Commission Regulation (EU) No 748/2012 of 3 August 2012 laying down implementing rules for the airworthiness and environmental certification of aircraft and related products, parts and appliances, as well as for the certification of design and production organisations (recast) Text with EEA relevance

• (b) Points 21L.A.63 to 21L.A.70 are not applicable to standard changes.

21L.A.63   Classification of changes to a type certificate

• (a) Changes to a type certificate shall be classified as minor or major.

• (b) A ‘minor change’ is a change that has no appreciable effect on the mass, balance, structural strength, reliability, certified noise or emissions levels, operational characteristics, or other characteristics affecting the airworthiness or the environmental compatibility of the product.

• (c) All other changes are ‘major changes’, unless the change in design, power, thrust, or mass is so extensive that a substantially complete investigation of compliance with the applicable type-certification basis or with the applicable environmental protection requirements or with the applicable detailed technical specifications is required, in which case the design shall be certified in accordance with Subpart B of this Annex.

• (d) The requirements for the approval of minor changes are those established in point 21L.A.67.

• (e) The requirements for the approval of major changes are those established in point 21L.A.68.

21L.A.64   Eligibility

• (a) Only the type-certificate holder may apply for the approval of a major change to a type certificate under this Subpart; all other applicants for a major change to a type certificate shall apply under Subpart E of this Annex.

• (b) Any natural or legal person may apply for the approval of a minor change to a type certificate under this Subpart.

21L.A.65   Application for a change to a type certificate

• (a) An application for the approval of a change to a type certificate shall be made in a form and manner established by the Agency.

• (b) For a major change to a type certificate, the applicant shall include in the application a compliance demonstration plan for the demonstration of compliance in accordance with point 21L.A.66, along with a proposal for the type-certification basis and the applicable environmental protection requirements, prepared in accordance with the requirements and options specified in point 21L.B.81.

21L.A.66   Demonstration of compliance

• (a) The applicant for a major change to a type certificate shall demonstrate compliance with the applicable type-certification basis and the applicable environmental protection requirements as established and notified to the applicant by the Agency in accordance with point 21L.B.81, and shall provide the Agency with the means by which such compliance has been demonstrated.

• (b) The applicant for a major change to a type certificate shall provide the Agency with a recorded justification of the means of compliance according to the compliance demonstration plan.

• (c) When carrying out testing and inspections to demonstrate compliance in accordance with point (a), the applicant shall have verified and documented this verification prior to carrying out any test:
• 1. for the test specimen, that:
• (i) the materials and processes adequately conform to the specifications for the proposed changed type design;
• (ii) the constituent parts of the products adequately conform to the drawings in the proposed changed type design;
• (iii) the manufacturing processes, construction and assembly adequately conform to those specified in the proposed changed type design; and
• 1. that the test and measuring equipment used for the test were adequate for the test and appropriately calibrated.

• (d) The flight testing for the purpose of obtaining an approval of a major change to a type certificate shall be conducted in accordance with the methods for such flight testing specified by the Agency. The applicant for a major change to a type certificate shall make all the flight tests necessary to determine compliance with the applicable type-certification basis and the applicable environmental protection requirements.

• (e) An applicant for a major change to a type certificate shall allow the Agency to:
• 1. review any data and information related to the demonstration of compliance;
• 1. witness or carry out any test or inspection conducted for the purpose of the demonstration of compliance; and
• 1. if it is considered necessary, conduct a physical inspection of the first article of that product in the final changed configuration to verify the compliance of the design with the type-certification basis and the applicable environmental protection requirements.

• (f) Upon completion of the compliance demonstration, the applicant shall declare to the Agency that:
• 1. they have demonstrated compliance with the type-certification basis and the applicable environmental protection requirements as established and notified to the applicant by the Agency in accordance with point 21L.B.81, according to the compliance demonstration plan; and
• 1. no feature or characteristic has been identified that may make the changed product unsafe or environmentally incompatible for the uses for which certification is requested.

21L.A.67   Requirements for the approval of a minor change to a type certificate

In order to be issued with an approval of a minor change to a type certificate, the applicant shall:

• (a) demonstrate that the change and the areas affected by the change comply:
• 1. with the type-certification basis and the applicable environmental protection requirements incorporated by reference in the type certificate; or
• 1. if the applicant chooses to, with the certification specifications that are applicable to the product on the date of the application for the change;

• (b) declare compliance with the type-certification basis and the applicable environmental protection requirements that apply in accordance with point (a)(1), or with the certification specifications chosen in accordance with point (a)(2), record the justifications of compliance in the compliance documents, and record that no feature or characteristic has been identified that may make the changed product unsafe for the uses for which certification is requested;

• (c) submit to the Agency the justification of compliance for the change and the declaration of compliance.

21L.A.68   Requirements for the approval of a major change to a type certificate

In order to be issued with an approval of a major change to a type certificate, the applicant shall:

• (a) demonstrate that the change and the areas affected by the change comply with the type-certification basis and the applicable environmental protection requirements, as established and notified to the applicant by the Agency in accordance with point 21L.B.81;

• (b) demonstrate compliance in accordance with point 21L.A.66;

• (c) demonstrate that there are no unresolved issues from the physical inspection of the first article of that product in the final changed configuration carried out by the Agency in accordance with point 21L.A.66(e)(3).

21L.A.69   Approval of a change to a type certificate under a privilege

• (a) The approval of a change to a type certificate that it has designed may be issued by an approved design organisation without an application according to point 21L.A.65 in accordance with the scope of its privileges provided for in points (2) and (8) of point 21.A.263(c) of Annex I (Part 21) instead of the Agency, as recorded in the terms of approval.

• (b) When issuing an approval of a change to type certificate in accordance with point (a), the design organisation shall:
• 1. ensure that all the substantiation data and justifications are available;
• 1. ensure that the compliance of the change with the type-certification basis and the applicable environmental protection requirements according to point (a)(1) of point 21L.A.67 or point (a) of point 21L.A.68 has been demonstrated and declared in accordance with point 21L.A.66;
• 1. confirm that it has not found:
• (i) any non-compliances with the type-certification basis or, where applicable, with the applicable environmental protection requirements, or with the certification specifications chosen;
• (ii) any feature or characteristic of the change that may make the changed product unsafe or environmentally incompatible for the uses for which certification is requested;
• 1. limit the approval of a change to a type certificate to the specific configuration(s) in the type certificate to which the change relates.

21L.A.70   Obligations for minor changes to a type certificate

The holder of an approval of a minor change to a type certificate shall ensure that the obligations for holders of minor change approvals of Subpart A of this Annex are undertaken.

