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NABL ACCREDITATION

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NABL ACCREDITATION NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORIES (NABL) is an autonomous body registered under Societies Act in1992 under the ... – PowerPoint PPT presentation

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Title: NABL ACCREDITATION


1
NABL ACCREDITATION
2
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 151892007 (for Medical Testing) ,
  • ISO/IEC 170252005 (for Testing, calibration)
  • ISO 170432010 (for PT providers)

4
The International Picture
  • NABL, India

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
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 15189 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 90012005 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
    laboratorys technical competence

14
  • In Sept. 2009, a joint IAF-ILAC-ISO Communiqué
    was issued.
  • It stated that a medical laboratorys
    fulfillment of the requirements of ISO 151892007
    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
    bodys 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 Correctiv
e Action by Laboratory
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)
Contd..
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 17025 and ISO 15189.
  • NABL has trained over 1000 assessors out of which
    829 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 www.nabl-india.org

30
NABL ADDRESS
  • Registered Office
  • Department of Science Technology
  • Technology Bhavan
  • New Mehrauli Road, New Delhi 110 016
  • NABL Secretariat (Contact Address)
  • 3rd Fl., NISCAIR, 14 Satsang Vihar Marg, New
    Mehrauli Rd,
  • New Delhi-110 067
  • Ph 011 26529718/19/20/24649999
  • Fax 011 26529716
  • Email info_at_nabl-india.org

31
THANKS
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