Commission Regulation (EC) No 1315/2007 (repealed)Show full title

Article 9 Review procedure of the proposed changes

1. The national supervisory authority shall review the safety arguments associated with new functional systems or changes to existing functional systems proposed by an organisation when:

(a) the severity assessment conducted in accordance with Annex II, point 3.2.4 of Regulation (EC) No 2096/2005 determines a severity class 1 or a severity class 2 for the potential effects of the hazards identified; or

(b) the implementation of the changes requires the introduction of new aviation standards.

When the national supervisory authority determines the need for a review in situations other than those referred to in points (a) and (b), it shall notify the organisation that it will undertake a safety review of the change notified.

2. The review shall be conducted in a manner commensurate with the level of risk posed by the new functional system or change to existing functional systems.

It shall:

(a) use documented procedures;

(b) be supported by documentation specifically intended to provide safety oversight personnel with guidance to perform their functions;

(c) consider the safety objectives, safety requirements and other safety-related conditions that are related to the change under consideration which have been identified in:

(i)

EC declarations of verification of systems;

(ii)

EC declarations of conformity or suitability for use of constituents of systems; or

(iii)

risk assessment and mitigation documentation established in accordance with applicable safety regulatory requirements;

(d) identify additional safety-related conditions associated to the implementation of the change, wherever needed;

(e) assess the acceptability of safety arguments presented, taking account of:

(i)

the identification of hazards;

(ii)

the consistency of the allocation of severity classes;

(iii)

the validity of the safety objectives;

(iv)

the validity, effectiveness and feasibility of safety requirements and any other safety-related conditions identified;

(v)

the demonstration that the safety objectives, safety requirements and other safety-related conditions are continuously met;

(vi)

the demonstration that the process used to produce the safety arguments meets the applicable safety regulatory requirements;

(f) verify the processes used by the organisations to produce the safety arguments in relation to the new functional system or changes to existing functional systems under consideration;

(g) identify the need for the verification of ongoing compliance;

(h) include any necessary coordination activities with the authorities responsible for the safety oversight of airworthiness and flight operations;

(i) provide notification of the acceptance, with conditions where applicable, or the non-acceptance, with supporting reasons, of the change under consideration.

3. The introduction into service of the change under consideration in the review shall be subject to acceptance by the national supervisory authority.