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NABL
NEWSCAST
Quality Council of
NABL
India
NABL operates as per ISO/IEC 17011: 2004 Conformity assessment General requirements for
accreditation bodies accrediting conformity assessment bodies.
Testing and Calibration laboratories as per ISO/ IEC 17025:2005 General requirements for the
competence of Testing and Calibration laboratories
Medical testing laboratories as per ISO 15189:2012 Medical laboratories-- Requirements for
quality and competence.
Proficiency Testing Providers (PTP) as per ISO/ IEC 17043:2010 Conformity assessment-
General requirements for Proficiency Testing Providers and
Reference Material Producers (RMP) as per ISO Guide 34: 2009/ ISO 17034:2016 General
requirements for the competence of Reference Material Producers.
Testing
ISO/ IEC 17025:2005
Reference Material
Producers (RMP) Calibration
ISO Guide 34: 2009/ ISO/ IEC 17025:2005
ISO 17034:2016
NABL
ISO/ IEC
17011:2004
Proficiency Testing
Medical Testing
Providers (PTP)
ISO 15189:2012
ISO/ IEC 17043:2010
SCOPE OF NABL ACCREDITATION
CALIBRATION FIELD
Mechanical Mechanical Microbiology &
TESTING FIELD
Fluid-Flow Serology
MEDICAL FIELD
Electrical
Thermal Histopathology
Electronics
Optical Haematology &
Non- Immuno-
Destructive Radiological haematology
Photometry Cytopathology
Radiological Nuclear
Thermal Medicine (in-
vitro test only)
Fluid Flow
Genetics
Forensic
TESTING
Testing Chemical
REFERENCE MATERIAL
Composition
PRODUCERS (RMP)
Calibration
PROVIDERS (PTP)
Engineering
Properties
Miscellaneous
NEW ACCREDITATION SCHEMES
The international arrangements are managed by ILAC in the fields of calibration, testing, medical
testing and inspection accreditation. The ILAC Mutual Recognition Arrangement (ILAC MRA) provides
significant technical underpinning to the calibration, testing, medical testing and inspection results of the
accredited conformity assessment bodies and in turn delivers confidence in the acceptance of results.
International Accreditation Forum (IAF) is the world association of Conformity Assessment Accreditation
Bodies and other bodies interested in conformity assessment in the fields of management systems,
products, services, personnel and other similar programmes of conformity assessment. Its primary
function is to develop a single worldwide program of conformity assessment which reduces risk for
business and its customers by assuring them that accredited certificates may be relied upon. Both
organizations, ILAC and IAF, work together and coordinate their efforts to enhance the accreditation and
the conformity assessment worldwide.
NABL has always participated and actively involved in various activities of APLAC & ILAC. NABL
regularly provides inputs and comments for document review, applications received for various
memberships. It also participates in General assembly/ mid-term meetings, workshops/ trainings. Also,
NABL contributes for Ballot and surveys carried out by APLAC & ILAC.
The IAF- ILAC 2016 Joint annual meetings were held at New Delhi from 26th October 2016 to 04th
November 2016. The event was jointly organized by NABL and NABCB. The event was a great success
and received accolades from ILAC and IAF for being a well organized event which served as a forum for
fruitful discussions and strategic planning. The event was attended by 300 delegates from about 80
countries.
Many major decisions and course of actions were defined in this annual joint meeting marking it a
milestone towards excellence in quality. The event came to an end by presenting certificates of MRA by
ILAC and MLA by IAF. The discussions and deliberations gave the participants time to refresh
themselves with the glimpse of Indian culture and cuisine as the event was planned during the festive
season in India. The participants had a remarkable time as they got to unwind with festival of lights
Diwali.
ASIA PACIFIC LABORATORY ACCREDITATION COOPERATION
(APLAC) EVALUATION 2016
Asia Pacific Laboratory accreditation cooperation (APLAC) is a cooperation of accreditation bodies in the
Asia Pacific region that accredit laboratories, inspection bodies and reference material producers. It is
recognized by the Asia Pacific Economic Cooperation (APEC) as one of five Specialist Regional Bodies
(SRBs) that support the work of the APEC Sub-Committee on Standards and Conformance. Its primary
aim is to establish, develop and expand a mutual recognition arrangement amongst accreditation bodies
in the region.
