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NABL Accreditation
MB
1
What is NABL ?
NABL specifies the general requirements
for the competence to carry out tests and
calibrations, including sampling. It covers
testing and calibration performed using
standard methods, non-standard methods,
and laboratory-developed methods.
MBS
2
National Accreditation Board for Testing and Calibration Laboratories
(NABL) is an autonomous body under the aegis of Department of Science &
Technology, Government of India, and is registered under the Societies Act.
NABL has been established with the objective to provide Government,
Industry and Society in general with a scheme for third- party assessment of
the quality and technical competence of testing and calibration laboratories.
Government of India has authorized NABL as the sole accreditation body
for Testing and Calibration laboratories.
In order to achieve this objective, NABL provides laboratory accreditation
services to laboratories that are performing tests / calibrations in accordance
with NABL criteria based on internationally accepted standard for laboratory
accreditation ISO/IEC 17025.
These services are offered in a non-discriminatory manner and are
accessible to all testing and calibration laboratories in India and abroad,
regardless of their ownership, legal status, size and degree of independence.
NABL has established its Accreditation System in accordance with ISO/IEC
17011:2004, which is followed internationally. NABL also compiles to the
requirement of APLAC MR001 for the fulfillment of APLAC MRA and ILAC
Arrangements. 192
MBS
3
Location of NABLOffice:
NABL Secretariat is functioning from its office situated at 3rd
Floor, NISCAIR, 14, Satsang Vihar Marg, New Mehrauli Road – New
Delhi 110067.
NABL Secretariat administers and co-ordinates all activitiesof
NABL including accreditation related activities for Testingand
Calibration laboratories.
Registered Office of NABL is located in Department of Science &
Technology, Technology Bhavan, and New Mehrauli Road, New Delhi
– 110016.
Office Timing: The working days of NABL are from Monday to
Friday. The office timings are from 9-00 a.m. to 5-30 p.m.
MBS
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CONCEPT
The concept of Laboratory Accreditation was developed to provide a means for third-
party certification of the competence of laboratories to perform specific type(s) of testing
and calibration.
Laboratory Accreditation provides formal recognition of competent laboratories, thus
providing a ready means for customers to find reliable testing and calibration services in
order to meet their demands.
Laboratory Accreditation enhances customer confidence in accepting testing/
calibration reports issued by accredited laboratories.
The globalization of Indian economy and the liberalization policies initiated by the
Government in reducing trade barriers and providing greater thrust to exports makes it
imperative for Accredited Laboratories to be at international level of competence.
MBS
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Benefits of Accreditation:
Potential increase in business due to enhanced
customer confidence and satisfaction.
Savings in terms of time and money due to
reduction or elimination of the need for re-testing .
Better control of laboratory operations and
feedback to laboratories as to whether they have
sound Quality Assurance System and are
technically competent.
MBS
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Increase of confidence in Testing / Calibration data
and personnel performing work.
Customers can search and identify the
laboratories accredited by NABL for their specific
requirements from the directory of Accredited
Laboratories.
Users of accredited laboratories will enjoy greater
access for their products, in both domestic and
international markets, when tested by accredited
laboratories.
MBS
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Types of Laboratory can seek
Accreditation:
Laboratories undertaking any sort of testing or
calibration in the specified fields.
Private or government laboratories.
Small operations to large multi-field laboratories.
Site facilities, temporary field operations and
mobile laboratories.
MBS
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TESTING
LABORATORIES
CALIBRATION
LABORATORIES
MEDICAL
LABORATORIES
 Biological
 Chemical
 Electrical
 Electronics
 Fluid-Flow
 Mechanical
 Non-Destructive
Testing
 Photometry
 Radiological
 Thermal
 Forensic
 Electro-Technical
 Mechanical
 Fluid Flow
 Thermal & Optical
 Radiological
 Clinical Biochemistry
 Clinical Pathology
 Haematology &
Immunohaematology
 Microbiology & Serology
 Histopathology
 Cytopathology
 Genetics
 Nuclear Medicine
(in- vitro tests only)
PROFICIENCY TESTING PROVIDERS
REFERENCE
MATERIAL
PRODUCERS
 Testing
 Calibration
 Medical
 Inspection
 Chemical Composition
 Biological &
Clinical Properties
 Physical Properties
 Engineering Properties
 Miscellaneous Properties
198
MBS
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10 Step Approach To
Accreditation
Awareness Training
Quality Policy & Objectives Finalization
Gap Analysis
Documentation / Process Design
Documentation / Process Implementation
Internal Audit
Management Review Meeting
Shadow Audit
Corrective –Preventive Actions
Final Certification Audit
MBS
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Step 1:- Awareness Training
Separate training sessions for top
management, middle management and
junior level management.
