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The Aviation Safety (Amendment) Regulations 2023

Type Statutory-Instrument

Publication 2023-05-30

State In force

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

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Made: at 12.00 p.m. on 30th May 2023

Laid before Parliament: at 2.30 p.m. on 30th May 2023

Coming into force

The Secretary of State makes these Regulations in exercise of the powers conferred by Articles 17(1), 19(1), 23(1), 27(1), 62(14) and 127(3) of Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules in the field of civil aviation[^f00001].

Citation, commencement and extent

1

(1) These Regulations may be cited as the Aviation Safety (Amendment) Regulations 2023.

(2) This regulation and regulations 2, 5, 6(1), 6(3)(a), (c) and (f), 6(4)(a), (c) and (d), 6(8)(a), (c)(i) and (e)(i), 6(9)(j)(ii), 6(11)(a) to (c), 6(13)(a), 8 to 13, 15(1) and (2), 16, 17(1), (2)(a) and (3), 18, 20, 21, 22(1) and (17), 25 to 28, 29(1) and (5) and 30 to 33 come into force on 21st June 2023.

(3) All other provisions of these Regulations come into force on 1st July 2024.

(4) These Regulations extend to England and Wales, Scotland and Northern Ireland.

Commission Regulation (EU) No 748/2012 (initial airworthiness)

2

Commission Regulation (EU) No 748/2012 of 3rd 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[^f00002], is amended in accordance with regulations 3 to 11.

Amendment of Article 8 of Commission Regulation (EU) No 748/2012

3

In Article 8 (design organisations), after paragraph 3 insert—

(4) By way of derogation from points 21.B.433(d)(1) and (2) of Annex I (Part 21), a design organisation that holds a valid approval certificate issued in accordance with Annex I (Part 21) must correct any findings of non-compliance related to the implementation of the SMS requirements before 1 July 2026. (5) On or after 1 July 2026, where a design organisation has not corrected any findings of non-compliance related to the implementation of the safety management requirements, that organisation’s approval certificate must be either revoked, limited or suspended in whole or part, dependent on the severity of the non-compliance.

Amendment of Article 9 of Commission Regulation (EU) No 748/2012

4

In Article 9 (production organisations)—

(a) in paragraph 1, after “(Part 21).” insert “This demonstration of capability is not required for the parts or appliances that an organisation manufactures which, in accordance with the provisions of Annex I (Part 21), are eligible for installation in a type-certified product without the need to be accompanied by an authorised release certificate (CAA Form 1).”;

(b) after paragraph 4 insert—

(5) By way of derogation from points 21.B.125(e) and 21.B.225(e) of Annex I (Part 21), a production organisation that holds a valid approval certificate issued in accordance with Annex I (Part 21) must correct any findings of non-compliance related to the implementation of the SMS requirements before 1 July 2026. (6) On or after 1 July 2026, where a production organisation has not corrected any findings of non-compliance related to the implementation of the safety management requirements, that organisation’s approval certificate must be either revoked, limited or suspended in whole or part, dependent on the severity of the non-compliance.

Amendment of Annex I to Commission Regulation (EU) No 748/2012

5

Annex I (Part 21) (certification of aircraft and related products, parts and appliances, and of design and production organisations) is amended in accordance with regulations 6 to 11.

Amendment of Section A of Annex I to Commission Regulation (EU) No 748/2012

6

(1) Section A (technical requirements) is amended as follows.

(2) In Subpart A (general provisions), after point 21.A.4 insert—

(21.A.5) All persons who hold, or have applied for, a type-certificate, restricted type-certificate, supplemental type-certificate, UKTSO authorisation, design or repair approval, permit to fly, production organisation approval certificate or letter of agreement under this Regulation must: (a) when they design a product, part or appliance, or a change or repair to a product, part or appliance: (1) establish and maintain a record-keeping system of the design information and data relating to the product, part or appliance; (2) make available to the CAA information on the record-keeping system (including information held on it) that is necessary to ensure the continued airworthiness of the product, part or appliance, the continued validity of the operational suitability data and compliance with the applicable environmental protection requirements; (b) when they produce a product, part or appliance: (1) record the details of the production process relevant to the conformity of the product, part or appliance with the applicable design data and the requirements imposed on them and their suppliers; (2) make that data available to the CAA in order to provide the information that is necessary to ensure the continued airworthiness of the product, part or appliance; (c) in respect of permits to fly: (1) maintain the documents produced under point 21.A.708 to establish and justify the flight conditions and make them available to the CAA in order to provide the information that is necessary to ensure the continued airworthiness of the aircraft; (2) where the permit to fly is issued by an organisation that has appropriate approval, maintain the documents associated with it, including inspection records and documents that support the approval of the flight conditions and the issue of the permit to fly itself and make them available to the CAA in order to provide the information that is necessary to ensure the continued airworthiness of the aircraft; (d) retain records of the competence and qualifications, referred to in points 21.A.139(c), 21.A.145(c), 21.A.239(c), 21.A.245(a) and 21.A.245(e)(1), of the personnel that are involved in the following functions: (1) design or production; (2) independent monitoring of the compliance of the organisation with the relevant requirements; (3) safety management; (e) retain records of the authorisation of personnel, in respect of employed personnel that: (1) exercise the privileges of the approved organisation pursuant to point 21.A.163 or 21.A.263, or both, as appropriate; (2) carry out the independent function to monitor the compliance of the organisation with the relevant requirements pursuant to point 21.A.139(e) or 21.A.239(e), or both, as appropriate; (3) carry out the independent verification function of the demonstration of compliance pursuant to point 21.A.239(d)(2). (21.A.6) The holder of a type-certificate, restricted type-certificate, or supplemental type-certificate must produce, maintain and update master copies of all manuals, or variations in the manuals, required by the applicable type-certification basis, the applicable operational suitability data certification basis and the environmental protection requirements for the product or article, and provide copies, on request, to the CAA. (21.A.7) (a) The holder of a type-certificate, restricted type-certificate, or supplemental type-certificate, design change or repair design approval must develop or reference the instructions which are necessary for ensuring that the airworthiness standard related to the product and any associated part is maintained throughout the operational life of the product, when demonstrating compliance with the applicable type-certification basis established and notified by the CAA in accordance with point 21.B.80. (b) At least one set of complete instructions for continued airworthiness must be provided by the holder of: (1) a type-certificate or restricted type-certificate to each known owner of one or more products upon delivery of that product or products, or upon the issuance of the first certificate of airworthiness or restricted certificate of airworthiness for the affected aircraft, whichever occurs later; (2) a supplemental type-certificate or design change approval to all known operators of the product affected by the change upon the release to service of the modified product; (3) a repair design approval to all known operators of the product affected by the repair upon the release to service of the product in which the repair design is embodied. The repaired product, part or appliance may, if the CAA agrees, be released into service before the related instructions for continued airworthiness have been completed, but this must be for a limited service period agreed by the CAA. (c) After that, any other person required to comply with those design approval holders’ instructions must be provided with them on request. (d) By way of derogation from point (b), the type-certificate holder or restricted type-certificate holder may delay the availability of a part of the instructions for continued airworthiness, dealing with long lead accomplishment instructions of a scheduled nature, until after the product or modified product has entered into service, but must make those instructions available before the use of the instructions is required for the product or modified product. (e) The design approval holder, who is required to provide instructions for continued airworthiness in accordance with point (b), must also make available changes to those instructions to all known operators of the product affected by the change and, on request, to any other person required to comply with those changes. On request, that design approval holder must demonstrate to the CAA the adequacy of the process for making changes to the instructions for continued airworthiness available in accordance with this point. (21.A.8) Any person that holds, or has applied for, a type-certificate, restricted type-certificate, supplemental type-certificate, UKTSO authorisation, design change or repair approval, certificate of airworthiness, noise certificate, permit to fly, design organisation approval, production organisation approval certificate or letter of agreement under this Regulation, must: (a) grant the CAA access to any facility, product, part or appliance, document, record, data, process, procedure or to any other material in order to review any report, make any inspection, or perform or witness any flight and ground test, as necessary, in order to verify the initial and continued compliance of the organisation with the applicable requirements of Regulation (EU) 2018/1139; (b) make arrangements to ensure the CAA has access, as provided for in point (a), and has access to the facilities of the person’s suppliers and subcontractors.

