Legalize
Legalize / European Union / Delegated Regulation

Commission Delegated Regulation (EU) 2022/201 of 10 December 2021 amending Regulation (EU) No 748/2012 as regards management systems and occurrence-reporting systems to be established by design and production organisations, as well as procedures applied by the Agency, and correcting that Regulation

Type Delegated Regulation
Publication 2022-02-15
State In force
Text As published
Department European Commission, MOVE
Source EUR-Lex
articles 3

This is the act as published. Later amendments are not folded into the text below: each one is a separate act in this repository and an entry in this law's history.

Reform history JSON API
15.2.2022 EN Official Journal of the European Union L 33/7

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to 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 and establishing a European Union Aviation Safety Agency, and amending Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of the European Parliament and of the Council, and repealing Regulations (EC) No 552/2004 and (EC) No 216/2008 of the European Parliament and of the Council and Council Regulation (EEC) No 3922/91 [^ntr1-L_2022033EN.01000701-E0001], and in particular Article 19(1) and Article 62(13) thereof,

Whereas:

HAS ADOPTED THIS REGULATION:

Article 1

Regulation (EU) No 748/2012 is amended as follows:

‘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) may correct, until 7 March 2025, any findings of non-compliance related to the Annex I requirements introduced by Commission Delegated Regulation (EU) 2022/201[^ntr*1-L_2022033EN.01000701-E0007].

Where after 7 March 2025, the organisation has not closed such findings, the approval certificate shall be revoked, limited or suspended in whole or in part.

[^ntr*1-L_2022033EN.01000701-E0007]: Commission Delegated Regulation (EU) 2022/201 of 10 December 2021 amending Regulation (EU) No 748/2012 as regards management systems and occurrence-reporting systems to be established by design and production organisations, as well as procedures applied by the Agency, and correcting that Regulation (OJ L 33, …, p. 7)’;"

  • (2) Annex I (Part 21) is amended in accordance with Annex I to this Regulation.

Article 2

Annex I (Part 21) to Regulation (EU) No 748/2012 is corrected in accordance with Annex II to this Regulation.

Article 3

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from 7 March 2023, with the exception of Article 2 which shall apply from 7 March 2022.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 10 December 2021.

For the Commission

The President

Ursula VON DER LEYEN

[^ntr1-L_2022033EN.01000701-E0001]: OJ L 212, 22.8.2018, p. 1.

[^ntr2-L_2022033EN.01000701-E0002]: Commission Regulation (EU) No 748/2012 of 3 August 2012 laying down implementing rules for the airworthiness and environmental certification of aircraft and related products, parts and appliances, as well as for the certification of design and production organisations (OJ L 224, 21.8.2012, p. 1).

[^ntr3-L_2022033EN.01000701-E0003]: Regulation (EU) No 376/2014 of the European Parliament and of the Council of 3 April 2014 on the reporting, analysis and follow-up of occurrences in civil aviation, amending Regulation (EU) No 996/2010 of the European Parliament and of the Council and repealing Directive 2003/42/EC of the European Parliament and of the Council and Commission Regulations (EC) No 1321/2007 and (EC) No 1330/2007 (OJ L 122, 24.4.2014, p. 18).

[^ntr5-L_2022033EN.01000701-E0005]: Commission Delegated Regulation (EU) 2021/699 of 21 December 2020 amending and correcting Regulation (EU) No 748/2012 as regards the instructions for continued airworthiness, the production of parts to be used during maintenance and the consideration of ageing aircraft aspects during certification (OJ L 145, 28.4.2021, p. 1).

[^ntr6-L_2022033EN.01000701-E0006]: Commission Regulation (EU) 2015/640 of 23 April 2015 on additional airworthiness specifications for a given type of operations and amending Regulation (EU) No 965/2012 (OJ L 106, 24.4.2015, p. 18).

ANNEX I

Annex I (Part 21) is amended as follows:

‘ Contents
21.1 Competent authority
21.2 Scope

SECTION A – TECHNICAL REQUIREMENTS

SUBPART A – GENERAL PROVISIONS
21.A.1 Scope
21.A.2 Undertaking by another person than the applicant for, or holder of, a certificate
21.A.3A Reporting system
21.A.3B Airworthiness directives
21.A.4 Coordination between design and production
21.A.5 Record-keeping
21.A.6 Manuals
21.A.7 Instructions for continued airworthiness
21.A.9 Access and investigation

SUBPART B – TYPE-CERTIFICATES AND RESTRICTED TYPE-CERTIFICATES
21.A.11 Scope
21.A.13 Eligibility
21.A.14 Demonstration of capability
21.A.15 Application
21.A.19 Changes requiring a new type-certificate
21.A.20 Demonstration of compliance with the type-certification basis, operational suitability data certification basis and environmental protection requirements
21.A.21 Requirements for the issuance of a type-certificate or restricted type-certificate
21.A.31 Type design
21.A.33 Inspections and tests
21.A.35 Flight tests
21.A.41 Type-certificate
21.A.44 Obligations of the holder
21.A.47 Transferability
21.A.51 Duration and continued validity
21.A.62 Availability of operational suitability data
21.A.65 Continuing structural integrity for aeroplanes structures

