third international workshop on conformity...
TRANSCRIPT
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Third International Workshop on Conformity Assessment
Pat Paladino
2007-12-10Rio de Janeiro, Brazil
The Relationship Between Regulatory Authorities and Accreditation Bodies
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2
Presentation Outline• The Standards Council of Canada
• The Canadian Legislative System
• Conformity Assessment
• Conformity Assessment and Legislation
• Questions
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Standards Council of Canada
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• Federal Crown Corporation in accordance with the Standards Council of Canada Act
• Founded in 1970
• Reports to the Canadian Parliament via the Federal Minister of Industry
Organization
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Organizational Structure
Standards Council of Canada(15 members of Council)
Chairman
Executive Director Executive AssistantManager, Quality
ManagementSystems
Director,IntergovernmentalAffaires and Trade
Director,Conformity
Assessment
Director,Standards
Treasurer andDirector,
Administration
Corporate Secretary& Director Corporate
Services
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Role and Purpose
• Role:• National and international mandate• Canadian member to international/regional standardization
organizations• Encourage the use of Standards
• Purpose:• To support Canadian competitiveness • To promote Canada’s social and economic well-being both
Nationally and Globally
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People Supporting the System• Over 15,000 members across Canada• Approximately 450 standards-development committees
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National Standards System (NSS)
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The Vision - The Canadian Standards Strategy
• Blueprint for Canadian standardization activities
• To advance the social and economic well-being of Canadians
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The National Conformity Assessment Principles for Canada
• National focus: benefits of standards and conformity assessment
• Working together towards a better quality of life
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Accreditation Programs
• Standards development organizations
• Conformity assessment bodies
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Standards Development Organizations
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Conformity Assessment Organizations
• Testing and calibration laboratories• Product certification bodies • Management system certification bodies• Inspection bodies• Personnel certification bodies • Proficiency testing providers• OECD – Good laboratory Practices (GLP)
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Canada’s Legislative System
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Inter-jurisdictional:Accountability and Cooperation Framework
Federal Government (1)
Municipal Governments
(1,100)
Private Sector Organizations/
Citizens(Millions)
Provincial/Territorial Governments
(13)
Federation of Canadian Municipalities (FCM)
Canadian Council of Ministers of the Environment (CCME)
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• Government of Canada’s Cabinet Directive on Streamlining Regulation which requires Government Departments to make use of national and international standards and conformity assessment procedures when they fulfill intended policy objectives.
• Cabinet Directive on Streamlining Regulation – http://www.regulation.gc.ca
Government of Canada: New Key Policy
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• Approximately 3,100 Federal regulations in Canada:
• Approximately 300 standards that are developed by SCC accredited Standards Development Organizations are referenced
• In addition, approximately 1,400 other industry and government standards are referenced which are developed by other organizations (e.g. industry associations, other countries standards development organizations to name a few)
Standards References in Federal Regulations
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• Minister responsible: Minister of the Environment• Act: Canadian Environmental Protection Act, 1999• Regulation: Gasoline Regulations (C-15.31 – SOR/90-247)• Standard: CAN/CGSB-3.- No. 19.5-2004: Methods of Testing Petroleum
and Associate Products Determination of Lead and Automotive Gasoline (Atomic Absorption)
