ANNEX IISupplementary provisions
ANNEX II Aspects for assessment by the authorising entity The information that shall be assessed by the authorising entity is specified per authorisation case. An (x) in the column for the applicable authorisation case indicates that this aspect is mandatory to assess for this authorisation case. First authorisation Renewed type authorisation Extended area of use New authorisation Authorisation in conformity to type 1 Application consistent with the pre-engagement baseline (when applicable) X X X X X 2 Authorisation case selected by the applicant is adequate X X X X X 3 The TSIs and other applicable Union law identified by the applicant are correct X X X X 4 Selected conformity assessment bodies (notified body(ies), assessment body (CSM RA)) have the proper accreditation or recognition as applicable X X X X 5 Non-applications of TSIs according to the provisions of Article 7 of Directive (EU) 2016/797: 5.1. Validity (time and area of use); 5.2. Applicable to the project; and 5.3. Consistent with the identified and applied rules. X X X X X 6 6.1. Is the applied methodology used for the requirements capture fit for purpose concerning the following aspects: (a) Has a standardised/accepted methodology been used?; and (b) Is the method intended for and suitable for the essential requirements it covers? 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: (a) Degree of independent assessment applied (b) System definition (c) Hazard identification and classification (d) Risk acceptance principles (e) Risk evaluation (f) Requirements established (g) Demonstration of compliance with the requirements (h) Hazard management (log) X X X 7 Sufficient evidence from the methodology used for the requirements capture: 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: (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. (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. 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: (a) System definition is complete and consistent with the design of the vehicle? (b) Hazard identification and classification is consistent and plausible? (c) All risks have been properly managed and mitigated? (d) Requirements derived from the risk management are properly traced to the risk and to the evidence of compliance with the requirement? (e) Structured and consistent management of the hazards throughout the process? (f) Is there a positive opinion from the independent assessment? X X X 8 EC Declarations of Verification and EC certificates (Article 15 Directive (EU) 2016/797), check: 8.1. Signatures 8.2. Validity 8.3. Scope 8.4. Conditions for use of the vehicle and other restrictions, non-compliances 8.5. Non-application of TSIs (when applicable) 8.6. All applicable legislation is covered, including other non-railway related legislation 8.7. Interoperability constituents (validity, scope, conditions for use and other restrictions): (a) EC certificates of conformity (b) EC certificates of suitability of use X X X X 9 Reports from Conformity assessment bodies (Article 15 Directive (EU) 2016/797), check: 9.1. Consistency with EC Declarations of Verification and EC certificates 9.2. All applicable rules are covered 9.3. Deviations & non-conformities (when applicable) are identified and match the non-application requests 9.4. Combination of modules used is allowed 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 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.). X X X X 10 Check of assessments from NSAs for the area of use, as specified in Article 43 X X X X 11 Validity of the original vehicle type authorisation X X X X 12 Original vehicle type authorisation is valid for the concerned area of use X X X 13 Existing conditions for use of the vehicle and other restrictions X X X 14 CSM on risk assessment, safety assessment report (Article 15 Regulation (EU) No 402/2013) covering the requirements capture for the essential requirements ‘safety’ for the subsystems and safe integration between subsystems positive opinion. X X X 15 CSM on risk assessment, safety assessment report (Article 15 Regulation (EU) No 402/2013) covering the potential modification of the overall safety level for the vehicle (significant change) positive opinion X X 16 Changes as compared to the authorised vehicle type are sufficiently described and match the CSM on risk assessment, safety assessment report (Article 15 Regulation (EU) No 402/2013) X 17 EC Declarations of Verification and EC certificates are properly updated in relation to the changed and/or updated rules X 18 Reports from conformity assessment bodies are properly updated in relation to the changed and/or updated rules: 18.1 Changed and/or updated rules are covered 18.2 There is evidence that the vehicle type still fulfils the requirements X 19 Evidence that the design of the vehicle type has not changed X X 20 Identification of the vehicle or series of vehicles covered by the declaration of conformity to the vehicle type X 21 Declaration of conformity to the type and supporting documents (Article 24 Directive (EU) 2016/797) X