueor use,orotherwiseassured
againstunintendeduse?
4.3.2.2 d) obsoletedocumentsretainedforeither
legalorknowledgepreservation
purposesaresuitablymarked?
4.3.2.3 Aremanagementsystemdocuments
generatedbythelaboratoryuniquely
identified?
Doesthisidentificationincludethedateof
issueand/orrevisionidentification,page
numbering,thetotalnumberofpagesora
marktosignifytheendofthedocument,and
theissuingauthority(ies)?
4.3.3.1 Arechangestodocumentsreviewedand
approvedbythesamefunctionthat
performedtheoriginalreviewunless
specificallydesignatedotherwise?
Dodesignatedpersonnelhaveaccessto
pertinentbackgrounduponwhichtobase
theirreviewandapproval?
4.3.3.2 Wherepracticable,isthealteredornewtext
identifiedinthedocumentortheappropriate
attachments?
______________________________________________________________________________________________________
Form# Issued:11/05 Rev.1.4
LF562k5 Revised:10/07 Page 8 of 52
ISO
Req.
Characteristic Yes No
Commentsregarding
deficiencies/effectiveness
(ifapplicable)
4.3.3.3 Ifthelaboratorysdocumentcontrolsystem
allowsfortheamendment ofdocumentsby
handpendingthereissueofthedocuments,
aretheproceduresandauthoritiesdefined?
Areamendmentsclearly:
marked?
initialed?
dated?
4.3.3.3 Isareviseddocumentformallyreissuedas
soonaspracticable?
4.3.3.4 Areproceduresestablishedtodescribehow
changesindocumentsmaintainedin
computerizedsystemsaremadeand
controlled?
4.4 ReviewofRequests,TendersandContracts
4.4.1 Hasthelaboratoryestablishedprocedures
forthereviewofrequests,tenders and
contracts?
Aretheseproceduresmaintained?
4.4.1 Dothepoliciesandproceduresforthese
reviewsleadingtoacontractfortesting
and/orcalibrationensurethat(ac):
a) therequirements,includingthemethods
tobeused,areadequatelydefined,
documentedandunderstood?
4.4.1 b) thelaboratoryhasthecapabilityand
resourcestomeettherequirements?
4.4.1 c) theappropriatetestand/orcalibration
methodisselectedandcapableof
meetingthecustomersrequirements?
4.4.1 Areany differencesbetweentherequestor
tenderandthecontractresolvedbeforeany
workcommences?
Iseachcontractacceptabletoboththe
laboratoryandthecustomer?
______________________________________________________________________________________________________
Form# Issued:11/05 Rev.1.4
LF562k5 Revised:10/07 Page 9 of 52
ISO
Req.
Characteristic Yes No
Commentsregarding
deficiencies/effectiveness
(ifapplicable)
4.4.2 Arerecordsofreviews,includingany
significantchanges,maintained?
Arerecordsmaintainedofpertinent
discussionswithacustomerrelatingtothe
customersrequirementsortheresultsofthe
workduringtheperiodofcontract
execution?
NOTE:Forreviewofroutineandother
simpletasks,thedateandidentification(e.g.
initials)ofpersonresponsibleforcarrying
outtheworkareadequate.Forrepetitive
routinetasks,thereviewneedonlybemade
attheinitialinquirystageor ongrantingof
thecontractforongoingroutinework,
providedthatthecustomersrequirements
remainunchanged.Forneworcomplex
tasks,amorecomprehensiverecordshould
bemaintained.
4.4.3 Doesthereviewalsocoveranyworkthatis
subcontractedbythelaboratory?
4.4.4 Isthecustomerinformedofanydeviation
fromthecontract?
4.4.5 Ifacontractneedstobeamendedafterwork
hascommenced,isthesamecontractreview
processrepeated?
Areanyamendmentscommunicatedtoall
affectedpersonnel?
4.5 SubcontractingofTestsandCalibrations
4.5.1 Whenalaboratorysubcontractswork,
whetherbecauseofunforeseenreasons
(workload,needforfurtherexpertiseor
temporaryincapacity)oronacontinuing
basis(permanentsubcontracting,agencyor
franchisingarrangements),isthiswork
placedwithacompetentsubcontractor?
Acompetentsubcontractorisonewho
complieswiththisstandardfortheworkin
question.
______________________________________________________________________________________________________
Form# Issued:11/05 Rev.1.4
LF562k5 Revised:10/07 Page 10 of 52
ISO
Req.
Characteristic Yes No
Commentsregarding
deficiencies/effectiveness
(ifapplicable)
4.5.2 Doesthelaboratoryadvisethecustomerof
thearrangementinwriting?
Whenappropriate,doesthelaboratorygain
theapprovalofthecustomer,preferablyin
writing?
4.5.3 Doesthelaboratoryshowresponsibilityto
thecustomerforthesubcontractorswork,
exceptinthecasewherethecustomerora
regulatoryauthorityspecifieswhich
subcontractoristobeused?
4.5.4 Doesthelaboratorymaintainaregisterofall
subcontractorsthatitusesfortestsand/or
calibrations?
Doesthelaboratorymaintainarecordof
evidenceofcompliancewiththisstandard
fortheworkinquestion?
4.6 PurchasingServicesandSupplies
4.6.1 Doesthelaboratoryhaveapolicyand
procedure(s)fortheselectionand
purchasing ofservicesandsuppliesituses
thataffectthequalityofthetestsand/or
calibrations?
Doproceduresexistforthepurchase,
receptionandstorageofreagentsand
laboratoryconsumablematerialsrelevantfor
thetestsandcalibrations?
4.6.2 Does thelaboratoryensurethatpurchased
supplies,reagentsandconsumablematerials
affectingthequalityoftestsand/or
calibrationsarenotuseduntiltheyhave
beeninspectedorotherwiseverifiedas
complyingwithstandardspecificationsor
requirements definedinthemethodsforthe
testsand/orcalibrationsconcerned?
4.6.2 Aretheservicesandsuppliesused
compliantwithspecifiedrequirements?
Arerecordsmaintainedofactiontakento
checkcompliance?
______________________________________________________________________________________________________
Form# Issued:11/05 Rev.1.4
LF562k5 Revised:10/07 Page 11 of 52
ISO
Req.
Characteristic Yes No
Commentsregarding
deficiencies/effectiveness
(ifapplicable)
4.6.3 Dopurchasingdocumentsforitems
affectingthequalityoflaboratoryoutput
containdatadescribingtheservicesand
suppliesordered?
Arethesepurchasingdocumentsreviewed
andapprovedfortechnicalcontentpriorto
release?
4.6.4 Doesthelaboratoryevaluatesuppliersof
criticalconsumables,suppliesandservices
thataffectthequalityoftestingand
calibration?
4.6.4 Arerecordsmaintainedofthese
evaluations?
Dotheylistthoseapproved?
4.7 ServicetotheCustomer
4.7.1 Doesthelaboratoryaffordcustomersor
theirrepresentativescooperationtoclarify
thecustomersrequestandinmonitoringthe
laboratorysperformanceinrelationtothe
workperformed,providedthatthe
laboratoryensuresconfidentialitytoother
customers?
NOTES:Suchcooperationmayincludea)
providingreasonableaccessforthe
witnessingoftestsand/orcalibrationsand
b)preparation,packaginganddispatchof
testand/orcalibrationitemsneededbythe
customerforverificationpurposes.
Communicationwiththecustomer,
especiallyinlargeassignments,shouldbe
maintainedthroughoutthework.Thelab
shouldinformthecustomerofanydelaysor
majordeviations.
4.7.2 Doesthelaboratoryseekbothpositiveand
negativefeedbackandisthefeedbackused
toimprovethemanagementsystem,testing
andcalibrationactivitiesandcustomer
service?
______________________________________________________________________________________________________
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LF562k5 Revised:10/07 Page 12 of 52
ISO
Req.
Characteristic Yes No
Commentsregarding
deficiencies/effectiveness
(ifapplicable)
4.8 Complaints
Doesthelaboratoryhaveapolicyand
procedurefortheresolutionofcomplaints
receivedfromcustomersorotherparties?
Arerecordsmaintainedofallcomplaints
andoftheinvestigationsandcorrective
actionstaken?
4.9 ControlofNonconformingTestingand/orCalibrationWork
4.9.1 Doesthelaboratoryhaveapolicyand
proceduresthatareimplementedwhenany
aspectofitstestingand/orcalibrationwork,
ortheresultsofthiswork,donotconformto
itsownproceduresortheagreed
requirementsofthecustomer?