NABL is full member Signatory to APLAC and ILAC Mutual Recognition Arrangement (MRA) since the
year 2000. Such arrangements facilitate the acceptance of test reports issued by NABL accredited CABs
with other MRA signatories to ILAC. The MRA status is based on the peer evaluation of an Accreditation
Body once in every four years. NABL had undergone APLAC evaluations in the years 2000, 2004, 2008
& 2012, the recent evaluation was done during July 2016. The Evaluation team comprised of evaluators
from Japan, The United States of America (USA), Malaysia, Thailand to evaluate the fields of Testing,
Calibration, Medical, PTP & RMP.
With a view to generate a mutli-stakeholder review and discussion forum with our customers, NABL
jointly with Confederation of Indian Industries (CII) has been continuously organizing annual National
Conclave Laboratory since 2012 in the different regions of the country.
The journey began with the first National Conclave for Laboratories organized on 04 th05th April 2012 at
Stein Auditorium, India Habitat Centre, New Delhi. The theme of the conclave was: Credible Laboratory
practices building confidence nationwide.
After the overwhelming success of the first conclave, the 2nd National Conclave for Laboratories with the
theme Innovative Practices in Laboratory Management was held at Bangalore during 16th-17th
September 2013. The conclave deliberated on key policy developments at the National and International
levels that had an impact on Indian laboratories in addition to enhancement in technical and service
portfolios, technical developments in product standards, test and calibration methods along with new
initiatives relating to accreditation.
The 3rd National Conclave for Laboratories on the theme Challenges in Managing Laboratories:
Delivering Competent Services was held at The Westin Pune on 28-29 October, 2014. The inaugural
session was graced by Dr. Sourabh Pal, Director, NCL, Dr. R.P. Singh, Secretary General, QCI and Mr.
Anil Relia, Director, NABL. The seminar discussed about the various challenges faced by Indian
laboratories in the wake of increasing customer expectations and challenges faced in developing
competencies in diagnostic laboratories in terms of importance of qualification, experience and training of
manpower. The conclave was also attended by SAARC participants from Nepal, Bhutan, Afghanistan, Sri
Lanka, Bangladesh and Maldives. The SAARC participants updated and discussed about the National
Infrastructure for laboratories and updates from their countries.
The 4th National Conclave for Laboratories was conducted on 14th-15th September 2015 at Stein
Auditorium, India Habitat Centre, New Delhi. The theme of the conclave was India Industry
Infrastructure; fostering economic growth and sustainable development. The conclave was honoured by
the presence of Dr. R.P. Singh, Secretary General QCI; Dr. Arvind Lal, Chairman and Managing Director,
Dr. Lal Path Labs; Mr. K.P. Chandy, Executive Director (Lubes) BPCL; Mr. Anupam Kaul, Principal
Counsellor (TQM) CII; Mr. Anil Relia, Director, NABL and Mr. N. Venkateswaran, Technical Operations
Manager (Testing) NABL. The seminar worked to develop a National Road map for the growth of Indias
Laboratory infrastructure over the next decade in line with national priorities, missions and global
demands.
The 5th National Conclave for Laboratories was conducted by NABL on 27th-28th October 2016 at Stein
Auditorium, Indian Habitat Centre, New Delhi. The National Conclave was held on the sidelines of the
IAF/ILAC joint annual meeting in New Delhi to take advantage of the presence of international experts
who were attending the meeting. The key themes of the conclave were:
Role of testing and calibration services in meeting demands of global supply chains
Business growth sectors for laboratory services
Key global developments in metrology, testing, calibration, reference materials and PT
programmes
New technologies in testing and calibration contributing to global value chain
Contribution of laboratory services in sustainable development
Managing integrity and ethical management of laboratory services
Dr. R. P. Singh delivered the inaugural address and the conclave got benefited from the participation
from ILAC and IAF Joint Annual Meeting. Many renowned speakers like Mr. Peter Unger, Chair ILAC; Mr.