(SUBPART C – NOT APPLICABLE)

SUBPART D – CHANGES TO TYPE-CERTIFICATES AND RESTRICTED TYPE-CERTIFICATES
21.A.90A Scope
21.A.90B Standard changes
21.A.90C Stand-alone changes to the instructions for continued airworthiness
21.A.91 Classification of changes to a type-certificate
21.A.92 Eligibility
21.A.93 Application
21.A.95 Requirements for approval of a minor change
21.A.97 Requirements for approval of a major change
21.A.101 Type-certification basis, operational suitability data certification basis and environmental protection requirements for a major change to a type-certificate
21.A.108 Availability of operational suitability data
21.A.109 Obligations and EPA marking

SUBPART E – SUPPLEMENTAL TYPE-CERTIFICATES
21.A.111 Scope
21.A.112A Eligibility
21.A.112B Demonstration of capability
21.A.113 Application for a supplemental type-certificate
21.A.115 Requirements for approval of major changes in the form of a supplemental type-certificate
21.A.116 Transferability
21.A.117 Changes to that part of a product covered by a supplemental type-certificate
21.A.118A Obligations and EPA marking
21.A.118B Duration and continued validity
21.A.120B Availability of operational suitability data

SUBPART F – PRODUCTION WITHOUT PRODUCTION ORGANISATION APPROVAL
21.A.121 Scope
21.A.122 Eligibility
21.A.124 Application
21.A.124A Means of compliance
21.A.125A Issuance of a letter of agreement
21.A.125B Findings and observations
21.A.125C Duration and continued validity
21.A.126 Production inspection system
21.A.127 Tests: aircraft
21.A.128 Tests: engines and propellers
21.A.129 Obligations of the production organisation
21.A.130 Statement of conformity

SUBPART G – PRODUCTION ORGANISATION APPROVAL
21.A.131 Scope
21.A.133 Eligibility
21.A.134 Application
21.A.134A Means of compliance
21.A.135 Issuance of production organisation approval
21.A.139 Production management system
21.A.143 Production organisation exposition
21.A.145 Resources
21.A.147 Changes in the production management system
21.A.148 Changes of location
21.A.149 Transferability
21.A.151 Terms of approval
21.A.153 Changes to the terms of approval
21.A.158 Findings and observations
21.A.159 Duration and continued validity
21.A.163 Privileges
21.A.165 Obligations of the holder

SUBPART H – CERTIFICATES OF AIRWORTHINESS AND RESTRICTED CERTIFICATES OF AIRWORTHINESS
21.A.171 Scope
21.A.172 Eligibility
21.A.173 Classification
21.A.174 Application
21.A.175 Language
21.A.177 Amendment or modification
21.A.179 Transferability and re-issuance within Member States
21.A.181 Duration and continued validity
21.A.182 Aircraft identification

SUBPART I – NOISE CERTIFICATES
21.A.201 Scope
21.A.203 Eligibility
21.A.204 Application
21.A.207 Amendment or modification
21.A.209 Transferability and re-issuance within Member States
21.A.211 Duration and continued validity

SUBPART J – DESIGN ORGANISATION APPROVAL
21.A.231 Scope
21.A.233 Eligibility
21.A.234 Application
21.A.235 Issue of design organisation approval
21.A.239 Design management system
21.A.243 Handbook
21.A.245 Resources
21.A.247 Changes in the design management system
21.A.249 Transferability
21.A.251 Terms of approval
21.A.253 Changes to the terms of approval
21.A.258 Findings and observations
21.A.259 Duration and continued validity
21.A.263 Privileges
21.A.265 Obligations of the holder

SUBPART K – PARTS AND APPLIANCES
21.A.301 Scope
21.A.303 Compliance with applicable requirements
21.A.305 Approval of parts and appliances
21.A.307 The eligibility of parts and appliances for installation

(SUBPART L – NOT APPLICABLE)

SUBPART M – REPAIRS
21.A.431A Scope
21.A.431B Standard repairs
21.A.432A Eligibility
21.A.432B Demonstration of capability
21.A.432C Application for a repair design approval
21.A.433 Requirements for approval of a repair design
21.A.435 Classification and approval of repair designs
21.A.439 Production of repair parts
21.A.441 Repair embodiment
21.A.443 Limitations
21.A.445 Unrepaired damage
21.A.451 Obligations and EPA marking

(SUBPART N – NOT APPLICABLE)

