NABL

1. NABL
Dr . K.VENKATESWARA RAJU
SHRI VISHNU COLLEGE OF PHARMACY
mail4venkey@gmail.com

2. NABL stands for National Accreditation Board For Testing And Calibration
Laboratories.
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 is an autonomous body under the aegis of Department of Science & Technology,
Government of India, and is registered under the Societies Act. It is only one of its kinds
that assess laboratories in India for quality and consistency in the results.
NABL has agreements with ILAC (International Laboratory Accreditation Conference)
and APLAC (Asia Pacific Laboratory Accreditation Cooperation).These are especially
valuable for International recognition and mutual acceptance of test results. In short
accreditation has worldwide acceptance.
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.
INTRODUCTION

3. Formal recognition of competence of a laboratory by an Accreditation body in
accordance with international criteria has many advantages:
1. Increased confidence in Testing/ Calibration Reports issued by the laboratory
2. Better control of laboratory operations and feedback to laboratories as to whether
they have sound Quality Assurance System and are technically competent
3. Potential increase in business due to enhanced customer confidence and satisfaction.
4. Customers can search and identify the laboratories accredited by NABL for their
specific requirements from the NABL Web-site or Directory of Accredited
Laboratories
5. Users of accredited laboratories enjoy greater access for their products, in both
domestic and international markets.
6. Savings in terms of time and money due to reduction or elimination of the need for
re-testing of products.
BENEFITS OF ACCREDITATION

4. NABL ACCREDITATION PROCEDURE
1. Any laboratory falling within the scope of NABL accreditation can apply in the prescribed application
form (i.e. NABL 151 for testing laboratories, NABL 152 for calibration Laboratory and NABL 153 for
medical laboratories) in triplicate with prescribed fee (as detailed in application form).
2. Along with application, two copies of the quality manual of the laboratory are to be filed. Quality
manual should describe the management-system in accordance with ISO/IEC 17025:2005 or ISO
15189:2007) whichever is applicable Laboratory should take special care in filling the scope of
accreditation for which the laboratory wishes to apply, for example, biological chemical.
3. If the laboratory feels any clause of the application form is not applicable in part or full, it should write
reasons for it. The application is to be filed with secretariat of NABL
4. On receipt of application form, quality manual and fees, NABL issues an acknowledgement to the
laboratory. After scrutiny of the application for its completeness, NABL Secretariat allocates a unique
laboratory ID number, which is used in correspondence with laboratory. If necessary, NABL
Secretariat may ask for additional Information, clarification etc.
5. Once the NABL has ascertained completeness of application, and obtained any other
information/clarification, it appoints a lead assessor. It is the responsibility of lead assessor to
evaluate adequacy of the quality manual pre-assess the laboratory including onsite assessment of the
laboratory. Onsite assessment is done with team of assessors commensurate with scope of
accreditation lead assessor finds quality manual inadequate, it informs NABL Secretariat and the
laboratory is asked to make amends.
6. After the quality manual is found adequate or laboratory makes amends to the quality manual based
on inadequacies pointed at a pre-assessment visit is organized by NABL. The laboratory before, the
pre-assessment visit ensure that it has carried out an internal audit and management review before
the pre-assessment.

5. NABL Accreditation Procedure – PRE ASSESMENT
The object of pre-assessment of the laboratory is to:
1.Evaluate non conformities, if any, in the implementation of quality system.
2.Assess the degree of preparedness of the laboratory for the assessment for accreditation
3.Determine the number of assessors required in various fields based on the scope of accreditation
number of locations to be visited.
The lead assessor submits a report to the NABL Secretariat and a copy is also given to the laboratory.
Laboratory has to take corrective action on the non-conformities pointed out in the report. A corrective
action report is required to be filed by the laboratory to the NABL Secretariat.
The next step is assessment of the laboratory by NABL. The NABL constitutes a team for assessment.
The team includes lead assessor (already appointed), technical assessors/experts to cover various fields
within the scope of accreditation requested. Constitution of team is conveyed to the laboratory. The
laboratory is free not to copy one or more members of the team by giving reasons for its non-acceptance.
After the finalization of assessment team, a date for onsite assessment is fixed.
The team carries out onsite assessment and prepares an Onsite assessment report. The assessment
report contains the evaluation of technical man power, all relevant materials examined, tests witnessed
including those of replicate testing/measurement, compliance to ISO/IEC 17025:2005 or ISO 15189207
whichever applicable.
Non-conformities, if observed are mentioned in the report. The team also provides a recommendation or
otherwise in the report. A summary of assessment report and copies of non conformities, if observed, are
provided to the laboratory.

6. NABL Accreditation Procedure
The assessment report is examined by the NABL Secretariat and follow up action as required is initiated.
Laboratory is required to take action on non-conformities or other concerns mentioned in the assessment
report and submit an action taken report within 60 days.
After the laboratory has reported action taken on the assessment report the accreditation committee
examines the assessment report, action taken report (by the laboratory), any other additional information
received from the laboratory and consequent verification report, if any.
If the committee finds deficiencies in assessment report, NABL Secretariat is asked to get clarification
from the lead assessor/assessor(s)/laboratory consumed. Once everything is in order, Accreditation
Committee makes recommendations to the Chairman, NABL for accreditation.
After Chairman approves accreditation recommendations. NABL Secretariat issues accreditation
certificate which has unique number, fields, date of validity along with scope of accreditation.
All decisions taken by NABL regarding grant of accreditation are open to appeal by the laboratory. The
appeal is to be addressed to the Chairman NABL.

