MARS Bratislava, 24-26 September 2006 Anna Karlsson Special adviser

1. Swedish Board for Accreditation and Conformity Assessment MARS Bratislava, 24-26 September 2006 Anna Karlsson Special adviser Department of legal and public affairs

2. SWEDAC - Accreditation - International cooperation - Designation of notified bodies - Market surveillance

3. New Approach – necessary infrastructure • Metrology • Standardization • Accreditation • Authority to designate notified bodies • Notified bodies • Conformity assessment • Sector authorities • Market surveillance

4. What is SWEDAC? • Public authority responsible to the- Ministry of Foreign Affairs - Ministry of Industry, Employment and Communication • National accreditation body • Central administrative authority- conformity assessment procedures- designation of notified bodies and conformity assessment bodies- coordination of market surveillance- legal metrology- precious metals

5. Board Director-General Administrative Department Economy Personnel Registry Internal service Quality Control Marketing Technical Department Legal Department Regulations Market surveillance Legal metrology Legal advice Precious metals Conformity assessment International Coordination International secretariat International & national projects Technical Committees Environment and Food unit Industry unit Vehicle unit Plants and Installations unit Certification unit Healthcare unit

6. Accreditation SWEDAC • the sole accreditation body in Sweden • fulfils the requirements in ISO/IEC 17011 • is member of EA, IAF, ILAC • issues regulations Act (1992:1119) and Ordinance (2005:894) on Conformity Assessment

7. Accreditation Certification bodies Laboratories Inspection bodies Requirements in regulations based on EN and ISO standards

8. Accreditation Certification bodies • products (EN 45011, ISO/IEC guide 65) • quality systems (EN 45012, ISO/IEC guide 62) • personnel (EN 45013) Laboratories (EN 17025) Inspection bodies (EN 17020)

9. Accreditation The assessment – documentary and on site - includes • quality systems • administrative procedures • working methods • technical competence Annual surveillance, full re-assessment every 4th year

10. International cooperation CA issues within EU, WTO, OECD, OIML Technical assistance Twinning Training

11. Designation of notified bodies Act (1992:1119) and Ordinance (2005:894) on Conformity Assessment SWEDAC • the sole designating authority in Sweden • obligation to notify all private legal entities fulfilling the requirements Requirements in EN 45000 – ISO 17000 + relevant directives

12. Designation of notified bodies Assessment procedure Dept. of legal affairs: • Legislation (directive, Swedish implementation, product group(s), module(s) • Independence • Impartiality • Economic stability • Liability assurance • Decision (Director-General) and notification to European Commission Dept. of technical affairs: • Technical competence Consultation with regulatory/sector authority

13. Designation of notified bodies Problem: not uniform assessments in member states • Uneven quality • Unfair competition • Loss of confidence in the system Solution: harmonisation (revision of the New Approach, EA involvement)

14. Market surveillance in Sweden The EEA Treaty 1993/94 • State monopoly system replaced by “open” system of CA • Transition from pre-market approval to market surveillance • Existing sector authorities responsible for market surveillance • Financing primarily through fees • SWEDAC appointed as coordination and contact body

15. Market surveillance authorities Authority Product categories machinery, PPE (professional use), pressure equipment construction products, lifts, hot water boilers electrical products, EMC poisonous gas in gas equipment, chemicals GPSD, toys, PPE (private use) medical devices, medicines and associated products trans-European conventional and high-speed rail systems radio and telecommunications terminal equipment electronic communications networks and services recreational crafts, marine equipment explosives, gas appliances, transportable pressure equipment exhaust cleaning requirements for vehicles, noise emissions legal metrology, precious metals motor vehicles, mobile machines The Swedish Work Environment Authority The National Board of Housing, Building and Planning The National Electrical Safety Board The National Chemicals Inspectorate The National Consumer Agency The National Medical Products Agency The Swedish Rail Agency The National Post and Telecom Agency The Swedish Radio and TV Authority The Swedish Maritime Administration The Swedish Rescue Services Agency The Swedish Environmental Protection Agency SWEDAC The National Road Administration

16. Review of the Swedish system 10 years of experience New directive on general product safety Review of the New Approach • 2003 Government Enquiry Commission • 2005 Government Bill on Market Surveillance • 2006 Ordinance on Market Surveillance

17. Enquiry Commission Report Conclusions • Maintain existing organisation of sector authorities • Higher political profile • Overall objective of market surveillance in new regulation • Stricter directions from government to authorities • Enhanced coordination between authorities • More active role for SWEDAC and the Market Surveillance Council • Increased resources to authorities

18. Government Bill Followed the main conclusions of the Commission proposals Strong political profile “Market surveillance should be conducted to the extent required to ensure that goods on the market fulfil the requirements.” No additional resources

19. Ordinance on market surveillance • In force since 1 January 2006 • General definition of market surveillance • Guidelines for market surveillance activities • Clarification of responsibilities • Requirement on cooperation and coordination of sector authorities • Market Surveillance Council

20. Ordinance on market surveillance Definition ”Measures by public authorities to ensure that a product made available on the market comply with existing requirements”

21. Ordinance on market surveillance Guidelines The need for market surveillance shall be assessed for each product category, taking into account • characteristics of a product • risks associated with the product • results from previous market surveillance • foreseeable use • other authorities’ market surveillance activities Authorities shall coordinate their market surveillance activities when suitable

22. The Market Surveillance Council • Representatives from sector authorities, Customs and the National Board of Trade • Industry and consumer organisations regularly invited • Secretariat at SWEDAC • 4-5 meetings/year

23. The Market Surveillance Council • Forum for cooperation and exchange of experiences • Horisontal role of coordination • Action plan • Annual report to Government • Information to the public and industry

24. Action Plan on Market Surveillance • Adopted by the Market Surveillance Council (Nov. 2005) • Replaces earlier annual reports from SWEDAC • More proactive • Focus on issues and problems common for all authorities • Suggests specific actions

25. Action Plan on Market Surveillance • Clarify responsibilities for different product categories • Develop methods for more efficient surveillance, e.g. risk assessment, systematic use of statistics. • Investigate the possibility to use accredited conformity assessment bodies • Explore more efficient means for information exchange • Develop routines for cooperation between market surveillance and customs authorities • Enhance consultations with industry • Increase information to industry and public, e.g. education, common website

26. Swedish Board for Accreditation and Conformity Assessment For more information www.swedac.se