SUBPART O – EUROPEAN TECHNICAL STANDARD ORDER AUTHORISATIONS
21.A.601 Scope
21.A.602A Eligibility
21.A.602B Demonstration of capability
21.A.603 Application
21.A.604 ETSO authorisation for an auxiliary power unit (APU)
21.A.605 Data requirements
21.A.606 Requirements for issuance of an ETSO authorisation
21.A.607 ETSO authorisation privileges
21.A.608 Declaration of design and performance (DDP)
21.A.609 Obligations of holders of ETSO authorisations
21.A.610 Approval for deviation
21.A.611 Design changes
21.A.619 Duration and continued validity
21.A.621 Transferability

SUBPART P – PERMIT TO FLY
21.A.701 Scope
21.A.703 Eligibility
21.A.707 Application for permit to fly
21.A.708 Flight conditions
21.A.709 Application for approval of flight conditions
21.A.710 Approval of flight conditions
21.A.711 Issuance of a permit to fly
21.A.713 Changes
21.A.715 Language
21.A.719 Transferability
21.A.723 Duration and continued validity
21.A.725 Renewal of permit to fly
21.A.727 Obligations of the holder of a permit to fly

SUBPART Q – IDENTIFICATION OF PRODUCTS, PARTS AND APPLIANCES
21.A.801 Identification of products
21.A.803 Handling of identification data
21.A.804 Identification of parts and appliances
21.A.805 Identification of critical parts
21.A.807 Identification of ETSO articles

SECTION B – PROCEDURES FOR COMPETENT AUTHORITIES

SUBPART A – GENERAL PROVISIONS
21.B.10 Oversight documentation
21.B.15 Information to the Agency
21.B.20 Immediate reaction to a safety problem
21.B.25 Management system
21.B.30 Allocation of tasks to qualified entities
21.B.35 Changes in the management system
21.B.55 Record-keeping
21.B.65 Suspension, limitation and revocation

SUBPART B – TYPE-CERTIFICATES AND RESTRICTED TYPE-CERTIFICATES
21.B.70 Certification specifications
21.B.75 Special conditions
21.B.80 Type-certification basis for a type-certificate or a restricted type-certificate
21.B.82 Operational suitability data certification basis for an aircraft type certificate or a restricted type-certificate
21.B.85 Designation of applicable environmental protection requirements for a type-certificate or a restricted type-certificate
21.B.100 Level of involvement
21.B.103 Issuance of a type-certificate or a restricted type-certificate

(SUBPART C – NOT APPLICABLE)

SUBPART D – CHANGES TO TYPE-CERTIFICATES AND RESTRICTED TYPE-CERTIFICATES
21.B.105 Type-certification basis, environmental protection requirements and operational suitability data certification basis for a major change to a type-certificate
21.B.107 Issuance of an approval of a change to a type-certificate

SUBPART E – SUPPLEMENTAL TYPE-CERTIFICATES
21.B.109 Type-certification basis, environmental protection requirements and operational suitability data certification basis for a supplemental type-certificate
21.B.111 Issuance of a supplemental type-certificate

SUBPART F – PRODUCTION WITHOUT PRODUCTION ORGANISATION APPROVAL
21.B.115 Means of compliance
21.B.120 Initial certification procedure
21.B.125 Findings and corrective actions; observations
21.B.135 Maintenance of the letter of agreement
21.B.140 Amendment of a letter of agreement

SUBPART G – PRODUCTION ORGANISATION APPROVAL
21.B.215 Means of compliance
21.B.220 Initial certification procedure
21.B.221 Oversight principles
21.B.222 Oversight programme
21.B.225 Findings and corrective actions; observations
21.B.240 Changes in the production management system

SUBPART H – CERTIFICATES OF AIRWORTHINESS AND RESTRICTED CERTIFICATES OF AIRWORTHINESS
21.B.320 Investigation
21.B.325 Issuance of airworthiness certificate
21.B.326 Certificate of airworthiness
21.B.327 Restricted certificate of airworthiness

SUBPART I – NOISE CERTIFICATES
21.B.420 Investigation
21.B.425 Issuance of noise certificates

SUBPART J – DESIGN ORGANISATION APPROVAL
21.B.430 Initial certification procedure
21.B.431 Oversight principles
21.B.432 Oversight programme
21.B.433 Findings and corrective actions; observations
21.B.435 Changes in the design management system

SUBPART K – PARTS AND APPLIANCES

(SUBPART L – NOT APPLICABLE)

SUBPART M – REPAIRS
21.B.450 Type-certification basis and environmental protection requirements for a major repair design approval
21.B.453 Issuance of a repair design approval

(SUBPART N – NOT APPLICABLE)

SUBPART O – EUROPEAN TECHNICAL STANDARD ORDER AUTHORISATIONS
21.B.480 Issuance of an ETSO authorisation

SUBPART P – PERMIT TO FLY
21.B.520 Investigation
21.B.525 Issuance of a permit to fly

