CHALLENGE OF STANDARDS &

CONFORMITY ASSESSMENT
FOR STARTUPS

Anil Jauhri
jauhrinail@gmail.com
+919810567765
 INTRODUCTION
Quality a major driver for products and services
in global market
Quality needs to be built into design of
product/service – so important from Day 1
Many products/services having health/safety
implications – hence need to enforce standards by
law – called technical regulations in product
segment – simply regulation for both
products/services
Sectors like Food/Drugs/Electrical appliances/
LPG cylinders amenable to regulations – services
like healthcare, aviation regulated too
 INTERNATIONAL SCENARIO
WTO regime – regulations on grounds of health,
safety, deceptive trade practices, environment,
national security etc – encourages use of
international standards – TBT Agreement
Two distinct regimes – sectors amenable to
Regulations and sectors driven by (Voluntary)
Standards - product and systems
Worldwide regulations responsibility of
governments – need a legislative instrument –
Standards (voluntary) driven by market – industry
and other stakeholders – govt initiates in
developing economies
 DOMESTIC REGULATION
• Several sectors in India are regulated – food, pharma,
electronics/IT good, electrical appliances, LPG
cylinders, partially medical devices
• India has deficit in regulations – since mid-2017 exercise
on to cover more products under regulations – toys,
machinery safety, chemicals – mostly under BIS Act
• Important to identify if your product has health, safety,
environment etc implications
• Likely to be regulated – to meet requirements set under
regulations – under BIS Act - generally BIS standards –
list on BIS website
• Even if not regulated currently, likely to be regulated –
so need to keep an eye
CHALLENGE OF WORLD MARKET
Industry to meet importing countries’ regulations
Typically more stringent than our domestic
regulations – so extra effort is needed – seafood
industry a glowing example – pharma - but most
struggle
Based largely on international standards – so
important to look at international standards
Safe to meet international stds – likely to meet most
countries’ regulations
 VOLUNTARY STANDARDS
Typically by National Standards Bodies – BIS in India -
hub of voluntary standards – Private bodies in most
developed countries having strong connect with industry
– Governmental in developing countries – yet standards
voluntary – ISO and IEC for International Standards
Buyer’s may demand – hence necessary to adopt – ISO
9001, ISO 22000, etc. – and the tribe is growing by the day
Industry standards like IATF 16949 in auto, AS 9100 in
aerospace, TL 9000 in telecom
If in voluntary sector, best to look at BIS website for
standards – 20000 standards, 60% product standards, BIS
certification available as option – for domestic market
 PRIVATE SUSTAINABILITY STANDARDS
Growing breed – made by private players – blessed
by stakeholders like retailers – not always
participatory or transparent
Protection against liability – reputational risk - as
global sourcing grows – concerns about social
issues – child labour, fair wages, workers’ safety
Even in regulated sector like Food – demanded by
buyers even if industry meets regulations of that
country – hence market reality and necessary
Examples: GlobalG.A.P. for Agri produce, FSSC
22000/ IFS/SQF/BRC for food, BAP for
aquaculture; SA 8000, WRAP for textiles
 CHALLENGE BEYOND STANDARDS
Ability to meet global standards or regulations
not enough
Manner of demonstrating compliance equally
important
Conformity assessment – inspection/
testing/certification
Variety of models available and prescribed –
from self declaration to intensive third party
assessment
No single model possible – depends on risk
 ROLE OF ACCREDITATION
How do we know a lab or certification body or
inspection agency competent?
Accreditation – attestation of competence of
conformity assessment bodies – Labs/Inspection/
Certification bodies
As per common international standards of ISO
NABCB/NABL – accreditation bodies in India for
certification/inspection and labs – part of QCI – DPIIT
ABs in all countries – concept of national ABs in
Europe by law – private in some countries like
USA/Japan etc – others mostly governmental
Facilitates international acceptance of test reports/
inspection reports/certifications
 INTERNATIONAL SYSTEM
International Accreditation Forum (IAF) – apex body –
global association of ABs for certification – MLA
International Laboratory Accreditation Cooperation
(ILAC) – global association of ABs for inspn/labs – MRA
Regional bodies – broadly each continent – Asia Pacific
Accreditation Cooperation (APAC), European
Accreditation Cooperation (EA), Inter American
Accreditation Cooperation (IAAC), African Accreditation
Cooperation (AFRAC), Arab Accreditation Cooperation
(ARAC) – oversight over individual ABs – MRA/MLA –
members of IAF/ILAC
Voluntary, non governmental system – increasingly
referred to in regulations and free trade agreements –
accredited conformity assessment acceptable
EQUIVALENCE FRAMEWORK
IAF / ILAC

European Accreditation
Asia Pacific Accreditation Inter American Accreditation
Cooperation
Cooperation (IAAC)
(EA) Cooperation (APAC)

ACCREDITATION BODY

ISO 17011
CB/IB/LAB
ISO 17020
ISO 17025
ISO 17021
ORGANIZATION / ITEM
UNDER INSPECTION /
ISO 17065
CERTIFICATION / ISO 17024
TESTING
Standards against
which certified –
ISO/IEC Standards
ISO 9001 / ISO14001
 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
 IMPORTANCE OF IAF SYSTEM
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 provides authentication needed for certification
 WHAT DO YOU NEED TO DO ?
Identify if you are in regulated sector
If yes, follow regulations - both requirements for product
and procedure for compliance – no choice
If product has health, safety considerations it would get
regulated
Voluntary standards/Private standards– identify what the
market asks for – buyers preferences choice whether to
adopt or not
Go for either BIS certification for domestic market or
accredited conformity assessment – IAF/ILAC system –
for both domestic/overseas market
 THANK YOU
FOR YOUR ATTENTION!

Any Questions ?