NABL accreditation : Principles and procedures, benefits , committees

1. NATIONAL ACCREDITATION
BOARD FOR TESTING AND
CALIBRATION
LABORATORIES {NABL}
Presented By:- Miss. Gayatri K. Bahatkar
Assistant Professor
B. Pharm 6th sem
Pharmaceutical Quality Assurnace

2. INDEX
 Introduction
 Principles of NABL Accreditation
 Importance of Accreditation
 Benefits of Accreditation
 Accreditation Areas
 Approaches to obtain NABL Accreditation
 Accreditation procedure

3. INTRODUCTION
 NABL – National Accreditation Board for Testing and
Calibration Laboratories
 Accreditation-The action or process of officially recognizing
an organization or person as having a particular status or
being qualified to perform a particular activity.
 NABL Accreditation- Provides the accreditation to
Conformity Assessment Bodies (Laboratories).
 NABL Schemes- include accreditation of technical
competence of testing, calibration, medical testing
laboratories, proficiency testing laboratories and reference
material providers.
 NABL is a constituent board of Quality Council of India
 NABL assesses laboratories in India for quality and
consistency in their results.

4. IMPORTANCE OF NABL ACCREDITATION
 The concept of Laboratory Accreditation developed to
provide a means of third – party certification of the
competence of laboratories to perform specific types
of testing and calibration.
 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.
 Enhances customer confidence in accepting testing
calibration reports issued by accredited laboratories.

5. BENEFITS OF NABL 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.
 Increase of confidence of testing/calibration data and
personal performing work.
 Customers can search and identify the laboratories accredited
by NABL for the 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.

6. NABL ACCREDITATION AREAS
TESTING
LABORATORIES
• Biological,
•Chemical,
•Electrical, testing,
•Thermal, forensic
CALIBRATION
LABORATORIES
•Electro-technical,
mechanical,
•Radiological,
•Thermal, optical,
•Fluid flow
MEDICAL
LABORATORIES
• Clinical
•biochemistry,
•Clinical
•pathology,
•genetics,
•cytopathology,
•serology area

7. REFERENCE
MATERIAL
LABORATORIES
• Biological Processes
•Engineering process
•Genetics industry
•Pharmaceutical
industries
PROFICIENCY
LABORATORIES
• Medical
•Inspection
•Calibration

8. APPROACHES TO OBTAIN ACCREDITATION
10 approaches for Accreditation
1. Awareness training should be given to the management
and all the personnel involved.
2. Quality policy & Objectives should be established
3. Gap Analysis analysis of all the departments in the
company and the relationship between each
departments
4. Documentation / process design
5. Documentation / process implementation
6. Internal audit by the company itself.
7. Management review meeting
8. Shadow audit – external audit
9. Corrective – preventive actions
10. Final certification audit

9. ELIGIBILITY CRITERIA FOR NABL APPROVAL
To satisfy the requirement of the NABL, the institution
Conformity Assessment Body (CAB) has to satisfy the
following eligibility criteria:
 First and foremost, the institution must be a CAB carrying out
relevant activities such as laboratory testing, calibration, food
processing, research, and development.
 A CAB institution must either appoint a representative to start
the formalities for the NABL approval process.
 The appointed representative must be aware of the existing
quality processes followed by the CАВ.
 The institution (CAB) must have developed a manual that
indicates the quality standards. Such quality standards must
satisfy the requirements of :
a) ISO/ IEC 17025: 2005; or
b) ISO 15189: 2012; or
c) ISO/IEC 17043/2010.

10.  The CAB must have an appointed manager who has
relevant training up to 4 days on internal audit and
management policies, which are followed.
 The quality document which is prepared by the CAB must
be implemented immediately. The CAB must also satisfy the
criteria as required, according to NABL 130- which provides
the criteria for Site testing and Site Calibration Laboratories.
 Any applicant must participate in the Proficiency Training
Program, which is conducted by the NABL or an
international institution. If there is no form of training
available, the institution can carry out an inter-lab
comparison when it comes to quality assessment. If a lab
wants to participate in the above event, then the minimum
standard must be one parameter or one test.
 The CAB must carry out at least one internal audit and
management review before applying for the NABL approval.

11. NABL ACCREDITATION PROCESS
Application by CAB to NABL for accreditation
Acknowledgement & scrutiny of application by
NABL secretariat
Adequacy of quality manual
Pre-assessment of laboratory by lead
assessor
Final assessment of laboratory by assessment
team

12. Scrutiny of assessment report by NABL
secretariat
Recommendation for accreditation by
accreditation committee
Approval for accreditation by chairman of
NABL
Issue of NABL Certificate by NABL
secretariat.
 During steps 2-6 feedback to laboratory is given and they are
recommended to do the necessary corrective action.

13. Step 1- Make an Application by CAB to NABL
 In this step, the institution must make an application to the
NABL. Along with the application, respective documents must
be submitted to the NABL. An application must be made in
triplicate (3 copies). Two copies must describe the quality
manual of the management system. This must be in
accordance with the requirement of the ISO/ IEC 17025: 2005
or ISO 15189: 2012 or ISO/IEC 17043:2010 or ISO
17034:2016.
Step 2- Acknowledgment & scrutiny of application
 The applicant has to pay the respective fee, which is present
under NABL 100. If an applicant does not want to make any
form of information disclosures, th same reasons must be
provided to authority.
Step 3- Receipt of Application
 When the application is received by the NABL Secretariat
(along with the requisite fee), a unique identification number
(UIN) will be issued. The applicant must quote this number in
all correspondences with the NABL.

14. Step 4- Pre-Assessment Visit by lead assessor
 If there are no discrepancies in the application, then a lead
assessor will be appointed to carry out a pre-assessment visit to
the CAB. The assessment is carried out to understand if there are
no discrepancies in the quality control adopted by the CAB. Along
with this, the assessor will find out if there is any other assessment
required to be carried out by the NABL.
Step 6- final Assessment by assessment Team
 When the CAB has taken all the measures to correct the issues,
the NABL will form a team constituted by the lead assessor,
technical experts, and other individuals who are experienced in
relevant fields and disciplines. The team analyses and finds out if
compliance is met in accordance with the required standards. If
there are any forms of discrepancies found in the CAB, there report
will be made and submitted Secretariat. In the report, remedies
would also be included to address the discrepancies. A copy of this
will be submitted to the respective CAB.
Step 7-Crrective Action by CAB
 When the NABL secretariat reviews the report, the CAB must take
follow-up action. This action must be taken within 60 days of the
Report of the Assessment Team. In action, the CAB must mention
the corrective action it has taken to mitigate difficulties.

15. Step 8- Scrutiny & Recommendations
 After the follow-up action is taken by the CAB; the
Accreditation Committee will make recommendations to the
NABL Chairman. The Chairman’s decision is not binding, and
it can be appealed the director of the NABL. discrepancies. A
copy of this will be submitted to the respective CAB.
Step 8- Grant of accreditation
 when the recommendation results in the grant of
accreditation NABL issue an accreditation certificate which
has a unique number & NABL hologram discipline date of
validity along with the scope of accreditation.
 The NABL accreditation certificate is valid for a period up to 2
year. NABL conduct annual surveillance of the CAB at
interval of one year which is aim to evaluating continue
compliance to the requirement of ISO/ IEC and relevant
specific criteria & NABL policies.