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ANNEX IU.K.PART 21Certification of aircraft and related products, parts and appliances, and of design and production organisations

SECTION AU.K.TECHNICAL REQUIREMENTS

SUBPART J —DESIGN ORGANISATION APPROVALU.K.

[F121.A.231 Scope U.K.

This Subpart establishes the procedure for the approval of design organisations and rules governing the rights and obligations of applicants for, and holders of, such approvals. In this Subpart, the references to type-certificates include type-certificates and restricted type-certificates.]

Textual Amendments

21.A.233EligibilityU.K.

Any natural or legal person (‘organisation’) shall be eligible as an applicant for an approval under this Subpart

(a)

in accordance with points 21.A.14, 21.A.112B, 21.A.432B or 21.A.602B; or

(b)

for approval of minor changes or minor repair design, when requested for the purpose of obtaining privileges under point 21.A.263.

21.A.234ApplicationU.K.

Each application for a design organisation approval shall be made in a form and manner established by the [F2CAA] and shall include an outline of the information required by point 21.A.243, and the terms of approval requested to be issued under point 21.A.251.

Textual Amendments

21.A.235Issue of design organisation approvalU.K.

An organisation shall be entitled to have a design organisation approval issued by the [F3CAA] when it has demonstrated compliance with the applicable requirements under this Subpart.

Textual Amendments

21.A.239Design assurance systemU.K.
(a)The design organisation shall demonstrate that it has established and is able to maintain a design assurance system for the control and supervision of the design, and of design changes, of products, parts and appliances covered by the application. This design assurance system shall be such as to enable the organisation:U.K.
1.

[F4to ensure that the design of the products, parts and appliances or the design change thereof, comply with the applicable type-certification basis, the applicable operational suitability data certification basis and environmental protection requirements; and]

2.

to ensure that its responsibilities are properly discharged in accordance with:

(i)

the appropriate provisions of this Annex I (Part 21); and

(ii)

the terms of approval issued under point 21.A.251;

3.

to independently monitor the compliance with, and adequacy of, the documented procedures of the system. This monitoring shall include a feed-back system to a person or a group of persons having the responsibility to ensure corrective actions.

Textual Amendments

(b)The design assurance system shall include an independent checking function of the showings of compliance on the basis of which the organisation submits compliance statements and associated documentation to the [F5CAA].U.K.

Textual Amendments

(c)The design organisation shall specify the manner in which the design assurance system accounts for the acceptability of the parts or appliances designed or the tasks performed by partners or subcontractors according to methods which are the subject of written procedures.U.K.
21.A.243DataU.K.
[F6(a) The design organisation shall furnish a handbook to the [F7CAA] describing, directly or by cross-reference, the organisation, the relevant procedures and the products or changes to products to be designed. If flight tests are to be conducted, a flight test operations manual defining the organisation's policies and procedures in relation to flight test shall be furnished. The flight test operations manual shall include: U.K.
(i)

a description of the organisation's processes for flight test, including the flight test organisation involvement into the permit to fly issuance process;

(ii)

crewing policy, including composition, competency, currency and flight time limitations, in accordance with Appendix XII to this Annex I (Part 21), where applicable;

(iii)

procedures for the carriage of persons other than crew members and for flight test training, when applicable;

(iv)

a policy for risk and safety management and associated methodologies;

(v)

procedures to identify the instruments and equipment to be carried;

(vi)

a list of documents that need to be produced for flight test.]

Textual Amendments

(b)Where any parts or appliances or any changes to the products are designed by partner organisations or subcontractors, the handbook shall include a statement of how the design organisation is able to give, for all parts and appliances, the assurance of compliance required by point 21.A.239(b), and shall contain, directly or by cross-reference, descriptions and information on the design activities and organisation of those partners or subcontractors, as necessary to establish this statement.U.K.
(c)The handbook shall be amended as necessary to remain an up-to-date description of the organisation, and copies of amendments shall be supplied to the [F7CAA].U.K.
(d)The design organisation shall furnish a statement of the qualifications and experience of the management staff and other persons responsible for making decisions affecting airworthiness and environmental protection in the organisation.U.K.
[F421.A.245 Approval requirements U.K.