Sean MacCurtain, Secretary ISO/CASCO; Mr. Raj Nathan, Senior Vice President, IAS, USA; Dr. Dana
Leaman, Chief NVLAP, USA.
CO-OPERATIONS ACROSS THE GLOBE
With a view to cooperate with the International fraternity of accreditation services, NABL under the
flagship of Quality Council of India (QCI) has signed Memorandum of Understanding (MoU) with few
countries namely:
Federal Accreditation Services (Rus Accreditation), Russia
National Centre of Accreditation (NCA), Republic of Kazakhastan
The Belarusian State Centre for Accreditation (BSCA), Belarus
GCC Accreditation Centre (GAC)
The objective of signing these MoUs is mutual cooperation for exchange of experience and technical
information on accreditation between the parties which includes
Close work at international level to assist each other in the field of accreditation or on
matters/issues related to accreditation, international standards on accreditation
Collaboration to conduct trainings
Cooperation with each other for accreditation or related matters of mutual interest at international
and regional bodies
Exposure Visit of Delegates from Ethiopian National Accreditation Office (ENAO),
Ethiopia
NABL extends cooperation by providing accreditation service in the SAARC region. NABL has accredited
many laboratories in the region. However, with the establishment and attainment of MRA status of the
Accreditation Body in the SAARC nations like BAB, Bangladesh and SLAB, Sri Lanka; the laboratories from
the respective economies are now informed and encouraged to contact the local Accreditation Bodies for
accreditation.
NABL is also an active member in SAARC Expert
Group on Accreditation (SEGA). During the SEGA
meets, the updates on the accreditation scenario in
all SAARC nations were discussed. It is deliberated
upon the cooperation that can be extended to each
other especially in the region where there is no
Accreditation body. The objective of SEGA is to the
establish conformity assessment system in the
SAARC region.
MoU with Bhutan Standards Body (BSB), Bhutan and Nepal Bureau of
Standards and Metrology (NBSM), Nepal
NABL is one of the well established Accreditation Body in SAARC region and extends its cooperation to
neighbouring member states in establishing accreditation services. With this objective, NABL had signed
MoU with BSB, Bhutan and NBSM. As per the MoU, BSB and NBSM operates as the Focal points in their
respective countries. NAFPs are established to function as a National administrative link between potential
clients within the country and the established foreign accreditation bodies which have international
recognition.
In this regard NABL had conducted five days Exposure visit for Officials from NAFPs (Bhutan & Nepal) at
its secretariat. The objective of the visit was to train NAFPs and to understand the international procedures
in accreditation. The visit was scheduled from 28th August- 04th September 2015 at NABL. In line with the
signed MoU, the NAFP in the economy is kept informed about the processing of application of accreditation
from the respective economy
The success of conclaves have paved way to make it a periodic event in the coming years.
June 09th marks World Accreditation Day, a The seminar started with the welcome address by Mr.
global initiative jointly established by the Anil Relia, Director, NABL followed by the World
International Laboratory Accreditation Accreditation Day message by Mr. Vipin Sahni, CEO,
Cooperation (ILAC) and International NABET.
Accreditation Forum (IAF) to raise awareness
on the importance of accreditation-related
activities and the value of providing confidence
in purchasing a quality product. This day is
celebrated across the world wherein major
national events, Seminars are organized to
communicate the value of accreditation to
Government, Regulators and stakeholders. For
past few years NABL has annually been
The Inaugural address was delivered by Chief guest Dr.
celebrating World accreditation Day. This year
R.P. Singh, Secretary General, Quality Council of India.
on 09th June 2016 a seminar was held by
Mr. Anil Jauhri later thanked the speakers and the
National Accreditation Board for Testing and
participants ensuring the cooperation and efforts put in
Calibration Laboratories (NABL), National
together by the host organizations for the Accreditation
Accreditation Board for Certification Bodies
services in the country. The seminar was participated
(NABCB) and National Accreditation Board for
by various regulators of the country like BIS, PNGRB
Education and training (NABET) jointly to
etc. The role of regulators in emphasizing accreditation
commemorate World Accreditation Day 2016,.
for improving the quality of products in the domestic
This years theme was Accreditation A
market was stressed upon.
