100 PDF

NABL 100
National Accreditation Board for

Testing and Calibration
Laboratories (NABL)
General Information Brochure
ISSUE DATE: 26-Jul-2018

Contents
Sl Contents Pages
Contents 1
1. Conformity Assessment 2
2. Benefits of Accreditation 5
3. About NABL 7
4. International Linkages 10
5. Scope of NABL Accreditation 11
6. Preparing for Accreditation 23
7. Eligibility for Accreditation 24
8. Accreditation Procedure 25
9. Maintaining Accreditation 31
10. Surveillance and Re-assessment 32
11. Appeals and Complaints 33
12. Rights and Obligations of CABs 34
13. Rights and Duties of NABL 36
14. NABL Finance and NABL Fee Structure 38
15. Modes of Payment 42
16. NABL Publications 45
17. Contact Addresses 47
National Accreditation Board for Testing and Calibration Laboratories 1/47

1. Conformity Assessment
International Standard ISO/IEC 17000 defines Conformity Assessment as a “Demonstration that

specified requirements related to a product, process, system, person or body are fulfilled.”
Conformity Assessment procedures, such as testing / calibration, inspection and certification,
offers assurance that products fulfill the requirements specified in regulation and standards.
Each organization must decide which type of conformity assessment is necessary for which
purpose. This decision should be based on an assessment of the risk involved with a particular
product or process, and on an understanding of the impact the associated costs and benefits
will have on achievable development.
Successive reviews of the WTO/TBT agreement have noted the usefulness of ISO/IEC
conformity assessment standards and guide in harmonizing the conformity assessment practice
and as benchmarks for the technical competence of assessment bodies, thus enhancing the
credibility and confidence in their results. ISO/IEC conformity assessment work therefore helps
to overcome technical trade barrier.
Accreditation is the third party attestation related to a conformity assessment body conveying
the formal demonstration of its competence to carry out specific conformity assessment task.
Conformity Assessment Body (CAB) is a body which includes Testing including Medical
Laboratory, Calibration Laboratory, Proficiency Testing Provider and Reference Material
Producers.
Laboratory accreditation is a procedure by which an authoritative body gives formal recognition

of technical competence for specific tests/ measurements, based on third party assessment and
following international standard.
The general requirements for laboratories or other organizations, to be considered competent to

carry out sampling, testing (other than medical) and calibration are specified in the International
Standard ISO/IEC 17025:2005 or ISO/IEC 17025:2017.
Another very important area under testing, which plays a vital role in human health, is medical /
clinical diagnostic testing. Requirements for quality and competence to carry out sampling and
testing in medical field are specified in the International Standard ISO 15189:2012.

Further, to strengthen the pre-examination process performed in sample Collection Centres /
Facility(ies), NABL also recognizes these Sample Collection Centres / Facility(ies) declared by
its associated accredited medical laboratories. NABL recognition of Sample Collection Centres/
Facility(ies) (SCF) declared by medical testing laboratories, is of paramount significance in
ensuring the quality services rendered by the Sample Collection Centres/ Facilities (SCF). The
assessment of all declared Sample Collection Centres/ Facility(ies) will ensure integrity of
samples and better control on pre-examination processes as quality of test results largely
depends on these processes. Moreover, this will also enhance the confidence of Sample
Collection Centres / Facility(ies) and accord due recognition to these Centres / Facilities (SCF).
The laboratory shall be responsible for the operation of the recognized Sample Collection
Centres / Facility(ies).
Proficiency Testing is the use of inter-laboratory comparison for determining the performance of
individual laboratories for specific tests. Participation in proficiency testing programmes provides
laboratories with an objective means of assessing and demonstrating the reliability of data they
are producing. The International Standard ISO/IEC 17043:2010 provides a consistent basis for
all interested parties to determine the competence of organizations that provide proficiency
testing.
Certified Reference Materials (CRMs) are 'controls' or standards used to check the quality and
metrological traceability of products, to validate analytical measurement methods, or for the
calibration of instruments. The reference material producer is fully responsible for project
planning and management, assignment of and decision on property values and relevant
uncertainties, authorization of property values and issue of the certificate and other statement
for the reference materials it produces. ISO 17034:2016 specifies General Requirements in
accordance with which a reference material producer has to demonstrate that it operates, if it is
to be recognized as competent to carry out the production of reference materials.
In the current global scenario an essential pre -requisite of trade is that any product or service
accepted formally in one economy must also be free to circulate in other economies without
having to undergo extensive re-testing. WTO recognizes that non acceptance of test results and
measurement data is a Technical Barrier to Trade. Global sourcing of components calls for
equivalence of measurement, which can be facilitated by a chain of accredited CABs.
Accreditation is considered as the first essential step for facilitating mutual acceptance of test
results and measurement data.

Confidence in accreditation is obtained by a transparent system of control over the accredited
CABs and an assurance given by the accreditation body that the accredited CAB fulfils the
accreditation criteria, at all times.
Accredited CABs can objectively state conformance of product or service to specified

requirements. It is important for the purchaser, regulator, government, and the public to be able
to identify accredited CABs.

2. Benefits of Accreditation
Formal recognition of competence of a laboratory by an Accreditation body in accordance with

international criteria has many advantages:
 Increased confidence in Testing/ Calibration Reports issued by the laboratory.
 Better control of laboratory operations and feedback to laboratories as to whether they
have sound Quality Assurance System and are technically competent.
 Potential increase in business due to enhanced customer confidence and satisfaction.
 Customers can search and identify the laboratories accredited by NABL for their specific
requirements from the NABL Web -site or Directory of Accredited Laboratories.
 Users of accredited laboratories enjoy greater access for their products, in both domestic
and international markets.
 Savings in terms of time and money due to reduction or elimination of the need for re-
testing of products.
The benefits of proficiency testing are widely recognized. These include:
 Comparison of a facility’s performance with that of other participating (peer) facilities

 Monitoring of a long-term facility performance
 Improvement in the performance of tests/calibrations following investigation and
identification of the cause(s) of unsatisfactory PT performance, and the introduction of
corrective action to prevent re-occurrence
 Staff education, training and competence monitoring
 Evaluation of methods, including the establishment of method precision and accuracy
 Estimation of measurement uncertainty
 Contribution to the facility’s overall risk management system
 Confidence building with interested parties, e.g. customers, accreditation bodies,
regulators, specifiers.
Proficiency testing providers play an important role in the value chain for assurance of products
and services. Being an accredited PTP gives the organization credibility for their PT services.

Formal recognition of competence of a RMP by an Accreditation body in accordance with
international criteria has many advantages
 Accreditation is an effective marketing tool for RMPs.

 Accreditation provides assurance that the accredited RMPs are competent to produce
the RMs as listed in the scope of accreditation.
 It provides confidence to RM users that the reference materials (RMs), and certified
reference materials (CRMs) in particular, are produced according to technically valid and
internationally recognized principles, and fitted for the intended uses.
 These uses include the assessment of precision and trueness of measurement methods,
quality control, assigning values to materials, calibration, and the establishment of
conventional scales. This eliminates the needs of the users to evaluate the quality of the
RMs themselves.
 RMs are used globally. Many economies around the world have accreditation bodies
offering accreditation to RMPs. These accreditation bodies have adopted ISO Guide 34:
2009 / ISO 17034:2016 as the criteria for RMP accreditation. This has helped
economies to adopt a uniform approach to determining RMP competence. This uniform
approach allows accreditation bodies in different economies to establish arrangements
among themselves, based on mutual evaluation and acceptance of each other’s RMP
accreditation systems.

