The document provides an overview of the National Accreditation Board for Testing and Calibration Laboratories (NABL), detailing its history, structure, and accreditation services. Established in 1973, NABL offers accreditation for testing and calibration laboratories in line with various ISO standards and is recognized internationally, promoting confidence in testing results across borders. It emphasizes the importance of impartiality in its operations and outlines the benefits of accreditation for laboratories and industry stakeholders.

1. NABL CERTIFICATION AND
ACCREDITATION
Prepared by: Miss Megha Modi
M-PHARM, SEM-1
DEPAETMENT OF PHARMACEUTICAL QUALITY
ASSURANCE
L.M. COLLEGE OF PHARMACY

2. Introduction
• National Accreditation Board for Testing and Calibration Laboratories (NABL) is an
accreditation body, with its accreditation system established in accordance with ISO/ IEC
17011. “Conformity Assessment –Requirements for Accreditation bodies accrediting
conformity assessment bodies.” NABL provides voluntary accreditation services to:
• Testing laboratories in accordance with ISO/ IEC 17025 ‘General Requirements for the
Competence of Testing and Calibration Laboratories’
• Calibration laboratories in accordance with ISO/ IEC 17025 ‘General Requirements for the
Competence of Testing and Calibration Laboratories’
• Medical testing laboratories in accordance with ISO 15189 ‘Medical laboratories -
Requirements for quality and competence’
• Proficiency Testing Providers (PTP) in accordance with ISO/IEC 17043 “Conformity
assessment — General requirements for proficiency testing” and
• Reference material producers (RMP) in accordance with ISO 17034 “General requirements for
the competence of reference material producers”.
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3. History of NABL
• 1973 - Planning Commission suggested Dept. of Science & Technology (DST) to look into
different aspects of testing facilities.
• 1982 - DST set up “National Coordination of Testing & Calibration Facilities(NCTCF)” for
providing accreditation services to testing & calibration laboratories.
• 1993 - Renamed as National Accreditation Board for Testing & Calibration Laboratories
(NABL).
• 1998 - Registered as an Autonomous Body (Societies Act 1860) under the aegis of DST.
• 2016 - Based on Cabinet Decision in 1996, NABL was merged with Quality Council of India as
a Constituent Board.
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4. Organization Structure
• NABL is one of the constituent boards of Quality Council of India (QCI), an autonomous body
under Department for Promotion of Industry & Internal Trade (DPIIT), Ministry of Commerce
and Industry, Government of India.
• NABL Board is chaired by Chairperson and has 25 members drawn from various organizations
of repute including representative of the Government, Industry, and other stakeholders to guide
and monitor the activities and progress of the Board. The day to day functions of NABL are
carried out by the staff of technical cadre and is headed by the Chief Executive Officer (CEO).
NABL staff comprises of Chief Executive Officer (CEO), Senior Directors/Directors, Joint
Directors, Deputy Directors, Assistant Directors, and Accreditation & Executive Officers. CEO,
NABL is responsible for administering and managing the operations of NABL.
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Employee Chart of NABL

8. NABLAccreditation Services
• Testing laboratories in accordance with ISO/ IEC 17025 ‘General Requirements for the Competence of Testing and
Calibration Laboratories’
• Calibration laboratories in accordance with ISO/ IEC 17025 ‘General Requirements for the Competence of Testing and
Calibration Laboratories’
• Medical testing laboratories in accordance with ISO 15189 ‘Medical laboratories -Requirements for quality and
competence’
• Proficiency Testing Providers (PTP) in accordance with ISO/IEC 17043 “Conformity assessment — General requirements
for proficiency testing” and
• Reference material producers (RMP) in accordance with ISO 17034 “General requirements for the competence of
reference material producers”.
• In addition, NABL also provides the following services (not covered under APAC/ILAC MRA):
• NABL Medical (Entry Level) Testing Labs {NABL M(EL)T LABS} Program
• Government Block Level Drinking Water Testing Laboratory Recognition Program
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9. What is Accreditation?
“Accreditation is the third-party attestation related to a
conformity assessment body conveying formal
demonstration of its competence, impartiality and
consistent operation in performing specific conformity
assessment activities”.
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10. About Accreditation
• Why Laboratory Accreditation?
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11. International Recognition
NABL is maintaining Linkages with International bodies-
❖ International Laboratory Accreditation Cooperation (ILAC) and
❖ Asia Pacific Accreditation Cooperation (APAC)
NABL is Mutual Recognition Arrangements (MRA) signatory to ILAC & APAC which
is based on mutual evaluation
❖Such MRA reduces technical barrier to trade and facilitates acceptance of test/ calibration
results between countries which MRA partners represent
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TESTED ONCE AND ACCEPTED EVERYWHERE

12. Global Acceptance of Reports
Test reports issued by an NABL accredited laboratory is
considered equivalent to those issued by ILAC/APAC MRA
partners.
International
Recognition

