IAAC GA Open Seminar

IAAC 12 th General Assembly
Ottawa, CANADA / August 11-19, 2007
IAAC GA Open Seminar
August 16, 2007
‘Making the Most of Accreditation’
Introduction
Faced with increased and divergent pressures, accreditation bodies in the Americas need greater
collaboration and cooperation from a broad stakeholder contingent to make the most of
accreditation. That was the theme underlying a recent event in Canada.
As part of the 12th General Assembly of the Inter-American Accreditation Cooperation (IAAC)
convened in Ottawa, Canada, the Standards Council of Canada (SCC) held an open seminar and
invited key Canadian stakeholders to speak and share experience about the benefits of
accreditation. The seminar focused on learning how to make the most of accreditation by looking
at the topic from various perspectives. A panel of experts discussed the dynamics of global
accreditation, provided an overview of the key organizations involved, outlined some of the
impediments and challenges to this work and explored possible solutions.
The seminar was moderated by the Vice Chair of the IAAC, Pat Paladino.
Approach
The seminar was designed to examine some of the many facets of gaining worldwide market
acceptance for conformity assessment and certification practices. This post-event summary
attempts to synthesize the information provided and present insights of the actual operational
experience and its meaningfulness to policy makers, private decision makers and end users. A
framework approach is used to convey the key points of Canada’s approach and experience; the
challenges, benefits and costs of accreditation; an estimate of net benefits; the observed trends
and successes; innovations in Canadian accreditation; and observations of the general future for
accreditation. Several sections also include key points drawn from the audience dialogue.
Summary
A description of Canadian experience
The description of Canadian accreditation experience starts first with the history and outline of
multi-lateral and global accreditation efforts; this serves as a backdrop to situate domestic growth
and experience. Canada is very much part of the international network and so is the experience
that it readily shares with others. More specific Canadian experiences follow.
Through time, Canada has seen changes and steady evolution of the public laboratory sector
during the 1980-1990’s sustained, in large part, by the learning investment accumulated through
the use of international standards, ISO/IEC Guide 25 and documents from ILAC and others.
At the same time, the effects of trade barriers; changing client demands; declining governmental
budgets and increasing litigation and other challenges did not go unnoticed or without impact.
This leads to several significant points about Canada’s experience. One is the diversity of subject
matter that includes forensic science, medical devices, national codes for housing and
infrastructure, and electrical standards that provide for common and repeated uses, interoperability,
and equipment maintenance. More than anything, Canada is known for
demonstrating the importance of partnerships for effective accreditation. Joint or
complementary approaches frequently lead to better risk mitigation and more equitable burden-
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IAAC 12 th General Assembly
Ottawa, CANADA / August 11-19, 2007
sharing among parties relative to the benefits provided as they occur. More will be said about
partnerships later.
The actual definition of accreditation has itself changed with time and experience. No longer
denoted simply as a formal recognition of a body carrying out specific tasks or activities,
accreditation now involves taking account of the overall public interest, and the integrity, quality
system and technical competence of the organizations concerned.
Canada’s collective experience over the past decade or two indicates that its accreditation
system has not only changed but diversified and grown; it is more flexible with less specific, and
more results-based methods and assessments; there is more demonstrable expertise; and it
more actively engages stakeholders including universities and the private sector.
Challenges, benefits and costs of accreditation
Challenges—exist everywhere, system-wide and with public and private sector users as
explained during the seminar. One of these is the lack of direct industry participation in various
bodies; another is some accreditation bodies are not yet signatories to relevant multi-lateral
agreements.
In Canada, various capacity restraints were noted within the economy, government, Parliament
and the fact that the SCC is a statutory corporation restricted by its legal mandate, the policy of
the government of the day and the resources available. In some cases, the very success of
accreditation can result in complacency whereby it is taken for granted by the marketplace and
the broader economy.
This can result in limitations on the availability of voluntary technical specialists and assessors;
assessor training; communications and coordination; and follow-ups regarding non-conformities
and test results when challenged. There is an associated and on-going challenge to ensure
consistency and sound interpretation of assessments as they occur—a system-wide need not
unique to Canada.
