Article 6Independent assessment
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 F1... 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 F2regulation 18A of the Railways and Other Guided Transport Systems (Safety) Regulations 2006 or paragraph 55A of the Schedule to the Channel Tunnel (Safety) (Amendment) Order 2013 F3 regulation 16AA of the Railways (Safety Management) Regulations (Northern Ireland) 2006; and
(b)
the conformity assessment carried out by F4an EU notified body or an approved body; and
(c)
any independent assessment carried out by the assessment body in accordance with this Regulation.
4.
F5The 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 F6...
(b)
a vehicle needs an additional authorisation for placing in service F7...
(c)
the safety certificate has to be updated due to alteration of the type or extent of the operation F8...
(d)
the safety certificate has to be revised due to substantial changes to the safety regulatory framework F9...
(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 F10...
(f)
the safety authorisation has to be revised due to substantial changes to the safety regulatory framework F11...
Where a significant change concerns a structural subsystem that needs an authorisation for placing in service F12..., 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 F13an approved body.