7. PREPARING FOR NABL ACCREDITATION
 When a laboratory decides to seek NABL accreditation, it should make a plan of action for obtaining
accreditation and nominate one person to coordinate all activities. The nominated person should be
conversant with laboratory's existing quality system.
 A list of external document is given in section 3.1 of this chapter. All these documents are available on
the website of NABL. The laboratory should get acquainted fully with the relevant documents and
understand the treatment procedure.
 Laboratory must assess the status of existing quality system and technical competence vis-à-vis the
requirement of ISO/IEC 17025 or ISO 15189 whichever is relevant.
 It may be mentioned here that quality manual is a policy document. It has to be supplemented by
other documents like procedural manuals, work instructions etc. NABL has prepared a guide for
preparing a quality manual (NABL 160). This document is also available on the website of NABL.
 Another requirement is that the applicant laboratory must have participated satisfactorily in the
proficiency testing program conducted by NABL/APLAC or any other national or International
accredited/recognized IT provider. If no PT program is available the laboratory can initiate an inter
laboratory comparison with adequate number of accredited laboratories. The minimum stipulated
participation for laboratories is one parameter/type of test/calibration per discipline, prior to grant of
accreditation.
 The Satisfactory performance should be defined in terms of Z score and En. If performance is
unsatisfactory, Laboratory is required to take corrective action and inform NABL.
The following documents give details of proficiency testing:
1.ISO/IEC Guide 43.
2.ILAC G13.
3.NABL 162, NABL 163, NABL 164

8. PREPARING FOR NABL ACCREDITATION
The applicant laboratory must have conducted at least one internal audit and a management review
before submission of application Guidance for internal audit and review may be taken from following
documents:
1.ISO 19011 - Guidelines for quality and/or environmental management system auditing.
2.NABL 161 - Guide for internal audit and management review for laboratories.
 The applicant laboratory must comply with all clauses of ISO/IEC 17025:2005 or ISO 15189-2007
whichever is applicable for pharmaceutical industry ISO/IEC 17025 is applicable.
 Now, it is amply clear that implementation of ISO/IEC 17025 is imperative for accreditation. While
discussing contents of ISO/ IEC 17025 a broad idea has been given what is to be done in
implementing the standard. Most of technical requirements of the standard are elements of GLP.
Information on the can be found in various chapters of the book. Many of the management
requirements are also elements of GLP and have been dealt in different chapters of the book.
 In the proceeding sections important aspects will be dealt without which accreditation process will not
progress.

9. 1.
1. General (ISO 17025:2005, 5.1)
2. Personnel (ISO 17025:2005, 5.2)
3. Accommodation and Environment
(ISO 17025:2005, 5.31)
TECHNICAL REQUIREMENTS:

10. The Laboratory Process
Laboratory
Report
Sample

11. GENERAL- TECHNICAL REQUIREMENTS
Laboratory
In GENERAL (ISO 17025:2005, 5.1)
 Factors influencing the correctness and reliability of the
tests performed
Sample
?

12. Factors determine correctness
and reliability of the tests
 Human factors
 Accommodation and
environmental conditions
 Test and calibration
methods, method validation
 Equipment
 Measurement traceability
 Sampling
 Handling test items

13. Personnel
(ISO 17025:2005, 5.2)

14. Management Requirements to
Personnel (ISO 17025: 2005, 4.1)
 Laboratory have managerial and technical personnel (irrespective of other responsibilities) who
have the authority and resources needed to carry out their duties and to identify the occurrence of
departures from the quality system and initiate actions if required
 Free from any undue internal and external pressures and influences
 Protection of the customers confidential information
 Specify responsibilities, authority and interrelations of all personnel which activities can influence
the quality of the result
 Appropropriate supervision of testing staff and trainees
 Technical management which has overall responsibility for operations and provision of resources
needed to ensure required quality of operations
 Quality manager: irrespective of other duties has defined responsibility and authority ensuring the
management system is implemented and followed at all times, has direct access to the highest
level of management
 Appoint deputies for key managerial personnel
 Ensure that personnel is aware of relevance and importance of their activities
 Top management shall ensure proper communication processes are established regarding
effectiveness of the management system

16. Technical Requirements to
Personnel (ISO 17025:2005, 5.2)
 Laboratory management shall ensure the competence of personnel for operation specific equipment, perform
tests, evaluate results, sign test reports
 Personnel responsible for opinions and interpretation at reports have relevant knowledge of technology including
legislation, understanding significance of deviations
 Training programme: Management formulates goals for education, training and skills of personnel. Needs are
identified and training programme is evaluated.
Job descriptions
 minimal responsibilities with respect to performing tests, planning and evaluation of tests, reporting opinions and
interpretations, method modification and validation new methods.
 Expertise and experience required
 Qualification and training programmes
 Managerial duties
 Authorization to perform particular types of sampling, tests, issuing tests reports, to give opinions and
interpretations, operation of particularly types of equipment
 Authorization of specified tasks is done including date on which it is confirmed and registrated and readily
available

17. Accommodation and environmental
conditions (ISO17025:2005, 5.3)
 Laboratory facilities will facilitate correct performance
of the tests and are documented
 Monitor, control and record conditions as required by
relevant specifications (biological sterility, dust,
humidity temperature, electrical supply etc.)
 Attention for access to certain test areas, good
housekeeping and effective separation of incompatible
activities

18. Thank you