NABL provides accreditation to laboratories in India based on international standards like ISO 15189 and ISO 17025. It ensures laboratories are properly qualified and provides benefits like increased confidence in test reports and worldwide acceptance. The accreditation process involves an application, document review, assessment of the laboratory's management system and technical competence, and surveillance after accreditation is granted. If qualified, NABL issues an accreditation certificate valid for two years.

1. NABL
CERTIFICATION
AND
ACCREDITATION
PRESENTED BY: SONIA
M.PHARM(PA & QA)
LAUREATE INSTITUTE OF PHARMACY

2. NABL
• NABL National Accreditation Board for Testing and
Calibration Laboratories Under QCI of Government of
India.
• is an autonomous body
• registered under Societies Act in1992

3. THE INTERNATIONAL STANDARDS FOLLOWED
ARE :
• ISO 15189:2007 (for Medical Testing) ,
• ISO/IEC 17025:2005 (for Testing, calibration)
• ISO 17043:2010 (for PT providers)

4. ILAC – INTERNATIONAL
LABORATORY ACCREDITATION
COOPERATION.
APLAC – ASIA PACIFIC
LABORATORY ACCREDITATION
COOPERATION.
MRA – MUTUAL RECOGNITION
AGREEMENT
IAF : INTERNATIONAL
ACCREDITATION FORUM

5. NABL
• NABL ,as an accreditation body, operates its own system as per ISO/IEC 17011 .
• 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
• NABL has agreements with ILAC (International Laboratory Accreditation
Conference) and APLAC (Asia Pacific Laboratory Accreditation Cooperation).
These are especially valuable for International recognition and mutual acceptance
of test results. In short accreditation has worldwide acceptance.

6. ACCREDITATION
• accreditation is a procedure by which an authoritative body gives formal recognition of technical
competence for specific tests/ measurements, based on third party assessment and following
international standard.
• General requirements for laboratories or other organizations, to be considered competent to carry
out sampling, testing including Diagnostic Radiology QA Testing and Software & IT System testing
(other than medical) and calibration are specified in the International Standard ISO/IEC 17025:2005
or ISO/IEC 17025:2017.l
• Scope of NABL Accreditation :
• Testing laboratories
• Calibration laboratories
• Medical laboratories

7. BENEFITS OF ACCREDITATION
• Customers can search laboratories: Customers can search and
identify the laboratories accredited by NABL for their specific
requirements from the NABL website or Directory of accredited
laboratories.
• Increased confidence in reports.
• The customers get services by credential staff.
• Savings in terms of time and money as it reduces or eliminates the
need of re-testing.

8. • Continuous improvement :Accreditation to laboratory stimulates
continuous improvement .It enables the laboratory in
demonstrating commitment to quality test reports.
• Systematic Control of lab work: Better control of laboratory
operations and feedback to laboratories.
• Benchmark with best laboratories : It also provides opportunity to
the laboratory to benchmark with the best

9. SCOPE OF NABL ACCREDITATION :
1) Testing Laboratories
• Biological
• Chemical Electrical
• Electronics
• Fluid-Flow Mechanical
• Non-Destructive Testing
• Optical and Photometry
• Radiological
• Thermal
• Forensic

10. 2) Calibration Laboratories
• Electro-Technical
• Mechanical
• Radiological
• Thermal
• Optical
• Fluid-Flow

11. 3) Medical Laboratories
• Clinical Biochemistry
• Clinical Pathology
• Genetics
• Cytopathology Hematology & Immuno-haematology
• Histopathology
• Microbiology& Serology
• Nuclear Medicine (only in-vitro tests)

12. OTHER ACCREDITATIONS
• PROFICIENCY TESTING PROVIDERS
(PTP)
• Testing
• Calibration
• Medical
• Inspection
• MATERIAL PRODUCERS (RMP)
• Chemical Composition
• Biological & Clinical Properties
• Physical Properties
• Engineering Properties
• Miscellaneous Properties

13. PREPARATION OF CAB BEFORE APPLYING FOR
NABL ACCREDITATION
• Appoint quality manager who has done “Internal Auditor Course
as per ISO:15189:2012.”
• Designate QM, TM & LD
• EQAS & IQC for all parameters
• Prepare quality manual and quality system manual
• Preparing SOP and WDI related to different process
• Training for all laboratory personnel.