SUBPART E –   SUPPLEMENTAL TYPE CERTIFICATES

21L.A.81   Scope

This Subpart establishes the procedure for natural or legal persons other than the holder of that type certificate for applying for the approval of major changes to type certificates, issued under Annex I (Part 21) or this Annex, of products within the scope of point 21L.A.21, provided that the changed product is still within the scope of that point, and establishes the rights and obligations of the applicants for, and holders of, those certificates.

21L.A.82   Eligibility

Any natural or legal person who has demonstrated, or is in the process of demonstrating, or have declared, their design capability in accordance with point 21L.A.83 may apply for a supplemental type certificate under the conditions laid down in this Subpart.

21L.A.83   Demonstration of design capability

An applicant for a supplemental type certificate shall demonstrate their design capability by:

• (a) holding a design organisation approval with terms of approval that cover the respective category of product, issued by the Agency in accordance with Subpart J of Section A of Annex I (Part 21); or

• (b) declaring their design capability for the scope of the product in accordance with Subpart J of this Annex.

21L.A.84   Application for a supplemental type certificate

• (a) An application for a supplemental type certificate shall be made in a form and manner established by the Agency.

• (b) When applying for a supplemental type certificate, the applicant shall:
• 1. include in the application the information required by point 21L.A.65(b);
• 1. specify whether the certification data has been or will be prepared completely by the applicant or on the basis of an arrangement with the owner of the type-certification data.

21L.A.85   Demonstration of compliance

• (a) The applicant for a supplemental type certificate shall demonstrate compliance with the applicable type-certification basis and the applicable environmental protection requirements as established and notified to the applicant by the Agency in accordance with point 21L.B.101 and shall provide the Agency with the means by which such compliance has been demonstrated.

• (b) The applicant for a supplemental type certificate shall provide the Agency with a recorded justification of the means of compliance within compliance documents according to the compliance demonstration plan.

• (c) When carrying out testing and inspections to demonstrate compliance in accordance with point (a), the applicant shall have verified and documented this verification prior to carrying out any test:
• 1. for the test specimen, that:
• (i) the materials and processes adequately conform to the specifications for the proposed changed type design;
• (ii) the constituent parts of the products adequately conform to the drawings in the proposed changed type design;
• (iii) the manufacturing processes, construction and assembly adequately conform to those specified in the proposed changed type design; and
• 1. that the test and measuring equipment used for the test were adequate for the test and appropriately calibrated.

• (d) The flight testing for the purpose of obtaining a supplemental type certificate shall be conducted in accordance with the methods for such flight testing specified by the Agency. The applicant for a supplemental type certificate shall make all the flight tests necessary to determine compliance with the applicable type-certification basis.

• (e) An applicant for a supplemental type certificate shall allow the Agency to:
• 1. review any data and information related to the demonstration of compliance;
• 1. witness or carry out any test or inspection conducted for the purpose of the demonstration of compliance; and
• 1. conduct a physical inspection of the first article of that product in the final changed configuration to verify the compliance of the design with the type-certification basis and the applicable environmental protection requirements.

• (f) Upon completion of the compliance demonstration, the applicant for a supplemental type certificate shall declare to the Agency that:
• 1. it has demonstrated compliance with the type-certification basis and the applicable environmental protection requirements as established and notified to the applicant by the Agency in accordance with points 21L.B.101, according to the compliance demonstration plan; and
• 1. no feature or characteristic has been identified that may make the changed product unsafe or environmentally incompatible for the uses for which certification is requested.

21L.A.86   Requirements for approval of a supplemental type certificate

• (a) In order to be issued with a supplemental type certificate, the applicant shall:
• 1. demonstrate their design capability in accordance with point 21L.A.83;
• 1. demonstrate that the change to a type certificate and the areas affected by the change comply with the type-certification basis and the applicable environmental protection requirements, as established by the Agency in accordance with point 21L.B.101;
• 1. demonstrate compliance in accordance with point 21L.A.85;
• 1. if the applicant has specified that they provided certification data on the basis of an arrangement with the owner of the type-certification data in accordance with point 21L.A.84(b), demonstrate that the type-certificate holder:
• (i) has no technical objection to the information submitted under point 21L.A.65; and
• (ii) has agreed to collaborate with the applicant to ensure the discharge of all the obligations for continued airworthiness of the changed product through compliance with points 21L.A.28 and 21L.A.88;
• 1. demonstrate that there are no unresolved issues from the physical inspection of the first article of that product in the final changed configuration carried out by the Agency in accordance with point 21L.A.85(e)(3).

• (b) A supplemental type certificate shall be limited to the specific configuration(s) in the type certificate to which the related major change relates.

21L.A.87   Approval of a supplemental type certificate under a privilege

• (a) The approval of a supplemental type certificate for a major change it has designed may be issued by an approved design organisation without an application according to point 21L.A.84 in accordance with the scope of its privileges provided for in point (9) of point 21.A.263(c) of Annex I (Part 21) instead of the Agency, as recorded in the terms of approval.

• (b) When issuing a supplemental type certificate in accordance with point (a), the design organisation shall:
• 1. ensure that all the substantiation data and justifications are available;
• 1. ensure that the compliance of the change with the type-certification basis and the applicable environmental protection requirements has been demonstrated and declared;
• 1. confirm that it has not found:
• (i) any non-compliances with the type-certification basis or, where applicable, with the applicable environmental protection requirements, or with the certification specifications chosen;
• (ii) any feature or characteristic of the change that may make the changed product unsafe or environmentally incompatible for the uses for which certification is requested;
• 1. limit the approval of the supplemental type certificate to the specific configuration(s) in the type certificate to which the change relates.

21L.A.88   Obligations of a holder of a supplemental type certificate

Each holder of a supplemental type certificate shall undertake the obligations of a supplemental type-certificate holder set forth in Subpart A of this Annex and shall continue to comply with the eligibility requirement under point 21L.A.82.

21L.A.89   Transferability of a supplemental type certificate

A supplemental type certificate may be transferred to a new holder, provided that the Agency has verified that the natural or legal person to whom the certificate is intended to be transferred is eligible in accordance with point 21L.A.83 to hold a supplemental type certificate and is able to undertake the obligations of a supplemental type-certificate holder under point 21L.A.88.

21L.A.90   Continued validity of a supplemental type certificate

• (a) A supplemental type certificate shall remain valid as long as:
• 1. the supplemental type certificate is not surrendered by the holder;
• 1. the holder of the supplemental type certificate remains in compliance with the relevant requirements of Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof, taking into account the provisions related to the handling of findings as specified under point 21L.B.21;
• 1. the supplemental type certificate is not revoked by the Agency in accordance with point 21L.B.22.

