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