Law Amending The Law On Accreditation Performed By The Bulgarian Accreditation Service

Original Language Title: Закон за изменение и допълнение на Закона за акредитацията, извършвана от Българската служба за акредитация

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Name of law
Law amending the Law on Accreditation Performed by the Bulgarian Accreditation Service




Name Bill
Bill amending the Law on Accreditation Performed by the Bulgarian Accreditation Service





Date of adoption
19/05/2010



Number / year Official Gazette
41/2010







DECREE № 131
Pursuant to Art. 98 pt. 4 of the Constitution of the Republic of Bulgaria
DECREE:
To be published in the "Official Gazette" Law amending the Law on Accreditation Performed by the Bulgarian Accreditation Service adopted by the National Assembly HLI 19 May 2010
Released in Sofia on May 28, 2010
President of the Republic, Georgi Parvanov
stamped with the state seal.
Minister of Justice Margarita Popova

Law amending the Law on Accreditation Performed by the Bulgarian Accreditation Service (prom. SG. 100 of 2005 .; amend., SG. 105 2005 SG. 30 of 2006, pcs. 42 and 82 of 2009)
§ 1. The name of the law is amended as follows: "law on national accreditation of conformity assessment".
§ 2. Article 1 shall be amended as follows:
"Art. 1. (1) This Act regulates:
1. work on the national accreditation bodies which carry out conformity assessment or other activities subject to accreditation schemes established by statutory instrument;
2. Structure and Operation of Executive Agency "Bulgarian Accreditation Service".
(2) This Act shall apply to bodies carrying out conformity assessment in both regulated and unregulated areas.
(3) Only accredited bodies for conformity assessment may be set to operate in conformity assessment in the areas regulated by law insofar as by law otherwise specified.
(4) This Act shall not apply for the accreditation of medical institutions implemented under the Hospitals Act. "
§ 3. Article 2 shall be amended as follows:
" Art. 2. (1) The Executive Agency "Bulgarian Accreditation Service" is the national accreditation body of the Republic of Bulgaria in accordance with Regulation (EC) № 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) № 339/93 (OJ, L 218/30 of August 13, 2008), hereinafter "Regulation (EC) № 765 / 2008 ".
(2) Executive Agency "Bulgarian Accreditation Service" is the only body in the Republic of Bulgaria who is entitled to conduct accreditation of conformity assessment.
(3) Monitoring of compliance of the Executive Agency "Bulgarian Accreditation Service" with Art. 8 of Regulation (EC) № 765/2008 is carried out by the Internal Audit Unit at the Ministry of Economy, Energy and Tourism periodically in accordance with the three-year strategic plan and taking into account the results of the last peer review. "
§ 4 . Article 3 is amended as follows:
"Art. 3. The accreditation is subject to the principles of legality, independence, impartiality, openness, equality, non-competition, carrying out accreditation profit and preservation of industrial and trade secrets. "
§ 5. Article 4 is amended so:
"Art. 4. The accreditation is carried out according to harmonized standards, details of which are published in the "Official Journal" of the European Union, according to Art. 11 of Regulation (EC) № 765/2008 and, where applicable, additional requirements including those set out in the sectoral accreditation schemes. "
§ 6. Article 5 is amended as follows:
" Art. 5. Accreditation can receive sole traders and legal persons established:
1. in the Republic of Bulgaria;
2. in another Member - State of the European Union in another country - party to the Agreement on the European Economic Area or Switzerland, in compliance with art. 7 of Regulation (EC) № 765/2008; 3
. in third countries. "
§ 7. In Chapter One creates art. 5:
"Art. 5a. (1) The documents issued by the authorities for conformity assessment are official documents if these bodies are accredited by the Executive Agency "Bulgarian Accreditation Service" in accordance with this Act.