4.9.1 Dothepolicyandproceduresensurethat(a
e):
a) theresponsibilitiesandauthoritiesfor
themanagementofnonconformingwork
aredesignatedandactions(including
haltingofworkandwithholdingoftest
reportsandcalibrationcertificates,as
necessary)aredefinedandtakenwhen
nonconformingwork isidentified?
4.9.1 b) anevaluationofthesignificanceofthe
nonconformingworkismade?
4.9.1 c) correctionistakenimmediately,together
withanydecisionabouttheacceptability
ofthenonconformingwork?
4.9.1 d) wherenecessary,the customerisnotified
andworkisrecalled?
4.9.1 e) theresponsibilityforauthorizingthe
resumptionofworkisdefined?
______________________________________________________________________________________________________
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LF562k5 Revised:10/07 Page 13 of 52
ISO
Req.
Characteristic Yes No
Commentsregarding
deficiencies/effectiveness
(ifapplicable)
4.9.2 Wheretheevaluationindicatesthatthe
nonconformingworkcouldrecurorthat
thereisdoubtaboutthecomplianceofthe
laboratorysoperationswithitsownpolicies
andprocedures,arethecorrectiveaction
procedurespromptlyfollowed?
4.10 Improvement
Hasthelaboratoryimprovedthe
effectivenessofitsmanagementsystem
throughtheuseofthequalitypolicy,quality
objectives,auditresults,analysisofdata,
correctiveandpreventiveactionsand
managementreview?
______________________________________________________________________________________________________
Form# Issued:11/05 Rev.1.4
LF562k5 Revised:10/07 Page 14 of 52
ISO
Req.
Characteristic Yes No
Commentsregarding
deficiencies/effectiveness
(ifapplicable)
4.11 CorrectiveAction
4.11.1 Hasthelaboratoryestablishedapolicyand
procedureforimplementingcorrective
actionwhennonconformingworkor
departuresfromthepoliciesandprocedures
inthemanagementsystemortechnical
operationshavebeenidentified?
Hasthelaboratorydesignatedappropriate
authoritiesforimplementingcorrective
actionintheabovesituations?
4.11.2 Doestheprocedureforcorrectiveaction
startwithaninvestigationtodeterminethe
rootcause(s)oftheproblem?
4.11.3 Wherecorrectiveactionisneeded,doesthe
laboratoryidentifypotentialcorrective
actions?
Doesthelaboratoryselectandimplement
theaction(s)mostlikelytoeliminatethe
problemandtoprevent recurrence?
4.11.3 Arecorrectiveactionstoadegree
appropriatetothemagnitudeandriskofthe
problem?
4.11.3 Doesthelaboratorydocumentand
implementanyrequiredchangesresulting
formcorrectiveactioninvestigations?
4.11.4 Doesthe laboratorymonitortheresultsto
ensurethatthecorrectiveactionstakenhave
beeneffective?
4.11.5 Wheretheidentificationofnonconformities
ordeparturescastsdoubtonthelaboratorys
compliancewithitsownpoliciesand
procedures,oronits compliancewiththis
standard,doesthelaboratoryensurethatthe
appropriateareasofactivityareauditedin
accordancewith4.14assoonaspossible?
NOTE:Anadditionalauditshouldbe
necessaryonlywhenaseriousissueorrisk
tothebusinessisidentified.
______________________________________________________________________________________________________
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ISO
Req.
Characteristic Yes No
Commentsregarding
deficiencies/effectiveness
(ifapplicable)
4.12 PreventiveAction
4.12.1 Areneededimprovementsandpotential
sourcesofnonconformities,eithertechnical
orconcerningthemanagementsystem,
identified?
4.12.2 Ifpreventiveactionisrequired,areaction
plans:
developed
implemented
andmonitored
toreducethelikelihoodoftheoccurrenceof
suchnonconformitiesandtotakeadvantage
oftheopportunitiesforimprovement?
4.12.2 Doproceduresforpreventiveactionsinclude
theinitiationofsuchactionsandapplication
ofcontrolstoensurethattheyareeffective?
4.13 ControlofRecords
4.13.1.1 Hasthelaboratoryestablishedprocedures
for:
identification
collection
indexing
access
filing
storage
maintenance
disposal
ofallqualityandtechnicalrecords?
Doesthelaboratorymaintainthese
procedures?
4.13.1.1 Dothequalityrecordsincludereportsfrom
internalauditsandmanagementreviewsas
wellasrecordsofcorrectiveandpreventive
actions?
______________________________________________________________________________________________________
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ISO
Req.
Characteristic Yes No
Commentsregarding
deficiencies/effectiveness
(ifapplicable)
4.13.1.2 Areallrecordslegible?
Areallrecordsretainedinsuchawaythat
theyarereadilyretrievableinfacilitiesthat
provideasuitableenvironmenttoprevent
damageordeteriorationandtopreventloss?
Aretheretentiontimesestablished?
4.13.1.3 Areallrecordsheldsecureandin
confidence?
4.13.1.4 Doesthelaboratoryhaveproceduresto
protectandbackuprecordsstored
electronicallyandtopreventunauthorized
accesstooramendmentoftheserecords?
4.13.2.1 Doesthelaboratoryretainrecordsof
originalobservations,deriveddataand
sufficientinformationtoestablish anaudit
trail,calibrationrecords,staffrecordsanda
copyofeachtestreportorcalibration
certificateissued,foradefinedperiod?
NOTE:Incertainfieldsitmaybe
impossibleorimpracticaltoretainrecords
ofalloriginalobservations.
4.13.2.1 Dotherecordsforeachtestorcalibration
containsufficientinformationtofacilitate,if
possible,identificationoffactorsaffecting
theuncertaintyandtoenablethetestor
calibrationtoberepeatedunderconditions
ascloseaspossibletotheoriginal?
4.13.2.1 Dotherecordsincludetheidentityof
personnelresponsibleforthe
sampling?
performanceofeachtestand/or
calibration?
andcheckingofresults?
4.13.2.2 Areobservations,dataandcalculations
recordedatthetimetheyaremade?
Aretheyidentifiabletothespecifictask?
______________________________________________________________________________________________________
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LF562k5 Revised:10/07 Page 17 of 52
ISO
Req.
Characteristic Yes No
Commentsregarding
deficiencies/effectiveness
(ifapplicable)
4.13.2.3 Whenmistakesoccurinrecords,iseach
mistakecrossedout,noterased,made
illegibleordeleted,andthecorrectvalue
enteredalongside?
Areallsuchalterationstorecordssignedor
initialedbythepersonmakingthe
correction?
Inthecaseofelectronicrecords,are
equivalentmeasurestakentoavoidlossor
changeoforiginaldata?
4.14 InternalAudits
4.14.1 Doesthelaboratoryperiodically,in
accordancewithapredeterminedschedule
andprocedure,conductinternalauditsofits
activitiestoverifythatitsoperations
continuetocomplywiththerequirementsof
themanagementsystemandthisstandard?
NOTE:Thecycleforinternalauditing
shouldnormallybecompletedinoneyear.
4.14.1 Doestheinternalauditprogramaddressall
elementsofthemanagementsystem,
includingthetestingand/orcalibration
activities?
4.14.1 Isittheresponsibilityofthequality
managertoplanandorganizeauditsas
requiredbythescheduleandrequestedby
management?
Aresuchauditsperformedbytrained
personnelwhoare,whereverresources
permit,independentoftheactivitytobe
audited?
4.14.2 Whenauditfindingscastdoubtonthe
effectivenessoftheoperationsoronthe
correctnessorvalidityofthelaboratorys
testorcalibrationresults,doesthe
laboratorytaketimelycorrectiveaction?
Doesthelaboratorynotifycustomersin
writingifinvestigationsshowthatthe
laboratoryresultsmayhavebeenaffected?
______________________________________________________________________________________________________
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ISO
Req.
Characteristic Yes No
Commentsregarding
deficiencies/effectiveness
(ifapplicable)
4.14.3 Arethefollowingrecorded:
areaofactivityaudited?
auditfindings?
correctiveactionsthatarise?
4.14.4 Dofollowupauditactivitiesverifyand
recordtheimplementationandeffectiveness
ofthecorrectiveactiontaken?
4.15 ManagementReviews
4.15.1 Inaccordancewithapredeterminedschedule
andprocedure,doesthelaboratorystop
managementperiodicallyconductareview
ofthelaboratorysmanagementsystemand
testingand/orcalibrationactivitiestoensure
theircontinuingsuitabilityand
effectiveness,andtointroducenecessary
changesorimprovements?