3. About NABL
NABL is a constituent Board of Quality Council of India (QCI). QCI is a registered society under
the Societies Registration Act, 1860. Department of Industrial Policy and Promotion, Ministry of
Commerce and Industry, Government of India is the nodal Department for QCI.
NABL has been established with the objective of providing Government, Industry Associations
and Industry in general with a scheme of Conformity Assessment Body’s accreditation which
involves third-party assessment of the technical competence of testing including medical and
calibration laboratories, proficiency testing providers and reference material producers.
The laboratory accreditation services to testing and calibration laboratories are provided in
accordance with ISO/ IEC 17025: 2005 or ISO/IEC 17025:2017 ‘General Requirements for the
Competence of Testing and Calibration Laboratories’ and ISO 15189: 2012 ‘Medical
laboratories -- Requirements for quality and competence’ The accreditation to Proficiency
testing providers are based on ISO/IEC 17043 :2010 “Conformity assessment -- General
requirements for proficiency testing” and to Reference Material Producers based on ISO
17034:2016 - General requirements for the competence of reference material producers ”The
fields, disciplines and groups for which the accreditation services are offered are listed in ‘Scope
of NABL Accreditation’.
NABL offers accreditation services in a non-discriminatory manner. These services are

accessible to all testing including medical and calibration laboratories, proficiency testing
providers and reference material producers in India and other countries in the region, regardless
of the size of the applicant CAB or its membership of any association or group or number of
CABs already accredited by NABL.
NABL has established its accreditation system in accordance with ISO/ IEC 17011: 2004
‘Conformity Assessment – General requirements for Accreditation bodies accrediting conformity
assessment bodies’. NABL accreditation system also takes note of the requirements of Mutual
Recognition Arrangements (MRAs) of which NABL is a member.
NABL publishes documents for the CABs, Assessors and its own use. A list of NABL documents
is given at the end of this document. All NABL documents meant for the use by persons outside
NABL, are available on NABL website www.nabl-india.org, free of cost.

Organization Structure of NABL
The organization structure of NABL has been designed to meet the requirements of an effective
and efficient accreditation system.
The Apex body in NABL organization is the NABL Board. The Board provides policy, guidelines
and direction to NABL. CEO, NABL is the Member Secretary of the NABL Board. NABL
Secretariat comprises of Chief Executive Officer (CEO), Director, Joint Director, Deputy
Director, Assistant Director, Quality Manager, Complaints Manager, Appeals Officer,
Accreditation Officers, Administration and support staff. The CEO, NABL is responsible for
administering and managing the day to day operations of NABL Secretariat.
The organization chart (Technical) of NABL is given below –
QCI Governing Body
NABL Board
Secretary General (QCI)
Chief Executive Officer

(CEO)
Director Director Director

(Testing, (Medical) International Affairs Manager
(Calibration)
Strategy Group PTP, RMP)
Complaints Manager
Marketing Cell
Training & Assessors
Quality Manager JD JD JD JD JD JD JD Monitoring Committees
(Gr.-C1) (Gr.-T1) (Gr.-T2) (Gr.-T3) (Gr.-Tn) (Gr.-M1) (Gr.-M2)
Accreditation Committees
Appeals Officer
DD/AD/Officers DD/AD/Officers DD/AD/Officers
Technical Committees
Assessors

NABL operates its accreditation process through empanelled Lead Assessors and Technical
Assessors covering all fields and disciplines as specified in the scope of NABL. All Lead
Assessor and Technical Assessors are personnel having considerable experience in CAB
activities. They are trained by NABL as per the relevant international accreditation criteria and
subsequently empanelled as assessors/ lead assessors through contractual agreements.
Recommendations of Accreditation Committee form the basis for accreditation decisions.

Membership of accreditation committees is drawn from NMIs and standards bodies,
experienced assessors (including those from accredited CABs), academic institutions, important
professional bodies, regulatory agencies/ bodies etc. The members of the Accreditation
Committee are selected on the basis of their technical knowledge and familiarity with
accreditation process. However care is taken while selecting composition of an Accreditation
Committee that expertise in all areas covered under the committee is available and no single
group or organization pre-dominates the committee.
The formulation of technical/ specific guidelines and other similar tasks is derived from various
ad-hoc technical committees set up for the purpose. Composition of Technical Committee is
mainly driven by the purpose for which the committee is set up. For multi-disciplinary fields or in
areas where two or more fields overlap, care is taken to include members from relevant fields so
that a balanced view emerges. Committee members are drawn from different organisations that
form the spectrum of interested parties.
Related bodies
The National Metrological Institutes (NMIs) namely National Physical Laboratory (NPL) and
Bhabha Atomic Research Centre (BARC); the Standards Bodies namely Bureau of Indian
Standards (BIS) and Standardization, Testing and Quality Certification (STQC), Council for
Industrial and Scientific Research (CSIR), the other Boards of Quality Council of India (QCI),
the other organizations under nodal department of QCI i.e. Department of Industrial Policy and
Promotion, the other Departments / organizations under nodal Ministry i.e. Ministry of Industry
and Commerce are the bodies related to NABL. Due care is taken to determine and avoid
potential for conflict of interest from the activities of the related bodies in the operation of NABL.

4. International Linkages
NABL maintains linkages with the international bodies like International Laboratory Accreditation
Co-operation (ILAC) and Asia Pacific Laboratory Accreditation Co-operation (APLAC). NABL is
a full member of ILAC and APLAC and regularly takes part in their meetings. More information
on these international co operations can be obtained from their web-sites www.ilac.org and
www.aplac.org respectively.
NABL is signatory to ILAC as well as APLAC Mutual Recognition Arrangements (MRA) for
accreditation of Testing including Medical and Calibration laboratories, which is based on
mutual evaluation and acceptance of other MRA Partner accreditation systems. Such
international arrangements facilitate acceptance of test/ calibration results between countries
which MRA partners represent. NABL is also signatory to APLAC MRA for accreditation of
Proficiency Testing Providers (PTP) and Reference Material Producers (RMP)
The information on ILAC and APLAC Mutual Recognition Arrangements (MRA s) is available at
NABL web-site. On request from the laboratories or their users, a copy of ILAC/ APLAC MRA is
provided.
In order to achieve the objective of the acceptance of test/ calibration data across the borders,
NABL operates and is committed to update its accreditation system as per international norms.
NABL operations conform to ISO/ IEC 17011: 2004.