The design organisation shall demonstrate, on the basis of the information submitted in accordance with point 21.A.243 that, in addition to complying with point 21.A.239:

(a)

the staff in all technical departments are of sufficient numbers and experience and have been given appropriate authority to be able to discharge their allocated responsibilities and these, together with the accommodation, facilities and equipment are adequate to enable the staff to achieve the airworthiness, operational suitability and environmental protection objectives for the product;

(b)

there is full and efficient coordination between departments and within departments in respect of airworthiness, operational suitability and environmental protection matters.]

[F421.A.247 Changes in design assurance system U.K.

After the issue of a design organisation approval, each change to the design assurance system that is significant to the showing of compliance or to the airworthiness, operational suitability and environmental protection of the product, shall be approved by the [F8CAA]. An application for approval shall be submitted in writing to the [F8CAA] and the design organisation shall demonstrate to the [F8CAA], on the basis of submission of proposed changes to the handbook, and before implementation of the change, that it will continue to comply with this Subpart after implementation.]

Textual Amendments

21.A.249TransferabilityU.K.

Except as a result of a change in ownership, which is deemed significant for the purposes of point 21.A.247, a design organisation approval is not transferable.

[F121.A.251 Terms of approval U.K.

The terms of approval shall identify the types of design work, the categories of products, parts and appliances for which the design organisation holds a design organisation approval, and the functions and duties that the organisation is approved to perform with regard to the airworthiness, operational suitability and environmental characteristics of the products. For design organisation approvals covering type-certification or [F9UKTSO] authorisation for auxiliary power units (APUs), the terms of approval shall contain in addition the list of products or APUs. Those terms shall be issued as part of a design organisation approval.]

Textual Amendments

21.A.253Changes to the terms of approvalU.K.

Each change to the terms of approval shall be approved by the [F10CAA]. An application for a change to the terms of approval shall be made in a form and manner established by the [F10CAA]. The design organisation shall comply with the applicable requirements of this Subpart.

Textual Amendments

21.A.257InvestigationsU.K.
(a)The design organisation shall make arrangements that allow the [F11CAA] to make any investigations, including investigations of partners and subcontractors, necessary to determine compliance and continued compliance with the applicable requirements of this Subpart.U.K.

Textual Amendments

(b)The design organisation shall allow the [F11CAA] to review any report and make any inspection and perform or witness any flight and ground test necessary to check the validity of the compliance statements submitted by the applicant under point 21.A.239(b).U.K.
21.A.258FindingsU.K.
[F1(a) When, during the investigations referred to in points 21.A.257 and 21.B.100, objective evidence is found demonstrating non-compliance of the holder of a design organisation approval with the applicable requirements of this Annex, the finding shall be classified as follows: U.K.
1.

a ‘level 1’ finding is any non-compliance with the requirements of this Annex that may lead to uncontrolled non-compliances with applicable requirements and affect the safety of the aircraft;

2.

a ‘level 2’ finding is any non-compliance with the requirements of this Annex that is not classified as a ‘level 1’ finding.]

(b)A level three finding is any item where it has been identified, by objective evidence, to contain potential problems that could lead to a non-compliance under point (a).U.K.
[F1(c) After receipt of notification of findings under the applicable administrative procedures established by the [F12CAA]: U.K.
1.

in the case of a ‘level 1’ finding, the holder of a design organisation approval shall demonstrate to the satisfaction of the [F12CAA] that it has taken adequate corrective action within a period of no more than 21 working days after written confirmation of the finding;

2.

in the case of a ‘level 2’ findings, the holder of a design organisation approval shall demonstrate to the satisfaction of the [F12CAA] that it has taken adequate corrective action within a time period set by the [F12CAA] which is appropriate to the nature of the finding and is initially no longer than three months. The [F12CAA] may extend that initial time period where it considers that the nature of the finding allows such extension and where the applicant has submitted a corrective action plan which the [F12CAA] finds satisfactory; and

3.

a ‘level 3’ finding shall not require immediate action by the holder of a design organisation approval.

