ED Decision 2025/007/R
AUDITS PERFORMED BY THIRD‑PARTY AUDITORS
(a) The GH organisation may contract a third‑party service provider to perform its internal audits and inspections as part of its compliance monitoring responsibilities, in accordance with point ORGH.MGM.200(b)(6). In such a case, the GH organisation should ensure the following:
(1) a documented arrangement has been established with the third‑party auditor;
(2) the audit applies an evaluation method designed to assess the operational, management and control systems of the GH organisation;
(3) the third‑party auditor and its evaluation method are independent and the auditors are impartial;
(4) the auditors are appropriately qualified and have sufficient knowledge, experience and training, including on‑the‑job training, to perform their allocated tasks;
(5) audits or at least the parts of them verifying the GH operations are performed on‑site;
(6) access of the third‑party auditor to the relevant data and facilities is granted at the level necessary to verify compliance with the applicable requirements;
(7) the GH organisation is granted access to the full audit report;
(8) procedures have been established for monitoring continued compliance of the organisation with the applicable requirements; and
(9) procedures have been established to notify the GH organisation of any non‑compliance with the applicable requirements and findings raised, the corrective actions to be taken, the follow‑up of these corrective actions and the closure of findings.
(b) The full audit report of the third‑party auditor should be made available to the competent authority upon request.
AMC2 ORGH.MGM.205 details conditions for contracting third-party auditors for internal audits, including independence, qualifications, on-site verification, access rights, and reporting to the competent authority.
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