STATE AGENCY
FOR METROLOGICAL AND
TECHNICAL SURVEILLANCE
ACCREDITATION – BG situation
8 - 10 April 2014, Prague
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Legal basis
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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).
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EU general principles
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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.
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National Accreditation Body
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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:
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certification of quality systems - 2005
certification of personnel - 2005
product certification, inspection bodies, EMAS –
2010
calibration and testing labs – 2011
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Accredited Bodies - March 2014
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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
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Notifying Authorities
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Ministry of Investment Planning – construction
products
Executive Agency “Maritime Administration” –
maritime equipment
Railway Administration Executive Agency railways
State Agency for Metrological and Technical
Surveillance – all NADs except above mentioned
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Legal basis for NA notifications by
SAMTS
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Law on Technical Requirements for Products –
stipulates the notification procedure;
Horisontal Framework Law, defining;
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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.
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Legal basis for NA notifications by
SAMTS
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Ordinances on essential requirements and
conformity assessment:
Secondary Legislation, defining;
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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;
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Implementation practice - BG
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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.
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Implementation practice - BG
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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.
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Notified bodies (by SAMTS)
2
1
1
EMC
4
SPV
2
CIVEX
1
1
Crafts
1
RTTE
2
ATEX
2
Lifts
Machinery
1
3
PED
LVD
T PE
MID
5
3
Cable
NAWI
HWB
5
3
NE
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Accreditation Status of NBs
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Accredited NBs – 5;
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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.
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NBs informal structures in BG
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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.
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Challenges for CABs/NBs
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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 accreditation for all – acting and
candidates.
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Thank you!
Web site:
www.damtn.government.bg
E-mail:
damtn@damtn.government.bg
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