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Standards experts. Accreditation solutions.Standards experts. Accreditation solutions.

EMA Workshop Standardization and Conformity Assessment Perspectives

COPANT General Assembly 20152015-04-16

Overview of Canada’s Standardization System

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

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The Canadian ContextPopulation: 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

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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.


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)

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Actuals - Funding for 2013-2014 (at March 31, 2014)

48%

39%

5%

4%2% 1% 1%

Parliamentary Appropria-tionAccreditation ServicesSCC estoreAdvisory ServicesEnquiry Point & Notification ServicesHosting ServicesOther Income


Canadian Standards Development

Regional activities International 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

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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

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Total of 8 SCC-Accredited Standards Development Organizations (SDOs) – SCC does not develop standards

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SCC accredits 470+ clients in Canada and abroad

Conformity Assessment Bodies

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“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

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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)

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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

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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.

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2011 2012 2013 2014 Trend

Number of Canadian standards 3,482 2,973 2,940 2,901 ↓Number of standards maintained by key international standardization organizations (ISO, IEC, ITU)

27,958 28,869 30,358 30,304 ↑

Number of active ISO, IEC, ITU technical committees 984 993 989 1,019 ↑Number of Canadian volunteer members participating in international standards development committees

2,758 2,619 2,628 2,649 ↓

Number of standards incorporated by reference in federal regulations 892 N/A 1,066 1,118 ↑

Total number of clients accredited by SCC 395 426 441 477 ↑

Trends in standardization: Key facts and figures:

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• 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

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• 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

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• 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

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Facilitating International Trade


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

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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

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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.

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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.

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Thank You – Any Questions?

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