(3) In Subpart B (type-certificates and restricted type-certificates)—

(a) in point 21.A.15—

(i) in point (b), after “the initial application” insert “by”;

(ii) in point (d), after “the initial application” insert “by”;

(b) in point 21.A.41, after “the operating limitations,” insert “the instructions for continued airworthiness,”;

(a) undertake the obligations laid down in points 21.A.3A to 21.A.8, 21.A.62 and 21.A.65 and, for this purpose, must continue to meet the qualification requirements for eligibility under point 21.A.13;

(d) for point 21.A.47 (including the heading) substitute—

(21.A.47) The transfer of a type-certificate, a restricted type-certificate or a UKTSO authorisation for an auxiliary power unit may only be made to a person that is able to undertake the obligations laid down in point 21.A.44, and, for this purpose, has demonstrated its capability in accordance with point 21.A.14.

(e) omit points 21.A.55, 21.A.57 and 21.A.61;

(f) after point 21.A.62 (availability of operational suitability data) insert—

(21.A.65) The holder of a type-certificate or restricted type-certificate for a large aeroplane must ensure that the continuing structural integrity programme remains valid throughout the operational life of the aeroplane, taking into account service experiences and current operations.

(4) In Subpart D (changes to type-certificates and restricted type-certificates)—

(a) in point 21.A.90B(a)(2), for “continuing” substitute “continued”;

(b) after point 21.A.90B, insert—

(21.A.90C) (a) Stand-alone changes to the instructions for continued airworthiness (“stand-alone changes”) are changes that are not directly prepared as a result of a change to the type design or repairs design. (b) Stand-alone changes can only be made by the holder of the design approval for which instructions for continued airworthiness have been established. (c) Points 21.A.91 to 21.A.109 do not apply to stand-alone changes that: (1) do not affect the airworthiness limitations section of the instructions for continued airworthiness, and (2) do not require the design approval holder to perform any additional demonstration of compliance with the certification basis. (d) Stand-alone changes referred to in point (c) must be approved by the design approval holder under procedures agreed with the CAA.

(i) in point (b), after “the initial application” insert “by”;

(ii) in point (c)(2), in the last sentence, for “any other change” substitute “a change to any other”;

(d) in point 21.A.101, after point (b) insert—

(ba) The derogation in point (b) does not apply to large aeroplanes subject to point 26.300 of Annex I to Commission Regulation (EU) 2015/640[^f00008]. For those large aeroplanes, the applicant must comply with certification specifications that provide at least an equivalent level of safety to points 26.300 and 26.330 of Annex I to Regulation (EU) 2015/640, except for applicants for supplemental type-certificates who are not required to take into account point 26.303.

(e) omit points 21.A.105 and 21.A.107;

(f) in point 21.A.109(a), for “21.A.4, 21.A.105, 21.A.107” substitute “21.A.4 to 21.A.8”.

(5) In Subpart E (supplemental type-certificates)—

(a) in point 21.A.118A(a)(1), for “21.A.3A, 21.A.3B, 21.A.4, 21.A.105, 21.A.119, 29.A.120A” substitute “21.A.3A to 21.A.8”;

(b) omit points 21.A.119 and 21.A.120A.

(6) In Subpart F (production without production organisation approval)—

(a) after point 21.A.124 insert—

(21.A.124A) (a) An organisation may, with prior approval from the CAA, use alternative means of compliance to establish compliance with this Regulation. (b) To obtain prior approval, referred to in point (a), an organisation must provide the CAA with a full explanation indicating how compliance with this Regulation is to be achieved, including any revisions to manuals or procedures.

(b) for point 21.A.125B (including the heading) substitute—

(21.A.125B) (a) After receipt of the notification of findings pursuant to point 21.B.125, the holder of a letter of agreement must, within the period agreed with the CAA: (1) identify the root cause of, and any contributing factors to, the non-compliance; (2) submit to the CAA a corrective action plan; (3) demonstrate the implementation of the corrective action plan to the satisfaction of the CAA. (b) Where observations are received pursuant to point 21.B.125(f), the holder of a letter of agreement must give due consideration to the observations received and must keep a record of the decisions taken in respect of those observations.

(a) The letter of agreement must state the period of time for which it is issued, which must not exceed one year. It remains valid subject to the following conditions: (1) the production organisation continues to comply with the applicable requirements of this Annex; (2) the production organisation, and its suppliers and contractors as appropriate, permit the CAA to carry out investigations in accordance with point 21.A.8; (3) the production organisation provides the CAA with evidence showing it maintains satisfactory control of the manufacture of products, parts and appliances under the letter of agreement; (4) the letter of agreement has not been revoked by the CAA under point 21.B.65 or surrendered by the production organisation, and its duration has not expired.

(d) in point 21.A.126(b)(5), for “because of departures from design data” substitute “because of deviations from design data”;

(e) omit point 21.A.126(b)(6).

(7) In Subpart G (production organisation approval)—

(a) after point 21.A.134 insert—

(21.A.134A) (a) An organisation may, with prior approval from the CAA, use alternative means of compliance to establish compliance with this Regulation. (b) To obtain prior approval, referred to in point (a), an organisation must provide the CAA with a full explanation indicating how compliance with this Regulation is to be achieved, including details of any revisions to manuals or procedures.

(b) for point 21.A.139 (including the heading) substitute—

(21.A.139) (a) The production organisation must establish, implement and maintain a production management system that includes a safety management element and a quality management element, with clearly defined accountability and lines of responsibility throughout the organisation. (b) The production management system must: (1) correspond to the size of the organisation, and to the nature and complexity of its activities, taking into account the hazards and associated risks inherent in those activities; (2) be established, implemented and maintained under the direct accountability of a single manager appointed pursuant to point 21.A.145(c)(1). (c) As part of the safety management element of the production management system, the production organisation must: (1) establish, implement and maintain a safety policy and the corresponding related safety objectives; (2) appoint key safety personnel in accordance with point 21.A.145(c)(2); (3) establish, implement and maintain a safety risk management process to identify safety hazards entailed by its aviation activities, evaluate them and manage associated risks, including taking actions to mitigate the risks and verify their effectiveness; (4) establish, implement and maintain a safety assurance process that includes: (i) the measurement and monitoring of the organisation’s safety performance; (ii) the management of changes in accordance with point 21.A.147; (iii) the principles for the continuous improvement of the safety management element; (5) promote safety in the organisation through: (i) training and education; (ii) communication; (6) establish an occurrence reporting system in accordance with point 21.A.3A in order to contribute to the continuous improvement of safety. (d) As part of the quality management element of the production management system, the production organisation must: (1) ensure that each product, part or appliance produced by the organisation or by its partner, or supplied from or subcontracted to outside parties, conforms to the applicable design data and is in condition for safe operation, thus enabling the exercise of the privileges set out in point 21.A.163; (2) establish, implement and maintain, as appropriate, within the scope of the approval, 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) airworthiness coordination with the applicant for, or holder of, the design approval; (x) records completion and retention; (xi) personnel competence and qualification; (xii) issue of airworthiness release documents; (xiii) handling, storage and packing; (xiv) internal quality audits and resulting corrective actions; (xv) work within the terms of approval performed at any location other than the approved facilities; (xvi) work carried out after completion of production but prior to delivery, to maintain the aircraft in a condition for safe operation; (xvii) issue of permit to fly and approval or associated flight conditions; (3) include specific provisions in the control procedures for any critical parts. (e) The production organisation must establish, as part of the production management system, an independent monitoring function to verify compliance of the organisation with the relevant requirements of this Annex as well as compliance with, and adequacy of, the production management system. Monitoring must include feedback to the person referred to in point 21.A.145(c)(2) and to the manager referred to in point 21.A.145(c)(1) to ensure, where necessary, the implementation of corrective action. (f) If the production organisation holds one or more additional organisation certificates within the scope of Regulation (EU) 2018/1139, the production management system may be integrated with that required under the additional certificate held.

(i) for the first paragraph of point (a) substitute—

(a) The production organisation must establish and maintain a production organisation exposition (“POE”) that provides directly or by cross-reference the following information related to the production management system as described in point 21.A.139:

(ii) in point (a)(3), after “21.A.145(c)(2)” insert “and 21.A.145(c)(4)”;

(iii) in point (a)(4), substitute “21.A.145(c)(1) and (2) with “21.A.145(c)(1), (2) and (4).”;

(iv) for point (a)(11) substitute—

(11) a description of the production management system and the policy, processes and procedures as provided for in point 21.A.139(c);

(v) in point (a)(12), for “21.A.139(a)” substitute “21.A.139(d)(1)”;

(vi) for point (b) substitute—

(b) The initial issue of the POE must be approved by the CAA. (c) The POE must be amended as necessary so that it remains an up-to-date description of the organisation. Copies of any amendments must be supplied to the CAA.