(2) Documents issued by foreign authorities for conformity assessment are considered public documents if they comply with the requirements applicable to them and are issued by bodies conformity assessment accredited by national accreditation bodies that successfully undergone peer evaluation under Regulation (EC) № 765/2008 for the area or under contractual obligations for recognition between the body recognized under Art. 14 of Regulation (EC) № 765/2008, and international accreditation bodies.
(3) The Executive Agency "Bulgarian Accreditation Service" provides information on national accreditation bodies meet the requirements of par. 2, on the website of the agency.
(4) The Executive Agency "Bulgarian Accreditation Service" give an opinion on the recognition of documents under par. 2, following receipt of a written request. "
§ 8. In art. 7 is amended as follows:
1. In para. 2 t. 2 is amended as follows:
"2. Commission unequivocally. "
2. In para. 5 words "receive" be replaced with "can receive."
§ 9. In art. 8 is amended as follows:
1. The text before item. 1 is amended as follows: "the Agency carries out non-profit activities, such as:".
2. In item. 1, 'the activities of art. 1, para. 1 "is replaced by" activities in conformity assessment ". 3
. Point 2 is amended as follows:
"2. maintains membership body recognized under Art. 14 of Regulation (EC) № 765/2008 ".
§ 10. In art. 10 be made the following amendments:
1. In para. 1:
a) points 1 and 2 are amended as follows:
"1. approve accreditation procedures and rules of the Agency;
2. accredited by issuing accreditation certificates and annexes containing the accredited scope; "
b) the item. 2a:
" 2a. re-issued accreditation certificates and their annexes in accordance with procedures for accreditation; "
c) point 4 is amended as follows:
" 4. new accreditation; "
d) pt. 5, the words" under Art. 1, para. 1 "shall be deleted;
E) paragraphs 9, 10 and 11 are amended as follows:
"9. approve rules for committee work of art. 7, para. 2 and Rules of the Accreditation Council after approval by the Accreditation Council;
10. approved price list of services provided by the agency after approval by the Accreditation Council;
11. carries out activities in the maintenance of accreditation and accreditation confirms; "
e) shall be created so. 12 and 13:
" 12. delegate powers to manage in the accreditation process;
13. prepare a draft budget of the agency and for approval by the Council on Accreditation. "
2. In para. 5 't. 3 "are replaced by" item. 2 ".
§ 11. A Art. 10a:
"Art. 10a. (1) The Executive Director of the Agency may be appointed person:
1. It has higher technical education degree "master" one of the main areas in which the agency performs accreditation;
2. It has at least 5 years of professional experience in the field of accreditation or conformity assessment, three years in performance assessments / audits; 3
. He has at least two years of experience in the management of economic and administrative structures;
4. speaks language of the body recognized under Art. 14 of Regulation (EC) № 765/2008.
(2) can not be executive face:
1. convicted for premeditated indictable offense, unless rehabilitated;
2. deprived of the right to hold such office; 3
. who is a sole proprietor, general partner, manager or member of the management board, supervisory board or board of directors in a legal entity;
4. which is or has been in the last three years a sole trader or a partner or shareholder in the entities carrying out activities in conformity assessment or advice on accreditation and conformity assessment;
5. which as an individual or carried out over the last three years pursued conformity assessment or advice on accreditation and conformity assessment;
6. in respect of which there is an effective act, which was established conflict of interest under the Law on prevention and disclosure of conflicts of interest.
(3) can not be CEO who does not meet all applicable requirements of standards and guidelines for their application, published in the "Official Journal" of the European Union, according to Art. 11 of Regulation (EC) № 765/2008.
(4) Deputy Executive Director shall be appointed a person who fulfills the requirements of para. 1 - 3. "
§ 12. Article 11 is amended as follows:
" Art. 11. (1) The Accreditation Council is a permanent body consisting of 26 members.
(2) the composition of the board under par. 1 includes the Executive Director of the Agency without the right aloud and 5 representatives of interested in accreditation parties organized into the following groups:

