Regional and global
conformity assessment
schemes:
issues for regulatory
authorities
Lorenza Jachia
Secretary, Working Party on Regulatory Cooperation
1 December, 2015
© Copyright 2015 United Nations Economic Commission for Europe.
UNECE WP. 6
What we are:
• Intergovernmental body
• Participation by: authorities, regional & int’l org, standards-setting bodies,
business, certification bodies, test houses, civil society
• From all UN Member States
• 1970 – 2015: 45+ years
Our mandate:
• þ Standardization þ Technical regulations þ Conformity assessment þ
Accreditation þ Metrology þ Market surveillance þ Risk Management þ
Education x standards
Our activities
• Develop and share info & best practice
• Capacity-building (trainings and awareness-raising events)
• Develop and maintain a set of recommendations
• Implement a set of initiatives on specific industrial sectors
© Copyright 2015 United Nations Economic Commission for Europe.
What are conformity assessment schemes?
• Systems based on
acceptance of conformity
assessment results of
each other’s Conformity
assessment processes
• Different from MRA: not a
form of cooperation among
governments – but can be
used by governments
• Different from MLAs in
which parties recognize
processes for testing,
certification, inspection,
and/or accreditation
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How can conformity assessment schemes help regulators?
• Drives down trade costs and
reduces time to market,
increasing the
competitiveness of local
industry
• Ensures that the products are
safe and efficient, minimizes
the risk to property and
persons, contributes to
environmental conservation
and public health
• In contrast to MRAs,
regulatory authorities are not
themselves responsible for
the conclusion and upkeep of
the agreements, saving their
own resources, and taking
advantage of existing
expertise
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Cooperation in CA among regulators: pre-market
Challenge for regulators is to go
beyond harmonization of
regulations and standards
Towards the international
harmonization of regulatory
systems, including through the
increased use of conformity
assessment schemes
Avoid duplication of testing and
enhancing the competitiveness
of the industry
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Cooperation in CA among regulators: post-market dimension
Standards
help define “how dangerous”
is the
product/service/equipment
≠
Conformity
assessment helps
control for probability
of non-compliance
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Global/regional schemes to increase probability of compliance
Internationally aligned and administered conformity
assessment improves the probability of compliance
for a regulator by:
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–
Improving the methodology of the assessment by
involving a wide range of expertise
–
Improving the quality of accreditation of the assessment
agencies
–
Improving the ongoing monitoring of the assessments
by having a wider pool of agencies using the
assessments
–
Reliably reporting failures so that in-market action can
be taken.
Some examples of use of CA schemes by regulatory agencies
ASEAN
Electrical and
Electronic
Equipment
ASEAN
Pharmaceutical
• Acceptance of test reports
(based on APLAC MRA &
IECEE CB Scheme) &
certification (based on PAC
MRA & IECEE CB – Full
Certification Scheme)
• Signed in 2000 and
implemented in 2004
•ASEAN MRA on Good
Manufacturing Practice (GMP)
of Inspection of Manufacturers
of medicinal products (signed in
2009)
•Inspections can be carried out
by competent local inspection
bodies resulting in cost savings
for manufacturers.
© Copyright 2015 United Nations Economic Commission for Europe..
OECD
MAD (Chemical
Safety)
• Mutual Acceptance of Data System provides that all member
countries must accept the chemical safety data developed in one
member using the OECD Test Guidelines and OECD principles of
Good Laboratory Practice.
Direct
acceptance of
IECEX scheme
certificates
• Australia and New Zealand: Mine Safety Operations (MSO) Division
for Department of Trade and Investment is the regulator for mining in
NSW Australia. Since 2007 NSW accepts equipment for use in the
mines from any IECEx Certifying Body
• USA: electrical equipment used offshore in hazardous locations, such
as on gas and oil rigs, mobile offshore drilling units and offshore
supply vessels MUST be certified or listed in accordance with either
National Regulations or the IECEx Scheme (starting from 2018)
New Zealand:
electrical
equipment
• Under the Electricity Safety Regulations 2010 under the Certification
Body Scheme of the Worldwide System for Conformity Testing and
Certification of Electrotechnical Equipment and Components, known
as the IECEE CB Scheme
Concerns expressed by regulators in moving towards CA schemes
• Regulators have concerns in moving
to international schemes:
– is the system reliable and
sustainable over the long run?
– how can regulatory authority obtain
information (that had been part of
approvals under existing national
systems)?
– what will happen in case an
accident is caused by equipment
certified by CB?
© Copyright 2015 United Nations Economic Commission for Europe..
When many regulators use the
same system: more effective
oversight of the process
When the system is part of a
solution that includes the whole
regulators system
Lessons learnt from past experience
• Making the move requires
–
–
–
–
certainty, inter alia as to: the scheme
ownership, its financial sustainability,
modalities for use of CA results by the CA
body, the scheme owner, the authorities,
policies for dealing with and resolving nonconformities; general conditions for
granting, maintaining, continuing,
extending the scope of, reducing the scope
of, suspending and withdrawing approval,
policies for prevention forgery and
fraudulent use of certificates, etc.
strong collaboration with the national
industry
a risk based approach to regulation
a holistic regulatory system design
© Copyright 2015 United Nations Economic Commission for Europe..
Advantages for regulators
– Conformity assessment schemes are
managed by an external body, that
follows set rules and involves
membership before making changes,
giving security and independence to the
scheme.
– Participation in the scheme by authorities
ensure that the scheme is and remains fit
for purpose for that regulatory body.
– Shared values – such as shard
expectations about work place safety and
environmental conservation and industry
accountability - are essential for the
success of the scheme
Recommendation L: from harmonization of technical
requirements to common regulatory systems
• Approved by UNECE in 2001
• New draft tabled for revision at the Working
Party session starting tomorrow
• Recommendation L sets out a model for
regulatory cooperation that is comprensive and
includes both pre and post market dime:
–
Common technical requirements
–
Reference to international standards as the basis for
the technical requirements
–
Provision on how compliance shall be
demonstrated. This may include reference to a
certification schemes
YOUR COMMENTS TO
THE REVISED
RECOMMENDATION
ARE WELCOME
© Copyright 2015 United Nations Economic Commission for Europe..
Issues for further discussion:
How to encourage awareness/uptake of systems of
assessment of conformity to standards by regulators?
What role for systems of conformity assessment in the
implementation of the 2030 agenda for sustainable
development?
Possible role of WP. 6
Regulatory use of schemes related to personnel/services
etc.
© Copyright 2015 United Nations Economic Commission for Europe..
Thank you
Lorenza Jachia
Secretary, Working Party on Regulatory Cooperation and Standardization Policies (WP.)
Lorenza.jachia@unece.org
© Copyright 2015 United Nations Economic Commission for Europe.