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Submission by the Standards Council of Canada (SCC)

Standards Council of Canada (SCC)
February 2004

Summary:

Using the six (6) headings identified by the External Advisory Committee on Smart Regulation (EACSR) as a framework, this document provides an overview of the Standards Council of Canada (SCC), notes the benefits of standardization (standards and conformity assessment procedures) for regulatory activity, identifies specific SCC programs and cooperative arrangements that may be of interest to EACSR discussions and provides several policy suggestions regarding the use of standardization measures in pursuit of smart regulation.

Overview - Standards Council of Canada:

The SCC is a federal Crown Corporation with a mandate to promote efficient and effective standardization in Canada. The SCC coordinates and oversees the work of the National Standards System (NSS), which includes Canadian organizations and individuals involved in voluntary standards development and conformity assessment activities. The SCC has a fifteen (15) member governing Council and reports to Parliament through the Minister of Industry. The SCC represents Canadian interests in many national, regional and international standardization organizations that develop both standards and standardization policies. The SCC also operates several accreditation programs covering a variety of areas. To date, the SCC has accredited approximately 400 organizations including:

  • Standards development organizations (SDOs);
  • Certification organizations;
  • Testing and calibration laboratories;
  • Management system registration organizations; and
  • Auditor certification bodies and auditor training course providers.

SCC activities are guided by the SCC Act and the Canadian Standards Strategy (CSS), a blueprint for enhanced standardization activity in Canada (launched in March 2000). The CSS provides direction and leadership on how to use standardization to best advance the social and economic well being of Canadians in a global economy.[1]

Standardization - Benefits for Smart Regulation

Standards and conformity assessment procedures provide benefits to all segments of Canadian society. In addition to providing citizens with nationally/internationally accepted product, process or service characteristics and methodologies, these documents also enhance innovation, facilitate the diffusion of new technologies and best practices, promote safety and competitiveness, lower production costs, improve interoperability of products and systems, provide tools for the continual improvement of quality and environmental management systems and provide consumer confidence in new or existing products and services. The SCC believes that these characteristics make standards and conformity assessment procedures and efficient and cost-effective policy option for regulators.

From a regulatory perspective, standards development corresponds to the creation of technical and/or substantive requirements while conformity assessment and related procedures relate to ensuring regulatory compliance.

EACSR Themes - Links to Standardization:

The EACSR has identified six (6) headings under which to examine Canadian approaches to smart regulation. These include International Cooperation, Federal/Provincial/Territorial Cooperation, Process Efficiency, Risk Management, Instruments for Government Action, and Defining the Public Interest. The following section describes the standardization-related provides an explanation and, where appropriate, provides examples of standardization

I. International Cooperation:

Use of international standards is a key element underlying good regulatory practice and enables Canada to meet international trade obligations as defined by the World Trade Organization- Technical Barriers to Trade (WTO/TBT) agreement. Through the SCC, Canadians participate in the development of international standards under the auspices of the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC).

Canada (SCC) actively participates in over 400 international standards development committees. Currently, Canadians are Chairs of 28 technical committees (TC) and subcommittees (SC). Canada provides the Secretariat for 25 TCs and SCs and is responsible for convening 89 WGs. The SCC is also a key player in the technical work of the ISO Committee on Conformity Assessment (CASCO), which develops the international standards and guides that underpin much of the global, regional and national conformity assessment activity.

The SCC has a strong record of adopting international standards as National Standards of Canada (NSC). For example, of the 189 NSCs approved by the SCC in 2001/2002, 84% were adopted from or based on international standards. Why is this important? Failure to harmonize standards between countries or regions can contribute to TBTs since standards assist in simplifying the international trading process.