5. Scope of NABL Accreditation
NABL Accreditation is currently given in the following fields and disciplines or groups. The multi-
disciplinary CABs shall have to apply in relevant discipline separately depending upon to which
discipline the scope belongs. For more details on scope of accreditation please refer the
relevant specific criteria.
TESTING LABORATORIES
− Biological
- Food and Agricultural Products
- Drugs and Pharmaceuticals
- Water
- Environment and Pollution
- Biocides
- Cosmetics and Essential Oils
- Industrial Cultures
- Seed Testing
- Plants and Plant Materials
- Molecular Analysis
- Cell Culture
- Resistance to Microbial Attack
- Biological Tests on Other Miscellaneous Test Items
- Biopesticides and Biofertilizers
- Toxicology
- Identification/Enumeration of Microbial Pathogens
- Residue Analysis
- Veterinary Testing
- Nutraceuticals & Functional Foods
- Nutritional Supplements

- Animal Food & Feed
- Antimicrobial activity Products
- AYUSH Products
- Biological Monitoring
- Biologicals Derived Pharmaceuticals
- Cosmetics & Essential Oil
- GM Products
- Marine /Aqua culture Food Products
- Medical Accessories & Surgical products
- Molecular Analysis
- Wild Life Forensic
− Chemical
- Adhesives
- Animal Food & Feeds
- AYUSH Products
- Atmospheric Pollution
- Building Material
- Cosmetics & Essential Oils
- Corrosion tests
- Drugs & Pharmaceuticals
- Explosives & Pyrotechnics
- Fertilizers
- Fire Fighting Equipments & Accessories
- Food & Agricultural products (Except Human Milk)
- Gases
- Glass
- Hazardous & Restricted Chemicals

- Industrial & Fine Chemicals
- Inks, dyes & pigments
- Lac & lac products
- Leather
- Lubricants
- Marine / Aqua culture Food Products
- Metallic coatings & treatment solutions
- Metals & Alloys
- Nutraceuticals & Functional Foods
- Ores & Minerals
- Paints & Surface Coating
- Paper and Pulp
- Pesticide Formulations
- Petroleum and Products
- Plastic & Resins
- Pollution & Environment
- Residues in Food Products
- Residues in Water
- Rubber & Rubber Products
- Soap detergent & Toiletries
- Soil and Rock
- Solid Fuels
- Textile (Woven & Non woven)
- Warfare Chemicals
- Water
- Wood and Wood Products

- Electrical
- Switchgear equipment
- Rotating electrical machines
- Transformers and Reactors
- Transmission line equipment and accessories
- Cables and accessories
- Power Capacitors
- Lamps, Luminaries and accessories
- Wiring accessories
- Domestic Electrical appliances
- Power Stabilizers and UPS
- Batteries
- Power system protection relays
- Measuring instruments
- Electrical materials
- High Voltage test facility
- Short Circuit test facility
- Electromagnetic interference (EMI) / Electromagnetic compatibility (EMC) test facility
- Environmental test facility
- Energy Efficiency Test facility
- Safety Test facility
- Electronics
- Audio equipment
- Domestic electronic appliances & accessories
- Electronic components & equipment sub assemblies
- EMC Test Facility
- Environmental Test Facility
- Equipment Used In Clinical Laboratory
- IT Equipment

- Medical Electrical Equipment
- Power supplies & stabilizers
- Safety Testing Facility
- Miscellaneous Products
− Fluid-Flow
- Air & Gases
- Liquids
- Miscellaneous
− Mechanical
- Automotive Components
- Buildings Materials
- Heating, Ventilating, and Air Conditioning (HVAC)
- Leather and Leather Products
- Mechanical Properties of Metals
- Metallography Test
- Noise & Vibration
- Paper & Paper products
- Performance/Durability/ Safety Test
- Plastics and Plastic Products
- Properties of Powder Metallurgical Products
- Rubber and Rubber Products
- Soil and Rock
- Sub Assembly/Ancillaries/Accessories
- Textile Materials
- Toys and Similar products
- Wood and Wood Products
- Thermal Testing

− Non-Destructive Testing
- Metals and Alloys
- Building Materials – Reinforced Concrete Structures
− Photometry
- Light Sources (Electric Lamp)
- Luminaires
- Glasses/Mirrors
− Radiological
- Radiation monitors
- Radiation sources
- Radiological/Nucleonic equipment
- Food and Agriculture Products
- Water
- Soil
− Forensic
- Biological Science
- Chemical Science
- Physical Science
- Others

− MEDICAL LABORATORIES
- Clinical Biochemistry
- Clinical Pathology
- Haematology & Immunohaematology
- Microbiology and Serology
- Histopathology
- Cytopathology
- Genetics
-
Nuclear Medicine (in-vitro tests only)
CALIBRATION LABORATORIES
− Electro-Technical
- Alternating Current (< 1 GHz)
- Direct Current
- RF/Microwave (1 GHz and Above)
- Time & Frequency
- EMI/ EMC
- Electrical equipment
- Temperature Simulation
- Oscilloscope
- Miscellaneous

− Mechanical
- Dimension (Basic - Measuring Instruments, gauges etc.)
- Dimension (Precision - Precision Instrument and Surface topology)
- Mass and Volume (Weights, Balance, Volume)
- Density and Viscosity
- Pressure and Vacuum
- Force (Load cell, UTM, Push pull, Torque)
- Hardness & Impact
- Acceleration, Speed and Acoustics
- Miscellaneous
− Fluid Flow
- Flow by Mass
- Flow by Volume
- Others
− Thermal
- Temperature
- Relative Humidity
− Optical
− Radiological
- Dosimeter (X-rays & Gamma rays)
- Area Survey Meter
- Medical Devices

PROFICIENCY TESTING PROVIDERS (PTP)
− Testing
- Biological
- Chemical
- Electrical
- Electronic
- Fluid-Flow
- Forensic
- Mechanical
- Non-Destructive
- Optical Photometry
- Radiological
- Thermal
− Calibration
- Electro-Technical
- Mechanical
- Fluid Flow
- Thermal
- Optical
- Radiological

− Medical
− Clinical Biochemistry
− Clinical Pathology
− Haematology & Immunohaematology
− Microbiology and Serology
− Histopathology
− Cytopathology
− Genetics
− Nuclear Medicine (in-vitro tests only)
− Inspection
- NDT
- Agriculture and agricultural products
- Manufactured goods
- IT products and services
- Tourism accommodation
- Health inspection
- Building construction and maintenance
- Industrial and commercial construction & maintenance
- Forensic inspection
- Industrial equipment and machinery
- Natural resources and refined products
- Transport
- Factory inspection
- Technical regulation inspection
- Environment & Environmental protection products
- Others

REFERENCE MATERIAL PRODUCERS (RMP)
− Chemical Composition
- Metals
- Inorganic reference materials
- Organic reference materials
- Environmental reference materials
- Health and industrial hygiene
- Engine wear materials
- Analysed gases
- Forensic reference materials
- Ion activity
− Biological and Clinical Properties
- General Medicine
- Clinical Chemistry
- Tissue Pathology and Cytology
- Haematology
- Immunohaematolog
- Immunology
- Parasitology
- Bacteriology and Mycology
- Virology
- Other biological and clinical reference Materials
- Forensic Reference Materials

− Physical Properties
- Reference Materials with Optical Properties
- Reference Materials with Electrical and Magnetic Properties
- Reference Materials for Frequency Measurements
- Reference Materials for Radio-activity
- Reference Materials for Thermo-dynamic Properties
- Reference Materials for Physico-chemical Properties
- Reference Materials for Fibre Identification
- Reference Materials for other properties
− Engineering Properties
- Surface Finish
- Sizing
- Non-Destructive Testing
- Hardness
- Impact Toughness
- Tensile Strength
- Elasticity
- Creep
- Fire Research
− Miscellaneous Properties

6. Preparing for Accreditation
Once the CAB decides to seek NABL accreditation, it should make a definite plan of action for
obtaining accreditation and nominate a responsible person to co-ordinate all activities related to
seeking accreditation. The person nominated should be familiar with CAB’s existing quality
system.
A list of NABL external documents is given at the end of this document and is also available on
NABL website under Publications – Accreditation Documents. The CAB should get fully
acquainted with relevant NABL documents and understand the assessment procedure and
methodology for filing an application.
CAB needs to ascertain the status of its existing quality system and technical competence with
regards to the requirement of ISO/ IEC 17025:2005/ ISO/IEC 17025:2017 or ISO 15189:2012 or
ISO/IEC 17043:2010 or ISO 17034:2016 whichever is relevant and requirements of NABL. The
questions the CAB needs to address are:
 Does the CAB have a quality management system? 