1. Ministries decided by the Council of Ministers;
2. organizations representing industry; 3
. organizations representing consumers;
4. organizations representing experts;
5. organizations representing accredited persons.
(3) organizations under par. 2 pt. 2-5 apply to the Agency for participation in the Accreditation Council containing the presentation of the organization and declared legitimate interest in the field of accreditation. Depending on the declared interest the Executive Director of the Agency sends the application to the relevant group under par. 2.
(4) Representatives of the groups under par. 2 shall be determined by the relevant ministries and organizations under par. 3 of them in a certain order.
(5) The Accreditation Council shall act by a qualified majority of four-fifths, with each of the five groups is entitled to one vote.
(6) The Accreditation Council:
1. together with the Executive Director determines the policy and goals of accreditation activities;
2. make proposals for amending the procedures of the agency; 3
. approve accreditation procedures and their amendments prior to their approval by the Executive Director;
4. approves rules for operation of the commissions of art. 7, para. 2 prior to their approval by the Executive Director;
5. approves rules for their work before their approval by the Executive Director;
6. approved price list for the services provided by the agency before its approval by the Executive Director;
7. ensure impartiality of the accreditation process by identifying and monitor the possibility of a conflict of interest in the Agency's activities and the activities of related bodies;
8. on a proposal from the Executive Director determines the list of persons who may be included in the Committee on objections;
9. give opinions on draft legislation related to accreditation activity;
10. approve the draft budget of the Agency on a proposal from the Executive Director;
11. an opinion to the Minister of Economy, Energy and Tourism in the annual report of the Executive Director.
(7) The Accreditation Council shall elect a Chairman and Vice-Chairman from among its members for a term of three years.
(8) The relevant ministries and organizations inform the Accreditation Council by the Executive Director of the Agency to change their representatives in the event of a change of their declared interest in the field of accreditation.
(9) The Accreditation Council shall be convened regular meetings at least twice a year by the President or the Executive Director.
(10) In carrying out its work, the Council accreditation is governed by the regulations and the documents under Art. 4 and is obliged to take the necessary measures within its competence to remove inconsistencies and / or implementation of recommendations - the result of peer review.
(11) Organizational and maintenance work of the Accreditation Council is provided by the agency. "
§ 13. In art. 12 be made the following amendments:
1. Paragraph 1 shall be amended as follows:
"(1) The commissions accreditation issue opinions on the basis of the evaluation carried out with a proposal for a decision under Art. 10, para. 1, p. 2-8, except in cases of art. 10, para. 1 pt. 2a and art. 36. "
2. In para. 4 finally put a comma and added "except in cases of art. 10, para. 5 when determined by the Deputy Executive Director. " 3
. Paragraph 5 shall be amended as follows:
"(5) The members of the Committee on Accreditation and members of the objections sign a declaration to ensure the confidentiality and declaration of impartiality within the meaning of Art. 10, para. 5. "
§ 14. In art. 13 is amended as follows:
1. Paragraph 1 shall be amended as follows:
"(1) Against acts of the executive director, respectively, of the Deputy Executive Director Art. 10, para. 1, p. 5-8 can submit complaints to the Committee on the objections within 7 days from their announcement. "
2. Paragraph 3 is amended as follows:
"(3) The composition of the object is determined in each case by the President or Vice-President of the Accreditation Council and includes a qualified lawyer, members of the Accreditation Council and persons from the list Art. 11, para. 6 para. 8. The members of the objections sign a declaration to ensure the confidentiality and declaration of impartiality within the meaning of Art. 10, para. 5. "
§ 15. Article 14 is repealed.
§ 16. In art. 15, para. 6 words "receive" be replaced with "can receive."
§ 17. In art. 17, para. 2 pt. 1 and 2 the words "name - the natural person" shall be deleted.
§ 18. In art. 18, para. 2 after the words "and published in the" add "section of the official."
§ 19. In art. 19 be made the following amendments:

