Assessment forms and checklist for clinical testing lab based on ISO 15189.docx

Assessment forms and checklist for clinical testing lab based on ISO 15189.docx

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AssessmentformsandchecklistforclinicaltestinglabbasedonISO15189

NABL

NATIONALACCREDITATIONBOARDFORTESTINGANDCALIBRATIONLABORATORIES

NABL217

ASSESSMENTFORMS

andCHECKLIST

（BasedonISO15189:

2007）

ISSUENO:

03

AMENDMENTNO:

02

ISSUEDATE:

27.06.2012

AMENDMENTDATE:

16.10.2012

AMENDMENTSHEET

Sl

PageNo.

ClauseNo.

DateofAmendment

AmendmentMade

Reasons

SignatureQO

SignatureDirector

1.

3/83

6/83

--

NAF1

22.08.2012

Laboratorylocations

Internalauditfinding

2.

16/83

4.1.5（i）

16.10.2012

Note:

DesignatedQualityManagershall.........accordingtoISO15189:

2007

APLACfindings

3.

4.

5.

6.

7.

8.

9.

10.

Contents

Sl.No.

Title

PageNo.

1.

AmendmentSheet

1

2.

Contents

2

3.

GuidetousetheNAFs&ChecklistsandCompilationoftheAssessmentReport

3

4.

NAF1–AssessmentSchedule

6

5.

NAF1A–AttendanceSheet（Opening/closingmeeting）

7

6.

NAF2–Assessor’sObservation

8

7.

NAF3–Test（s）witnessedbytheAssessmentTeam

9

8.

NAF3A–DetailsofRe-TestingwitnessedduringAssessment

10

9.

NAF4–SummaryonNon-Conformities

11

10.

NAF5–ConsolidatedNon-Conformities

12

11.

NAF6–SummaryofAssessment

13

12.

Checklist1–ByLeadAssessor

14

13.

Checklist2–Test（s）Witness-ByTechnicalAssessor

50

14.

Checklist3–ForMedicalLaboratoryCollectionCentres

78

15.

Form71–RecommendedAuthorisedSignatories

81

16.

Form72–RecommendedScopeofAccreditation

82

17.

Form74–DeclarationofImpartiality&Confidentiality

83

GuidetousetheNABLAssessmentForms,Checklists&otherFormsbasedonISO15189:

2007andCompilationoftheAssessmentReport

ItispresumedthattheAssessorswhohavebeennominatedbytheNABLSecretariat,arefullyawareoftheNABLAccreditationprocess,itsobjectivesandtheon-siteAssessmentprocedure.ThisdocumentcontainsAssessmentformsNAF1to6,Checklists1and2andForms71to74,whichwillformapartoftheAssessmentReport.ThedocumentshallguidetheLeadAssessorandtheTechnicalAssessor（s）incompletingvariousforms&checklistsandcompiletheassessmentreport.

RoleofLeadAssessor

BeforethestartofAssessmenttheLeadAssessorshouldprepareanAssessmentscheduleinNAF1whichshouldincludethelaboratorylocations/departments/sections/areas/activitiestobeassessedandassignmenttovariousAssessorsbasedontheirexpertise.TheObserver（PotentialAssessor）shouldalsobeguidedabouttheconductofassessment.

TheLeadAssessormustreviewtheLaboratory’sdocumentedManagementSystemtoverifycompliancewiththerequirementsofISO15189:

2007.HeshouldassessthatthedocumentedManagementSystemisindeedimplemented&effective,asdescribedandrecordobservationsinNAF2.HeshouldalsocompleteChecklist1andrecordconclusion/commentsrelatedtotherequirementsofrespectiveclausenumber.AllNon-Conformitiesmustbeidentifiedandreported,separatelyoneachsheetinNAF4.Nononconformityshallbeclosedduringtheassessment.Laboratoryshallevaluatetherootcauseofthenonconformityandproposecorrectionandcorrectiveaction.ThemaximumtimeperiodgivenforalaboratorytoclosetheNonconformityistwomonthsfromthedateofassessment.

AsaleaderoftheAssessmentteam,hewouldcollectthereportsanddocumentsfromallTechnicalAssessorsincludinghisownreportandcompileit.AconsolidatedstatementofNon-ConformitiesraisedduringtheAssessmentshallbelistedinNAF5.If,duringSurveillanceorRe-assessment,acaseoftotalsystemfailureandgrossnegligenceintechnicalaspectsisnoticed,theLeadAssessorwillattheearliestinformNABLandelaboratelybringitoutintheAssessmentsummary（NAF-6）ofassessmentreport.HewouldfinallysummarisetheconductofAssessmentandrecordtherecommendationsinNAF6.

HemustgetanendorsementfromthelaboratoryonNAF6andhandoveraphotocopyoftheformsNAF4,5,and6totheLaboratorytoenablethemtotakecorrectiveactions.Copyofrecommendedscope,authorisedsignatoriesshallalsobegiventothelaboratory.

TheLeadAssessorisalsorequiredtomonitortheperformanceofTechnicalAssessor（s）andtheObserver.HeshallrecommendwhethertheObserveriscapabletoperformtheroleofaTechnicalAssessorinhisnextvisit.Hiscomments/ratingforeachTechnicalAssessorshallbeenclosedwiththereportinForm45.

