NABL 2012 VS 2022

NABL

1. NABL
Dr. Ajit Kumar Singh
1
st
year PGT
CNCI, Kolkata, 700160
Moderator
Dr. SubharanshuMandal MD
Associate professor
Department of laboratory medicine
Chittaranjan National Cancer Institute
Kolkata 700160

2. PravinMali
QCI
NABL–General
ScopeofNABL
Accreditation Areas
CertificationVsAccreditation
ProcessofNABL Accreditation
Benefit of Accreditation
Chittaranjan National Cancer Institute
Kolkata 700160

3. INTRODUCTION
NABL–NationalAccreditationBoardforTestingandCalibrationLaboratory
•
NABLAccreditation–providestheaccreditationtoConformityAssessmentBodies
(Laboratories).
•
NABLSchemes –includeaccreditationoftechnicalcompetenceoftesting,
calibration,medicaltestinglaboratories,proficiencytestinglaboratoriesandreference
materialproviders.
•NABLisaconstituentboardofQualityCouncilofIndia
•
NABLassesseslaboratoriesinIndiaforqualityandconsistencyintheirresults.
Chittaranjan National Cancer Institute
Kolkata 700160

4. PravinMali
Primeministeroffice
Chittaranjan National Cancer Institute
Kolkata 700160

5. PravinMali
QCIisgovernedby aCouncilof38memberswithequalrepresentationsof
government,industryandconsumers
.
⦿Chairman of QCI is appointed by the Prime Minister's office onrecommendationof
thegovernmentandindustry.
⦿Council is the apex level body responsible for formulating the

strategy,

generalpolicy,

constitutionand

monitoringofvariouscomponentsofQCI.
⦿Each Board functions independently with its own Chairpersonappointedby theQCI.

6. PravinMali
⦿is anautonomousbody
⦿registeredunder
SocietiesActin1992
⦿under the aegis of
Department of Science&
Technology, Government
of India.
Chittaranjan National Cancer Institute
Kolkata 700160

7. PravinMali

NABL is signatory to APLAC / ILAC Mutual Recognition
Arrangements(MRA)since2000 afteritsfirstevaluation
byAPLAC.

Second&ThirdevaluationbyAPLACin2004 & 2008
respectively.

FourthevaluationCompletedinSep2012.
Chittaranjan National Cancer Institute
Kolkata 700160

8. PravinMali
Chittaranjan National Cancer Institute
Kolkata 700160

9. PravinMali
⦿
NABL Grants accreditation in almost all
areas ofscience,engineeringandmedical
testing.
The internationalstandardsfollowedare:

ISO15189:2012(forMedical
Testing),or ISO 15189:2022
Chittaranjan National Cancer Institute
Kolkata 700160

10. NABLACCREDITATIONAREAS
TESTING
LABORATORIES
•
Biological,
Chemical,
Electricaltesting,
Thermal,
Forensic
CALIBRATION
LABORATORIES
•
Electro-technical,
mechanical,
radiological,
thermal,optical,
fluidflow
MEDICAL
LABORATORIES
•
Clinicalbiochemistry
•Clinical pathology
•Hematology
•Immunology
•Histopathology
•Genetics
•Cytopathology
•Serology
•Microbiology
Chittaranjan National Cancer Institute
Kolkata 700160

11. PravinMali
Biological,
Chemical,
Electrical,
Electronics,Fluid-
Flow,Mechanical,
non-Destructive
Testing,
Optical&
Photometry,
Radiological,
Thermal,Forensic
Electro-Technical
Mechanical
Radiological
Thermal
Optical
Fluid-Flow
Clinical Biochemistry
Clinical Pathology
Genetics
Cytopathology
Hematology&Immuno-
haematology
Histopathology
Microbiology&Serology
Nuclear Medicine(only
in-vitrotests)
TestingLaboratoriesCalibrationLaboratoriesMedicalLaboratories
Chittaranjan National Cancer Institute
Kolkata 700160

12. ISO:15189
over the years

2007

Previously
ISO 15189:2007
2012
Now
ISO 15189:2012
2022
Replace by
ISO 15189:2022
Chittaranjan National Cancer Institute
Kolkata 700160

13. Changes in ISO 15189:2022

ISO 15189:2012
1.
Scope
2.
Normative references
3.
Term and definitions
4.
Management requirements
5.
Technical requirements
ISO 15189:2022
1. Scope
2. Normative references
3. Term and definitions
4. General requirements
5. Structural and governance
requirements
6. Resource requirements
7. Process requirements
8. Management system
requirements
Chittaranjan National Cancer Institute
Kolkata 700160

