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STATE AGENCY FOR METROLOGY AND TECHNICAL SURVEILLANCE

STATE AGENCY FOR METROLOGY AND TECHNICAL SURVEILLANCE. INCOLAB project Initiative and coordination to prepare laboratories in newly associated states for full implementation of the Low Voltage Directive (LVD) Project Member: Bulgaria

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STATE AGENCY FOR METROLOGY AND TECHNICAL SURVEILLANCE

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  1. STATE AGENCY FOR METROLOGY AND TECHNICAL SURVEILLANCE INCOLAB project Initiative and coordination to prepare laboratories in newly associated states for full implementation of the Low Voltage Directive (LVD) Project Member: Bulgaria Local coordinator: Kristina Petkova, SAMTS

  2. GENERAL INFORMATION • Population: 7 973 671 • Area: 110 912 km2 • Capital city: Sofia (1 172 000) • Language: Bulgarian • Currency: 1 Euro = 1,97 lev • GDP: 1705 USD per capita (2001) • GDP growth: 4,0 % • System of units: SI

  3. INCOLAB PROJECT PARTICIPANTS : • Project Member Organisation: - State Agency for Metrology and Technical Surveillance(SAMTS) • Regulatory bodies and administrative structures: - State Agency for Metrology and Technical Surveillance - Executive Agency “Certification and Testing” (EA “C & T”) - Executive Agency “Bulgarian Accreditation Service” (EA “BAS”) - Commission of Trade and Consumer Protection (CTCP) • Testing Laboratory: - Household electrical appliances - Varna (within EA “C&T”) • Producers of electrical appliances: - Gama-Kabel Plc. - Eldom Invest Ltd.

  4. STATE AGENCY FOR METROLOGY AND TECHNICAL SURVEILLANCE (SAMTS) SAMTS manages, co-ordinates and supervises the implementation of the state policy in the field of: • ensuring uniformity of measurements; • testing and verification activities; • products conformity assessment activities; • technical surveillance of high-risk equipment; • market surveillance.

  5. Former structure Law on National Standardisation Law on Measurements Law on Technical Requirements to Products Law on Ambient Clean Air EC 98/34 State Agency for Standardisation and Metrology Directorate “International Cooperation and European Integration” The National Enquiry Point Notifying Authority General Directorate “Market Surveil-lance” General Directorate “Testing and Certification” General Directorate “Technical Surveil-lance” General Directorate “Quality Control of Liquid Fuels” General Directorate “Measures andMeasuring Instruments” General Directorate “National Centre for Metrology" “Standardisation” Directorate Certification Department RD … RD TCs TCs TCs NL NL NL RD RD RD RI RI CU CU TL TL Regional Departments Technical Committees National Laboratories Regional Departments Regional Inspectorates Control Units Testing Laboratories

  6. Segregation of the institutions according to Bulgarian legislation: • State Agency for Metrology and Technical Surveillance under the Council of Ministers. Responsible for metrology, technical surveillance of high-risk equipment, market surveillance under the New Approach Directives and designation of conformity assessment bodies • Executive Agency “Certification and Testing” under the Minister of Economy. The agency is established as a temporary structure for a period no longer than 2 years and afterwards it will be transformed into a commercial entity • Bulgarian Institute for Standardisation under the Council of Ministers – independent legal entity

  7. Present structure Law on Technical Requirements to Products Law on Ambient Clean Air Law on Measurements LawonAmbient CleanAir EC 98/34 State Agency for Metrology and Technical Surveillance Directorate “International Cooperation and European Integration” The National Enquiry Point Notifying Authority General Directorate “Market Surveil-lance” Directorate “Conformity Assessment” General Directorate “Technical Surveil-lance” General Directorate “Quality Control of Liquid Fuels” General Directorate “Measures andMeasuring Instruments” General Directorate “National Centre for Metrology" General Directorate "Metrological Supervision" RD … RD RI RI RI NL NL NL RD RD RD RI RI CU CU Regional Inspectorates National Laboratories Regional Departments Regional Inspectorates Regional Departments Control Units

