STATE AGENCY FOR METROLOGY AND TECHNICAL SURVEILLANCE

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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

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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

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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 CT)
• Producers of electrical appliances
• - Gama-Kabel Plc.
• - Eldom Invest Ltd.

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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.

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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 Technical Surveil-lance
General Directorate Market Surveil-lance
General Directorate Testing and Certification
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
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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

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Present structure
Law on Technical Requirements to Products
Law on Ambient Clean Air
Law on Measurements
Law on Ambient Clean Air
EC 98/34
State Agency for Metrology and Technical
Surveillance
Directorate International Cooperation and
European Integration The National Enquiry
Point Notifying Authority
General Directorate Technical Surveil-lance
General Directorate Market Surveil-lance
Directorate Conformity Assessment
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
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Executive Agency Certification and Testing (EA
CT)

• EA CT 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 CT has its own laboratories for testing of
  electrical appliances, electro-magnetic
  compatibility, food-stuff and agricultural
  products, tobacco and tobacco products.

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EA CT

• MAIN EACT 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.

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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 0001993
  series of standard, the European co-operation for
  accreditation (EA) guidance documents and BDS EN
  ISO/IEC 17 0252001.

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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

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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.

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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.

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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 170252001. The test results are used for
  performing products conformity assessment for
  the purposes of manufacturers, certification
  and control bodies.
• TL/HEAs 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.

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TL/HEA

• On national level the laboratory has been
  issued three accreditation certificates
•    ? 118-A/01.08.1994 and ? 562-?/15.07.1998 -
  by the Committee for Standardisation and
  Metrology
•    ? 562-?/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 170251999. Since 2001
  the laboratory has been following an
  accreditation procedure of RvA - the Netherlands
  holding a registration for accreditation number L
  373.

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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.

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ELDOM INVEST Ltd.

• 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.

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CONFORMITY ASSESSMENT OF PRODUCTS IN BULGARIA

• The product conformity assessment to the
  essential requirements in Bulgaria is carried
  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.

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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.

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• 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 CT 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.