• Standards developer: Canada’s General Standards Board (CGSB-PWGSC)
• Legislative link: http://alert.scc.ca/std_e/std19116.html
Example of Standards in Federal Regulations
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Benefits of standards for use in legislation• Reduction in barriers to trade
• Elimination of unnecessary regulatory burdens (incorporation of international best practices in domestic regulatory systems)
• Reduces time and costs for changes
• Enhanced consideration for the views of interested parties in standardization work
• Foster respect for intergovernmental and international agreements in regulatory practices
• Increased confidence of foreign investors and trade partners in the national industries
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Conformity Assessment
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Conformity Assessment Programs
SCCISO/IEC 17011 AND
IAF GD 1: 2004
PALCANISO/IEC 17025 AND
ILAC 17025
CBISO/IEC GUIDE 65
ANDIAF GD 65
IBAPISO/IEC 17020 AND
IAF GD 20: 2003
MSAPISO/IEC 17021
PCBAPISO/IEC 17024 AND
IAF GD 24: 2003
SDO (SCC’s Standards Branch)
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Market Drivers For Certification
• Industry policy
• Government policy
• Customers
• Non-Governmental Organization’s
• International policy
• Procurement Policies
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Program for Accreditation of Laboratories – Canada (PALCAN)
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PALCAN
MAIN PROGRAMS
Program Specialty
Areas (PSAs)
SCCISO/IEC 17011 AND
IAF GD 1: 2004
PALCANCB
ISO/IEC GUIDE 65 AND
IAF GD 65
IBAPISO/IEC 17020 AND
IAF GD 20: 2003
MSAPISO/IEC GD 62 andISO/IEC GD 66 and
IAF GDs 62/66
PCBAPISO/IEC 17024 AND
IAF GD 24: 2003ATP
Calibration and Testing Laboratories
ISO/IEC 17025
Agriculture & Food Program (AFP)
Environmental Analysis
Fastners
SDO (SCC’s Standards Branch)
Forensic Testing
Information Technology Security Evaluation Testing
(ITSET)
Good Laboratory Practice (GLP)
Mineral Analysis
Calibration (CLAS)Test Method
Development and Non-Routine Testing
Medical LaboratoriesISO/IEC 15189
Proficiency Testing Providers
ISO/IEC Guide 43ILAC G13
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Example: Clean Water
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Clean Water
• Environmental Incident – Driver of Change
• Government response• “. . . All drinking water-testing should be performed only
be accredited facilities . . . “.
• Ontario Safe Drinking Water Act (2002)• Use licensed and accredited laboratories
• Ontario Ministry of the Environment Memorandum of Understanding (MOU) with the Standards Council of Canada . . . focus on laboratory testing
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Laboratory
Client
Ontario Ministry of
Environment
Accreditation Body
Clean Water System in Ontario
Protocol of Accepted Drinking-Water Testing Methods
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Clean Water: Why Accreditation?• Laboratory benefits
– Enhance expertise and efficiencies• Client benefits
– Confidence in testing results• Regulatory benefits
– Better information to protect public health and environment• Public benefits
– Building trust in the system overall• Business benefits
– New environmental technology and innovation for improving water treatment operations
– Exportability of environmental technologies
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Management Systems Accreditation Program
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MSAPSCC
ISO/IEC 17011 ANDIAF GD 1: 2004
PALCANISO/IEC 17025 AND
ILAC 17025
CBISO/IEC GUIDE 65
ANDIAF GD 65
IBAPISO/IEC 17020 AND
IAF GD 20: 2003
MSAP PCBAPISO/IEC 17024 AND
IAF GD 24: 2003ATP
QMSISO 17021
EMSISO 17021
ISO 9001
AS 9000
QS 9000
TE 9000
EMSISO 14001
OHSISO 17021 FSMS
ISO 22003
EMSHOPCAN/CSA 771
ISMSISO 27006
SDO (SCC’sStandards Branch)
SFMPCAN/CSA Z809SFI 2005-2009
ISO 22000BSI 18001
ANSI/AIHA Z10CAN/CSA Z1000
TL 9000
MAINPROGRAMS
INDUSTRYSECTOR
PROGRAMS
ISO 27001
CMDCASISO 17021
ISO 13485
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Example: Sustainable Forest Management
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Canada’s Sustainable Forest Management Accreditation Program
• National Sustainable Forest Management standard – (CAN/CSA Z809) (e.g. based on Canadian Council of Forest Ministers’ (CCFM) framework of Criteria and Indicators – related to biological diversity, ecosystem condition, productivity, soil and water, aboriginal interests etc.)