(d) in point 21.A.145—

(i) for the words before point (a), substitute “The production organisation must demonstrate that:”;

(ii) in point (a)—

(aa) for “with regard to general approval requirements,” substitute “the”;

(bb) for “discharge obligations” substitute “discharge its obligations”;

(iii) in point (b)—

(aa) for “environmental data”, in both places it occurs, substitute “environmental protection data”;

(bb) for point (1) substitute—

(1) the production organisation holds all data it needs to determine conformity with the applicable design data. Such data may originate from the CAA and from the holder of, or applicant for, the type-certificate, restricted type-certificate or design approval, and may include any exemption granted from the environmental protection requirements;

(iv) in point (c)—

(aa) for points (1) and (2) substitute—

(1) an accountable manager has been appointed by the production organisation with the authority to ensure that, within the organisation, all production is performed to the required standards and that the production organisation is continuously in compliance with the requirements of the production management system referred to in point 21.A.139, and the date and procedures identified in the POE referred to in point 21.A.143; (2) a person has been nominated by the accountable manager to ensure that the organisation is in compliance with the requirements of this Annex, and is identified, together with the extent of their authority; (4) the person nominated for the purpose of point (2) must be: (i) responsible to, and have direct access to, the accountable manager appointed under point (1); and (ii) have appropriate knowledge, background and experience to discharge their responsibilities.”; (bb) in point (c)(3), after “environmental” insert “protection

(v) in point (d)—

(aa) in the words before point (1), for “under the scope or terms of approval” substitute “within the scope of the terms of approval”;

(bb) for points (1) to (3) substitute—

(1) they have appropriate knowledge, background, including that gained through undertaking other functions in the organisation, and experience to discharge their allocated responsibilities; (2) they are provided with evidence of the scope of their authorisation.

(e) omit point 21.A.157;

(f) for points 21.A.158 and 21.A.159 (in each case, including the heading) substitute—

(21.A.158) (a) After receipt of the notification of findings under 21.B.225(e), the holder of the production organisation approval certificate must: (1) identify the root cause of, and contributing factors to, the non-compliance; (2) define a corrective action plan; (3) demonstrate the implementation of the corrective action plan to the satisfaction of the CAA. (b) The actions referred to in point (a) must be performed within the period agreed with the CAA in accordance with point 21.B.225. (c) Where the holder of the production organisation approval certificate receives a notice of observations from the CAA pursuant to point 21.B.225(f), the holder of the production organisation approval certificate must give due consideration to the observations made and must keep a record of the decisions taken in respect of those observations. (21.A.159) (a) A production organisation approval certificate must be issued for an unlimited period of time pursuant to point 21.B.220. It is valid from the date of issue and remains valid subject to the following conditions: (1) the production organisation continues to comply with the applicable requirements of Regulation (EU) 2018/1139; (2) the production organisation, and its suppliers or subcontractors, as appropriate, permit the CAA to carry out investigations in accordance with point 21.A.8; (3) the production organisation provides the CAA with evidence showing that it maintains satisfactory control of products, parts and appliances under the approval; (4) the production organisation approval certificate has not been revoked by the CAA under point 21.B.65 or surrendered by the production organisation. (b) Upon surrender or revocation, the production organisation approval certificate must be returned to the CAA.

(8) In Subpart H (certificates of airworthiness and restricted certificates of airworthiness)—

(a) in point 21.A.174(b)(3)(ii)—

(i) for “Annex I (Part-M) or” substitute “Annex I (Part-M), or an airworthiness review certificate in accordance with””;

(ii) at the end of the last unnumbered paragraph insert—

, —the date on which the first certificate of airworthiness was issued and, if the standards of Volume 3 of Annex 16[^f00003] to the Chicago Convention[^f00004] apply, the CO2 metric value data

(b) omit point 21.A.180;

(i) for point (1) substitute—

(1) the aircraft continuing to comply with the applicable type design and continued airworthiness requirements; and

(ii) for point (4) substitute—

(4) the certificate having not been revoked by the CAA under point 21.B.65 or surrendered by the certificate holder.

(d) omit point 21.A.210;

(e) in point 21.A.211(a)—

(i) for point (1) substitute—

(1) the aircraft continuing to comply with the applicable type design and continued airworthiness requirements; and

(ii) for point (4) substitute—

(4) the certificate having not been revoked by the CAA under point 21.B.65 or surrendered by the certificate holder.

(9) In Subpart J (design organisation approval)—

(a) for point 21.A.239 (including the heading) substitute—

(21.A.239) (a) The design organisation must establish, implement and maintain a design management system that includes a safety management element and a design assurance element with clearly defined accountability and lines of responsibility throughout the organisation. (b) The design management system must: (1) correspond to the size of the organisation and to the nature and complexity of its activities, taking into account the hazards and associated risks inherent in those activities; (2) be established, implemented and maintained under the accountability of a single manager appointed pursuant to point 21.A.245(a). (c) As part of the safety management element of the design management system, the design organisation must: (1) establish, implement and maintain a safety policy and the corresponding related safety objectives; (2) appoint key safety personnel in accordance with point 21.A.245(b); (3) establish, implement and maintain a safety risk management process that includes the identification of aviation safety hazards entailed by its activities, their evaluation and the management of the associated risks, including taking actions to mitigate the risks and verify their effectiveness; (4) establish, implement and maintain a safety assurance process that includes: (i) the measurement and monitoring of the organisation’s safety performance; (ii) the management of changes in accordance with points 21.A.243(c) and 21.A.247; (iii) the principles for the continuous improvement of the safety management element; (5) promote safety in the organisation through: (i) training and education; (ii) communication; (6) establish an occurrence reporting system in accordance with point 21.A.3A in order to contribute to continuous improvement of safety. (d) As part of the design assurance element of the design management system, the design organisation must: (1) establish, implement, and maintain a system for control and supervision of the design, of design changes and repairs, of products, parts and appliances covered by the terms of approval, which must: (i) include an airworthiness function responsible for ensuring that the design of products, parts and appliances, or the design changes and repairs, comply with the applicable type-certification basis, the applicable operational suitability data certification basis and the environmental protection requirements; (ii) ensure that the design organisation properly discharges its responsibilities in accordance with this Annex and with the terms of approval issued under point 21.A.251; (2) establish, implement and maintain an independent verification function on the basis of which the design organisation demonstrates compliance with the applicable airworthiness, operational suitability data and environmental protection requirements; (3) specify the manner in which the design management system accounts for the acceptability of the parts or appliances that are designed or the tasks that are performed by its partners or subcontractors according to the methods which are the subject of written procedures. (e) The design organisation must establish, as part of the design management system, an independent monitoring function to verify compliance of the organisation with the relevant requirements of this Annex as well as the compliance with, and adequacy of, the design management system. Monitoring must include feedback to the person referred to in point 21.A.245(b) and to the manager referred to in point 21.A.245(a) to ensure, where necessary, the implementation of appropriate corrective action. (f) If the design organisation holds one or more additional organisation certificates within the scope of Regulation (EU) 2018/1139, the design management system may be integrated with that required under the additional certificate.

(b) in point 21.A.243—

(i) for point (a) substitute—

(a) As part of the design management system, the design organisation must create and give to the CAA a handbook that describes, directly or by cross-reference: (i) the organisation and its relevant policies, processes and procedures; (ii) the type of design work; (iii) the categories of products, parts and appliances for which the design organisation holds a design organisation approval, as identified in the terms of approval issued under point 21.A.251 and, where relevant, the interfaces with and the control of its partners or subcontractors.

(ii) in point (b)—

(aa) for “give” substitute “demonstrate”;

(bb) for “21.A.239(b)” substitute “21.A.239(d)(2)”;

(iii) for point (d) substitute—

(d) The design organisation must establish, maintain and supply to the CAA a statement of the qualifications and experience of the management staff and of other persons in the organisation who are responsible for decisions that affect airworthiness, operational suitability data and environmental protection.