4.15.1 Doesthereviewtakeaccountof:
thesuitabilityofpoliciesandprocedures?
reportsfrommanagerialandsupervisory
personnel?
theoutcomeofrecentinternalaudits?
correctiveandpreventiveactions?
assessments byexternalbodies?
theresultsofinterlaboratorycomparisons
orproficiencytests?
changesinthevolumeandtypeofwork?
customerfeedback?
complaints?
recommendationsforimprovement?
otherrelevantfactors,suchasquality
controlactivities,resourcesandstaff
training?
NOTE:AtypicalperiodforMRisonce
every12months.
4.15.2 Arefindingsfrommanagementreviewsand
ensuingactionsrecorded?
Doesmanagementensurethatthoseactions
arecarriedoutwithinanappropriateand
agreedtimescale?
______________________________________________________________________________________________________
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LF562k5 Revised:10/07 Page 19 of 52
ISO
Req.
Characteristic Yes No
Commentsregarding
deficiencies/effectiveness
(ifapplicable)
TECHNICALREQUIREMENTS
5.1 General
5.1.1 Manyfactorsdeterminethecorrectnessand
reliabilityofthetestsand/orcalibrations
performedbyalaboratory.Thesefactors
include:
humanfactors
accommodationandenvironmental
conditions
testandcalibrationmethodsandmethod
validation
equipment
measurementtraceability
sampling
handlingoftestandcalibrationitems
5.1.2 Theextenttowhichthefactorscontributeto
thetotaluncertaintyofmeasurementdiffers
considerablybetween(typesof)testsand
calibrations.
Doesthelaboratorytakeaccountofthese
factorsindeveloping:
testandcalibrationmethodsand
procedures?
trainingandqualificationofpersonnel?
selectionandcalibrationoftheequipment
ituses?
5.2 Personnel(Notrequiredforsurveillanceunlesscriticalchangeshaveoccurred)
5.2.1 Doesthelaboratorymanagementensurethe
competenceofallwho:
operatespecificequipment?
performtestsand/orcalibrations?
evaluateresults?
signtestreportsandcalibration
certificates?
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LF562k5 Revised:10/07 Page 20 of 52
ISO
Req.
Characteristic Yes No
Commentsregarding
deficiencies/effectiveness
(ifapplicable)
5.2.1 NOTE:Thepersonnelresponsibleforthe
opinionsandinterpretationintestreports
should,inadditiontotheappropriate
qualifications,training,experienceand
satisfactoryknowledgeofthetesting,also
haverelevantknowledgeofthetechnology
usedforthemanufacturingoftheitems,
materials,products,etc.tested,ortheway
theyareusedorintendedtobeused,andof
thedefectsordegradationswhichmayoccur
duringorinserviceknowledgeofthe
generalrequirementsexpressedinthe
legislation andstandardsunderstandingof
thesignificanceofdeviationsfoundwith
regardtothenormaluseoftheitems
concerned.
5.2.1 Whenusingstaffundergoingtraining,is
appropriatesupervisionprovided?
5.2.1 Arethosepersonnelperformingspecific
tasksqualifiedonthebasisofappropriate
education,training,experienceand/or
demonstratedskills,asrequired?
5.2.2 Doesthelaboratorymanagementformulate
thegoalswithrespecttotheeducation,
trainingandskillsofthelaboratory
personnel?
5.2.2 Doesthelaboratoryhaveapolicyand
proceduresforidentifyingtrainingneedsand
providingtrainingofpersonnel?
5.2.2. Isthetrainingprogramrelevanttothe
laboratoryspresentandanticipatedtasks?
5.2.2 Istheeffectivenessofthetrainingactions
takenevaluated?
5.2.3 Doesthelaboratoryusepersonnelwhoare
employedby,orundercontractto,the
laboratory?
Wherecontractedandadditionaltechnical
andkeysupportpersonnelareused,doesthe
laboratoryensurethat suchpersonnelare
supervisedandcompetentandthatthey
workinaccordancewiththelaboratorys
______________________________________________________________________________________________________
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LF562k5 Revised:10/07 Page 21 of 52
ISO
Req.
Characteristic Yes No
Commentsregarding
deficiencies/effectiveness
(ifapplicable)
managementsystem?
______________________________________________________________________________________________________
Form# Issued:11/05 Rev.1.4
LF562k5 Revised:10/07 Page 22 of 52
ISO
Req.
Characteristic Yes No
Commentsregarding
deficiencies/effectiveness
(ifapplicable)
5.2.4 Doesthelaboratorymaintaincurrentjob
descriptionsforthefollowingtypesof
personnelinvolvedintestsand/or
calibrations:
managerial?
technical?
keysupport?
NOTE:Jobdescriptions,asaminimum,
shoulddefine:
responsibilitiesforperforming
tests/calibrations
responsibilitiesforplanningand
evaluationofresultsoftests/calibrations
responsibilitiesforreporting
interpretations
responsibilitiesformethodmodifications
anddevelopmentandvalidationofnew
methods
expertise/experiencerequired
qualifications/trainingprograms
managerialduties
5.2.5 Doesthemanagementauthorizespecific
personnelto:
performparticulartypesofsampling,test
and/orcalibration?
toissuetestreportsandcalibration
certificates?
togiveopinionsandinterpretations?
tooperateparticulartypesofequipment?
5.2.5 Doesthelaboratorymaintainrecordsofthe
relevantauthorization(s),competence,
educationalandprofessionalqualifications,
training,skillsandexperienceofall
technicalpersonnel,includingcontracted
personnel?
Isthisinformationreadilyavailable?
Doesitincludethedateonwhich
authorizationand/orcompetencewas
confirmed?
______________________________________________________________________________________________________
Form# Issued:11/05 Rev.1.4
LF562k5 Revised:10/07 Page 23 of 52
ISO
Req.
Characteristic Yes No
Commentsregarding
deficiencies/effectiveness
(ifapplicable)
5.3 AccommodationandEnvironmentalConditions
5.3.1 Arelaboratoryfacilitiesfortestingand/or
calibration,includingbutnotlimitedto
energysources,lightingandenvironmental
conditions,suchastofacilitatecorrect
performanceofthetestsand/orcalibrations?
5.3.1 Doesthelaboratoryensurethatthe
environmentalconditionsdonotinvalidate
theresultsoradverselyaffecttherequired
qualityofanymeasurement?
5.3.1 Isparticularcaretakenwhensamplingand
testsand/orcalibrationsareundertakenat
sitesotherthanapermanentlaboratory
facility?
5.3.1 Arethetechnicalrequirementsfor
accommodationandenvironmental
conditionsthatcanaffecttheresultsoftests
andcalibrationsdocumented?
5.3.2 Doesthelaboratory:
monitor?
control?
andrecord?
environmentalconditionsasrequiredbythe
relevantspecifications,methodsand
proceduresorwheretheyinfluencethe
qualityofresults?
5.3.2 Isdueattentionpaid,forexample,to
biologicalsterility,dust,electromagnetic
disturbances,radiation,humidity,electrical
supply,temperature,andsound/vibration
levels,asappropriatetothetechnical
activitiesconcerned?
5.3.2 Aretestsandcalibrationsstoppedwhenthe
environmentalconditionsjeopardizethe
resultsoftestsand/orcalibrations?
5.3.3 Isthereeffectiveseparationbetween
neighboringareasinwhichthereare
incompatibleactivities?
Aremeasurestakentopreventcross
contamination?
______________________________________________________________________________________________________
Form# Issued:11/05 Rev.1.4
LF562k5 Revised:10/07 Page 24 of 52
ISO
Req.
Characteristic Yes No
Commentsregarding
deficiencies/effectiveness
(ifapplicable)
5.3.4 Areaccesstoanduseofareasaffectingthe
qualityofthetestsand/orcalibrations
controlled?
Hasthelaboratorydeterminedtheextentof
controlbasedonitsparticular
circumstances?
5.3.5 Aremeasurestakentoensuregood
housekeepinginthelaboratory?
Arespecialprocedurespreparedwhere
necessary?
5.4 TestandCalibrationMethodsandMethodValidation
5.4.1 Doesthelaboratoryuseappropriate
methodsandproceduresforalltestsand/or
calibrationswithinitsscope?
Theseincludesampling,handling,transport,
storageandpreparationofitemstobetested
and/orcalibrated,andwhereappropriate,an
estimationofthemeasurementuncertainty
aswellasstatisticaltechniquesforanalysis
oftest and/orcalibrationdata.
5.4.1 Doesthelaboratoryhaveinstructionsonthe
operationofallrelevantequipment,andon
thehandlingandpreparationofitemsfor
testingand/orcalibrationwheretheabsence
ofsuchinstructionscouldjeopardizethe
resultsoftestsand/orcalibration?
