The Railways (Interoperability) Regulations 2011

[F1 (This Schedule substantially reproduces Annex VI to the Directive with amendments to correct deficiencies arising from the UK’s withdrawal from the European Union.) U.K.

Textual Amendments

F1 Sch. 4 inserted (31.12.2020) by The Railways (Interoperability) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/345), reg. 1(2), Sch. 3 (as amended by The Railways (Interoperability) (Miscellaneous Amendments and Revocations) (EU Exit) Regulations 2020 (S.I. 2020/318), regs. 1(2)(b), 5(13)(a), 5(13)(b), 5(13)(c), 5(13)(d)); 2020 c. 1, Sch. 5 para. 1(1)

1.   General principles U.K.

“UK verification” means a procedure carried out by a project entity applying for an authorisation pursuant to regulation 6 or regulation 17, to demonstrate that the requirements of these Regulations and any NTSNs or relevant NTRs relating to a subsystem have been fulfilled and the subsystem may be authorised to be placed in service.

2.   UK certificate of verification issued by an approved body U.K.

2.1.   Introduction U.K.

For the purpose of these Regulations, the verification by reference to NTSNs is the procedure whereby an approved body checks and certifies that the subsystem complies with the relevant NTSNs, save for any applicable UK specific cases contained in those NTSNs.

This is without prejudice to the obligations of the project entity to comply with any other enactment or rule of law, including any verifications by the assessment bodies required by other legislation.

2.2.   Intermediate statement of verification (ISV) U.K.

(2.2.1) Principles

At the request of the project entity, the verifications may be done for parts of a subsystem or may be limited to certain stages of the UK verification assessment procedure. In these cases, the results of UK verification may be documented in an “intermediate statement of verification” (ISV) issued by the approved body chosen by the project entity.

The ISV must provide reference to the NTSNs with which the conformity has been assessed.

(2.2.2) Parts of the subsystem

The project entity may apply for an ISV for any part into which they decide to split the subsystem. Each part shall be checked at each stage as set out in point 2.2.3.

(2.2.3) Stages of the UK verification procedure

The subsystem, or certain parts of the subsystem, shall be checked at each of the following stages—

(a) overall design,

(b) production: construction, including, in particular, civil-engineering activities, manufacturing, constituent assembly and overall adjustment,

(c) final testing.

The project entity may apply for an ISV for the design stage (including type tests) and for the production stage for the whole subsystem or for any part into which the project entity decided to split it (see point 2.2.2).

2.3.   UK certificate of verification U.K.

(2.3.1)  The approved bodies responsible for the UK verification must assess the design, production and final testing of the subsystem and must draw up the UK certificate of verification intended for the project entity. In turn, the project entity must draw up the UK declaration of verification. The UK certificate of verification must provide reference to the NTSNs with which the conformity has been assessed.

Where a subsystem has not been assessed for its conformity with all relevant NTSNs (e.g. in the case of an exemption, partial application of NTSNs for upgrade or renewal, transitional period in an NTSN or UK specific case), the UK certificate of verification shall give the precise reference to the NTSNs or their parts whose conformity has not been examined by the approved body during the UK verification assessment procedure.

( 2.3.2) Where an ISV has been issued, whether by an approved body, an EU notified body, or a designated body, the approved body responsible for the verification of the subsystem must take the ISV into account, and before issuing its UK certificate of verification, must:

(a) verify that the ISV correctly covers the relevant requirements of the NTSNs,

(b) check all aspects that are not covered by the ISV, and

(c) check the final testing of the subsystem as a whole.

(2.3.3) In the case of a modification to a subsystem already covered by a certificate of verification, the approved body shall perform only those examinations and tests that are relevant and necessary, i.e. assessment shall relate only to the parts of the subsystem that are changed and their interfaces to the unchanged parts of the subsystem.

(2.3.4) Each approved body involved in the verification of a subsystem shall draw up a technical file in accordance with regulation 17 covering the scope of its activities.

