21L.A.12 Means of compliance

DESCRIPTION SUPPORTING THE ALTERNATIVE MEANS OF COMPLIANCE (AltMoC)

(a)The description of the AltMoC should include:

(1)a summary of the AltMoC;

(2)the content of the AltMoC;

(3)a statement that compliance with the applicable regulation is achieved; and

(4)in support of that statement, an assessment which demonstrates that the AltMoC reach(es) an acceptable level of safety, taking into account the level of safety that is achieved by the corresponding Agency’s AMC.

(b)All these elements that describe the AltMoC are an integral part of the management system records, in accordance with point 21L.A.7.

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 with, and facilitate the verification activities of the competent authorities in relation to, that Regulation and its delegated and implementing acts. AMC are published by EASA to achieve those objectives. While competent authorities and regulated entities are not legally bound to use the AMC, applying them is recommended.

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

(1)by its competent authority (see GM1 21L.B.24); or by that organisation and approved by its competent authority (see point (c)). An AltMoC does not allow deviation from Regulation (EU) 2018/1139 and its delegated or implementing acts.

(c)AltMoC that are established by an organisation and approved by its competent authority An organisation that wishes to use a different means of compliance than the one published by EASA may propose an AltMoC to the competent authority and use it only once the competent authority has approved it. In that case, the organisation is responsible for demonstrating how that AltMoC establishes compliance with the relevant regulation. The approval of an AltMoC is granted to the organisation by its competent authority on an individual basis and is restricted to that specific organisation. Other organisations that wish to use the same AltMoC should go through the AltMoC process (i.e. demonstrate how that AltMoC establishes compliance with the relevant regulation) and obtain an individual approval from their competent authority.

WHEN AN ALTERNATIVE MEANS OF COMPLIANCE (AltMoC) IS REQUIRED When there is no Agency AMC to a certain point of a given regulation, the means of compliance that are proposed by an organisation to that point do not need to go through the AltMoC process. It is the responsibility of the competent authority to verify that compliance with a given regulation is achieved. However, in certain cases, the organisation may propose, and the competent authority may agree, to have such means of compliance go through the AltMoC process. When there is an Agency AMC, the AltMoC process is required in the following cases (non-exhaustive list): an AltMoC to a given regulation is technically different from the AMC that is published by EASA; and a form is significantly different from the one that is included in the EASA AMC. Note: A form that is required by a delegated or implementing act cannot be modified. Examples of issues that are not considered to require the AltMoC process include but are not limited to: editorial changes to an Agency AMC, as long as they do not change the intent of the AMC; and incorporating an Agency AMC into the organisational structure, organisational processes, or standard operating procedures of an organisation with different wording and terminology that are customised to the organisation’s environment if it does not change the intent of the AMC and its associated level of safety.