• (b) Upon surrender or revocation, the type certificate shall be returned to the Agency.

21L.A.91   Changes to a part of a product covered by a supplemental type certificate

• (a) A minor change to a part of a product covered by a supplemental type certificate shall be approved in accordance with Subpart D of this Annex.

• (b) A major change to that part of a product covered by a supplemental type certificate shall be approved as a separate supplemental type certificate in accordance with this Subpart.

• (c) By way of derogation from point (b), a major change to that part of a product covered by a supplemental type certificate submitted by the supplemental type-certificate holder may be approved as a change to the existing supplemental type certificate in accordance with points 21L.A.63 to 21L.A.69.

SUBPART F –   CHANGES TO AIRCRAFT FOR WHICH DESIGN COMPLIANCE HAS BEEN DECLARED

21L.A.101   Scope

This Subpart establishes:

• (a) the procedure for declaring the compliance of a change to the design of an aircraft which was subject to a declaration made in accordance with Subpart C of this Annex;

• (b) the rights and obligations of the declarant making a declaration of compliance of the change referred to in point (a); and

• (c) provisions regarding the standard changes that do not require a declaration of design compliance.

21L.A.102   Standard changes

• (a) Standard changes are changes to the design of an aircraft which was subject to a declaration made in accordance with Subpart C of this Annex and which:
• 1. follow the design data included in the certification specifications issued by the Agency, containing the acceptable methods, techniques and practices for carrying out and identifying standard changes, including the associated instructions for continued airworthiness; and
• 1. are not in conflict with the design data covered by the declaration of aircraft design compliance made in accordance with Subpart C of this Annex.

• (b) Points 21L.A.103 to 21L.A.108 are not applicable to standard changes.

21L.A.103   Classification of changes to the design of an aircraft for which design compliance has been declared

• (a) Changes to the design of an aircraft which was subject to a declaration made in accordance with Subpart C of this Annex shall be classified as minor or major, using the criteria laid down in points 21L.A.63 (b) and (c).

• (b) The design compliance of a minor change shall be declared in accordance with point 21L.A.105.

• (c) The design compliance of a major change shall be declared in accordance with point 21L.A.107.

21L.A.104   Eligibility

• (a) A declarant who made a declaration of aircraft design compliance in accordance with Subpart C of this Annex may declare compliance of a minor change to the design of that aircraft under the conditions laid down in this Subpart. In addition, such a declaration of compliance may also be made, under the conditions laid down in this Subpart, by a design organisation approved in accordance with point (c)(3) of point 21.A.263 of Annex I (Part 21).

• (b) Only the declarant who made a declaration of aircraft design compliance in accordance with Subpart C of this Annex may declare the compliance of a major change to the design of an aircraft for which design compliance has been declared in accordance with Subpart C of this Annex, under the conditions laid down in this Subpart.

• (c) By derogation from point (b) of point 21.L.A.104, if the declarant who made a declaration of aircraft design compliance in accordance with Subpart C of this Annex is no longer active or is unresponsive to requests for design changes, the compliance of a changed aircraft design may also be declared in accordance with Subpart C of this Annex by a design organisation approved in accordance with point (c)(4) of point 21.A.263 of Annex I (Part 21) within the scope of their terms of approval, or by any other natural or legal person who is able to undertake the obligations laid down in point 21L.A.47 with respect to that changed aircraft.

21L.A.105   Declaration of design compliance for minor changes

• (a) Prior to installing or incorporating or agreeing with a production organisation to install or incorporate a minor change to the design of an aircraft for which design compliance has been declared in accordance with Subpart C of this Annex the organisation that has designed that minor change shall declare that the design of that minor change complies with:
• 1. either the detailed technical specifications incorporated by reference in the declaration of design compliance of the aircraft, unless those detailed technical specifications or parts of them are no longer applicable in accordance with point 21L.B.61 because the Agency has determined that experience from other similar products in service or products that have similar design features has shown that unsafe conditions may develop, and the detailed technical specifications that were referenced in the declaration of design compliance of the aircraft do not address this unsafe condition, or
• 1. the detailed technical specifications applicable, on the date on which the declaration is made in accordance with point 21L.B.61, if chosen by the declarant; and
• 1. the applicable environmental protection requirements referred to in point 21L.B.61 which are applicable on the date on which the declaration is made.

• (b) The declaration of design compliance shall be made in a form and manner established by the Agency.

• (c) The declarant or the organisation that has designed the minor change shall maintain a register of minor changes to the design of aircraft for which design compliance has been declared, and make any declaration made in accordance with point (a) available to the Agency upon request.

21L.A.106   Obligations of the person making a declaration of compliance of the design of a minor change

Any person that has made a declaration of compliance of a minor change to an aircraft design in accordance with point 21L.A.105 shall:

• (a) maintain a register of those declarations and shall make those declarations available to the Agency upon request;

• (b) retain all supporting documents for a declaration of design compliance, and make them available to the Agency upon request;

• (c) undertake all other obligations of a declarant of a declaration of design compliance set forth in Subpart A of this Annex.

21L.A.107   Declaration of design compliance for a major change

• (a) Prior to installing or incorporating or agreeing with a production organisation to install or incorporate a major change to the design of an aircraft for which design compliance has been declared in accordance with Subpart C of this Annex, the organisation that has designed that major change shall declare that the design of that major change and the areas affected by that change comply with:
• 1. either the detailed technical specifications incorporated by reference in the declaration of design compliance of the aircraft, unless those detailed technical specifications or parts of them are no longer applicable in accordance with point 21L.B.61 because the Agency has determined that experience from other similar products in service or products that have similar design features has shown that unsafe conditions may develop and the detailed technical specifications that were referenced in the declaration of design compliance of the aircraft do not address this unsafe condition, or
• 1. the detailed technical specifications applicable on the date on which the declaration is made in accordance with point 21L.B.61, if chosen by the declarant; and
• 1. the applicable environmental protection requirements referred to in point 21L.B.61 which are applicable on the date on which the declaration is made.

• (b) The declaration of design compliance shall be made in a form and manner established by the Agency.

