ED Decision 2023/014/R
SPECIFIC NATURE OF THE ORGANISATION AND COMPLEXITY OF ITS ACTIVITIES — RESULTS OF PAST OVERSIGHT ACTIVITIES
When determining the oversight programme, including a relevant sample of design 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;
(c) the procedure for the management and the scope of non-significant changes;
(d) the number of locations and the activities performed at each location;
(e) the number and scope of subcontractors that perform design activities; and
(f) the overall volume of activity and, as applicable, per specific product.
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