REPUBLIC OF LITHUANIA
LAW
ON CONFORMITY ASSESSMENT
6 October 1998 No VIII-870
Vilnius
(As last amended on 24 March 2011 – No XI-1299)
CHAPTER ONE
GENERAL PROVISIONS
Article 1. Purpose of the Law
1. This Law shall establish the basis for the regulation of conformity assessment of products, processes, services, management systems, competence of persons to perform a certain type of work, define subjects of conformity assessment, functions of these subjects, lay down procedures of suspension of accreditation certificates, removal of the suspension of accreditation certificates and withdrawal of accreditation certificates, establish the grounds for suspension and withdrawal of the authority of notified bodies.
2. The provisions of this Law have been harmonized with the legal acts of the European Union listed in the Annex to this Law.
Article 2. Definitions
1. ‘Accreditation’ shall have the meaning assigned to it by 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 (hereinafter referred to as ‘Regulation (EC) No 765/2008’).
2. ‘Accreditation certificate’ shall mean a document attesting that a conformity assessment body meets the requirements of legal acts and/or standards.
4. ‘Conformity assessment body’ shall have the meaning assigned to it by Regulation (EC) No 765/2008.
5. ‘Conformity inspection body’ (hereinafter referred to as an ‘inspection body’) shall mean a legal person or a branch, registered in the Republic of Lithuania, of an enterprise established in a state of the European Economic Area, performing conformity assessment by measuring, observing, testing and inspecting the parameters specified in legal acts and/or standards.
6. ‘Conformity surveillance’ (hereinafter referred to as ‘surveillance’) shall mean periodic checks whether a product, process, service, management system, conformity assessment body or competence of a person to perform a certain type of work complies with the requirements of legal acts and/or standards.
7. ‘Conformity certificate’ shall mean a document attesting that a product, process, service or management system complies with the requirements of legal acts and/or standards.
8. ‘Conformity’ shall mean correspondence between a product, process, service, management system, conformity assessment body or competence of a person to perform a certain type of work and the requirements of legal acts and/or standards.
9. ‘Test’ shall mean the determination of parameters of products or processes in accordance with the procedure validated in the manner prescribed by standards.
12. ‘Calibration laboratory’ shall mean a laboratory carrying out calibration of measuring instruments.
13. ‘Qualification certificate’ shall mean a document attesting that the competence of a person to perform a certain type of work complies with the requirements of legal acts and/or standards.
14. ‘Calibration of a measuring instrument’ shall have the meaning assigned to it by the Law of the Republic of Lithuania on Metrology.
15. ‘Unregulated field of activity' shall mean conformity assessment of processes, services, management systems, conformity assessment bodies or competence of persons to perform a certain type of work, where such conformity assessment is not defined as compulsory by legal acts.
16. ‘Notified body’ shall mean an accredited testing laboratory, certification or inspection body which are designated by a ministry or any other institution authorised by the Government of the Republic of Lithuania (hereinafter referred to as the 'Government') to carry out conformity assessment pursuant to the requirements of the legal acts implementing the European Union law and of which the European Commission and the states of the European Economic Area are notified.
17. ‘Service’ shall mean an activity intended to satisfy the needs of a client as well as results of such activity.
18. ‘Process’ shall mean activities defined by legal acts and/or standards which transform inputs into products.
20. ‘Regulated field of activity' shall mean compulsory conformity assessment of products, processes, services, conformity assessment bodies or competence of persons to perform a certain type of work, as defined by legal acts.
21. ‘Certification body’ shall mean a legal person or a branch, registered in the Republic of Lithuania, of an enterprise established in a state of the European Economic Area, attesting that a product, process, service, management system or the competence of a person to perform a certain type of work complies with the requirements of legal acts and/or standards.
