International Perspective of

Accreditation

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 CONTENTS
Global or International Perspective of
Accreditation :
• National Quality Infrastructure
• National Quality Infrastructure & International
Linkages
• Accreditation
• International Laboratory Accreditation Cooperation
(ILAC)
• ASIA PACIFIC ACCREDITATION COOPERATION (APAC)
• NABL- A TYPICAL ACCREDITATION BODY
 MEASUREMENT- RELATED IMPORTANT
ISSUES

• Extensively in demand but often go unnoticed

• Effect human lives, as common citizens and
consumers , in many ways as:
- Trade and consumer protection
- Safety and health care
- Environmental protection
- Law and order
 HISTORY OF MEASUREMENT &
FACTORS LEADING TO GLOBALISATION
• DEVELOPMENT OF SI UNITS
• CREATION OF CGPM , CIPM & BIPM
• ESTABLISHMENT OF GATT & WTO
• TRADE AGREEMENTS - SPS & TBT
• OBLIGATION UNDER THESE AGREEMENTS
• Standards, Tech. Regulations ,Conformity Assessment Procedure
–DO NOT CREATE UNNECESSARY OBSTACLES
• TECH REGULATIONS- SERVE LEGITIMATE OBJECTIVES
• Standards Should Be Based On International Standards
• Can Be Deviated Based On Scientific Reasons / Geographic &
Climatic Cond.
• HARMONISATION OF STANDARDS
National Quality Infrastructure
Globalization
stimulates
Free Trade Agreements
facilitate
Globalized Supply Chains
require
Harmonized Standards
implemented through
Testing & Certification
must have
Accreditation
demonstrates
Technical Competence
ends up in
Globalized Products

QUALITY INFRASTRUCTURE IS ESSENTIAL

 National Quality Infrastructure & International
Linkages

Metrology

Certification National Testing

Quality
Infrastructure

Standardization Accreditation

No.6
CODEX 6
 Globally operating metrology system- Harmonization of
Metrology
 Uniform system of harmonized legal regulations:
WTO/OIML(International Organization of Legal Metrology -1955)
• “Legal metrology“- concerns regulatory requirements of
measurements and measuring instruments for the protection of
health, public safety, the environment, enabling taxation,
protection of consumers and fair trade".
 Worldwide recognition of traceability measurement results on the
basis of SI : CIPM/BIPM International Bureau of Weights and
Measures
 BIPM reports to the
International Committee for Weights and Measures (French:
Comité international des poids et mesures, CIPM),
 Under the authority of the Metric Convention, the BIPM helps to
ensure uniformity of SI weights and measures around the world
Globally operating metrology system

Treaty of meter (1875)

General Conference on Weights and Measures (CGPM)

Consultative International Committee for Weights

Committees and Measures (CIPM)

International Bureau of Weights and

Measures (BIPM)
 BIPM
(International Standards/ SI units)

Key
Comparison
National Metrological Institute
Metrological (National Standards)
Infrastructure in
a country Accredited Calibration Laboratory
(Secondary Standards)
Transfer
Standards
In House Calibration Laboratory
(Company/working Standards)

Domain of
the company Company’s Test Equipment

Product to be manufactured
Metrology structure in India

NPL/ BARC /IILM

(Reference / primary standards)

Other government/ private/ accredited labs

(Secondary standards)

Company / accredited labs

(Working standards)
 Accreditation- Definition

“Third-party attestation related to a conformity

assessment body conveying formal
demonstration of its competence to carry out
specific conformity assessment tasks”

For NABL Use Only

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 ACCREDITATION
Procedure by which an authoritative body (NABL) gives
formal recognition that a body (laboratory) or person
(signatory) is competent to carry out specific tasks
(scope)

 Criteria - ISO/IEC 17025 (includes all those requirements

of ISO 9001 relevant to the scope of laboratories)
 Assures the client that the procedures and test results
are technically valid
 Recognizes the technical competence of laboratory staff
 Endorses the laboratory operates the management
system effectively

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 CERTIFICATION

Procedure by which a third-party (certification body)

gives a written assurance that a product, process or
service (of an organisation) conforms to specified
requirements

 Specified requirements - ISO 9001

 Assures the client that the organization has in place an
effective quality or environmental management system
 Does not confer technical credibility of the test result

Certification is not appropriate for laboratories or

inspection bodies 13
Globally operating Conformity Assessment system-
Harmonization of Accreditation

 Harmonization of requirements concern in

competence of test labs/Accreditation Bodies :
ILAC in the fields of testing , calibration , medical
testing and inspection bodies.
 Harmonization of requirements concern in
competence of certification bodies: IAF
 International Accreditation Forum, Inc. (IAF) - world
association of Conformity Assessment Accreditation
bodies in the fields of management systems,
products, services, personnel and other similar
programs of conformity assessment
 INTERNATIONAL LABORATORY ACCREDITATION
COOPERATION (ILAC)

• ILAC is an international cooperation of laboratory

accreditation bodies formed in 1977 ( as Conference) to help
remove technical barriers to trade by promotion of
acceptance of accredited test & calibration results with the
aim of “ a product tested once and accepted everywhere”.
• In Aug 2003 , 44 Lab Accreditation Bodies of ILAC signed
MRA ( the ILAC Arrangement) to promote acceptance of
accredited test and calibration data & developing global
network of accredited labs.
• ABs are assessed and recognized as COMPETENT by ILAC
Arrangement Signatories, after peer-reviewed ( to meet the
ILAC Criteria).
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 ILAC MRA- Purpose

To develop a global network of

accredited testing, calibration and
inspection facilities that can be relied on
to provide accurate data and results.

