WORLD TRADE
ORGANIZATIONG/TBT/W/210
20 June 2003
(03-3336)
Committee on Technical Barriers to Trade Original:  English
CANADA’S APPROACH TO VOLUNTARY
CONFORMITY ASSESSMENT
Submission by Canada
I INTRODUCTION1. The Second Triennial Review of the Technical Barriers to Trade (TBT) Agreement made
significant progress on the longstanding issue of in ternational standards in the Decision on Principles
for the Development of International Standards, Guides and Recommendations (Annex 4).  However,apart from agreement on an indicative list of the different approaches to conformity assessment
(Annex 5), the review did not substantially address the issue of conformity assessment.  In particular,
the TBT Committee was unable to agree on the adoption of best practices or principles governing
conformity assessment and provided little guidance on how this matter could be addressed in the
future.  It is expected that this issue will be more properly addressed during the 2003 Third TriennialReview.
2. As a follow-up to the Second Triennial Revi ew, this paper highlights key elements of
Canada’s experience in the area of voluntary conformity assessment.  The sharing of information on
national approaches to conformity assessment helps promote the development of best practices and
procedures and a broader understanding on how to implement the TBT Agreement in ways that
minimize trade barriers.
II ACCREDITATION
3. In Canada the voluntary conformity assessment system is based on accreditation.
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Achievement of consistent results through accreditation is dependent on the application of
internationally harmonized standards, guides and recommendations that have been developed on thebasis of consensus.  Such documents encapsulate criteria and procedures related both to accreditation
bodies and accredited programs (e.g. inspection, testing, calibration, quality and environmental
system registration/certification, product certification and certification of personnel).  This foundation
provides the necessary confidence among users of conformity assessment services, including business
and government, and accounts for the growth of accreditation-based conformity assessment servicesthroughout the world.
4. Annex Four of the Report of the Second Triennial Review of the TBT Agreement extends the
seven (7) principles for the development of inte rnational standards to include the development of
those international standards, guides and recommendations related to conformity assessment.Aligning such documents with core TBT principles promotes their wider acceptance among members
of the global conformity assessment community.  Canada, through the Standards Council of Canada
                                                     
1  The First Triennial Review of the TBT Agreement noted that among the different approaches to
conformity assessment, accreditation represents an independent test of the technical competence of conformity
assessment bodies (CABs).G/TBT/W/210
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(SCC), is an active participant in the development of the international standards, guides and
recommendations.  The SCC participates in a number of Working Groups (WGs) of the International
Organization for Standardization’s (ISO) Committee on Conformity Assessment (CASCO) and holds
the convenorship of Working Group 22, which is undertaking revision of ISO/IEC Guide 60 - Code of
good practice for conformity assessment .
5. Accreditation activities based on the use of international standards, guides and
recommendations provides additional benefits for conformity assessment organizations.  Increasing
global acceptance and application of these document s is helping to foster greater international
harmonization of conformity assessment practices and procedures. This trend is apparent in the
evolution of international and regional conformity assessment systems.2  Such systems have expanded
rapidly in recent years, encompass members from both developed and developing countries and link
accreditation bodies that apply internationally-harmonized standards and guides.  These systems
provide for recognition of the equivalency of voluntary accreditation programs and policies through
the development of multi-lateral arrangements (MRAs/MLAs).
6. International and regional conformity systems provide the framework for an emerging global
accreditation regime based on the principle “one accreditation, accepted everywhere”.  These systems
have the potential to reduce or eliminate duplicative costs of conformity assessment and reduce delays
in the delivery of products to market.  The signing of the ILAC MRA in November 2000 and the
decision to extend the PAC and IAF MLAs to include environmental management systems and
product certification are key milestones is this process.  The TBT Agreement endorses internationaland regional accreditation systems and encourages TBT Members both to participate in the
arrangements and adopt their corresponding documents.  However, there remain a number of
challenges including wider consumer and regulatory acceptance and the need for greater participation
by developing countries and small and medium sized enterprises (SMEs).  The reciprocal acceptance
of accreditation-based conformity assessment results will require a certain level of confidence andmutual trust that will take time to cultivate and promote.  TBT Members are encouraged to involve all
domestic stakeholders so that the full benefits of national participation in these systems are realized.
The SCC has signed agreements in ILAC, IAF, APLAC, IAAC and PAC and participates in the
policy direction of these organizations.
7. The SCC operates Canada’s national voluntary accreditation program.  Currently, there are
accreditation programs for organizations involved in testing, calibration, product certification,
registration/certification of ISO 9000 quality and ISO 14000 environmental management systems,
auditor training, and auditor certification. Users of conformity assessment services value the
recognition that accreditation brings, as indicated by growing demands for the service.  Between 2001
and 2002, the total number of organizations accredited by the Standards Council of Canada reached
377, a sixteen (16) percent increase over 2000-2001.  New programs are expected in the growing list
of sectors in the ISO 9000 and ISO 14000 areas.  In addition, new programs for the accreditation ofbodies that certify personnel and for the accreditation of inspection bodies, utilizing ISO/IEC 17024
Conformity assessment – General requirements for bodies operating certification of persons  and
ISO/IEC 17020:1998  General criteria for the operation of various types of bodies performing
inspection respectively, will soon be launched.
