1. Standards experts. Accreditation solutions. EMA Workshop Standardization and Conformity Assessment Perspectives COPANT General Assembly 2015 2015-04-16 Overview of Canada’s Standardization System

2. Standards experts. Accreditation solutions. Overview of Presentation Standards Council of Canada’s mandate SCC outreach program to stakeholders –Governments –Industry sectors An example of outreach to stakeholders - Accreditation of labs – mineral analysis program specialty area 2

3. Standards experts. Accreditation solutions. The Canadian Context 3 Population: 34.9 million Land area: 9.9 M sq. kilometers Governments: Federal; 10 Provinces / 3 Territories; and over 2,900 municipalities Official languages: English and French

4. Standards experts. Accreditation solutions. 4 Standards Council of Canada Federal Crown Corporation created by the Standards Council of Canada Act Founded in 1970 Reports to the Canadian Parliament via the Federal Minister of Industry Mission To lead and facilitate the development and use of national and international standards and accreditation services To enhance Canada's competitiveness and well-being.

5. Standards experts. Accreditation solutions. SCC Mandate From the Standards Council of Canada Act under Mandate and Powers (section 4) Mandate to: –Coordinate standardization activities in Canada –Accredit Standards Development Organizations & Conformity Assessment Bodies –Approve National Standards of Canada –Advise federal and provincial governments –Support strategic priorities of industry and governments –Represent Canada at international and regional forums (ISO, IEC) 5

6. Standards experts. Accreditation solutions. 6 Actuals - Funding for 2013-2014 (at March 31, 2014)

7. Standards experts. Accreditation solutions. Canadian Standards Development Regional activitiesInternational Standards Development Accreditation of Standards Development Organizations to SCC’s requirements Approval of National Standards of Canada Facilitation of the development/update of standards on behalf of Government/Industry Participation in: Pan-American Standards Commission (COPANT) Pacific Area Standards Congress (PASC) Forum of the IEC National Committees of the Americas (FINCA) Réseau Normalisation et Francophonie (RNF) Coordination of Canada’s participation in international standards development activities at ISO and IEC, including policy committees – COPOLCO, CASCO, IEC CAB Coordination of Canada’s Standardization activities 7

8. Standards experts. Accreditation solutions. Canada’s National Accreditation Body Standards development organizations (SDOs) Conformity assessment bodies (CABs) –Verification of competence:  People, expertise, resources and equipment to carry out specific tasks SCC accreditation programs increasingly referenced in regulations to manage compliance in a variety of sectors, including: –Consumer product safety –Food and drugs testing laboratories –GHG verification bodies 8

9. Standards experts. Accreditation solutions. Total of 8 SCC-Accredited Standards Development Organizations (SDOs) – SCC does not develop standards 9

10. Standards experts. Accreditation solutions. SCC accredits 470+ clients in Canada and abroad Conformity Assessment Bodies 10

11. Standards experts. Accreditation solutions. “One test accepted everywhere” Participation in International Accreditation Forum, Inc. (IAF) –Inter-American Accreditation Cooperation (IAAC) –Pacific Accreditation Cooperation (PAC) Participation in International Laboratory Accreditation Cooperation (ILAC) –Asia Pacific Laboratory Accreditation Cooperation (APLAC) International and Regional Conformity Assessment Activities 11

12. Standards experts. Accreditation solutions. Canada’s Participation in Conformity Assessment Activities – International Policy level and IEC CA Schemes ISO CASCO: WG 42, ISO 17011 – Conformity Assessment, General Requirements for Accreditation Bodies Accrediting Conformity Assessment Bodies WG 44, ISO 17025 – General Requirements for the Competence of Testing and Calibration Laboratories ISO CASCO / Chair’s Policy and Coordination Group IEC Conformity Assessment Board (CAB) – elected member IEC System of Conformity Assessment Schemes: –Electrotechnical Equipment and Components (IECEE) –Equipment for use in Explosive Atmospheres (IECEx) –Equipment for use in Renewable Energy Applications (IECRE) 12

13. Standards experts. Accreditation solutions. Standardization is an important source of economic growth. 80% of world trade is influenced by standards –as among one of the most trade dependent nations of the G-7, standardization is critical to the Canadian economy –driving GDP and labour productivity growth are key benefits of standardization Standardization helps protect the health and safety of Canadians in a wide number of sectors: –consumer products, healthcare, and the environment Standardization Matters 13

