21.A.124A 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 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 alternative means of compliance (AltMoC) that are established:

(1)by its competent authority (see GM1 21.B.115 and GM1 21.B.215); or

(2)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 MoC than the one published by EASA can propose an AltMoC to the competent authority and use it only once the competent authority approves it. In that case, the organisation is responsible for demonstrating how that AltMoC establishes compliance with the 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 regulation) and obtain individual approval from their competent authority.

WHEN AN ALTERNATIVE MEANS OF COMPLIANCE IS NEEDED When there is no EASA AMC to a certain point of a regulation, the means of compliance (MoC) that are proposed by the 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 the regulation is achieved. However, in certain cases, the organisation may propose, and the competent authority may agree, to have such MoC go through the AltMoC process. When there is an EASA AMC, the AltMoC process is needed in the following cases (non-exhaustive list): an AltMoC to the regulation is technically different to 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 EASA AMC, as long as they do not change the intent of the AMC; and incorporating an EASA 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.

DESCRIPTION SUPPORTING THE ALTERNATIVE MEANS OF COMPLIANCE

(a)The description of the alternative means of compliance (AltMoC) should include:

(1)a summary of the AltMoC;

(2)the content of the AltMoC;

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

(4)in support of that statement, an assessment that demonstrates that the AltMoC reaches an acceptable level of safety, taking into account the level of safety that is achieved by the corresponding EASA AMC.

(b)All these elements that describe the AltMoC are an integral part of the management system records, in accordance with point 21.A.5.

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 alternative means of compliance (AltMoC) that are established:

(1)by its competent authority (see GM1 21.B.115 and GM1 21.B.215); or

(2)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 MoC than the one published by EASA can propose an AltMoC to the competent authority and use it only once the competent authority approves it. In that case, the organisation is responsible for demonstrating how that AltMoC establishes compliance with the 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 regulation) and obtain individual approval from their competent authority.

WHEN AN ALTERNATIVE MEANS OF COMPLIANCE IS NEEDED When there is no EASA AMC to a certain point of a regulation, the means of compliance (MoC) that are proposed by the 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 the regulation is achieved. However, in certain cases, the organisation may propose, and the competent authority may agree, to have such MoC go through the AltMoC process. When there is an EASA AMC, the AltMoC process is needed in the following cases (non-exhaustive list): an AltMoC to the regulation is technically different to 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 EASA AMC, as long as they do not change the intent of the AMC; and incorporating an EASA 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.

DESCRIPTION SUPPORTING THE ALTERNATIVE MEANS OF COMPLIANCE

(a)The description of the alternative means of compliance (AltMoC) should include:

(1)a summary of the AltMoC;

(2)the content of the AltMoC;

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

(4)in support of that statement, an assessment that demonstrates that the AltMoC reaches an acceptable level of safety, taking into account the level of safety that is achieved by the corresponding EASA AMC.

(b)All these elements that describe the AltMoC are an integral part of the management system records, in accordance with point 21.A.5.