With the wide global acceptance of international standards, there are increasing pressures for mutual recognition of testing and certification. This trend is apparent in the evolution of international and regional voluntary mutual recognition arrangements (MLAs/MRAs), which provide the framework for an emerging global accreditation regime. These arrangements, which are based on equivalency between accreditation programs, promote acceptance of the concept "one standard, one test - accepted everywhere". They help to eliminate or reduce the need for repetitive testing and certification which, in turn, promotes regulatory efficiency and helps overcome standards-related TBTs.

The SCC, on behalf of Canada, is an active participant in international arrangements including the International Accreditation Forum (IAF) and the International Laboratory Accreditation Cooperation (ILAC). The SCC also participates in several regional arrangements including the Asia-Pacific Laboratory Accreditation Cooperation (APLAC), the Pacific Accreditation Cooperation (PAC) and the Interamerican Cooperation for Accreditation (IAAC). 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.

Canada is also a member of the International Electrotechnical Commission (IEC) System for Conformity Testing and Certification of Electrical Equipment (IECEE-CB Scheme). The IEC CB Scheme is a market-driven, private sector mechanism which promotes acceptance of test certificates based on specific IEC standards without the need for further testing and evaluation. Certificates issued under the Scheme are recognized by SCC-accredited certification bodies whose certifications are, in turn, accepted in Canada by provincial and territorial government electrical safety regulators, eliminating the need for re-assessment.

Through these international activities, Canadians are able to positively influence the development of international standards, conformity assessment procedures and guidance documents. For a mid-sized country with limited resources, the standards development process and existing committee infrastructures provide Canada with documents that contain international best-practices which are updated on a regular basis. The SCC believes that increased use of these documents and arrangements could provide Canadian regulators with cost-effective and internationally-recognized approaches for their regulatory activities.

II. Federal/Provincial/Territorial Cooperation:

The SCC works closely with the federal, provincial and territorial government departments in promoting standards as an excellent component of and/or compliment to traditional regulatory approaches. The SCC's Provincial-Territorial Advisory Committee (PTAC)[2], an advisory committee composed of one member from each province and territory, serves as SCC's primary linkage to provincial and territorial governments and regularly brings forward standards and conformity assessment issues of interest to the SCC. The SCC also utilizes its Regulators Sub-Committee (a sub-committee of the Advisory Committee on Conformity Assessment) to engage the Canadian regulatory community on standardization issues.

The main vehicle for federal/provincial/territorial standardization cooperation is conformity assessment. Conformity assessment is the practice of determining if a material, product, service or system meets the requirements of a particular standard. As governments have downsized and reorganized, public authorities have looked to the NSS to provide conformity assessment services. The SCC has entered into partnership programs with a number of federal and provincial departments and agencies to deliver accreditation services in a number of areas (see page four). The partnership approach has proven to be effective by enabling regulators to satisfy their specific requirements while minimizing costly oversight.

Product certification by an SCC-accredited body is also accepted for a range of provincially-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 and territories have regulatory jurisdiction (e.g. electrical safety), products certified by an 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 WTO/TBT Agreement. The SCC believes that partnership approaches between the SCC and federal, provincial or territorial governments provide regulatory departments with a cost-efficient and proven system for service delivery.

Three examples of federal/provincial/territorial cooperation using standardization to achieve regulatory objectives include:

Ontario's Safe Drinking Water Act[3]

The contamination of a municipal water system in Walkerton Ontario brought the issue of safe drinking water to the public's attention. When the Ontario Safe Drinking Water Act was tabled, a key element was mandatory accreditation for water-testing laboratories. The subsequent legislation (Ontario Reg. 459/00) made SCC accreditation mandatory in order for these laboratories to receive a provincial license. To deliver this service, the SCC, in partnership with the Canadian Association for Environmental Analytical Laboratories (CAEAL), established a rigorous program for the accreditation of environmental testing laboratories. The SCC/CAEAL program is an effective vehicle for the Ontario government to implement components of this legislation in a cost-effective manner. Leveraging the expertise of the SCC/CAECL in proficiency testing and quality management helps to ensure that the infrastructure to support healthy water resources is maintained.