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 ILAC MRA- BENEFITS
o The ILAC MRA provides a credible and technically robust
framework on which to further develop and enhance
government to government bilateral and multilateral
international trade agreements.
o The ILAC MRA acts as an internationally recognised ‘stamp of
approval’ to demonstrate compliance against agreed standards
and requirements. (Accredited Once, Accepted Everywhere).
o Duplication is minimised as test and calibration data included in
submissions for product approvals can be evaluated without re-
testing.
o Accreditation and the ILAC MRA helps regulators meet their
own legislated responsibilities by providing a globally
recognised system to accept accredited test reports.
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 ILAC MRA- EVALUATION PROCESS
o Each accreditation body that is a signatory to the ILAC
MRA commits to :
o Maintain conformity with the current version of ISO/IEC
17011.
o Ensure that all laboratories accredited are complying to
appropriate laboratory standards (ISO/IEC 17025 for
testing and calibration laboratories and ISO 15189 for
Medical Laboratories)
o Ensure that all inspection bodies accredited are complying
to appropriate inspection standards (ISO/IEC 17020 )

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 ILAC - REGIONAL COOPERATION BODIES
Recognised Regional Cooperation Bodies:
o Asia Pacific Accreditation Cooperation (APAC) - Australia
o European Co-operation For Accreditation (EA)- France
o Inter American Accreditation Cooperation (IAAC)- Mexico
o Arab Accreditation Cooperation (ARAC)- Morocco
o African Accreditation Cooperation (AFRAC)- South Africa

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 ASIA PACIFIC ACCREDITATION COOPERATION (APAC)

• Asia Pacific Laboratory Accreditation Cooperation (APLAC) was initiated

in 1992 as a forum for laboratory accreditation bodies in the Asia Pacific
region.
• Its primary aim was to establish, develop and expand MRA among
accreditation bodies in the region.
• The inaugural signing of the APLAC MRA occurred on 19 November 1997,
with 7 accreditation bodies signing the MRA for testing and calibration.
• The MRA was extended in November 2003 to include inspection, and ISO
15189 in April 2007.
• The inaugural signing of the extended APLAC MRA to include accreditation
of Reference Material Producers (RMPs) (ISO 17034:2016) took place in
December 2007 and PTP ( ISO/IEC 17043) in June 2014
• APLAC & Pacific Accreditation Cooperation (PAC) amalgamated into one
body called Asia Pacific Accreditation Cooperation (APAC) . APAC formally
became operational on 01.01.2019.

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 APAC MRA - Assisting Trade
• APAC MRA enhances acceptance of test, calibration and
inspection reports, RM certificates and PTP reports
amongst signatory economies
• APAC MRA signatories recognise equivalence of each
others’ accredited facilities
• APAC MRA is an international recognition for accredited
laboratories, inspection bodies , RMPs and PTPs
• APAC MRA reduces or eliminates need for re-
testing or re-inspection of imported goods
• Entry into global ILAC Arrangement (for testing
and calibration only)
 Accreditation- International Scenario

ILAC

EA

ARAC APAC IAAC

AFRAC SADCA

ILAC International Laboratory Accreditation Cooperation

EA European Cooperation for Accreditation
APAC Asia Pacific Accreditation Cooperation
IAAC Inter-American Accreditation Cooperation
SADCA Southern African Development Community Accreditation
AFRAC African Regional Accreditation Cooperation
ARAC Arab Accreditation Cooperation
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 ILAC

EAC APAC

C C C C C C C C

C C
C
C
Lab
Lab
SADCA ILAC - International Laboratory Accreditation Cooperation
EA - European co-operation for Accreditation
SADCA - Southern African Development Cooperation for
IAAC Accreditation
APAC - Asia Pacific Accreditation Cooperation
IAAC - Inter-American Accreditation Cooperation

GLOBAL SIGNATORIES 23
 Conformity Assessment Structure
International International
GOVERNMENT
Mutual Recognition Mutual recognition
Recognizes Accreditation Bodies
(ILAC ) ( IAF )

Regional Regional
Mutual Recognition Mutual recognition
( APLAC ) ( PAC )
Accreditation Bodies
Accredited laboratories , Inspection Bodies, Certification Bodies
(ISO/IEC 17011)

