GM2 21.B.220 Initial certification procedure

APPLICATION RECEIVED FROM ORGANISATIONS WITH FACILITIES/PARTNERS/SUPPLIERS/SUBCONTRACTORS LOCATED IN A THIRD COUNTRY

The obligations of the applicant are totally independent from the surveillance exercised by the competent authority. It is not acceptable that the applicant relies on the surveillance activities of the competent authority to simplify its tasks.

Facilities located in a third country

When any part of the production facilities of an applicant for a POA is located outside the Member States, then the location will be treated in all aspects as part of the applicant’s POA organisation.

Therefore, the investigating competent authority will include the facilities outside the Member States:

(a) fully in their investigation and surveillance activities for the applicant for, or holder of, the POA;

(b) in the terms of approval of the EASA Form 55 (see Part 21 Appendix X) when issuing the POA.

Partners/suppliers/subcontractors located in a third country

The competent authority should define, on the basis of Part 21 and its associated AMC and GM, a clear procedure on supplier control. This procedure should include the control of partners/suppliers/subcontractors of the applicant for, or holder of, a POA that are located outside the Member States.

In respect of the applicant for, or holder, of the POA, the competent authority should:

(1) investigate, for the initial approval and consequent continued surveillance, the production organisation, and its partners/suppliers/subcontractors at the necessary level, to ensure that the organisation can comply with the requirements of Part 21;

(2) in accordance with the competent authority procedure, assess and accept the documented procedure for supplier control as part of the POA holder’s quality system, and changes to that procedure prior to implementation; and

(3) in accordance with the competent authority procedure, assess the necessary level of surveillance to be exercised by the production organisation on partners / suppliers / subcontractors and check the audit plan of the production organisation against this level.

The level of cooperation between the competent authority and the competent authority of the third country where a partner/supplier/subcontractor of the production organisation is located may influence the authorities’ activities concerning this partner/supplier/subcontractor. Cooperation with the competent authority of the third country should be based on the capability and goodwill of that authority, and a complete interchange of necessary information.

The involvement of this competent authority of the third country in the surveillance of the partner/supplier/subcontractor will be based on the following principles:

(a) A recognition agreement under Article 68 of Regulation EU) 2018/1139 covering production subjects has been concluded:

(1) The competent authority in accordance with GM1 21.A.139(d)(1) may decide that direct surveillance of the POA holder activities at the foreign location may not be necessary.

(2) In any other case, provisions of the recognition agreement on the subject apply (technical assistance, etc.).

(b) If a recognition agreement has not been concluded, or it does not cover production subjects, it may be necessary that the competent authority of the Member State, EASA, and the competent authority of a third country enter into a specific working arrangement addressing the following matters:

(1) acceptance by the competent authority of the third country of conducting surveillance of the relevant production activities on behalf of the competent authority, under the respective quality standards defined by the competent authority.

(2) tasks to be performed; and

(3) practical methods.

These arrangements are between authorities and do not relieve the applicant of its obligations.

— In all cases, even though surveillance tasks are delegated to the competent authority of the third country, the competent authority remains the responsible authority and may consequently exercise direct surveillance if necessary.

— If it is not possible to delegate surveillance tasks to the competent authority of the third country, the competent authority will have to establish a direct surveillance programme in accordance with its procedure concerning supplier control as part of the overall surveillance of the POA holder.