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REPUBLIC OF LITHUANIA

REPUBLIC OF LITHUANIA REPUBLIC OF LITHUANIA LAW ON THE CONFORMITY ASSESSMENT October 6, 1998 No. VIII - 870 Vilnius Chapter I GENERAL PROVISIONS Article

  1. Scope of the Law
  2. This Law shall establish the structure of the system of conformity assessment of products, processes, services, quality systems and qualifications of personnel, the main obligations and rights of authorised bodies, National Accreditation Bureau, certification bodies, testing and calibration laboratories, inspection bodies and suppliers and other principles of this system.
  3. This Law shall not apply to accreditation of health care activities. Article
  4. The Basic Definitions in this Law
  5. Conformity is fulfilment by a product, process or service of specified requirements.
  6. Conformity assessment is any activity concerned with determining directly or indirectly to what extent a product, process or service satisfies the specified requirements.
  7. Conformity surveillance system is conformity evaluation to determine the continuing conformity to specified requirements.
  8. Certificate of conformity is a document issued under the rules of a certification system, providing confidence that a duly identified product, process or service, is in conformity with a specific standard or other normative document.
  9. Mark of conformity (certification) is a protected mark, issued and applied under rules of a certification system, indicating that confidence is provided that the relevant product, process or service is in conformity with a specific standard or other normative document.
  10. Accreditation is a procedure by which the National Accreditation Bureau gives formal recognition that a legal person and also an enterprise not having the rights of a legal person, is competent to carry out conformity assessment activities.
  11. Test is a technical operation that consists of the determination of one or more characteristics of a given product, process or service according to a specified procedure.
  12. Calibration is determination of whether a measurement instrument corresponds to measurement standard.
  13. Inspection body is a legal person and also an enterprise not having the rights of a legal person, who perform conformity evaluation by observation and judgement accompanied as appropriate by measurement, testing or gauging.
  14. Certificate of competence is a document issued under the rules of certification system, attesting that a natural person is competent to perform certain functions according to the requirements specified by international or European standards.
  15. Quality system is the entirety of organisational structure, procedures, processes and resources, needed to implement quality management.
  16. Product is the result of activities or processes.
  17. Process is the entirety of all the activities involved in restructuring (processing) of output.
  18. Service is the result of supplier activity, intended to satisfy the needs of a client.
  19. Notified body is a test laboratory, certification or inspection body, which is assigned responsibility by the state, for conformity assessment, and notifies other states of this, also.
  20. Certification is a procedure by which a certification body gives assurance that a product, process, service, or natural person’s competence, conforms to specified requirements.
  21. Certification body is a legal person also, an enterprise not having the rights of a legal person, who performs the certification procedure.
  22. Supplier is a natural or legal person also, an enterprise not having the rights of a legal person. This concept is applied to manufacturers, distributors, importers, installers, service organisations, etc.
  23. Supplier’s declaration is a procedure by which a supplier gives written assurance that a product, process or service conforms to specific requirements.
  24. Mandatory assessment area is an area of activity, in which authorised bodies have established mandatory conformity assessment of products, processes or services to the requirements of safety and harmlessness to health and environment.
  25. Non-mandatory assessment area is an area of activity, in which authorised bodies have not established mandatory assessment of conformity products, processes or services to the requirements of safety and harmlessness to health and environment.
  26. Authorised institution is an institution, which has been assigned the management functions in connection with conformity assessment, by the Law or by the Government of the Republic of Lithuania. Chapter II STRUCTURE OF THE CONFORMITY ASSESSMENT SYSTEM Article
  27. Objects of Conformity Assessment The following shall be objects of conformity assessment according to this Law: 1) products, processes and services; 2) quality systems; 3) competence of personnel to perform a certain type of work. Article
  28. Participants of the Conformity Assessment System
  29. The following shall be the participants of the conformity assessment system: 1) authorised institutions; 2) the National Accreditation Bureau; 3) certification bodies; 4) testing and calibration laboratories; 5) inspection bodies; 6) suppliers.
  30. Participants in the conformity assessment system shall follow this Law, other legal acts, international agreements and standards conforming to the requirements of international and European Union legal acts and standards. Article
  31. Conformity Assessment in Mandatory and Non-mandatory Areas
  32. Authorised institutions shall establish the order of conformity assessment in a mandatory area. Only the notified or accredited certification and inspection bodies and testing laboratories shall participate in the conformity assessment activities.
  33. In a non-mandatory area, conformity assessment shall be conducted on a voluntary basis, on the supplier’s initiative, striving to meet market needs. Accredited or non-accredited certification and inspection bodies and testing laboratories shall participate in conformity assessment activity. Calibration services may be supplied only by accredited calibration laboratories. Chapter III THE MAIN RIGHTS AND OBLIGATIONS OF THE PARTICIPANTS OF THE CONFORMITY ASSESSMENT SYSTEM Article
  34. Authorised Institutions Authorised institutions: 1) shall according to certain international and European Union legal acts, establish mandatory conformity assessment of specific objects indicated in Article 3 of this Law and requirements applied to them; 2) shall notify the certification and inspection bodies and testing laboratories responsible for conformity assessment, suspend or withdraw the authorisation given them, should they fail to observe notification regulations which have been approved in accordance with the procedure established by the Government. Article
