NABL

NABL

1. NABL
Dr . K.VENKATESWARA RAJU
SHRI VISHNU COLLEGE OF PHARMACY
[email protected]

2. NABLstandsforNationalAccreditationBoardForTestingAndCalibration
Laboratories.
NABLisanautonomoussocietyprovidingAccreditation(Recognition)ofTechnical
competenceofatesting,calibration,medicallaboratory&Proficiencytestingprovider
(PTP)&ReferenceMaterialProducer(RMP).
NABLisanautonomousbodyundertheaegisofDepartmentofScience&Technology,
GovernmentofIndia,andisregisteredundertheSocietiesAct.Itisonlyoneofitskinds
thatassesslaboratoriesinIndiaforqualityandconsistencyintheresults.
NABLhasagreementswithILAC(InternationalLaboratoryAccreditationConference)
andAPLAC(AsiaPacificLaboratoryAccreditationCooperation).Theseareespecially
valuableforInternationalrecognitionandmutualacceptanceoftestresults.Inshort
accreditationhasworldwideacceptance.
TheconceptofLaboratoryAccreditationwasdevelopedtoprovideameansforthird
partycertificationofthecompetenceoflaboratoriestoperformspecifictype(s)of
testing.
INTRODUCTION

3. FormalrecognitionofcompetenceofalaboratorybyanAccreditationbodyin
accordancewithinternationalcriteriahasmanyadvantages:
1.IncreasedconfidenceinTesting/CalibrationReportsissuedbythelaboratory
2.Bettercontroloflaboratoryoperationsandfeedbacktolaboratoriesastowhether
theyhavesoundQualityAssuranceSystemandaretechnicallycompetent
3.Potentialincreaseinbusinessduetoenhancedcustomerconfidenceandsatisfaction.
4.CustomerscansearchandidentifythelaboratoriesaccreditedbyNABLfortheir
specificrequirementsfromtheNABLWeb-siteorDirectoryofAccredited
Laboratories
5.Usersofaccreditedlaboratoriesenjoygreateraccessfortheirproducts,inboth
domesticandinternationalmarkets.
6.Savingsintermsoftimeandmoneyduetoreductionoreliminationoftheneedfor
re-testingofproducts.
BENEFITS OF ACCREDITATION

4. NABL ACCREDITATION PROCEDURE
1.AnylaboratoryfallingwithinthescopeofNABLaccreditationcanapplyintheprescribedapplication
form(i.e.NABL151fortestinglaboratories,NABL152forcalibrationLaboratoryandNABL153for
medicallaboratories)intriplicatewithprescribedfee(asdetailedinapplicationform).
2.Alongwithapplication,twocopiesofthequalitymanualofthelaboratoryaretobefiled.Quality
manualshoulddescribethemanagement-systeminaccordancewithISO/IEC17025:2005orISO
15189:2007)whicheverisapplicableLaboratoryshouldtakespecialcareinfillingthescopeof
accreditationforwhichthelaboratorywishestoapply,forexample,biologicalchemical.
3.Ifthelaboratoryfeelsanyclauseoftheapplicationformisnotapplicableinpartorfull,itshouldwrite
reasonsforit.TheapplicationistobefiledwithsecretariatofNABL
4.Onreceiptofapplicationform,qualitymanualandfees,NABLissuesanacknowledgementtothe
laboratory.Afterscrutinyoftheapplicationforitscompleteness,NABLSecretariatallocatesaunique
laboratoryIDnumber,whichisusedincorrespondencewithlaboratory.Ifnecessary,NABL
SecretariatmayaskforadditionalInformation,clarificationetc.
5.OncetheNABLhasascertainedcompletenessofapplication,andobtainedanyother
information/clarification,itappointsaleadassessor.Itistheresponsibilityofleadassessorto
evaluateadequacyofthequalitymanualpre-assessthelaboratoryincludingonsiteassessmentofthe
laboratory.Onsiteassessmentisdonewithteamofassessorscommensuratewithscopeof
accreditationleadassessorfindsqualitymanualinadequate,itinformsNABLSecretariatandthe
laboratoryisaskedtomakeamends.
6.Afterthequalitymanualisfoundadequateorlaboratorymakesamendstothequalitymanualbased
oninadequaciespointedatapre-assessmentvisitisorganizedbyNABL.Thelaboratorybefore,the
pre-assessmentvisitensurethatithascarriedoutaninternalauditandmanagementreviewbefore
thepre-assessment.