Global tool to Support Public Policy.
ISSUE AND REVISION OF NABL DOCUMENTS
To keep pace with the dynamic requirements of regulators, standard bodies and other inter governmental
organizations, NABL accomplished the task of revising its management system and technical documents.
Being an MRA signatory, NABL aligns its documents with APLAC & ILAC policy documents such as NABL
142 Policy for Traceability measurements with ILAC P: 10, NABL-133 Policy for use of NABL symbol/ claim
of accreditation with ILAC P: 8 etc. Earlier NABL documents were only for laboratory but by the virtue of
expansion of NABL activities for Accreditation of PTP and RMP, NABL has published new documents for
these accreditation programs. NABL has amended all the existing documents to include the new activities
and CABs.
Other than for PTP & RMP, NABL has also published a new document NABL-201 Procedure for dealing
changes in accredited Conformity Assessment Bodys operations was designed exclusively for the ease of
the accredited CABs to get them acquainted with the various NABL procedures.
Classification and standardization of product groups across all the specific criteria documents of testing/
calibration and medical disciplines was conducted by formulating committees involving NABL officers and
relevant external experts. Qualification and experience requirements for the authorized signatories were
also revised across all the specific criteria documents to bring uniformity in decision making. Management
Information System (MIS) and NABL website were also updated accordingly.
During revision of the procedural documents, NABL Quality Cell also considered the feedbacks/ inputs
received from NABL officers along with changes as per office orders issued from time to time.
Under the technical documents NABL 112 Specific Criteria for Accreditation of Medical Laboratories was
revised in alignment with new version of ISO 15189 issued in the year 2012. Further for better clarity NABL
122 Specific Criteria for Calibration Laboratories in Mechanical Discipline has been revised in terms of
segregation of the calibration parameters like dimension metrology, Force proving instruments, pressure
indicating devices into separate chapters.
In all 79 NABL documents including management system, policy level documents and technical criteria were
revised
ENHANCING ASSESSORS POOL OF VARIOUS EXPERTISE
NABL constantly endeavors to increase its pool of trained assessors from all appropriate sources to cater
ever increasing demands of accreditation. The assessors are selected for training from various
fields/facilities who are actively involved in CABs or Industries.
The course material is based on APLAC TR 001 Guidelines on Training Course for Assessors and ILAC
G3 Guidelines for Training Courses for Assessors used by Laboratory Accreditation Schemes and ISO
19011: 2011 Guidelines for auditing management systems'.
The standard ISO 15189:2007 has undergone revision and the third edition of the ISO 15189:2012 has
now superseded the previous two editions of this International standard. ISO 15189:2007 version was
valid only till 29 February, 2016.
NABL has converted 687 Medical accredited laboratories to ISO 15189:2012 version from ISO
15189:2007 version within the stipulated time frame. To achieve this milestone, NABL conducted various
assessors conclave all over the country to bring uniformity and harmonization of assessment of Medical
laboratories in accordance with ISO 15189:2012 wherein 350 assessors were trained as per ISO
15189:2012.
RECOGNITION OF ACCREDITATION
BY GOVERN MENT AND
REGULATORS
Ministry of Health & Family Welfare (CGHS & Govt. Hospital Laboratories)
Ministry of Health & Family Welfare (Central Drugs Standard Control Organization)
Ministry of Health & Family Welfare (Food Safety and Standards Authority of India ,
FSSAI)
Ministry of Commerce & Industry (Export Inspection Council)
Ministry of Commerce & Industry (Agricultural & Processed Food Export Development
Authority (APEDA), The Marine Products Exports Development Authority (MPEDA) etc.
