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Law No. 245 Of 29 April 2002 Approving Ordinance No. 38/1998 On The Accreditation And Conformity Assessment Infrastructure

Original Language Title:  LEGE nr. 245 din 29 aprilie 2002 pentru aprobarea Ordonanţei Guvernului nr. 38/1998 privind acreditarea şi infrastructura pentru evaluarea conformităţii

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LEGE no. 245 245 of 29 April 2002 for approval Government Ordinance no. 38/1998 on accreditation and infrastructure for conformity assessment
ISSUER PARLIAMENT
Published in OFFICIAL MONITOR no. 313 313 of 13 May 2002



The Romanian Parliament adopts this law + Article 1 Approval Government Ordinance no. 38 38 of 30 January 1998 on accreditation and infrastructure for conformity assessment, published in the Official Gazette of Romania, Part I, no. 43 of 30 January 1998, with the following amendments and additions: 1. The title of the ordinance shall read as follows: " ORDINANCE on the accreditation of laboratories and bodies for conformity assessment " 2. Article 1 shall read as follows: "" Art. 1. -This ordinance establishes the basic principles and the organisational framework of the accreditation activity of laboratories and bodies for conformity assessment. " 3. Article 2 shall read as follows: "" Art. 2. -(1) For the purposes of this ordinance, the terms are defined as follows: a) accreditation-the procedure by which the national accreditation body, recognized according to the law, attests that a laboratory or a body is competent to carry out specific tasks; b) quality audit-systematic and independent examination in order to determine whether the activities relating to quality and the related results satisfy the predetermined provisions, as well as whether these provisions are actually implemented and are appropriate to achieve the objectives; c) certification-the procedure by which a third party gives written assurance that a product, process or service complies with the specified conditions; d) conformity-fulfilment by a product, process or service of the specified conditions; e) the infrastructure for conformity assessment-the assembly of laboratories and bodies carrying out tests, calibrations, personnel certifications, quality systems, environmental management systems, and inspection; f) regulation-document containing binding rules and adopted by an authority; g) regulatory technical regulation which provides for technical conditions, either directly or by reference to a standard, to a technical specification, to a code of good practice, or to take full account of their content; h) traceability-the ability to find the history, use or location of an entity by registered identifications; when associated with calibration, the term shall cool the measuring equipment to the national or international, primary standards, constants or fundamental physical properties, or reference materials. (2) The terms defined in par. ((1) shall be completed with the terms defined in art. 4 4 of Law no. 608/2001 on conformity assessment of products. ' 4. In Article 3, letter d) shall read as follows: "d) promote the protection of the life, health and safety of natural persons and the environment and the defence of the interests of consumers." 5. In Article 4, letters b), c) and e)-j) shall read as follows: " b) representation of public interests; c) voluntary character; .............................................................. e) participation of specialized bodies of public administration; f) impartial treatment of appeals; g) harmonization with European and international accreditation rules; h) free access to accreditation of all applicants, without discrimination; i) insurance of confidentiality and protection of trade secret; j) application of the national reference standards of the SR EN 45000 series, of the SR EN ISO 9000 series and of the SR EN ISO 14000 series, as well as of those to be adopted in this field. ' 6. in Article 4, point k) shall be repealed. 7. In Article 5 (1), the introductory part and the letters e) and g) shall read as follows: "" Art. 5-(1) Based on the fulfilment of the criteria contained in national reference standards, they may be accredited: ............................................................... e) personnel certification bodies, whose work is carried out in the field of conformity assessment; ............................................................... g) inspection bodies in the field of conformity assessment. " 8. The title of Chapter II shall read as follows: "" CHAPTER II National accreditation body ' 9. Article 6 shall read as follows: "" Art. 6. -The national accreditation body shall: 1. to be a legal person of private law, of public utility, having legal status of association without patrimonial purpose, established according to the provisions Government Ordinance no. 26/2000 on associations and foundations, the objective of which is to develop the accreditation and certification of conformity and to confer confidence in the technical competence, impartiality and integrity of accredited bodies and laboratories; 2. have the favorable assessment of the state authority that coordinates the field of quality infrastructure and conformity assessment; 3. to apply the basic principles of accreditation provided for in art. 4 4; 4. have the following main tasks: a) developing and updating the rules of accreditation according to the evolution of European and international