CSA, UL, CB and CE Certification

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CSA, UL, CB and CE Certification
ApprovalsWELCOME Ontario PDMA Date May 27,
2008

• Garry Lee, P.Eng.
• Engineering Manager
• Global Advantage International

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Standards and Certification

• Standards affect nearly every electrical product
  and service you encounter
• They may deal with safety and quality
  requirements, efficiency, compatibility,
  reliability, environmental issues, etc.

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Standards and Certification (contd)

• The ability to sell products in a particular
  marketplace often depends on the manufacturers
  ability to design their product to comply with
  applicable standards and obtain the
  certifications and approvals necessary to satisfy
  regulatory requirements
• Certification is the process for verifying
  compliance with the requirements or standards

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Standards

• Most standards are voluntary
• Since standards organizations are not government
  bodies, they dont have the power to make
  standards mandatory
• A standard only becomes law if a federal, state,
  regional, provincial, or municipal government
  references it in legislation

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Standards (contd)

• There are many different Standards organizations
  including
• CSA, UL, VDE, American National Standards
  Institute (ANSI)
• International Organization for Standardization
  (ISO) A worldwide federation of national
  standards bodies representing approx 140
  countries
• International Electrotechnical Commission (IEC)
  a worldwide body focusing on international
  harmonization of standards for electrical,
  electronic and telecommunications products and
  systems

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Standards (contd)

• European Committee for Electrotechnical
  Standardization (CENELEC) Responsible for
  European Standards (EN Standards)
• International Telecommunications Union (ITU)

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Why Do Products Need To Be Certified or Approved ?

• For liability purposes and to satisfy regulatory
  requirements, manufacturers are often required
  to obtain independent, third party certification
  or approval of their products

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Why Do Products Need To Be Certified or Approved
? (contd)

• Certification may be mandated by trade or
  industry associations
• To demonstrate to purchasers a commitment to
  safety and quality

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Certification and Approval Marks

• Different marks offered by a number of
  Certification Bodies in countries throughout the
  world
• Certification or Approval marks indicate that the
  product has been independently tested and
  certified to meet the applicable recognized
  standards for safety or performance
• Acceptance of various marks depends on regulatory
  authorities

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Who Certifies and Approves ?

• There are a number of organizations throughout
  the world who certify and approve products to a
  wide variety of standards
• Within North America, the major Certification and
  Testing organizations include CSA, UL, TUV and ITS

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Who Certifies and Approves ? (contd)

• These certification and testing organizations are
  accredited by various government agencies (such
  as SCC and OSHA)
• Accreditation involves the verification that an
  organization has the competence to carry out a
  specific function

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SCC

• The Standards Council of Canada (SCC) is a
  federal Crown Corporation with the mandate to
  promote efficient and effective standardization
• Oversees Canadas National Standards System
• Represents Canadas interests in
  standards-related matters in foreign and
  international forums

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OSHA

• Occupational Safety Health Administration
  (OSHA) falls under the U.S. Department of Labor
• Administers the Nationally Recognized Testing
  Laboratory (NRTL) Program
• NRTLs are third-party organizations recognized
  by OSHA as having the capability to provide
  product safety testing and certification services
  to the manufacturers of a wide range of products
  for use in the American workplace

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SCC and OSHA

• SCC has accredited a number of Certification
  Organizations and Testing Organizations in
  Canada, including CSA, UL, TÜV America and ITS
• OSHA currently recognizes 18 NRTLs, including
  CSA International, UL, TÜV America and ITS who
  test to applicable US Standards (including ANSI,
  UL, CSA, NSF and others)

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CSA

• CSA Group is an independent, not-for-profit
  membership-based association serving consumers,
  business and government
• Founded in Canada in 1919
• Presently consists of three divisions (CSA, CSA
  International and QMI)
• Canadian Standards Association responsible for
  standards development, information products, sale
  of publications, training and membership services

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CSA (contd)

• CSA International responsible for product
  testing and certification
• Quality Management Institute (QMI) responsible
  for management systems registration
• Worldwide network of offices and partners

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UL

• Underwriters Laboratories Inc. (UL) is an
  independent, not-for-profit product-safety
  testing and certification organization
• Founded in the United States in 1894
• Leader in product-safety testing and
  certification in the United States
• Developed and maintains more than 800 Standards
• UL has customers in 96 countries

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UL
(contd)

• More than 66,000 manufacturers produce
  UL-certified products, and each year, more than
  17 billion UL Marks appear on products
• Conducts more than 500,000 follow-up visits
  annually to audit compliance with product
  certification requirements
• Laboratory, testing and certification facilities
  located around the world

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Electrical Installations in Canada