14. Standards experts. Accreditation solutions. Why Conformity Assessment is important to us? As we know, conformity assessment is the process used to demonstrate that a product, service or system meets specified requirements – most likely requirements of an International standard. Showing that a product, service or system meets certain requirements has a number of benefits: > It provides consumers with added confidence. > It gives the company a competitive edge. > It helps regulators ensure that health, safety or environmental conditions are met. The main forms of conformity assessment are certification, inspection and testing. Although testing is the most widely used, certification is the best known. 14

15. Standards experts. Accreditation solutions. 2011201220132014Trend Number of Canadian standards3,4822,9732,9402,901 ↓ Number of standards maintained by key international standardization organizations (ISO, IEC, ITU) 27,95828,86930,35830,304 ↑ Number of active ISO, IEC, ITU technical committees 9849939891,019 ↑ Number of Canadian volunteer members participating in international standards development committees 2,7582,6192,6282,649 ↓ Number of standards incorporated by reference in federal regulations 892N/A1,0661,118 ↑ Total number of clients accredited by SCC 395426441477 ↑ Trends in standardization: Key facts and figures: 15

16. Standards experts. Accreditation solutions. Standardization solutions for Government and Industry –Monitoring standards referenced in Provincial/Territorial regulations –Projects supporting Canada’s Agreement on Internal Trade (AIT) Government-wide approach to standardization Funding critical standards in federal regulations Harmonization and Regulatory alignment – nationally, regionally and internationally Supporting a stronger Canadian voice in sectors of strategic importance for Canadian industry 2015-16 Key Priorities 16

17. Standards experts. Accreditation solutions. SCC expanded its initiative related to standards referenced in regulations to the provinces and territories Objective for all Provinces and Territories to have baseline data on the standards referenced in regulation Similar to national trade/economic goals – enable flow of goods, east-west, as well as, north-south – aligned with the Agreement on internal trade Reaching Inter-provincial Alignment 17

18. Standards experts. Accreditation solutions. SCC continues to be engaged with Canada-US Regulatory Cooperation Council (RCC) in areas of significance to Canada: Differences in requirements have been estimated to result in: - increased product costs-to-market of 25% to 40% - lost market opportunities in excess of $500M Standards are referenced extensively in regulations of both countries –A number developed by either Canadian or US SDOs only recognized in local jurisdiction(s) –Duplicative requirements between jurisdictions –Products can be rejected even if they match or exceed the standards required in the importing markets Looking at ways to create greater alignment between jurisdictions/major trading partners Standardization has been identified as one of the fastest way to commercialize national innovations into new markets 18 Facilitating International Trade

19. Standards experts. Accreditation solutions. Pilot Projects for Joint Canada-US Standards SCC & ANSI: pilot projects to facilitate development of joint Canada-US standards (e.g. Plumbing/heating sector) Focus on new or emerging product areas where: –Neither standards nor regulations currently exist –Standards development would benefit the greatest number of users Aimed to support Canada-US Regulatory Cooperation Council (RCC), reduce red tape and help address price gap between Canadian and U.S. consumer products SCC is monitoring and documenting results to gauge potential for future Canada-US joint standards 19

20. Standards experts. Accreditation solutions. SCC’s Accreditation Services - Key Activities SCC accredits conformity assessment bodies, such as testing laboratories and product certification bodies, to internationally recognized standards. SCC operates accreditation and recognition programs for: Standard Development Organizations (SDOs) Calibration and testing laboratories Good laboratory practices Greenhouse gas (GHG) validators and verifiers Inspection bodies Management systems certification bodies Bodies that offer Certification of persons Product and service certification bodies 20

21. Standards experts. Accreditation solutions. Outreach to industry: Accreditation of Labs – mineral analysis PSA Canada, with its natural resources, is heavily involved in mining exploration and operations at home and abroad Because of that expertise and experience, it is estimated that 80 % of the financing for world mining exploration is raised on Canadian Stock exchanges In 1997, a large fraud about an ore body and its potential (Bre-X) lead to regulation in Canada and to the realization that more scrutiny was required on the work done by laboratories carrying out mineral analysis. In 1998, SCC, who is already accrediting labs under ISO/IEC 17025, developed a specialty area program aimed at mineral analysis. 21

22. Standards experts. Accreditation solutions. Accreditation of Labs – mineral analysis PSA The specialty area program was developed with the experts in the mineral analysis field recognized in Canada and abroad Only SCC offers this specialty area program associated with ISO 17025 A lot of our Canadian customers in this specialty area program also have operations in South America or have joint ventures with organizations in South America As of today, more than 33 labs are accredited for mineral analysis, 10 are located in Peru, 1 in Argentina and 1 in Chile. And this program is growing. 22

23. Standards experts. Accreditation solutions. Thank You – Any Questions? 23