4.—(1) The requirements for a safety management system referred to in regulation 3(1)(a) are that—
(a)subject to paragraph (2), it is established to ensure that any railway system—
(i)can achieve the CSTs; and
(ii)is in conformity with relevant national safety rules and relevant safety requirements laid down in TSIs;
(b)it applies the relevant parts of CSMs;
(c)it meets the requirements and contains the elements set out in Schedule 1, adapted to the character, extent and other characteristics of the operation in question;
(d)subject to paragraph (2), it ensures the control of all categories of risk including new or existing risk associated with the operation in question which, without prejudice to the generality of the foregoing, shall include such risks relating to the—
(i)supply of maintenance and material;
(ii)use of contractors; and
(iii)placing in service of new or altered vehicles the design or construction of which incorporates significant changes compared to any vehicle already in use on any railway and which changes would be capable of significantly increasing an existing risk or creating a significant safety risk;
(e)it takes into account, where appropriate and reasonable, the risks arising as a result of activities carried on by other persons; and
(f)all parts of it are documented.
(2) The requirements in paragraph (1)(a) and (d) shall be met where the safety management system of a railway operator or of an applicant for a safety certificate or a safety authorisation taken with that of any relevant railway operator is capable of meeting the requirements of the paragraph in question.
(3) In paragraph (2), “relevant railway operator” means another railway operator whose operation is capable of materially affecting the safety of the operation carried on by the first operator.
(4) In paragraph 1(d)(iii) where such new or altered vehicles are intended to be first taken into service, then before that taking into service any railway operator shall ensure that it has—
(a)an established written safety verification scheme which meets the requirements and contains the elements set out in Schedule 4; and
(b)appointed a competent person to undertake that safety verification, and the competent person has undertaken that safety verification in relation to the new or altered vehicles.
(5) Where a new or altered vehicle has been authorised under regulation 4(1)(a) of the Interoperability Regulations for the placing into service on any railway, that authorisation shall be treated as satisfying the requirements of paragraph (4).
(6) In this regulation placing in service shall mean first placed in service for the provision of any railway service, and in ascertaining when this takes place no regard shall be had to any trials or testing that takes place to the relevant vehicle.
(7) The requirements for a safety management system referred to in regulation 3(2)(a) are the requirements in paragraphs (1) to (6) save that any reference to new or altered vehicles in those paragraphs shall be replaced with a reference to new or altered infrastructure and that it—
(a)ensures the control of all categories of risk associated with the placing into service of new or altered infrastructure the design or construction of which incorporates significant changes compared to any infrastructure already in use on any railway and which changes would be capable of significantly increasing an existing risk or creating a significant safety risk;
(b)takes into account the effects of operations of railway operators; and
(c)contains provisions to ensure that the way in which the infrastructure manager carries out its operation makes it possible for any railway operator to operate in accordance with—
(i)relevant TSIs and national safety rules; and
(ii)the means adopted by the railway operator to meet the requirements referred to in regulation 5(4), of which the Department accepted that there was sufficient evidence upon issue or amendment of its safety certificate pursuant to these Regulations; and
(d)aims to co–ordinate the emergency procedures of the infrastructure manager or of the applicant for a safety authorisation with those of any railway operator,
and in each case the requirements in sub–paragraphs (a) to (d) shall only apply in relation to any railway operator that operate or will operate a train in relation to the infrastructure of the infrastructure manager or of the applicant for a safety authorisation in question.