Use of Conformity
Assessment in Regulation
in Canada
Presented by G. Rae Dulmage, Director, Standards
Department, Government Relations Office and
External Affairs
© 2011 Underwriters Laboratories Inc.
Outline
• Canadian Regulatory System
• Canadian Conformity Assessment System
• Canadian Standards System
• Case Studies
• Best Practices
• Innovations
• Gaps and Issues
• Key Takeaways
Canadian Regulatory System
Under Canada's constitution, provinces and territories
regulate design and construction of new house and buildings; the
maintenance and operation of fire safety systems in existing
buildings and the electrical safety of buildings and equipment.
Adoption and enforcement of the codes are the responsibility of the
provincial and territorial authorities having jurisdiction.
Canadian Conformity Assessment System
Certification bodies must participate and engage with the Standards
Council of Canada (SCC) recognized Regulatory Councils in the
product areas they are recognized in
SCC accreditation is required by the regulators
The SCC Canada accredits Standards Development Organizations
and various types of conformity assessment organizations:
• Testing and Calibration Laboratories
• Management Systems (QMS and EMS) Certification Bodies
• Personnel Certification Bodies
• Product/Service/System Certification Bodies
• Inspection Bodies
Canadian Conformity Assessment System
3rd Party System
System Cycle
Installation
Codes
Product
Standards and
Certification
Inspection and
Enforcement
(verification)
Safe Products and
Safe Installations
Canadian Standards System
Case Study - Electrical Equipment
Electrical (Canadian Electrical Code)
• Provinces and Territories are responsible for Public Safety
• Legislation and Code adoption mandate 3rd Party certification
• Only exception to certification is Special Inspection (Field
Evaluation)
• Standards (CSA and ULC) are listed in Canadian Electrical Code.
• Example: Ground Fault Circuit Breakers
o Required to meet CAN/CSA-C22.2 No. 144-M91 (R2011) as per
Provincial and Territorial Legislation
o Testing and conformity assessment by 3rd party (UL)
o Compliance to standards = Certification Mark
o With Certification comes acceptance in the Canadian Marketplace
© 2011 Underwriters Laboratories Inc.
7
Boiler and Pressure Vessels and Plumbing
Case Studies
Plumbing / Gas (National Plumbing Code of Canada and CSA B149.1)
• Provinces and Territories are responsible for Public Safety
• Legislation and Code adoption mandate 3rd Party certification
• Special Inspection allowed for equipment not available as certified
• Example: Plastic Plumbing Fixtures
o Required to meet CSA B45.0 and CSA B45.5 Standards
• Example: Gas Fired Low Pressure Boilers
o Required to meet ANSI Z21.3/CSA 4.9 Standard
(Both the plumbing and gas certification process is identical to
Electrical)
© 2011 Underwriters Laboratories Inc.
8
Case Study - Medical Device
Medical Devices (Various Standards)
• Regulated by Health Canada
o 3 elements – Device License; ISO 13485:2003 CMDCAS and a
Medical Device Establishment License
o Classes I to IV
• Health Canada, Medical Devices Regulation list appropriate
standards.
• Electrical products require 3rd Party Certification
• Example: Medical Equipment
o Required to meet C22.2 No. 601.1 and others.
o Testing and conformity assessment by 3rd party (UL)
o Compliance to standards = Certification Mark
© 2011 Underwriters Laboratories Inc.
9
Case Study - Building Materials
Building (National Building Code of Canada)
Adopted by all Provinces and Territories which allows for Certification
and Evaluation to standards
Building Code for Construction
Standards listed in National Building Code therefore mandatory
requirement
Example: Mineral Fibre Thermal Insulation
• Required to meet CAN/ULC-S702 and ULC-S129
• Testing and conformity assessment by 3rd party (UL)
• Certain product evaluated by 3rd Party (Not certification)
• Certification = Mark, Evaluation = Report for AHJ acceptance
© 2011 Underwriters Laboratories Inc.
