Annex II Aspects for assessment by the authorising entity

Non-applications of TSIs according to the provisions of Article 7 of Directive (EU) 2016/797:

1. 5.1.

   Validity (time and area of use);

2. 5.2.

   Applicable to the project; and

3. 5.3.

   Consistent with the identified and applied rules.

1. 6.1.

   Is the applied methodology used for the requirements capture fit for purpose concerning the following aspects:

   1. (a)

      Has a standardised/accepted methodology been used?; and

   2. (b)

      Is the method intended for and suitable for the essential requirements it covers?

2. 6.2.

   When the methodology applied is not standardised or covers other essential requirements than it is intended for, the following aspects shall be checked to evaluate if they are sufficiently considered and covered by the methodology:

   1. (a)

      Degree of independent assessment applied

   2. (b)

      System definition

   3. (c)

      Hazard identification and classification

   4. (d)

      Risk acceptance principles

   5. (e)

      Risk evaluation

   6. (f)

      Requirements established

   7. (g)

      Demonstration of compliance with the requirements

   8. (h)

      Hazard management (log)

Sufficient evidence from the methodology used for the requirements capture:

1. 7.1.

   When the risk management process set out in Annex I of Regulation (EU) No 402/2013, has been used as the methodology for requirements capture the following shall be checked:

   1. (a)

      CSM on risk assessment, declaration by the proposer (Article 16 Regulation (EU) No 402/2013) is signed by the proposer and supports that all identified hazards and associated risks are controlled to an acceptable level.

   2. (b)

      CSM on risk assessment, safety assessment report (Article 15 Regulation (EU) No 402/2013) supports the declaration by the proposer for the specified scope according to Article 13 and at least the essential requirement safety for subsystems and safe integration between subsystems within the vehicle.

2. 7.2.

   When another methodology than the risk management process set out in Annex I of Regulation (EU) No 402/2013, has been used as the methodology for requirements capture the following shall be checked:

   1. (a)

      System definition is complete and consistent with the design of the vehicle?

   2. (b)

      Hazard identification and classification is consistent and plausible?

   3. (c)

      All risks have been properly managed and mitigated?

   4. (d)

      Requirements derived from the risk management are properly traced to the risk and to the evidence of compliance with the requirement?

   5. (e)

      Structured and consistent management of the hazards throughout the process?

   6. (f)

      Is there a positive opinion from the independent assessment?

EC Declarations of Verification and EC certificates (Article 15 Directive (EU) 2016/797), check:

1. 8.1.

   Signatures

2. 8.2.

   Validity

3. 8.3.

   Scope

4. 8.4.

   Conditions for use of the vehicle and other restrictions, non-compliances

5. 8.5.

   Non-application of TSIs (when applicable)

6. 8.6.

   All applicable legislation is covered, including other non-railway related legislation

7. 8.7.

   Interoperability constituents (validity, scope, conditions for use and other restrictions):

   1. (a)

      EC certificates of conformity

   2. (b)

      EC certificates of suitability of use

Reports from Conformity assessment bodies (Article 15 Directive (EU) 2016/797), check:

1. 9.1.

   Consistency with EC Declarations of Verification and EC certificates

2. 9.2.

   All applicable rules are covered

3. 9.3.

   Deviations & non-conformities (when applicable) are identified and match the non-application requests

4. 9.4.

   Combination of modules used is allowed

5. 9.5.

   Conditions for use of the vehicle and other restrictions are properly identified and are consistent with the conditions in the application for authorisation

6. 9.6.

   The supporting evidences used by the conformity assessment bodies are matching the applicable assessment phases described in TSIs (design review, type test, etc.).

Reports from conformity assessment bodies are properly updated in relation to the changed and/or updated rules:

1. 18.1

   Changed and/or updated rules are covered

2. 18.2

   There is evidence that the vehicle type still fulfils the requirements