SUBPART Q – IDENTIFICATION OF PRODUCTS, PARTS AND APPLIANCES

Appendices

Appendix I – EASA Form 1 – Authorised Release Certificate

Appendix II – EASA Form 15a and 15c – Airworthiness Review Certificate

Appendix III – EASA Form 20a – Permit to Fly

Appendix IV – EASA Form 20b – Permit to Fly (issued by approved organisations)

Appendix V – EASA Form 24 – Restricted Certificate of Airworthiness

Appendix VI – EASA Form 25 – Certificate of Airworthiness

Appendix VII – EASA Form 45 – Noise Certificate

Appendix VIII – EASA Form 52 – Aircraft statement of conformity

Appendix IX – EASA Form 53 – Certificate of Release to Service

Appendix X – EASA Form 55 – Production organisation approval certificate

Appendix XI – EASA Form 65 – Letter of Agreement for production without production organisation approval

Appendix XII – Categories of flight tests and associated flight test crew qualification.’;

‘21.A.1   Scope

This Subpart establishes the general rights and obligations of the applicant for, and holder of, any certificate that has been issued or is to be issued in accordance with this Annex.’;

‘21.A.3A   Reporting system

  • (a) Without prejudice to Regulation (EU) No 376/2014 of the European Parliament and of the Council[^ntr*1-L_2022033EN.01001001-E0001] and its delegated and implementing acts, all natural or legal persons that have applied for or hold a type-certificate, restricted type-certificate, supplemental type-certificate, European Technical Standard Order (ETSO) authorisation, major repair design approval or any other relevant approval deemed to have been issued under this Regulation shall:
    1. establish and maintain a system for collecting, investigating and analysing occurrence reports in order to identify adverse trends or to address deficiencies and to extract occurrences whose reporting is mandatory in accordance with point 3 and those which are reported voluntarily. When the principal place of business is located in a Member State, a single system may be established to meet the requirements of Regulation (EU) No 376/2014 of of the European Parliament and of the Council and its implementing acts and of Regulation (EU) 2018/1139 and its delegated and implementing acts. The reporting system shall include:
  • (i) reports of and information related to failures, malfunctions, defects or other occurrences which cause or might cause adverse effects on the continuing airworthiness of the product, part or appliance covered by the type-certificate, restricted type-certificate, supplemental type-certificate, ETSO authorisation, major repair design approval or by any other relevant approval deemed to have been issued under this Regulation;
  • (ii) errors, near misses and hazards that do not fall under point (i);
    1. make available to known operators of the product, part or appliance and, on request, to any person authorised under other implementing or delegated acts the information about the system established in accordance with point 1, and on how to provide reports of and information related to failures, malfunctions, defects or other occurrences referred to in point 1(i);
    1. report to the Agency any failure, malfunction, defect or other occurrence of which it is aware and is related to a product, part or appliance covered by the type-certificate, restricted type-certificate, supplemental type-certificate, ETSO authorisation, major repair design approval or by any other relevant approval deemed to have been issued under this Regulation, and which has resulted or may result in an unsafe condition.
  • (b) Without prejudice to Regulation (EU) No 376/2014 of the European Parliament and of the Council and its delegated and implementing acts, any natural or legal person that holds or has applied for a production organisation approval certificate under Subpart G of this Section, or that produces a product, part or appliance under Subpart F of this Section, shall:
    1. establish and maintain a system for collecting and assessing occurrence reports, including reports on errors, near misses and hazards, in order to identify adverse trends or to address deficiencies and extract occurrences whose reporting is mandatory in accordance with points 2 and 3 and those which are reported voluntarily. For organisations that have their principal place of business in a Member State, a single system may be established to meet the requirements of Regulation (EU) No 376/2014 of the European Parliament and of the Council and its implementing acts and of Regulation (EU) 2018/1139 and its delegated and implementing acts;
    1. report to the responsible design approval holder all the cases where products, parts or appliances have been released by the production organisation and possible deviations from the applicable design data have been subsequently identified, and investigate with the design approval holder to identify those deviations which could lead to an unsafe condition;
    1. report to the competent authority of the Member State responsible in accordance with point 21.1 and the Agency the deviations that have been identified in accordance with point 21.A.3A(b)2 and which could lead to an unsafe condition;
    1. if the production organisation acts as a supplier to another production organisation, also report to that other organisation all the cases where it has released products, parts or appliances to that organisation and possible deviations from the applicable design data have been subsequently identified.
  • (c) Without prejudice to Regulation (EU) No 376/2014 of the European Parliament and of the Council and its delegated and implementing acts, any natural or legal person, when reporting in accordance with points (a)(3), (b)(2), (b)(3) and (b)(4), shall appropriately protect the confidentiality of the person who reports and of the person(s) mentioned in the report.
  • (d) Without prejudice to Regulation (EU) No 376/2014 of the European Parliament and of the Council and its delegated and implementing acts, any natural or legal person shall make the reports referred to in points (a)(3) and (b)(3) in a form and manner established by the Agency or the competent authority, respectively, and dispatch them as soon as practicable and in any case not later than 72 hours after the natural or legal person has identified that the occurrence may lead to a possible unsafe condition, unless exceptional circumstances prevent this.
  • (e) Without prejudice to Regulation (EU) No 376/2014 of the European Parliament and of the Council and its delegated and implementing acts, if an occurrence reported under point (a)(3) or under point (b)(3) results from a deficiency in the design or a production deficiency, the holder of the type-certificate, restricted type-certificate, supplemental type-certificate, major repair design approval, ETSO authorisation or any other relevant approval deemed to have been issued under this Regulation, or the production organisation as appropriate, shall investigate the reason for the deficiency and report to the competent authority of the Member State responsible in accordance with point 21.1 and to the Agency the results of its investigation and any action it intends to take or proposes to be taken to correct that deficiency.
  • (f) If the competent authority finds that action is required to correct the deficiency, the holder of the type-certificate, restricted type-certificate, supplemental type-certificate, major repair design approval, ETSO authorisation or any other relevant approval deemed to have been issued under this Regulation, or the production organisation as appropriate, shall submit the relevant data to the competent authority upon its request.

