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1 Underwriters Laboratories Inc. Trends in Conformity Assessment Erin Grossi Manager, International Affairs UL Government Affairs Washington, DC
Copyright © 2007 Underwriters Laboratories Inc. ® All rights reserved 2 Overview of UL Independent, not-for-profit organization dedicated to public safety. Global reach with subsidiaries in 26 countries, including Brazil. Leader in standards development, product safety testing and certification, including quality systems registrations. UL has more than 800 published standards covering more than 14,000 product categories. 21 billion UL Marks appeared on products in 2006.
Copyright © 2007 Underwriters Laboratories Inc. ® All rights reserved 3 US Regulatory System: Privatizing CA Activities In the US, moves to accredit private sector conformity assessment bodies for regulatory purposes: - FDA Accredited Persons Program 510(k) pre-market clearance - FCC Telecommunications Certification Bodies In some sectors, private sector certification preceded gov. regulation and is still effective (e.g. fire protection equipment, electrical safety).
Copyright © 2007 Underwriters Laboratories Inc. ® All rights reserved 4 Third-Party CA Versus SDoC Continued perception that OSHA NRTL program (Third-Party CA) is effective. - Calls for Suppliers Declaration of Conformity (SDoC) in high-tech sector - Failure rate of products on first pass through certification programs average 50%. This causes re-design and alterations to reach compliance.
Copyright © 2007 Underwriters Laboratories Inc. ® All rights reserved 5 Introduction of New Technologies CA for new technologies: - Nanotechnology - Biofuels - High-Tech (e.g.chem/nuclear/bio detection devices) - Generators Involves challenges: -Health/Safety Issues -Inconclusive Research -Balance Speed to Market with Safety -Liability Concerns for SDOs and Conformity Assessment Bodies Copyright © 2006 Contract Manufacturing Services ® All rights reserved
Copyright © 2007 Underwriters Laboratories Inc. ® All rights reserved 6 Factoring in Consumer Behavior Conformity Assessment Bodies are challenged to factor consumer behavior into safety requirements.
Copyright © 2007 Underwriters Laboratories Inc. ® All rights reserved 7 Evolution of Safety From: To:
Copyright © 2007 Underwriters Laboratories Inc. ® All rights reserved 8 International Concerns Supply chains for products are global. What does this mean for manufacturers? - Manufacturers have to maintain product safety/quality as components move around the world. - Manufacturers must be aware of chemicals or other sources of contamination introduced in products during production. - Manufacturers may need certification services in new locations around the world to follow production. - Manufacturers want to minimize effort/cost associated with product certification for international markets.
Copyright © 2007 Underwriters Laboratories Inc. ® All rights reserved 9 International Concerns Supply chains for products are global. What does this mean for certification bodies? - Certification bodies must provide quality management system registrations for increased sectors and combine certifications with quality audits. - Certification bodies must meet the needs of manufacturers for risk assessments throughout the supply chain. - Certification bodies must constantly analyze production logistics globally and shift resources in order to meet needs. - Certification bodies must seek national treatment abroad to provide customers one-stop shopping.
Copyright © 2007 Underwriters Laboratories Inc. ® All rights reserved 10 International Concerns Supply chains for products are global. What does this mean for regulators? - Regulators must seek alignments to harmonize product requirements globally and accept conformity assessment results from foreign bodies. - Regulators must strive to achieve a global culture of safety.
Copyright © 2007 Underwriters Laboratories Inc. ® All rights reserved 11 Counterfeiting Certification Marks Counterfeit certification marks pose serious threats to health and safety. UL takes a zero-tolerance approach to counterfeiting. Developing countries are often dumping grounds for unsafe, shoddy products. Need for increased market surveillance and education at all levels.
Copyright © 2007 Underwriters Laboratories Inc. ® All rights reserved 12 Thank You! For more information,contact Erin W. Grossi Manager, International Affairs Erin.Waldron-Grossi@us.ul.com 202-296-7841
Copyright© Underwriters Laboratories Inc. All rights reserved. No portion of this material may be reprinted in any form without the express written.
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