Division 2

The organisation shall have procedures to guarantee conformity with the essential requirements for interoperability, including updates throughout the lifecycle, by:

1. (a)

   ensuring compliance with the specifications related to the basic parameters for interoperability as set out in the relevant technical specifications for interoperability (TSIs);

2. (b)

   verifying in all circumstances the consistency of the maintenance file with the authorisation related to the vehicle (including any national safety requirements), including the conformity to the technical file and the type of records as in the European Register of Authorised Types of Vehicles (ERATV);

3. (c)

   managing any substitution in the framework of maintenance;

4. (d)

   identifying the need for risk assessment of the potential impact of the change in question on the safety of the railway system, by application of the common safety methods related to the risk evaluation and assessment methods as adopted pursuant to point (a) of Article 6(1) of Directive (EU) 2016/798;

5. (e)

   managing the configuration of all technical changes affecting the system integrity of the vehicle.