(21.A.245) (a) The design organisation must appoint a head of the design organisation, who is an accountable manager, to ensure that the organisation’s design activities are performed to the required standards and that the design organisation continues to comply with the requirements of the design management system referred to in point 21.A.239 and the procedures specified in the handbook referred to in point 21.A.243. (b) The head of the design organisation must nominate and determine the extent of the authority of: (1) a head of airworthiness; (2) a head of independent monitoring; (3) depending on the size of the organisation and the nature and complexity of its activities, any other person that is required to ensure that the organisation complies with the requirements of this Annex. (c) By way of derogation from point 21.A.245(b)(1), the airworthiness function referred to in point 21.A.239(d)(1)(i) may be performed under the direct supervision of the head of the design organisation where: (1) the scope of activities, or work, of the design organisation, as identified in the terms of approval issued under point 21.A.251, is limited to minor changes, minor repairs, or both; or (2) for a limited period of time, which is to be agreed with the CAA, the design organisation does not have a nominated head of airworthiness and the exercise of that function under the direct supervision of the head of the design organisation is commensurate with the scope and level of the organisation’s activities. (d) The persons nominated pursuant to point (b) must: (1) have direct access to, and be answerable to, the head of the design organisation; (2) have the appropriate knowledge, background and experience to discharge their responsibilities. (e) The design organisation must ensure that: (1) there are sufficient number of suitably experienced technical department staff with the appropriate authority to discharge their allocated responsibilities and the facilities, equipment and accommodation are adequate to enable those staff to fulfil the airworthiness, operational suitability data and environmental protection requirements as regards the product; (2) there is full and efficient coordination between the departments and within the departments in respect of airworthiness, operational suitability data and environmental protection matters.

(d) in the heading to point 21.A.247, for “assurance” substitute “management”;

(e) in point 21.A.247—

(i) for “assurance” substitute “management”;

(ii) after “product,” insert “part or appliance”;

(iii) after “approved by the CAA” insert “before being implemented”;

(f) omit point 21.A.257;

(g) for point 21.A.258 (including the heading) substitute—

(21.A.258) (a) After receipt of a notification of findings in accordance with point 21.B.433, the holder of the design organisation approval must: (1) identify the root cause of, and any contributing factors to, the non-compliance; (2) establish a corrective action plan; (3) demonstrate the implementation of the corrective action plan to the satisfaction of the CAA. (b) The actions in point (a) must be undertaken within the period set by the CAA in accordance with point 21.B.433. (c) Where the holder of the design organisation approval certificate receives a notification of observations pursuant to 21.B.433(e), the holder of the design organisation approval certificate must give due consideration to the observations made and must keep a record of decisions taken in respect of those observations.

(h) for point 21.A.259 substitute—

(a) The CAA must issue a design organisation approval for an unlimited period of time pursuant to point 21.B.430. It is valid from the date of issue and remains valid subject to compliance with all the following conditions: (1) the design organisation continues to comply with Regulation (EU) 2018/1139, taking into account the provisions of point 21.B.433 of this Annex related to the handling of findings; (2) the holder of the design organisation approval, and its partners and subcontractors as appropriate, acknowledge that the CAA may carry out investigations in accordance with point 21.A.8; (3) the design organisation provides the CAA with evidence showing that the design management system of the organisation maintains satisfactory control and supervision of the design of products, repairs and changes to the products under the approval; (4) the design organisation approval certificate has not been revoked by the CAA under point 21.B.65 or surrendered by the design organisation. (b) Upon surrender or revocation, the production organisation approval certificate must be returned to the CAA.

(i) in point 21.A.263(c)—

(i) for “, as established by the CAA” substitute “issued under point 21.A.251”;

(ii) for “design assurance system” substitute “design management system”;

(j) in point 21.A.265—

(i) for point (c) substitute—

(c) determine that the design of the products, or of the changes or repairs to the products, complies with the applicable type-certification basis, operational suitability data certification basis, and the environmental protection requirements, and has no unsafe features;

(ii) in point (h), for “EASA.21J” substitute “CAA.21J”;

(iii) at the end of point (h) insert—

; (i) comply with Subpart A of this Section.

(10) In Subpart K (parts and appliances), for point 21.A.307 (including the heading) substitute—

(21.A.307) (a) A part or appliance is eligible for installation in a type-certified product when it is in a condition for safe operation, marked in accordance with Subpart Q and accompanied by an authorised release certificate (CAA Form 1), certifying that the item was manufactured in conformity with approved design data. (b) By way of derogation from point (a), where the conditions in point (c) are met, the following parts or appliances do not require a CAA Form 1 in order to be eligible for installation in a type-certified product: (1) a standard part; (2) in the case of ELA1 or ELA2, a part or appliance that is: (i) not life-limited, nor part of the primary structure, nor part of the flight controls; (ii) identified for installation in the specific aircraft; and (iii) to be installed in an aircraft whose owner has verified compliance with the applicable conditions in (i) and (ii), and has accepted responsibility for this compliance; (3) a part or appliance for which the consequences of a non-conformity with its approved design data have a negligible safety effect on the product, and which is identified as such by the holder of the design approval in the instructions for continued airworthiness. In order to determine the safety effects of a non-conforming part or appliance, the design approval holder may establish in the instructions for continued airworthiness specific verification activities to be conducted by the installer of the part or appliance on the product; (4) in the case of the embodiment of a standard change in accordance with point 21.A.90B, or a standard repair in accordance with point 21.A.431B, a part or appliance for which the consequences of a non-conformity with its design data have a negligible safety effect on the product, and which is identified as such in the certification specifications for standard changes and standard repairs issued in accordance with point 21.A.90B(a)(2) and 21.A.431B(a)(2). In order to determine the safety effects of a non-conforming part or appliance, specific verification activities to be conducted by the installer of the part or appliance on the product may be established in the certification specifications referred to above; (5) a part or appliance exempted from an airworthiness approval under Commission Regulation (EU) No 965/2012[^f00009]; and (6) a part or appliance that is an item of a higher assembly identified in points (1) to (5). (c) Parts and appliances listed in point (b) are eligible for installation in a type-certified product without being accompanied by a CAA Form 1, provided that the installer holds a document issued by the person or organisation that manufactured the part or appliance, which declares the name of the part or appliance, the part number, and the conformity of the part of appliance with its design data, and which contains the issuance date.

(11) In Subpart M (repairs)—

(a) in point 21.A.431B(a)(2), for “continuing” substitute “continued”;

(b) in point 21.A.432C(b), after “the initial application” insert “by”;

(i) after point (3), omit “and”;

(ii) at the end of point (4), insert—

; and (5) when, for a repair to an aeroplane subject to point 26.302 of Annex I to Regulation (EU) 2015/640, it has been demonstrated that the structural integrity of the repair and affected structure is at least equivalent to the level of structural integrity established for the baseline structure by point 26.302 of Annex I to that Regulation

(d) omit points 21.A.447 and 21.A.449;

(e) in point 21.A.451—

(i) in point (a)(1)(i)—

(aa) after “21.A.4,” insert “21.A.5 to 21.A.8,”;

(bb) for “, 21.A.443, 21.A.447 and 21.A.449” substitute “and 21.A.443”;

(ii) in point (b)(1), for “21.A.447 and 21.A.449” substitute “21.A.5 and 21.A.7”.

(12) In Subpart O (United Kingdom Technical Standard Order authorisations)—

(a) in point 21.A.604(a)—

(i) after “derogation from points” insert “21.A.8,”;

(ii) for “21.A.615” substitute “21.A.621”;

(iii) after “21.A.44” insert “21.A.47,”;

(b) in point 21.A.609—

(i) in point (b), for “a current file of complete” to the end, substitute “an updated set of complete technical data and records in accordance with point 21.A.5;”;

(ii) in point (f), for “and 21.A.4;” substitute “, 21.A.4 and 21.A.8;”;

(d) for point 21.A.619 (including the heading) substitute—

(21.A.619) (a) A UKTSO authorisation, issued by the CAA under point 21.B.480, is valid from the date of issue and remains valid for an unlimited period subject to compliance with the following conditions: (1) the conditions set when the UKTSO authorisation was issued continue to be observed by the UKTSO authorisation holder; (2) the obligations specified in point 21.A.609 continue to be discharged by the UKTSO authorisation holder; (3) the UKTSO authorisation holder, and its suppliers and subcontractors as appropriate, acknowledge that the CAA may carry out investigations in accordance with point 21.A.8; (4) in the opinion of the CAA the UKTSO article has not given rise to unacceptable hazards in service; (5) the UKTSO authorisation has not been revoked by the CAA under point 21.B.65 or surrendered by its holder. (b) Upon surrender or revocation, the UKTSO authorisation must be returned to the CAA.

