Appendix ANNEX F CONFORMITY ASSESSMENT PROCEDURE

This conformity assessment procedure describes that part of the procedure by which a Body authorised by the MS ascertains and attests that the maintenance arrangements, representative of the maintenance envisaged, meet the provisions of the relevant TSI and ensure the respect of the basic parameters and essential requirements during the subsystem life.

The application shall include:

• the name and address of the contracting entity and if the application is lodged by the authorised representative, his name and address in addition;

• a written declaration that the same application has not been lodged with any other Body;

• any technical requirement, resulting from the design phase, that must be taken into account during maintenance

• the maintenance arrangements documentation, as described in point 3;

• the technical documentation as described in point 4.

The copy of the maintenance arrangement documentation submitted shall be the final version approved by the applicant.

The body authorised by the MS may request further copies if needed for carrying out the assessment.

• a description of how the maintenance arrangements shall be implemented, used and controlled;

• details of all maintenance required to be carried out, including its frequency;

• operational scenarios showing how necessary feedback information (and all other information relating to the maintenance) flows around the subsystem and other product/subsystems to support the process of maintenance;

• procedures (or reference to procedures) for specific processes according to the product/subsystem maintenance operations;

• a procedure for the management of modifications and updating of the maintenance arrangements;

• a description of any hardware and software required to read the maintenance arrangements;

• a description of all necessary elements to make the maintenance arrangements operational^f1.

The technical documentation, which justifies the maintenance arrangements, shall contain:

• a general type-description, (overview of how the subsystem works and a description of the technical functionality);

• a specification stating the conditions and the context within which the subsystem shall be used and maintained;

• demonstration of consistency between the requirements of the TSI the maintenance organisation, the technical functionality and the maintenance arrangements;

• descriptions, explanations and all the records necessary for understanding the development of the maintenance arrangements;

• records of the work done to validate the maintenance arrangements;

• records of the analysis of equipment used and people affected by the maintenance arrangements;

• conditions for use and maintenance of the interoperability constituent (restrictions of running time or distance, wear limits etc);

• a list of the technical specifications, against which the maintenance arrangements of the subsystem have been validated.

• identify the relevant provisions of the TSI with which the maintenance arrangement must comply;

• check that the maintenance arrangements documentation and technical documentation are complete and in accordance with the points 3 and 4;

• perform an examination of each development phase of the maintenance arrangements and their results to evaluate:

  • if each phase has been managed in a controlled manner;

  • the capability to fulfil the requirements for conformity for the maintenance arrangements;

• document its findings with regards to compliance of the maintenance arrangement with the TSI provisions.

The relevant parts of the technical documentation, including the description of maintenance arrangements and their conditions of implementation, must be annexed to the report and a copy kept by the body authorised by the MS.

If the contracting entity is denied a maintenance arrangements examination report, the body authorised by the MS must provide detailed reasons for such denial.

Provision must be made for an appeals procedure.