8. As governments have downsized and reorganized, public authorities have looked to the
voluntary system to provide conformity assessment services.  In Canada, accreditation programs have
broad acceptance at both national and sub-national levels.  The SCC has entered into partnership
                                                     
2 Examples include  the International Laboratory Accreditation Cooperation  (ILAC),  the International
Accreditation Forum (IAF), the Asia-Pacific Laboratory Accreditation Cooperation (APLAC),  the PacificAccreditation Cooperation (PAC),  the European co-operation for Accreditation (EA), the Interamerican
Cooperation for Accreditation (IAAC) and the Southern Africa Cooperation for Accreditation (SADCA).G/TBT/W/210
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programs with a number of federal and provincial departments and agencies to deliver accreditation
services in the areas of testing and calibration laboratories.  This partnership approach has proven to
be cost effective and to satisfy regulatory needs.  Another partnership example involves the use of
SCC-accredited quality management system (QMS) registrars by Health Canada.  After the
introduction of new regulations requiring medical devices sold in Canada to be designed andmanufactured under a registered QMS that conforms to international standards ISO 13485 or ISO
13488, Health Canada partnered with the SCC to qualify accredited QMS registration organizations to
register manufacturers’ quality management systems to the appropriate standards.  Product
certification by an SCC-accredited body is also accepted for a growing range of federally-regulated
products and services.  Harmonization between provincial jurisdictions in the acceptance of the results
of conformity assessment is a longstanding feature of Canada’s regulatory environment.  In a number
of areas in which provinces have regulatory jurisdiction (e.g. electrical safety), products certified byan SCC-accredited product certification body are accepted throughout Canada.  This coordinated
approach facilitates inter-provincial trade in electrical products and helps ensure provincial
compliance with the substantive provisions of the TBT Agreement.
III. OTHER APPROACHES TO CONFORMITY ASSESSMENT
9. The TBT Second Triennial Review noted that there are different approaches to conformity
assessment and emphasized the need to maintain fl exibility in their application, depending upon the
sectors involved and different requirements of Members, including the perceived level of risk.  The
application of a variety of approaches to conformity assessment poses both opportunities and
challenges, particularly for the regulatory community.  Suppliers’ declaration of conformity (SDoC), a
popular method of demonstrating regulatory compliance in a number of sectors (e.g. automobiles,telecommunications and electronics) has received much attention in the TBT Committee.  While
SDoC may offer economic benefits by reducing delays in delivery to market, its widespread
acceptance will depend on a demonstrated capacity to consistently address health and safety concerns,
the existence of stringent legal penalties and enforcement networks and the provision of appropriate
consumer redress mechanisms. Currently in Canada, regulators accept SDoC in the fields ofelectromagnetic compatibility (EMC) and telecomm unication terminal attachment equipment (TTE).
Continued research and dialogue will help to fost er a wider understanding of SDoC and its impact on
the Canadian regulatory environment.  The goal  is to engage all involved domestic parties in
discussions on this issue in order to in gain a bala nced view of the costs and benefits of SDoC and
provide an understanding of the most appropriate circumstances and sectors for its application.  Asstated in its paper for the Second Triennial Review, Canada believes that formal accreditation of
private testing and inspection bodies operating in support of SDoC would help facilitate wider
acceptance of the concept among regulators and the public.  The pending completion of the two-part
international standard ( ISO/IEC 17050-1 General requirements for suppliers’ declaration of
conformity and ISO/IEC 17050-2 Supporting documentat ion for suppliers’ declaration of conformity )
will also provide a basis for greater consistency of this conformity assessment approach.
10. Established international product certification schemes also play an important role in
Canada’s conformity assessment regime.  A number of Canadian accredited certification bodies are
members of the multilateral IEC System for Conformity Testing and Certification of Electrical
Equipment (IECEE CB Scheme) which promotes acceptance of test certificates based on specific IEC
standards without the need for further testing and evaluation.  Certificates issued under the Schemeare recognized by SCC -accredited certification bodies whose certifications are accepted in Canada by
provincial government electrical safety regulators, eliminating the need for re-assessment.  In order to
demonstrate its openness and multilateral character, The CB Scheme, once previously restricted to
IEC members, is now being expanded to include non-IEC members.  Manufacturers in developing
countries where there are few IEC members are expected to be the primary beneficiaries of theexpansion since they will avoid the need for repeat testing once the product has been certified by an
IECEE CB Scheme member.  A similar IEC scheme fo r Products used in Explosive Atmospheres, theG/TBT/W/210
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IECEx Scheme, is currently gaining strength and is expected to greatly improve market access for
products in this sensitive and highly regulated field.  Canada is a founding member of the IECEx and
is an active participant.  The success of the IEC Schemes may have implications for other sectors.
11. Canada notes that participation in the development of international standards and guides,
adoption of these documents in support of regulatory objectives, participation in accreditation-based
conformity assessment arrangements and sector schemes and participation in and promotion of
innovative conformity assessment processes can provide members with a variety of internationally-
accepted approaches to conformity assessment.  This multi-faceted approach provides a range of
voluntary conformity assessment instruments and enables stakeholders to meet multiple customer
demands and regulatory requirements.           
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