A recent and continuing challenge is the pace of change effecting markets and the constant
transitioning from old to new tools and technologies—something shared world-wide. Overall, the
principal accreditation challenge today is to do more, bring better results, faster.
Benefits—Canada’s single-window approach was highlighted. Its use was shown that it can lead
to economic or public sector benefits, from contract simplification to confidence-building.
For the voluntary or private sector, accreditation can provide independent evidence that an
organization conforms to, or uses internationally-recognized best practices; again this puts
confidence into the work performed or the quality of products or services provided; it also serves
as a performance benchmark for the internal management of the accredited body itself. In
particular sectors such as electricity distribution, demonstrated conformity assessment ensures
better integration of standardized requirements, safer distribution of electrical energy and
minimization of product re-testing. Importantly, from a Canadian perspective, it opens up global
markets for electrical manufacturers.
Benefits are also prevalent in public sectors. Noteworthy is the example of the medical devices
program that makes use of the ISO 13485 standard and other features. Through this initiative,
Health Canada is able to achieve its stated mission and regulatory objectives at optimal cost
without diminishing or limiting its policy responsibility for control of safe devices. As well, the
government increases the safety of devices available and improves the quality of life for many
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IAAC 12 th General Assembly
Ottawa, CANADA / August 11-19, 2007
Canadians. Simultaneously, manufacturers of devices are able to demonstrate publicly their
capability as recognized suppliers.
Costs—not much was said about costs of accreditation throughout the seminar although indeed
they exist. In Canada, some costs, e.g., the SCC’s annual Parliamentary appropriation and
revenue stream based primarily on fees are known and publicly available. Some overhead costs,
such as salaries, training, etc. are known or can be traced up and down or across the
accreditation system; so in some respect various, segmented costs can be compiled but, as yet,
the overall aggregative cost of accreditation is unknown for Canada. The same may be said
about other country or regional costs of accreditation.
Net benefits of accreditation
There is anecdotal evidence of net benefits, notwithstanding the challenges and the costs
concerned.
It was revealed, for example, there are some realizations of unpredicted efficiencies as well as
evidence of continual improvement. Both public and private sectors observed instances of more
effectiveness in safety without compromising national requirements as well as better leverage of
management systems certification and use of auditors without building separate systems with
their parallel and attendant costs.
Of particular note was the distinction needing to be made between ISO 9001 certification and
accreditation, i.e., the difference between conformity to quality management (QMS)
specifications, and verification and assurance of competency. It was argued that the real value
equation for accreditation occurs with the delivery of objective and consistent services to the
marketplace, taking into account the commercial dynamics prevailing at any point in time.
Trends and successes
Panelists and others are noting trends in accreditation that include—increasing ISO 9000
alignment across sectors; more and better harmonized documentation, and increasing use and
support provided by information technology.
SCC itself is seeing continued demand for accreditation from existing client sectors and programs
while introducing new programs in response to new or emerging needs, e.g., occupational health
and safety, food safety and others.
Various successes were noted including improved health care and longevity, better electrical
service delivery and safety, higher levels of test result acceptances, better prevention of serious
laboratory error, and overall enhanced supplier-customer confidence—the bottom line of
accreditation.
In Canada, there seems to be more recognition, for example, of third-party evaluations of
laboratory capabilities and competencies within the regulated sectors; also enhanced use and
recognition of accreditation is being made by the courts and the legal system.
Innovation in Canadian accreditation
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IAAC 12 th General Assembly
Ottawa, CANADA / August 11-19, 2007
While not unique, several examples were mentioned of Canada’s efforts to improve its
accreditation programs. These include the importance of reading and understanding the
marketplace, and of accreditation bodies understanding their own strengths and weaknesses.
In Canada, this led the SCC and others to collaborate and design new program structures such
as joint partnerships or multiple-stakeholder efforts in respect to various regulatory needs at the
federal and provincial levels.