5.4.1 Areallinstructions,standards,manualsand
referencedatarelevanttothelaboratorys
workkeptuptodateandmadeavailableto
personnel?
5.4.1 Doesdeviationfromtestandcalibration
methodsoccurONLY ifthedeviationhas
been:
documented?
technicallyjustified?
authorized?
acceptedbythecustomer?
______________________________________________________________________________________________________
Form# Issued:11/05 Rev.1.4
LF562k5 Revised:10/07 Page 25 of 52
ISO
Req.
Characteristic Yes No
Commentsregarding
deficiencies/effectiveness
(ifapplicable)
5.4.2 Doesthelaboratoryusetestand/or
calibrationmethods,includingmethodsfor
sampling,whichmeettheneedsofthe
customer?
Arethesemethodsappropriateforthetests
and/orcalibrationstheyundertake?
5.4.2 Aremethodspublishedininternational,
regionalornationalstandardspreferably
used?
Doesthelaboratoryensurethatitusesthe
latestvalideditionofastandardunlessitis
notappropriateorpossibletodoso?
Isthestandardsupplementedwithadditional
detailstoensureconsistentapplication?
5.4.2 Whenthecustomer doesnotspecifythe
method,doesthelaboratoryselect
appropriatemethodsthathavebeen
publishedeitherininternational,national
standards,bytechnicalorganizations,in
relevantscientifictextsorjournals,oras
specifiedbythemanufacturersof the
equipment?
Iftheabovedoesnotapply,arethe
laboratorydevelopedmethodsormethods
adoptedbythelaboratoryappropriatefor
theintendeduseandvalidated?
5.4.2 Isthecustomerinformedastothemethod
chosen?
5.4.2 Isthelaboratory abletoconfirmthatitcan
properlyoperatestandardmethodsbefore
introducingthetestsorcalibrations?
Ifthestandardmethodchanges,isthe
confirmationrepeated?
5.4.2 Doesthelaboratoryinformthecustomer
whenthemethodproposedbythecustomer
isconsideredinappropriateoroutofdate?
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LF562k5 Revised:10/07 Page 26 of 52
ISO
Req.
Characteristic Yes No
Commentsregarding
deficiencies/effectiveness
(ifapplicable)
5.4.3 Istheintroductionoftestandcalibration
methodsdevelopedbythelaboratoryforits
ownuseaplannedactivity?
Istheintroductionassignedtoqualified
personnelequippedwithadequate
resources?
5.4.3 Areplansupdatedasdevelopment
proceeds?
Iseffectivecommunicationamongstall
personnelinvolvedensured?
5.4.4 Whenitisnecessary tousemethodsnot
coveredbystandardmethods,arethese
subjecttoagreementwiththecustomer?
Dotheyincludeaclearspecificationofthe
customersrequirementsandthepurposeof
thetestand/orcalibration?
Hadthemethoddevelopedbeenvalidated
appropriatelybeforeuse?
5.4.4 NOTE:Fornewtestand/orcalibration
methods,proceduresshouldbedeveloped
priortothetestsand/orcalibrationsbeing
performedandshouldcontainatleastthe
following:
______________________________________________________________________________________________________
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LF562k5 Revised:10/07 Page 27 of 52
ISO
Req.
Characteristic Yes No
Commentsregarding
deficiencies/effectiveness
(ifapplicable)
5.4.4 a) appropriateidentification
b) scope
c) descriptionofitembeingtested/cal.
d) parametersorquantities/rangestobe
determined
e) apparatusandequipment,including
technicalperformance requirements
f) referencestandards/materialsreq.
g) environmentalconditionsrequiredand
stabilizationperiodneeded
h) descriptionofprocedure,including:
affixingofidentificationmarks,
handling,transporting,storingand
prep.ofitems
checks tobemadebeforeworkstarts
checksthatequipmentisworking
properly,andwhererequired,
calibrationandadjustmentof
equipmentbeforeuse
methodofrecordingobservationsand
results
anysafetymeasuresobserved
i) criteriaand/orreq.forapproval/rejection
j) datatoberecordedandmethodof
analysisandpresentation
k) uncertaintyorprocedureforestimating
uncertainty
5.4.5.1 Doesthelaboratoryfollowthedefinitionof
validationastheconfirmationby
examinationandtheprovisionofobjective
evidencethattheparticularrequirementsfor
aspecificintendedusearefulfilled?
5.4.5.2 Doesthelaboratoryvalidatethefollowingto
confirmthatthemethodsarefitforthe
intendeduse?
nonstandardmethods
labdesigned/developedmethods
standardmethodsusedoutsidetheir
intendedscope
amplifications/modificationsofstandard
methods
______________________________________________________________________________________________________
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LF562k5 Revised:10/07 Page 28 of 52
ISO
Req.
Characteristic Yes No
Commentsregarding
deficiencies/effectiveness
(ifapplicable)
5.4.5.2 NOTE:Thetechniquesusedfor
determinationofperformanceofamethod
shouldbeoneof,oracombinationof,the
following:
calibrationusingreferencestandardsor
materials
comparisonofresultsachievedwithother
methods
interlaboratorycomparisons
systematicassessmentof thefactors
influencingtheresult
assessmentoftheuncertaintyoftheresults
basedonscientificunderstandingofthe
theoreticalprinciplesofthemethodand
practicalexperience
5.4.5.2 Isthevalidationasextensiveasisnecessary
tomeetthe needsofthegivenapplicationor
fieldofapplication?
NOTE:Whensomechangesaremadeinthe
validatednonstandardmethods,the
influenceofsuchchangesshouldbe
documentedand,ifappropriate,anew
validationshouldoccur.
5.4.5.2 Doesthelaboratoryrecord:
theresultsobtained?
theprocedureusedforthevalidation?
astatementastowhetherthemethodisfit
fortheintendeduse?
5.4.5.3 Aretherangeandaccuracyofthevalues
obtainablefromvalidatedmethods(e.g.the
uncertaintyoftheresults,detectionlimit,
selectivityofmethod,linearity,limitof
repeatabilityand/orreproducibility,
robustnessagainstexternalinfluences
and/orcrosssensitivityagainstinterference
fromthematrixofthesample/testobject)as
assessed fortheintendeduse,relevanttothe
customersneeds?
______________________________________________________________________________________________________
Form# Issued:11/05 Rev.1.4
LF562k5 Revised:10/07 Page 29 of 52
ISO
Req.
Characteristic Yes No
Commentsregarding
deficiencies/effectiveness
(ifapplicable)
5.4.5.3 NOTE:Validationincludesspecificationof
therequirements,determinationofthe
characteristicsofthemethods,acheckthat
therequirementscanbefulfilledbyusing
themethodandastatementonthevalidity.
Asmethoddevelopmentproceeds,regular
reviewshouldbecarriedouttoverifythat
thecustomersneedsarestillbeingmet.
Anychangeinrequirementsrequiring
modificationstothedevelopmentplan
shouldbeapprovedandauthorized.
5.4.6.1 Doesthecalibrationlaboratory,oratesting
laboratoryperformingitsowncalibrations,
haveaproceduretoestimatetheuncertainty
ofmeasurementforallcalibrationsand
typesofcalibrations?
Istheprocedureapplied?
5.4.6.2 Doesthetestinglaboratoryhaveprocedures
forestimatinguncertaintyofmeasurement?
Aretheseproceduresapplied?
5.4.6.2 Incertaincases,thenature ofthetest
methodmayprecluderigorous,
metrologicallyandstatisticallyvalid
calculationofuncertaintyofmeasurement.
Inthesecases,doesthelaboratoryatleast
attempttoidentifyallthecomponentsof
uncertaintyandmakeareasonable
estimation?
5.4.6.2 Doesthelaboratoryensurethattheformof
reportingoftheresultdoesnotgiveawrong
impressionoftheuncertainty?
5.4.6.2 Isreasonableestimationbasedon
knowledgeoftheperformanceofthemethod
andonthemeasurementscope?
5.4.6.2 Doesthereasonableestimationmakeuseof,
forexample,previousexperienceand
validationdata?
______________________________________________________________________________________________________
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LF562k5 Revised:10/07 Page 30 of 52
ISO
Req.
Characteristic Yes No
Commentsregarding
deficiencies/effectiveness
(ifapplicable)
5.4.6.2 NOTE:Inthosecaseswhereawell
recognizedtestmethodspecifieslimitsto
thevaluesofthemajorsourcesof
uncertaintyofmeasurementandspecifies
theformofpresentationofcalculated
results,thelabisconsideredtohave
satisfiedthisclausebyfollowingthetest
methodandreporting instructions.
5.4.6.3 Whenestimatingtheuncertaintyof
measurement,areallelementsinthe
uncertaintybudgetappropriatemethodsof
analysisincludedinthecalculation?