practice in this field; b) application of national policy in the field of accreditation; c) the establishment and application of the criteria for selecting the assessors/technical experts involved in the accreditation/supervision process and the criteria for monitoring their activity; d) accreditation of the bodies and laboratories referred to in art. 5 5 para. ((1) and issue of the accreditation certificate; e) the granting of the right of use of the national accreditation mark to laboratories and accredited bodies; f) Romania's representation in European and international accreditation organizations; g) development of international partnership in the field of accreditation, mutual recognition of accreditation and certification of conformity; h) participation in the development of regulations on the protection of life, health and safety of individuals, as well as of the environment and the defence of i) participation at national, European and international level in the development of standards in its field of activity; j) provision of training and knowledge transfer services in the field of accreditation; k) collection, processing, storage and dissemination of information on accreditation; l) editing, publishing and dissemination of documents on accreditation; m) elaboration and publication of an annual activity report; 5. keep records on: a) laboratories and bodies referred to in art. 5 5 para. (1) applying for accreditation, as well as accredited laboratories and bodies; b) members of the national accreditation body; c) the technical accreditation committees and their members; d) the evaluators and experts involved in the accreditation; 6. to constitute and make available to the public a collection of guides and other national and international documents relating to accreditation; 7. ensure the balanced participation in the accreditation of representatives of the authorities concerned, producers, trade unions, organisations for the protection of the interests of consumers, professional associations, bodies and accredited laboratories and the like; 8. establish in accordance with national reference standards: a) the rules for granting, maintaining, suspending and withdrawing the accreditation certificate of bodies and laboratories; b) the rules on the handling of complaints and appeals; c) conditions of use of the national accreditation mark; d) the criteria for selecting the assessors/experts involved in the accreditation; 9. to initiate, propose and stimulate the organization of comparative interlaboratory tests; 10. to perform any other duties provided for in other normative acts, in connection with its main purpose; 11. to periodically inform the authorities about activities in the field of accreditation and to provide expertise, if requested; 12. to collaborate with the Romanian Bureau of Legal Metrology in order to ensure the traceability of measurements to national and international standards. " 10. Article 7 shall read as follows: "" Art. 7. -(1) Provisions of art. 6 6 must be contained within the framework of the national accreditation body. (2) The status of the national accreditation body must comply with the provisions of the framework statute, of the present ordinance, Government Ordinance no. 26/2000 ,, and the following: A. may be a member of the national accreditation body, with the approval of the general meeting, any legal person who agrees with the status and wishes to support the achievement of its purpose; B. general assembly of members of the national accreditation body shall be structured in colleges, as follows: a) College of accredited bodies, comprising representatives of accredited laboratories and certification bodies and inspection bodies, as well as their non-patrimonial associations; b) College of beneficiaries, comprising representatives of legal entities benefiting from the services of accredited laboratories and bodies, such as economic agents, including small and medium-sized enterprises, employers ' organizations, trade and industry, financial-banking and insurance organizations, trade associations, federations and trade union confederations, and the like, including non-patrimonial associations thereof; c) College of consumers, comprising representatives of organizations without patrimonial purpose of defending the interests of consumers, persons with disabilities, human rights, experts and consultants in the field of quality and/or in the field of environmental protection, educational institutions, universities, technology transfer, incubation and innovation centres, local development and the like; d) The College of Authorities, which includes representatives of public regulators interested in the development of the National System of Quality Infrastructure and conformity assessment; C. the structure of the management and administration bodies, to ensure the balanced representation of each college, namely the interests represented in them; D. the national standardisation body shall be a member of the national accreditation body as well as its Governing Board; E. the State authority coordinating the field of quality infrastructure and conformity assessment shall, by order, appoint its representative from the College of the authorities to the Governing Board; accreditation and has the right to veto decisions contrary to national policy in the field of accreditation. (3) The state authority coordinating the field of quality infrastructure and conformity assessment will develop the framework status of the national accreditation body, provided in par. (1), approved by order of the ruler or within 30 days from the publication of the law for the approval of this ordinance in the Official Gazette of Romania, Part I. " 11. Article 8 shall be repealed. 