1. NABL ACCREDITATION

2. registered under Societies Act in1992
NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORIES (NABL)
is an autonomous body
registered under Societies Act in1992
under the aegis of Department of Science & Technology, Government of India. 

3. NABL
Grants accreditation in almost all areas of science, engineering and medical testing.
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. The International Picture
ILAC EA
APLAC
IAAC
SADCA
NABL, India
NABL ,as an accreditation body, operates its own system as per ISO/IEC
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

5. Scope of NABL Accreditation
Testing Laboratories
Biological
Chemical
Electrical
Electronics
Fluid-Flow
Mechanical
Non-Destructive Testing
Optical and Photometry
Radiological
Thermal
Forensic

6. Scope of NABL Accreditation
Calibration Laboratories
Electro-Technical
Mechanical
Radiological
Thermal
Optical
Fluid-Flow

7. Scope of NABL Accreditation
Medical Laboratories
Clinical Biochemistry
Clinical Pathology
Genetics
Cytopathology
Hematology & Immuno-haematology
Histopathology
Microbiology& Serology
Nuclear Medicine (only in-vitro tests)

8. MEDICAL LABORATORY ACCREDITATION
A very new concept
Given by ISO (International Organisation of Standardization)

9. Medical Laboratory Accreditation Compliance to ISO and getting it verified by third party Certificate of recognition (by NABL)

10. Medical Laboratories-Particular requirements for quality and competence”
Prepared by Technical Committee ISO/TC 212(medical laboratory professionals)
Being used in most of the developed countries

11. 1) True or reliable results(Accurate results)
2) Reproducible results( Precise results)
3) Timely release of the results(TAT)

12. CERTIFICATION Vs ACCREDITATION
Example ISO 9001:2005 Certification Certification does not make any statement about the technical competence of the laboratory.

13. Accreditation-Example ISO 15189
Uses criteria specifically developed to determine technical competence of the laboratory.
This is an independent evaluation of laboratory’s technical competence

14. In Sept. 2009, a joint IAF-ILAC-ISO Communiqué was issued.
It stated that “a medical laboratory’s fulfillment of the requirements of ISO 15189:2007 means the laboratory meets both the technical competence as well as management system requirements that are necessary for it to deliver technically valid test results.

15. BENEFITS OF 15189 ACCREDITATION
Stake holders- patients, insurance companies, referring clinicians
Laboratories
Other Benefits

16. Benefits of Accreditation (contd)
Accreditation benefits all stake holders.
Benefits to the customers
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.

17. 2.Increased confidence in reports : The labs are required to participate in proficiency testing which is again demonstration of competence. So, there is increased confidence in the reports released by the laboratory.
3.The customers get services by credential staff.
6.Savings in terms of time and money as it reduces or eliminates the need of re-testing.

18. Benefits of Accreditation (contd)
Benefits for the laboratory:
1.Use of NABL symbol: The accredited laboratories can issue test reports bearing the accreditation body’s symbol or endorsement, as an indication of accreditation.
2.International Recognition: Lab accreditation is highly regarded both nationally and internationally as an indicator of technical competence
3.Satisfaction of the staff: The staff in an accredited laboratory is satisfied as it provides for continuous learning ,good working environment, leadership. .

19. BENEFITS OF ACCREDITATION(CONTD)
4.Continuous improvement : Accreditation to a laboratory stimulates continuous improvement .It enables the laboratory in demonstrating commitment to quality test reports. 5.Systematic Control of lab work : Better control of laboratory operations and feedback to laboratories 6.Benchmark with best laboratories : It also provides opportunity to the laboratory to benchmark with the best

20. 7.Rise in business : There is marked increase in the business of the labs as the accredited status can be seen by the clients on NABL website.
Other Benefits:
1.It raises community confidence in the services provided by the laboratory.
2.Finally, Accreditation provides an objective system of empanelment by insurance and other third parties.
3.It encourages medical tourism.

21. CGHS Empanelment
In year 2009, mandatory NABL accreditation for CGHS empanelment gave a push which caused increased influx of application for accreditation.
The impact could be seen in year 2010 & 2011 as increase in number of labs which were granted accreditation

22. ACCREDITATION PROCESS
Application for Accreditation
(by Laboratory)
Feedback to
Laboratory
and
Necessary
Corrective
Action by
Acknowledgement & Scrutiny of Application
(by NABL Secretariat) )
Adequacy of Quality Manual
(by Lead Assessor)
Pre-Assessment of Laboratory
(by Lead Assessor)
Final Assessment of Laboratory
(by Assessment Team)
Scrutiny of Assessment Report
(by NABL Secretariat)
Recommendations for Accreditation
(by Accreditation Committee)
Approval for Accreditation
(( by Chairman NABL)
Issue of Accreditation Certificate
(by NABL Secretariat)

23. Accreditation Certificate

24. How scope is defined – Medical Laboratory (Biochemistry) (LAB - XYZ)
Cont’d..

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. Assessors Training Programs
NABL organizes its own Assessors’ training courses as per ISO/IEC and ISO
NABL has trained over 1000 assessors out of which are presently empanelled.
NABL has organized Assessors’ training courses for Sri Lanka, Nepal, Bangladesh, Mauritius & Mongolia.
Assessors Conclave

27. Customer Profile Private Medical Testing Laboratories :
SRL Ranbaxy Limited, Mumbai
Dr. Lal Path Labs Pvt., Ltd., New Delhi
Max Labs 24X7, Max Super Speciality Hospital, New Delhi
Apollo Gleneagles Hospitals, Kolkata
Wockhardt Laboratory Services, Bangalore
TATA Memorial Hospital – Diagnostic Services, Mumbai
B. M. Birla Heart Research Centre, Kolkata
Reliance Life Sciences Pvt. Ltd., Mumbai
Manipal Acunova – Central Reference Laboratory, Bangalore
Sir Ganga Ram Hospital, Clinical Laboratory Services, New Delhi
Metropolis Health Services (India) private Limited, Mumbai

28. Status of NABL Accreditation (as on 31st December 2012)
Testing Laboratories
Laboratories accredited : 1001
Calibration Laboratories
Laboratories accredited : 396
Medical Laboratories
Laboratories accredited : 392
Total Laboratories Accredited : 1789

29. NABL WEBSITE
NABL provides the information of Accredited laboratories in its web site

30. NABL ADDRESS Registered Office Department of Science & Technology
Technology Bhavan
New Mehrauli Road, New Delhi –
NABL Secretariat (Contact Address)
3rd Fl., NISCAIR, 14 Satsang Vihar Marg, New Mehrauli Rd,
New Delhi
Ph: /19/20/
Fax :

31. THANKS