Q: What is NABL?

A: NABL stands for National Accreditation Board for testing & calibration Laboratories.
NABL is a Constituent Board of Quality Council of India. 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 & 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 is 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”.

NABL offers accreditation services in a non-discriminatory manner. NABL has established its accreditation
system in accordance with ISO/ IEC 17011: 2017 “Conformity Assessment – 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.

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 recognises 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.

NABL went a step further in removing technical barriers to trade and achieved the status of signatory to Asia
Pacific Laboratory Accreditation Cooperation (APAC) Mutual Recognition Arrangement (MRA) and International
Laboratory Accreditation Cooperation (ILAC) Arrangement based on a peer evaluation by APAC in 2000. This
was a major step towards mutual acceptance of test results and measurement data across Indian borders. NABL
went through the peer APAC evaluation in 2004, 2008, 2012 & 2016 and reaffirmed its APAC / ILAC signatory
status with extension of scope for Proficiency testing providers (PTP) as per the standard ISO/IEC 17043:2010 &
Reference materials producers (RMP) as per the standard ISO 17034: 2016. Today, the test results and
measurement data produced by Indian accredited CABs are acceptable amongst economies which MRA
partners represent.

NABL provides accreditation in all major fields of Science and Engineering such as Biological, Chemical,
Electrical, Electronics, Mechanical, Fluid-Flow, Non-Destructive, Photometry, Radiological, Thermal & Forensics
under testing facilities and Electro-Technical, Mechanical, Fluid Flow, Thermal, Optical, Medical Devices &
Radiological under Calibration facilities. NABL also provides accreditation for medical testing laboratories. In
addition, NABL also offers accreditation for Proficiency testing providers & Reference Material producers and is
now signatory to APAC MRA for both.
 Q: What is the vision & mission of NABL?

A: NABL Vision

To be the world’s leading accreditation body and to enhance stakeholders’

confidence in its services.

NABL Mission

To strengthen the accreditation system accepted across the globe by

providing high quality, value driven services, fostering APAC/ILAC MRA,
empanelling competent assessors, creating awareness among the stake
holders, initiating new programs supporting accreditation activities and
pursuing organisational excellence.

Why Accreditation ?
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, Certified Reference Material Producer.

The liberalization of trade and industry policies of the Government of India has created quality consciousness in
domestic trade and provided greater thrust for export. As a consequence testing centres and laboratories have
to demonstrably operate at an internationally acceptable level of competence.

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
standards.

Similarly, Proficiency testing Provider accreditation gives formal recognition of competence for organizations
that provide proficiency testing. Reference Material Producers Accreditation gives formal recognition of
competence to carry out the production of reference materials based on third party assessment and following
international standards.

Benefits of Accreditation
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.

Proficiency testing providers play an important role in the value chain for assurance of products
and services. Being an accredited PTP gives the organisation credibility for their PT services. The
benefits of proficiency testing are widely recognized. These include:

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

2. Monitoring of a long-term facility performance
3. 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
4. Staff education, training and competence monitoring
5. Evaluation of methods, including the establishment of method precision and accuracy
6. Estimation of measurement uncertainty
7. Contribution to the facility’s overall risk management system
8. Confidence building with interested parties, e.g. customers, accreditation bodies, regulators.

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

international criteria has many advantages:

1. Accreditation is an effective marketing tool for RMPs.

2. Accreditation provides assurance that the accredited RMPs are competent to produce the RMs as listed in
the scope of accreditation.
3. 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.
4. 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.
5. RMs are used globally. Many economies around the world have accreditation bodies offering
accreditation to RMPs. These accreditation bodies have adopted ISO Guide 34 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.

Scope of Accreditation
NABL Accreditation is currently given in the following fields and disciplines. 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.