5. NABL Accreditation Procedure –PRE ASSESMENT
Theobjectofpre-assessmentofthelaboratoryisto:
1.Evaluatenonconformities,ifany,intheimplementationofqualitysystem.
2.Assessthedegreeofpreparednessofthelaboratoryfortheassessmentforaccreditation
3.Determinethenumberofassessorsrequiredinvariousfieldsbasedonthescopeofaccreditation
numberoflocationstobevisited.
TheleadassessorsubmitsareporttotheNABLSecretariatandacopyisalsogiventothelaboratory.
Laboratoryhastotakecorrectiveactiononthenon-conformitiespointedoutinthereport.Acorrective
actionreportisrequiredtobefiledbythelaboratorytotheNABLSecretariat.
ThenextstepisassessmentofthelaboratorybyNABL.TheNABLconstitutesateamforassessment.
Theteamincludesleadassessor(alreadyappointed),technicalassessors/expertstocovervariousfields
withinthescopeofaccreditationrequested.Constitutionofteamisconveyedtothelaboratory.The
laboratoryisfreenottocopyoneormoremembersoftheteambygivingreasonsforitsnon-acceptance.
Afterthefinalizationofassessmentteam,adateforonsiteassessmentisfixed.
TheteamcarriesoutonsiteassessmentandpreparesanOnsiteassessmentreport.Theassessment
reportcontainstheevaluationoftechnicalmanpower,allrelevantmaterialsexamined,testswitnessed
includingthoseofreplicatetesting/measurement,compliancetoISO/IEC17025:2005orISO15189207
whicheverapplicable.
Non-conformities,ifobservedarementionedinthereport.Theteamalsoprovidesarecommendationor
otherwiseinthereport.Asummaryofassessmentreportandcopiesofnonconformities,ifobserved,are
providedtothelaboratory.

6. NABL Accreditation Procedure
TheassessmentreportisexaminedbytheNABLSecretariatandfollowupactionasrequiredisinitiated.
Laboratoryisrequiredtotakeactiononnon-conformitiesorotherconcernsmentionedintheassessment
reportandsubmitanactiontakenreportwithin60days.
Afterthelaboratoryhasreportedactiontakenontheassessmentreporttheaccreditationcommittee
examinestheassessmentreport,actiontakenreport(bythelaboratory),anyotheradditionalinformation
receivedfromthelaboratoryandconsequentverificationreport,ifany.
Ifthecommitteefindsdeficienciesinassessmentreport,NABLSecretariatisaskedtogetclarification
fromtheleadassessor/assessor(s)/laboratoryconsumed.Onceeverythingisinorder,Accreditation
CommitteemakesrecommendationstotheChairman,NABLforaccreditation.
AfterChairmanapprovesaccreditationrecommendations.NABLSecretariatissuesaccreditation
certificatewhichhasuniquenumber,fields,dateofvalidityalongwithscopeofaccreditation.
AlldecisionstakenbyNABLregardinggrantofaccreditationareopentoappealbythelaboratory.The
appealistobeaddressedtotheChairmanNABL.

7. PREPARING FOR NABL ACCREDITATION
WhenalaboratorydecidestoseekNABLaccreditation,itshouldmakeaplanofactionforobtaining
accreditationandnominateonepersontocoordinateallactivities.Thenominatedpersonshouldbe
conversantwithlaboratory'sexistingqualitysystem.
Alistofexternaldocumentisgiveninsection3.1ofthischapter.Allthesedocumentsareavailableon
thewebsiteofNABL.Thelaboratoryshouldgetacquaintedfullywiththerelevantdocumentsand
understandthetreatmentprocedure.
Laboratorymustassessthestatusofexistingqualitysystemandtechnicalcompetencevis-à-visthe
requirementofISO/IEC17025orISO15189whicheverisrelevant.
Itmaybementionedherethatqualitymanualisapolicydocument.Ithastobesupplementedby
otherdocumentslikeproceduralmanuals,workinstructionsetc.NABLhaspreparedaguidefor
preparingaqualitymanual(NABL160).ThisdocumentisalsoavailableonthewebsiteofNABL.
Anotherrequirementisthattheapplicantlaboratorymusthaveparticipatedsatisfactorilyinthe
proficiencytestingprogramconductedbyNABL/APLACoranyothernationalorInternational
accredited/recognizedITprovider.IfnoPTprogramisavailablethelaboratorycaninitiateaninter
laboratorycomparisonwithadequatenumberofaccreditedlaboratories.Theminimumstipulated
participationforlaboratoriesisoneparameter/typeoftest/calibrationperdiscipline,priortograntof
accreditation.
TheSatisfactoryperformanceshouldbedefinedintermsofZscoreandEn.Ifperformanceis
unsatisfactory,LaboratoryisrequiredtotakecorrectiveactionandinformNABL.
Thefollowingdocumentsgivedetailsofproficiencytesting:
1.ISO/IECGuide43.
2.ILACG13.
3.NABL162,NABL163,NABL164

