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AMC1 21.B.430 Initial certification procedure

ED Decision 2023/014/R

VERIFICATION OF COMPLIANCE — INITIAL CERTIFICATION AUDITS

(a) In order to verify the organisation’s compliance with the applicable requirements, the investigation by the competent authority should include one or more audit(s) of the organisation, together with interviews of the personnel, typically carried out at the organisation’s facilities.

(b) The competent authority should only conduct such an audit if it is satisfied that the application and supporting documentation are in compliance with the applicable requirements.

(c) The audit(s) should address the following areas:

(1) the organisation’s core processes;

(2) the detailed management structure, notably its adequacy;

(3) the personnel: the adequacy of the number of staff, and of their qualifications and experience with regard to the intended terms of approval and the associated privileges;

(4) the processes used for safety risk management and compliance monitoring (independent monitoring function);

(5) the facilities and their adequacy regarding the organisation’s intended terms of approval including its scope of work; and

(6) the documentation based on which the approval should be granted.