10
Case Study - Fire Protection
Fire (National Fire Code of Canada)
Adopted by all Provinces and Territories which allows for Certification
Fire Code applies after construction for Occupancy
Standards listed in National Fire Code therefore Mandatory
requirement
E.g.: Fire Alarm Control Panels
• Required to meet CAN/ULC-S527
• Testing and conformity assessment by 3rd party (UL)
• Compliance to standards = Certification Mark
• With Certification comes acceptance in the Canadian Marketplace
© 2011 Underwriters Laboratories Inc.
11
Case Study - Energy Efficiency
Energy Efficiency
Provincial and Territorial Legislation adopt National Energy Code of
Canada for Buildings
Additional Federal legislation sits with Natural Resources Canada (NR
Can.)
Energy Efficiency Regulation, Federally regulated
NRCan. Regulation harmonizing with Department of Energy (DoE)
United States
Canada United States Regulatory Cooperation Council
Example: Clothes Dryers
• Required to meet CAN/CSA-C361-92
• EE testing and Conformity Assessment by 3rd Party (UL)
• Energuide Label mandatory for Consumer acceptance
© 2011 Underwriters Laboratories Inc.
12
Case Study - Special Inspection
Special Inspection (SPE-1000 for Electrical, SPE-3000 for
Electromedical (Draft), CSA B149.3 for Gas)
Provincial and Territorial legislation allows for Special Inspection
Used where no Canadian standard exist, for limited production
products and one of a kind.
Special Inspection Bodies Accredited by Standards Council of Canada
Example: Large Wind Turbine
• Required to meet SPE-1000 Evaluation
• Tested and Evaluated in the field
• Label for one of a kind piece of equipment
• Not a substitute for product certification
(Same process for Electromedical to the SPE-3000 and for Gas
appliance to the B149.3)
© 2011 Underwriters Laboratories Inc.
13
Best Practices – Conformity Assessment
Initial Evaluation
Product Testing
Periodic Factory Inspection
Mark of Conformity
• CB Mark on Product
• Manufacturer and Product Listed in a Published List of Materials and
Equipment
• Internal Audits and Controls
CB is audited regularly by the Standards Council of Canada
CB must maintain active and sustained communication with the
Regulatory Groups and be aware of and engaged in standards
development
Innovation
Regulatory Impact Analysis Process Improvement
•
Building, Fire, Plumbing and Energy Code Project
Referencing Standards within Canada’s National Model Code System
• Undergoing implementation
Greater and continuous National Coordination:
• National Public Safety Advisory Council, Provincial and Territorial
Advisory Council, Standards Development Organization Advisory
Council and Provincial and Territorial Policy Advisory Committee on
Codes
Drive to be early implementers of innovation
© 2011 Underwriters Laboratories Inc.
15
Gaps and Issues
Gaps – Provincial and Federal Conformity Assessment requirements
and Regulatory Systems do not always interconnect
- Timing of Code and standards adoption not consistent
Issues – One Code system maintains 3rd Party Marks while the other
mandates 3rd party but provides no guidance
- Standards references are not up to date in codes, regulation a
the federal and provincial/territorial level
- Same jurisdiction but different regulations calling up different
standards
© 2011 Underwriters Laboratories Inc.
16
Key Takeaways
Conformity Assessment System in Canada is well established
• Regulatory, Conformity Assessment and Standards are well
connected
Public expectation is for consistent and open Conformity Assessment in
all sectors
Regulation is divided and can cross over sectors
Accreditation is a requirement and an expectation
Standards are the point of assessing conformity
Regulators have provincial or territorial power
• Regulator implements and interprets
• Local authorities enforce
One code per sector with provinces and territories have full application
Health Canada and NRCan have federal power on Consumer Product,
Medical Devices, Natural and Health Products and Drugs
© 2011 Underwriters Laboratories Inc.
17
THANK YOU.
G. Rae Dulmage
Director, Standards Department, Government Relations
Office and External Affairs
ULC Standards and Underwriters Laboratories of Canada
171 Nepean Street, Suite 400
Ottawa, Ontario K2P OB4
T: +1 613 755 2729 Ext. 61429
Direct: +1 613 368 4429
F: +1 613 231 5977
Email: rae.dulmage@ul.com
Download PDF