[^ntr*1-L_2022033EN.01001001-E0001]: Regulation (EU) No 376/2014 of the European Parliament and of the Council of 3 April 2014 on the reporting, analysis and follow-up of occurrences in civil aviation, amending Regulation (EU) No 996/2010 of the European Parliament and of the Council and repealing Directive 2003/42/EC of the European Parliament and of the Council and Commission Regulations (EC) No 1321/2007 and (EC) No 1330/2007 (OJ L 122, 24.4.2014, p. 18).’;"

  • (4) point 21.A.5 is replaced by the following:

‘21.A.5   Record-keeping

All natural or legal persons that hold or have applied for a type-certificate, restricted type-certificate, supplemental type-certificate, ETSO authorisation, design or repair approval, permit to fly, production organisation approval certificate or letter of agreement under this Regulation shall:

  • (a) when they design a product, part or appliance or changes or repairs thereto, establish a record-keeping system and maintain the relevant design information/data; that information/data shall be made available to the Agency in order to provide the information/data 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, record the details of the production process relevant to the conformity of the product, part or appliances with the applicable design data, and the requirements imposed on their partners and suppliers, and make that data available to their competent authority in order to provide the information that is necessary to ensure the continuing airworthiness of the product, part or appliance;
  • (c) with regard to permits to fly:
    1. maintain the documents that are produced to establish and justify the flight conditions, and make them available to the Agency and to their competent authority of the Member State in order to provide the information that is necessary to ensure the continued airworthiness of the aircraft;
    1. when they issue a permit to fly under the privilege of approved organisations, maintain the documents associated with it, including inspection records and documents that support the approval of the flight conditions and the issuance of the permit to fly itself, and make them available to the Agency and to their competent authority of the Member State responsible for the oversight of the organisation 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(b), 21.A.145(c), 21.A.239(c), 21.A.245(a) or 21.A.245(e)(1), of the personnel that are involved in the following functions:
    1. design or production;
    1. independent monitoring of the compliance of the organisation with the relevant requirements;
    1. safety management;
  • (e) retain records of the authorisation of personnel, when they employ personnel that:
    1. exercise the privileges of the approved organisation pursuant to points 21.A.163 and/or 21.A.263, as appropriate;
    1. carry out the independent function to monitor the compliance of the organisation with the relevant requirements pursuant to points 21.A.139(e) and/or 21.A.239(e), as appropriate;
    1. carry out the independent verification function of the demonstration of compliance pursuant to point 21.A.239(d)(2).’;

‘21.A.9   Access and investigation

Any natural or legal person that holds or has applied for a type-certificate, restricted type-certificate, supplemental type-certificate, ETSO 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, shall:

  • (a) grant the competent authority access to any facility, product, part and 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 and its delegated and implementing acts.;
  • (b) make arrangements to ensure the competent authority has access, as provided for in point (a), also in respect of the natural or legal person’s partners, suppliers and subcontractors.’;
  • ‘(a) undertake the obligations laid down in points 21.A.3A, 21.A.3B, 21.A.4, 21.A.5, 21.A.6, 21.A.7, 21.A.9, 21.A.62 and 21.A.65, and, for this purpose, shall continue to meet the qualification requirements for eligibility under point 21.A.13;’;

‘21.A.47   Transferability

The transfer of a type-certificate or a restricted type-certificate or an ETSO authorisation for an auxiliary power unit may only be made to a natural or legal 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.’;

  • ‘(a) undertake the obligations laid down in points 21.A.4, 21.A.5, 21.A.6, 21.A.7, 21.A.9 and 21.A.108;’;
  • ‘1. laid down in points 21.A.3A, 21.A.3B, 21.A.4, 21.A.5, 21.A.6, 21.A.7, 21.A.9 and 21.A.120B;’;

‘21.A.124A   Means of compliance

  • (a) An organisation may use any alternative means of compliance to establish compliance with this Regulation.
  • (b) If an organisation wishes to use an alternative means of compliance, it shall, prior to using it, provide the competent authority with a full description. The description shall include any revisions to manuals or procedures that may be relevant, as well as an explanation indicating how compliance with this Regulation is achieved.