14. 5.1 Personnel

5.1.1 GENERAL

5.1.2 PERSONNEL QUALIFICATIONS

5.1.3 JOB DESCRIPTIONS

5.1.4 PERSONNEL INTRODUCTION TO THE ORGANIZATIONAL ENVIRONMENT

5.1.5 TRAINING

5.1.6 COMPETENCE ASSESSMENT

5.1.7 REVIEWS OF STAFF PERFORMANCE

5.1.8 CONTINUING EDUCATION AND PROFESSIONAL DEVELOPMENT

5.1.9 PERSONNEL RECORDS

15. 5.2 Accommodation and environmental
conditions

5.2.1 GENERAL

5.2.2 LABORATORY AND OFFICE FACILITIES

5.2.3 STORAGE FACILITIES

5.2.4 STAFF FACILITIES

5.2.5 PATIENT SAMPLE COLLECTION FACILITIES

5.2.6 FACILITY MAINTENANCE AND ENVIRONMENTAL CONDITIONS

16. 5.3 Laboratory equipment, reagents, and
consumables

5.3.1 EQUIPMENT

5.3.2 REAGENTS AND CONSUMABLES

17. 5.4 Pre-examination processes

5.4.1 GENERAL

5.4.2 INFORMATION FOR PATIENTS AND USERS

5.4.3 REQUEST FORM INFORMATION

5.4.4 PRIMARY SAMPLE COLLECTION AND HANDLING

5.4.5 SAMPLE TRANSPORTATION

5.4.6 SAMPLE RECEPTION

5.4.7 PRE-EXAMINATION HANDLING, PREPARATION AND STORAGE

18. 5.5 Examination processes

5.5.1 SELECTION, VERIFICATION AND VALIDATION OF EXAMINATION
PROCEDURES

5.5.2 BIOLOGICAL REFERENCE INTERVALS OR CLINICAL DECISION VALUES

5.5.3 DOCUMENTATION OF EXAMINATION PROCEDURES

19. 5.6 Ensuring quality of examination results

5.6.1GENERAL

5.6.2QUALITY CONTROL

5.6.3INTERLABORATORY COMPARISONS

5.6.4COMPARABILITY OF EXAMINATION RESULTS

20. 5.7 Post-analyses processes

5.7.1REVIEW OF RESULTS

5.7.2STORAGE, RETENTION AND DISPOSAL OF CLINICAL SAMPLES

21. 5.8 Reporting of results

5.8.1GENERAL

5.8.2REPORT ATTRIBUTES

5.8.3REPORT CONTENT

22. 5.9 Release of results

5.9.1GENERAL

5.9.2AUTOMATED SELECTION AND REPORTING OF RESULTS

5.9.3REVISED REPORTS

23. Application of the new standard

Beyond medical laboratories to other healthcare
services such as
•
Diagnostic imaging
•
Respiratory therapy
•
Physiological sciences
•
Blood banks and transfusion services

The use of this standard will help to
•
Facilitate cooperation between medical laboratories and other healthcare services.
•
Assist in the exchange of information , and
•
Harmonization of methods and procedures.
Chittaranjan National Cancer Institute
Kolkata 700160

24. PravinMali
CERTIFICATION
ACCREDITATION
⦿Certification is a
comprehensive
evaluation of a process,
system, product,
event, or skill typically
measured against some
existingnorm or
standard.
⦿Certification does not
make any statement
about the technical
competence of the
laboratory.
ExampleISO
9001:2005
Certification
⦿Accreditation is the formal
declaration by a neutral third
party that the certification
program isadministered in a
way that meets the relevant
norms or standards of
certification program.
⦿Thisisanindependent
evaluationof
laboratory’stechnical
competence.
Example
ISO17025Accreditation
Chittaranjan National Cancer Institute
Kolkata 700160

25. Customer Laboratory Others
Chittaranjan National Cancer Institute
Kolkata 700160

26. PravinMali
oIndividualscansearchlaboratories
oIncreasedconfidenceinreports
oTheindividualsgetservicesbycredentialstaff.
oSavingsintermsoftimeandmoneyasitreduces
oreliminatestheneedofre-testing.
Chittaranjan National Cancer Institute
Kolkata 700160

27. PravinMali
oUseofNABLsymbol
oInternationalRecognition
oSatisfactionofthestaff
oContinuous improvement
oSystematic Control of lab work
Chittaranjan National Cancer Institute
Kolkata 700160

28. PravinMali
oBenchmarkwithbestlaboratories
oRiseinbusiness
Chittaranjan National Cancer Institute
Kolkata 700160

29. NABLACCREDITATIONPROCESS
1.Applicationforaccreditation
2.Acknowledgement&scrutinyofapplicationbyNABL
secretariat
3.Adequacyofqualitymanual
4.Pre-assessmentoflaboratorybylead assessor
5.Finalassessmentoflaboratorybyassessmentteam
6.ScrutinyofassessmentreportbyNABLsecretariat
7.Recommendationforaccreditationbyaccreditation
committee
8.Approvalforaccreditation bychairmanofNABL
9.IssueofNABLCertificatebyNABLsecretariat.
Duringsteps2-6feedbacktolaboratoryisgivenandthey
arerecommendedtodo thenecessary correctiveaction.

30. PravinMali
1.ApplicationforAccreditation
(byLaboratory)
2.Acknowledgement&ScrutinyofApplication
(byNABLSecretariat)
AdequacyofQualityManual
(by LeadAssessor)
Pre-AssessmentofLaboratory
(by LeadAssessor)
FinalAssessmentofLaboratory
(byAssessmentTeam)
ScrutinyofAssessment Report
(byNABLSecretariat)
RecommendationsforAccreditation
(byAccreditationCommittee)
ApprovalforAccreditation
((byChairmanNABL)
IssueofAccreditationCertificate
(byNABLSecretariat)
Feedback
to
Laboratory
and
Necessary
Corrective
Action
by
Laboratory
Chittaranjan National Cancer Institute
Kolkata 700160

31. APPROACHESTOOBTAINACCREDITATION
10approachesforAccreditation
1.Awarenesstrainingshouldbegiventothemanagement andallthepersonnel
involved.
2.Qualitypolicy &Objectives should beestablished
3.GapAnalysis–analysisofallthedepartmentsinthe hospitalandthe
relationshipbetweeneachdepartments
4.Documentation/processdesign
5.Documentation/processimplementation
6.Internalauditbythecompany itself.
7.Managementreview meeting
8.Shadow audit–externalaudit
9.Corrective –preventiveactions
10.Finalcertification audit
Chittaranjan National Cancer Institute
Kolkata 700160

32. Thank you…