  35. The National Accreditation Bureau
  36. The Government or an institution authorised by it, shall establish the National Accreditation Bureau and approve its statutes.
  37. The National Accreditation Bureau shall: 1) assess the certification and inspection bodies and testing laboratories proposed for notification by authorised institutions; 2) accredit certification and inspection bodies, testing and calibration laboratories by their request, issue accreditation certificates and supply information relevant to them according to the procedure established by the National Accreditation Bureau; 3) perform surveillance of the activities of accredited and notified certification and inspection bodies and testing and calibration laboratories; 4) withdraw accreditation certificates or suspend their validity according to procedure established by the National Accreditation Bureau, should the accredited certification and inspection body or testing and calibration laboratory fail to observe the provisions of part 2 of Article 4 of this Law; 5) seek that accreditation results and activity of the accredited certification and inspection bodies and testing and calibration laboratories would be internationally recognised; 6) according to competence, represent the interests of the Republic of Lithuania in issues of conformity assessment in international organisations and foreign countries. Article
  38. Certification Bodies and their Types
  39. Legal persons and also, enterprises which do not have the rights of legal persons, who follow the provisions of part 2 of Article 4 and Article 5, may act in the capacity of certification bodies.
  40. Certification bodies are: 1) product certification bodies; 2) quality systems certification bodies; 3) personnel certification bodies. Article
  41. Product Certification Bodies Product certification bodies shall: 1) certify products, processes and services and issue certificates of conformity; 2) perform surveillance of certified products, processes and services; 3) withdraw certificates of conformity or suspend validity thereof or of the use of mark of conformity, according to the procedure established by legal acts regulating conformity assessment, if the supplier fails to observe the rules of certification; 4) seek international recognition of certificates of conformity and recognise, the certificates of conformity of other countries, according to established procedure. Article
  42. Quality System Certification Bodies Quality system certification bodies shall: 1) certify quality systems and issue quality system certificates; 2) perform surveillance of quality systems; 3) withdraw quality system certificates or suspend the validity thereof in accordance with the procedure established by legal acts regulating conformity assessment, if certification rules are not observed. Article
  43. Personnel Certification Bodies Personnel certification bodies shall: 1) certify personnel recognising their competence in performing certain types of work; 2) survey activities of certified personnel; 3) withdraw competence certificates or suspend validity thereof in accordance with the procedure established by legal acts, regulating conformity assessment, if personnel fail to observe the rules of certification. Article
  44. Testing and Calibration Laboratories Legal persons and also enterprises which do not have the rights of legal persons, who follow the provisions of part 2 of Article 4 and Article 5 of this Law, may act in the capacity of testing and calibration laboratories. Article
  45. Testing Laboratories Testing laboratories shall: 1) perform tests; 2) issue reports of test results. Article
  46. Calibration Laboratories Calibration laboratories shall: 1) perform calibration of measurement instruments; 2) issue calibration certificates. Article
  47. Inspection Bodies
  48. Legal persons and also enterprises which do not have the rights of legal persons, who follow the provisions of part 2 of Article 4 and Article 5 of this Law, may act in the capacity of inspection bodies.
  49. An inspection body shall: 1) verify, whether products, processes and services conform to the requirements specified for them; 2) conduct conformity surveillance according to their competence; 3) issue inspection reports and/or inspection certificates. Article
  50. Suppliers
  51. Suppliers shall ensure the conformity of products, processes and services.
  52. Suppliers shall declare that products, processes and services meet the requirements of documents, referred in the declaration. Article
  53. Reimbursement of Costs of Conformity Assessment Work
  54. Legal persons as well as bodies not having the rights of legal persons, who wish to become accredited, shall compensate for accreditation expenses according to the valuations approved in accordance with the procedure established by the Government.
  55. Legal and natural persons shall compensate the expenses incurred in certification and surveillance of meeting its conditions, inspection and testing in the mandatory assessment area, according to valuations, approved in accordance with the procedure established by the Government; in the non-regulatory assessment area they shall compensate such expenses according to contract. Article
  56. Examination of Appeals It shall be possible to appeal the decisions adopted by the National Accreditation Bureau and the conformity assessment system participants accredited by it, within 15 days before the Appeals Commission, whose statutes shall be approved according to the procedure established by the Government or body authorised by it. Should the decision of this commission be disputed, it may be appealed in district court. Chapter IV FINAL PROVISIONS Article
  57. Recognition of Conformity Assessment Documents Issued in Foreign Countries Conformity assessment documents issued by foreign countries shall be recognised in accordance with the procedure established by international agreements. Article
  58. Liability of Participants of Conformity Assessment System Participants of the conformity assessment system, who shall be in violation of the requirements of this Law, shall be held liable according to the procedure established by the laws of the Republic of Lithuania. I promulgate this Law passed by the Seimas of the Republic of Lithuania. PRESIDENT OF THE REPUBLIC VALDAS ADAMKUS

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