• (c) The declaration shall contain at least the following information:
• 1. the name of the person submitting the declaration, and their address/place of business;
• 1. the declaration reference number of the aircraft to which the major change relates;
• 1. a unique reference for identifying the major change;
• 1. indication of the detailed technical specifications and the applicable environmental protection requirements with which the declarant declares compliance;
• 1. a signed statement made under the sole responsibility of the person making the declaration that the design of the major change is in compliance with the detailed technical specifications and the applicable environmental protection requirements referred to in point (4), according to the compliance demonstration plan referred to in point (d)(3);
• 1. a signed statement made under the sole responsibility of the person making the declaration that no features or characteristics have been identified by that person that may make the aircraft unsafe or environmentally incompatible for the intended use;
• 1. a signed commitment that the person making the declaration will undertake the obligations referred to in point 21L.A.47 in respect of the changed aircraft design;
• 1. the instructions for continued airworthiness;
• 1. the operating limitations, if changed;
• 1. the data sheet for airworthiness and, if applicable, the record of emissions compliance;
• 1. the data sheet for noise, if applicable;
• 1. any other conditions or limitations prescribed for the aircraft in the applicable detailed technical specifications and the applicable environmental protection requirements with which the declarant declares compliance.

• (d) The declarant that designs a major change shall submit the declaration referred to in point (c) to the Agency. Together with this declaration, the declarant shall provide to the Agency:
• 1. a description of the major change;
• 1. basic data about the major change, including the operating characteristics, design features and any limitations;
• 1. a compliance demonstration plan detailing the means for compliance demonstration that was followed during the compliance demonstration;
• 1. recorded justifications of compliance within the compliance data obtained from the compliance activities that have been conducted according to the compliance demonstration plan;
• 1. the means by which such compliance with the applicable detailed technical specifications and applicable environmental protection requirements in point 21L.B.61 has been demonstrated;
• 1. where compliance is demonstrated by carrying out tests, recorded justification of the conformity of the test articles and equipment, demonstrating:
• (i) for the test specimen, that:
• (A) the materials and processes adequately conformed to the specifications for the design;
• (B) the constituent parts of the products adequately conformed to the drawings in the design; and
• (C) the manufacturing processes, construction and assembly adequately conformed to those specified in the design;
• (ii) that the test and measuring equipment used for the test were adequate for the test and appropriately calibrated;
• 1. reports, results of inspections or tests that the declarant found necessary to determine that the aircraft complies with the applicable detailed technical specifications and applicable environmental protection requirements.

• (e) The declaration of a major change to a declaration of design compliance shall be limited to the specific configuration(s) in the declaration of design compliance to which the change relates.

21L.A.108   Compliance activities for declaring compliance of a major change

Prior to making a declaration of compliance in accordance with point 21L.A.107, the declarant shall, for that specific design:

• (a) establish a compliance demonstration plan detailing the means for compliance demonstration that shall be followed during the compliance demonstration. This document shall be updated as necessary;

• (b) record the justification of compliance within compliance documents according to the compliance demonstration plan;

• (c) perform testing and inspections as necessary in accordance with the compliance demonstration plan;

• (d) ensure and record the conformity of the test articles and equipment and ensure that the test specimen conforms to the specifications, drawings, manufacturing processes, construction and assembly means in the design;

• (e) ensure that the test and measuring equipment to be used for testing are adequate for testing and appropriately calibrated;

• (f) allow the Agency to conduct or participate in any inspections or tests of aircraft in the final or suitably mature design and production configuration that are necessary to determine that the changed product has no feature or characteristic that makes the aircraft unsafe or environmentally incompatible for the intended use;

• (g) carry out flight testing, in accordance with the methods for such flight testing specified by the Agency, as necessary to determine that the aircraft complies with the applicable detailed technical specifications and the applicable environmental protection requirements.

SUBPART G –   DECLARED PRODUCTION ORGANISATIONS

21L.A.121   Scope

• (a) This Subpart establishes:
• 1. the procedures for declaring the production capability of natural and legal persons showing the conformity of products and parts with the applicable design data;
• 1. the rights and obligations of the natural and legal persons making a declaration of production capability referred to in point (1).

• (b) The following categories of products and parts may be produced by organisations which have made a declaration of production capability in accordance with this Subpart:
• 1. products and parts the design of which has been certified in accordance with this Annex;
• 1. aircraft the design of which is covered by a declaration made in accordance with this Annex, and their engines, propellers and parts.

21L.A.122   Eligibility

Any natural or legal person (‘organisation’) may declare their production capability under this Subpart, if that person:

• (a) has applied or intends to apply for the approval of the design of the product or part in accordance with this Annex; or

• (b) has declared or intends to declare the compliance of an aircraft design in accordance with this Annex; or

• (c) is collaborating with the applicant for, or holder of, an approval of the design of the product to be issued or issued in accordance with this Annex, or with the organisation that has declared or intends to declare the compliance of that aircraft design in accordance with this Annex, in order to ensure that the manufactured product or part is in conformity to that design, and to ensure the continued airworthiness of the product or part.

21L.A.123   Declaration of production capability

• (a) Prior to producing any products or parts, an organisation intending to show the conformity of those products or parts with the applicable design data shall declare its production capability.

• (b) The declaration, and any subsequent changes thereto, shall be made in a form and manner established by the competent authority.

• (c) The declaration shall include the information necessary for the competent authority to become familiar with the organisation and the intended scope of work, and shall include at least the following:
• 1. the registered name of the organisation;
• 1. the contact details of the organisation’s registered address of their principal place of business and, where applicable, the contact and the operating sites of the organisation;
• 1. the names and contact details of the accountable manager of the organisation nominated in accordance with point (c)(1) of point 21L.A.125;
• 1. the intended scope of work;
• 1. the date of the intended commencement of production;
• 1. a statement confirming that the organisation:
• (i) has a management system for production in accordance with point (a) of point 21L.A.124; and
• (ii) will maintain the management system for production in compliance with this Subpart;
• 1. a statement confirming that the organisation will adhere to the processes and procedures established in accordance with point (d) of point 21L.A.124;
• 1. a statement that the organisation agrees to undertake the obligations of a declared production organisation in accordance with point 21L.A.127.

• (d) The declaration of production capability shall be submitted to the competent authority.

21L.A.124   Management system for production

• (a) The declared production organisation shall establish, implement, and maintain a management system for production with clear accountability and lines of responsibility throughout the organisation that:
• 1. corresponds to the nature and complexity of its activities and the size of the organisation, and takes into account the hazards and associated risks inherent in these activities;
• 1. is established under the accountability of an accountable manager nominated according to point (c)(1) of point 21L.A.125.