 If yes, is the quality management system documented and effective? 

 If no, what are the corrective steps needed? 
It must be remembered that quality manual is a policy document, which has to be supplemented
by a set of other documents like procedural manuals, work instructions etc. Requirements of the
applicable standard and relevant NABL specific criteria should be discussed amongst
concerned staff of the CAB. This will enable them to understand their strengths and
weaknesses.
For preparing the quality manual or verifying its contents, the CAB may get its technical
personnel trained in training programs on quality management system for CAB personnel
organized by various institutes. The proposed Quality manager shall have undergone 4-days
formal training on management system and internal audit based on relevant standard.
The CAB must ensure that the procedures described in the Quality Manual and other
documents are being implemented.

7. Eligibility for Accreditation
The applicant CAB must comply with all clauses of ISO/ IEC 17025: 2005/ ISO/IEC 17025:2017
or ISO 15189: 2012 or ISO/IEC 17043:2010 or ISO 17034:2016 whichever is applicable. The
applicant CAB must also comply with the relevant NABL specific criteria.
In case the laboratory performs site testing/ calibration, it must also comply with NABL
130 ‘Specific criteria for site testing and site calibration laboratories’.
The applicant CAB must have participated satisfactorily in the proficiency testing program,
wherever applicable, conducted by NABL/ APLAC or any other national or international
accredited/ recognized PT provider. If no suitable PT program is available the CAB 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 and an on-going program as per NABL 163. The satisfactory
performance shall be defined in term of z-score and En number respectively or any other
acceptable internationally accepted method. For unsatisfactory performance, the CAB is to take
corrective action and inform NABL. ISO/ IEC 17043, NABL 163 and NABL 164 give details of
proficiency testing.
The applicant CAB must have conducted at least one internal audit and a management review
before the submission of application. ISO 19011 ‘Guidelines for auditing management systems'
and NABL 161 ‘Guide for Internal Audit and Management Review for CABs’ provides the
necessary guidance for CABs.

8. Accreditation Procedure
Application for Accreditation

(by CAB)
Acknowledgement & Scrutiny of

Application (by NABL Secretariat)
Information
to
Document review (by Lead Assessor) CAB
*Pre-Assessment of CAB and

(by Lead Assessor)
Final Assessment of CAB Necessary

(by Assessment Team) Corrective
Action
by
Scrutiny of Assessment Report CAB
(by NABL Secretariat)
Recommendations for Accreditation

(by Accreditation Committee)
Approval for Accreditation

(by Chairman, NABL)
Issue of Accreditation Certificate

(by NABL Secretariat)
* Preassessment of CAB is optional and depends on the willingness of the CAB to undertake
Flow Diagram of Accreditation Process

Application for Accreditation
The CAB is required to apply in the prescribed application form (NABL 151 for testing
laboratories, NABL 152 for calibration laboratories, NABL 153 for medical laboratories along
with associated Sample Collection Centre/ Facilities (SCF), NABL 180 for PTP and NABL 190
for RMP), in one copy/ discipline along with one copy of the quality manual of the CAB that
should describe the management system in accordance with ISO/ IEC 17025: 2005/ or
ISO/IEC 17025:2017 or ISO 15189: 2012 or ISO/IEC 17043:2010 or ISO 17034:2016
whichever is applicable. The application is to be accompanied with the prescribed application
fee as detailed in this document. CAB has to take special care in filling the scope of
accreditation for which the CAB wishes to apply. In case, the CAB finds any clause (in part or
full) not applicable to the CAB, it is expected to furnish the reasons.
Acknowledgement and Registration of Application
NABL Secretariat on receipt of application form, the quality manual and the fees issues an
acknowledgement to the CAB. After scrutiny of application for its completeness in all respects,
a unique ID number is allocated to the CAB, which is used for correspondence with the CAB.
NABL Secretariat may ask for additional information/ clarification(s) at this stage, if found
necessary.
Appointment of Lead Assessor
NABL secretariat appoints a Lead assessor from the list of empanelled assessors. The lead
assessor does the document review on behalf of NABL and submits the report to NABL
secretariat.
Document Review
The preliminary document review of the application and management system document/
quality manual submitted by the CAB is carried out by NABL Secretariat whereas the detailed
review is carried out by Lead Assessor.
The lead assessor informs NABL regarding the document review, indicating inadequacies (if
any).The CAB amends the relevant documents and also implements the management system
accordingly.

Pre-Assessment
In case there are no inadequacies in the document review after satisfactory corrective action
by the CAB, a pre -assessment of the CAB is conducted by lead assessor appointed by NABL.
Since Pre-assessment is optional, CAB shall express its willingness in writing to undergo the
same. The CAB must ensure their preparedness by carrying out an internal audit and a
management review before the pre -assessment.
The pre-assessment of the CAB is conducted to:
a. evaluate non-conformities (if any) in the implementation of the quality system.

b. assess the degree of preparedness of the CAB for the assessment
c. determine the number of assessors required in various fields based on the scope of
accreditation, number of key location to be visited etc.
The lead assessor submits a pre-assessment report to NABL Secretariat with a copy to the
CAB. The CAB takes corrective actions on the non-conformities raised on the documented
management system and its implementation and submits a report to NABL Secretariat.

Assessment
After the CAB has taken corrective actions, NABL proposes constitution of an assessment
team. The team includes the lead assessor (generally same who is already appointed for pre-
assessment), the technical assessor(s)/ expert(s) in order to cover various fields within the
scope of accreditation sought. NABL may also nominate an observer. NABL seeks CAB’s
acceptance for the proposed assessment team and the CAB is free not to accept one or more
members of the proposed assessment team by giving specific reason(s) for their non -
acceptance.
After the constitution of assessment team is finalized, NABL fixes dates for on-site
assessment in consultation with the CAB, the lead assessor and technical assessor(s)/
expert(s).
The assessment team reviews the CAB ’s documented management system and verifies its
compliance with the requirements of ISO/ IEC 17025: 2005/ ISO/IEC 17025:2017 or ISO
15189: 2012 or ISO/IEC 17043:2010 or ISO 17034:2016 whichever is applicable and relevant
specific criteria and other NABL policies. The documented Management system, SOPs, work
instructions, test methods etc. are assessed for their implementation and effectiveness. The
CAB’s technical competence to perform specific tasks is also evaluated.
The assessment report contains the evaluation of technical manpower, all relevant material
examined, test witnessed including those of replicate testing/ measurement, compliance to
ISO/ IEC 17025: 2005/ ISO/IEC 17025:2017 or ISO 15189: 2012 or ISO/IEC 17043:2010 or
ISO 17034:2016 whichever is applicable and relevant NABL specific criteria. The non-
conformities if identified are reported in the assessment report. It also provides a
recommendation towards grant of accreditation or otherwise. The report prepared by the
assessment team is sent to NABL Secretariat. However a copy of summary of assessment
report and copies of non-conformities if any, are provided to the CAB at the end of the
assessment visit.
Assessment of each declared Sample Collection Centre/ Facility (SCF) of a medical laboratory
will be done in each accreditation cycle. This may be done along with assessment of the
laboratory or separately as the case may be.