1. In para. 1 after the words "get accreditation" add "re-accreditation or extension of accreditation" and a comma.
2. In para. 2 after the words "comply with the requirements" insert "and the deadlines." 3
. Paragraphs 3, 4, 5 and 6 are amended as follows:
"(3) Within 30 days of submission of the application the agency assesses the capabilities and competence of its execution and shall check the completeness and correctness of submitted documents under par. 1, as in the case of incompleteness or irregularity of the applicant be given instructions and set a deadline for their removal.
(4) In establishing lack of ability or competence of the Agency to perform accreditation in respect of the proposed range, location of the business language used by the applicant or other specific conditions relating to the requirements for accreditation or failure of the instructions, refusing opening and application with submitted documents be returned to the applicant.
(5) Within 14 days after the establishment of the completeness and accuracy of all documents required under par. 1 Agency agree with the applicant designated lead assessor for specific application. After receiving the specified lead assessor by the person wishing to obtain accreditation agency opens accreditation procedure.
(6) In case of justified disapproval of the designated lead assessor agency again assess opportunities to implement the submitted application and perform actions under par. 3 - 5. "
4. In para. 7 the number "18" is replaced by "14".
5. A par. 8:
"(8) The rights of the person applying for accreditation can be transferred under Art. 22, para. 3. "
§ 20. Article 21 is repealed.
§ 21. In art. 22 be made the following amendments:
1. In para. 1, 'the activities of art. 1, para. 1 "is replaced by" activities in conformity assessment ".
2. Paragraph 2 is amended as follows:
"(2) The certificate of accreditation is personal and not subject to assignment or transfer by the accredited person."
Third. A par. 3:
"(3) granted accreditation may be transferred in compliance with the accreditation procedure of the agency."
§ 22. In art. 23 is amended as follows:
1. Point 3 is amended as follows:
"3. name, headquarters and address and identification code - a legal entity or sole trader or equivalent data on a foreign legal entity. "
2. Point 6 is amended as follows:
"6. type of activity conformity assessment, scope, date of issue and validity; The scope can be presented in an annex to the certificate; ". 3
. Section 8 is amended as follows:
"8. number and date of the application, if any; ".
§ 23. In art. 24 be made the following amendments:
1. In para. 1, second sentence, the word "three" is replaced by "7 days".
2. A par. 6:
"(6) An appeal under par. 4 orders issued under par. 1 and Art. 35, para. 1, does not stop their execution. "
§ 24. In art. 25 words "the expiry of 6 months from the refusal and" are deleted.
§ 25. In art. 27 be made the following amendments:
1. In para. 1 the words "specified in an order issued" shall be replaced with "defined by regulation."
2. Paragraphs 2 and 3 are amended as follows:
"(2) No later than eight months before the expiry date of accreditation of the person who wishes to obtain re-accreditation, apply for re-accreditation, which is seen in the order and terms of art . 19.
(3) Upon opening accordance with Art. 19, para. 5 re-accreditation agency performs under Art. 20 within the expiry of the certificate already granted accreditation. "
Third. In para. 4 after the word "circumstances" insert "at the request of the person applying for re-accreditation."
§ 26. In art. 28 para. 1 is amended as follows:
"(1) The Executive Director shall issue a certificate of re-accreditation or re-accreditation refuses respectively under Art. 20, para. 6 and Art. 24, para. 1. "
§ 27. In art. 29 be made the following amendments:
1. In para. 1 shall be added "in the order and terms of art. 19 ".
2. In para. 3 words "registration of the application under par. 1 "is replaced by" opening of Art. 19, para. 5 ".
§ 28. In art. 30 para. 1, 'a reasoned order "and" or art. 21 "shall be deleted.
§ 29. The title of Chapter Six is ​​amended as follows: "Maintaining accreditation."
§ 30. Article 31 is amended as follows:
"Art. 31. (1) The maintenance of accreditation is carried out throughout the term of validity of the certificate of accreditation.

(2) The maintenance of accreditation includes supervision and other actions carried out by the agency in order to ensure continuous compliance of the activities of accredited persons with the requirements and procedures for accreditation of the agency and maintain confidence in the quality of accredited persons services.
(3) The activities of maintenance of accreditation is carried out in an order determined by procedures for accreditation of the agency. "
§ 31. In art. 32 is amended as follows:
1. In the text before item. 1, 'the following types of surveillance "are deleted.
2. Point 2 is amended as follows:
"2. emergency assessment on information obtained about changes in the conditions under which it was granted accreditation received written reports about violations by accredited persons, published or publicized critical materials in the media, signals an incorrect reference to accreditation, misleading use of accreditation in promotional materials and other. "
§ 32. Article 34 is amended as follows:
" Art. 34. (1) Upon detection of non-compliance of accredited persons or candidates for accreditation with the accreditation requirements and procedures of the Agency Executive Director restricts accredited or requested accreditation scope, temporarily restrict the scope of accreditation, suspend, refuse or withdraw accreditation.
(2) Limiting the scope of accreditation occurs when objective evidence found during site assessments or otherwise indicate that the accredited person does not comply with the accreditation requirements for a particular part of the accredited scope, but does not affect its ability to operate in the rest of the scope or duration of the temporary restriction of the scope of accreditation and accredited person fails to prove its ability to perform the activities for which temporarily limited its accreditation.
(3) Temporary limitation of the scope of accreditation for a period of six months shall be made when the accredited person is temporarily unable to perform some of the activities that have been accredited, and they do not affect its ability to operate at rest part of the range.
(4) Suspension of accreditation for a period of six months occurs when objective evidence found during site assessments or otherwise indicate that the accredited person does not comply with the requirements for accreditation and procedures of the agency and it It did not take effective and timely corrective actions. Suspension of accreditation is a process by which accreditation is temporarily invalid.
(5) Withdrawal or denial of accreditation is done when the accredited person or candidate for accreditation:
1. It is unable to carry out the activities for which it is accredited or applied;
2. does not or maintain one or more of the requirements for accreditation, leading to the conclusion that the activities of the body for conformity assessment, competence and management system are unable to provide the necessary quality of service, including the authenticity of certificates issued by documents; 3
. in a period of accreditation relies in its activities of non-accredited accreditation scope;
4. issued false or forged document or a document containing false information;
5. Agency compromise with their acts or omissions;
6. in the period under par. 4 fails to demonstrate to the agency's ability to perform activities that are accredited;
7. does not pay accreditation services according to the approved price list. "
§ 33. In art. 35, para. 1 finally put a comma and added "except under Art. 36, which does not need an opinion from the Commission on Accreditation. "
§ 34. In art. 36 finally put a comma and added "accompanied by an original certificate of accreditation and the Annex to it."
§ 35. Article 37 is amended as follows:
"Art. 37. (1) The limitation of the scope of accreditation temporarily limiting the scope of accreditation, suspension or withdrawal of accreditation person is obliged to return the originals agency of the accreditation certificate and the Annex hereto within 14 days of receipt of the order of Art . 35, para. 1. A person with a suspended or withdrawn accreditation is obliged to stop reference on accreditation, whether contested or not the order.
(2) The person whose accreditation is limited or temporarily limited scope receives accreditation certificate and its annex with limited or temporarily limited scope. "
§ 36. Article 38 is amended as follows:
" Art. 38. (1) A person whose accreditation is revoked may reapply for accreditation not earlier than six months from the date of entry into force of the order for withdrawal of accreditation and presentation of evidence that they eliminate disparities with the accreditation requirements .