The organisation may use those alternative means of compliance subject to prior approval from the competent authority.’;

  • ‘21.A.125A Issuance of a letter of agreement’

‘21.A.125B   Findings and observations

  • (a) After receipt of the notification of findings in accordance with point 21.B.125, the holder of a letter of agreement shall:
    1. identify the root cause(s) of, and contributing factor(s) to, the non-compliance;
    1. define a corrective action plan;
    1. demonstrate the implementation of the corrective action to the satisfaction of the competent authority.
  • (b) The actions referred to in point (a) shall be performed within the period agreed with that competent authority in accordance with point 21.B.125.
  • (c) The observations received in accordance with point 21.B.125(e) shall be given due consideration by the holder of the letter of agreement. The organisation shall record the decisions taken in respect of those observations.’;

‘21.A.125C   Duration and continued validity

  • (a) The letter of agreement shall be issued for a limited period of time that in any case shall not exceed 1 year. It shall remain valid subject to the organisation’s compliance with all the following conditions:
    1. the production organisation continues to comply with the applicable requirements of this Annex;
    1. the production organisation or any of its partners, suppliers or subcontractors acknowledges that the competent authority may carry out investigations in accordance with point 21.A.9;
    1. the production organisation is able to provide the competent authority with evidence showing that it maintains satisfactory control of the manufacture of products, parts and appliances under the letter of agreement;
    1. the letter of agreement has not been revoked by the competent authority under point 21.B.65, has not been surrendered by the production organisation, and its duration has not expired.
  • (b) Upon surrender, revocation or expiry, the letter of agreement shall be returned to the competent authority.’;
  • ‘5. materials and parts that are withheld because of deviations from type design or production specifications, and that are to be considered for installation in the finished product, are subjected to an approved engineering and manufacturing review procedure. Those materials and parts that have been found in that procedure to be serviceable shall be properly identified and reinspected if it is necessary to be reworked or repaired. Materials and parts rejected in that procedure shall be marked and disposed of to ensure that they are not incorporated in the final product.’;
  • ‘21.A.129 Obligations of the production organisation’;
  • ‘(e) comply with Subpart A of this Section.’;

‘21.A.134A   Means of compliance

  • (a) An organisation may use any alternative means of compliance to establish compliance with this Regulation.
  • (b) If an organisation wishes to use an alternative means of compliance, it shall, prior to using it, provide the competent authority with a full description. The description shall include any revisions to manuals or procedures that may be relevant, as well as an explanation indicating how compliance with this Regulation is achieved.

The organisation may use those alternative means of compliance subject to prior approval from the competent authority..’;

  • ‘21.A.135 Issuance of production organisation approval’

‘21.A.139   Production management system

  • (a) The production organisation shall 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 shall:
    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;
    1. 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 shall:
    1. establish, implement and maintain a safety policy and the corresponding related safety objectives;
    1. appoint key safety personnel in accordance with point 21.A.145(c)(2);
    1. 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;
    1. 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;
    1. promote safety in the organisation through:
  • (i) training and education;
  • (ii) communication;
    1. 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 shall:
    1. ensure that each product, part or appliance produced by the organisation or by its partners, 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;
    1. 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) verifying 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) the 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) the completion and retention of records;
  • (xi) the competence and qualifications of personnel;
  • (xii) the issue of airworthiness release documents;
  • (xiii) handling, storage and packing;
  • (xiv) internal quality audits and the resulting corrective actions;
  • (xv) work within the terms of approval performed at any location other than the approved facilities;
  • (xvi) work performed after the completion of production but prior to delivery, to maintain the aircraft in a condition for safe operation;
  • (xvii) the issue of a permit to fly and approval of the associated flight conditions;
    1. include specific provisions in the control procedures for any critical parts.
  • (e) The production organisation shall 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 shall include feedback to the person or group of persons 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(s) held.’;
  • ‘21.A.143 Production organisation exposition’;
  • ‘(a) The production organisation shall 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:’;
  • ‘11. a description of the production management system, the policy, processes and procedures as provided for in point 21.A.139(c);’;
  • ‘12. a list of the outside parties referred to in point 21.A.139(d)(1);’;
  • ‘(b) The initial issue of the POE shall be approved by the competent authority.’;
  • ‘(c) The POE shall be amended as necessary so that it remains an up-to-date description of the organisation. Copies of any amendments shall be supplied to the competent authority.’;