13. NABL is signatory to Asia Pacific Accreditation Co-operation (APAC) Mutual
Recognition Arrangements (MRA) and International Laboratory Accreditation Co-
operation (ILAC) MRA since 2000.
• First evaluated by APLAC in 2000 (for Testing and Calibration)
• Second evaluation by APLAC in 2004 (for Testing & Calibration)
• Third evaluation by APLAC in 2008 (for Testing, Calibration and Medical)
• Fourth evaluation by APLAC in 2012 (for Testing, Calibration and Medical)
• Fifth evaluation by APLAC in 2016 (for Testing, Calibration, Medical, PTP and RMP)
• Sixth evaluation by APAC in 2021 (for Testing, Calibration, Medical, PTP and RMP)
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14. IMPARTIALITY POLICY
NABL and its personnel and committee members are committed to ensure integrity of its
systems and operations at all times. NABL acts impartially and avoids any conflict of
interest that may compromise its ability to make impartial decisions. NABL ensures:
1. To carry out accreditation activities in a non-discriminatory manner.
2. There are no constraints that might influence decision making.
3. That it does not engage in any activity which could compromise its impartiality.
4. That it does not provide consultancy to conformity assessment bodies, nor does it undertake
any conformity assessment activities itself. It does not promote the services of any specific body.
5. Fair representation of stakeholders in NABL Board.
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17. Benefits of Accreditation
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18. ISO/IEC 17025
• ISO/IEC 17025 enables laboratories to demonstrate that they operate competently and generate
valid results, thereby promoting confidence in their work both nationally and around the world.
• It also helps facilitate cooperation between laboratories and other bodies by generating wider
acceptance of results between countries. Test reports and certificates can be accepted from one
country to another without the need for further testing, which, in turn, improves international
trade.
• https://youtu.be/gUBpGSpAfcM
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19. Who is ISO/IEC 17025 for?
• ISO/IEC 17025 is useful for any organization that performs testing, sampling or
calibration and wants reliable results. This includes all types of laboratories,
whether they be owned and operated by government, industry or, in fact, any
other organization. The standard is also useful to universities, research centers,
governments, regulators, inspection bodies, product certification organizations
and other conformity assessment bodies with the need to do testing, sampling
or calibration.
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20. Why has ISO/IEC 17025 been revised?
• The last version of ISO/IEC 17025 was published in 2005 and, since then,
market conditions and technology have changed. The new version covers
technical changes, vocabulary and developments in IT techniques. It also takes
into consideration the latest version of ISO 9001.
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21. What is a management system?
• A management system is the way in which an organization manages the interrelated
parts of its business in order to achieve its objectives. These objectives can relate to a
number of different topics, including product or service quality, operational efficiency,
environmental performance, health and safety in the workplace and many more.
• The benefits of an effective management system to an organization include:
More efficient use of resources and improved financial performance
Improved risk management and protection of people and the environment
Increased capability to deliver consistent and improved services and products, thereby
increasing value to customers and all other stakeholders
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28. Acceptance by Government & Regulators
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30. NABL Grants Accreditation to :
• Testing Laboratories as per ISO/IEC 17025(NABL 120) NABL 400
• Calibration Laboratories as per ISO/IEC 17025(NABL 120) NABL 500
• Medical Laboratories as per ISO 15189 NABL 600
• Proficiency Testing Providers (PTP) as per ISO/IEC 17043(NABL 180) NABL 700
• Reference Material Producers (RMP) as per ISO 17034 (NABL 191) NABL 800
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34. Accreditation Process
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35. Appeal is a request by the person or organization that
provides, or that is, the object of conformity assessment to a
conformity assessment body or an accreditation body for
reconsideration by that body of a decision it has made
relating to that object.
APPEALS

36. Complaint is an expression of dissatisfaction, other than
appeal, by any person or organization to a conformity
assessment body or an accreditation body, relating to the
activities of that body, where a response is expected.
COMPLAINTS

37. Rights of NABL
• NABL requires all CABs to conform to ISO/IEC 17025: 2017 or ISO 15189: 2012 or ISO/IEC
17043: 2010 or ISO 17034: 2016 whichever is applicable and also to the NABL policy
documents & relevant NABL specific criteria (wherever applicable) to seek and maintain
accreditation and adapt to the changes in the requirements of accreditation. NABL requires
that all CABs shall accept and/sign document NABL 131 ‘Terms And Conditions for Obtaining
and Maintaining NABL Accreditation’ and abide by it. During the application or assessment
process, if there is evidence of any fraudulent activities, furnishing of false information or
concealment of information, NABL shall reject the application, or terminate the assessment
process.
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38. If there is evidence of fraudulent activities, providing of false information or concealment of information
at any time during the accreditation cycle, NABL will initiate the process for adverse decision. NABL
may also refuse provision of services to a CAB because of its antecedents, availability of proven evidence
of fraudulent behavior, falsification of information, violation of terms and conditions for obtaining and
maintaining NABL Accreditation or deliberate violation of accreditation requirements. The refusal of
services due to these reasons based upon the historical evidences is not treated as discriminatory act
against any CAB.
NABL has the right to: i. effect changes in standards on which CAB accreditation is based in accordance
with international norms ii. prescribe additional requirements to supplement international standards as
application documents/ criteria documents iii. decide on policies related to accreditation in consultation
with stakeholders iv. appoint assessment teams v. decide on implementation schedules in consultation
with the CABs vi. take action against CAB in accordance with the accreditation requirements vii. take
adverse decisions in accordance with the accreditation requirements and giving reasons for the same viii.
Publish accreditation status of CAB on its website/ Newsletter etc.
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40. NABL Team (leadership)
Jaxay Shah
CHAIRPERSON,
QCI
Mr. Rajesh
Maheshwari
SECRETARY
GENERAL,I/c QCI
Padma Shri Prof.
Subbanna
Ayyappan,
Chairperson, NABL
Mr. N
Venkateswaran,
CEO, NABL
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41. https://nabl-india.org/
https://www.iso.org/ISO-IEC-17025-testing-and-
calibration-laboratories.html
REFERENCES

42. Thank you
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