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GM2 ARGH.OVS.330(g);(j) Cooperative oversight

ED Decision 2025/006/R

COOPERATIVE OVERSIGHT RESPONSIBILITIES IN THE CASE OF SYSTEMIC NON-COMPLIANCE (LEVEL 2 FINDINGS)

(a) If a systemic non-compliance of a GH organisation providing services in more than one Member State is not addressed at the management system level, it may cascade down to all the individual stations, thus generating findings at all stations where the organisation provides GH services. That is why a systemic non-compliance requires enhanced communication and cooperation between all the competent authorities overseeing that GH organisation: it is essential that they all apply similar corrective actions to address that non-compliance in the same manner at the affected stations under their oversight.

(b) When the competent authority of the Member State in which the organisation has its PPoB raises a finding on a management system component, it can already be considered potential systemic non-compliance. The other competent authorities concerned will use this information when preparing their own audits/inspections of stations in their Member State. Each competent authority is responsible for verifying that the systemic non-compliance has been addressed at the individual stations in its Member State.

(c) If a level 2 finding is raised by any competent authority other than that of the Member State in which the organisation has its PPoB, the systemic or operational nature of that non-compliance can only be determined once another audit/inspection in another Member State confirms it. As the information from all audits and inspections is shared among the competent authorities involved in the oversight of that organisation, they will all be aware of the systemic findings. As in the situation described in point (b), the other competent authorities concerned will use this information when preparing their own audits/inspections in their Member State. Each competent authority is responsible for verifying that the systemic non-compliance has been addressed at the individual stations in its Member State.

(d) The information related to systemic non-compliance can be useful for assessing the safety performance of the organisation as a whole.