ED Decision 2025/006/R
(a) To ensure that the identified areas of non-compliance are adequately addressed by the GH organisation, the competent authority should:
(1) review the root cause(s) identified by the organisation for each confirmed finding, together with the corrective action plan;
(2) be satisfied that the root cause(s) identified and the corrective actions proposed by the GH organisation are adequate to correct the non-compliance and prevent recurrence;
(3) assess the implementation of the accepted corrective actions;
(4) be satisfied that the accepted corrective actions have been adequately implemented;
(5) conclude the findings only after the actions in points (1) to (4) have been completed; and
(6) record all findings and observations.
(b) In the case of level 2 findings, the competent authority should first grant the GH organisation a period to submit a corrective action plan including the root cause(s). This period should be shorter than the corrective action implementation period, to provide sufficient time for the authority to agree on an acceptable corrective action plan and for the GH organisation to implement it before the end of the implementation period.
(c) The competent authority should monitor all due dates agreed in accordance with points (a) and (b).
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