Canadian Medical Devices Conformity Assessment System (CMDCAS)[4]

CMDCAS is a unique approach to regulatory cooperation that has been developed by Health Canada in collaboration with the SCC to implement new medical device regulations. In a bid to harmonize Canada's medical device regulations with those of our international trading partners, Health Canada introduced new regulations in 1998 requiring medical devices sold in Canada to be designed and manufactured under a registered quality management system that conforms to international standards ISO 13485 or ISO 13488 (quality systems for medical devices). The SCC qualifies accredited QMS registration organizations to register manufacturers' quality management systems to the appropriate standards. Health Canada oversees the process and provides technical expertise. Benefits to this partnership are expected to lead to greater confidence in medical devices sold in Canada, improve device design and manufacturing controls, and assist Health Canada in maintaining its regulatory role while making effective use of the third-party registration system.

SCC-Ontario Ministry of Natural Resources (OMNR) Sustainable Forest Management[5]

To harvest forest products in Ontario, forest companies must first obtain a license from OMNR. The OMNR is the legislated authority responsible for sustainable forest management of all Crown land forests within the province. The SCC's Sustainable Forestry Management (SFM) sector program uses its Environmental Management Accreditation Program as a base and utilizes the National SFM standard (CAN/CSA Z809), developed by the Canadian Standards Association. When audited by an SCC-accredited Registration Body, the ISO 14001 standard, combined with CAN/CSA Z809 standards provide significant contributions to verification that an applicant satisfies OMNR's sustainable forest management regulatory requirements. Through this agreement, SCC acknowledges the role that OMNR's regulatory framework and Independent Forest Audits can contribute to satisfying national SFM requirements on Crown lands. OMNR monitors and independently audits licensees for both compliance with requirements and effectiveness of management activities in achieving set objectives.

III. Process Efficiency:

The NSS offers Canadian regulators a ready-made and flexible system from which to draw expertise and resources. Thousands of Canadian citizens participate on national, regional and international standards development committees, sub-committees and working groups which employ the consensus principle. These committees are built around balanced matrices which help to ensure that all interested segments of society are included in the standards development process (e.g. industry, government, consumer groups, environmental groups, etc.). The standards development process is buttressed by an equally comprehensive conformity assessment system (discussed above). The conformity assessment system is also underpinned by the SCC's many accreditation programs. These systems are subject to regular internal audits and peer review by our international standardization colleagues and are consistent with Canada's international trade agreements. The SCC believes that increased regulatory understanding of, and access to, this system would increase the efficiency of our regulatory system without compromising consumer safety.

Given the many new products, services and service providers entering the Canadian marketplace, timely information and consumer confidence are necessary for regulators to do their jobs effectively. The SCC offers a variety of on-line services that provide for a more open and transparent system, reduce regulatory burden and allow Canadians to respond to technical enquiries from other economies. Some of these on-line services include:

Export Alert![6] - Under Canada's obligations to WTO and the North American Free Trade Agreement (NAFTA), signatories are required to establish national Enquiry Points. Standards bodies and regulators in signatory countries are required to notify when they plan to introduce new or amended technical regulations and conformity assessment procedures. Export Alert! is a unique customized, automated e-mail notification service where notifications of proposed regulatory changes received from the WTO re distributed electronically to subscribers daily. This free e-mail notification service keeps Canadians abreast of regulatory changes in Canada and in global markets. One of the most important features of the service is the opportunity to comment on any proposed changes. Comments submitted are sent directly to the regulators, and taken into consideration as regulatory changes are finalized.

RegWatch[7] - RegWatch is a unique database of voluntary standards referenced in Canadian federal regulations. For members of government and private industry, RegWatch serves as a tool in identifying information on Canadian, foreign and international standards referenced in Canadian federal law. The database also provides links to the full text of Canadian regulations citing standards. There is no cost to use this service.