Textual Amendments

(d) In cases of ‘level 1’ or ‘level 2’ findings, the design organisation approval may be subject to a partial or full suspension or revocation under the applicable administrative procedures established by the [F12CAA]. In that case, the holder of a design organisation approval shall provide confirmation of receipt of the notice of suspension or revocation of the design organisation approval in a timely manner.]U.K.
21.A.259Duration and continued validityU.K.
(a)A design organisation approval shall be issued for an unlimited duration. It shall remain valid unless:U.K.
1.

the design organisation fails to demonstrate compliance with the applicable requirements of this Subpart; or

2.

the [F13CAA] is prevented by the holder or any of its partners or subcontractors to perform the investigations in accordance with point 21.A.257; or

3.

there is evidence that the design assurance system cannot maintain satisfactory control and supervision of the design of products or changes thereof under the approval; or

4.

the certificate has been surrendered or revoked under the applicable administrative procedures established by the [F13CAA].

Textual Amendments

(b)Upon surrender or revocation, the certificate shall be returned to the [F13CAA].U.K.
[F121.A.263 Privileges U.K.
(a)

(Reserved)

(b)

(Reserved)

(c)

A holder of a design organisation approval shall be entitled, within the scope of its terms of approval, as established by the [F14CAA], and under the relevant procedures of the design assurance system:

1.

to classify changes to a type-certificate or to a supplemental type-certificate and repair designs as ‘ major ’ or ‘minor’ ;

2.

to approve minor changes to a type-certificate or to a supplemental type-certificate and minor repair designs;

3.

(Reserved);

4.

(Reserved);

5.

to approve certain major repair designs under Subpart M to products or auxiliary power units (APUs);

6.

to approve for certain aircraft the flight conditions under which a permit to fly can be issued in accordance with point 21.A.710(a)(2), except for permits to fly to be issued for the purpose of point 21.A.701(a)(15);

7.

to issue a permit to fly in accordance with point 21.A.711(b) for an aircraft it has designed or modified, or for which it has approved, in accordance with point 21.A.263(c)(6), the flight conditions under which the permit to fly can be issued, and where the holder of a design organisation approval itself:

(i)

controls the configuration of the aircraft, and

(ii)

attests conformity with the design conditions approved for the flight;

8.

to approve certain major changes to a type-certificate under Subpart D; and

9.

to issue certain supplemental type-certificates under Subpart E and approve certain major changes to those certificates.]

Textual Amendments

[F121.A.265 Obligations of the holder U.K.

The holder of a design organisation approval shall, within the scope of its terms of approval, as established by the [F15CAA]:

Textual Amendments

(a)

maintain the handbook required under point 21.A.243 in conformity with the design assurance system;

(b)

ensure that this handbook or the relevant procedures included by cross-reference are used as a basic working document within the organisation;

(c)

determine that the design of products, or changes or repairs thereto comply with the applicable specifications and requirements and have no unsafe features;

(d)

provide the [F15CAA] with statements and associated documentation confirming compliance with point (c), except for approval processes carried out in accordance with point 21.A.263(c);

(e)

provide to the [F15CAA] data and information related to the actions required under point 21.A.3B;

(f)

determine, in accordance with point 21.A.263(c)(6), the flight conditions under which a permit to fly can be issued;

(g)

establish, in accordance with point 21.A.263(c)(7), compliance with points (b) and (e) of point 21.A.711 before issuing a permit to fly to an aircraft;

(h)

designate data and information issued under the authority of the approved design organisation within the scope of its terms of approval as established by the [F15CAA] with the following statement: ‘The technical content of this document is approved under the authority of the DOA ref. [F16CAA.21J].[XXXX]’.]

Textual Amendments

F16Word in Annex 1 point 21.A.265(h) substituted (21.6.2023) by The Aviation Safety (Amendment) Regulations 2023 (S.I. 2023/588), regs. 1(2), 6(9)(j)(ii)