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Regulation (EU) 2016/796 of the European Parliament and of the Council of 11 May 2016 on the European Union Agency for Railways and repealing Regulation (EC) No 881/2004 (Text with EEA relevance) article 34 CELEX: 32016R0796 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. |
Regulation (EU) 2016/796 of the European Parliament and of the Council of 11 May 2016 on the European Union Agency for Railways and repealing Regulation (EC) No 881/2004 (Text with EEA relevance) article 34 CELEX: 32016R0796 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. |
Regulation (EU) 2016/796 of the European Parliament and of the Council of 11 May 2016 on the European Union Agency for Railways and repealing Regulation (EC) No 881/2004 (Text with EEA relevance) article 34 CELEX: 32016R0796 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. |
Regulation (EU) 2016/796 of the European Parliament and of the Council of 11 May 2016 on the European Union Agency for Railways and repealing Regulation (EC) No 881/2004 (Text with EEA relevance) article 34 CELEX: 32016R0796 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. |