Executive Agency "Bulgarian Accreditation Service" is the national accreditation body of the Republic of Bulgaria in accordance with Regulation (EC) No. 765/2008 of the European Parliament and of the Council of July 9, 2008 to determine the requirements for accreditation and market supervision in in connection with the marketing of products and for the repeal of Regulation (EEC) No. 339/93 (ОВ, L 218/30 of August 13, 2008), hereinafter referred to as "Regulation (EC) No. 765/2008".
Executive Agency "Bulgarian Accreditation Service" is the only body in the Republic of Bulgaria that has the right to carry out accreditation of conformity assessment bodies. Executive Agency "Bulgarian Accreditation Service" (EA BAS) is the national accreditation body of:
- Testing laboratories, including Medical laboratories;
- Calibration laboratories;
- Inspection bodies;
- Bodies for certification of products, including for organic production and biological products;
- Bodies for validation and verification;
- Bodies for certification of management systems - ISO 9001, ISO 14001, OHSAS 18001/ISO 45001, ISO 22000 and ISO/IEC 27001, ISO 50001, ISO 39001;
- Bodies for certification of persons;
- Environmental auditors (EMAS);
- Proficiency testing (PT) providers
EA BAS also inspects and certifies the compliance of laboratories with Good Laboratory Practice (GLP).
EA BAS is a full member of the European Accreditation Organization (EA) since 2001 and is a party to the Multilateral Agreement on Mutual Recognition of Accreditation Schemes for the following fields:
- Calibration laboratories;
- Testing laboratories, including medical laboratories;
- Inspection bodies;
- Product certification authorities;
- Authorities for certification of persons;
- Bodies for certification of management systems;
- Validation and verification bodies.
EA BAS, in its capacity as a National Accreditation Body, which is responsible for the accreditation of Еnvironmental Аuditors (EMAS) and the supervision of the activities carried out by EMAS in accordance with Regulation (EC) No. 1221/2009, participates in Forum meetings of Accreditation and Licensing Bodies (FALB) and is subject to peer review for the accreditation of EMAS.
EA BAS is a full member of the International Accreditation Forum (IAF) since September 2016 and is a party to the Multilateral Agreement on the Mutual Recognition of Accreditation Schemes (IAF MLA) for the following fields:
- Certification of persons
- Certification of management systems (ISO 9001, ISO 14001)
- Certification of products
- Validation and verification bodies
EA BAS is a full member of the International Organization for Laboratory Accreditation (ILAC) since October 2016 and is a party to the Multilateral Agreement on the Mutual Recognition of Accreditation Schemes (ILAC MRA) for the following areas:
- Testing laboratories
- Medical laboratories
- Calibration laboratories
- Inspection bodies
EA BAS works on the basis of the laws of the country, the standards of the ISO/IEC 17000 series, EA Guides, ISO/IEC, IAF/ILAC. The Agency develops and adopts a number of rules, norms, procedures, documents and organizational practices for harmonization with European law. EA BAS interacts with individuals and legal entities from the governmental and non-governmental sectors.
Technical Accreditation Committees (TACs) have been approved for individual fields of accreditation, which have advisory functions regarding the technical requirements for accreditation and technical issues regarding the implementation of accreditation systems.
The Accreditation Commission and the Objections Commission in the EA BAS system guarantee the objectivity and impartiality of accreditation decisions.
The Agency conducts educational and qualification activities for its employees and for external evaluators under programs ensuring competence commensurate with international requirements.
EA BAS maintains direct business relations and carries out fruitful cooperation with international organizations and with national institutions from the quality infrastructure.
Through its activities, EA BAS ensures the competitiveness of domestically produced goods according to international and European quality and safety standards, promoting their establishment on the Bulgarian and world markets.
Brief historical background:
The national accreditation body - Bulgarian Accreditation Service was established on November 23, 1998. by Decree of the Council of Ministers No. 228 of October 23, 1998.
At the time of its establishment, the Bulgarian Accreditation Service was attached to the Committee for Standardization and Metrology (CSM) and consisted of 15 people with the main accreditation functions of:
- Testing and calibration laboratories
- Legal entities for certification of products, of quality systems and of persons;
- Legal entities for inspection according to the requirements of БДС EN 45004
Before the establishment of the Agency in 1998, the activity on accreditation of testing laboratories was carried out by the Department "Accreditation of Laboratories" at the CSM, and the activity on accreditation of calibration laboratories by the Department "Accreditation of Calibration Laboratories" at the National Center for Metrology (NCM) to CSM. Until 1998 accreditation of certification bodies and inspection bodies has not been carried out with an officially announced procedure by CSM or another organization in Bulgaria.
In 1999 in connection with art. 4 of the Law on Administration, the Bulgarian Accreditation Service under the CSM is transformed into Executive Agency "Bulgarian Accreditation Service" (EA BAS) under the Minister of Economy.
In 2005 the first law regulating the conditions and procedure for accreditation is promulgated, entitled "Law on Accreditation Carried Out by the Bulgarian Accreditation Service", promulgated Official Gazette, no. 100 from 13.12.2005, in force from 14.01.2006. The law defines IA BSA as a specialized state body for accreditation of the persons who carry out the activities of: testing, calibration, certification of products, certification of management systems, certification of personnel, as well as of control bodies and environmental inspectors. The law expands the agency's powers with those for accreditation of Environmental Auditors (EMAS).
On June 1, 2010 amendments and additions to the law of 2005 were adopted, changing the name of the law from the "Accreditation Act performed by the Bulgarian Accreditation Service" to the "Law on the National Accreditation of Conformity Assessment Bodies (LNACAB), promulgated Official Gazette, no. 41 of 2010, takes effect from 01.06.2010.
The law designates the Executive Agency "Bulgarian Accreditation Service" as the national accreditation body of the Republic of Bulgaria in accordance with Regulation (EC) No. 765/2008 of the European Parliament and of the Council. LNACAB indicates EA BAS as the only body in the Republic of Bulgaria that has the right to carry out accreditation of conformity assessment bodies.
At the moment, the agency is a state body, a legal entity with its seat in Sofia, a secondary administrator of budget credits to the Minister of Economy.
INFORMATION ON EA BAS ANALYSIS PERFORMED BY IA IN CONNECTION WITH THE IDENTIFICATION OF THE BODIES ASSOCIATED WITH IT
Pursuant to clause 4.4.6 of БДС EN ISO/IEC 17011:2017, EA BAS prepares a documented analysis regarding its related bodies, which is reported for review by management and presented for information to interested parties represented in the Accreditation Council.
The analysis is based on a survey of all Ministries and related structures, identifying and documenting those providing conformity assessment services or consulting services and analyzing EA BAS's relationships with them, in order to determine possible conflicts of interest. The analysis shows that the relevant structures identified as agency-related bodies:
- have different senior management for the policy development activities related to the functioning of the accreditation body; to control the implementation of policies and procedures; to control the finances of the accreditation body; for accreditation decisions; for contractual obligations; for delegation of authority to committees or individuals, if necessary to undertake certain actions on behalf of senior management
- have personnel other than those employed in the accreditation decision-making process
- they have no possibility to influence the result of the accreditation assessment
- have completely different names, logos and symbols
which is why they do not compromise the confidentiality, objectivity and impartiality of the accreditation activity carried out by EA BAS.