Independent assessment
Article 6
1. An assessment body shall carry out an independent assessment of the suitability of both the application of the risk management process as set out in Annex I and of its results. This assessment body shall meet the criteria listed in Annex II. Where the assessment body is not already designated by existing Union or national legislation, the proposer shall appoint its own assessment body at the earliest appropriate stage of the risk assessment process. 2. To perform the independent assessment, the assessment body shall: (a) ensure it has a thorough understanding of the significant change based on the documentation provided by the proposer; (b) conduct an assessment of the processes used for managing safety and quality during the design and implementation of the significant change, if those processes are not already certified by a relevant conformity assessment body; (c) conduct an assessment of the application of those safety and quality processes during the design and implementation of the significant change. Having completed its assessment in accordance with points (a), (b) and (c), the assessment body shall deliver the safety assessment report provided for in Article 15 and Annex III. 3. Duplication of work between the following assessments shall be avoided: (a) the assessment of conformity of the safety management system and of the system of maintenance of entities in charge of maintenance as required by Directive 2004/49/EC; and (b) the conformity assessment carried out by a notified body as defined by Article 2(j) of Directive 2008/57/EC or a body designated in accordance with Article 17 of that Directive; and (c) any independent assessment carried out by the assessment body in accordance with this Regulation. 4. Without prejudice to Union legislation, the proposer may choose the national safety authority as assessment body where that national safety authority offers this service and where the significant changes concern the following cases: (a) a vehicle needs an authorisation for placing in service, as referred to in Articles 22(2) and 24(2) of Directive 2008/57/EC; (b) a vehicle needs an additional authorisation for placing in service, as referred to in Articles 23(5) and 25(4) of Directive 2008/57/EC; (c) the safety certificate has to be updated due to alteration of the type or extent of the operation, as referred to in Article 10(5) of Directive 2004/49/EC; (d) the safety certificate has to be revised due to substantial changes to the safety regulatory framework, as referred to in Article 10(5) of Directive 2004/49/EC; (e) the safety authorisation has to be updated due to substantial changes to the infrastructure, signalling or energy supply, or to the principles of their operation and maintenance, as referred to in Article 11(2) of Directive 2004/49/EC; (f) the safety authorisation has to be revised due to substantial changes to the safety regulatory framework, as referred to in Article 11(2) of Directive 2004/49/EC. Where a significant change concerns a structural subsystem that needs an authorisation for placing in service as referred to in Article 15(1) or Article 20 of Directive 2008/57/EC, the proposer may choose the national safety authority as assessment body, where that national safety authority offers this service, unless the proposer has already given that task to a notified body in accordance with Article 18(2) of that Directive.