• (b) The management system for production shall include a means to manage quality by maintaining a quality system that shall:
• 1. ensure that each product or part produced by the declared production organisation or by its partners, or supplied from or subcontracted to outside parties, conforms to the applicable design data and is in a condition for safe operation;
• 1. establish, implement, and maintain, as appropriate, within the scope of their activities, control procedures for:
• (i) document issue, approval, or change;
• (ii) vendor and subcontractor assessment, audit and control;
• (iii) verification that incoming products, parts, materials, and equipment, including items supplied new or used by buyers of products, are as specified in the applicable design data;
• (iv) identification and traceability;
• (v) manufacturing processes;
• (vi) inspection and testing, including production flight tests;
• (vii) calibration of tools, jigs, and test equipment;
• (viii) non-conforming item control;
• (ix) the collaboration with the applicant for, or holder of, the design approval or the declarant of a declaration of design compliance;
• (x) the completion and retention of records;
• (xi) ensuring the competence and qualifications of personnel;
• (xii) the issue of airworthiness release documents;
• (xiii) handling, storage and packing;
• (xiv) internal quality audits and the resulting corrective actions;
• (xv) work performed at any location other than the operating sites included in the declaration;
• (xvi) work carried out after the completion of production but prior to delivery, to maintain the aircraft in a condition for safe operation;
• (xvii) the request for the issuance of permits to fly and the approval of associated flight conditions;
• 1. include specific provisions in the control procedures for any critical parts.

• (c) The declared production organisation shall establish, as part of their management system for production, an independent function to monitor the compliance of the organisation with the relevant requirements, and compliance with, and the adequacy of, the production management system. This monitoring shall include a system to provide feedback to the person or group of persons referred to in points (c)(1) and (2) of point 21L.A.125 to ensure, as necessary, corrective action.

• (d) The declared production organisation shall establish, maintain and keep updated, as part of their management system for production, processes and procedures that ensure the compliance of products that are produced with the applicable design data. The declared production organisation shall make documentary evidence of these processes and procedures available to the competent authority upon request.

• (e) The declared production organisation shall have procedures in place to ensure that newly manufactured aircraft are maintained in accordance with the applicable maintenance instructions and are kept in an airworthy condition and, if applicable, that a certificate of release to service is issued for any maintenance that has been completed.

• (f) If the declared production organisation holds (an)other organisation certificate(s) issued on the basis of Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof, the production organisation may integrate the production management system with the management system that is required for the issuance of the other certificate(s).

21L.A.125   Resources of the declared production organisation

The declared production organisation shall ensure that:

• (a) the facilities, working conditions, equipment and tools, processes and associated materials, the number and competence of staff, and the general organisation are adequate to discharge its obligations under point 21L.A.127;

• (b) with regard to all necessary airworthiness and environmental protection data:
• 1. it is in receipt of such data from the Agency, and from the declarant of design compliance or the holder of, or the applicant for, the type certificate, or design approval, to determine its conformity with the applicable design data;
• 1. it has established a procedure to ensure that airworthiness and environmental compatibility data is correctly incorporated into its production data;
• 1. such data is kept up to date and made available to all personnel who need access to such data to perform their duties;

• (c) with regard to management and staff:
• 1. an accountable manager has been nominated by the declared production organisation with authority to ensure that, within the organisation, all production is performed to the required standards and that the declared production organisation is continuously in compliance with the requirements of the management system for production referred to in point (a) of point 21L.A.124, and the processes and the procedures identified in point (d) of point 21L.A.124;
• 1. a person or group of persons has or have been nominated by the accountable manager to ensure that the organisation is in compliance with the requirements of this Subpart, and is (are) identified, together with the extent of their authority. Such a person or group of persons shall be responsible to the accountable manager and have direct access to them. They shall have the appropriate knowledge, background and experience to discharge their responsibilities;
• 1. staff at all levels have been given appropriate authority to be able to discharge their allocated responsibilities and that there is full and effective coordination within the declared production organisation in respect of airworthiness and environmental compatibility data matters;
• 1. the organisational structure of the organisation along with the key personnel who are responsible for ensuring that the organisation is in compliance with this Subpart is documented and kept updated;

• (d) with regard to certifying staff, authorised by the declared production organisation to sign the documents issued under point 21L.A.126 within the scope of declared production activities:
• 1. the knowledge, background (including other functions in the organisation), and experience of the certifying staff are appropriate to discharge their allocated responsibilities;
• 1. certifying staff are provided with evidence of the scope of their authorisation. A list of certifying staff shall be maintained by the declared production organisation.

21L.A.126   Scope of work

• (a) A declared production organisation is entitled to show the conformity of the products and parts that are within the scope of this Section and that it has produced within the declared scope of work, with the applicable design data.

• (b) A declared production organisation is entitled, for a complete aircraft, after presentation of an aircraft statement of conformity (EASA Form 52B), to apply:
• 1. for an aircraft that conforms to a type design approved in accordance with Subpart B of Section B of this Annex, for a certificate of airworthiness and a noise certificate;
• 1. for an aircraft that conforms to a design for which compliance has been declared in accordance with Subpart C of this Annex, for a restricted certificate of airworthiness and a restricted noise certificate.

• (c) A declared production organisation is entitled to issue authorised release certificates (EASA Form 1) for engines, propellers and parts that either conform to:
• 1. approved design data issued in accordance with Subparts B, D, E or M of Section B of this Annex;
• 1. declared design data for which design compliance has been declared in accordance with Subparts C, F or N of this Annex;
• 1. production data based upon all the necessary approved design data as provided by a repair design approval holder.

• (d) A declared production organisation is entitled to recommend the conditions for an aircraft that it has produced and for which it has attested conformity with the applicable design data, under which a permit to fly can be issued by the competent authority under Subpart P of Annex I (Part 21).

• (e) A declared production organisation is entitled to maintain a new aircraft that it has produced, as necessary to keep it in an airworthy condition, unless Regulation (EU) No 1321/2014 requires the maintenance to be performed under such rules, and to issue a certificate of release to service (EASA Form 53B) in respect of that maintenance.

21L.A.127   Obligations of the declared production organisation

• (a) The declared production organisation shall work in accordance with clearly defined procedures, practices and processes.

• (b) If the declared production organisation intends to conduct flight tests, then it shall prepare, maintain and keep updated an operations manual that includes a description of the organisation’s policies and processes for flight testing. The declared production organisation shall make this manual available to the competent authority upon request.

• (c) For completed aircraft, prior to submitting an aircraft statement of conformity (EASA Form 52B) to the competent authority, the declared production organisation shall ensure that the aircraft is in a condition for safe operation and conforms to:
• 1. the approved type design of a type-certified product issued in accordance with Subpart B of Section B of this Annex, or
• 1. the design data of an aircraft for which design compliance has been declared in accordance with Subpart C of this Annex.

