Role of Accreditation in Food Sector

Anil Jauhri
Ex-CEO, NABCB
jauhrinail@gmail.com
+919810567765
 International Scenario
Increasing use of standards for products, services,
processes and systems – mandatory on grounds of health,
safety, environment, national security, unfair trade
practices – called regulations or sanitary and
phytosanitary (SPS) measures in food – food regulations
Need for checking compliance to prescribed
regulations and voluntary standards - conformity
assessment – inspection/testing/certification
Rules for international trade – written in two agreements
in WTO
 Agreement on Technical Barriers to Trade (TBT Agreement)
 Agreement on Sanitary and Phytosanitary Measures (SPS
Agreement)
 Important Issues
Two issues worldwide:
Confidence in conformity assessment –
accurate, reliable – can lab test to ppb or ppt, is
inspection body competent to audit GMP/GHP,
can certification body certify dairy plants
International acceptability for facilitating
trade - Need for recognition of
inspection/testing/certification across borders –
test report or certification issued in India accepted
in USA or EU
Accomplished through accreditation
 Provision in WTO TBT Agreement
“Members shall ensure, whenever possible, that results
of conformity assessment procedures in other Members
are accepted…adequate and enduring technical
competence of the relevant conformity assessment
bodies in the exporting Member, so that confidence in
the continued reliability of their conformity
assessment results can exist; in this regard, verified
compliance, for instance through accreditation,
with relevant guides or recommendations issued by
international standardizing bodies shall be taken into
account as an indication of adequate technical
competence”
Article 6
What is Conformity Assessment
Demonstration that specified requirements
relating to a product, process, system, person or
body are fulfilled – bottled water or biscuits, GHP,
FSMS, food safety supervisor, food safety auditor
Conformity assessment includes activities such as
testing, inspection and certification, as well as
the accreditation of conformity assessment
bodies
Object of conformity assessment – to be clear –
is it product, or process or person
 Accreditation
Third-party attestation related to a
conformity assessment body conveying
formal demonstration of its competence
to carry out specific conformity assessment
tasks – ISO 17000
First, Second and Third party – what it
means
Only applies to conformity assessment
bodies – not to be confused with education
or healthcare accreditation – not covered
 Accreditation Standards

ISO CASCO - ISO's policy development Committee on

Conformity Assessment
 ISO 17011 – Requirements for Accreditation Bodies
 ISO 17020 - Requirements for Inspection Bodies
 ISO 17021 - Requirements for Management Systems CBs – ISO
9001/ISO 14001
 ISO 17024 - Requirements for Bodies Certifying Personnel
 ISO 17025 - Requirements for Testing & Calibration Labs
 ISO 17029 – Requirements for bodies carrying out
Validation/Verification
 ISO 17065 - Requirements for Bodies Certifying Products,
Processes and Services
 ISO 22003 - Requirements for CBs for FSMS - basis for operation
of CBs as well as their accreditation – cross refers to ISO 17021
 ISO 27006 – Requirements for ISMS CBs – cross refers to ISO 17021
 ISO 50003 – Requirements for EnMS CBs – cross refers to ISO
17021 … and many more standards
 International Accreditation System

International Bodies - Association of accreditation bodies –
International Accreditation Forum (IAF) for CBs, International
Laboratory Accreditation Cooperation (ILAC) for Labs and IBs

Regional Bodies – Asia Pacific Accreditation Cooperation (APAC)
wef 1 Jan 2019 – earlier PAC/APLAC – specialist body of APEC –
some govt endorsment

Similar bodies in other Continents – recognized by IAF/ILAC -
European Accreditation Cooperation (EA), Inter American
Accreditation Cooperation (IAAC), African Accreditation
Cooperation (AFRAC), Arab Accreditation Cooperation (ARAC)

Multilateral Mutual Recognition Arrangement – MLAs in IAF,
MRAs in ILAC
 Accreditation Framework
Peer
Evaluation

ACCREDITATION

International Standards

CONFORMITY ASSESSMENT BODIES

Standards / regulatory
requirements / scheme criteria

PRODUCT & SERVICE PROVIDERS

CONFIDENCE TRUST ASSURANCE

GOVERNMENT CONSUMERS PURCHASERS

 Global Vision
A single worldwide program of conformity assessment which

reduces risk for business, regulators and the consumer, by

ensuring that accredited services can be relied upon.
Government and Regulators relying on the IAF and ILAC

Arrangements (MLA / MRA) to further develop or enhance trade

agreements.
To support the freedom of world trade by eliminating technical

barriers, realizing the free-trade goal of ‘Tested, Inspected

or Certified Once and Accepted Everywhere'
 Equivalence Framework
IAF / ILAC

EUROPEAN ACCREDITATION ASIA PACIFIC ACCREDITATION INTER AMERICAN

COOPERATION COOPERATION ACCREDITATION
(EA) (APAC) COOPERATION (IAAC)