• Requirements contained in C22.1, Canadian
  Electrical Code, Part 1 - Safety Standard for
  Electrical Installations
• Developed and maintained by CSA
• Covers installation and maintenance of electrical
  equipment. Concerned with prevention of fire and
  shock hazards and proper operation and
  maintenance of electrical installations and
  electrical equipment
• Revised every four years

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Electrical Installation in the US

• Requirements contained in NFPA 70, National
  Electrical Code (NEC)
• NEC developed and maintained by the National Fire
  Protection Agency (NFPA)
• NEC focuses on the proper installation of
  electrical systems and equipment to protect
  people and property from the potential dangers of
  electricity
• Revised every three years

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Electrical Installations (contd)

• CEC and NEC are not harmonized, but contain
  similar requirements
• Contain requirements for wiring, wiring methods,
  materials, grounding, protection, installation
  requirements for different types of equipment,
  etc.
• CEC and NEC Handbooks exist which explain intent
  and rationale of requirements

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Electrical Installations (contd)

• CEC and NEC may be subject to additional
  requirements contained in local codes
• Subject to local regulatory authorities or
  Authority Having Jurisdiction (AHJ)
• Electrical equipment and components used in
  installations must also be approved
• Special requirements for different types of
  locations (such as hospitals, hazardous
  locations, outdoor locations, etc.)

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Product Certification Process (CSA, UL)

• Identify applicable requirements
• Obtain quotation from agency
• Make Application
• Provide representative samples, information,
  schematics, supporting documentation,
  installation instructions, etc.
• Preliminary Review

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Product Certification Process (contd)

• Preparation of test plan
• Testing to appropriate requirements (testing may
  be done in-house or as witness testing at the
  manufacturers site or at another qualified
  facility)
• Construction review and draft report preparation
• Inform manufacturer of Findings and Alterations
  required (may require modified sample for
  evaluation and additional testing or re-testing)

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Product Certification Process (contd)

• Review responses to Findings and finalize report
• Report to be reviewed and approved
• Certification / Approval Documents issued
  (Certificate of Compliance / Notice of
  Authorization, Certification / Listing Records,
  Report)
• Follow-up Service Agreement signed with the
  Certification agency

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Ongoing Compliance

• Once a product is certified or approved, the
  process isnt finished
• Manufacturer is responsible for ongoing
  compliance of the product
• Subject to annual inspections at each
  manufacturing location ( of inspection visits
  may vary)
• Non-conformances must be addressed. Production
  may be stopped and products may have to be
  recalled (depending on nature of deficiency).

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Ongoing Compliance (contd)

• Some products are subject to re-examination
• Modifications to products after approval need to
  be addressed (updates to reports to cover
  alternate construction)
• Certified or Approved products may need to comply
  with new, revised or updated requirements
  (grandfathering period is often allowed)

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Europe and CE Marking

• Regulatory situation is different in Europe
• European Union (EU) consists of 15 Member States
  Austria, Belgium, Denmark, Finland, France,
  Germany, Greece, Ireland, Italy, Luxembourg,
  Netherlands, Portugal, Spain, Sweden and the
  United Kingdom
• 10 new Member States joined EU in 2004 Cyprus,
  Czech Republic, Estonia, Hungary, Latvia,
  Lithuania, Malta, Poland, Slovakia and Slovenia

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Europe and CE Marking (contd)

• European Economic Area (EEA) includes the 15 EU
  Member States and the three European Free Trade
  Association (EFTA) States (Iceland, Liechtenstein
  and Norway)
• Creation of single market in Europe eliminated
  barriers to trade between member states and
  provides for free movement of goods Developed New
  Approach to technical harmonization and
  standardization
• Establishment of various Directives and
  determination of essential requirements

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Europe and CE Marking (contd)

• The CE mark is a European marking of conformity
  indicating that a product complies with the
  essential requirements of the applicable European
  laws or Directives with respect to safety,
  health, environment and consumer protection
• Other marks may appear on products but the CE
  Marking is the only marking symbolizing
  conformity to all the legal obligations relating
  to manufacturers for a given product as required
  by the applicable New Approach Directives

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Directives
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Manufacturer Responsibilities

• Manufacturer is the person who is responsible for
  designing and manufacturing a product with a view
  to placing it on the European Community market on
  his own behalf
• Manufacturer is obliged to ensure that a product
  intended to be placed on the market is designed,
  manufactured and conformity assessed to the
  essential requirements in accordance with the
  provisions of the applicable Directives

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Manufacturer Responsibilities (contd)

• Manufacturer needs to identify all Directives
  that are applicable to their product
• For example, some products may require both the
  Low Voltage Directive and the EMC Directive,
  other products may require both the Medical
  Devices Directive and the EMC Directive, etc.

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Conformity Assessment

• Conformity Assessment is process by which
  compliance with the essential requirements set by
  the Directives is determined
• Process may be carried out with or without the
  use of standards
• May use harmonized European Standards (EN
  Standards). Products meeting harmonized EN
  Standards are granted presumption of conformity
  with essential requirements

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Conformity Assessment (contd)

• Conformity Assessment may vary in levels of
  complexity depending on the level of risk
  associated with the products being assessed
• Conformity Assessment is subdivided into modules
  which relate to the design phase of products,
  their production phase or both. The eight basic
  modules and their eight possible variants can be
  combined with each other in a variety of ways to
  establish complete conformity assessment
  procedures

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Conformity Assessment (contd)

• Each New Approach Directive describes the range
  and contents of possible conformity assessment
  procedures
• Can vary from self-declaration to involvement of
  a third party (Notified Body)

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Notified Bodies

• Notified Bodies are independent test houses or
  certification bodies that carry out the
  conformity assessment procedures referred to in
  the applicable Directives when a third party is
  required.
• Notified Bodies are designated and notified by
  Member states

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Technical Documentation

• Manufacturer must prepare a Technical File which
  is intended to provide information on the design,
  manufacture and operation of the product
• The Technical File includes the information that
  proves the technical basis for conformity of the
  product to the requirements stated by the
  Directive(s)
• Technical File must be kept for 10 years after
  the last unit of the product has been placed on
  the market, unless otherwise stated

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CE Marking

• The CE conformity marking consists of the
  initials "CE" taking the form shown
• CE in the term CE Marking stands for Conformité
  Européenne (European Conformity)

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CE Marking (contd)

• CE Marking is affixed by manufacturer or his
  Authorized Representative , established in the
  European Union
• Must be affixed visibly, legibly and indelibly to
  the product, its data plate or, where this is not
  possible, to its packaging
• Where a Notified Body is involved in the
  production control phase according to the
  applicable directives, its identification number
  must also follow the CE Marking

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CB Scheme

• An international system for acceptance of test
  reports dealing with safety of electrical and
  electronic products
• A multilateral agreement among participating
  countries and certification organizations based
  on principle of mutual recognition by members of
  test results for obtaining certification or
  approval at national level
• Based on use of International (IEC) Standards and
  declared National Differences

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CB Scheme (contd)

• Currently 43 countries in the CB Scheme with 54
  National Certification Bodies (NCBs) and and 129
  CB Testing Laboratories (CBTLs)
• List of NCBs and their scope of recognition
  published in the CB Bulletin
• Manufacturer applies to an NCB for testing of
  their product to relevant IEC Standard(s) and
  National Differences of countries where product
  will be marketed

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CB Scheme (contd)

• NCB conducts testing and evaluation through CBTL
  and issues CB Test Report and CB Test Certificate
  
• To obtain product certification in target
  markets, manufacturer makes application to an NCB
  in the target country and submits CB Test
  Certificate, CB Test Report (with national
  differences) and sample of product for
  verification. Usually, no additional testing will
  be required. NCB issues certification based on
  use of the CB Test Report

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Other Requirements

• Depending on the type of equipment manufacturers
  and products may also have to comply with other
  standards and requirements such as
• EMC requirements (CISPR, FCC, Industry Canada)
• Requirements for products incorporating lasers
  (FDA and CDRH requirements)
• Requirements for Medical Equipment (FDA)
• Quality System Registration (ISO 9000, ISO 14000
  Series requirements)

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Useful Options

• For limited production quantities Special
  Inspection / Field Evaluation (conducted by TÜV
  America, CSA, UL)
• Technical Information Service (TIS)
• Export / Import Assistance
• Multiple Listing
• Use of Agents / Consultants they are familiar
  with requirements and procedures

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Who We Are

• Independent Test Lab
• Product Safety Consultant
• Agent acting on behalf of manufacturers in
  dealing with various Certification Bodies
• Experienced personnel in Medical Equipment,
  Information Technology Equipment, Laboratory
  Equipment and EMC/EMI

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Global Advantage - Consultants

• Strong working relationship with various
  Certification Bodies
• Certification process
• Witness testing program with UL, CSA, etc.
• Provide solutions to clients if there are product
  non-compliance issues
• GAI has the greatest amount of different product
  categories of any ULC agent

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Global Advantage - Consultants (contd)

• Provide technical regulatory evaluation of the
  product in the design stage
• Provide performance testing
• Large client list including JDSU, IBM, Sunrise
  Medical, GE Healthcare, Welch Allyn, Ciena
• Manage all regulatory approvals- (UL, CSA, EMC,
  FDA, Health Canada, CE, etc.)

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If you require assistance

• Please feel free to contact us at
• Tel [phone]
• Fax [phone]
• Cell [phone]
• E-mail garry_at_globaladvantage.ca
• Global Advantage International
• 180 Brodie Dr Unit 2
• Toronto, Ontario L3B 3K8