• (d) For products (other than complete aircraft) and parts, the declared production organisation shall ensure prior to issuing an authorised release certificate (EASA Form 1) that the product or part is in a condition for safe operation and conforms to the approved type design of a type-certified product issued in accordance with Subpart B, D, E or M of Section B of this Annex or conforms to the design data of an aircraft for which design compliance has been declared in accordance with Subpart C, F or M of this Annex.

• (e) For engines, the declared production organisation shall ensure that the completed engine is in compliance with the applicable engine exhaust emissions requirements applicable on the date of production of the engine.

• (f) The declared production organisation shall include, in any authorised release certificates (EASA Form 1) that are issued by it, the reference number issued by the competent authority in accordance with point 21L.B.142 for this declared production organisation.

• (g) The declared production organisation shall ensure that the organisation records the details of any work that is completed.

• (h) The declared production organisation shall provide, to the design holder or the declarant of a declaration of design compliance, continuing airworthiness support for any products or parts that they have produced.

• (i) The declared production organisation shall have an archiving system that records the requirements that have been placed on other organisations, such as suppliers and subcontractors. The declared production organisation shall make the archived data available to the competent authority for continuing airworthiness purposes.

• (j) For the production of new aircraft, the declared production organisation shall ensure that the aircraft is kept in an airworthy condition and that maintenance is performed, including any necessary repairs in accordance with the applicable design data, prior to the issuance of an aircraft statement of conformity (EASA Form 52B).

• (k) Where the declared production organisation issues a certificate of release to service after such maintenance, it shall determine that each completed aircraft has been subjected to the necessary maintenance and is in a condition for safe operation, prior to issuing that certificate.

• (l) The declared production organisation shall comply with the requirements in Subpart A of this Annex applicable to a declared production organisation.

21L.A.128   Notification of changes and cessation of activities

The declared production organisation shall notify the competent authority without undue delay of the following:

• (a) any changes to the information that has been declared in accordance with point (c) of point 21L.A.123;

• (b) any changes to the management system for production that are significant to the showing of conformity or to the airworthiness and environmental compatibility characteristics of the product or part;

• (c) the cessation of some of or all the activities covered by the declaration.

SUBPART H –   CERTIFICATES OF AIRWORTHINESS AND RESTRICTED CERTIFICATES OF AIRWORTHINESS

21L.A.141   Scope

This Subpart establishes the procedure for applying for a certificate of airworthiness or a restricted certificate of airworthiness for an aircraft whose design has been certified or declared in accordance with this Annex, and establishes the rights and obligations of the applicants for, and holders of, those certificates.

21L.A.142   Eligibility

Any natural or legal person under whose name an aircraft is registered or will be registered in a Member State (‘Member State of registry’) may apply for a certificate of airworthiness or for a restricted certificate of airworthiness for that aircraft under the conditions laid down in this Subpart.

21L.A.143   Application for a certificate of airworthiness or a restricted certificate of airworthiness

• (a) A natural or legal person shall apply for a certificate of airworthiness or a restricted certificate of airworthiness in a form and manner established by the competent authority of the Member State of registry.

• (b) A natural or legal person may apply for:
• 1. a certificate of airworthiness for aircraft which conform to a type certificate that has been issued by the Agency in accordance with Subpart B of Section B of this Annex; or
• 1. a restricted certificate of airworthiness for aircraft which conform to a declaration of design compliance in accordance with Subpart C of this Annex which is registered by the Agency in accordance with point 21L.B.63 at the time of application.

• (c) For a new aircraft that conforms to a type certificate issued by the Agency, the applicant shall include in the application:
• 1. an aircraft statement of conformity (EASA Form 52 or EASA Form 52B) that is either issued or signed by:
• (i) a production organisation that has declared their production capability under Subpart G of this Annex and has been registered by the competent authority in accordance with point 21L.B.142; or
• (ii) a production organisation approval holder under the privileges of point (b) of point 21.A.163 of Annex I (Part 21);
• 1. the mass and balance statement corresponding to the aircraft current configuration, as applicable;
• 1. the flight manual if required by the applicable type-certification basis.

• (d) For a new aircraft that conforms to a declaration of design compliance which is registered by the Agency, the applicant shall include in the application:
• 1. an aircraft statement of conformity (EASA Form 52B) that is either issued or signed by:
• (i) a natural or legal person in accordance with Subpart R of this Annex;
• (ii) a production organisation that has declared their production capability under Subpart G of this Annex and has been registered by the competent authority in accordance with point 21L.B.142; or
• (iii) a production organisation approval holder under the privileges of point (d) of point 21.A.163 of Annex I (Part 21);
• 1. the mass and balance statement corresponding to the aircraft current configuration, as applicable;
• 1. the flight manual if required by the applicable detailed technical specifications for the declaration of design compliance.

• (e) For a used aircraft which at the time of the application has an airworthiness certificate issued in accordance with this Annex, the applicant shall include in the application a copy of such certificate and one of the following:
• 1. a valid airworthiness review certificate (ARC) issued in accordance with Annex I (Part-M) or Annex Vb (Part-ML) to Regulation (EU) No 1321/2014, as applicable;
• 1. a recommendation for the issuance of an airworthiness review certificate pursuant to an airworthiness review in accordance with Annex I (Part-M) to Regulation (EU) No 1321/2014, where the conditions set out in point M.A.901(b)(1) of Annex I (Part-M) to Regulation (EU) No 1321/2014 are not met.

• (f) For a used aircraft which at the time of the application does not have an airworthiness certificate issued in accordance with this Annex, the applicant shall include all of the following documentation in the application:
• 1. a statement from the appropriate authority that was responsible for the oversight of the aircraft reflecting the airworthiness status of the aircraft at the time that authority ceased its oversight responsibilities;
• 1. the historical records necessary to establish the production, configuration and maintenance standard of the aircraft;
• 1. the mass and balance statement corresponding to the aircraft current configuration, as applicable;
• 1. the flight manual if required by the applicable type-certification basis or by the applicable detailed technical specifications for the declaration of design compliance;
• 1. a recommendation for the issuance of an airworthiness review certificate pursuant to an airworthiness review in accordance with Annex I (Part-M) to Regulation (EU) No 1321/2014 or an airworthiness review certificate in accordance with Annex Vb (Part-ML) to Regulation (EU) No 1321/2014, unless it is agreed that the airworthiness review is to be carried out by the competent authority;
• 1. if the former airworthiness certificate of the aircraft was issued in accordance with this Annex but has been subsequently revoked or surrendered, alternatively to the statement required in point 1, all of the following documentation:
• (i) a statement containing:
• (A) the details of the reasons for the revocation or surrender of the airworthiness certificate;
• (B) the details of how the aircraft has been preserved and maintained since the revocation or surrender of the airworthiness certificate;
• (C) all other relevant information related to the condition and history of the aircraft;
• (ii) an evaluation programme developed and carried out in accordance with points 21L.A.143(h)(3) and 21L.A.143(h)(4), unless otherwise agreed by the competent authority of the Member State of registry.