CALIBRATION
TESTING LABORATORIES MEDICAL LABORATORIES
LABORATORIES

·Biological ·Electro-Technical ·Clinical Biochemistry

·Chemical ·Mechanical ·Clinical Pathology
·Electrical ·FluidFlow ·Haematology & Immunohematology
·Electronics ·Thermal & Optical ·Microbiology & Serology
·Fluid-Flow · Radiological ·Histopathology
·Mechanical ·Cytopathology
·Non-DestructiveTesting ·Genetics
·Photometry ·Nuclear Medicine (in-vitro tests
·Radiological only)
·Thermal
· Forensic

PROFICIENCY TESTING REFERENCE MATERIAL PRODUCERS

PROVIDERS

·Testing · Chemical Composition

·Calibration · Biological & Clinical Properties
·Medical .Physical Properties
· Inspection · Engineering Properties
· Miscellaneous Properties
 Preparation & Eligibility for Accreditation

1. 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 who should be familiar with CAB’s existing quality system.
2. The CAB should get fully acquainted with relevant NABL documents and understand the assessment
procedure and methodology for filing an application.
3. A CAB wishing to be accredited by NABL must have a Quality Manual on its Quality System satisfying the
requirements as described in various clauses of ISO/ IEC 17025:2005 or ISO 15189:2012 or ISO/IEC
17043:2010 or ISO Guide 34:2009 whichever is relevant and requirements of relevant NABL specific
criteria and needs to ascertain the status of its existing quality system and technical competence.
4. The proposed Quality manager shall have undergone 4-days formal training on management system and
internal audit based on relevant standard.
5. The CAB must ensure that the procedures described in the Quality Manual and other documents are
being implemented. In case the laboratory performs site testing/ calibration, it must also comply with
NABL 130 “Specific criteria for site testing and site calibration laboratories‟.
6. 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/ recognised 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.
7. The applicant CAB must have conducted at least one internal audit and a management review before the
submission of application.

Process of 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, NABL 180 for PTP and NABL
190 for RMP), in three copies along with two copies of the quality manual of the CAB that should
describe the management system in accordance with ISO/ IEC 17025: 2005 or ISO 15189: 2012 or
ISO/IEC 17043:2010 or ISO Guide 34:2009 whichever is applicable. The application is to be
accompanied with the prescribed application fee as detailed in NABL 100. 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.

 NABL Secretariat on receipt of application form, the quality manual and the fees issues an
acknowledgement to the CAB indicating a unique ID number, which is used for correspondence with
the CAB. After scrutiny of application for its completeness in all respects, NABL Secretariat may ask
for additional information/ clarification(s), if necessary.

 In case there are no inadequacies in the quality manual or after satisfactory corrective action by the
CAB, a pre -assessment visit of the CAB is organised by lead assessor appointed by NABL. The pre-
assessment of the CAB is conducted to evaluate non-conformities (if any) in the implementation of the
quality system, to assess the degree of preparedness of the CAB for the assessment, to 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.

 After the CAB has taken satisfactory corrective actions, NABL finalizes the constitution of assessment
team in consultation with the CAB. The team includes the lead assessor and technical assessor(s)/
expert(s) in order to cover various fields/ disciplines/ groups within the scope of accreditation sought.
NABL may also nominate an observer. The assessment team reviews the CAB’s documented
management system and verifies its compliance with the requirements of ISO/ IEC 17025: 2005 or
ISO 15189: 2012 or ISO/IEC 17043:2010 or ISO Guide 34:2009 whichever is applicable and relevant
specific criteria and other NABL policies. The CAB’s technical competence to perform specific tasks is
also evaluated. 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.

 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 and submit a report to NABL
Secretariat within 60 days. NABL monitors the progress of closing of non-conformities.
  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
everything is in order, the Accreditation Committee makes appropriate recommendations regarding
accreditation of the CAB to the Chairman, NABL.

 All decision taken by NABL are open to appeal by the CAB. The appeal is to be addressed to the
Director, NABL.

 When the recommendation results in the grant of accreditation, NABL issues an accreditation
certificate which has an unique number and NABL hologram, discipline, date of validity along with the
scope of accreditation.

 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.

 The accredited CABs at all times shall conform to the requirements of ISO/ IEC 17025: 2005 or ISO
15189: 2012 or ISO/IEC 17043:2010 or ISO Guide 34:2009 whichever is applicable and relevant
specific criteria and NABL Policies. 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 NABL accreditation certificate is valid for a period of 2 years. NABL conducts annual Surveillance
of the CAB at intervals of one year which is aimed at evaluating continued compliance to the
requirements of ISO/ IEC 17025: 2005 or ISO 15189: 2012 or ISO/IEC 17043:2010 or ISO Guide
34:2009 whichever is applicable and relevant specific criteria and NABL Policies.