(13) In Subpart P (permit to fly)—

(a) in point 21.A.711(d), after “granted in accordance with” insert “point M.A.711 of Annex I (Part-M) of Regulation (EU) No 1321/2014,”;

(b) omit point 21.A.721;

(i) after “subject to” insert “compliance with all the following conditions”;

(ii) in point (1)—

(aa) for “compliance” substitute “the organisation continues to comply”;

(bb) after “permit to fly” insert “as set out in point 21.A.711(e)”;

(iii) for point (2) substitute—

(2) the holder, and its suppliers or subcontractors as appropriate, acknowledge that the CAA may carry out investigations in accordance with point 21.A.8; (2A) the permit to fly has not been revoked by the CAA under point 21.B.65 or surrendered by its holder;

(d) omit point 21.A.729.

(14) In Subpart Q (identification of products, parts and appliances), in point 21.A.804—

(a) in point (a), in the words before point (1), after “appliance” insert “which is eligible for installation in a type-certified product”;

(b) in point (a)(3), after “UKTSO articles” insert “and for parts and appliances covered under point (b) of point 21.A.307”;

Amendment of Section B of Annex I to Commission Regulation (EU) No 748/2012

7

(1) Section B (procedures for the CAA) is amended as follows.

(2) In Subpart A (general provisions)—

(a) in point 21.B.5—

(i) for point (a) substitute—

(a) This section establishes the conditions for conducting the certification oversight and enforcement tasks as well as the administrative and management system requirements to be complied with by the CAA when exercising its tasks and responsibilities referred to in this Annex.

(ii) in point (b), for “Article 19 of Regulation (EC) No 216/2008” substitute “Article 76 Regulation (EU) 2018/1139”;

(b) after point 21.B.5 insert—

(21.B.6) (a) Without prejudice to Regulation (EU) No 376/2014, the CAA must implement a system to appropriately collect, analyse and disseminate safety information. (b) Upon analysing the safety information, the CAA must take adequate measures to address any safety problem identified. (c) The CAA must immediately notify measures taken under point (b) to all persons who need to comply with them under Regulation (EU) 2018/1139.

(21.B.25) (a) The CAA must establish and maintain a management system, including at least the following: (1) documented policies and procedures to describe the organisation, the means and methods for establishing compliance with Regulation (EU) 2018/1139. Those policies and procedures must be kept up to date, and must serve as the basic working documents within the CAA for all its related tasks; (2) sufficient personnel to perform its tasks and discharge its responsibilities, together with a system to plan the availability of personnel to ensure proper completion of all tasks; (3) qualified personnel that have the necessary knowledge and experience and training to perform their allocated tasks and receive initial and recurrent training to ensure continuing competency; (4) adequate facilities and office accommodation for personnel to perform their allocated tasks; (5) a means of monitoring compliance of the management system with the relevant requirements and the adequacy of the procedures, including an internal audit process and a safety risk management process. This must include a system for feedback of audit findings to the senior management of the CAA to ensure the implementation of corrective actions as necessary; (6) a person with responsibility to the senior management of the CAA for compliance monitoring. (b) The CAA must, for each field of activity, including the management system, appoint one or more persons with the overall responsibility for the management of the relevant task.

(d) for point 21.B.30 (including the heading) substitute—

(21.B.30) (a) The CAA may allocate tasks related to the initial certification or to the continuing oversight of products and parts and persons subject to Regulation (EU) 2018/1139 to qualified entities. When allocating tasks, the CAA must: (1) ensure it has a system in place to continuously assess compliance of the qualified entity with Annex VI to Regulation (EU) 2018/1139. That system and the assessment results must be documented; (2) establish a written agreement with the qualified entity, approved by both parties at the appropriate management level, which specifies: (i) the tasks to be performed; (ii) the declarations, reports and records to be provided; (iii) the technical conditions to be met when performing such tasks; (iv) the related liability coverage; (v) the protection given to the information acquired when carrying out such tasks. (b) The CAA must ensure that the internal audit process and the safety risk management process established under point 21.B.25(a)(5) covers all the certification and continuing oversight tasks performed by the qualified entity on its behalf.

(e) for point 21.B.35 (including the heading) substitute—

(21.B.35) (a) The CAA must have a system in place to identify changes that affect its capability to perform its tasks and discharge its responsibilities as defined in Regulation (EU) 2018/1139. That system must enable the CAA to take action necessary to ensure that its management system remains adequate and effective. (b) The CAA must, in a timely manner, update its management system to reflect any changes to Regulation (EU) 2018/1139 to ensure its effective implementation.

(f) omit point 21.B.40;

(g) for point 21.B.55 (including the heading) substitute—

(21.B.55) (a) The CAA must establish a record-keeping system that allows the adequate storage, accessibility and traceability of: (1) the documented policies and procedures of the management system; (2) personnel training, qualification and authorisation records; (3) allocation of tasks, covering the elements required by point 21.B.30, as well as the details of tasks allocated; (4) certification processes and continuing oversight of certified organisations, including: (i) the application for a certificate, approval, authorisation and letter of agreement; (ii) the CAA’s continuing oversight programme, including all the assessments, audits and inspection records; (iii) the certificates, approvals, authorisations and letters of agreement issued, including any changes to them; (iv) a copy of the oversight programme, listing the dates when audits are due and when audits were carried out; (v) copies of all formal correspondence; (vi) recommendations for the issue or continuation of a certificate, an approval, authorisation or a letter of agreement, details of findings and actions taken by the organisations to close those findings, including the date of closure, enforcement actions and observations; (vii) any relevant assessment, audit and inspection report issued by the competent authority of a third country; (viii) copies of any other documents approved by the CAA; (5) Statements of Conformity (CAA Form 52, Appendix VIII) and Authorised Release Certificates (CAA Form 1, Appendix I) that have been validated by the CAA for organisations that produce products, parts or appliances without a production organisation approval certificate according to Subpart F of Section A of this Annex. (b) The CAA must include in the record keeping: (1) documents supporting the use of alternative means of compliance; (2) safety information in accordance with point 21.B.6(a) and follow-up measures; (3) the use of safeguard and flexibility provisions in accordance with Articles 70, 71(1) and 76(4) of Regulation (EU) 2018/1139. (c) The CAA must maintain a list of all the certificates, approvals, authorisations and letters of agreement it has issued. (d) All the records referred to in points (a) to (c) must be kept for at least 5 years, in so far as that is compatible with data protection legislation.

(h) at the end of Subpart A insert—

(21.B.65) (a) The CAA must: (1) suspend a relevant approval where it considers there are reasonable grounds to believe that such action is necessary to prevent a credible threat to aircraft safety; (2) suspend, revoke or limit a relevant approval where such action is required pursuant to point 21.B.125, 21.B.225 or 21.B.433; (3) suspend or revoke a certificate of airworthiness or a noise certificate upon evidence that any of the conditions specified in points 21.A.181(a) and 21.A.211(a) are not met; (4) suspend or limit in whole or in part a relevant approval where unforeseeable circumstances outside the control of the CAA prevent its inspectors from discharging their oversight responsibilities over the oversight planning circle. (b) In this point, “relevant approval” means a certificate, approval, permit to fly, authorisation or letter of agreement.

(3) In Subpart E (supplemental type-certificates), after point 21.B.111 insert—

(21.B.115) (a) AMC may be used to establish compliance with Regulation (EU) 2018/1139 and this Regulation. (b) Alternative means of compliance may be used by an organisation to establish compliance with this Regulation when approved by the CAA.

(4) In Subpart F (production without production organisation approval)—

(a) for point 21.B.120 (including the heading) substitute—

(21.B.120) (a) The CAA must: (1) upon receipt of an application for a letter of agreement for the purpose of demonstrating conformity of the individual products, parts and appliances, verify the applicant’s compliance with the applicable requirements; (2) record all the findings issued, closure actions and recommendations for the issue of the letter of agreement; (3) confirm in writing to the applicant all findings raised during the verification; (4) issue the letter of agreement (CAA Form 65, Appendix XI) when satisfied that the applicant complies with the applicable requirements. (b) The letter of agreement must: (1) contain the scope of the agreement, a termination date and, where applicable, the appropriate limitations; (2) not exceed one year in duration. (c) Where the application is in relation to initial certification, the CAA may only issue the letter of agreement after being satisfied that all findings have been corrected to its satisfaction.

