ED Decision 2025/007/R
COMPLIANCE MONITORING FUNCTION
Those performing the compliance monitoring function should be responsible for ensuring that the compliance monitoring process established in accordance with point ORGH.MGM.200(b)(6) is properly and consistently implemented and continued compliance with the applicable regulatory requirements.
(a) If more than one person is appointed to perform the compliance monitoring function, the accountable manager should identify the person who acts as the unique focal point (i.e. the ‘compliance monitoring manager’.)
(b) The person(s) responsible for compliance monitoring should:
(1) be able to demonstrate relevant knowledge of, and appropriate experience in GH operations, and qualification(s) and experience in compliance monitoring;
(2) have knowledge of the applicable requirements in the GH domain; and
(3) have access to all parts of the GH organisation and, as necessary, any contracted service provider.
(c) In a small GH organisation, this function may be executed by the accountable manager if the accountable manager complies with points (b)(1) and (2).
(d) If the compliance monitoring function and the safety management function are cumulated in one person, the accountable manager should ensure that:
(1) sufficient resources are allocated to both functions, considering the size and complexity of the organisation;
(2) the person is qualified and competent to perform both functions;
(3) any potential conflict of interest between the two functions is addressed.
(e) The independence of the compliance monitoring function should be established by ensuring that audits and inspections are carried out by personnel not responsible for the function, procedure or products being audited.
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