Included in the new structures were new features, in some cases custom-designed to enhance
flexibility. Again, the one-window approach to accreditation that involves grouping specialties
under broader scopes for accreditation results in better service to multiple clients, and/or to
multiple programs held within individual client portfolios.
Another example is simply taking the initiative as opportunities arise. This happened in the
case of forensics science and its expansion since 1994 when a WG was first established by the
Canadian Society of Forensic Science; this entailed responding to new Canadian DNA databank
legislation to provide support and assurances of adherence to accepted practices and standards
and provision of proper and credible documentation on test methods, results, reporting and expert
testimony.
Future for accreditation
To be more effective in the future, accreditation bodies need to clearly define and agree on a
definition of purpose and use. One observation is that accreditation bodies need to do much
more to clarify and promote the distinction and value of accreditation, as a tool, over certification.
A suggestion was that this could be supplemented by improving understanding of the varying
value equations for accreditation across sectors, and possibly across economies and regions.
More promotion and continued development of regional and global networks were stressed as
important and beneficial over time at the international level. In addition, involvement of users
from industry; possible reciprocity arrangements among regulatory bodies; more focus on scoping
and other technical issues; plus more support for mutual recognition schemes were felt to be
important. Some countries not yet at the level of recognition are looking for short-term strategies
to improve industry relationships and expressed interest in the Canadian approach of early
inclusiveness, transparency and multi-stakeholder decision-making.
The emergence of supplier declarations was raised as a potential threat to accreditation. Various
discussions, for example, in Europe or at multi-lateral bodies like the Organization for Economic
Cooperation and Development (OECD) and the Technical Barriers to Trade Committee (TBT) of
the World Trade Organization (WTO) were noted by participants. Certain clarifications or updates
on the status of these activities were provided to enhance current understanding and
comprehension of participants. Nonetheless, shared concerns remained, in particular about
product safety issues and the credibility of supplier assertions.
Various stakeholders are now asking accreditation bodies to remain or get involved in these
developments and discussions. There is also a challenge from some parties to encourage
accreditation bodies to consider countering the declaration proponents and actions. At the same
time, there is need for some accreditation bodies to embrace more open competition in markets
and to remove their monopolies in some sectors, or in some regions.
In Canada, it was felt that the future could bring demands in the private sector for more diversity
of action and more service competition. This could result in greater segmentation of accreditation
clients. In certain sectors, there could be more emphasis on supply chain competencies in more
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IAAC 12 th General Assembly
Ottawa, CANADA / August 11-19, 2007
areas of product manufacture and safety, and more emphasis on human resources and
credentialing pushed by concerns about the availability of experienced and competent labour.
These demands are not only national but global and could be triggered, or linked to issues
surrounding corporate governance, management systems, public accountability and ethical
practices.
In the regulated sectors, there could be more demands and partnerships with respect to
infrastructure, product and food safety, carbon management and emission verification. In the
Americas, there is a lot to give and a lot to get from each of these future endeavors; conversely, if
any of these accreditation efforts is not done right, it could result in a lot to lose.
Conclusion
It is clear that all participants are challenging and wanting the accreditation system to improve, to
become better, more viable and more market-relevant while maintaining the backstay of public
interest and safety. Confidence building and maintenance remain paramount.
Arguably, there is need for the accreditation community and its associated economies to make
more extensive use of its design, capacity and any prior investment to bring about more
commercial or public policy outcomes that add to the future of the Americas—more public and
consumer safety, more environmental protection, increased productivity, new products and
technologies, innovations, trade expansion, etc. In Canada, accreditation may still be underutilized
relative to its full potential as a national practice. On balance, it was felt that accreditation
for Canada can result in sound science and overall good management.
On the whole, there is enthusiasm about accreditation. It seems there is merit and hope that in
working together north and south in the Americas, through bodies like the IAAC, more can be
done to improve and, in some areas, even lead the rest of the world to better accreditation
outcomes and benefits.
D.A. Durrant, Chairman
SCC/ACCA
23 August, 2007
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