ACCREDITATION BODY
(AB)
ISO 17011

ISO 17020
ISO 17025
CB/IB/LAB ISO 17021
ISO 17065

Standards against
ORGANIZATION / ITEM which certified –
UNDER INSPECTION / ISO/IEC Standards
CERTIFICATION / TESTING ISO 9001 / ISO22000
 Benefits of Accreditation
Recognition of Technical Competence
Minimizes risks for regulators and scheme owners
International Recognition
Increased efficiency – competition among CABs
helps
Marketing advantage & Increased business for
accredited bodies – claim to international stds
Minimizes re-testing/inspection & reduces costs
Customer confidence & satisfaction
 Growing Importance Of Conformity
Assessment
WTO study of STCs in TBT Committee – not directly
applicable to food – but good indication - 30% based on
standards – 70% based on conformity assessment procedures
Understandable as more and more countries adopt
international standards for products
But conformity assessment procedures differ – will differ
USFDA requiring assessment of accreditation bodies to
accept 3rd party certification – huge cost – not accepting IAF
MLA
Many countries requiring accreditation of labs as per ISO
17025 or inspection as per ISO 17020 – some requiring mutual
recognition arrangements of IAF/ILAC
 Developments in Accreditation
Accreditation growing worldwide
Most countries – esp developing countries – have a single
national accreditation body – NABCB/NABL in India
EU first to codify this concept – EC Regulation 765/2008
wef 1 Jan 2010 – each member state to have a single NAB –
non profit, non competitive, public service – reqmts
beyond ISO 17011
Some countries – ABs private and more than one – USA,
Japan
Some joint ABs – GAC in gulf, SADCAS in Africa
Many developing countries not having AB – Bhutan,
Maldives, Laos – could be an impediment for exports
Accreditation in Regulations
Regulators worldwide stretched for resources – numbers,
sometimes expertise
Use of third party agencies – labs, inspection growing – can
assess themselves if they wish - attractive option to
recognize accredited third party bodies –– independent
check – compliance to int stds - international equivalence
an added bonus
Accepted norm under TBT – now growing in food – labs as
per ISO 17025, inspection as per ISO 17020, use of or
cognizance to certification as per ISO 17021-1 or ISO 17065 –
Organic/GAP/Halal certifications
USFDA assessing ABs – accepting certification by
accredited CBs - EC/Canada regulations refer to ISO 17020
for inspection – use of accredited labs widespread
 Accreditation in Voluntary Sector
Food sector having many internationally known
voluntary/pvt standards and certifications – ISO
22000, GlobalGAP, BRC, IFS, SQF, FSSC 22000 etc.
Either MS or Process certification schemes - invariably
rely on accredited CBs and Labs
IAF system of endorsing schemes and covering them
under IAF MLA – GlobalGAP, FAMI QS endorsed
Interaction between GFSI and IAF to use IAF system
for all GFSI benchmarked schemes
IAF bringing out a document on evaluating schemes –
ABs now required to determine suitability
 Indian Scenario
Use of accreditation in regulations - FSSAI notifying
labs accredited by NABL; https://
fssai.gov.in/cms/food-laboratories.php
187 labs, 18 Referral Labs for appeals, 12 National
Referral labs
food safety audit agencies accredited by NABCB -
Food Safety and Standards (Food Safety Auditing) Reg
ulations, 2018
List of notified agencies at https://
fssai.gov.in/cms/third-party-audit.php
30 nos notified
 Export Regulation
India regulates exports under Export (Inspection &
Quality Control) Act, 1963
Export Inspection Council (EIC) supported by 5
Export Inspection Agencies (EIAs)
EIC Lab Recognition Scheme – recognizes labs based
on NABL accreditation
Organic regulation by APEDA – organic certification
bodies accredited as per ISO 17065 by APEDA itself
APEDA recognizes food labs accredited by NABL
Accreditation vital basis of export regulation
 Voluntary Regime in India
India free market – all international certifications
available - ISO 22000, FSSC 22000, BRC, BAP,
GlobalGAP etc.
BIS certification for ISI mark – NABL accredited labs
Agmark certification for agri products – NABL
accredited labs
Indian schemes by QCI – IndGAP/IndiaGHP/
IndiaHACCP certification schemes – NABCB
accredited CBs; NABL accredited labs if needed
Accreditation important component of voluntary
regimes worldwide
 Risk in Certification
Legally no bar on anyone setting up a lab or inspection agency or
certifying agency
How to establish its authentic, competent
Unaccredited CABs – issuing unaccredited test reports/ certificates –
one problem
Private ABs outside IAF system – CBs claiming accreditation – no
knowledge of credentials
Indian market full of such bodies – unauthentic, even fraudulent
certificates
Ministries, govt agencies, purchase organizations/deptts do not know
– duped by such certificates
IAF system even though voluntary provides authentication needed for
certification – not required by law
Some examples follow
 Contents
1. Name and address of the organization certified
2. Scope of certification describing its activities under
certification – e.g. production, packing and sale of dairy
products ….(broad list of products)
3. Standard (or sometimes scheme or regulation) against
which certification is granted e.g. ISO 9001 or ISO 22000
(standard) or FSSC 22000 (scheme) – in general guidance
standards are not amenable to certification – these have to
be formal, requirement standards or specifications for
products or process – Codex HACCP not for certification
4. Date of issue and expiry of certificate
 Contents (Contd)

5. Unique identification number of the certificate

6. Name and address of the CB
7. Logo of the CB
8. Accreditation symbol indicating the name of the AB
which has accredited the CB (in most countries, in the
absence of any law requiring certification bodies to register,
accreditation is the only way of recognizing a competent,
authentic certification body)
9. IAF Mark (optional) – indicating that the certificate is
covered under the Multilateral Mutual Recognition
Arrangement (MLA) of IAF and hence is internationally
equivalent and acceptable in the market
 Conclusion
Accreditation growing in importance
Both in regulations as well as in voluntary sectors
Regulations can be administered more effectively
using 3rd party agencies
Voluntary certifications – market driven –
contribute to better implementation of
regulations – increasingly regulators giving
cognizance – Codex formulating guidelines
Risk in Indian market – safe to rely on
NABCB/NABL accreditation
 THANK YOU
FOR YOUR ATTENTION!

Any Questions ?