Scrutiny of Assessment Report
The assessment report is examined by NABL Secretariat and follow up action as required is
initiated. CAB has to take necessary corrective action on non - conformities/ concerns and
submit a report to NABL Secretariat within 30 days. NABL monitors the progress of closing of
non -conformities.
If any non-conformity is observed during the assessment of a Sample Collection Centre/

facility (SCF), the laboratory shall be asked to take corrective actions within 30 days time. In
case the laboratory fails to take corrective actions or there is a consistent system failure, an
appropriate and proportionate action against the laboratory will be taken.
Accreditation Committee
After satisfactory corrective action by the CAB, the Accreditation Committee examines the
assessment report, additional information received from the CAB and the consequent
verification, if any.
In case the Accreditation Committee finds deficiencies in the assessment report, the NABL
Secretariat obtains clarification from the Lead Assessor/ Assessor/ CAB concerned. In case
everything is in order, the Accreditation Committee makes appropriate recommendations
regarding accreditation of the CAB to the Chairman, NABL.
All decisions taken by NABL regarding grant of accreditation are open to appeal by the CAB.
The appeal is to be addressed to the CEO, NABL.
Issue of Accreditation Certificate
When the recommendation results in the grant of accreditation, NABL issues an accreditation
certificate which has a unique number and NABL hologram / Unique Code, discipline, date of
validity along with the scope of accreditation.
The accreditation certificate for testing laboratory defines field of test, items/ materials/
products tested, specific tests performed, specification/ standard methods or techniques used,
range of testing/ limit of detection, wherever applicable.
The accreditation certificate for calibration laboratory defines the calibration field, product/ item
calibrated, range of measurement, Calibration and Measurement Capability (CMC) and
measurement/ calibration equipment and method used.

The accreditation certificate for medical laboratory defines field of test, items/ materials/
products tested, specific tests performed, specification/ standard methods or techniques used,
range of testing/ limit of detection, wherever applicable and MU / CV%. The annexure to the
accreditation certificate will also contain the details of recognized Sample Collection Centres/
Facilities associated.
The accreditation certificate for proficiency testing provider defines the Proficiency Testing
scheme, proficiency testing item, Analyte / Parameter / Test method.
The accreditation certificate for reference material producer defines the type of RM/CRM
Category / Sub Category, Reference Material, properties of the certified analyte / parameter
and range of property.
For site laboratory, tests/ calibrations performed at site are clearly identified in the scope of
accreditation while issuing the certificate.
The applicant CAB must make all payments due to NABL, before the accreditation
certificate(s) is/ are issued to them.

9. Maintaining Accreditation
Conformance to Applicable standards and NABL requirements
The accredited laboratories at all times shall conform to the requirements of ISO/ IEC 17025:
2005/ ISO/IEC 17025:2017 or ISO 15189: 2012 or ISO/IEC 17043:2010 or ISO 17034:2016
whichever is applicable and relevant specific criteria and NABL Policies.
NABL Terms and Conditions
The accredited CABs are required to comply at all times with the terms and conditions of
NABL given in NABL 131 ‘Terms & Conditions for obtaining and maintaining NABL
Accreditation’. The CABs are required to submit a signed copy of NABL 131 indicating their
willingness to abide by the terms and conditions given in NABL 131.
Modifications to the Accreditation Criteria
If the accreditation criteria are modified by ISO/ ILAC/ APLAC/ NABL, the CAB is informed of
this giving a transition period of at least 6 months to align its operations in accordance with
the modified criteria.
Adverse decision against the laboratories
If the CAB at any point of time does not conform to the applicable standards and NABL
criteria; or does not maintain the NABL terms and conditions; or is not able to align itself to
the modified criteria, NABL may take adverse decision against the CAB like denial of
accreditation, scope reduction, abeyance, suspension or forced withdrawal. NABL 216
‘Procedure for dealing with adverse decisions’ gives the details.

10. Surveillance and Re-assessment
The NABL accreditation certificate is valid for a period of 2 years. NABL conducts annual
Surveillance which is aimed at evaluating continued compliance with ISO/ IEC 17025: 2005/
ISO/IEC 17025:2017 or ISO 15189: 2012 or ISO/IEC 17043:2010 or ISO 17034:2016
whichever is applicable and relevant NABL specific criteria and Policies. The types of
surveillances are given below:
On-Site Surveillance
For the newly accredited CABs, in the first cycle of Accreditation, NABL conducts an on-site
surveillance within 12 months from the date of accreditation. The first surveillance is similar
to initial assessment and covers entire extension to the scope, (if any).
Desktop Surveillance
The desktop surveillance consists of calling of records from the CAB to ascertain that the
CAB continues to maintain the requirements of ISO/ IEC 17025: 2005/ ISO/IEC 17025:2017
or ISO 15189: 2012 or ISO/IEC 17043:2010 or ISO 17034:2016 whichever are applicable
and relevant NABL specific criteria. From the second cycle onwards the CAB is subjected to
desktop surveillance within 12 months of each re-accreditation.
Reassessment
The accredited CAB is subjected to re-assessment every 2 years. The CAB has to apply 6
months before the expiry of accreditation to allow NABL to organize assessment of the CAB,
so that the continuity of the accreditation status is maintained.
The renewal application is submitted in the prescribed form (NABL 151/ NABL 152/ NABL
153/ NABL180/ NABL190 ) in three copies along with two copies of Quality Manual of the
CAB which describes the latest management system in accordance with ISO/ IEC 17025:
2005/ ISO/IEC 17025:2017 or ISO 15189: 2012 or ISO/IEC 17043:2010, ISO 17034:2016
whichever is applicable.
The application is to be accompanied by the prescribed renewal fee, as detailed in the

application form. The CAB may request extension to the scope of accreditation, which should
explicitly be mentioned in the application form.

11. Appeals and Complaints
Appeals
NABL is open to appeals from the CABs against its decisions. The decisions against which
appeals are entertained relate to denial of accreditation, reduction of scope of accreditation
or abeyance/ suspension/ forced withdrawal of accreditation. The details are provided in
NABL 134 ‘Procedure for Dealing with Appeals against Adverse Decisions Taken by NABL’.
Complaints
NABL is open to receiving complaints for any of the activities performed by its officials,
assessors, accreditation committee members and the accredited CABs. The details are
provided in NABL 132 ‘Procedure for Dealing with Complaints’.

12. Rights and Obligations of CABs
Rights of CABs
 CABs are entitled to receive information related to CAB accreditation. They can access
NABL’s website www.nabl-india.org which gives information necessary for NABL
accreditation. 

 NABL is obliged to make available information on CAB’s scope of accreditation, validity
dates for its accreditation certificate(s) and contact details to users of the CABs. This
information is provided at NABL web -site. 

 The CABs are free to approach any accredited CAB for traceability of measurements
provided they fulfill the conditions laid down in NABL 142 ‘NABL Policy on Calibration
and Traceability of Measurements ’.
 CAB has the right to object to appointment of specific member(s) of assessment team
by giving valid reasons. 

 NABL accredited CAB has the right to use ‘NABL Symbol’ on the test/ calibration
reports issued by it as long as the test/ calibration is included in its scope of
accreditation. Detailed requirements governing use of ‘NABL Symbol’ and claim of
accreditation have been stated in NABL 133. 

 NABL is open to receiving complaints for any of the activities performed by its officials,
assessors, accreditation committee members and the accredited CABs. 


 NABL is open to appeals from the CABs against its decisions. The cases may involve
refusal of accreditation, scope reduction, abeyance, suspension or forced withdrawal. 

Obligations of the CABs
 An accredited CAB is obliged to fulfill requirements of relevant standard and NABL

Specific Criteria and NABL 131 ‘Terms and conditions for maintaining NABL
accreditation’, at all times. 