• (g) Unless otherwise agreed, the statements referred to in points (c)(1), (d)(1) and (f)(1) shall be issued no more than 60 days before the presentation of the aircraft to the competent authority of the Member State of registry.

• (h) By way of derogation from point 21L.A.143(f)(1), in exceptional cases and with prior agreement by the competent authority, an application may be made without a statement reflecting the airworthiness status of the aircraft, provided that all the following conditions are met:
• 1. the competent authority of the Member State of registry is satisfied that the airworthiness statement has not been denied by the former aviation authority because of airworthiness concerns, unless those concerns have been addressed and corrected;
• 1. there is evidence available to the competent authority of the Member State of registry as to the approved design according to which the aircraft was initially built and delivered;
• 1. an evaluation programme is developed detailing the investigations which are necessary to compensate for the lack of the airworthiness statement referred to in point 21L.A.143(f)(1).
• 1. the investigation activities were conducted in accordance with the evaluation programme, and the results have been summarised in an evaluation report;
• 1. upon request by the competent authority of the Member State of registry, the applicant provides access to, and copies of, any information that was used to generate the evaluation programme and evaluation report. The evaluation programme referred to in the first paragraph, point (3), shall ensure that the aircraft and its records are in a condition that makes the aircraft eligible for the issuance of an airworthiness certificate, through comprehensive investigations conducted by an approved organisation or the competent authority. The programme shall identify any discrepancies or deficiencies which, after the necessary corrective actions, will bring the aircraft into compliance with the applicable airworthiness standards. The evaluation programme shall not replace the tasks carried out by the person or organisation responsible for continuing airworthiness or airworthiness review tasks, but shall complement them. The evaluation programme shall be developed, and the investigations detailed in it shall be performed, by:
• (i) an organisation approved in accordance with point CAMO.A.125(g) of Annex Vc (Part-CAMO) or point CAO.A.095(c)(3) of Annex Vd (Part-CAO) to Regulation (EU) No 1321/2014;
• (ii) the competent authority of the Member State of registry, only for aircraft of 2 730  kg MTOM and below and upon the acceptance of that authority. The evaluation programme shall specify the activities to be performed to identify the status of the aircraft with regard to conformity to the approved type design, existing modifications and repairs and maintenance, and continuing airworthiness status. The evaluation programme, if developed by an organisation referred to in the third paragraph, point (i), shall be accepted by the competent authority of the Member State of registry before the evaluation is conducted.

21L.A.144   Obligations of the applicant for a certificate of airworthiness or a restricted certificate of airworthiness

The applicant for a certificate of airworthiness or for a restricted certificate of airworthiness shall:

• (a) present the manuals, placards, listings, and instrument markings and other necessary information required by the applicable type-certification basis or by the applicable detailed technical specifications for declarations of design compliance in one or more of the official language(s) of the European Union acceptable to the competent authority of the Member State of registry;

• (b) demonstrate that their aircraft is identified in accordance with Subpart Q of this Annex;

• (c) arrange for inspections of the competent authority of the Member State of registry to assess whether the aircraft has any non-conformities that could affect the safety of the aircraft.

21L.A.145   Transferability

The airworthiness certificate and the airworthiness review certificate shall be transferred together with the aircraft provided that the aircraft remains on the same register.

21L.A.146   Continued validity of a certificate of airworthiness and of a restricted certificate of airworthiness

• (a) A certificate of airworthiness or a restricted certificate of airworthiness shall remain valid as long as:
• 1. the aircraft remains on the same register;
• 1. the certificate has not been surrendered by the holder;
• 1. the aircraft remains in compliance with the relevant requirements of Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof and with the applicable type design or with the applicable design data of an aircraft for which design compliance has been declared, and with the continuing airworthiness requirements, taking into account the provisions related to the handling of findings as specified under point 21L.B.21;
• 1. the certificate has not been revoked by the competent authority of the Member State of registry under point 21L.B.22.

• (b) Upon surrender or revocation, the certificate shall be returned to the competent authority of the Member State of registry.

SUBPART I –   NOISE CERTIFICATES AND RESTRICTED NOISE CERTIFICATES

21L.A.161   Scope

This Subpart establishes the procedure for applying for a noise certificate or a restricted noise certificate for an aircraft whose design has been certified or declared in accordance with this Annex and establishes the rights and obligations of the applicants for, and holders of, those certificates.

21L.A.162   Eligibility

Any natural or legal person under whose name an aircraft is registered or will be registered in a Member State may apply for a noise certificate or a restricted noise certificate for that aircraft under the conditions laid down in this Subpart.

21L.A.163   Application

• (a) A natural or legal person shall apply for a noise certificate or a restricted noise certificate in a form and manner established by the competent authority of the Member State of registry.

• (b) A natural or legal person may apply for:
• 1. a noise certificate for aircraft which conform to a type certificate that has been issued by the Agency in accordance with Subpart B of Section B of this Annex; or
• 1. a restricted noise certificate for aircraft which conform to a declaration of design compliance submitted in accordance with Subpart C of this Annex which is registered by the Agency in accordance with point 21L.B.63 at the time of application.

• (c) The applicant shall include in the application:
• 1. with regard to new aircraft:
• (i) an aircraft statement of conformity (EASA Form 52 or EASA Form 52B) that is either issued or signed by:
• (A) a natural or legal person in accordance with Subpart R of this Annex;
• (B) a production organisation that has declared their production capability under Subpart G of this Annex and has been registered by the competent authority in accordance with point 21L.B.142; or
• (C) a production organisation approval holder under the privileges of point (b) of point 21.A.163 of Annex I (Part 21);
• (ii) the reference to the noise record within the Agency database of noise levels reflecting the noise information determined in accordance with the applicable noise requirements;
• 1. with regard to used aircraft:
• (i) the reference to the noise record within the Agency database of noise levels reflecting the noise information determined in accordance with the applicable noise requirements; and
• (ii) the historical records to establish the production, modification, and maintenance standard of the aircraft.

