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21L.B.16 Management system

Regulation (EU) 2022/1361

(a) The competent authority shall establish and maintain a management system, including as a minimum:

1. documented policies and procedures to describe its organisation, means and methods to achieve compliance with Regulation (EU) 2018/1139 and Regulation (EU) No 376/2014 and the delegated and implementing acts adopted on the basis thereof. The procedures shall be kept up to date, and serve as the basic working documents within that competent authority for all related tasks;

2. a sufficient number of personnel to perform its tasks and discharge its responsibilities. A system shall be in place to plan the availability of personnel, in order to ensure the proper completion of all tasks;

3. personnel who are qualified to perform their allocated tasks and who have the necessary knowledge, experience, initial and recurrent training to ensure continuing competency;

4. adequate facilities and office accommodation to perform the allocated tasks;

5. a function to monitor the compliance of the management system with the relevant requirements, and the adequacy of the procedures, including the establishment of an internal audit process, and a safety risk management process. The compliance monitoring function shall include a system to provide feedback about audit findings to the senior management of the competent authority to ensure the implementation of corrective actions as necessary;

6. a person or group of persons having a responsibility to the senior management of the competent authority for the compliance monitoring function.

(b) The competent authority shall, for each field of activity, including the management system, appoint one or more persons with the overall responsibility for the management of the relevant task(s).

(c) The competent authority shall establish procedures for participation in a mutual exchange of all the necessary information with any other competent authorities concerned and provide them with assistance, whether from within the Member State or in other Member States, including on:

1. all the findings raised and any follow-up actions taken as a result of the oversight of persons and organisations that carry out activities in the territory of a Member State, but certified by the competent authority of another Member State, or by the Agency;

2. any information stemming from mandatory and voluntary occurrence reporting as required by point 21L.A.3.

(d) A copy of the procedures related to the management system of the competent authority of the Member State and any amendments to those procedures shall be made available to the Agency for the purpose of standardisation.