14. ACCREDITATION
PROCEDURE

15. 1) APPLICATION FOR ACCREDITATION
• CABs are required to apply through NABL Web Portal (www.nabl-india.org) to
NABL in prescribed application form :
• NABL 151, NABL 152, NABL 153 : for Testing/ Calibration Laboratories .
• NABL 156 : Medical Imaging- Conformity Assessment Body (MI-CAB) .
• NABL 180 and NABL 190 : Proficiency Testing Providers & Reference Material
Producers
• NABL 100 : application fee

16. 2)ACKNOWLEDGEMENT AND REGISTRATION OF
APPLICATION
• NABL Secretariat send an acknowledgement
with a unique ID number to the CAB on
receipt of online application form along with
Management system document / quality
manual and the fees,.

17. 3)APPOINTMENT OF LEAD ASSESSOR
• NABL secretariat appoints a Lead assessor from
the list of empanelled assessors. The lead assessor
does the document review on behalf of NABL and
submits the report to NABL secretariat.

18. 4)DOCUMENT REVIEW
• The preliminary document review of the
application and management system document/
quality manual submitted by the CAB is carried
out by NABL Secretariat .
• Detailed review is carried out by Lead Assessor.

19. 5)PRE-ASSESSMENT
• Pre –assessment of the CAB is conducted by lead assessor appointed by NABL.
Since Pre-assessment is optional, CAB shall express its willingness in writing to
undergo the same.
• The pre-assessment of the CAB is conducted to:
• Evaluate non-conformities (if any) in the implementation of the quality system.
• Assess the degree of preparedness of the CAB for the assessment
• Determine the number of assessors required in various fields based on the
scope of accreditation, number of key locations to be visited etc.

20. 6) ASSESSMENT
• NABL proposes constitution of an assessment team.
• The team includes the lead assessor , the technical assessors/
experts in order to cover various fields within the scope of
accreditation sought.
• NABL seeks CAB’s acceptance for the proposed assessment team
and the CAB is free not to accept one or more members of the
proposed assessment team by giving specific reason for their non
–acceptance.
• NABL fixes dates for on-site assessment in consultation with the

21. • The documented Management system, SOPs, work instructions, test
methods etc. are assessed for their effectiveness.
• The CAB’s technical competence to perform specific tasks is also
evaluated.
• The assessment report contains the evaluation of technical
manpower, all relevant material examined, test witnessed including
those of replicate testing/ measurement, compliance to ISO/ IEC
guidelines.
• Assessment report. also provides a recommendation towards grant
of accreditation or otherwise.
• Assessment report prepared by the assessment team is sent to
NABL Secretariat.

22. 7)SCRUTINY OF ASSESSMENT REPORT
• The assessment report is examined by NABL Secretariat
and follow up action as required is initiated.
• CAB has to take necessary corrective action on non –
conformities/ concerns and submit a report to NABL
Secretariat within 30 days.
• NABL monitors the progress of closing of non –
conformities.

23. 8)ACCREDITATION COMMITTEE
• The Accreditation Committee examines the assessment report, additional information
received from the CAB .
• In case the Accreditation Committee finds deficiencies in the assessment report, the
NABL Secretariat obtains clarification from the Lead Assessor/ Assessor/ CAB concerne
• He Accreditation Committee makes appropriate recommendations regarding
accreditation of the CAB to the Chairman, NABL.
• All decisions taken by NABL regarding grant of accreditation are open to appeal by the
CAB the appeal is to be addressed to the CEO, NABL.

24. 9)ISSUE OF ACCREDITATION CERTIFICATE
•When the recommendation results in the
grant of accreditation, NABL issues an
accreditation certificate which has a unique
number and QR Code, discipline, date of
validity along with the scope of
accreditation.

25. SURVEILLANCE & RE-ASSESSMENT
• The Accreditation is valid for the period of 2 years.
• NABL conducts an annual Surveillance of the accredited
laboratories.
• The laboratory must apply for renewal of accreditation at
least six months before the expiry of validity of accreditation.
• A Re-assessment is similar to the final Assessment and is
conducted before the expiry of Accreditation.

26. THANK YOU