 The CAB is obliged to disclose name of the consultant; if applicable, at the time of
applying for accreditation. 

 The CAB is expected to provide access to all premises where key activities of CAB are
performed and afford access to all relevant information, documents and records
necessary to assess CAB’s compliance to the relevant criteria, standards and NABL
131. 

 The CAB is expected to facilitate work of the assessment team by providing necessary
amenities including arrangement of appropriate test samples/ devices for calibration
and staff to demonstrate tests/ calibrations/ PTP and RMP activities. 

 An accredited CAB can claim accreditation only with respect to the scope for which it
has been granted accreditation as detailed in NABL 133, and not use accreditation in a
manner to bring disrepute to NABL. 

 The CAB is required to notify NABL of any change that may affect the ability of the
CAB to fulfill requirements of accreditation, within 15 days. Notifiable changes include
(but are not restricted to): change in legal status, change in ownership, changes in
organization, change in top management, change in key personnel and authorized
signatories, major change in policies, change in locations etc. 

 The CAB is required to pay necessary fees as determined by NABL from time to time. 

13. Rights and Duties of NABL
Rights of NABL
 NABL requires that all CABs will conform to ISO/ IEC 17025: 2005/ ISO/IEC
17025:2017 or ISO 15189: 2012 or ISO/IEC 17043:2010 or ISO 17034:2016
whichever is applicable and relevant NABL specific criteria to seek and maintain
accreditation and adapt to the changes in the requirements of accreditation. 

 NABL requires that all accredited CABs will sign NABL 131 ‘Terms and conditions for
obtaining and maintaining NABL accreditation’ and abide by it. 

 NABL has the right to: 

- effect changes in standards on which CAB accreditation is based in accordance
with international norms
- decide on policies related to accreditation in consultation with stakeholders
- appoint assessment teams in consultation with CAB and the assessors
- decide on implementation schedules in consultation with the CABs
- take action against CAB giving valid reasons for the same
- take adverse decisions giving reasons for the same

Duties of NABL
 NABL is obliged to make available information on CABs’ scope of accreditation, validity

dates for its certificate(s) and contact details to users of the CABs. This information is
provided at NABL web -site. 

 NABL is obliged to provide information on Mutual Recognition Arrangement (MRA) with
APLAC and ILAC partners and other International arrangements. The information is
provided on NABL web -site and more information can also be provided on request. 

 NABL provides the CAB with information about suitable ways to obtain traceability of
measurement relevant to the scope for which accreditation is granted. The information
is provided in NABL-142 ‘Policy on Calibration and Traceability of Measurement’.
Further, the details of calibration laboratories accredited by NABL can be obtained from
Laboratory search option provided on NABL website. 

 NABL communicates changes to the requirements of accreditation such as ISO/ IEC
17025:2005 or ISO/IEC 17025:2017 or ISO 15189 or ISO/IEC 17043 or ISO
17034:2016, ILAC & APLAC documents, NABL specific criteria documents or any other
requirements through NABL website. NABL gives sufficient notice to the laboratories to
enable them to implement the changes. 


 NABL provides adequate mechanism to resolve complaints received for any of the
activities performed by its officials, assessors, accreditation committee members and
the accredited CABs. 


 NABL provides adequate mechanism to address the appeals received from the CABs
against its decisions. 

14. NABL Finance and NABL Fee Structure
NABL Finance
NABL derives its funds from the revenue generated through accreditation activities.
NABL Fee Structure

A uniform fee structure is maintained for all CABs and the charges are maintained at a
reasonable level so that CABs are not denied participation in the accreditation process because
of unreasonable financial conditions. The information about the fee structure for various field(s)/
discipline(s) is given below:
FY 2017-18 FY 2018-19
till 31.03.2018 w.e.f. 01.04.2018
Application Testing Laboratories: Rs. 11,000 Rs. 11,000
Fee For 01 product group/ discipline (eg. Metals &
alloys, Food & agricultural products, Drugs &
(non-refundable, to pharmaceuticals, Textiles etc.)
be paid along with
the application) Forensic Laboratories Rs. 44,000 Rs. 44,000
Medical Laboratories (covering all fields) &

Associated Sample Collection
Centre/Facility (SCF)
Small Laboratories (below 100 patients/ Rs. 18,700 Rs. 18,700 +
day/location+) Rs. 200 per
SCF
Medium Laboratories (101-400 patients/ Rs. 44,000 Rs. 44,000 +
day/location+) Rs. 200 per
SCF
Large Laboratories (401-1000 patients/ Rs. 1,10,000 Rs. 1,10,000
day/location+) + Rs. 200 per
SCF
Very Large Laboratories (above 1000 patients/ Rs. 2,20,000 Rs. 2,20,000
day/location+) + Rs. 200 per
SCF
+ Multilocation laboratory - a laboratory with more than one location in the same city, with
same legal identity and with overlapping scopes in different locations.
Note: Application fee for Multi-location Medical laboratory shall be the fee of one location
based on number of patients received per day at that location plus the fee of second location
based on number of patients received per day and so on………..
Calibration Laboratories:
Mechanical – For 01 group (eg. Dimension, force Rs. 11,000 Rs. 11,000
etc)
Electro-Technical (all parameters) Rs. 33,000 Rs. 33,000
Thermal (all parameters) Rs. 22,000 Rs. 22,000
Fluid Flow (all parameters) Rs. 22,000 Rs. 22,000
Optical (all parameters) Rs. 22,000 Rs. 22,000
Radiological (all parameters) Rs. 22,000 Rs. 22,000
Medical Devices (Upto 10 equipments) Rs. 50,000 Rs. 50,000
Proficiency Testing Providers:

For one scheme per field Rs. 25,000 Rs. 25,000
Additional Proficiency Test Item (matrix / Rs.10,000 Rs.10,000
group / field)

Reference Material Producers:
Per Category – upto 2 sub-categories Rs. 25,000 Rs. 25,000
For each additional sub category Rs. 5,000 Rs. 5,000
Enhancement Testing Laboratories
of Scope (apart Rs.5,500 per Rs.5,500 per
Any extension in the existing accredited group group
from the scheduled scope per discipline of testing
re-assessment) For each additional product group in each Rs.11,000 Rs.11,000
discipline of testing
Medical Laboratories & Associated

Sample Collection Centre/Facility (SCF)
Any extension in the existing accredited scope Rs. 5,500 Rs. 5,500
Any addition in Sample Collection N/A Rs. 200 per
Centre/Facility (SCF) SCF
Forensic Laboratories
Any extension in the existing accredited Rs. 5,500 Rs. 5,500
scope
Calibration Laboratories:
Mechanical –Any extension in the existing Rs.5,500 Rs.5,500
accredited scope per group per
discipline
- For each additional product Rs.11,000 Rs.11,000
group per discipline
For extension in Electro-Technical, Thermal, Rs. 5,500 Rs. 5,500
Fluid Flow, Optical, Radiological disciplines
Medical Devices (Upto two equipments) Rs. 5,500 Rs. 5,500
Proficiency Testing Providers:

Additional Proficiency Test Item (matrix / Rs.10,000 Rs.10,000
group / field)
Reference Material Producers:

For each additional sub category Rs. 5,000 Rs. 5,000
Change in Any addition of authorized signatory(s) apart Rs. 5,500 / Rs. 5,500 /
from the scheduled assessment request request
Authorized
signatory
Change of Testing, Calibration and Medical