12. The title of Chapter IV shall read as follows: "" CHAPTER IV Final provisions ' 13. After the title of Chapter IV, Article 8 ^ 1 shall be inserted as follows: "" Art. 8 8 ^ 1. -The Ministry of Industry and Resources is the state authority that coordinates the field of quality infrastructure and conformity assessment and has the responsibility of developing strategies and policies in this field, which includes accreditation. " 14. Article 9 shall read as follows: "" Art. 9. -(1) The national accreditation body, established according to the provisions of art. 6 6 section 1, is hereinafter referred to as the Association. (2) The Association, as a national accreditation body, operates under the coordination of the Ministry of Industry and Resources. " 15 articles 10 and 11 shall be repealed. 16. Article 12 shall read as follows: "" Art. 12. -(1) The amounts representing the dues that the Association must pay as a member or affiliate of international, European and regional accreditation organizations can be allocated through the budget of the Ministry of Industry and Resources, in limited funds available. (2) The funds required to participate in the works of European and international accreditation bodies may be allocated through the budget of the Ministry of Industry and Resources, within the limits of available funds, at the request of the Association annual meetings. " 17. Article 13 shall be repealed. 18. Article 14 shall read as follows: "" Art. 14. -For the services offered, provided in art. 6 6 section 3 lit. c), d) and i)-k), as well as for other services provided in the statute the Association has the right to establish and collect, as the case may be, tariffs. " 19. Article 15 shall read as follows: "" Art. 15. -(1) In Romania the Association acquires, rightfully, the exclusivity of the exercise of the duties provided in 6 6 section 3 lit. a)-f). (2) The Association shall not be entitled to provide certification and inspection, testing and calibration services, as well as consultancy for obtaining or maintaining accreditation. " 20. Article 16 shall read as follows: "" Art. 16. -(1) National accreditation mark < > is the property of the Ministry of Industry and Resources, is registered with the State Office for Inventions and Trademarks and is awarded directly for administration to the recognized Association. (2) The national accreditation mark is a graphic representation containing the word < > accompanied by national insignia, certifying that a body or laboratory is competent to carry out specific tasks in the field for which it is accredited by the recognised Association. The national accreditation mark is set out in the Annex which forms an integral part of this Ordinance. ' 21. Article 17 shall read as follows: "" Art. 17. -(1) The Ministry of Industry and Resources shall grant or withdraw the recognition of the Association as a national accreditation body under the conditions of this ordinance The granting or withdrawal of recognition is by order of the Minister of Industry and Resources. ((2) The recognition of the Association as a national accreditation body is valid as long as it complies with the provisions of this ordinance. " 22. Articles 18 to 20 shall be repealed. 23. Article 21 shall read as follows: "" Art. 21. -In case of liquidation or withdrawal of recognition, the patrimony acquired by the Association through programs financed directly or indirectly by the Ministry of Industry and Resources, as well as the national accreditation mark < > shall be transferred directly to another association recognized in accordance with the provisions of 24. Article 22 shall be repealed. 25. Article 23 shall read as follows: "" Art. 23. -In application of the provisions of this ordinance the Minister of Industry and Resources issues orders and instructions 26. The Annex shall read as follows: "" ANNEX NATIONAL ACCREDITATION MARK < > National accreditation mark < > > consists of an ellipse having the horizontal semi-axis/semi-axis ratio 2:1. The vertical axis is the symmetry axis for < >, Romanian coat of arms and < > >. < > > font Times New Roman, corp 24 ● < > >-font Times New Roman, corp 36. The mark is shown in the following figure: image NOTE: The brand is colored as follows: ● < > >: -the letters "RO"Blue-the letters" MAN "yellow-the letters" IA " red ● Romanian coat of arms: in official colors ● < > >: -the letters "RE"blue-letter" N "yellow-the letters" AR " red ● Missing: black If the mark is to be increased or reduced, it is necessary to respect the proportions shown in the figure above. ' + Article 2 Government Ordinance no. 38/1998 , with the amendments and completions brought by this law, will be republished in the Official Gazette of Romania, Part I, giving the texts a new numbering. This law was adopted by the Chamber of Deputies at its meeting on April 8, 2002, in compliance with the provisions of 74 74 para. (2) of the Romanian Constitution. CHAMBER OF DEPUTIES PRESIDENT VALER DORNEANU This law was adopted by the Senate at the meeting of 8 April 2002, in compliance with the provisions of art. 74 74 para. (2) of the Romanian Constitution. p. SENATE PRESIDENT, DORU IOAN TARACILA ----------------