Accreditation of laboratories is a process through which an authorized body examines and certifies the competence and quality systems of a laboratory based on predefined standards. NABL is India's national accreditation body that specifies the requirements for testing and calibration laboratories to be considered technically competent. The accreditation process involves identifying standards, assessment procedures, training, documentation, internal audits, management reviews, and a final certification audit. Laboratories must prepare for accreditation by training personnel, documenting procedures, implementing quality control, participating in proficiency testing, and addressing any gaps before applying to NABL for assessment.

1. Prepared By:- Ms. Mali Sunayana M.
Asst.Professor
Subject:-Pharmaceutical Quality Assurance
Sahyadri College Of Pharmacy, Methwade,
Sangola
UNIT-I TOPIC-
VI

2.  INTRODUCTION:
 Laboratory studies form an important part of
assessing the quality of products.
 For results to be accepted at national and
international levels, the must be proven to be reliable.
 DEFINITION:-
 Accreditation of laboratories is a process through
which an authorized, independent agency examines
and certifies the competence and quality systems of a
laboratory based on particular predefined standards.
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3.  Accreditation provides formal recognition of the
technical competence of a laboratory for particular
measurements or tests based on results from a third
party assessments.
Identify the authoritative body
Adopt necessary standard
Establish Assessment mechanism
Fig.1 : Accreditation Process
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4. What is NABL ?
 NABL is an autonomous society providing Accreditation
(Recognition) of Technical competence of a testing,
calibration, medical laboratory & Proficiency testing
provider (PTP) & Reference Material Producer (RMP).
 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.
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5. • NABL is an autonomous body under the aegis of Department of
Science & Technology, Government of India, and is registered under
the Societies Act.
• NABL stands for National Accreditation Board For Testing And
Calibration Laboratories.
• NABL has agreements with ILAC (International Laboratory
Accreditation Conference) and APLAC (Asia Pacific Laboratory
Accreditation Cooperation).
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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.
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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.
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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.
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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
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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
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11.  STEP 1:- AWARENESS TRAINING
 CAB applies in the prescribed form in triplicate and
attach two copies of their quality manual describing
their management system as per ISO OR IEC
guidelines as applicable.
 Separate training sessions for top management,
middle management and junior level management.
 Creates a motivating environment throughout the
organization for ISO 17025 implementation.
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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.
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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.
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14. Step 4:-Documentation / Process
Design
 Quality Manual
 Functional Procedures
 Work Instructions
 System Procedures
 Formats
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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.
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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.
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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.
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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.
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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.
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20. Step 10:-Final Certification Audit
 Upon completion of various stages of accreditation
audit, the audit, your organization will be awarded
accreditation.
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21.  Obtain NABL documents from the NABL Secretariat to get
familiar with the assessment process and details required
for the application.
 Ensure training of one person by NABL on quality
Management System and Internal Audit.
 Prepare a quality manual in keeping with the standards.
 For each test / investigation done in the laboratory,
prepare a SOP
.
 Calibrate instruments and equipment used in testing.
Preparing for Accreditation:-
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22.  Train Personal on documentation aspects.
 Check the status of current technical competence and quality
system by comparing with NABL Standards and address
deficiencies encountered.
 Prepare a quality manual and all other documents required by
NABL.
 Include Internal Quality Control(IQC) in sample analysis.
 Take part in External Quality Assessment Schemes(EQAs)
 Evaluate compliance with IQC and EQAs; take corrective actions
where necessary.
 Perform internal audit and management review to assess
preparedness for NABL assessment.
 After everything is satisfactory, apply for accreditation to NABL
with the prescribed fees.
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23. 1) Define the terms ‘Accreditation ‘ and ‘NABL’.
2) Write a note on NABL Accreditation in INDIA.
3) Describe how a laboratory must prepare for
NABL Accreditation.
 REVIEW QUESTIONS
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24.  REFERENCE
1) A Text book of Pharmaceutical Quality Assurance by the
author Anusuya R.Kashi, Bindu Sukumaran, And Veena
P. Nirali Prakashan. Page No.6.1-6.5
2) www.slideshare.com
3) www.google.com
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