• Agreement with Ontario Natural Resources• Sustainable Forest Management Accreditation Program (1999)• Canada is the global market leader – EMS/SFM certification• Market access - signatory to the Programme for the Endorsement
of Forest Certification Schemes (PEFC) Mutual Recognition Agreement (i.e. INMETRO is a member of this scheme as well)
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Example: Canadian Medical Devices Conformity Assessment System (CMDCAS)
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Canadian Medical Devices Assessment System
• CDMCAS – regulatory/conformity assessment program
• Health Canada and Standards Council of Canada – 2003
• Only Medical Device Program in the World Recognized by Regulator
• SCC only accreditation body delivering services on behalf of Health Canada/Government of Canada
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Certification Bodies Accreditation Program (CBAP)
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Program Scope
Product certification bodies certify a diverse range of products and services such as electrical equipment, plywood, hockey helmets, fuel burning appliances etc.
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Expanding the CB Program
New Program - Chain of Custody of Forest Based Products Accreditations to PEFC Annex 4 International
Standard for Chain of Custody for Forest Based Products
Allows traceability of wood and wood materials from certified sustainable forests up the chain to processors, manufacturers, distributors and retailers of wood products.
Organic Food Health and safety concerns about foods Claims made by growers and retailers Regulated sector that relies on certification
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Regulated Areas - Product Certification
Electrical Safety• CACES – Regulatory Authority Body for Electrical Safety in
Canada• Any CB delivering certifications must be accredited by SCC
Gas Products (natural and propane)• Inter-provincial Gas Advisory Council (IGAC) • Any CB delivering certifications must be accredited by SCC• Fuel burning appliances (e.g. furnaces, stoves)
Plumbing Regulatory Authorities Plumbing Products in Canada• Provincial/Territorial Subcommittee on Plumbing Codes
(PTSPC) • Canadian Advisory Council on Plumbing (CACP)
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Regulated Areas – Product Certification (cont)
Building Products• Provincial/Territorial Subcommittee on Building Codes
(PTSBC)• Building Code of Canada
Drinking Water • Federal/Provincial/Territorial Committee on Drinking
Water• Product certification related to: drinking water treatment
system.
Energy Efficiency• Natural Resource Canada (NRCan) – Regulatory
Authority and Product Marking (electrical and gas appliances)
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Inspection Bodies Accreditation Program (IBAP)
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Program Scope
Inspection of:
• Electrical Equipment• Medical Gas Piping Systems• Sprinkler Systems • Electro-medical Equipment (dev.)
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Expanding the IB Program
• New areas such as Installation of Polyurethane Foam Insulation and Fire Alarm and Electrical systems inspections.
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Personnel Certification Body Accreditation Program (PCBAP)
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Program Scope
• Voluntary personnel certification organizations (e.g. Insulation Specialist, Auditors, Health and Safety Professionals, Scuba Divers, Financial Planners etc.) and Organizations with delegated authority (e.g. Medical Doctors, Dentists, Nurses, Engineers, Accountants etc.)
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Conformity Assessment and Legislation
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Governmental Arrangements
• Health Canada – Canadian Medical Device Conformity Assessment System (CMDCAS)
• Ontario Ministry of the Environment – Drinking Water License Agreement
• Pest Management Regulatory Agency – Monitoring of facilities involved in testing of pest control products
• Ontario Ministry of Natural Resources – Sustainable Forest Management
• Canadian Food Inspection Agency (CFIA) – Technical Assessors• National Research Council (NRC) – Calibration/Testing Laboratories• Department of Foreign Affairs and International Trade (DFAIT) – World
Trade Organization/North American Free Trade Agreement Inquiry Point
• Pari-Mutuel Agency – Facilities involved in detection of the uncontrolled drugs and medications in race horses
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If you have any questions, please contact:
• Pat Paladino, Director, Conformity Assessment Branch, SCC• Email: [email protected]
Tel: +1-613-238-3222Web address: http://www.scc.ca