NOTE:Thepredictedlongtermbehaviorof
thetestedand/orcalibrateditemisnot
normallytakenintoaccountwhenestimating
themeasurementuncertainty.
5.4.7.1 Arecalculationsanddatatransferssubject
toappropriatechecksinasystematic
manner?
5.4.7.2 Whencomputersorautomatedequipment
areusedfortheacquisition,processing,
recording,reporting,storageorretrievalof
testorcalibrationdata,doesthelaboratory
ensurethat(ac):
a) computersoftwaredevelopedbytheuser
isdocumentedinsufficientdetailandis
suitablyvalidatedasbeingadequatefor
use?
NOTE:Commercialofftheshelfsoftware
issufficientlyvalidated.However,lab
softwareconfigurationormodifications
shouldbevalidatedasin5.4.7.2a.
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Form# Issued:11/05 Rev.1.4
LF562k5 Revised:10/07 Page 31 of 52
ISO
Req.
Characteristic Yes No
Commentsregarding
deficiencies/effectiveness
(ifapplicable)
5.4.7.2 b) forprotectingthedata,proceduresare:
established?
implemented?
Dosuchproceduresinclude,butarenot
limitedto:
integrityandconfidentialityofdataentry
orcollection?
datastorage?
datatransmission?
dataprocessing?
5.4.7.2 c) computersandautomatedequipmentare
maintainedtoensureproperfunctioning
andareprovidedwiththeenvironmental
andoperatingconditionsnecessaryto
maintaintheintegrityoftestand
calibrationdata?
5.5 Equipment
5.5.1 Isthe laboratoryfurnishedwithallitemsof
sampling,measurementandtestequipment
requiredforthecorrectperformanceofthe
testsand/orcalibrations(including
sampling,preparationoftestand/or
calibrationitems,processingandanalysisof
testand/or calibrationdata)?
5.5.1 Inthosecaseswherethelaboratoryneedsto
useequipmentoutsideitspermanentcontrol,
doesitensurethattherequirementsofthis
standardaremet?
5.5.2 Isequipmentanditssoftwareusedfor
testing,calibrationand samplingcapableof
achievingtheaccuracyrequired?
Doesitcomplywithspecificationsrelevant
tothetestsand/orcalibrationsconcerned?
5.5.2 Havecalibrationprogramsbeenestablished
forkeyquantitiesorvaluesofthe
instrumentswherethesepropertieshavea
significanteffectontheresults?
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Form# Issued:11/05 Rev.1.4
LF562k5 Revised:10/07 Page 32 of 52
ISO
Req.
Characteristic Yes No
Commentsregarding
deficiencies/effectiveness
(ifapplicable)
5.5.2 Beforebeingplacedintoservice,is
equipment(includingthatusedfor
sampling)calibratedorcheckedtoestablish
thatitmeetsthelaboratorysspecification
requirementsandcomplieswiththerelevant
standardspecifications?
Isitcheckedand/orcalibratedbeforeuse?
5.5.3 Istheequipmentoperatedbyauthorized
personnel?
5.5.3 Arecurrentinstructionsontheuseand
maintenanceofequipment(includingany
relevantmanualsprovidedbythe
manufacturer)readilyavailableforuseby
theappropriatelaboratorypersonnel?
5.5.4 Iseachitemofequipmentanditssoftware
usedfortestingandcalibrationand
significanttotheresult,whenpracticable,
uniquelyidentified?
5.5.5 Arerecordsofeachitemofequipmentand
itssoftwaresignificanttothetestsand/or
calibrationsperformedmaintained?
5.5.5 Dotherecordsincludeat leastthefollowing
(ah):
a) theidentityoftheitemofequipmentand
itssoftware?
5.5.5 b) themanufacturersname,type
identification,andserialnumberorother
uniqueidentification?
5.5.5 c) checksthatequipmentcomplieswiththe
specification?
5.5.5 d) thecurrentlocation,whereappropriate?
5.5.5 e) themanufacturersinstructions,if
available,orreferencetotheirlocation?
5.5.5 f) dates,resultsandcopiesofreportsand
certificatesofallcalibrations,
adjustments,acceptancecriteriaandthe
duedateofnextcalibration?
______________________________________________________________________________________________________
Form# Issued:11/05 Rev.1.4
LF562k5 Revised:10/07 Page 33 of 52
ISO
Req.
Characteristic Yes No
Commentsregarding
deficiencies/effectiveness
(ifapplicable)
5.5.5 g) themaintenanceplan,where
appropriate,andmaintenancecarriedout
todate?
5.5.5 h) anydamage,malfunction,modification
orrepairtotheequipment?
5.5.6 Doesthelaboratoryhaveprocedures
coveringthefollowingtoensureproper
functioningandinordertoprevent
contaminationordeterioration:
safehandling?
transport?
storage?
useandplannedmaintenanceofmeasuring
equipment?
5.5.7 Isequipmentthathasbeensubjectedto
overloadingormishandling,givessuspect
results,orhasbeenshowntobedefectiveor
outsidespecifiedlimitstakenoutofservice?
5.5.7 Isitisolatedtopreventitsuseorclearly
labeledormarkedasbeingoutofservice
untilithasbeenrepairedandshownby
calibrationortesttoperformcorrectly?
5.5.7 Doesthelaboratoryexaminetheeffectof
thedefectordeparturefromspecifiedlimits
onprevioustestsand/orcalibrations?
DoesthelabinstitutetheControlof
NonconformingWorkprocedure?
5.5.8 Wheneverpracticable,isallequipment
underthecontrolofthelaboratoryand
requiringcalibrationlabeled,codedor
otherwiseidentifiedtoindicatethestatusof
calibration,includingthedatewhenlast
calibratedandthedateorexpirationcriteria
whenrecalibrationisdue?
5.5.9 When,forwhateverreason,equipmentgoes
outsidethedirectcontrolofthelaboratory,
doesthelaboratoryensurethatthefunction
andcalibrationstatusoftheequipmentare
checkedandshowntobesatisfactorybefore
theequipmentisreturnedtoservice?
______________________________________________________________________________________________________
Form# Issued:11/05 Rev.1.4
LF562k5 Revised:10/07 Page 34 of 52
ISO
Req.
Characteristic Yes No
Commentsregarding
deficiencies/effectiveness
(ifapplicable)
5.5.10 Whenintermediatechecksareneededto
maintainconfidenceinthecalibrationstatus
oftheequipment,arethesecheckscarried
outaccordingtoadefinedprocedure?
5.5.11 Wherecalibrationsgiverisetoasetof
correctionfactors,doesthelaboratoryhave
procedurestoensurethatcopies(e.g.in
computersoftware)arecorrectlyupdated?
5.5.12 Istestandcalibrationequipment,including
bothhardwareandsoftware,safeguarded
fromadjustmentsthatwouldinvalidatethe
testand/orcalibrationresults?
5.6 MeasurementTraceability
Note: Mustincludeevidenceoftraceabilityforallaspectsof5.6
5.6.1 Isallequipmentusedfortestsand/or
calibrations,includingequipmentfor
subsidiarymeasurements(e.g.for
environmentalconditions)havinga
significanteffectontheaccuracyorvalidity
oftheresultofthetest,calibrationor
samplingcalibratedbeforebeingputinto
service?
Doesthelaboratoryhaveanestablished
programandprocedureforthecalibrationof
itsequipment?
5.6.2.1.1 Forcalibrationlaboratories,istheprogram
forcalibrationofequipmentdesignedand
operatedsoastoensurethatcalibrations
andmeasurementsmadebythelaboratory
aretraceabletotheInternationalSystemof
Units(SI)?
5.6.2.1.1 Doesacalibrationlaboratoryestablish
traceabilityofitsownmeasurement
standardsandmeasuringinstrumentstothe
SIbymeansofanunbrokenchainof
calibrationsorcomparisonslinkingthemto
relevantprimarystandardsoftheSI
measurementunits?
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LF562k5 Revised:10/07 Page 35 of 52
ISO
Req.
Characteristic Yes No
Commentsregarding
deficiencies/effectiveness
(ifapplicable)
5.6.2.1.1 IsthelinktoSIunitsachievedbyreference
tonationalmeasurementstandards?
5.6.2.1.1 Arethenationalmeasurementstandards
primarystandards,whichareprimary
realizationsoftheSIunitsoragreed
representationsofSIunitsbasedon
fundamentalphysicalconstants,or
Aretheysecondarystandards(standards
calibratedbyanothernationalmetrology
institute)?