(b) for point 21.B.125 (including the heading) substitute—

(21.B.125) (a) The CAA must have a system in place to analyse findings for their safety significance. (b) The CAA must issue a level 1 finding where any significant non-compliance is detected with the applicable requirements of Regulation (EU) 2018/1139, with the organisation’s procedures or manuals, or with the certificate including the terms of approval, which lowers safety or seriously endangers flight safety. (c) Level 1 findings include: (1) any failure to grant the CAA access to the organisation’s facilities referred to in point 21.A.8 during normal operating hours and after two written requests; (2) obtaining the letter of agreement or maintaining its validity by falsification of the submitted documentary evidence; and (3) any evidence of malpractice or fraudulent use of the letter of agreement. (d) The CAA must issue a level 2 finding where any non-compliance is detected with the applicable requirements of Regulation (EU) 2018/1139, the organisation’s procedures and manuals, or with the terms of the letter of agreement, which is not classified as a level 1 finding. (e) When a finding is detected during oversight or by any other means, the CAA must, without prejudice to any additional action required by Regulation (EU) 2018/1139, issue the finding to the organisation and request corrective action to address the non-compliance identified. (1) Where there are any level 1 findings, the CAA must take immediate and appropriate action to prohibit or limit the activities of the organisation involved. Where appropriate, this action may be to revoke the letter of agreement or limit or suspend it in whole or in part, depending on the extent of the finding, until successful corrective action has been taken by the organisation. (2) Where there are any level 2 findings, the CAA must: (i) grant the organisation a corrective action implementation period appropriate to the nature of the finding which must not be more than 3 months from the date of the written communication under point (e). At the end of that period, and subject to the nature of the finding, the CAA may extend the 3-month period provided that a corrective action plan has been agreed with the CAA; (ii) assess the corrective action plan and implementation method proposed by the organisation following the written communication under point (e), and if the assessment concludes that they are sufficient to address the non-compliance, accept them. (3) Where the organisation fails to submit an acceptable corrective action plan or fails to perform the corrective action within the time period accepted or extended by the CAA, the CAA must raise the finding to level 1 and action must be taken as laid down in point (e)(1). (f) The CAA may issue observations for any of the following cases not requiring level 1 or level 2 findings: (1) for any item whose performance has been assessed to be ineffective; (2) when it has been identified that an item has the potential to cause a non-compliance under point (d) or (e); (3) when suggestions or improvements are of interest for the overall safety performance of the organisation. (g) The CAA must communicate the observations issued under this point in writing to the organisation and must keep a record of those observations and communications. (h) The CAA, subject to the nature of the finding, may extend the 3 month corrective action implementation period provided that a corrective action plan has been agreed with the CAA.

(d) at the end of Subpart F, insert—

(21.B.215) (a) AMC may be used to establish compliance with Regulation (EU)2018/1139. (b) Alternative means of compliance may be used by an organisation to establish compliance with this Regulation when approved by the CAA.

(5) In Subpart G (production organisation approval)—

(a) for point 21.B.220 (including the heading) substitute—

(21.B.220) (a) Upon receipt of an application for the initial issue of a production organisation approval certificate, the CAA must verify the applicant’s compliance with the applicable requirements. (b) The CAA must convene a meeting with the accountable manager of the applicant at least once during the investigation for initial certification to ensure that this person understands their role and accountability. (c) The CAA must record all findings issued, closure actions and recommendations for the issue of the production organisation approval certificate. (d) The CAA must confirm to the applicant in writing all the findings raised during the verification. (e) For initial certification, all findings must be corrected to the satisfaction of the CAA before the certificate can be issued. (f) When the CAA is satisfied that the applicant complies with the applicable requirements, the CAA must issue the production organisation approval certificate (CAA Form 55 in Appendix X). (g) The certificate reference number must be included on the production organisation approval certificate. (h) The certificate must be issued for an unlimited duration. The privileges and scope of the activities that the organisation is approved to conduct, including any limitations as applicable, must be specified in the terms of approval attached to the certificate.

(b) after point 21.B.220 insert—

(21.B.221) (a) In carrying out the oversight programme under point 21.B.222, the CAA must verify: (1) compliance with the requirements that are applicable to organisations prior to issue of the production organisation approval certificate; (2) continued compliance with the applicable requirements of the organisations it has certified; (3) the implementation of appropriate safety measures mandated by the CAA according to point 21.B.6(c). (b) This verification must: (1) be supported by documentation specifically intended to provide CAA personnel responsible for oversight with guidance to perform their functions; (2) provide the organisations concerned with the results of oversight activities; (3) be based on assessments, audits, inspections and, if needed, unannounced inspections; (4) provide the CAA with the evidence of non-compliance needed in case further action is required, including the measures provided for in point 21.B.225. (c) The CAA must establish the scope of the oversight in points (a) and (b) taking into account the results of past oversight activities and the safety priorities. (d) The CAA must collect and process any information deemed necessary for performing its oversight activities. (21.B.222) (a) The CAA must establish and maintain an oversight programme covering the oversight activities in point 21.B.221(a). (b) The oversight programme must be based on the assessment of the associated risks and take into account the specific nature of the organisation, the complexity of its activities, and the results of past certification and past oversight activities. Within each oversight planning cycle, it must include: (1) assessments, audits and inspections, including, as appropriate: (i) management system assessments and process audits; (ii) product audits of a relevant sample of the products, parts and appliances that are within the scope of the approval of the organisation; (iii) sampling of the work performed; (iv) unannounced inspection; (2) meetings between the accountable manager and the CAA to ensure both parties remain informed of all significant issues. (c) The oversight planning cycle must not exceed 24 months. (d) Notwithstanding point (c), the oversight planning cycle may be extended to 36 months if the CAA has, in the preceding 24 months, established that: (1) the organisation has demonstrated that it can effectively identify aviation safety hazards and manage the associated risks; (2) the organisation has continuously demonstrated compliance with points 21.A.147 and 21.A.148 and it has full control over all changes to the production management system; (3) no level 1 findings have been issued; (4) all corrective actions have been implemented within the time period agreed with the CAA under point 21.B.225. (e) Notwithstanding points (c) and (d), the oversight planning cycle may be further extended to a maximum of 48 months if, in addition to the conditions set out at point (d), the organisation has established, and the CAA has approved, an effective, continuous system for reporting to the CAA on the safety performance and regulatory compliance of the organisation itself. (f) The oversight planning cycle may be reduced if there is evidence that the safety performance of the organisation has decreased. (g) The oversight programme must include records of the dates when assessments, audits, inspections and meetings are due, and when assessments, audits, inspections and meetings have been effectively carried out. (h) At the completion of each oversight planning cycle, the CAA must issue a recommendation report on the continuation of the approval, reflecting the results of the oversight.

(21.B.225) (a) The CAA must have a system in place to analyse findings for their safety significance. (b) The CAA must issue a level 1 finding where any significant non-compliance is detected with the applicable requirements of Regulation (EU) 2018/1139, with the organisation’s procedures or manuals, or with the certificate including the terms of approval, which lowers safety or seriously endangers flight safety. (c) Level 1 findings include: (1) any failure to grant the CAA access to the organisation’s facilities mentioned in point 21.A.8 during normal operating hours and after two written requests; (2) obtaining the production organisation approval certificate or maintaining its validity by falsification of submitted documentary evidence; (3) any evidence of malpractice or fraudulent use of the production organisation approval certificate; (4) failure to appoint an accountable manager pursuant to point 21.A.245(a). (d) The CAA must issue a level 2 finding where any non-compliance is detected with the applicable requirements of Regulation (EU) 2018/1139, with the organisation’s procedures or manuals, or with the certificate including the terms of approval, which is not classified as a level 1 finding. (e) When a finding is detected during oversight or by any other means, the CAA must, without prejudice to any additional action required by Regulation (EU) 2018/1139, write to the organisation and request corrective action to address the non-compliance identified. (1) If there are any level 1 findings, the CAA must take immediate and appropriate action to prohibit or limit the activities of the organisation involved and, if appropriate, revoke the production organisation approval certificate or limit or suspend it in whole or in part, depending on the extent of the level 1 finding, until successful corrective action has been taken by the organisation. (2) If there are any level 2 findings, the CAA must grant the organisation a corrective action implementation period appropriate to the nature of the finding which must not be more than 3 months from the date of the written communication under point (e). (3) If there are any level 2 findings, the CAA must assess the corrective action and implementation plan proposed by the organisation following the written communication under point (e), and if the assessment concludes that these are sufficient to address the non-compliance, accept them. (4) Subject to the nature of the finding, at the end of the 3 month period referred to in point (e)(2), the CAA may extend the 3 month period provided that the organisation has agreed a corrective action plan with the CAA. (5) If there are any level 2 findings, if the organisation fails to submit an acceptable corrective action plan or fails to perform the corrective action within the time period accepted or extended by the CAA, the finding must be raised to level 1, and action must be taken as laid down in point (e)(1). (f) The CAA may issue observations for any of the following cases not requiring level 1 or level 2 findings: (1) for any item whose performance has been assessed to be ineffective; or (2) when it has been identified that an item has the potential to cause a non-compliance under point (b) or (d); (3) when suggestions or improvements are of interest for the overall safety performance of the organisation. (g) The CAA must notify the production organisation in writing of any observations issued under point (f) and must keep a record of those observations.