Creates a motivating environment
throughout the organization for ISO 17025
implementation.
MBS
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Step 2:-Quality Policy &
Objectives
Work shop with top management on
development of quality policy.
Work shop with top management and
middle level functional management on
development of quality objectives.
MBS
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Step 3:-Gap Analysis
Understanding of all the operations of the
organization.
Development of process map for the
activities of the organization.
Comparing existing operations with
requirements of ISO 17025:2005 standard.
MBS
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Step 4:-Documentation /
Process Design
Quality Manual
Functional Procedures
Work Instructions
System Procedures
Formats
MBS
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Step 5:-Documentation /
Process Implementation
Work–shop on process / document
implementation as per ISO 17025
requirements.
Departmental / Individual assistance in
implementing the new processes /
documents.
MBS
15
Step 6:-Internal Audit
Internal Audit Training & Examination
(Optional).
Successful employees / we carry out
internal audit of the organization covering
all the departments and operations.
Suggest corrective and preventive actions
for improvements in each of the audited
departments.
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Step 7:-Management Review
Meeting
Quality Policy & Objectives
Results of internal audit
Results of supplier evaluation
Results of customer complaints
Results of customer feedback etc.
MBS
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Step 8:-Shadow Audit
A replica of final certification audit.
Finds degree of compliance with ISO
17025 standard.
Gives an idea to the employees about the
conduct of the final certification audit.
MBS
18
Step 9:-Corrective –
Preventive Actions
On the basis of shadow audit conducted in
the last step, all the non-conformities will
be assigned corrective and preventive
actions.
A check will ensure that all the NCs are
closed and the organization is ready for the
final certification audit.
MBS
19
Step 10:-Final Certification
Audit
Upon completion of various stages of
accreditation audit, the audit, your
organization will be awarded accreditation.
Reference
http://www.nabl-india.org
MBS
21
MBS
22
TRY TO REMEMBER THIS FOR GPAT 2021????????
1. Abbreviation of NABL.
2.Location of NABL office.
3.Benefits of Accreditation.
4.Types of laboratories can seek
accreditation.
5.10 step approach.
MBS
23
THANK
YOU
ALL
THE
BEST
MBS

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NABL.pptx

  • 2. What is NABL ? NABL specifies the general requirements for the competence to carry out tests and calibrations, including sampling. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods. MBS 2
  • 3. National Accreditation Board for Testing and Calibration Laboratories (NABL) is an autonomous body under the aegis of Department of Science & Technology, Government of India, and is registered under the Societies Act. NABL has been established with the objective to provide Government, Industry and Society in general with a scheme for third- party assessment of the quality and technical competence of testing and calibration laboratories. Government of India has authorized NABL as the sole accreditation body for Testing and Calibration laboratories. In order to achieve this objective, NABL provides laboratory accreditation services to laboratories that are performing tests / calibrations in accordance with NABL criteria based on internationally accepted standard for laboratory accreditation ISO/IEC 17025. These services are offered in a non-discriminatory manner and are accessible to all testing and calibration laboratories in India and abroad, regardless of their ownership, legal status, size and degree of independence. NABL has established its Accreditation System in accordance with ISO/IEC 17011:2004, which is followed internationally. NABL also compiles to the requirement of APLAC MR001 for the fulfillment of APLAC MRA and ILAC Arrangements. 192 MBS 3
  • 4. Location of NABLOffice: NABL Secretariat is functioning from its office situated at 3rd Floor, NISCAIR, 14, Satsang Vihar Marg, New Mehrauli Road – New Delhi 110067. NABL Secretariat administers and co-ordinates all activitiesof NABL including accreditation related activities for Testingand Calibration laboratories. Registered Office of NABL is located in Department of Science & Technology, Technology Bhavan, and New Mehrauli Road, New Delhi – 110016. Office Timing: The working days of NABL are from Monday to Friday. The office timings are from 9-00 a.m. to 5-30 p.m. MBS 4
