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Sofia 02 December 2004 Perspectives from a Dutch Test house

European Conformity Assessment (ECA) (Project INCOLAB G7RT-CT-2002-05106). Sofia 02 December 2004 Perspectives from a Dutch Test house. Pieter de Beer debeer@eps.tno.nl TNO EPS The Netherlands. Introduction. TNO Electronic Products & Services Independent testing laboratory

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Sofia 02 December 2004 Perspectives from a Dutch Test house

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  1. European Conformity Assessment (ECA) (Project INCOLAB G7RT-CT-2002-05106) Sofia 02 December 2004Perspectives from a Dutch Test house Pieter de Beer debeer@eps.tno.nl TNO EPS The Netherlands

  2. Introduction • TNO Electronic Products & Services • Independent testing laboratory • NEN-EN ISO/IEC 17025 accredited. • LVD testing • EMF exposure testing • EMC testing • Telecommunications testing • LVD body notified by…. • Notified Body for R&TTE Directive 1999/5/EC • Competent Body EMC Directive 89/336/EEC INCOLAB Sofia 2 December 2004

  3. Content of presentation • History • Legislations • Legal position • Financial position • Accreditations • Notified Body issues • Questions? INCOLAB Sofia 2 December 2004

  4. History • Governmental task • Making the laws • Implementing the laws • Testing • Market surveillance • Privatization • Changes in legislations • Changes in responsibilities INCOLAB Sofia 2 December 2004

  5. Legislations • New Conformity assessment procedures • Fragmentation of tasks • National approach • EU approach • Pre market access testing • A priory testing • After market access testing • A posterior testing • Liabilities • Government • Manufacturer INCOLAB Sofia 2 December 2004

  6. Legal position • Pre market access testing • Compliance verified (guaranteed?) • Mandatory testing • Protected position (no commercial pressure) • Appointed • National requirements • After market access testing • Presumption of compliance declared • No mandatory testing • Testing in competition • Not appointed • EU requirements (harmonization) INCOLAB Sofia 2 December 2004

  7. Old situation Part of market access procedure per country! Financed by applicant Testing costs Administration costs (access) No limit in budgets Compliance verified Market surveillance Budget? New situation Part of market access procedure just once for EU Financed by applicant Testing fee No administration costs Commercial budget Compliance declared Market surveillance Budget? Financial position INCOLAB Sofia 2 December 2004

  8. Accreditations • Old situation: • Appointment requirements • New situation: • Directive requirements • Laboratories: • Accredited • Not accredited • Notified Body • Accreditation • Quality requirements • NEN-EN ISO/IEC 17025 • Laboratory => compliance testing • EN 45004/11/12 • Product “certification” => NB task? • Testing and “certification” in one entity INCOLAB Sofia 2 December 2004

  9. Notified Body Issues DESIGN PHASE PRODUCTION PHASE MODULE A MODULE C MODULE D ISO 9002 MODULE B (NB) MODULE E MANUFACTURER ISO 9003 MODULE F MODULE G ISO 9001 MODULE H NB INCOLAB Sofia 2 December 2004

  10. Notified Body Issues (cont’d) • NB Task described in Blue Guide: http://europa.eu.int/comm/enterprise/ newapproach/legislation/guide/legislation.htm • NB mainly for production control • Modules C, F • NB for quality assurance • Modules D,E,H • NB special tasks • Modules B, G (A) • NB as consultant? INCOLAB Sofia 2 December 2004

  11. Notified Body Issues (cont’d) • Task of NB • Mandatory • NB Approval • NB Opinion • Use of NB number • Consulting NB • Just one • More than one • Response time • 4 weeks • Exchange of information • In case of negative “opinion” INCOLAB Sofia 2 December 2004

  12. Notified Body Issues (cont’d) • LVD Notified Body Forum • LVD-NBF secretariat: EEPCA 142 rue du Faubourg St-Denis 75010 PARIS, France Fax: +33 140373563 email: secretariat@eepca.org • Chairman: M. van der Dussen (KEMA) • Secretary: N. Kleinjan (EEPCA) INCOLAB Sofia 2 December 2004

  13. End of presentation • Questions? INCOLAB Sofia 2 December 2004

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