2.4.   Technical file accompanying the UK declaration of verification U.K.

The technical file accompanying the UK declaration of verification shall be assembled by the project entity and must contain the following:

(a) technical characteristics linked to the design including general and detailed drawings with respect to execution, electrical and hydraulic diagrams, control-circuit diagrams, description of data-processing and automatic systems to the level of detail sufficient for documenting the verification of conformity carried out, documentation on operation and maintenance, etc., relevant for the subsystem concerned;

(b) a list of interoperability constituents incorporated into the subsystem;

(c) the technical files compiled by each of the EU notified bodies or approved bodies involved in the verification of the subsystem, which shall include:

(i) copies of the EC or UK declarations of conformity or suitability for use established for interoperability constituents and accompanied, where appropriate, by the corresponding calculation notes and a copy of the records of the tests and examinations carried out by the approved body or EU notified body on the basis of the common technical specifications,

(ii) where available, the ISV that accompanies the certificate of verification, including the result of verification by the approved body or by the EU notified body of the ISV validity,

(iii) the certificate of verification, accompanied by corresponding calculation notes and signed by the EU notified body responsible for the verification, stating that the subsystem complies with the requirements of the relevant TSIs or by the approved body responsible for the verification, stating that the subsystem complies with the requirements of the relevant NTSNs, and mentioning any reservations recorded during performance of the activities and not withdrawn; the certificate of verification should also be accompanied by the inspection and audit reports drawn up by the same body in connection with its task, as specified in points 2.5.2 and 2.5.3;

(d) any other certificates that may have been issued as part of a verification process in accordance with any other enactment or rule of law;

(e) when verification of safe integration is required pursuant to the Railways and Other Guided Transport Systems (Safety) Regulations 2006, or the Railways (Safety Management) Regulations (Northern Ireland) 2006 the relevant technical file shall include the assessors’ report(s) on the common safety methods (CSM) on risk assessment.

2.5.   Surveillance by approved body U.K.

(2.5.1) The approved body responsible for checking production must have permanent access to building sites, production workshops, storage areas and, where appropriate, prefabrication or testing facilities and, more generally, to all premises which it considers necessary for its task. The approved body must receive from the project entity all the documents needed for that purpose and, in particular, the implementation plans and technical documentation concerning the subsystem.

(2.5.2) The approved body responsible for checking implementation must periodically carry out audits in order to confirm compliance with the relevant NTSNs. It must provide those responsible for implementation with an audit report. Its presence may be required at certain stages of the building operations.

(2.5.3) In addition, the approved body may pay unexpected visits to the worksite or to the production workshops. At the time of such visits the approved body may conduct complete or partial audits. It must provide those responsible for implementation with an inspection report and if appropriate, an audit report.

(2.5.4) The approved body shall be able to monitor a subsystem on which an interoperability constituent is mounted in order to assess, where required by the corresponding NTSNs, its suitability for use in its intended railway environment.

2.6.   Submission U.K.

A copy of the technical file accompanying the UK declaration of verification must be kept by the project entity throughout the service life of the subsystem.

The documentation submitted for an application for an authorisation for placing in service shall be submitted to the Safety Authority.

2.7.   Publication U.K.

Each approved body must periodically publish relevant information concerning:

(a) requests for verification and ISV received,

(b) requests for assessment of conformity or suitability for use of interoperability constituents,

(c) ISVs issued or refused,

(d) UK certificates of conformity or suitability for use issued or refused,

(e) UK certificates of verification issued or refused.

3.   UK certificate of verification issued by a designated body U.K.

3.1.   Introduction U.K.

In any case where UK specific rules apply, the verification shall include a procedure whereby the designated body checks and certifies that that subsystem complies with the UK specific rules.

3.2.   Certificate of verification U.K.

The designated body must draw up the UK certificate of verification intended for the project entity.

The certificate shall contain a precise reference to the UK specific rule(s) whose conformity has been examined by the designated body in the UK verification process.

In the case of UK specific rules related to the subsystems composing a vehicle, the designated body shall divide the certificate into two parts, one part including the references to those UK specific rules strictly related to the technical compatibility between the vehicle and the network concerned, and the other part for all other UK specific rules.

3.3.   Technical file U.K.

The technical file compiled by the designated body and accompanying the UK certificate of verification in the case of UK specific rules must be included in the technical file accompanying the UK declaration of verification referred to in point 2.4 and shall contain the technical data relevant for the assessment of the conformity of the subsystem with those UK specific rules.

4.   Verification of parts of subsystems U.K.

If a UK certificate of verification is to be issued for certain parts of a subsystem, the provisions of this Schedule shall apply mutatis mutandis for those parts.]