(2) Certification Body whose accreditation has been revoked must withdraw / cancel all certificates granted under accreditation within two months from the date of withdrawal. Certification Bodies must be submitted to the Agency a list of certifications provided by them with evidence of their withdrawal / termination. "
§ 37. Article 39 is repealed.
§ 38. Article 40 is amended as follows:
"Art. 40. Who does not fulfill its obligation under Art. 37, para. 1, does not return the originals of the accreditation certificate and the Annex thereto shall be liable to a pecuniary penalty in the amount of 2,000 lev. "
§ 39. In art. 41 be made the following amendments:
1. In para. 1:
a) in item. 1 number "1000" is replaced by "2000";
B) in item. 2 number "2000" is replaced by "4000";
C) in item. 3 numbers "3000" and "5000" are replaced by "6000" and "10000".
2. In para. 2 words "fine or" are deleted. 3
. A par. 3:
"(3) not accredited by the agency or by a national accreditation body of another Member persons in its activities rely on the accreditation activities of conformity assessment, shall be punished with:
1. fine or penalty payment in the amount of 2,000 lev - for first offense;
2. fine or property sanction 4000 lev - for repeated or systematic violations. "
§ 40. A Art. 41a:
"Art. 41a. (1) Who the operation of accreditation bodies for conformity assessment in violation of the provision of Art. 2 para. 1 shall be punished with a fine or property sanction 50 000 Levs.
(2) For repeated or systematic violations punishment under par. 1 fine or penalty amounting 75 000 Levs.
(3) Violations shall be established by acts issued by officials authorized by the Minister of Economy, Energy and Tourism.
(4) The penalty shall be issued by the Minister of Economy, Energy and Tourism or authorized by officials. "
§ 41. In additional provision be made the following amendments:
1. The name "Additional provisions" are amended as follows: "Additional provisions".
2. In § 1:
a) points 2, 3 and 4 shall be repealed;
B) paragraph 5 is amended as follows:
"5. "Organizations accredited persons" legal non-profit entities in which at least half of the members are accredited by the agency faces. "
C) point 9 shall be repealed. 3
. Created §1a and 1b:
"§1a. For the purposes of this law, the definitions of art. 2 of Regulation (EC) № 765/2008.
§ 1b. For the purposes of this law, the definitions of harmonized standards for which data are published in the "Official Journal" of the European Union, according to Art. 11 of Regulation (EC) № 765/2008. "
Transitional and Final Provisions
§ 42. created before the enactment of this law the Accreditation Council retains its status and perform the functions of art. 11, and within three months of entry into force of the law aligns its activities in accordance with its requirements.
§ 43. Within two months of the entry into force of this Act accreditation activity to comply with its requirements.
§ 44. This Act shall enter into force on the day of its promulgation in the "Official Gazette".
The law was adopted by the 41 th National Assembly on May 19, 2010 and was affixed with the official seal of the National Assembly.
Chairman of the National Assembly Tsetska Tsacheva
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