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ACCREDITATION – BG situation

8 - 10 April 2014, Prague

STATE AGENCYSTATE AGENCY

FOR FOR METROLOGICAL ANDMETROLOGICAL AND

TECHNICAL SURVEILLANCETECHNICAL SURVEILLANCE

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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).

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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.

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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

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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

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Notifying Authorities

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

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.

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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;

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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.

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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.

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EMC

SPV

CIVEX

Crafts

RTTE

ATEX

Lifts

Machinery

PED

LVD

T PE

MID

Cable

NAWI

HWB

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Notified bodies (by SAMTS)

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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.

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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.

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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 accreditation for all – acting and

candidates.

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Web site: www.damtn.government.bg E-mail: damtn@damtn.government.bg

Thank you!