RoleofTechnicalAssessor

TheTechnicalAssessorshouldclearlyunderstandtheareas/activitiestobeassessedbyhim.HemustreviewtheLaboratory’sdocumentedsystemtoverifycompliancewiththerequirementsofISO15189:

2007andrelatedNABLSpecificCriteria.HeshouldassesstoverifythatthedocumentedSOPs,testmethods,recordsareindeedimplemented&effective,asdescribedandrecordobservationsinNAF2.HeshouldalsocompleteChecklist2relatedtotherequirementsofrespectiveclausenumberandNAF3fortheTest（s）witnessedbyhim.

AssessorsshallinterviewtheLaboratory’sAuthorisedSignatoryfortheircompetence,andrecommendinForm71.AssessorsshallreferNABL112forrequirementsofauthorisedsignatory.

AllNon-Conformitiesmustbeidentifiedandreported,separatelyoneachsheetinNAF4.TheScopeofAccreditationtobegrantedtotheLaboratorymustbecheckedthoroughlywithnecessaryrecommendationsonForm72.AnydeletionsoralterationsinthescopemustbeclearlybroughtoutandsignedbyboththeLaboratoryRepresentativeandtheAssessor.

ThereportshouldbehandedovertotheLeadAssessoralongwiththeTA/DAform.WhentheLeadAssessor,alsoperformsthejobofaTechnicalAssessor,heshouldfollowtheaboveprocedure.

RoleofTechnicalExpert

TheroleofTechnicalExpertissameasofTechnicalAssessor,excepthewillseekguidanceofLeadAssessorinfillingtherelevantforms,checklistetc.

RoleofObserver

TheObserver（PotentialAssessor）willbeassignedtoaccompanytheLeadAssessorandTechnicalAssessor（s）asperthescheduleprovidedtohim.HeshallbeguidedbytheLeadAssessorandtheTechnicalAssessor（s）.HeisnotrequiredtosubmitanyreporthoweverhisTA/DAformmaybesubmittedtotheLeadAssessor.Heisnotentitledforpaymentofanyhonorarium.

CompilationofAssessmentReport

TheAssessmentReportshouldconsistofvariousdocumentsintheorderasindicatedinNAF6.Eachformorchecklistshouldbecarefullyfilledin.Thepagesshouldbeseriallynumberedintheboxprovidedattherighttopcornerofeachpage,startingfromNAF6.

TheassessmentreportshouldbesubmittedtotheNABLSecretariatwithin10daysfromthecompletionofassessment.TheLeadAssessorshouldreturnalldocumentstoNABL/laboratorywhichhavebeenforwardedtohimforconductingtheassessmentsuchasLaboratory’sQualityManual,Applicationformetc.Form74–Declarationofmaintainingimpartiality&confidentialitymustbefilledupbytheLeadAssessor,allTechnicalAssessors&Observerandenclosedwiththeassessmentreport.TheTA/DAformsoftheTechnicalAssessorsandhisownmayalsobeenclosedalongwiththeassessmentreport.

***

NAF–1

ASSESSMENTSCHEDULE

Laboratory:

QualityManager:

Date（s）ofVisit:

TypeofVisit:

Assessment/1stSurveillance/Re-Assessment/Supplementaryvisit

Field:

MedicalTesting

Discipline（s）:

AssessmentStandard:

Laboratory’sQualityManual,ISO15189:

2007andSpecificCriteriaNABL112

AssessmentTimings

Opening/ClosingMeetingDate/Time

DailyDebriefingDate/Time

（attheendofeachday）

Morning:

AMtoPM

Afternoon:

PMtoPM

OpeningMeeting:

ClosingMeeting:

Day1:

Day2:

Day3:

NameandExpertise

oftheAssessor

ScheduleofLocations/Department/Section/ActivitytobeAssessed（datewise）

Day1

Day2

Day3

Morning

Afternoon

Morning

Afternoon

Morning

Afternoon

LeadAssessor

Assessor1

Assessor2

Assessor3

Assessor4

Assessor5

Assessor6

Assessor7

Observer

（onlyforobservation）

SignatureofLeadAssessor

NAF–1A

ATTENDANCESHEET（OPENING/CLOSINGMEETING）

Laboratory:

Date&Time:

TypeofVisit:

Assessment/1stSurveillance/Re-Assessment/Supplementaryvisit

Sl.

Assessors/LabPersonnelPresent

Capacity/Designation

Signature

NAF–2

ASSESSOR’SOBSERVATIONS

Laboratory:

Date:

Department:

ActivityAssessed:

Auditee:

Education:

YearsofExperience:

SL

OBSERVATION

REMARKS

Signature&NameofAssessor

NAF–3

TEST（S）WITNESSEDBYTHEASSESSSMENTTEAM

（TobefilledinbyeachTechnicalAssessor）

Laboratory:

Date（s）ofVisit:

Assessor:

Discipline:

Ref.toObs.inNAF2

Test（s）witnessed

TestMethodUsedorStandardReferred

Remarks

SignatureofAssessor

RemarksbyLeadAssessor,ifany

SignatureofLeadAssessor

NAF–3A

DETAILSOFRE-TESTINGWITNESSEDDURINGASSESSMENT

（To