  8. ExecutiveAgency “CertificationandTesting” (EA “C&T”) • EA “C&T” is established as a legal entity according to Decree №221/ 25.09.2002 of the Council of Ministers. It is responsible for certification of products according to the requirements of normative documents and standards; certification, registration or conformity assessment of quality systems according to the requirements of BDS EN ISO 9000 and BDS EN ISO 14 000 as well as certification of personnel - assessors, quality specialists and auditors of quality systems. • EA “C&T” has its own laboratories for testing of electrical appliances, electro-magnetic compatibility, food-stuff and agricultural products, tobacco and tobacco products.

  9. EA “C&T” MAINEA“C&T” ACTIVITIES: • products testing for certification and conformity assessment purposes; • products certification for conformity with the requirements of BDS as well as for the conformity assessment purposes; • certification of quality systems; • personnel certification for conformity with the requirements of normative documents and standards; • registration of assessed or certified products, quality systems and personnel; • training of assessors, quality specialists and quality systems auditors; • participation in international and European organisations in the field of conformity assessment and quality systems.

  10. Executive Agency “Bulgarian Accreditation Service”(EA “BAS”) • EA “BAS” is an independent national accreditation body to the Ministry of economy. • EA “BAS" accredits and carries out a follows-up surveillance of testing and calibration laboratories; certification bodies of products, personnel, quality and environmental management systems; inspection bodies. • EA “BAS" maintains a register of accreditation certificates and publishes them in its official bulletin. • EA “BAS” operates based on the BDS EN 45 000:1993 series of standard, the European co-operation for accreditation (EA) guidance documents and BDS EN ISO/IEC 17 025:2001.

  11. EA “BAS” • EA “BAS" is a full member of the EA. The agency participates in the sessions of the general assembly of EA with the right to vote. • EA “BAS” is working actively on achieving the EA criteria for becoming a signatory to the multilateral agreement (MLA) for the different accreditation schemes. • Technical committees for accreditation are established in its competence, each covering a relevant sector of the national economy and being empowered with advisory functions with regard to the technical requirements for accreditation and principles related to the implementation of accreditation systems

  12. Commission of Trade and Consumer Protection (CTCP) • CTCP established within the Ministry of Trade and Tourism is an enforcing authority responsible for implementation of enforcing product safety legislation. • CTCP is a state body and its legal basis is the Law on consumer protection and rules of trade entered into force on 2 July 1999. • The administrative structure of CTCP includes 28 regional units spread all over the country. • In the field of product safety CTCP is a coordinator of the activities of different control bodies such as: National veterinary service; National grain and grain feed control inspectorate; State hygienic and epidemiological service, etc.

  13. CTCP CTCP is authorised to: • Issue an order for suspending placing on the market of a product if there are serious reasons to believe that it is dangerous; • Issue an order for prohibition placing on the market of dangerous products; • Issue an order for withdrawal or distraction of dangerous products; • Notify the competent bodies when violations of the normative acts concerning the rights and interests of consumers are found out; • Advise consumers on consumer protection matters including safety issues.

  14. Testing Laboratory for Household electrical appliances - Varna (TL/HEA) • The Testing Laboratory for Household Electrical Appliances - Varna was established in 1980 having the statute of a state laboratory for testing the safety and functionality of household electrical appliances. At present it is part of the Executive Agency “Certification and Testing“. • The laboratory carries out the tests according to a number of European safety standards for household appliances and its activities are in compliance with the requirements of BDS EN ISO/IEC 17025:2001. The test results are used for performing products conformity assessment for the purposes of manufacturers, certification and control bodies. • TL/HEA’s main clients are: companies manufacturing household electrical appliances in Bulgaria; control units in Directorate “Market surveillance“ of SAMTS; Committee of Trade and Consumers Protection; Consumers Association; trade companies and compliance assessment certification companies.

