145.A.120 Means of compliance

GENERAL

(a)Acceptable means of compliance (AMC), as referred to in Article 76(3) of Regulation (EU) 2018/1139, are a tool to standardise the demonstration of compliance and facilitate the verification activities of the competent authorities with Regulation (EU) 2018/1139 and its delegated and implementing acts. They are published by the Agency to achieve these objectives. Whereas the competent authorities and the regulated entities are not legally bound to use them, applying them is recommended.

(b)If an organisation wishes to use means to comply with the Regulation different from the AMC established by EASA, that organisation may need to demonstrate compliance with Regulation (EU) 2018/1139 and its delegated and implementing acts by using alternative means of compliance (AltMoC):

(1)established by its competent authority — see GM1 145.B.120; or

(2)established by that organisation and approved by its competent authority — see point (c) below. An AltMoC does not allow deviation from Regulation (EU) 2018/1139 and its delegated or implementing acts.

(c)AltMoC established by an organisation and approved by its competent authority: An organisation wishing to use a different means of compliance than the one published by the Agency, can propose and implement an AltMoC only once the competent authority approves it. In this case, the organisation is responsible for demonstrating how that AltMoC establishes compliance with the Regulation. This approval will be granted by its competent authority on an individual basis and restricted to that specific applicant. Other organisations wishing to use the same means of compliance should follow the AltMoC process (demonstrating compliance with the Regulation) and obtain individual approval from their competent authority.

WHEN AN ALTERNATIVE MEANS OF COMPLIANCE IS NEEDED When there is no EASA AMC for a certain requirement in the Regulation, the means of compliance proposed by the organisation to that point of the Regulation do not need to go through the AltMoC process. It is the responsibility of the competent authority to verify that compliance with the Regulation is met. However, in certain cases the organisation may propose, and the competent authority may agree, to have such means of compliance follow the AltMoC process. When there is an EASA AMC, the AltMoC process is needed in the following (not exhaustive) cases: a means to comply with the Regulation is technically different in character to the AMC published by EASA; A Form is significantly different from the one proposed in the EASA AMC. Note: A Form required by the delegated and implementing acts cannot be changed. Examples of issues not considered to require an AltMoC process include, but are not limited to: editorial changes to an EASA AMC, as long as it does not change the intent of the AMC; — transposing an EASA AMC into the organisational structure, organisational processes, or standard operating procedures with different wording and terminology customised to the organisation’s environment, if this does not change the intent of the AMC and its associated level of safety.

DESCRIPTION SUPPORTING THE ALTERNATIVE MEANS OF COMPLIANCE

(a)The description of the AltMoC should include: a summary of the AltMoC; the content of the AltMoC; a statement that compliance with the Regulation is achieved; and in support of that statement, an assessment demonstrating that the AltMoC reaches an acceptable level of safety, taking into account the level of safety provided by the corresponding EASA AMC.

(b)All these elements describing the AltMoC form an integral part of the management system records to be kept in accordance with 145.A.55.