ED Decision 2012/007/R
COMPLIANCE MONITORING - GENERAL
(a) The organisational set-up of the compliance monitoring function should reflect the size of the organisation and the nature and complexity of its activities. The compliance monitoring manager may perform all audits and inspections himself/herself or appoint one or more auditors by choosing personnel having the related competence as defined in AMC1 ORA.GEN.200(a)(6) point (c)(3)(iii), either from within or outside the organisation.
(b) Regardless of the option chosen it must be ensured that the independence of the audit function is not affected, in particular in cases where those performing the audit or inspection are also responsible for other functions within the organisation.
(c) In case external personnel are used to perform compliance audits or inspections:
(1) any such audits or inspections are performed under the responsibility of the compliance monitoring manager; and
(2) the organisation remains responsible to ensure that the external personnel has relevant knowledge, background and experience as appropriate to the activities being audited or inspected; including knowledge and experience in compliance monitoring.
(d) The organisation retains the ultimate responsibility for the effectiveness of the compliance monitoring function in particular for the effective implementation and follow-up of all corrective actions.
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