• (d) Unless otherwise agreed, the statements referred to in point (c)(1)(i) shall be issued no more than 60 days before the presentation of the aircraft to the competent authority of the Member State of registry.

21L.A.164   Transferability and re-issuance of noise certificates and restricted noise certificates within Member States

Where the ownership of an aircraft has changed:

• (a) if the aircraft remains on the same register, the noise certificate, or the restricted noise certificate issued in accordance with Subpart I of Section B of this Annex, shall be transferred together with the aircraft;

• (b) if the aircraft is intended to be registered in another Member State, the natural or legal person under whose name the aircraft will be registered shall apply to the competent authority of the new Member State of registry for a new noise certificate or restricted noise certificate and shall include in this application the former noise certificate or restricted noise certificate issued in accordance with Subpart I of Section B of this Annex.

21L.A.165   Continued validity of a noise certificate and of a restricted noise certificate

• (a) A noise certificate or a restricted noise certificate shall remain valid as long as:
• 1. the aircraft remains on the same register;
• 1. the certificate has not been surrendered by the holder;
• 1. the aircraft remains in compliance with the applicable environmental protection requirements of Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof and with the applicable type design or with the applicable design data of an aircraft for which design compliance has been declared, taking into account the provisions related to the handling of findings as specified under point 21L.B.21;
• 1. the certificate has not been revoked by the competent authority of the Member State of registry under point 21L.B.22.

• (b) Upon surrender or revocation, the certificate shall be returned to the competent authority of the Member State of registry.

SUBPART J –   DECLARED DESIGN ORGANISATIONS

21L.A.171   Scope

This Subpart establishes:

• (a) the procedure for declaring the design capability by natural and legal persons who design products under this Section; and

• (b) the rights and obligations of the persons making declarations of design capability referred to in point (a).

21L.A.172   Eligibility

Any natural or legal person (‘organisation’ in this Subpart) required by point 21L.A.22, point 21L.A.82 or point 21L.A.204 to demonstrate their design capability may declare their capability under the conditions laid down in this Subpart.

21L.A.173   Declaration of design capability

• (a) Prior to or at the same time as applying for a design approval under this Section, or prior to submitting the application for the approval of flight conditions in accordance with point 21.A.710 of Annex I (Part 21) of a product designed by it, whatever comes first, the organisation shall submit a declaration of design capability to the Agency.

• (b) The declaration, and any subsequent changes thereto, shall be made in a form and manner established by the Agency.

• (c) The declaration shall include the information necessary for the Agency to become familiar with the organisation and the intended scope of work, and shall include at least the following:
• 1. the registered name of the organisation;
• 1. the contact details of the organisation’s registered address of the principal place of business and, where applicable, of the operating sites of the organisation;
• 1. the names and contact details of the head of the design organisation;
• 1. the intended scope of work;
• 1. a statement confirming that the organisation:
• (i) has a management system for design in accordance with point (a) of point 21L.A.174; and
• (ii) will maintain the management system for design in compliance with this Subpart;
• 1. a statement confirming that the organisation will adhere to the processes and procedures established in accordance with point (d) of point 21L.A.174;
• 1. a statement that the organisation agrees to undertake the obligations of a declared design organisation in accordance with point 21L.A.177.

• (d) The declaration of design capability shall be submitted to the Agency.

21L.A.174   Management system for design

• (a) The declared design organisation shall establish, implement, and maintain a management system for design with clear accountability and lines of responsibility throughout the organisation that:
• 1. corresponds to the nature and complexity of its activities and the size of the organisation, and takes into account the hazards and associated risks inherent in these activities;
• 1. is established under the accountability of a single manager nominated as the head of the design organisation according to point (a) of point 21L.A.175.

• (b) The declared design organisation shall have, as part of their management system for design, a means to provide design assurance by establishing, implementing and maintaining a system for the control and supervision of the design, and of design changes and repairs, of products. This system shall:
• 1. include an airworthiness function responsible for ensuring that the designs of products and the designs of changes and repairs thereto comply with the applicable type-certification basis and the applicable environmental protection requirements;
• 1. establish, implement and maintain an independent function to verify the demonstration of compliance on the basis of which the organisation declares compliance with the applicable type-certification basis and with the applicable environmental protection requirements;
• 1. specify the manner in which the design assurance system accounts for the acceptability of the parts that are designed or the tasks that are performed by partners or subcontractors according to methods which are the subjects of written procedures.

• (c) The declared design organisation shall establish, as part of their management system for design, an independent function to monitor the compliance of the organisation with the relevant requirements, and compliance with, and adequacy of, the management system for design. This monitoring shall include a system to provide feedback to the person or a group of persons referred to in point (b) of point 21L.A.175, and to the accountable manager referred to in point (a) of point 21L.A.175 to ensure, as necessary, corrective action.

• (d) The declared design organisation shall establish, maintain and keep updated processes and procedures that ensure the design compliance of products with the applicable type-certification basis, applicable detailed technical specifications and applicable environmental protection requirements. The declared design organisation shall make documentary evidence of these processes and procedures available to the Agency upon request.

• (e) Where any parts or any changes to the products are designed by partner organisations or subcontractors, the processes and procedures in point (d) shall include a description of how the design organisation is able to give, for all parts, the assurance of compliance required by point (b)(2), and shall contain, directly or by cross-reference, descriptions and information on the design activities and organisation of those partners or subcontractors.

• (f) If the declared design organisation holds (an)other organisation certificate(s) issued on the basis of Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof, the declared design organisation may integrate the design management system with the management system that is required for the issuance of the other certificate(s).

21L.A.175   Resources of the declared design organisation

• (a) The declared design organisation shall nominate a head of the design organisation with the authority for ensuring that, within the organisation, all design activities are performed to the required standards and that the declared design organisation is continuously in compliance with the requirements for the management system for design referred to in points (a) to (c) of point 21L.A.174 and the processes and procedures referred to in point (d) of point 21L.A.174.

• (b) The head of the design organisation shall nominate and identify key personnel within the organisation that are responsible for:
• 1. ensuring that the designs of products and the designs of changes and repairs thereto comply with the applicable type-certification basis, applicable detailed technical specifications and applicable environmental protection requirements;
• 1. the independent monitoring of the compliance and adequacy function; and
• 1. depending on the size of the organisation, any other person or group of persons who is or are needed to ensure that the organisation is in compliance with the requirements of this Section.

• (c) The person or group of persons identified in point (b) shall:
• 1. be responsible to the head of the design organisation and have direct access to them;
• 1. have the appropriate knowledge, background and experience to discharge their allocated responsibilities.