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12.—(1) The duty holder who prepares a safety case pursuant to these Regulations shall, subject to paragraphs (2) and (3), include in the safety case sufficient particulars to demonstrate that—
(a)his management system is adequate to ensure—
(i)that the relevant statutory provisions will, in respect of matters within his control, be complied with; and
(ii)the satisfactory management of arrangements with contractors and sub-contractors;
(b)he has established adequate arrangements for audit and for the making of reports thereof;
(c)all hazards with the potential to cause a major accident have been identified; and
(d)all major accident risks have been evaluated and measures have been, or will be, taken to control those risks to ensure that the relevant statutory provisions will be complied with.
(2) Paragraph (1) shall only require the particulars in the safety case to demonstrate the matters referred to in that paragraph to the extent that it is reasonable to expect the duty holder to address them at the time of sending the safety case to the Executive.
(3) In this regulation, “audit” means systematic assessment of the adequacy of the management system to achieve the purpose referred to in paragraph (1)(a) carried out by persons who are sufficiently independent of the system (but who may be employed by the duty holder) to ensure that such assessment is objective.
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