‘21.A.145   Resources

The production organisation shall demonstrate that:

  • (a) the facilities, working conditions, equipment and tools, processes and associated materials, number and competence of staff, and the general organisation are adequate to discharge its obligations under point 21.A.165;
  • (b) with regard to all the necessary airworthiness and environmental protection data:
    1. the production organisation holds all data it needs to determine conformity with the applicable design data. Such data may originate from the Agency 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;
    1. the production organisation has established a procedure to ensure that the airworthiness and environmental protection data are correctly incorporated in its production data;
    1. such data are kept up to date and made available to all personnel that need access to such data to perform their duties;
  • (c) with regard to management and staff:
    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 data and procedures identified in the POE referred to in point 21.A.143;
    1. a person or group of persons has/have been nominated by the accountable manager to ensure that the organisation is in compliance with the requirements of this Annex, and are identified, together with the extent of their authority; such person or group of persons shall be responsible to the accountable manager and have direct access to him. The person or group of persons shall have the appropriate knowledge, background and experience to discharge their responsibilities;
    1. staff at all levels have been given the appropriate authority to be able to discharge their allocated responsibilities and that there is full and effective coordination within the production organisation in respect of airworthiness and environmental protection data matters;
  • (d) with regard to certifying staff authorised by the production organisation to sign the documents issued under point 21.A.163 within the scope of the terms of approval:
    1. they have the appropriate knowledge, background (including other functions in the organisation) and experience to discharge their allocated responsibilities;
    1. they are provided with evidence of the scope of their authorisation.’;

‘21.A.147   Changes in the production management system

After the issue of a production organisation approval certificate, each change in the production management system that is significant for the demonstration of conformity or the airworthiness and environmental protection characteristics of the product, part or appliance, shall be approved by the competent authority before being implemented. The production organisation shall submit an application for approval to the competent authority demonstrating that it will continue to comply with this Annex.’;

‘21.A.158   Findings and observations

  • (a) After receipt of the notification of findings in accordance with point 21.B.225, the holder of the production organisation approval certificate shall:
    1. identify the root cause(s) of, and contributing factor(s) to, the non-compliance;
    1. define a corrective action plan;
    1. demonstrate the implementation of the corrective action to the satisfaction of the competent authority.
  • (b) The actions referred to in point (a) shall be performed within the period agreed with that competent authority in accordance with point 21.B.225.
  • (c) The observations received in accordance with 21.B.225(e) shall be given due consideration by the holder of the production organisation approval certificate. The organisation shall record the decisions taken in respect of those observations.’;

‘21.A.159   Duration and continued validity

  • (a) A production organisation approval certificate shall be issued for an unlimited period of time. It shall remain valid subject to the production organisation’s compliance with all the following conditions:
    1. the production organisation continues to comply with the applicable requirements of Regulation (EU) 2018/1139 and its delegated and implementing acts;
    1. the competent authority is permitted by the production organisation or by any of its partners, suppliers or subcontractors to perform the investigations in accordance with point 21.A.9;
    1. the production organisation is able to provide the competent authority with evidence showing that it maintains satisfactory control of the manufacture of products, parts and appliances under the approval;
    1. the production organisation approval certificate has not been revoked by the competent authority under point 21.B.65, or surrendered by the production organisation.
  • (b) Upon surrender or revocation, the production organisation approval certificate shall be returned to the competent authority.’;
  • ‘(d) provide assistance to the holder of the type-certificate or other design approval in dealing with any continuing airworthiness actions that are related to the products, parts or appliances that have been produced;
  • (e) where, under its terms of approval, the holder of a production organisation approval intends to issue a certificate of release to service, determine, prior to issuing the certificate, that each completed aircraft has been subjected to necessary maintenance and is in condition for safe operation;
  • (f) where applicable, under the privilege set out in point 21.A.163(e), determine the conditions under which a permit to fly can be issued;
  • (g) where applicable, under the privilege set out in point 21.A.163(e), establish compliance with points 21.A.711(c) and (e) before issuing an aircraft with a permit to fly;
  • (h) comply with Subpart A of this Section.’;
  • ‘(a) An airworthiness certificate shall be issued for an unlimited period of time. It shall remain valid subject to compliance with all the following conditions:’;
  • ‘1. the aircraft continues to comply with the applicable type design and continued airworthiness requirements; and’;
  • ‘4. the certificate has not been revoked by the competent authority under point 21.B.65, or surrendered by the certificate holder.’;
  • ‘(a) A noise certificate shall be issued for an unlimited period of time. It shall remain valid subject to compliance with all the following conditions:’;
  • ‘1. the aircraft continues to comply with the applicable type design and continued airworthiness requirements; and’;
  • ‘(4) the certificate has not been revoked by the competent authority under point 21.B.65, or surrendered by the certificate holder.’;