(d) omit points 21.B.230 and 21.B.235;

(e) for point 21.B.240 (including heading) substitute—

(21.B.240) (a) Upon receipt of an application for a significant change to the production management system, the CAA must verify the organisation’s compliance with the applicable requirements of this Annex before issuing the approval. (b) The CAA must establish the conditions under which the organisation may operate during the evaluation of a change unless the CAA determines that the production organisation approval certificate needs to be suspended. (c) When satisfied the organisation complies with the applicable requirements, the CAA must approve the change. (d) Without prejudice to any other enforcement measures, where the organisation implements a significant change to the production management system without prior approval of the CAA under point (c), the CAA may suspend, limit or revoke the organisation’s certificate if it considers necessary. (e) For non-significant changes to the production management system, the CAA must include the review of such changes in its continuing oversight in accordance with the principles set out in point 21.B.221. Where any non-compliance is found, the CAA must notify the organisation, request further changes and act in accordance with point 21.B.225.

(f) omit points 21.B.245 and 21.B.260.

(6) In Subpart H (certificates of airworthiness and restricted certificates of airworthiness)—

(a) for point 21.B.325(c) substitute—

(c) For new aircraft, and used aircraft originating from a third country, in addition to the appropriate airworthiness certificate referred to in point (a) or (b), the CAA must issue: (1) for aircraft subject to Annex I (Part-M) to Regulation (EU) No 1321/2014, an initial airworthiness review certificate (CAA Form 15a, Appendix II); (2) for new aircraft subject to Annex Vb (Part-ML) to Regulation (EU) No 1321/2014, an initial airworthiness review certificate (CAA Form 15c, Appendix II); (3) for used aircraft originating from a third country, and subject to Annex Vb (Part-ML) to Regulation (EU) No 1321/2014, an initial airworthiness review certificate (CAA Form 15c, Appendix II), when the CAA has performed the airworthiness review.

(b) omit points 21.B.330 and 21.B.345.

(7) In Subpart I (noise certificates), omit points 21.B.430 and 21.B.445.

(8) For Subpart J (design organisation approval), substitute—

(21.B.430) (a) Upon receiving an application for the initial issue of a design organisation approval, the CAA must verify the applicant’s compliance with the applicable requirements. (b) A meeting with the head of the design organisation must be convened at least once during the investigation for initial certification to ensure that this person understands their role and accountability. (c) The CAA must record all the findings issued, closure actions and recommendations for the issue of the design organisation approval. (d) The CAA must confirm to the applicant in writing all the findings raised during the verification. For initial certification, all findings must be corrected to the satisfaction of the CAA before the design organisation approval can be issued. (e) When satisfied that the applicant complies with the applicable requirements, the CAA must issue the design organisation approval. (f) The certificate reference number must be included in the design organisation approval in a manner specified by the CAA. (g) The certificate must be issued for an unlimited period of time. The privileges and the scope of the activities that the design organisation is approved to perform, including any limitations as applicable, must be specified in the terms of approval attached to the design organisation approval. (21.B.431) (a) The CAA must verify whether certified organisations continue to comply with the applicable requirements. (b) The verification must: (1) be supported by documentation specifically intended to provide CAA personnel responsible for oversight with guidance to perform their functions; (2) provide the organisations concerned with the results of oversight activities; (3) be based on assessments, audits, and inspections pursuant to point 21.B.432 and, if needed, unannounced inspections; (4) provide the CAA with the evidence needed in case further action is required, including the measures provided for in point 21.B.433. (c) The CAA must establish the scope of the oversight set out in point (b) taking into account the results of past oversight activities and the safety priorities. (d) The CAA must collect and process any information deemed necessary for performing oversight activities. (21.B.432) (a) The CAA must establish and maintain an oversight programme covering the oversight activities required to comply with point 21.A.431(a). (b) The oversight programme must take into account the specific nature of the organisation, the complexity of its activities, and the results of past certification and oversight activities, and it must be based on the assessment of the associated risks. It must include, within each oversight planning cycle: (1) assessments, audits and inspections, including, where appropriate: (i) management system assessments and process audits; (ii) product audits of a relevant sample of the design and certification of the products, parts and appliances that are within the scope of work of the organisation; (iii) sampling of the work performed; (iv) unannounced inspections; (2) meetings between the head of the design organisation and the CAA to ensure that both parties remain informed of all significant issues. (c) The oversight planning cycle must not exceed 24 months. (d) Notwithstanding point (c), the oversight planning cycle may be extended to 36 months if the CAA has established that during the previous 24 months: (1) the organisation has demonstrated that it can effectively identify aviation safety hazards and manage the associated risks; (2) the organisation has continuously demonstrated compliance with point 21.A.247 and has full control over all changes to the design management system; (3) no level 1 findings have been issued; (4) all corrective actions have been implemented within the time period that was accepted or extended by the CAA as provided for in point 21.B.433(e). (e) Notwithstanding points (c) and (d), the oversight planning cycle may be further extended to a maximum of 48 months if, in addition to the conditions laid down in point (d), the organisation has established, and the CAA has approved, an effective continuous system for reporting to the CAA on the safety performance and regulatory compliance of the organisation itself. (f) The oversight planning cycle may be reduced if there is evidence that the safety performance of the organisation has decreased. (g) The oversight programme must include records of the dates when assessments, audits, inspections and meetings are due, and when assessments, audits, inspections and meetings have been effectively carried out. (h) At the completion of each oversight planning cycle, the CAA must issue a recommendation report on the continuation of the approval, reflecting the results of the oversight. (21.B.433) (a) The CAA must have a system in place to analyse findings for their safety significance. (b) The CAA must issue a level 1 finding where a severe non-compliance is detected with the applicable requirements of Regulation (EU) 2018/1139, with the organisation’s procedures or manuals, or with the design organisation’s certificate including the terms of approval, which may lead to uncontrolled non-compliances and to a potential unsafe condition. (c) Level 1 findings include: (1) any failure to grant the CAA access to the organisation’s facilities referred to in point 21.A.8 during normal operating hours and after two written requests; (2) obtaining the design organisation approval or maintaining its validity by falsification of the submitted documentary evidence; (3) any evidence of malpractice or fraudulent use of the design organisation approval; (4) failure to appoint a head of the design organisation pursuant to point 21.A.245(a). (d) The CAA must issue a level 2 finding where any non-compliance, which is not classified as a level 1 finding is detected with the applicable requirements of Regulation (EU) 2018/1139, with the organisation’s procedures or manuals, or with the certificate including the terms of approval. (e) Where a finding is detected during oversight or by any other means, the CAA must, without prejudice to any additional action required by Regulation (EU) 2018/1139, communicate the finding in writing to the organisation and request corrective action to address the non-compliance identified. (1) Where there are any level 1 findings: (i) the CAA must grant the organisation a corrective action implementation period, appropriate to the nature of the finding, which must not be more than 1 month commencing from the date of the written communication of the finding to the organisation under point (e); (ii) the CAA must assess the corrective action plan and implementation plan proposed by the organisation, and if it concludes that they are sufficient to address the non-compliance, accept them; (iii) where the organisation fails to submit an acceptable corrective action plan, or fails to perform the corrective action within the time period accepted by the CAA, take immediate and appropriate action to prohibit or limit the activities of the organisation involved and, if appropriate, take action to revoke the design organisation approval or to limit or suspend it in whole or in part, depending on the extent of the level 1 finding, until successful corrective action has been taken by the organisation. (2) Where there are any level 2 findings: (i) the CAA must grant the organisation a corrective action implementation period, appropriate to the nature of the finding, which must not be more than 3 months commencing from the date of the written communication of the finding to the organisation under point (e). At the end of the 3 month period, and subject to the nature of the finding, the CAA may extend the 3 month period provided that a corrective action plan has been agreed by the CAA; (ii) the CAA must assess the corrective action and the implementation plan proposed by the organisation, and if it concludes that they are sufficient to address the non-compliance, accept them; (iii) where the organisation fails to submit an acceptable corrective action plan or fails to perform the corrective action within the time period accepted or extended by the CAA, the CAA must raise the finding to level 1 and action must be taken as laid down in point (e)(1). (f) The CAA may issue observations for any of the following cases not requiring level 1 or level 2 findings: (1) for any item whose performance has been assessed as ineffective; (2) when it has been identified that an item has the potential to cause a non-compliance under points (b), (c) or (d); (3) when suggestions or improvements are of interest for the overall safety performance of the organisation. (g) The observations issued under this point must be communicated in writing to the organisation and recorded by the CAA. (21B.435) (a) Upon receiving an application for a significant change to the design management system, the CAA must verify the organisation’s compliance with the applicable requirements of Regulation (EU) 2018/1139 before issuing the approval. (b) The CAA must establish the conditions under which the organisation may operate during the change unless the CAA determines that the design organisation approval needs to be suspended. (c) When it is satisfied that the organisation complies with the applicable requirements of Regulation (EU) 2018/1139, the CAA must approve the change. (d) Without prejudice to any additional enforcement measures, if the organisation implements a significant change to the design management system without having received the approval of the CAA pursuant to point (c), the CAA must consider the need to suspend, limit or revoke the organisation’s certificate. (e) For non-significant changes to the design management system, the CAA must include the review of such changes in its continuing oversight in accordance with the principles set out in point 21.B.431. If any non-compliance is found, the CAA must notify the organisation, request further changes and act in accordance with point 21.B.433.

