ED Decision 2023/014/R
SPECIFIC NATURE OF THE ORGANISATION AND COMPLEXITY OF ITS ACTVITIES — RESULTS OF PAST OVERSIGHT ACTIVITIES
When determining the oversight programme, including a relevant sample of production activities under the scope of the organisation as product audits, the competent authority should consider in particular the following elements, as applicable:
(a) the effectiveness of the organisation’s management system in identifying and addressing non‑compliances and safety hazards;
(b) the implementation by the organisation of any industry standards that are directly relevant to the organisation’s activity subject to Part 21;
(b) the procedures for the management and the scope of non-significant changes;
(c) any specific procedures implemented by the organisation that are related to any alternative means of compliance used;
(d) the number of approved locations and the activities performed at each location;
(e) the number and scope of subcontractors that perform production activities; and
(f) the volume of activity for each product or parts.
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