CHAPTER TWO
OBJECTS OF CONFORMITY ASSESSMENT. CONFORMITY ASSESSMENT IN REGULATED AND UNREGULATED FIELDS OF ACTIVITY
Article 3. Objects of Conformity Assessment
Objects of conformity assessment shall be as follows:
Article 4. Conformity Assessment in Regulated and Unregulated Fields of Activity
1. Conformity assessment shall be carried out in the regulated field of activity by notified, accredited bodies or other certification and inspection bodies as well as testing laboratories authorised in accordance with the procedure laid down by legal acts.
Article 5. Subjects of Conformity Assessment
1. Subjects of conformity assessment shall be as follows:
Article 6. Functions of Ministries and other Institutions Authorised by the Government
Ministries and other institutions authorised by the Government shall:
1) within their remit and in accordance with the procedure laid down by laws and other legal acts, implement legal acts of the European Union related to conformity assessment and set out the procedure of conformity assessment in the regulated field of activity;
2) in accordance with the procedure laid down by the Government, take decisions on the designation of accredited certification and inspection bodies and testing laboratories seeking to be notified bodies, notify the European Commission and the states of the European Economic Area about them, carry out the surveillance of these bodies and suspend and withdraw the authority of notified bodies in accordance with the procedure laid down in Chapter Four of this Law.
Article 7. National Accreditation Bureau and its Functions
1. The National Accreditation Bureau shall be a budgetary institution. It shall be established and its regulations shall be approved by the Government.
2. The National Accreditation Bureau shall:
1) assess and accredit certification and inspection bodies, testing and calibration laboratories, issue accreditation certificates in accordance with the procedure laid down by the National Accreditation Bureau and make available to the public the information about accredited conformity assessment bodies;
2) carry out the surveillance of accredited certification and inspection bodies, testing and calibration laboratories;
3) suspend accreditation certificates, revoke the suspension of accreditation certificates and withdraw accreditation certificates in accordance with the procedure laid down in Chapter IV of this Law;
4) ensure the recognition, at international level, of accreditation results and activities of accredited certification and inspection bodies as well as testing and calibration laboratories;
5) within its remit, represent the interests of the Republic of Lithuania regarding conformity assessment issues in international organisations and other states;
Article 8. Certification Bodies
Certification bodies shall be as follows:
Article 9. Functions of a Product Certification Body
Product certification bodies shall:
Article 10. Functions of Management Systems Certification Bodies
Management systems certification bodies shall:
Article 11. Functions of Bodies for Certification of the Competence of Persons to Perform a Certain Type of Work
Bodies for certification of the competence of persons to perform a certain type of work shall:
1) evaluate the competence of persons to perform a certain type of work and issue qualification certificates;
Article 12. Functions of Testing Laboratories
Testing laboratories shall:
Article 13. Functions of Calibration Laboratories
Calibration laboratories shall:
Article 14. Functions of Inspection Bodies
Inspection bodies shall:
Article 15. Functions of Notified Bodies
Notified bodies shall:
CHAPTER FOUR
SUSPENSION OF ACCREDITATION CERTIFICATES, REMOVAL OF SUSPENSION OF ACCREDITATION CERTIFICATES AND WITHDRAWAL OF
ACCREDITATION CERTIFICATES. SUSPENSION AND WITHDRAWAL OF AUTHORITY OF NOTIFIED BODIES
Article 16. Suspension of Accreditation Certificates
1. Accreditation certificates shall be suspended:
2) where the National Accreditation Bureau, while carrying out the surveillance of a conformity assessment body, establishes that it violated this Law, other legal acts, regulating conformity assessment, or the standards and has failed to eliminate the said violations within the time limit set out by the National Accreditation Bureau; the time limit shall not exceed three months.
2. A conformity assessment body shall submit to the National Accreditation Bureau a request to suspend an accreditation certificate. At the request of the conformity assessment body, the accreditation certificate shall be suspended for a period not exceeding six months from the date of the receipt of the request.
