Overview (table of contents)
The full text of the Ordinance on requirements for designated bodies in the rail sector
Under section 21 h, paragraph 1 1. paragraph, and article 26, paragraph 2, of the law on rail, see. lovbekendtgørelse nr. 1249 of 11. November 2010, shall be determined pursuant to the authority in accordance with § 24 h, paragraph 1: scope and definitions
§ 1. The notice applies to conformity assessment bodies, which are registered with the Agency and who wish to be appointed to carry out tasks of assessing conformity with national technical regulations and subsystems to implement the verification procedure of the subsystems in the rail sector in accordance with the interoperability directive in cases where the national technical regulations shall apply.
§ 2. For the purposes of this order: 1) Subsystems: the result of the rail system's Division into structural or functional subsystems, see. Article 2 (e) and annex II of the interoperability directive.
2) interoperability directive: European Parliament and Council Directive 2008/57/EC of 17 May 2006. June 2008 on the interoperability of the railway system in the community, as amended. The directive is implemented by Decree No. 459 of 28. April 2010 with subsequent amendments.
3) national technical rules: The national, technical regulations, as Denmark pursuant to interoperabilitetsdirektivets article 17, paragraph 3, has informed the EU Commission (also called national technical rules notified).
4) conformity assessment: A process for determining whether a product, process, service, system, person or body are fulfilled the specific requirements that apply to them.
5) conformity assessment body means a body that performs conformity assessment tasks, including calibration, testing, certification and inspection.
6) designated bodies: the bodies which have been entrusted with the task of assessing conformity with national technical regulations and subsystems to implement the verification procedure of the subsystems in accordance with the interoperability directive in cases where the national technical regulations shall apply.
§ 3. Conformity assessment bodies wishing to be appointed to carry out tasks of assessing conformity with national technical regulations and subsystems to implement the verification procedure of the subsystems in accordance with the interoperability directive in cases where the national technical regulations apply shall: 1) meet the requirements of the Executive order on Annex 1 and 2) have taken out professional liability insurance, which covers the activities they perform as designated body without prejudice to article. Annex 1.
(2). Where the conformity assessment body accredited, see. Executive Order No. 1195 of 13. December 2011 on the requirements for notified bodies in the rail sector, recognised body as designated body under this Ordinance, if the accreditation also includes the respective national technical rules.
§ 4. Designation of conformity bodies referred to in article 6. § 1, shall be made by public transport.
(2). Application for designation are submitted to the Traffic Agency. Documentation for compliance with the requirements of the basic regulation. Annex 1, must be attached to the application.
(3). The nomination, see. (1) is valid for a period of up to 5 years.
(4). Where the conformity assessment body accredited, see. § 3, paragraph 2, the application shall be accompanied by evidence that the accreditation includes the respective national technical rules.
(5). After designating conformity assessment body shall be referred to as "designated body".
(6). The name of the notified body and the indication of the designation includes, what tasks will be published on the Agency's website Traffic.
§ 5. Provided that with the body changes of significance for designation, the notified body shall, as soon as possible give Traffic agency thereof.
§ 6. Traffic agency supervises the designated bodies in accordance with the provisions of this Ordinance, which has not been accredited, fulfils the conditions set out in this notice.
§ 7. Traffic Board may revoke the designation if the body no longer meets the conditions necessary for the nomination.
(2). If the notified body no longer meets the conditions laid down, as specified in annex 1, the Agency shall immediately provide Traffic agency thereof.
Waiver and appeal
§ 8. Danish transport authority may exempt from the requirements of this Ordinance, when it is compatible with EU rules in this area.
§ 9. Decisions of the Traffic Agency pursuant to this order may be appealed to the Secretary of State.
Date of entry into force of
§ 10. The notice shall enter into force on the 1. June 2012.
Danish transport authority, the 16. may 2012 Carley H/Lucy
Annex 1 CRITERIA, which DESIGNATED BODIES MUST MEET 1. The body, its Director and the staff responsible must carry out the checks, may not become involved either directly or as authorized representatives in the design, manufacture, construction, marketing or maintenance of the interoperability constituents or subsystems or in their use; They also may not be involved in the operation. This does not exclude that there may be exchanged technical information between the manufacturer and the notified body.
2. the body and the staff responsible for the checks must carry out the checks with the greatest possible professional integrity and technical competence and must be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of the inspection, especially from persons or groups of persons with an interest in the result of verifications.
In particular, the body and the staff responsible for the checks must be functionally independent of the authorities designated to issue authorisations in accordance with the interoperability directive (Directive 2008/57/EC), licences under licensing directive (Directive 95/18/EC) and security certificates pursuant to the railway safety directive (Directive 2004/49/EC), as well as by the units responsible for carrying out accident investigations.
3. The body must have at its disposal the necessary staff and possess the means required to perform adequately the technical and administrative tasks linked with the checks; It must also have access to the equipment needed to implement the exceptional checks.
4. The staff responsible for the checks must possess:
— sound technical and vocational training
– satisfactory knowledge of the requirements for the tests they carry out and adequate experience of such inspections
– the ability to draw up the certificates, records and reports to demonstrate that the results of the checks.
5. the independence of the staff responsible for inspections must be guaranteed. The remuneration of each Member of staff must not depend on how many checks the person performs, or by checking the results.
6. The body must take out liability insurance unless its liability is assumed by the State under national law, or the Member State itself is directly responsible for the inspections.
7. The staff of the body are bound by professional secrecy (except to the competent administrative authorities and the investigation units in the State in which it operates as well as the investigatory units responsible for conducting investigations of accidents caused by the failure of the interoperability constituents or subsystems checked) with regard to all information gained in carrying out its activities in accordance with this directive or any provision of national law issued in implementation thereof.