Commission Regulation (EC) No 1315/2007 (repealed)Dangos y teitl llawn

Article 6 Safety regulatory audits

1. National supervisory authorities, or recognised organisations as delegated by them, shall conduct safety regulatory audits.

2. The safety regulatory audits referred to in paragraph 1 shall:

(a) provide national supervisory authorities with evidence of compliance with applicable safety regulatory requirements and with implementing arrangements by evaluating the need for improvement or corrective action;

(b) be independent of internal auditing activities undertaken by the organisation concerned as part of its safety or quality management systems;

(c) be conducted by auditors qualified in accordance with the requirements of Article 11;

(d) apply to complete implementing arrangements or elements thereof, and to processes, products or services;

(e) determine whether:

(i)

implementing arrangements comply with safety regulatory requirements;

(ii)

actions taken comply with the implementing arrangements;

(iii)

the results of actions taken match the results expected from the implementing arrangements;

(f) lead to the correction of any identified non-conformities in accordance with Article 7.

3. Within the inspection programme required by Article 7 of Regulation (EC) No 2096/2005, national supervisory authorities shall establish and update at least annually a programme of safety regulatory audits in order to:

(a) cover all the areas of potential safety concern, with a focus on those areas where problems have been identified;

(b) cover all the organisations and services operating under the supervision of the national supervisory authority;

(c) ensure that audits are conducted in a manner commensurate to the level of risk posed by the organisations’ activities;

(d) ensure that sufficient audits are conducted over a period of two years to check the compliance of all these organisations with applicable safety regulatory requirements in all the relevant areas of the functional system;

(e) ensure follow up of the implementation of corrective actions.

4. National supervisory authorities may decide to modify the scope of pre-planned audits, and to include additional audits, wherever that need arises.

5. National supervisory authorities shall decide which arrangements, elements, services, products, physical locations and activities are to be audited within a specified time frame.

6. Audit observations and identified non-conformities shall be documented. The latter shall be supported by evidence, and identified in terms of the applicable safety regulatory requirements and their implementing arrangements against which the audit has been conducted.

An audit report, including the details of the non-conformities, shall be drawn up.