MARS
Bratislava, 24-26 September 2006
Anna Karlsson
Special adviser
Department of legal and public affairs
Swedish Board for Accreditation and Conformity AssessmentSwedish Board for Accreditation and Conformity Assessment
SWEDAC
- Accreditation
- International cooperation
- Designation of notified bodies
- Market surveillance
New Approach – necessary infrastructure
• Metrology• Standardization• Accreditation• Authority to designate notified bodies • Notified bodies• Conformity assessment• Sector authorities• Market surveillance
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
Industry unit
Vehicle unit
Environment and Food
unit
Certification unit
Plants and Installations unit
Legal Department
RegulationsMarket surveillanceLegal metrologyLegal advicePrecious metalsConformity assessment
Administrative Department
Economy Personnel Registry Internal service
Technical Committees
International Coordination
International secretariat
International & national projects
Technical Department
Director-General
Board
Quality Control
Healthcare unit
Marketing
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
Accreditation
Certification bodies
Laboratories
Inspection bodies
Requirements in regulations based on EN and ISO standards
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)
Accreditation
The assessment – documentary and on site - includes• quality systems• administrative procedures• working methods• technical competence
Annual surveillance, full re-assessment every 4th year
International cooperation
CA issues within EU, WTO, OECD, OIML
Technical assistance
Twinning
Training
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
Designation of notified bodiesAssessment 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
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)
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
Market surveillance in Sweden
Market surveillance authorities
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
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
Authority Product categories
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
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
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
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
Definition
”Measures by public authorities to ensure that a product
made available on the market comply with existing
requirements”
Ordinance on market surveillance
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 activitieswhen suitable
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
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
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
• 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
Action Plan on Market Surveillance
Swedish Board for Accreditation and Conformity AssessmentSwedish Board for Accreditation and Conformity Assessment
For more information
www.swedac.se