Ministry of Communications & Information Technology (Telecommunication
Engineering Center ,TEC)
Ministry of Electronics and Information Technology (DeITY)
Ministry of Power (Bureau of Energy Efficiency, BEE)
Ministry of Environment & Forests (Central Pollution Control Board, CPCB)
Ministry of Consumer Affairs (Bureau of Indian Standards, BIS)
Ministry of Urban Development (Central Public Works Department, CPWD), State
PWDs
Ministry of Road Transport & Highways (NHAI)
Ministry of Defence (Ordnance Factory Board, CQAE)
Ministry of Home Affairs (CRPF, ITBP, BSF, CISF etc.)
Delhi Metro Railway Corporation (DMRC)
Ministry of Consumer Affairs (Weights and Measures)
Ministry of Drinking Water and Sanitation
Ministry of Home Affairs (Forensic Labs)
Ministry of Commerce & Industry (Tea Board, Coffee Board, Spices Board etc.)
Insurance companies can rely on reports of medical labs
PARTICIPATION IN INTERNATIONAL CONFERENCES, WORKSHOPS
AND EVALUATION OF ACCREDITATION BODIES
IAF/ILAC Joint Annual Meeting held from 24th October to 04th November 2016 at New Delhi, India
3500 2828
2500 1643
1891
1500
1000
500
0
Mar Mar Mar Mar Mar Mar Mar Mar
2010 2011 2012 2013 2014 2015 2016 2017
PTP 14 RMP 4
CALIBRATION 669
With the increased awareness of the society for Quality and in view of business demands the inflow of
application for accreditation of CABs is increasing at an exponential rate
MASTER LIST OF DOCUMENTS
All the documents are available on NABL website www.nabl-india.org under publications>>
NABL Documents>> and can be downloaded for free.
ACCREDITATION PROCEDURE
FIRST ACCREDITATION
quality manual CYCLE desktop
adequacy surveillance
preassessment reassessment
assessment on-site
surveillance
reassessment
GRANT OF SECOND
ACCREDITATION ACCREDITATION CYCLE
BENEFITS OF ACCREDITATION
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 2015-16 &
Application Fee FY 16-17
(non-refundable, to Testing Laboratories: Rs. 22,000
be paid along with Upto 2 product groups per discipline of testing (eg. Metals & alloys,
the application) Food & agricultural products, Drugs & pharmaceuticals, Textiles
etc.)
For each additional product group in each discipline of testing Rs. 11,000
Medical Laboratories
(covering all fields):
Small Laboratories (below 100 patients/ day/location*) Rs. 18,700
Medium Laboratories (101-400 patients/ day/location*) Rs. 44,000
Large Laboratories (401-1000* patients/ day/location*) Rs. 1,10,000
Very Large Laboratories (above 1000 patients/ day/location*) Rs. 2,20,000
Laboratories operating from multiple locations (more than one Rs. 2,20,000
location in the same city)
Charges For Collection Centers
Number of Collection centers
up to 10 Rs.3,300
>10-50 Rs.7,700
> 50- 100 Rs.15,400
More than 100 Rs.30,800
Forensic Laboratories (covering all sub disciplines): Rs.44,000
Calibration Laboratories:
Mechanical - upto 2 groups (eg. dimension, force etc) Rs. 22,000
- for each additional group Rs. 11,000
Electro-Technical (all parameters) Rs. 33,000
Thermal (all parameters) Rs. 22,000
Fluid Flow (all parameters) Rs. 22,000
Optical (all parameters) Rs. 22,000
Radiological (all parameters) Rs. 22,000
Proficiency Testing Providers:
For one scheme per field Rs. 25,000
Additional Proficiency Test Item (matrix / group / field) Rs. 10,000
Reference Material Producers:
Per Category upto 2 sub-categories Rs. 25,000
For each additional sub category Rs. 5,000
Enhancement of Testing Laboratories Rs.5,500 per
Scope (apart from Any extension in the existing accredited scope per discipline of group
the scheduled re- testing
assessment)
For each additional product group in each discipline of testing Rs.11,000
Medical Laboratories
Any extension in the existing accredited scope Rs.5,500
Any extension in the existing accredited scope Rs.5,500
Calibration Laboratories
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