5.6.2.1.1 Whenusingexternalcalibrationservices,is
traceabilityofmeasurementassuredbythe
useofcalibrationservicesfromlaboratories
thatcandemonstratecompetence,
measurementcapabilityandtraceability?
5.6.2.1.1 Dothecalibrationcertificates issuedby
theselaboratoriescontainthemeasurement
results,includingthemeasurement
uncertaintyand/orastatementof
compliancewithanidentifiedmetrological
specification?
5.6.2.1.2 Therearecertaincalibrationsthatcurrently
cannotbestrictlymadeinSIunits.Inthese
cases,doescalibrationprovideconfidencein
measurementsbyestablishingtraceabilityto
appropriatemeasurementstandardssuchas:
theuseofcertifiedreferencematerials
providedbyacompetentsuppliertogivea
reliablephysicalorchemical
characterizationofamaterial?
theuseofspecifiedmethodsand/or
consensusstandardsthatareclearly
describedandagreedbyallparties
concerned?
Doesthelaboratoryparticipateinasuitable
programofproficiencytesting? (Assessor
mustprovidecopiesofPTreportsin
package.)
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ISO
Req.
Characteristic Yes No
Commentsregarding
deficiencies/effectiveness
(ifapplicable)
5.6.2.2.1 Fortestinglaboratories,therequirements
givenin5.6.2.1applyformeasuringandtest
equipmentwithmeasuringfunctionsused,
unlessithasbeenestablishedthatthe
associatedcontributionfromthecalibration
contributeslittletothetotaluncertaintyof
thetestresult.
Whentheabovesituationarises,doesthe
laboratoryensurethattheequipmentused
canprovidetheuncertaintyofmeasurement
needed?
5.6.2.2.2 WheretraceabilityofmeasurementstoSI
unitsisnotpossibleand/ornotrelevant,
doesthecalibrationlaboratoryfollowthe
samerequirementsfortraceabilityto,for
example,certifiedreferencematerials,and
agreedmethodsand/orconsensusstandards?
5.6.3.1 Doesthelaboratoryhaveaprogramand
procedureforthecalibrationofitsreference
standards?
5.6.3.1 Arereferencestandardscalibratedbyabody
thatcanprovidetraceabilityasdescribedin
5.6.2.1?
5.6.3.1 Aresuchreferencestandardsof
measurementheldbythelaboratoryusedfor
calibrationonlyandfornootherpurpose,
unlessitcanbeshownthattheir
performanceasreferencestandardswould
notbeinvalidated?
5.6.3.1 Arereferencestandardscalibratedbefore
andafteranyadjustment?
5.6.3.2 Arereferencematerials,wherepossible,
traceabletoSIunitsofmeasurement,orto
certifiedreferencematerials?
5.6.3.2 Areinternal referencematerialscheckedas
farasistechnicallyandeconomically
practicable?
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Form# Issued:11/05 Rev.1.4
LF562k5 Revised:10/07 Page 37 of 52
ISO
Req.
Characteristic Yes No
Commentsregarding
deficiencies/effectiveness
(ifapplicable)
5.6.3.3 Arechecksneededtomaintainconfidencein
thecalibrationstatusofreference,primary,
transferorworkingstandardsandreference
materialscarriedoutaccordingtodefined
proceduresandschedules?
5.6.3.4 Doesthelaboratoryhaveproceduresforsafe
handling,transport,storageanduseof
referencestandards andmaterialsinorderto
preventcontaminationordeteriorationand
inordertoprotecttheirintegrity?
5.7 Sampling
5.7.1 Doesthelaboratoryhaveasamplingplan
andproceduresforsamplingwhenitcarries
outsamplingofsubstances,materialsor
productsforsubsequenttestingor
calibration?
5.7.1 Isthesamplingplanavailableatthelocation
wheresamplingisundertaken?
Isthesamplingprocedureavailableatthe
locationwheresamplingisundertaken?
5.7.1 Aresamplingplans,wheneverreasonable,
basedonappropriatestatisticalmethods?
5.7.1 Doesthesamplingprocessaddressthe
factorstobecontrolledtoensurethevalidity
ofthetestandcalibrationresults?
5.7.2 Wherethecustomerrequiresdeviations,
additionsorexclusionsfromthe
documentedsamplingprocedure,arethese
recordedindetailwiththeappropriate
samplingdata?
Aretheseincludedinalldocuments
containingtestand/orcalibrationresults?
Arethesecommunicatedtotheappropriate
personnel?
5.7.3 Doesthelaboratoryhaveproceduresfor
recordingrelevantdataandoperations
relatingtosamplingthatformspartofthe
testingorcalibrationdone?
______________________________________________________________________________________________________
Form# Issued:11/05 Rev.1.4
LF562k5 Revised:10/07 Page 38 of 52
ISO
Req.
Characteristic Yes No
Commentsregarding
deficiencies/effectiveness
(ifapplicable)
5.7.3 Dotheserecordsinclude:
thesamplingprocedureused?
theidentificationofthesampler?
environmentalconditions(ifrelevant)?
diagramsorotherequivalentmeansto
identifythesamplinglocationsas
necessary?
ifappropriate,thestatisticsthesampling
proceduresarebasedupon?
5.8 HandlingofTestandCalibrationItems
5.8.1 Doesthelaboratoryhaveproceduresforthe
followingregardingtestand/orcalibration
items,includingallprovisionsnecessaryto
protecttheintegrityof thetestorcalibration
item,andtoprotecttheinterestsofthe
laboratoryandcustomer:
transportation?
receipt?
handling?
protection?
storage?
retentionand/ordisposal?
5.8.2 Doesthelaboratoryhaveasystemfor
identifyingtestand/orcalibrationitems?
5.8.2 Istheidentificationretainedthroughoutthe
lifeoftheiteminthelaboratory?
5.8.2 Isthesystemdesignedandoperatedsoasto
ensurethatitemscannotbeconfused
physicallyorwhenreferredtoinrecordsor
other documents?
Doesthesystem,ifappropriate,
accommodateasubdivisionofgroupsof
itemsandthetransferofitemswithinand
fromthelaboratory?
5.8.3 Uponreceiptofthetestorcalibrationitem,
areabnormalitiesordeparturesfromnormal
orspecifiedconditions,asdescribedinthe
testorcalibrationmethod,recorded?
______________________________________________________________________________________________________
Form# Issued:11/05 Rev.1.4
LF562k5 Revised:10/07 Page 39 of 52
ISO
Req.
Characteristic Yes No
Commentsregarding
deficiencies/effectiveness
(ifapplicable)
5.8.3 Whenthereisdoubtastothesuitabilityof
anitemfortestorcalibration,orwhenan
itemdoesnotconformtothedescription
provided,orthetestorcalibrationrequired
isnotspecifiedinsufficientdetail,doesthe
laboratoryconsultthecustomerforfurther
instructionsbeforeproceeding?
Isthediscussionrecorded?
5.8.4 Doesthelaboratoryhaveproceduresand
appropriatefacilitiesforavoiding
deterioration,lossordamagetothetestor
calibrationitemduringstorage,handling
andpreparation?
5.8.4 Arehandlinginstructionsprovidedwiththe
itemfollowed?
5.8.4 Whenitemshavetobestoredorconditioned
underspecifiedenvironmentalconditions,
aretheseconditionsmaintained,monitored
andrecorded?
5.8.4 Whereattestorcalibrationitemoraportion
ofanitemistobeheldsecure,doesthe
laboratoryhavearrangementsforstorage
andsecuritythatprotecttheconditionand
integrityofthesecureditemsorportions
concerned?
5.9 AssuringtheQualityofTestandCalibrationResults
5.9.1 Doesthelaboratoryhavequalitycontrol
proceduresformonitoringthevalidityof
testsandcalibrationsundertaken?
5.9.1 Istheresultingdatarecordedinsuchaway
thattrendsaredetectable,andwhere
practicable,statisticaltechniquesappliedto
thereviewingoftheresults?
Isthismonitoringplannedandreviewed?
5.9.1 Doesthismonitoringinclude,(butisnot
limitedto)(ae):
a) regularuseofcertifiedreference
materialsand/orinternalqualitycontrol
usingsecondaryreferencematerials?
______________________________________________________________________________________________________
Form# Issued:11/05 Rev.1.4
LF562k5 Revised:10/07 Page 40 of 52
ISO
Req.
Characteristic Yes No
Commentsregarding
deficiencies/effectiveness
(ifapplicable)
5.9.1 b) participationininterlaboratory
comparisonorproficiencytesting
programs?
Assessormustshowevidencethatthisis
takingplace.
5.9.1 c) replicatetestsorcalibrationsusingthe
sameordifferentmethods?