8. PREPARING FOR NABL ACCREDITATION
Theapplicantlaboratorymusthaveconductedatleastoneinternalauditandamanagementreview
beforesubmissionofapplicationGuidanceforinternalauditandreviewmaybetakenfromfollowing
documents:
1.ISO19011-Guidelinesforqualityand/orenvironmentalmanagementsystemauditing.
2.NABL161-Guideforinternalauditandmanagementreviewforlaboratories.
TheapplicantlaboratorymustcomplywithallclausesofISO/IEC17025:2005orISO15189-2007
whicheverisapplicableforpharmaceuticalindustryISO/IEC17025isapplicable.
Now,itisamplyclearthatimplementationofISO/IEC17025isimperativeforaccreditation.While
discussingcontentsofISO/IEC17025abroadideahasbeengivenwhatistobedonein
implementingthestandard.MostoftechnicalrequirementsofthestandardareelementsofGLP.
Informationonthecanbefoundinvariouschaptersofthebook.Manyofthemanagement
requirementsarealsoelementsofGLPandhavebeendealtindifferentchaptersofthebook.
Intheproceedingsectionsimportantaspectswillbedealtwithoutwhichaccreditationprocesswillnot
progress.

9. 1.
1.General (ISO 17025:2005, 5.1)
2.Personnel (ISO 17025:2005, 5.2)
3.Accommodation and Environment
(ISO 17025:2005, 5.31)
TECHNICAL REQUIREMENTS:

10. The Laboratory Process
Laboratory
Report
Sample

11. GENERAL-TECHNICAL REQUIREMENTS
Laboratory
In GENERAL (ISO 17025:2005, 5.1)
Factors influencing the correctness and reliability of the
tests performed
Sample
?

12. Factors determine correctness
and reliability of the tests
Human factors
Accommodation and
environmental conditions
Test and calibration
methods, method validation
Equipment
Measurement traceability
Sampling
Handling test items

13. Personnel
(ISO 17025:2005, 5.2)

14. Management Requirements to
Personnel (ISO 17025: 2005, 4.1)
Laboratoryhavemanagerialandtechnicalpersonnel(irrespectiveofotherresponsibilities)who
havetheauthorityandresourcesneededtocarryouttheirdutiesandtoidentifytheoccurrenceof
departuresfromthequalitysystemandinitiateactionsifrequired
Freefromanyundueinternalandexternalpressuresandinfluences
Protectionofthecustomersconfidentialinformation
Specifyresponsibilities,authorityandinterrelationsofallpersonnelwhichactivitiescaninfluence
thequalityoftheresult
Appropropriatesupervisionoftestingstaffandtrainees
Technicalmanagementwhichhasoverallresponsibilityforoperationsandprovisionofresources
neededtoensurerequiredqualityofoperations
Qualitymanager:irrespectiveofotherdutieshasdefinedresponsibilityandauthorityensuringthe
managementsystemisimplementedandfollowedatalltimes,hasdirectaccesstothehighest
levelofmanagement
Appointdeputiesforkeymanagerialpersonnel
Ensurethatpersonnelisawareofrelevanceandimportanceoftheiractivities
Topmanagementshallensurepropercommunicationprocessesareestablishedregarding
effectivenessofthemanagementsystem

16. Technical Requirements to
Personnel (ISO 17025:2005, 5.2)
Laboratorymanagementshallensurethecompetenceofpersonnelforoperationspecificequipment,perform
tests,evaluateresults,signtestreports
Personnelresponsibleforopinionsandinterpretationatreportshaverelevantknowledgeoftechnologyincluding
legislation,understandingsignificanceofdeviations
Trainingprogramme:Managementformulatesgoalsforeducation,trainingandskillsofpersonnel.Needsare
identifiedandtrainingprogrammeisevaluated.
Jobdescriptions
minimalresponsibilitieswithrespecttoperformingtests,planningandevaluationoftests,reportingopinionsand
interpretations,methodmodificationandvalidationnewmethods.
Expertiseandexperiencerequired
Qualificationandtrainingprogrammes
Managerialduties
Authorizationtoperformparticulartypesofsampling,tests,issuingtestsreports,togiveopinionsand
interpretations,operationofparticularlytypesofequipment
Authorizationofspecifiedtasksisdoneincludingdateonwhichitisconfirmedandregistratedandreadily
available

17. Accommodation and environmental
conditions (ISO17025:2005, 5.3)
Laboratoryfacilitieswillfacilitatecorrectperformance
ofthetestsandaredocumented
Monitor,controlandrecordconditionsasrequiredby
relevantspecifications(biologicalsterility,dust,
humiditytemperature,electricalsupplyetc.)
Attentionforaccesstocertaintestareas,good
housekeepingandeffectiveseparationofincompatible
activities

18. Thank you