 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 organise assessment of the CAB, so that the
continuity of the accreditation status is maintained.

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 CABs

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 as per NABL 216 “Procedure for dealing with adverse decisions‟.

Complaints & Appeals

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”.

NABL is open to appeals from the CABs against its decisions. The details are provided in NABL 134 “Procedure
for Dealing with Appeals against Adverse Decisions Taken by NABL”.
 International Recognition

NABL maintains linkages with the international bodies like International Laboratory Accreditation
Co-operation (ILAC) and Asia Pacific Accreditation Co-operation (APAC). NABL is a full member
of ILAC and APAC 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.apac-
accreditation.org respectively.

NABL is signatory to ILAC as well as APAC 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. NABL is also having APAC
Mutual Recognition Arrangements(MRA) for Proficiency Testing Provider & Reference materials
producers. Such international arrangements facilitate acceptance of test/ calibration results between
countries which MRA partners represent.

The information on ILAC and APAC Mutual Recognition Arrangements (MRAs) is available at
NABL web-site. On request from the laboratories or their users, a copy of ILAC/ APAC 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: 2017.

NABL APAC/ ILAC MRA Signatory Status

 Impartiality Policy

Impartiality is the backbone of NABL activities and is of paramount significance in maintaining the
confidence amongst the stakeholders about its accreditation system. NABL is committed to
safeguard the impartiality while dealing with accreditation at all levels. NABL adheres to the
requirement of ISO/IEC 17011: 2017 ‘Conformity assessment - Requirements for accreditation
bodies accrediting conformity assessment bodies’ that accreditation shall be undertaken impartially.
NABL is a part of a not for profit organization and is designed in such a way as to ensure that
impartiality is not compromised by any undue commercial, financial or other pressures. NABL does
not engage in any activities which could compromise its impartiality; it does not provide consultancy
to conformity assessment bodies, nor does it undertake any conformity assessment activities itself
and it does not promote the services of any specific body. NABL does provide training to external
parties although these courses are confined to the provision of generic information that is freely
available in the public domain. NABL applies its policies and procedures in a non-discriminatory
manner and its services are available to all bodies whose accreditation applications fall within its
defined scope of activities. It is applicable to all regardless of number of personnel, number of
bodies already accredited or membership of any association or group. NABL board as the apex body
of NABL, responsible for making all kind of policy decisions regarding providing resources and
financial support including feasibility studies of the new accreditation programs, review of
performance of personnel involved in accreditation and safeguarding the impartiality arising out of
its activities, is having fair representation from the stakeholders ensuring that no one interest
predominates The impartiality and objectivity of the accreditation services that NABL provides is
tightly controlled. All personnel involved in management, assessments and any other NABL
accreditation activities are required to declare any potential conflicts of interest. Accreditation
decisions are made by competent persons independent of the assessment of the conformity
assessment body under review. In the event that customers or other stakeholders have concerns
regarding the impartiality or objectivity of NABL, NABL has non-discriminatory procedures in place
for handling complaints and appeals.
Q: Is nabl a government body?

A: 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.

Q: What does NABL stand for? What’s its use?

A: 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). These are especially valuable for International
recognition and mutual acceptance of test results. In short accreditation has
worldwide acceptance.

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. 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.

Q: Does NABL follow any ISO guidelines?

A: NABL follows ISO 15189:2007, which is specific ISO followed world wide for
medical laboratories. This standard is used by APLAC (Asia Pacific Laboratory
Accreditation Cooperation) and ILAC (International Laboratory Accreditation Co-
operation) etc.
This means that an NABL accredited laboratory in India follows the same
guidelines as any other accredited laboratory in the world.

Q: What is the difference between ISO certification and NABL accreditation?

A: NABL accreditation is based on evaluation of technical competence whereas
ISO certification is based upon verification of proper documentation. Though
documentation forms an essential and important part of NABL, it lays down great
emphasis on quality and the lab can be denied accreditation if one does not
comply with the quality standards.
Q: Is the activity of NABL monitored by some independent authority?
A: NABL has established its Accreditation System in accordance with ISO/IEC
17011:2004, which is followed internationally. In addition NABL has to also
comply with the requirements of APLAC (Asia Pacific Laboratory Accreditation
Cooperation) MR001 which it satisfies.

Q: Is NABL accreditation mandatory in the country?