5.9.1 d) retestingorrecalibrationofretained
items?
5.9.1 e) correlationofresultsfordifferent
characteristicsofanitem?
5.9.2 Isqualitycontroldataanalyzedand,
whereitisfoundoutsidepredefined
criteria,plannedactiontakentocorrect
theproblemandtopreventincorrect
resultsfrombeingreported?
5.10 ReportingtheResults
5.10.1 Aretheresultsofeachtest,calibration,or
seriesoftestsorcalibrationscarriedoutby
thelaboratoryreportedaccurately,clearly,
unambiguouslyandobjectively,andin
accordancewithanyspecificinstructionsin
thetestorcalibrationmethods?
5.10.1 Aretheresultsreported,usuallyinatest
reportorcalibrationcertificate?
Doesthereportincludealltheinformation
requestedbythecustomerandnecessaryfor
theinterpretationofthetestorcalibration
resultsandallinformationrequiredbythe
methodused?(Thisinformationisnormally
thatrequiredby5.10.2and5.10.3or
5.10.4.)
5.10.1 Inthecaseoftestsorcalibrationsperformed
forinternalcustomers,orinthecaseofa
writtenagreementwiththecustomer,arethe
resultsreportedinasimplifiedway?
5.10.1 Isanyinformationlistedin5.10.2to5.10.4,
whichisnotreportedto thecustomer,
readilyavailableinthelaboratorythat
carriedoutthetestand/orcalibrations?
______________________________________________________________________________________________________
Form# Issued:11/05 Rev.1.4
LF562k5 Revised:10/07 Page 41 of 52
ISO
Req.
Characteristic Yes No
Commentsregarding
deficiencies/effectiveness
(ifapplicable)
5.10.2 Doeseachtestorcalibrationcertificate
include atleastthefollowinginformation(a
k),unlessthelaboratoryhasvalidreasons
fornotdoingso:
5.10.2 a) atitle(e.g.TestReportorCalibration
Certificate)?
5.10.2 b) thenameandaddressofthelaboratory,
andthelocationwherethetests and/or
calibrationswerecarriedout,ifdifferent
fromtheaddressofthelaboratory?
5.10.2 c) uniqueidentificationofthetestreportor
calibrationcertificate(suchastheserial
number),andoneachpagean
identificationinordertoensurethatthe
pageisrecognizedasapartofthetest
reportorcalibrationcertificate,anda
clearidentificationoftheendofthe
reportorcertificate?
5.10.2 d) thecustomersnameandaddress?
5.10.2 e) identificationofthemethodused?
5.10.2 f) adescriptionof,theconditionof,and
unambiguousidentificationoftheitem(s)
testedorcalibrated?
5.10.2 g) thedateofreceiptofthetestor
calibrationitem(s)wherethisiscriticalto
thevalidityandapplicationoftheresults,
andthe date(s)ofperformanceofthetest
orcalibration?
5.10.2 h) referencetothesamplingplanand
proceduresusedbythelaboratoryor
otherbodieswherethesearerelevantto
thevalidityorapplicationoftheresults?
5.10.2 i) thetestorcalibrationresultswith,where
appropriate,theunitsofmeasurement?
5.10.2 j) thename(s),function(s),andsignature(s)
orequivalentidentificationofperson(s)
authorizingthetestreportorcalibration
certificate?
5.10.2 k) whererelevant,astatementtotheeffect
thattheresultsrelateonlytotheitems
testedorcalibrated?
______________________________________________________________________________________________________
Form# Issued:11/05 Rev.1.4
LF562k5 Revised:10/07 Page 42 of 52
ISO
Req.
Characteristic Yes No
Commentsregarding
deficiencies/effectiveness
(ifapplicable)
5.10.2 NOTE:Hardcopiesoftestreportsand
calibrationcertificatesshouldalsoinclude
thepagenumberandtotalnumberofpages.
Labsshouldincludeastatementspecifying
report/certificateshallnotbereproduced
exceptinfull,withoutwrittenapprovalby
thelaboratory.
5.10.3.1 Inadditiontotherequirementslistedin
5.10.2,dotestreports,wherenecessary,
includethefollowing(ae):
5.10.3.1 a) deviationsfrom,additionsto,or
exclusionsfromthetestmethod,and
informationonspecifictestconditions,
suchasenvironmentalconditions?
5.10.3.1 b) whererelevant,astatementof
compliance/noncompliancewith
requirementsand/orspecifications?
5.10.3.1 c) whereapplicable,astatementonthe
estimateduncertaintyofmeasurement?
(informationonuncertaintyisneededin
testreportswhenitisrelevanttothe
validityorapplicationofthetestresults,
whenacustomersinstructionso
requires,orwhentheuncertaintyaffects
compliancetoaspecificationlimit.)
5.10.3.1 d) whereappropriateandneeded,opinions
andinterpretations?
5.10.3.1 e) additionalinformationthatmaybe
requiredbyspecificmethods,customers,
orgroupsofcustomers?
5.10.3.2 Inadditiontotherequirementslistedin
5.10.2and5.10.3.1,dotestreports
containingtheresultsofsamplinginclude
thefollowing (af),wherenecessary,forthe
interpretationoftestresults:
5.10.3.2 a) thedateofsampling?
______________________________________________________________________________________________________
Form# Issued:11/05 Rev.1.4
LF562k5 Revised:10/07 Page 43 of 52
ISO
Req.
Characteristic Yes No
Commentsregarding
deficiencies/effectiveness
(ifapplicable)
5.10.3.2 b) unambiguousidentificationofthe
substance,materialorproductsampled
(includingthenameofthemanufacturer,
themodelortypeofdesignationand
serialnumbersasappropriate)?
5.10.3.2 c) thelocationofsampling,includingany
diagrams,sketchesorphotographs?
5.10.3.2 d) areferencetothesamplingplanand
proceduresused?
5.10.3.2 e) detailsofanyenvironmentalconditions
duringsamplingthatmayaffectthe
interpretationofthetestresults?
5.10.3.2 f) anystandardorotherspecificationfor
thesamplingmethodor procedure,and
deviations,additionstoorexclusions
fromthespecificationconcerned?
5.10.4.1 Inadditiontotherequirementslistedin
5.10.2,docalibrationcertificatesincludethe
following(ac),wherenecessary,forthe
interpretationofcalibrationresults:
5.10.4.1 a) theconditions(e.g.environmental)
underwhichthecalibrationsweremade
thathaveaninfluenceonthe
measurementresults?
5.10.4.1 b) theuncertaintyofmeasurementand/ora
statementofcompliancewithan
identifiedmetrologicalspecificationor
clausesthereof?
5.10.4.1 c) evidencethatthemeasurementsare
traceable?
5.10.4.2 Doesthecalibrationcertificaterelateonlyto
quantitiesandtheresultsoffunctionaltests?
5.10.4.2 Ifastatementofcompliancewitha
specificationismade,doesthisidentify
whichclausesofthespecificationaremetor
notmet?
______________________________________________________________________________________________________
Form# Issued:11/05 Rev.1.4
LF562k5 Revised:10/07 Page 44 of 52
ISO
Req.
Characteristic Yes No
Commentsregarding
deficiencies/effectiveness
(ifapplicable)
5.10.4.2 Whenastatementofcompliancewitha
specificationismadeomittingthe
measurementresultsandassociated
uncertainties,doesthelaboratoryrecord
thoseresultsandmaintainthemforpossible
futurereference?
5.10.4.2 Whenstatementsofcompliancearemade,is
theuncertaintyofmeasurementtakeninto
account?
5.10.4.3 Whenaninstrumentforcalibrationhasbeen
adjustedorrepaired,arethecalibration
resultsbeforeandafteradjustmentorrepair,
ifavailable,reported?
5.10.4.4 Dothecalibrationcertificates(orcalibration
labels)containanyrecommendationonthe
calibrationinterval,exceptwherethishas
beenagreedwiththecustomer?
Thisrequirementmaybesupersededby
legalregulations.
5.10.5 Whenopinionsandinterpretationsare
included,doesthelaboratorydocumentthe
basisuponwhichtheopinionsand
interpretationshavebeenmade?
Areopinionsandinterpretationsclearly
markedassuchinatestreport?
5.10.6 Whenthetestreportcontainsresultsoftests
performedbysubcontractors,arethese
resultsclearlyidentified?
Doesthesubcontractorreporttheresultsin
writingorelectronically?
5.10.6 Whenacalibrationhasbeensubcontracted,
doesthelaboratoryperformingthework
issuethecalibrationcertificatetothe
contractinglaboratory?