  15. TL/HEA • On national level the laboratory has been issued three accreditation certificates: ·   № 118-A/01.08.1994 and № 562-И/15.07.1998 - by the Committee for Standardisation and Metrology ·   № 562-И/04.09.2000 - by the EA “Bulgarian Accreditation Service” for compliance with EN 45001. • In 2000 the laboratory was included in the project PSO99/BG/9/1 and now it is under preparation for international accreditation in compliance with EN ISO/IEC 17025:1999. Since 2001 the laboratory has been following an accreditation procedure of RvA - the Netherlands holding a registration for accreditation number L 373.

  16. PRODUCERS OF ELECTRICAL APPLIANCES : GAMA-KABEL Plc. • Gama-Kable Plc. is established as a state company in 1975 and privatized in 1995. • Its main activities are related to the production of cable products of the following groups: • wires and cords for electrical installations, internal wiring, automobiles, etc; • power cables up to 1 kV; • cables for control and signalization; • communication and data transmission cables; • shipboard cables. • A part of its cable products are certified by VDE-Institute and a part of its shipboard cables are certified by Lloyd Register. • The company has a certified quality management system according to the requirements of ISO 9001. • Gama-Kable Plc. has is own testing laboratory which is accredited according to the requirements of BDS EN 45001.

  17. ELDOM INVESTLtd. • The company is established as a state company in 1987 and privatized in 1996. • Its main activities are related to: • manufacturing of electrical boilers (75 models and modifications) - 120 000 items per year • manufacturing of spare parts • preparation of service documentation • supply, installation, adjustment and putting into operation of boilers • maintenance and repairing of boilers in guarantee and post guarantee period provided by more than 60 services all over the country • testing and conformity assessment of boilers for compliance with safety and functional requirements • personnel training. • The company has a certified quality management system according to the requirements of ISO 9002 and certificates for compliance with the requirements of LVD and EMC Directives of EC.

  18. CONFORMITY ASSESSMENT OF PRODUCTS IN BULGARIA • The product conformity assessment to the essential requirements in Bulgaria iscarried out, depending on the conformity assessment procedures laid down in the relevant ordinances,either by the persons who place products on the market and/or put them into service or by the conformity assessment bodies designated by the state authorities. • According to the Law on technical requirements to products the products that are in conformity with the relevant conformity assessment procedures are marked with national conformity mark . This marking is mandatory and must be affixed before the product is placed on the market and put into service unless some specific regulations require otherwise.

  19. PRODUCT CERTIFICATION SYSTEM IN BULGARIA • Compulsory certification • Compulsory certification of tractors and forestry machines according to the national Law on Registration and Control of Agricultural and Forestry Machines The Bulgarian certification bodies are the two Testing Centers for Agricultural, Forestry Machines and Spare Parts to the Ministry of Agriculture and Forestry • Compulsory certification of products covered by the New Approach Directives The activities in the field of conformity assessment of products with the essential requirements are regulated by the Law on Technical Requirements to Products.

  20. Voluntary certification • Voluntary certification of products in the field of industrial products (e.g. shoes industry, clothing and textile, furniture), foodstuffs and tobacco according to Bulgarian State Standards (BDS) The applied certification system is based on testing activities and evaluation of technical producing conditions (where there is no implemented quality management system, QMS) or evaluation of the implemented QMS. A certificate is issued on the basis of the test results and evaluation made. • Voluntary certification of Quality Management Systems (QMS) according to BDS EN ISO 9000 series and Environmental Management Systems (EMS) according to BDS EN ISO 14 001 In Bulgaria the EA “C&T” as well as other certifying organisations, Bulgarian and foreign subsidiaries, carry out management systems certification. A certificate is issued on the basis of the evaluation made according to relevant certification procedures under corresponding management system standards.

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