Laboratories-
Certificate Any change in the name and or premises of the Rs. 5,500 Rs. 5,500
laboratory leading to issue of new accreditation
certificate with scope
RMP & PTP-
Any change in the name and or premises of the Rs. 3,000 Rs. 3,000
laboratory leading to issue of new accreditation
certificate with scope
Annual Testing laboratories except Forensic Rs. 22,000 Rs. 24,000

Accreditation laboratories (per discipline):
Forensic laboratories Rs. 44,000 Rs. 48,000

Fee (per year from
the date of Calibration laboratories(per discipline) Rs. 22,000 Rs. 24,000
accreditation) except Electro-technical calibration laboratories
Electro-technical laboratories Rs. 33,000 Rs. 36,000
Note-
RMP & PTP Rs. 25,000 Rs. 27,500
Annual Accreditation
fee is payable in
advance and is non Medical Laboratories (covering all
refundable and non- disciplines) & Sample Collection
adjustable.
Centre/Facility (SCF)
In case of co- Small Laboratories (upto 100 patients/ day/location+) Rs. 18,700 Rs. 20,000 +
terminus of Rs. 1,000 per
accreditation validity,
the fee will be SCF
charged on pro-rata Medium Laboratories (101-400 patients/ Rs. 44,000 Rs. 48,000 +
basis day/location+) Rs. 1,000 per
SCF
Large Laboratories (401 -1000* patients/ Rs. 1,10,000 Rs. 1,20,000
day/location+) + Rs. 1,000
per SCF
Very Large Laboratories (above 1000 patients/ Rs. 2,20,000 Rs. 2,40,000
day/location+) + Rs. 1,000
per SCF
+ Multilocation laboratory - a laboratory with more than one location in the same city, with
same legal identity and with overlapping scopes in different locations’
Note: In case of Medical laboratory having Multi-locations, Annual Accreditation fee shall be
charged based on the location with maximum number of patients per day.
Overhead For each assessment including Desktop Rs. 11000 Rs. 11,000
Charges surveillance, irrespective of number of
disciplines
Assessment Comprising of - Travel, Boarding, Lodging

Charges - Honorarium for NABL Assessors
(payable after the - Overhead Charges
completion of
assessment visit to
the CAB) For Sample Collection Centre / Facility (SCF) charges on Rs. 5,000 per
lump-sum basis including Honorarium, travel and overhead SCF
expenses
Travel, The CAB will make the arrangements as per the following entitlements.
Boarding and Any travel or boarding and lodging beyond the following entitlement shall
be agreed upon in advance by the CAB under the intimation to NABL.
Lodging
expenditure A. Travel
 If the journey is more than 300 Km, travel to be made by Air in
economy class (Apex fare).
 If the journey is less than 300 Km, travel to be made by train in
2nd AC Class / AC Chair Class or by AC Bus.
 If outstation journey is made by own car, the reimbursement will be
restricted to 2nd AC class fare by train.
 Travel within the city by taxi will be reimbursed on production of
receipts / bills. In absence of taxi bills or travel by own car within the
city, claim will be reimbursed @ Rs.15 per km.
 Any other relevant expenses during the travel will be reimbursed only
on production of receipts / bills.

B. Boarding and Lodging
 A single occupancy AC accommodation to be provided for each
Assessor/ Observer in a reasonably good hotel / guesthouse and
arrangement for local transportation from temporary residence to the
CAB site and airport / railway station / bus stand to be made.
 The CAB shall pay for meals of Assessor/ Observer during the stay,
within the reasonable limitations.
Note: The travel, boarding & lodging for NABL Officials joining assessment
as Observer, shall be borne by NABL.
Honorarium for Document review by Lead Assessor Rs. 2,000

NABL Pre-Assessment, Assessment, Surveillance, Verification,
Assessors Special Visit
- by Lead Assessor Rs. 4,500 per
day
- by Technical Assessor/ Expert Rs. 4,000 per
day
Note: In addition to the above mentioned fee, GST @ 18.0 % is to be paid along with said charges / fees.

Modes of Payment –
S. Options Remarks
No.
1 Cheque / Demand Draft in favour of  No account number or branch to be
‘Quality Council of India’ payable at mentioned on Cheque / DD. Payee should
Gurugram / Gurgaon be only ‘Quality Council of India’;
 Cheque / DD to be sent to NABL Office at
the following address:
Plot no. 45, Sector 44,
Gurugram, Haryana – 122003.
2 Payment gateway for making online Gateway may be accessed from the home
payments page of NABL website.
 Existing CABs may obtain the Login
(Preferred and easiest method as credentials from NABL;
payment is easily traceable and  New CABs may pay directly through
reconcilable in an accurate and timely gateway without any login.
manner)
3 NEFT to following account :  Virtual Account no. will be unique for each
CAB and to be obtained from NABL;
Quality Council of India  Use only this virtual account no. for
HDFC Bank making all payments related to that CAB;
Kanjurmarg Branch, Mumbai  Use correct virtual account number to
IFSC Code – HDFC0004989 avoid the payment being accounted for
against wrong CAB Id;
Virtual A/c No. – Unique for each CAB,  Do not use any other account of ‘Quality
to be provided by NABL. Council of India’ for NEFT.

Fee Structure for Accreditation of Overseas Conformity Assessment
Bodies outside India
FEE STRUCTURE FOR SAARC COUNTRIES
(Effective from 15.01.2018)
Application Fee: 400 USD/ discipline (e.g. Mechanical testing,

Medical testing, Electro –technical calibration
etc.)
Document Review and Associated 200 USD
Home Based Assessment (e.g.
Document Review & Desktop
Surveillance)
Change in Authorized signatory 100 USD/ Request
Enhancement of Scope (apart from 200 USD/ Product group
the scheduled re-assessment)
Change of Certificate 100 USD
(Any change in the name and or
premises of the laboratory leading to
issue of new accreditation certificate
with scope)
Assessment Charges: 100 USD/ Man day
Accreditation Fee: 350 USD/ Annum/ discipline
FEE STRUCTURE FOR OVERSEAS CABs OTHER THAN SAARC COUNTRIES

(Effective from 15.01.2018)
Application Fee: 1000 USD / discipline (e.g. Mechanical testing,
Medical testing, Electro –technical calibration
etc.)
Document Review and Associated 500 USD
Home Based Assessment (e.g.
Document Review & Desktop
Surveillance)
Change in Authorized signatory 250 USD/ Request
Enhancement of Scope (apart from 300 USD/ Product group
the scheduled re-assessment)
Change of Certificate 200 USD
(Any change in the name and or
premises of the laboratory leading to
issue of new accreditation certificate
with scope)
Assessment Charges: 600 USD/ Man day
Accreditation Fee: 1000 USD/ Annum/Field
Note - Overseas CABs to contact NABL for making the payments

Entitlement of Assessment Team -
The laboratory/ PTP/ RMP shall make arrangements for Travel, boarding & lodging for the
assessment team. A single occupancy accommodation may be provided for each Assessor/
Observer in a good hotel and arrangement for local transportation from temporary residence
to the laboratory/ PTP / RMP site & airport.
The Laboratory / PTP/ RMP shall assist in VISA and arrange other logistics like travel
insurance and accommodation.