3. A decision to suspend the accreditation certificate shall be taken by the Director of the National Accreditation Bureau. The decision to suspend the accreditation certificate shall state the grounds for the suspension of the accreditation certificate, the time period for which the accreditation certificate is suspended as well as the period during which the conformity assessment body must eliminate the violations constituting the reason for the suspension of the accreditation certificate where the decision to suspend the accreditation certificate is taken in the case specified in subparagraph 2 of paragraph 1of this Article.
Article 17. Removal of Suspension of Accreditation Certificates
1. Suspension of accreditation certificates shall be removed where, upon the request of a conformity assessment body, the National Accreditation Bureau carries out assessment and determines that the conformity assessment body:
1) complies with the requirements of this Law, other legal acts, regulating conformity assessment, or of the standards after the suspension of the accreditation certificate at the request of the conformity assessment body, or
2. A decision to remove the suspension of the accreditation certificate shall be taken by the Director of the National Accreditation Bureau. The decision to remove the suspension of the accreditation certificate shall state the grounds for the removal of the suspension of the accreditation certificate.
Article 18. Withdrawal of Accreditation Certificates
1. Accreditation certificates shall be withdrawn:
2) where the conformity assessment body has failed, within the time limit set out by the National Accreditation Bureau, to eliminate violations due to which the accreditation certificate was suspended, or
3) where the conformity assessment body, for which the accreditation certificate is suspended at it own request, upon the expiration of the time period of suspension of the accreditation certificate does not apply to the National Accreditation Bureau with a request to carry out assessment and to remove the suspension of the accreditation certificate, or
2. A decision to withdraw the accreditation certificate shall be taken by the Director of the National Accreditation Bureau. The decision to withdraw the accreditation certificate shall state the grounds for the withdrawal of the accreditation certificate.
Article 19. Suspension of Authority of Notified Bodies
1. Ministries or other institutions authorised by the Government and specified in Article 6 of this Law shall take decisions on the suspension of authority of the notified bodies subject to their surveillance:
2. A ministry or any other institution authorised by the Government shall suspend the authority of the notified body for the time limit not exceeding three months.
Article 20. Withdrawal of Authority of Notified Bodies
1. Ministries or other institutions authorised Government and specified in Article 6 of this Law shall take decisions on the withdrawal of authority of the notified bodies subject to their surveillance:
2) if within the time period for which the authority of a notified body has been suspended it has not applied to the ministry or any other institution authorised by the Government and has not presented the documents proving the elimination of violations, where its powers have been suspended in the case specified in subparagraph 2 of paragraph 1 of Article 19 of this Law.
Article 21. Payment for Conformity Assessment Work
1. Testing and calibration laboratories, certification and inspection bodies, wishing to become accredited, shall pay the expenses related to conformity assessment and accreditation according to the rates approved in accordance with the procedure laid down by the Government.
2. Legal and natural persons shall pay the expenses related to certification, inspection, testing and calibration according to contracts.
Article 22. Filing of Complaints
1. Decisions taken by the National Accreditation Bureau and the conformity assessment bodies accredited by it may be appealed against to the Appeals Commission of Conformity Assessment within 15 calendar days after the receipt of the decision. The regulations of the said Commission shall be approved in accordance with the procedure laid down by the Government or the ministry authorised by it. Should the decision of this commission be disputed, it may be appealed against in administrative court.
Article 23. Recognition of Conformity Assessment Documents Issued in Other Countries
Conformity assessment documents issued in other countries shall be recognised in accordance with the procedure established by international agreements.
Article 24. Liability of Subjects of Conformity Assessment
Subjects of conformity assessment who have violated the requirements of this Law shall be held liable in accordance with the procedure established by the laws of the Republic of Lithuania.
Annex to
the Law of the Republic of Lithuania
on Conformity Assessment
LEGAL ACTS OF THE EUROPEAN UNION IMPLEMENTED BY THIS LAW
1. 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 (OJ 2008 L 218, p. 30).