Laboratories Inspection Product QMS Certifiers EMS Certifiers Personnel

Bodies Certifier Certify
Test items/ Inspect designs, Certify Quality Certify
Materials License Management Environmental Personnel as
Processes, Products to use Management
or Calibrate Products, systems Competent
Equipment. Services, Plant a Cert. Mark ISO/IEC – Systems ISO/IEC –
ISO/IEC - ISO/IEC –
ISO/IES 17025 ISO/IEC 17020 Guide 65 Guide 62 Guide 66 17024

Generates Design,
processes An Item or Personnel
technically Companies are
Products Material is Companies are Are Certified
valid test certified
Services ,Plant Certified Certified To Check
results / ISO 9001
are certified (Standards/ ISO 14001 Against
calibration (Standard/ Specifications) Requirements
data Specifications)
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INTERNATIONAL STANDARDS APPLICABLE TO
LABORATORIES
 ISO/IEC 17000 : Conformity assessment -Vocabulary
and general principles

 ISO/IEC17025 :General Requirements for the

Competence of Testing &
Calibration Laboratories

 ISO 15189 :Medical Laboratories -

Particular Requirements for Quality and
Competence

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 INTERNATIONAL STANDARDS APPLICABLE
TO LABORATORIES

 ISO 17043 Conformity Testing: General

requirements for proficiency
testing
 ISO 17034 General requirements for the
competence of reference material producers

 ISO/IEC 17011 General Requirements for

Accreditation Bodies Accrediting
Conformity Assessment Bodies

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 A TYPICAL ACCREDITATION BODY

 National accreditation body

 May be established by Act of Parliament
 User and/or government funded, “not for
profit” organization
 General third-party accreditation body
 Member Signatory to ILAC / APAC
 Internationally recognized through MRAs

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 NABL- International Recognition
o NABL is signatory to Asia Pacific Laboratory Accreditation Co-operation (APAC)
Mutual Recognition Arrangements (MRA) and International Laboratory
Accreditation Co-operation (ILAC) MRA since 2000
o First evaluated by APLAC in 2000 (for Testing and Calibration)
o Second evaluation by APLAC in 2004 (for Testing & Calibration)
o Third evaluation by APLAC in 2008 (for Testing, Calibration and Medical)
o Fourth evaluation by APLAC in 2012 (for Testing, Calibration, Medical)
o Fifth evaluation by APLAC in 2016 (for Testing, Calibration, Medical, PTP and
RMP)
o Sixth evaluation by APAC in 2020 (for Testing, Calibration, Medical, PTP and
RMP
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 ABOUT NABL
o NABL is an constituent board under the Quality council of India,
Department of Industrial Policy & Promotion, Government of India,
and is registered under the Societies Act.
o NABL has been established with the objectives to provide
Government and Industries with a scheme for third-party assessment
in Testing, Calibration & Medical Laboratories, Proficiency Testing
Providers and Reference Material Producers.
o Program started in 1981
o First Accreditation granted in 1992
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 NABL- Objectives
o Promote & Implement Accreditation system for laboratories,
Proficiency Testing Providers and Reference Material Producers
o Provide timely accreditation services to laboratories
o Create awareness on Accreditation

o Maintain data-base for Assessors & Monitor Performance

o Conducting training programs for Assessors & NABL Staff

o Maintain linkages with ILAC & APAC through various meetings

o Promote MRA with other ABs for acceptance of test reports

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 NABL Accredits For:
Testing Calibration Medical
Laboratories Laboratories Laboratories
ISO 17025 ISO 17025 ISO 15189

• Biological • Electro-Technical o Clinical Biochemistry

• Chemical • Mechanical o Clinical Pathology
• • o Haematology and
Electrical Radiological
Immuno-haematology
• Electronics • Thermal o Microbiology &
• Fluid-Flow • Optical Serology
• Mechanical • Fluid-Flow o Histopathology
• Non-Destructive o Cytopathology
Testing o Genetics
• Optical and o Nuclear Medicine (In-
• Photometry vitroTest Only)
• Radiological
• Thermal
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 BENEFITS OF ACCREDITATION

• Global Acceptance/Equivalence of Reports - Test reports issued

by an accredited laboratory is acceptable among all ILAC MRA
partners and considered equivalent to those issued by
ILAC/APAC MRA partners
• Public and industry acceptance
• Assurance to clients of good laboratory practices
• Provides comparability in measurements
• Decision makers can rely on test results
• Improves staff motivation
• Ensures better support in the event of legal challenge
• Saves money by getting it right at first time.
• Better control of laboratory operations
• Improves staff confidence and enhances business
• Enhanced customer confidence and satisfaction
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 INDIAN SCENARIO
• NABL- National Accreditation Board for Testing
and Calibration Laboratories
• NABET- National Accreditation Board for
Education & Training
• NABH- National Accreditation Board for
Hospitals & Health Care Providers
• NABCB- National Accreditation Board for
Certification Bodies
 NABCB

NABH QCI NABET

NABL

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NABC • Member IAF
B

NABL • Member APLAC

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Thanks

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