Standards Alert[8] - Registering to the Standards Alert! e-mail notification service will provide users with information about changes to the Canadian and international standards they are tracking.

IV. Risk Management:

Canada's reliance on trade and vibrant consumer market result in many new products, services and service providers entering the Canadian market each year. The SCC believes that the use of international standards and conformity assessment procedures in the production, testing and certification of these products and services can help to mitigate associated risks. When combined with Canada's rigorous accreditation system, an additional layer of confidence is added. The SCC believes that the usage of SCC accreditation programs in regulatory activity incorporates independent assessment (carried out by neutral experts and based on internationally-recognized documents and procedures) into the system of regulatory checks and balances. The SCC's accreditation programs include:

Certification Bodies Accreditation Program (CBAP) - Certification bodies (CB) are accredited to conduct certification in a variety of areas (e.g. automotive, information technology, organics, and wood products). CBs provide independent, third party evaluations.

Program for the Accreditation of Laboratories - Canada (PALCAN) - More than 350 labs are accredited in program specialty areas such as calibration, environmental, food, forensics and information technology security evaluation and testing.

Environmental Management Systems Accreditation Program (EMSAP)/Quality Management Systems Accreditation Program (QMSAP) - More than 20 registration bodies are accredited to conduct registrations to the ISO 9001 QMS and ISO 14001 EMS standards. Sector-specific applicants are included such as QS 9000 for the automotive industry and CAN/CSA Z809 for Sustainable Forest Management (SFM).

Inspection Body Accreditation Program (IBAP) - Inspection body accreditation is the process of assessing and publicly recognizing the integrity and reliability of inspection services. Inspections ensure the safety and fitness for use of products and materials, and ensure the safety of facilities, equipment and systems. The first fields of inspection for this new program are electrical safety, and hospital medical gas delivery systems.

Personnel Certification Bodies Accreditation Program (PCBAP) - This program is based on ISO/IEC 17024, General requirements for bodies operating certification for persons, and provides assurance that the person being certified is capable and competent to supply the services in question. Examples include banking and hospitality.

V. Instruments for Government Action:

As described in the previous sections, the SCC offers a variety of approaches and programs that provide regulators with 'alternative instruments' to achieve their objectives. However, many Government of Canada (GoC) departments and agencies neither fully understand the NSS nor appreciate its applicability. In an effort to improve this situation, the SCC assisted Industry Canada with the development of Standards Systems: A Guide for Regulators which outlines the methodology and benefits of incorporating standards into regulation. This publication is available on the Strategis Web site[9] and is currently under revision.

The main impetus for GoC usage of the standards and conformity assessment procedures is the Regulatory Impact Assessment Statement (RIAS)[10]. While a reference to consider the use of international standards exists in the RIAS, the reference is not very forceful and there is no requirement to document why the standards option was not selected (a valuable source of information for the standardization community). The SCC believes that a revision of the Regulatory Impact Assessment Statement (RIAS) could help to promote increased understanding of the NSS and result in more frequent use of standards and conformity assessment procedures (including accreditation) in regulations.

VI. Defining the Public Interest:

The structure and operation of the NSS, specifically the development of consensus-based standards, provides an opportunity for all interested stakeholders, including government officials, consumer groups and regulators, to participate in a development process which is open, balanced, transparent and inclusive. The standards and conformity assessment procedures that result are often very applicable to meeting a variety of regulatory objectives.

The SCC administers the NSS and helps to oversee the standards development infrastructure. The SCC has accredited four (4) standards development organizations (SDOs)[11] to administer technical committees that are responsible for developing and writing standards. Development of National Standards of Canada (NSC) is coordinated through these SDOs, which strive to achieve consensus and incorporate the best practices of all interested parties. Developing, maintaining and implementing standards involves the participation of over 14,000 volunteers and 300 member organizations including industry, government, non-governmental organizations, regulators and the general public. Volunteers are often leaders in their field, and they bring much knowledge to standards development committees in which they participate.

