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GM1 ORGH.MGM.200(b)(6) General requirements for the management system

ED Decision 2025/007/R

COMPLIANCE MONITORING — GENERAL

(a) The completion of a safety risk register is one of the most relevant methods of compliance monitoring, along with the documentation related to safety risk management and to mitigation measures and their implementation.

(b) The person(s) responsible for compliance monitoring may perform all audits and inspections themselves or appoint one or more auditors by choosing personnel with the relevant competence and qualification (as defined in point (b) of AMC1 ORGH.MGM.210(g)(1)), from either within or outside the GH organisation.

(c) Regardless of the option chosen, it is recommended that the independence of the audit function remain unaffected, in particular where those persons performing the audit or inspection are also responsible for other functions within the GH organisation.

(d) When compliance audits or inspections are performed by a contracted party:

(1) it is recommended that any such audits or inspections be performed under the responsibility of the person(s) responsible for compliance monitoring within the GH organisation; and

(2) the GH organisation remains responsible for ensuring that the personnel of the contracted party have knowledge and experience relevant to the activities being audited or inspected, including qualifications and experience in compliance monitoring.

(e) The GH organisation remains responsible for ensuring the effectiveness of compliance monitoring, in particular for the effective implementation and follow‑up of all corrective actions.