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AMC1 21.B.222(c) Oversight programme

ED Decision 2023/014/R

OVERSIGHT PLANNING CYCLE — AUDIT

(a) For each organisation approved by the competent authority, all applicable requirements including processes should be audited at periods that do not exceed the applicable oversight planning cycle. The beginning of the first oversight planning cycle is normally determined by the date of issue of the first approval. If the competent authority wishes to align the oversight planning cycle with the calendar year, it should shorten the first oversight planning cycle accordingly.

(b) The oversight planning should include at least one on-site audit within each oversight planning cycle. For organisations that carry out their regular activities at more than one site, the determination of the sites and the requirements to be audited at these sites should consider the results of past oversight activities and the volume of activity at each site, as well as the main risk areas identified.

(c) For organisations that hold more than one approval under Regulation (EU) 2018/1139, the competent authority may define an integrated oversight schedule to include all the applicable audit items. In order to avoid any duplication of audits, credit may be granted for any specific audit items already completed during the current oversight planning cycle, provided that:

(1) the specific audit item is the same for all the approvals under consideration;

(2) there is satisfactory evidence on record that the specific audit items were carried out and that all corrective actions have been implemented to the satisfaction of the competent authority; and

(3) the competent authority should be satisfied that there is no evidence that standards have deteriorated regarding those specific audit items for which credit is granted.