5.10.7 Inthecaseoftransmissionoftestor
calibrationresultsbytelephone,telex,
facsimileorotherelectronicor
electromagneticmeans,aretherequirements
ofthisstandardmet?
______________________________________________________________________________________________________
Form# Issued:11/05 Rev.1.4
LF562k5 Revised:10/07 Page 45 of 52
ISO
Req.
Characteristic Yes No
Commentsregarding
deficiencies/effectiveness
(ifapplicable)
5.10.8 Istheformatdesignedtoaccommodateeach
typeoftestorcalibrationcarriedoutandto
minimizethepossibilityof
misunderstandingormisuse?
5.10.9 Arematerialamendmentstoatest
report/calibrationcertificateafterissue
madeonlyintheformofafurther
document,datatransfer,includinga
statementequivalenttoSupplementtoTest
Report(orCalibrationCertificate)?
5.10.9 Dosuchamendmentsmeetallthe
requirementsofthisstandard?
5.10.9 Whenitisnecessarytoissueacomplete
newtestreportorcalibrationcertificate,is
thisuniquelyidentified?
Doesthiscontainareferencetotheoriginal
thatitreplaces?
AdditionalRequirements(Requiredforsurveillanceandreaccreditation assessments)
*ObjectiveEvidenceofLaboratorysutilizationofPJLAsaccreditationsymbolmustbeincludedin
thepackage.Thisincludesbutnotlimitedto(Websitepage,letterhead,testorcalibrationreport
includingsubcontractedresultsifutilizedandcalibrationlabels)*
*IfanyoftherequirementsofSOP3arenotfollowedanonconformancemustbewritten*
Useof
the
Symbol
Istheaccreditedlaboratoryutilizingthe
correctsymbol(i.e.testingand/or
calibration)?
Isthesymbolreproducedinasizethatis
clearlydistinguishable?
Isthesymbolreproducedinasinglecolor
(blackorasinglecolorbelongingtothe
housestyleoftheaccreditedlab)?
Isthesymbolidentifiable?
Istheaccreditedlaboratoryproperlystating
theiraccreditationstatus?Accreditedto
ISO/IEC17025:2005orutilizingtheILAC
criterialistedintheSOP3Procedure.
(ILACguidancenotmandatory)
______________________________________________________________________________________________________
Form# Issued:11/05 Rev.1.4
LF562k5 Revised:10/07 Page 46 of 52
Istheaccreditedlaboratoryproperlyusing
thesymbolon:
a) promotionalmaterialandbusiness
stationary?
b) testorcalibrationcertificatesor
labels?(Seenote1)
c) website?
d) technicalliterature?
e) businessreports
f) quotationsorproposalsforwork?
(symbolsmayonlybelistedfor
accreditedlaboratories)
Note1Wherestatementsofopinionand
interpretationareoutsidethescopeofthe
accreditation,thelaboratoryshallincludea
disclaimerinthereportorcertificatecloseto
theaccreditationsymbolsuchasthe
opinions/interpretationsexpressedonthis
reportareoutsidethescopeofthis
laboratorysaccreditation.
Istheaccreditedlaboratoryappropriately
usingthesymbolby not placingthesymbol
on:
a) legaldocuments(i.e.contractsor
checks)
b) ontest/calibrationcertificatesorany
othermaterialreferencingworkor
itemsnotcoveredbyscopeof
accreditation?
c) anydocumentationofsitesthatare
notaccreditedbyPJLA
d) onsubcontractorscertificatesor
documentation?
______________________________________________________________________________________________________
Form# Issued:11/05 Rev.1.4
LF562k5 Revised:10/07 Page 47 of 52
e) onproductsoritemswhich
laboratoryhastestedorcalibrated
(exceptcalibrationlabels)?
Wheretestsorcalibrationsoutside
thescopeoftheaccreditationare
includedonreports,certificatesor
enclosedletterswithresults,hasthe
laboratoryclearlydefinedThis
laboratoryisnotaccreditedforthe
testsorcalibrationsmarked?
SubcontractedTestsorCalibrations
Iftheaccreditedlaboratoryincludedthe
resultsofsubcontractedtestsorcalibrations
onreportsorcertificatescanthey
demonstratethattheyhave:
a) obtainedapprovalfromthe
subcontractedlaboratory?
b) obtained approvalfromthe
subcontractortoreportexcerpts
fromthesubcontractorsreporton
thecertificate?
c) objectiveevidencethatthe
subcontractoritselfisaccreditedfor
thespecifictestsorcalibrations
concernedandresultshavebeen
includedinthesubcontractors
endorsedreportorcertificate?
CalibrationLabelsonEquipment
DoesthelaboratoryutilizethePJLA
accreditationsymbolontheircalibration
labels?
Ifyes,doesthelabelscontain:
a) thenameoftheaccredited
calibrationlaboratoryorits
accreditationnumber?
b) equipmentidentification?
______________________________________________________________________________________________________
Form# Issued:11/05 Rev.1.4
LF562k5 Revised:10/07 Page 48 of 52
c) dateofcurrentcalibration?
d) crossreferencetothecalibration
certificatesissuedinrespectofthe
calibration?
Doesthelaboratoryuseanyoversightor
recognitionbodylogoorsymbolon their
certificates,reportsoranyothermaterial?If
yes,whichbodyslogoorsymbolarethey
using?
**Tobereviewedatallassessments(Accreditation,SurveillanceandReaccreditation**
PL1ProficiencyTestingRequirementsforApplicantandAccreditedLaboratories
Forapplicantlaboratories:
IsthereobjectiveevidenceforPTactivity
foreachitemtobeincludedwithinproposed
scopeofaccreditation?
Aretheresultsmeaningfuli.e.demonstrating
thelaboratoryscompetenceinperforming
specifiedtestsorcalibrations?
Foraccreditedlaboratories:
Isthereadocumentedproficiencytesting
planorschedule?
Doesthisplanorscheduleincludeallitems
includedonthescopeofaccreditationtobe
testedwithinafouryearperiod?
Hasthelaboratorycompletedatleastone
proficiencytesteachyear?
Hastheproficiencyplanorschedulebeen
approvedbyPJLA?
Foranyunfavorableresultsgatheredduring
proficiencytesting,wasappropriate
correctiveactiontaken?
______________________________________________________________________________________________________
Form# Issued:11/05 Rev.1.4
LF562k5 Revised:10/07 Page 49 of 52
ISO
Req.
Characteristic Yes No
Commentsregarding
deficiencies/effectiveness
(ifapplicable)
PL2MeasurementTraceabilityPolicy
Doesthelaboratoryhavedocumentedpoliciesand
proceduresregardingmeasurementtraceabilityand
referencethistraceabilityontest/calibrationreports?
Doesthelaboratoryhavedocumentedprocedures
detailingtheverification,transportandstorageof
referencestandards?
Hasthelaboratoryemployedtheservicesofanexternal
calibrationprovider(s)thatareaccreditedtoISO/IEC
17025:2005forthecalibration(s)performed?
Ifnot,canthelaboratorydemonstratereverse
traceability,anuninterruptedchain,backtoNISTor
anotherNMI?
Doesthelaboratoryhaveonfileandavailablethecurrent
certificatesandscopesofaccreditationfortheexternal
calibrationlaboratoriesemployed?
PL3PolicyonMeasurementUncertaintyforCalibrationandTestingLaboratories
Forapplicantlaboratories:
Hasthelaboratoryapplieditsdocumentedprocedureto
providemeasurementuncertaintiesforeverymeasured
quantity,instrumentorgagelistedinitsscopeof
accreditation?
(Wellrecognizedtestmethodsorcalibrationprocedures
thatspecifylimitstothevaluesofmajorsourcesof
uncertaintieswillmeetthisrequirement)
For accreditedlaboratories:
Arestateduncertaintiesperiodicallyreviewedand
updatedtoevaluatechangestobemadetoanyinfluence
listedinanuncertaintybudget?
Doesthelaboratoryincludeametrologicalstatementor
referenceestimateduncertainties oncalibration/test
reports?
______________________________________________________________________________________________________
Form# Issued:11/05 Rev.1.4
LF562k5 Revised:10/07 Page 50 of 52
SurveillanceofPreviousNonconformitiesandCorrectiveAction
Theassessorshallverifythatpreviousnonconformities
havebeenresolvedandthatcorrectiveactionshavebeen
effectivelyimplemented.
AdditionalNotes:
______________________________________________________________________________________________________
Form# Issued:11/05 Rev.1.4
LF562k5 Revised:10/07 Page 51 of 52
AdditionalNotes:
______________________________________________________________________________________________________
Form# Issued:11/05 Rev.1.4
LF562k5 Revised:10/07 Page 52 of 52
AdditionalNotes: