Global Advantage International CSA, UL, CB and CE Certification & Approvals WELCOME Ontario PDMA...

Global Advantage International

CSA, UL, CB and CE Certification & Approvals

WELCOME

Ontario PDMA Date: May 27, 2008

Garry Lee, P.Eng.Engineering ManagerGlobal Advantage International

www.globaladvantage.ca 2




Standards and Certification

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



Standards and Certification (cont’d)

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



Standards

Most standards are voluntarySince standards organizations are not government bodies, they don’t have the power to make standards mandatoryA standard only becomes law if a federal, state, regional, provincial, or municipal government references it in legislation



Standards (cont’d)

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 countriesInternational Electrotechnical Commission (IEC) – a worldwide body focusing on international harmonization of standards for electrical, electronic and telecommunications products and systems



Standards (cont’d)

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



Why Do Products Need To Be Certified or Approved ?

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



Why Do Products Need To Be Certified or Approved ? (cont’d)

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



Certification and Approval Marks

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



Who Certifies and Approves ?

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



Who Certifies and Approves ? (cont’d)

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



SCC

The Standards Council of Canada (SCC) is a federal Crown Corporation with the mandate to promote efficient and effective standardizationOversees Canada’s National Standards SystemRepresents Canada’s interests in standards-related matters in foreign and international forums



OSHAOccupational Safety & Health Administration (OSHA) falls under the U.S. Department of LaborAdministers the Nationally Recognized Testing Laboratory (NRTL) ProgramNRTL’s 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



SCC and OSHA

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



CSA CSA Group is an independent, not-for-profit membership-based association serving consumers, business and governmentFounded in Canada in 1919Presently 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



CSA (cont’d)

CSA International – responsible for product testing and certificationQuality Management Institute (QMI) – responsible for management systems registrationWorldwide network of offices and partners



UL

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



UL (cont’d)

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



Electrical Installations in CanadaRequirements contained in C22.1, Canadian Electrical Code, Part 1 - Safety Standard for Electrical InstallationsDeveloped and maintained by CSACovers installation and maintenance of electrical equipment. Concerned with prevention of fire and shock hazards and proper operation and maintenance of electrical installations and electrical equipmentRevised every four years



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 electricityRevised every three years



Electrical Installations (cont’d)

CEC and NEC are not harmonized, but contain similar requirementsContain 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



Electrical Installations (cont’d)

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



Product Certification Process (CSA, UL)

Identify applicable requirementsObtain quotation from agencyMake ApplicationProvide representative samples, information, schematics, supporting documentation, installation instructions, etc.Preliminary Review



Product Certification Process (cont’d)

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



Product Certification Process (cont’d)

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



Ongoing ComplianceOnce a product is certified or approved, the process isn’t finished …Manufacturer is responsible for ongoing compliance of the productSubject 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).



Ongoing Compliance (cont’d)

Some products are subject to re-examinationModifications 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)



Europe and CE MarkingRegulatory situation is different in EuropeEuropean Union (EU) consists of 15 Member States: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden and the United Kingdom10 new Member States joined EU in 2004: Cyprus, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Slovakia and Slovenia



Europe and CE Marking (cont’d)

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 standardizationEstablishment of various Directives and determination of essential requirements



Europe and CE Marking (cont’d)

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 protectionOther 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



Directives



Manufacturer ResponsibilitiesManufacturer 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 behalfManufacturer 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



Manufacturer Responsibilities (cont’d)

Manufacturer needs to identify all Directives that are applicable to their productFor 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.



Conformity Assessment

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



Conformity Assessment (cont’d)

Conformity Assessment may vary in levels of complexity depending on the level of risk associated with the products being assessedConformity 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



Conformity Assessment (cont’d)

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



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



Technical DocumentationManufacturer must prepare a Technical File which is intended to provide information on the design, manufacture and operation of the productThe 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



CE Marking

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



CE Marking (cont’d)

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



CB SchemeAn international system for acceptance of test reports dealing with safety of electrical and electronic productsA 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 levelBased on use of International (IEC) Standards and declared National Differences



CB Scheme (cont’d)

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



CB Scheme (cont’d)

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



Other RequirementsDepending 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)



Useful Options

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



Who We Are

Independent Test LabProduct Safety ConsultantAgent acting on behalf of manufacturers in dealing with various Certification BodiesExperienced personnel in Medical Equipment, Information Technology Equipment, Laboratory Equipment and EMC/EMI



Global Advantage - Consultants

Strong working relationship with various Certification BodiesCertification 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



Global Advantage - Consultants (cont’d)

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



If you require assistance:

Please feel free to contact us at:Tel: (905) 883-3919 Fax: (905) 883-7995Cell: (416) 722‑0925E‑mail: [email protected]

Global Advantage International180 Brodie Dr – Unit 2

Toronto, Ontario L3B 3K8

Global Advantage International CSA, UL, CB and CE Certification & Approvals WELCOME Ontario PDMA...

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