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AMC1 ORGH.GEN.150 Findings and corrective actions

ED Decision 2025/007/R

GENERAL

(a) The corrective action plan defined by the organisation providing GH services should address the effects of the non‑compliance, as well as its root cause(s) and contributing factors.

(b) When a finding is raised at an individual station of a GH organisation providing GH services in more than one Member State (which may or may not be part of a single GH organisation business grouping), the GH organisation may decide how to implement the corrective action — either at the station level, at Member State level or at the management system level, with the aim of addressing the issue at all stations where the same finding has been raised.

(c) In the case of level 2 findings, as referred to in point ARGH.OVS.325 of Commission Implementing Regulation (EU) 2025/23, the GH organisation should submit a root cause analysis and a corrective action plan to the competent authority within a specified period. This period should be shorter than the corrective action implementation period, in order to provide sufficient time for the competent authority to agree on the submitted corrective action plan and for the GH organisation to implement it before the end of the implementation period.