A: No. It is purely voluntary.

Q: How many labs are currently NABL accredited in the country?

A: At present only 139 Labs are accredited in the entire country.

Q: Is accreditation a one-time phenomenon?

A : NABL accreditation is not a one-time phenomenon. Laboratory accreditation is
valid for a period of 2 years only. During these 2 years NABL conducts periodical
surprise surveillances of the laboratory on an annual basis. Accreditation can be
revoked if the laboratory fails to maintain the standards of NABL even during
these two years.

Q: Is NABL like any other inspection with all its nuances?

A: NABL is a very professional and ethical body and the assessors give guidance
rather than do policing

Q: Who comprise the NABL assessing team?

A: For each inspection, there is one lead assessor and other technical assessors
for assessing different departments of the laboratory. These are qualified people
from government, semi government and private organizations who have got
special training from NABL.

Q: What does this all mean for the common man, patient and the doctor?
A: It means that your lab is continuously striving for quality and this will further
progress our cause of providing quality services. Laboratory Accreditation
provides formal recognition of competent laboratories like ours, thus providing a
ready means for customers to find reliable testing services in order to meet the
demands.
National Accreditation Board for Testing and Calibration Laboratories (NABL),
a Constituent Board of Quality Council of India 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.

NABL is a full member (MRA signatory) to International Laboratory

Accreditation Co-operation (ILAC) as well as Asia Pacific Laboratory
Accreditation Co-operation (APLAC) since 2000 on the basis of peer
evaluation by APLAC as per ISO/IEC 17011:2004.

NABL stands for the National Accreditation Board for Testing and Calibration Laboratories. This body
functions independently under Department of Science and Technology of the Indian Government. NABL
is registered via the societies act. NABL is entirely responsible for Testing and Calibration laboratories and
no other body can accredit these laboratories. NABL is the only body that is authorised by the Government
of India.
Those laboratories that work under the prescribed limits and standards are the ones that are accredited by
NACL. NACL has separate regulations for medical laboratories and separate for general scientific
laboratories. Any and every laboratory can call for an NACL accreditation.
NABL’s system is similar to ISO/IEC 17011:2004. Hence, it complies with the international standards
apart from complying with APLAC MR001. APLAC MR001 is necessary in order to check the
proficiency of a laboratory. These proficiency tests are carried out in alliance by the NABL and the
accredited laboratories. The results aren’t stated publicly and always stay confidential between the NABL
and the accredited laboratory. If a laboratory doesn’t succeed in the proficiency test then, they are required
to make the necessary corrections in the process. If the laboratory fails terribly or fails twice in the
proficiency test then the chances of NABL accreditation are next to nil.

NABL PORTAL
As technology change accelerates exponentially and new digital platforms
are emerging, NABL aim to provide with an end-to-end solution to its
stakeholders by developing online portal.
This portal serve as a way for stakeholders to gain secure web access to
systems that allows them to provide a one-stop window for the entire
accreditation process like submission of online application, making all the
assessment charges etc.

Q: What is nabl approved lab?

A: National Accreditation Board for Testing & 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) for a specific scope following IEC/ISO17025:2017, ISO
15189:2012, IEC/ISO 17043:2010 [1] & IEC/ISO 17034:2016 [2] Standards. It has Mutual
Recognition Arrangements with Asia Pacific Laboratory Accreditation
Cooperation(APLAC), Mutual Recognition Arrangement (MRA), International Laboratory
Accreditation Cooperation (ILAC)
NABL provides accreditation in all major fields of Science and Engineering such as
Biological, Chemical, Electrical, Electronics, Mechanical, Fluid-Flow, Non-Destructive,
Photometry, Radiological, Thermal & Forensics under testing facilities and Electro-
Technical, Mechanical, Fluid Flow, Thermal, Optical & Radiological under Calibration
facilities. NABL also provides accreditation for medical testing laboratories. In addition,
NABL also offers accreditation for Proficiency testing providers & Reference Material
producers and is now signatory to APLAC MRA for both.

Q: Why is nabl needed?

A: Govt. of India has authorized NABL as the sole accreditation body for testing and
calibration laboratories. The objective of NABL is to provide third party assessment of quality
and technical competence. ... This has imparted international recognition toNABL accredited
laboratories.

Q: What is meant by cab in nabl?

