Monitoring of the performance and decision-making of national safety authorities
1. In order to perform the tasks entrusted to it and to assist the Commission in fulfilling its duties under the TFEU, the Agency shall monitor the performance and decision-making of national safety authorities through audit and inspections, on behalf of the Commission.
2. The Agency shall be entitled to audit:
(a)
the capacity of national safety authorities to execute tasks relating to railway safety and interoperability; and
(b)
the effectiveness of the monitoring by national safety authorities of safety management systems of actors as referred to in Article 17 of Directive (EU) 2016/798.
The Management Board shall adopt the policy, working methods, procedures and practical arrangements for the application of this paragraph, including, where appropriate, arrangements regarding consultation with Member States before the publication of information.
The Agency shall promote the inclusion in the audit team of qualified auditors from national safety authorities that are not subject to the actual audit. For that purpose, the Agency shall establish a list of qualified auditors and provide them with training when needed.
3. The Agency shall issue audit reports and send them to the national safety authority concerned, to the Member State concerned and to the Commission. Each audit report shall include, in particular, a list of any deficiencies identified by the Agency as well as recommendations for improvement.
4. If the Agency considers that the deficiencies referred to in paragraph 3 prevent the national safety authority concerned from effectively performing its tasks in relation to railway safety and interoperability, the Agency shall recommend to the national safety authority that it take appropriate steps within a mutually agreed time limit, taking into account the seriousness of the deficiency. The Member State concerned shall be kept informed by the Agency about such a recommendation.
5. Where a national safety authority disagrees with the Agency's recommendations referred to in paragraph 4, or does not take the appropriate steps referred to in paragraph 4, or where no answer is given by a national safety authority in response to the Agency's recommendations within 3 months of receipt thereof, the Agency shall inform the Commission.
6. The Commission shall inform the Member State concerned of the issue and ask it to state its position regarding the recommendation referred to in paragraph 4. Where the answers provided are deemed not to be sufficient or, where no answer is given by the Member State within 3 months of the Commission's request, the Commission may within 6 months take appropriate action concerning the steps to be taken as a result of the audit, where relevant.
7. The Agency shall be entitled to conduct pre-announced inspections of national safety authorities, to verify specific areas of their activities and operation, and in particular to review documents, processes and records relating to their tasks as referred to in Directive (EU) 2016/798. The inspections may be conducted on an ad hoc basis or in accordance with a plan developed by the Agency. The duration of an inspection shall not exceed 2 days. The national authorities of the Member States shall facilitate the work of the Agency's staff. The Agency shall provide the Commission, the Member State concerned and the national safety authority concerned with a report on each inspection.
The policy, working methods and procedure for performing the inspections shall be adopted by the Management Board.
Monitoring of notified conformity assessment bodies
1. For the purposes of Article 41 of Directive (EU) 2016/797, the Agency shall support the Commission in monitoring the notified conformity assessment bodies through the provision of assistance to accreditation bodies and to the relevant national authorities, and through audits and inspections, as provided for in paragraphs 2 to 6.
2. The Agency shall support harmonised accreditation of notified conformity assessment bodies, in particular by giving the accreditation bodies appropriate guidance on evaluation criteria and procedures to assess whether notified bodies meet the requirements referred to in Chapter VI of Directive (EU) 2016/797, via the European accreditation infrastructure recognised pursuant to Article 14 of Regulation (EC) No 765/2008.
3. In the case of notified conformity assessment bodies which are not accredited in accordance with Article 27 of Directive (EU) 2016/797, the Agency may audit their capacity to meet the requirements laid down in Article 30 of Directive (EU) 2016/797. The procedure for performing audits shall be adopted by the Management Board.
4. The Agency shall issue audit reports covering the activities referred to in paragraph 3 and send them to the notified conformity assessment body concerned, to the Member State concerned and to the Commission. Each audit report shall include, in particular, a list of any deficiencies identified by the Agency as well as recommendations for improvement. If the Agency considers that those deficiencies prevent the notified conformity assessment body concerned from effectively performing its tasks in relation to railway interoperability, the Agency shall adopt a recommendation requesting the Member State in which that notified body is established to take appropriate steps, within a mutually agreed time limit, taking into account the seriousness of the deficiency.
5. Where a Member State disagrees with the recommendation referred to in paragraph 4 or does not take the appropriate steps referred to in paragraph 4, or where no answer is given by a notified body in response to the Agency's recommendation within 3 months of receipt thereof, the Agency shall inform the Commission. The Commission shall inform the Member State concerned about the issue and ask it to state its position regarding the recommendation. Where the answers provided are deemed not to be sufficient or where no answer is given by the Member State within 3 months of receipt of the Commission's request, the Commission may adopt a decision within a period of 6 months.
6. The Agency shall be entitled to conduct pre-announced or unannounced inspections of notified conformity assessment bodies, to verify specific areas of their activities and operation, and in particular to review documents, certificates and records relating to their tasks as referred to in Article 41 of Directive (EU) 2016/797. In the case of accredited bodies, the Agency shall cooperate with the relevant national accreditation bodies. In the case of conformity assessment bodies which are not accredited, the Agency shall cooperate with the relevant national authorities that recognised the notified bodies concerned. The inspections may be conducted on an ad hoc basis or in accordance with the policy, working methods and procedures developed by the Agency. The duration of an inspection shall not exceed 2 days. The notified conformity assessment bodies shall facilitate the work of the Agency's staff. The Agency shall provide the Commission and the Member State concerned with a report on each inspection.
Monitoring progress of railway safety and interoperability
1. The Agency, together with the national investigation bodies, shall collect relevant data on accidents and incidents, taking into account the contribution of the national investigation bodies to the safety of the Union rail system.
2. The Agency shall monitor the overall safety performance of the Union rail system. The Agency may in particular seek the assistance of the bodies referred to in Article 38, including assistance in the form of the collection of data and access to the results of the peer review in accordance with Article 22(7) of Directive (EU) 2016/798. The Agency shall also draw on the data collected by Eurostat and shall cooperate with Eurostat to prevent any duplication of work and to ensure methodological consistency between the CSIs and the indicators used in other modes of transport.
3. At the Commission's request, the Agency shall issue recommendations on how to improve the interoperability of the Union rail system, in particular by facilitating coordination between railway undertakings and infrastructure managers, or between infrastructure managers.
4. The Agency shall monitor progress on the safety and interoperability of the Union rail system. Every 2 years it shall present to the Commission, and publish, a report on progress on safety and interoperability in the single European railway area.
5. The Agency shall, at the Commission's request, provide reports on the state of implementation and application of Union legislation on railway safety and interoperability in a given Member State.
6. The Agency shall, at the request of a Member State or the Commission, provide an overview of the safety and interoperability level of the Union rail system and establish a dedicated tool for that purpose, in accordance with Article 53(2) of Directive (EU) 2016/797.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