The SCC believes that the NSS is an excellent vehicle to help define public interest, that the consensus approach provides a balanced and inclusive approach to standards development and that the NSS could benefit from greater regulatory participation and usage.

SCC Policy Recommendations to the EACSR:

Given the expanding standards and conformity assessment needs of the GoC and other Canadian stakeholders, the SCC submits the following eight (8) policy recommendations for the consideration of EACSR members:

  1. Encourage the revision of the current Government of Canada Regulatory Impact Assessment Statement (RIAS) to include an obligation to consider referencing documentary standards and conformity assessment procedures in all areas of regulation.
  2. Encourage the rigorous application of the RIAS by GoC regulatory departments and agencies, specifically the development and implementation of a reporting requirement (and the maintenance of accurate records and/or data) for the consideration of documentary standards and conformity assessment procedures.
  3. Employ the principles outlined in Annex 4 of the Report of the Second Triennial Review of the WTO/TBT Agreement (including transparency, openness, impartiality and consensus, effectiveness and relevance, coherence, and addressing the concerns of developing countries) when considering the use of international standards.
  4. Encourage greater involvement of GoC regulatory officials in the development of national and international standards and conformity assessment procedures. Increased participation could lead to increased regulatory understanding of the standards development processes and could reduce the regulatory 'reluctance' associated with using standardization mechanisms. Such involvement would also promote increased international harmonization of regulatory regimes in a manner which reflects Canadian interests.
  5. Encourage the use of accreditation (the formal recognition of the competence of an organization to perform a particular conformity assessment function) to increase public confidence in regulatory processes and outputs (e.g. use of accredited laboratories, use of conformity assessment results provided by accredited conformity assessment bodies, use of personnel trained by accredited organizations, etc.).
  6. Encourage "partnerships" between GoC regulatory departments and agencies and the SCC or its accredited clients to facilitate the delivery of regulatory services. Regulators are able to utilize existing systems and trained personnel while maintaining regulatory oversight (e.g. Health Canada / SCC - Canadian Medical Devices Conformity Assessment System - CMDCAS).
  7. Wherever possible, encourage GoC regulatory departments and agencies to adopt common international standards and conformity assessment procedures (on a sector-by-sector basis), especially those used by Canada's major trading partners. The emphasis should then be placed on further harmonization (overcoming or accommodating any remaining differences or deviations).
  8. Encourage greater regulatory recognition (i.e. North American - USA & Mexico) of the International Electrotechnical Commission (IEC) System for Conformity Testing and Certification of Electrical Equipment (IECEE CB Scheme).

[1] See Standards Council of Canada Canadian Standards Strategy and Implementation Proposals, 2000. (http://www.scc.ca/en/about/corporate_plans/proposal.pdf)

[2] See http://www.scc.ca/en/about/governance/advisory/advisory_committees.shtml

[3] See http://www.scc.ca/en/news_events/pr/MSE1376_7.shtml

[4] See http://www.scc.ca/en/programs/iso_reg/medical.shtml

[5] See http://www.scc.ca/en/news_events/pr/MSE1376_24.shtml

[6] See http://www.scc.ca/en/news_events/subscriptions/export_alert.shtml

[7] See http://www.scc.ca/en/news_events/subscriptions/regwatch.shtml

[8] See http://www.scc.ca/en/news_events/subscriptions/standards_alert.shtml

[9] See http://strategics.ic.gc.ca/stdsguide.

[10] See http://www.pco-bcp.gc.ca/raoics-srdc/default.asp?Language=E&Page=Publications&Sub=GovernmentofCanadaRegula

[11] The four SDOs are Bureau de normalization de Québec (BNQ), Canadian General Standards Board (CGSB), Canadian Standards Association (CSA), and Underwriters Laboratories of Canada (ULC).

Mise à jour:  9/21/2004

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