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NABL 2012 VS 2022
1. NABL
Dr. Ajit Kumar Singh
1st year PGT
CNCI, Kolkata, 700160
Moderator
Dr. Subharanshu Mandal MD
Associate professor
Department of laboratory medicine
Chittaranjan National Cancer Institute
Kolkata 700160
2. Pravin
Mali
QCI
NABL – General
Scope of NABL
Accreditation Areas
Certification Vs Accreditation
Process of NABL Accreditation
Benefit of Accreditation
Chittaranjan National Cancer Institute
Kolkata 700160
3. INTRODUCTION
NABL – National Accreditation Board for Testing and Calibration Laboratory
•NABL Accreditation – provides the accreditation to Conformity Assessment Bodies
(Laboratories).
•NABL Schemes – include accreditation of technical competence of testing,
calibration, medical testing laboratories, proficiency testing laboratories and reference
material providers.
• NABLis a constituent board of Quality Council of India
•NABL assesses laboratories in India for quality and consistency in their results.
Chittaranjan National Cancer Institute
Kolkata 700160
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QCI is governed by a Council of 38 members with equal representations of
government, industry and consumers.
⦿Chairman of QCI is appointed by the Prime Minister's office on recommendation of
the government and industry.
⦿Council is the apex level body responsible for formulating the
strategy,
general policy,
constitution and
monitoring of various components of QCI .
⦿Each Board functions independently with its own Chairperson appointed by the QCI.
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⦿ is an autonomous body
⦿ registered under
Societies Act in1992
⦿under the aegis of
Department of Science &
Technology, Government
of India.
Chittaranjan National Cancer Institute
Kolkata 700160
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NABL is signatory to APLAC / ILAC Mutual Recognition
Arrangements (MRA) since 2000 after its first evaluation
by APLAC .
Second & Third evaluation by APLAC in 2004 & 2008
respectively.
Fourth evaluation Completed in Sep 2012.
Chittaranjan National Cancer Institute
Kolkata 700160
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⦿NABL Grants accreditation in almost all
areas of science, engineering and medical
testing.
The international standards followed are :
ISO 15189:2012 (for Medical
Testing) , or ISO 15189:2022
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
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
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CERTIFICATION ACCREDITATION
⦿Certification is a
comprehensive
evaluation of a process,
system, product,
event, or skill typically
measured against some
existing norm or
standard.
⦿Certification does not
make any statement
about the technical
competence of the
laboratory.
Example ISO
9001:2005
Certification
⦿Accreditation is the formal
declaration by a neutral third
party that the certification
program is administered in a
way that meets the relevant
norms or standards of
certification program.
⦿This is an independent
evaluation of
laboratory’s technical
competence.
Example
ISO 17025 Accreditation
Chittaranjan National Cancer Institute
Kolkata 700160
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o Individuals can search laboratories
o Increased confidence in reports
o The individuals get services by credential staff.
o Savings in terms of time and money as it reduces
or eliminates the need of re-testing.
Chittaranjan National Cancer Institute
Kolkata 700160
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o Use of NABL symbol
o International Recognition
o Satisfaction of the staff
o Continuous improvement
o Systematic Control of lab work Chittaranjan National Cancer Institute
Kolkata 700160
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o Benchmark with best laboratories
o Rise in business
Chittaranjan National Cancer Institute
Kolkata 700160
29. NABL ACCREDITATION PROCESS
1. Application for accreditation
2. Acknowledgement & scrutiny of application by NABL
secretariat
3. Adequacy of quality manual
4. Pre-assessment of laboratory by lead assessor
5. Final assessment of laboratory by assessment team
6. Scrutiny of assessment report by NABL secretariat
7. Recommendation for accreditation by accreditation
committee
8. Approval for accreditation by chairman of NABL
9. Issue of NABLCertificate by NABLsecretariat.
During steps 2 - 6 feedback to laboratory is given and they
are recommended to do the necessary corrective action.
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1.Application for Accreditation
(by Laboratory)
2.Acknowledgement & Scrutiny of Application
(by NABL Secretariat)
Adequacy of Quality Manual
(by Lead Assessor)
Pre-Assessment of Laboratory
(by Lead Assessor)
FinalAssessment of Laboratory
(by Assessment Team)
Scrutiny of Assessment Report
(by NABL Secretariat)
Recommendations forAccreditation
(by Accreditation Committee)
Approval for Accreditation
(( by Chairman NABL)
Issue of Accreditation Certificate
(by NABL Secretariat)
Feedback
to
Laboratory
and
Necessary
Corrective
Action
by
Laboratory
Chittaranjan National Cancer Institute
Kolkata 700160
31. APPROACHES TO OBTAIN ACCREDITATION
10 approaches forAccreditation
1. Awareness training should be given to the management and all the personnel
involved.
2. Quality policy & Objectives should be established
3. Gap Analysis – analysis of all the departments in the hospital and the
relationship between each departments
4. Documentation / process design
5. Documentation / process implementation
6. Internal audit by the company itself.
7. Management review meeting
8. Shadow audit – external audit
9. Corrective – preventive actions
10. Final certification audit
Chittaranjan National Cancer Institute
Kolkata 700160