  • 5. CONCEPT The concept of Laboratory Accreditation was developed to provide a means for third- party certification of the competence of laboratories to perform specific type(s) of testing and calibration. Laboratory Accreditation provides formal recognition of competent laboratories, thus providing a ready means for customers to find reliable testing and calibration services in order to meet their demands. Laboratory Accreditation enhances customer confidence in accepting testing/ calibration reports issued by accredited laboratories. The globalization of Indian economy and the liberalization policies initiated by the Government in reducing trade barriers and providing greater thrust to exports makes it imperative for Accredited Laboratories to be at international level of competence. MBS 5
  • 6. Benefits of Accreditation: Potential increase in business due to enhanced customer confidence and satisfaction. Savings in terms of time and money due to reduction or elimination of the need for re-testing . Better control of laboratory operations and feedback to laboratories as to whether they have sound Quality Assurance System and are technically competent. MBS 6
  • 7. Increase of confidence in Testing / Calibration data and personnel performing work. Customers can search and identify the laboratories accredited by NABL for their specific requirements from the directory of Accredited Laboratories. Users of accredited laboratories will enjoy greater access for their products, in both domestic and international markets, when tested by accredited laboratories. MBS 7
  • 8. Types of Laboratory can seek Accreditation: Laboratories undertaking any sort of testing or calibration in the specified fields. Private or government laboratories. Small operations to large multi-field laboratories. Site facilities, temporary field operations and mobile laboratories. MBS 8
  • 9. TESTING LABORATORIES CALIBRATION LABORATORIES MEDICAL LABORATORIES  Biological  Chemical  Electrical  Electronics  Fluid-Flow  Mechanical  Non-Destructive Testing  Photometry  Radiological  Thermal  Forensic  Electro-Technical  Mechanical  Fluid Flow  Thermal & Optical  Radiological  Clinical Biochemistry  Clinical Pathology  Haematology & Immunohaematology  Microbiology & Serology  Histopathology  Cytopathology  Genetics  Nuclear Medicine (in- vitro tests only) PROFICIENCY TESTING PROVIDERS REFERENCE MATERIAL PRODUCERS  Testing  Calibration  Medical  Inspection  Chemical Composition  Biological & Clinical Properties  Physical Properties  Engineering Properties  Miscellaneous Properties 198 MBS 9
  • 10. 10 Step Approach To Accreditation Awareness Training Quality Policy & Objectives Finalization Gap Analysis Documentation / Process Design Documentation / Process Implementation Internal Audit Management Review Meeting Shadow Audit Corrective –Preventive Actions Final Certification Audit MBS 10
  • 11. Step 1:- Awareness Training Separate training sessions for top management, middle management and junior level management. Creates a motivating environment throughout the organization for ISO 17025 implementation. MBS 11
  • 12. Step 2:-Quality Policy & Objectives Work shop with top management on development of quality policy. Work shop with top management and middle level functional management on development of quality objectives. MBS 12
  • 13. Step 3:-Gap Analysis Understanding of all the operations of the organization. Development of process map for the activities of the organization. Comparing existing operations with requirements of ISO 17025:2005 standard. MBS 13
  • 14. Step 4:-Documentation / Process Design Quality Manual Functional Procedures Work Instructions System Procedures Formats MBS 14
  • 15. Step 5:-Documentation / Process Implementation Work–shop on process / document implementation as per ISO 17025 requirements. Departmental / Individual assistance in implementing the new processes / documents. MBS 15
  • 16. Step 6:-Internal Audit Internal Audit Training & Examination (Optional). Successful employees / we carry out internal audit of the organization covering all the departments and operations. Suggest corrective and preventive actions for improvements in each of the audited departments. MBS 16
  • 17. Step 7:-Management Review Meeting Quality Policy & Objectives Results of internal audit Results of supplier evaluation Results of customer complaints Results of customer feedback etc. MBS 17
  • 18. Step 8:-Shadow Audit A replica of final certification audit. Finds degree of compliance with ISO 17025 standard. Gives an idea to the employees about the conduct of the final certification audit. MBS 18
  • 19. Step 9:-Corrective – Preventive Actions On the basis of shadow audit conducted in the last step, all the non-conformities will be assigned corrective and preventive actions. A check will ensure that all the NCs are closed and the organization is ready for the final certification audit. MBS 19
  • 20. Step 10:-Final Certification Audit Upon completion of various stages of accreditation audit, the audit, your organization will be awarded accreditation.
  • 22. MBS 22 TRY TO REMEMBER THIS FOR GPAT 2021???????? 1. Abbreviation of NABL. 2.Location of NABL office. 3.Benefits of Accreditation. 4.Types of laboratories can seek accreditation. 5.10 step approach.