15. NABL Publications
Sl Name of Document Doc. No.
1. General Information Brochure NABL 100

2. Specific Criteria for Biological Testing Laboratories NABL 102
3. Specific Guidelines for Chemical Testing Laboratories NABL 103
4. Specific Criteria for Electrical Testing Laboratories NABL 104
5. Specific Criteria for Electronics Testing Laboratories NABL 105
6. Specific Criteria for Fluid Flow Testing Laboratories NABL 106
7. Guidelines and Specific Criteria for Accreditation of Mechanical Testing NABL 107
Laboratories
8. Specific Criteria for Non -Destructive Testing Laboratories NABL 108
9. Specific Criteria for Photometry Testing Laboratories NABL 109
10. Specific Criteria for Radiological Testing Laboratories NABL 110
11. Procedure for Recognition of Sample Collection Centre/ Facility declared by Medical NABL 111
Laboratories ( CABs)
11. Specific Criteria for Accreditation of Medical Laboratories NABL 112
12. Specific Guidelines for Accreditation of Forensic Science Laboratories NABL 113
13. NABL Guidelines for Food Testing Laboratories NABL 114
14. Specific Criteria for Calibration Laboratories in Electro-Technical Discipline NABL 121
15. Specific Criteria for Calibration Laboratories in Mechanical Discipline NABL 122
(01 to 15)
16. Specific Criteria for Calibration Laboratories in Radiological Discipline NABL 123
17. Specific Criteria for Calibration Laboratories in Thermal and Optical Discipline NABL 124
18. Specific Criteria for Calibration Laboratories in Fluid Flow Discipline NABL 125
19. Specific Criteria for Calibration of Medical Devices NABL 126
19. Specific Criteria for Site Testing and Site Calibration Laboratories NABL 130
20. Terms & Conditions for Obtaining and Maintaining NABL Accreditation NABL 131
21. Procedure for Dealing with Complaints NABL 132

22. NABL Policy for Use of NABL Symbol / Claim of Accreditation by Accredited Conformity NABL 133
Assessment Bodies (Laboratories / PTP / RMP)
23. Procedure for Dealing with Appeals against Adverse Decisions taken by NABL NABL 134
24. Guidelines for Estimation and Expression of Uncertainty in Measurement NABL 141
25. Policy on Calibration and Traceability of Measurements NABL 142

26. Policy on Calibration and Measurement Capability (CMC) and Uncertainty in Calibration NABL 143
27. Application Form for Testing Laboratories NABL 151
28. Application Form for Calibration Laboratories NABL 152
29. Application Form for Medical Testing Laboratories NABL 153

30. Guide for Preparing a Quality Manual NABL 160
31. Guide for Internal Audit and Management Review for Conformity Assessment Bodies NABL 161
(Laboratories / PTP / RMP)
32. Policy for Participation in Proficiency Testing Activities NABL 163
33. Guidelines for Inter-Laboratory Comparison for Calibration Laboratories where formal PT NABL 164
programs are not available
34. NABL’s Policies for Accreditation ( as per ISO/IEC 17025:2017) NABL 165
35. Sample Calculations for Uncertainty of Measurement in Electrical Testing NABL 174
36. Application Form for Proficiency Testing Providers (PTP) NABL 180
37. Specific criteria for PT Provider Accreditation NABL 181

38. Pre-assessment guidelines and forms (based on ISO/IEC 17043:2010) NABL 182
39. Assessment forms and checklist (based on ISO/IEC 17043: 2010) NABL183
40. Application Form for Reference Material Producers (RMP) NABL190

41. Specific Criteria for Reference Material Producer Accreditation NABL191
42. Pre-Assessment Guidelines & Forms (based on ISO Guide 34:2009) NABL192
43. Assessment Forms And Checklist (based On ISO Guide 34:2009) NABL 193
44 Assessment Forms And Checklist (based On ISO 17034:2016) NABL 194
45. Procedure for dealing with Changes in Accredited Conformity Assessment Body’s NABL 201
Operations
46. Pre-Assessment Guidelines and Forms (based on ISO 15189:2012) NABL 208
47. Pre-Assessment Guidelines and Forms (based on ISO/IEC 17025:2005) NABL 209
48. Assessor Guide NABL 210
49. Assessment Forms & Checklists (based on ISO/ IEC 17025:2005 ) NABL 215
50. Procedures for Dealing with Adverse Decisions NABL 216
51. Assessment Forms & Checklists (based on ISO 15189:2012 ) NABL 217
52. Desktop Surveillance NABL 218
53. Assessment Forms and Checklist (Based on ISO/IEC 17025:2017) NABL 219
54. Bio-data of Assessors NABL 221
55. Contract between NABL and Assessors NABL 230
56. Directory of Accredited Testing Laboratories NABL 400
57. Directory of Accredited Calibration Laboratories NABL 500
58. Directory of Accredited Medical Testing Laboratories NABL 600
59. Directory of Accredited PTP NABL 700
60. Directory of Accredited RMP NABL 800

Note: All NABL documents can be downloaded free of cost from NABL website: www.nabl -india.org.

16. Contact Addresses
Secretariat: National Accreditation Board for Testing and

Calibration Laboratories (NABL)
NABL House,
Plot No. 45, Sector 44,
Gurugram - 122002,
Haryana, India
Tel. no.: +91-124-4679700 (30 lines)
Fax: +91-124-4679799
E-mail: [email protected]
Website: www.nabl-india.org
Website : www.nabl-india.org
Email: [email protected]

National Accreditation Board for Testing and Calibration Laboratories (NABL)
NABL House,
Plot No. 45, Sector 44,
Gurgaon - 122002, Haryana, India
Tel. no.: +91-124-4679700 (30 lines)
Fax: +91-124-4679799
E-mail: [email protected]
Website: www.nabl-india.org

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National Accreditation Board for

General Information Brochure

ISSUE DATE: 26-Jul-2018

5. Scope of NABL Accreditation 11

6. Preparing for Accreditation 23

7. Eligibility for Accreditation 24

10. Surveillance and Re-assessment 32

11. Appeals and Complaints 33

12. Rights and Obligations of CABs 34

13. Rights and Duties of NABL 36

14. NABL Finance and NABL Fee Structure 38

15. Modes of Payment 42

16. NABL Publications 45

17. Contact Addresses 47

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International Standard ISO/IEC 17000 defines Conformity Assessment as a “Demonstration that

Laboratory accreditation is a procedure by which an authoritative body gives formal recognition

The general requirements for laboratories or other organizations, to be considered competent to

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Accredited CABs can objectively state conformance of product or service to specified

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Formal recognition of competence of a laboratory by an Accreditation body in accordance with

The benefits of proficiency testing are widely recognized. These include:

 Comparison of a facility’s performance with that of other participating (peer) facilities

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 Accreditation is an effective marketing tool for RMPs.

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NABL offers accreditation services in a non-discriminatory manner. These services are

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The organization chart (Technical) of NABL is given below –

QCI Governing Body

Secretary General (QCI)

Chief Executive Officer

Director Director Director

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Recommendations of Accreditation Committee form the basis for accreditation decisions.

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- Food and Agricultural Products

- Drugs and Pharmaceuticals

- Environment and Pollution

- Cosmetics and Essential Oils

- Plants and Plant Materials

- Resistance to Microbial Attack

- Biological Tests on Other Miscellaneous Test Items

- Biopesticides and Biofertilizers

- Identification/Enumeration of Microbial Pathogens

- Nutraceuticals & Functional Foods

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- Antimicrobial activity Products

- Biologicals Derived Pharmaceuticals

- Cosmetics & Essential Oil

- Marine /Aqua culture Food Products

- Medical Accessories & Surgical products

- Wild Life Forensic

- Animal Food & Feeds

- Cosmetics & Essential Oils