ACCREDITATION – BG situation

1. STATE AGENCY FOR METROLOGICAL AND TECHNICAL SURVEILLANCE ACCREDITATION – BG situation 8 - 10 April 2014, Prague 1

2. Legal basis • REGULATION (EC) No 765/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93; • Accreditation is carried out by one single national accreditation body appointed by its Member State (Art 4.1); • Accreditation is performed as a public authority activity (Art 4.5); • National accreditation body operates free from commercial motivations (Art 8.1) and on a not-for- profit basis (Art 4.7); • National accreditation bodies do not compete with conformity assessment bodies and among each other (Art 6.1 and Art 6.2). 2

3. EU general principles • Principle of use of accreditation as a privilege tool for assessment of NBs competence, forming the last level of control : • Appointment of single National Accreditation Body. • National decision on use the accreditation as a precondition for notification, enforced by respective amendment of acting national legislation on notification if necessary. • Development of sectoral schemes for assessment of CABs for notification purposes. 3

4. National Accreditation Body • Executive Agency Bulgarian Accreditation Service to the Minister of Economy – established in December 1999; • Law on accreditation – adopted in 2005; • Law on National Accreditation of Conformity Assessment Bodies - 2010 • EA full member – 2001; • EA MLA signatory – 2005 - 2011: • certification of quality systems - 2005 • certification of personnel - 2005 • product certification, inspection bodies, EMAS – 2010 • calibration and testing labs – 2011

5. Accredited Bodies - March 2014 • Total number – 568 • Testing labs – 214 • Calibration labs – 16 • Testing and calibration labs – 11 • Inspection bodies – 290 • MS certification bodies – 13 • Product certification bodies – 8 • Certification of persons – 4 • Verifiers - 2

6. Notifying Authorities • Ministry of Investment Planning – construction products   • ExecutiveAgency “Maritime Administration” – maritime equipment   • Railway Administration Executive Agency - railways   • State Agency for Metrological and Technical Surveillance – all NADs except above mentioned

7. Legal basis for NA notifications by SAMTS Law on Technical Requirements for Products – stipulates the notification procedure; Horisontal Framework Law, defining; Scope, Objectives, general Obligations of Economic Operators; Preconditions for placing products on the Market – conformity assessment procedures, assessment procedure of CABs (notified bodies) competence; Market Surveillance provisions –responsible authorities, powers and obligations; Penalty provisions; Transitional and final provisions – definitions, entering into force.

8. Legal basis for NA notifications by SAMTS Ordinances on essential requirements and conformity assessment: Secondary Legislation, defining; Scope, Specific Obligations of Economic Operators; Requirements for placing products on the Market – applicable conformity assessment procedures, additional specific requirements for CABs (notified bodies); Essential Requirements; Modules on conformity assessment; Transitional and final provisions – definitions, entering into force;

9. Implementation practice - BG • Notification based on both – accreditation and without accreditation; • For accredited candidates – light procedure, that promotes the advantage of accreditation - technical competence acknowledged. • Legal transparent procedure for assessment of CABs competence established in the Law; • Right to appeal decision on designation and further notification. • Provision to restrict or withdraw the notification in case of non proper fulfillment of obligations related to conformity assessment. 9

10. Implementation practice - BG • Requirement for Notified bodies according to Law on Technical Requirements to Products : • Full compliance in term of competence requirements. • Obligation to participate in European NBs working Groups – at least one representative by sector. • Obligation to follow European Standardization bodies work – to participate in TCs. • Obligation to report annually to the notifying authority – State Agency for Metrological and Technical Surveillance on their activities. • In case of incompliance - penalty provisions. 10

11. Notified bodies (by SAMTS)

12. Accreditation Status of NBs • Accredited NBs – 5; • 17020 – 4 • 17024 – 1 • Accredited in house labs – 11; • Non accredited in house labs – 6; • Accredited sub-contracted labs – 15; • Non-accredited sub-contracted labs -5.

13. NBs informal structures in BG • Support to designated/notified bodies • establishment of National Board of designated bodies • establishment of national working groups by sector: • Working Group 1:Gas appliances; • Working Group 2:Pressure equipment and simple pressure vessels; • Working Group 3:Equipment designed for use within certain voltage limits, electromagnetic compatibility and radio and telecommunications terminal equipment • Working Group 4: Machinery; • Working Group 5: Lifts; • Working Group 6: Toys. 13

14. Challenges for CABs/NBs • Need of training; • Need of testing equipment; • Support for participation in NB working groups at EU level; • Participation in standardization TCs work; • Participation in international projects; • Obligatory accreditationfor all – acting and candidates.

15. Thank you! Web site: www.damtn.government.bg E-mail: damtn@damtn.government.bg 15