Utdrag från regelverket:

AMC1 ORA.GEN.200(a)(6) Management system

(3)(1) To ensure that the organisation continues to meet the requirements of this Part and other applicable Parts, the accountable manager should designate a compliance monitoring manager. The role of the compliance monitoring manager is to ensure that the activities of the organisation are monitored for compliance with the applicable regulatory requirements , and any additional requirements as established by the organisation, and that these activities are being carried out properly under the supervision of the relevant head of functional area.

(3)(2) The compliance monitoring manager should be responsible for ensuring that the compliance monitoring programme is properly implemented, maintained and continually reviewed and improved.

(3)(3) The compliance monitoring manager should:
(i) have direct access to the accountable manager;
(ii) not be one of the other persons referred to in ORA.GEN.210(b);
(iii) be able to demonstrate relevant knowledge, background and appropriate experience related to the activities of the organisation; including knowledge and experience in compliance monitoring; and
(iv) have access to all parts of the organisation, and as necessary, any contracted organisation.

(3)(4) In the case of a non-complex organisation, this task may be exercised by the accountable manager provided he/she has demonstrated having the related competence as defined in (c)(3)(iii).

(3)(5) In the case the same person acts as compliance monitoring manager and as safety manager, the accountable manager, with regards to his/her direct accountability for safety, should ensure that sufficient resources are allocated to both functions, taking into account the size of the organisation and the nature and complexity of its activities.

Målsättning

En Compliance monitoring manager

  • ska kunna uppvisa kunskap och erfarenhet av den verksamhet som bedrivs samt ha kunskap och erfarenhet av arbete med regelefterlevnad.
  • kan använda externa auditörer om kompetens i den egna organisationen saknas, men är ansvarig för att bedöma dem som engageras inom Compliance monitoring programme.
  • ska ha tillträde till alla delar i organisationen och alla eventuella leverantörer
  • ska ha direkt tillgång till accountable manager, och vid tillfället för intervjun, kunna redogöra hur och med vilken frekvens kontakt med AM skall ske.
  • ha kunskap om funktionerna inom ledningssystemet.
  • ha förståelse för att rollen som compliance monitoring manager skiljer sig åt från den tidigare rollen som quality manager.
  • skall, vid tillfället för intervjun, kunna beskriva hur han/hon tänkt genomföra internrevision (audit) på alla applicerbara delar av verksamheten.