(9) In Subpart P (permit to fly), omit points 21.B.445, 21.B.530 and 21.B.545.

Amendment of Appendix II to Annex I to Commission Regulation (EU) No 748/2012

8

In Appendix II, for CAA Form 15 (airworthiness review certificate) substitute—

Amendment of Appendix VIII to Annex I to Commission Regulation (EU) No 748/2012

9

In Appendix VIII, for CAA Form 52 (aircraft statement of conformity) substitute—

Amendment of Appendix X to Annex I to Commission Regulation (EU) No 748/2012

10

In Appendix X, for CAA Form 55 (production organisation approval certificate) substitute—

Amendment of Appendix XI to Annex I to Commission Regulation (EU) No 748/2012

11

In Appendix XI, for CAA Form 65 (letter of agreement for production organisation approval) substitute—

Commission Regulation (EU) No 1321/2014 (continuing airworthiness)

12

Commission Regulation (EU) No 1321/2014 on the continuing airworthiness of aircraft and aeronautical products, parts and appliances, and on the approval of organisations and personnel involved in these tasks is amended in accordance with regulations 13 to 31.

Amendment of Article 3 of Commission Regulation (EU) No 1321/2014

13

In Article 3 (continuing airworthiness requirements), in paragraph 5, for “24 September 2019” substitute “24 March 2020”.

Amendment of Article 4 of Commission Regulation (EU) No 1321/2014

14

In Article 4 (approvals for organisations involved in the continuing airworthiness of aircraft), after paragraph 6 insert—

A maintenance organisation that holds a valid approval certificate issued in accordance with Annex II (Part-145) must correct any findings of non-compliance related to the implementation of the Safety Management System requirements before 1 July 2026. Where, on or after 1 July 2026, the organisation has not closed such findings, the approval certificate must be revoked, limited or suspended in whole or in part.

Amendment of Article 5 of Commission Regulation (EU) No 1321/2014

15

(1) Article 5 (certifying staff) is amended as follows.

(2) In paragraph 1—

(a) for “M.A.801(d)” substitute “M.A.801(c)”;

(b) omit “CAO.A.035(d) and”;

(3) After paragraph 6 insert—

(7) Limited certifying staff authorisations issued to flight engineer licence holders pursuant to point 145.A.30(j)(3) or (4) of Annex II (Part-145) before 1 July 2024 continue to be valid until they expire or until they are revoked by the maintenance organisation.

Amendment of Article 8 of Commission Regulation (EU) No 1321/2014

16

In Article 8 (entry into force), omit paragraph 7.

Amendment of Annex I (Part-M) to Commission Regulation (EU) No 1321/2014

17

(1) Annex I (Part-M) is amended as follows.

(2) In Subpart H (certificate of release to service – CRS)—

(a) in point M.A.801(d), for “(2)” substitute “(1)”;

(b) for point M.A.802(a), substitute—

(a) Except for components released to service by a maintenance organisation that is approved in accordance with Annex II (Part-145) and cases covered by M.A.502A, a CRS shall be issued at the completion of any maintenance work carried out on an aircraft component in accordance with point M.A.501.

(3) In Subpart I (airworthiness review certificate), in point M.A.901(e), for “For aircraft not used by air carriers licensed in accordance with Regulation (EC) No 1008/2008[^f00005], and for aircraft of 2730 kg MTOM and below” substitute “For aircraft of 2370 kg MTOM and below not used by air carriers licensed in accordance with Regulation (EC) No 1008/2008”.

Amendment of Appendix III to Annex I to Commission Regulation (EU) No 1321/2014

18

In Appendix III, for CAA Form 15b (airworthiness review certificate) substitute—

Amendment of Appendix IV to Annex I to Commission Regulation (EU) No 1321/2014

19

(1) Appendix IV (class and ratings system) is amended as follows.

(2) In the heading to Appendix IV—

(a) for “the approval” substitute “for the terms of approval”;

(b) omit “and Annex II (Part-145)”.

(3) For points (1) and (2) substitute—

(1) Except as stated otherwise for the smallest organisations referred to in point (11), the table in point (12) provides for the standard system for the approval of a maintenance organisation referred to in Annex I (Part-M), Subpart F. An organisation must be granted an approval that ranges from a single class and rating with limitations to all classes and ratings with limitations. (2) In addition to the table referred to in point (12), the approved maintenance organisation must indicate its scope of work in its maintenance organisation manual.

(4) For points (8) to (12) substitute—

(8) The limitation section is intended to give the CAA the flexibility to customise the approval to any particular organisation. Ratings must be mentioned on the approval only when appropriately limited. The table referred to in point (12) specifies the types of limitation possible. Whilst maintenance is listed last in each class rating it is acceptable to stress the maintenance task rather than the aircraft or engine type or manufacturer, if this is more appropriate to the organisation (an example could be avionic systems installations and related maintenance). Such mention in the limitation section indicates that the maintenance organisation is approved to carry out maintenance up to and including this particular type or task. (9) Where reference is made to series, type and group in the limitation section of class A and B, “series” means a specific type series such as Cessna 150, Cessna 172, Beech 55 series or Continental O-200 series; “type” means a specific type or model such as Cessna 172RG type; any number of series or types may be quoted; “group” means for example Cessna single piston engine aircraft or Lycoming non-supercharged piston engines, etc. (10) Where a lengthy capability list is used which could be subject to frequent amendments, then such amendments may be performed in accordance with the indirect approval procedure referred to in points M.A.604(c) and M.B.606(c). (11) A maintenance organisation which employs only one person to both plan and carry out all maintenance can only hold a limited scope of approval rating which may be further limited by the CAA depending on the capability of the particular organisation. The maximum permissible limits are: [image omitted]

(5) Point (13) is renumbered as point (12).

(6) In point (12), as renumbered by paragraph (5), in the table, omit the first entry for “A1 Aeroplanes above 5700kg”.

Amendment of Appendix VII to Annex I to Commission Regulation (EU) No 1321/2014

20

In Appendix VII (complex maintenance tasks), in the first sentence, for “points (b)(2) and (c) of point M.A.801” substitute “point M.A.801(b)”.

Amendment of Annex II to Commission Regulation (EU) No 1321/2014

21

Annex II (Part-145) is amended in accordance with regulations 22 to 24.

Amendment of Section A of Annex II to Commission Regulation (EU) No 1321/2014

22

(1) Section A is amended as follows.

(2) In the section heading, after “technical” insert “and organisational”.

(3) In point 145.A.10, after “approval” insert “certificate”.

(4) For point 145.A.15 (including the heading) substitute—

(145.A.15) (a) An application for a certificate or an amendment to an existing certificate in accordance with this Annex must be made in a form and manner established by the CAA, taking into account the applicable requirements of Annex I (Part-M), Annex Vb (Part-ML) and this Annex. (b) Applicants for an initial certificate pursuant to this Annex must provide the CAA with: (1) the results of a pre-audit performed by the organisation against the applicable requirements provided for in Annex I (Part-M), Annex Vb (Part-ML) and this Annex; (2) documentation demonstrating how they intend to ensure compliance with the requirements of this Regulation.

(5) For point 145.A.20 substitute—

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