A: 3.6 Certification Body (CB) means a body that issues a conformance certificate and may
also conduct conformity assessment activities. 3.7 Conformity Assessment Body
(CAB) means a body that conducts conformity assessment activities.

Q: What is NABH and NABL accreditation?

A: NABH (National Accreditation Board for Hospitals & Healthcare Providers) is a

constituent board of Quality Council of India, set up to establish and
operateaccreditation programme for healthcare organizations. NABH Accreditation to a
hospital stimulates continuous improvement. ... The NABH Accreditation will naturally help
Hospital to be in the A Category. NationalAccreditation Board for Testing & Calibration
Laboratories (NABL), similar to theNABH, is also an autonomous body, under the Quality
Council of India.

NABL-LATEST NEWS
In a bid to encourage diagnostic laboratories performing basic tests to adopt quality practices thus improving
healthcare system at grassroot level in the country, the National Accreditation Board for Testing and Calibration
Laboratories (NABL) has come out with entry level accreditation scheme for basic composite (small) medical
laboratories.

It is estimated that there are about 1,00,000 diagnostic laboratories in India. Of them, 80 per cent are supposedly
small, 18 per cent are medium and only 2 per cent of them are large sized. Most of the small laboratories are
performing routine/basic testing and are situated in peripheral remote areas. They have mostly never opted for
 NABL accreditation because accreditation is not mandatory for clinical laboratories in India.

Of the estimated 1,00,000 diagnostic laboratories in India, only about 1000 are accredited by NABL. This is about
1 per cent of the total number of diagnostics laboratories in the country.

To address gaps in quality practices of majority of laboratories, NABL has proposed to start voluntary scheme for
accreditation of small diagnostic laboratories, stated a NABL release.

In order to bring maximum number of laboratories under this scheme, the criteria have been based on the
requirements enlisted in gazette notification dated May 18, 2018 by Union health ministry to amend Clinical
Establishments (Central Government) Rules, 2012.

Interested laboratories will be required to submit application. The application will be accompanied by checklist
filled-in by the laboratories themselves.

The checklist covers scope of services provided by small laboratories such as routine biochemistry tests,
hematology tests, medical microbiology & immunology tests. As per checklist, laboratories should have certain
infrastructure facilities - public utilities, sample collection facility, specimen and slides preservation facility,
counselling room for HIV (If HIV test is done), temperature control for specialized equipment, signage displaying
name, qualification and registration number of laboratory in-charge, type of investigation and charges.

Laboratories should have minimum medical diagnostic instruments, fire extinguisher, sterilization such as hot air
oven or autoclave, grievance registration and disposal mechanism, process of calibration of equipment and
reagents, patient Information and education mechanism. They should register under the provisions of Biomedical
Waste Management Rules, 2016 with state or Union territories’ or Pollution Control Board.

They should comply with infection control practices and waste segregation practices as per Bio Medical Waste
Management Rules, 2016. They should maintain reports of all patients date wise and specialty wise, keep record
of technicians working in laboratory. maintain quality control in the form of external quality assurance scheme or
inter-laboratory comparison, as the case may be.

As per checklist, the minimum qualification of technical head of laboratory or specialist or authorized signatories
is MBBS from a recognized university institution- which is desirable. It means laboratory technicians with DMLT
or BSc, MLT or M.Sc Biochemistry or Microbiology qualification from a recognized university or institution who
are essential in laboratories can sign medical report.

The checklist will be finalised after reviewing comments from stakeholders. The last date for receiving comments
from stakeholders is November 25, 2018.

On submission of application along with compiled checklist, a laboratory will be assessed by an expert from
NABL. The entry level certificate will be issued to the laboratory with validity of two years. In addition to the initial
assessment, NABL may conduct one or more unannounced assessment of the laboratory during two years of
cycle. It is desired that the laboratories achieve accreditation as per ISO 15189 after these two years. However,
the laboratories can continue with this scheme by applying for renewal and undergoing re-assessment.

The scheme will not be covered under International Laboratory Accreditation Cooperation/Asia Pacific Laboratory
Accreditation Cooperation/Mutual Recognition Arrangements. State health departments can adopt this for public
health laboratories. The laboratories can switch to accreditation as per ISO 15189 at any point of time. However,
the other way round is not allowed and laboratories once accredited will not be covered under this scheme.