‘21.A.239   Design management system

  • (a) The design organisation shall 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 shall:
    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;
    1. 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 shall:
    1. establish, implement and maintain a safety policy and the corresponding related safety objectives;
    1. appoint key safety personnel in accordance with point 21.A.245(b);
    1. 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;
    1. 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;
    1. promote safety in the organisation through:
  • (i) training and education;
  • (ii) communication;
    1. 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 shall:
    1. establish, implement and maintain a system for the control and supervision of the design, and of design changes and repairs, of products, parts and appliances covered by the terms of approval; that system shall:
  • (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;
    1. 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;
    1. 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 shall 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 shall include feedback to the person or the group of persons 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 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(s).’;

‘21.A.243   Handbook

  • (a) As part of the design management system, the design organisation shall create and furnish to the Agency a handbook that describes, directly or by cross reference, the organisation, its relevant policies, processes and procedures, the type of design work, and 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 in accordance with point 21.A.251 and, where relevant, the interfaces with and the control of its partners or subcontractors.

If flight tests are to be conducted, a flight test operations manual that defines the organisation’s policies and procedures in relation to flight tests shall also be created and furnished to the Agency. The flight test operations manual shall include:

    1. a description of the organisation’s processes for flight tests, including its involvement in the process for issuing a permit to fly;
    1. crewing policy, including composition, competency, currency and flight time limitations, in accordance with Appendix XII, where applicable;
    1. procedures for the carriage of persons other than the crew members and for flight test training, where applicable;
    1. a policy for the risk and safety management and associated methodologies;
    1. procedures to identify the instruments and equipment to be carried on board;
    1. a list of documents that need to be produced for the flight test.
  • (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 demonstrate, for all parts and appliances, the compliance in accordance with point 21.A.239(d)(2), and shall contain, directly or by cross reference, descriptions of and information on the design activities and the organisation of those partner organisations or subcontractors, as necessary to establish the statement.
  • (c) The handbook shall be amended as necessary to remain an up-to-date description of the organisation, and copies of the amendments shall be provided to the Agency.
  • (d) The design organisation shall establish and maintain a statement of the qualifications and experience of the management staff and of other persons in the organisation that are responsible for making decisions that affect airworthiness, operational suitability data and environmental protection matters. It shall submit that statement to the competent authority’;

‘21.A.245   Resources

  • (a) The organisation shall appoint a head of the design organisation with the authority to ensure that, within the organisation, all design activities are performed to the required standards and that the design organisation is continuously in compliance 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 shall nominate and specify the extent of authority of:
    1. a chief of the airworthiness function;
    1. a chief of the independent monitoring function;
    1. depending on the size of the organisation and the nature and complexity of its activities, any other person or group of persons that are 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 in either of the following cases:
    1. where the scope of activities of/of work of the design organisation, as identified in the terms of approval issued under point 21.A.251, is limited to minor changes and/or minor repairs;
    1. for a limited period of time when the design organisation does not have a nominated chief of the airworthiness function 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 person or group of persons nominated pursuant to point (b) shall:
    1. be answerable to the head of the design organisation and have direct access to them;
    1. have the appropriate knowledge, background and experience to discharge their responsibilities.
  • (e) The design organisation shall ensure that:
    1. the staff in all technical departments are of sufficient numbers and experience and have been given the appropriate authority to be able to discharge their allocated responsibilities and the facilities, equipment and accommodation that are adequate to enable the staff to fulfil the airworthiness, operational suitability data and environmental protection requirements as regards the product;
    1. there is full and efficient coordination between the departments and within the departments in respect of airworthiness, operational suitability data and environmental protection matters.’;

‘21.A.247   Changes in the design management system

After the issue of a design organisation approval, each change to the design management system that is significant to the demonstration of compliance or to the airworthiness, operational suitability and environmental protection of the product, part or appliance shall be approved by the Agency before being implemented. The design organisation shall submit to the Agency an application for approval demonstrating, on the basis of the proposed changes to the handbook, that it will continue to comply with this Annex.’;

‘21.A.258   Findings and observations

  • (a) After the receipt of the notification of findings in accordance with point 21.B.433, the holder of the design organisation approval shall:
    1. identify the root cause(s) of, and contributing factor(s) to, the non-compliance;
    1. establish a corrective action plan;
    1. demonstrate the implementation of the corrective action to the satisfaction of the Agency.
  • (b) The actions referred to in point (a) shall be performed within the period agreed by the Agency in accordance with point 21.B.433.
  • (c) The observations received in accordance with point 21.B.433(e) shall be given due consideration by the holder of the design organisation approval. The organisation shall record the decisions taken in respect of those observations.’;

‘21.A.259   Duration and continued validity

  • (a) A design organisation approval shall be issued for an unlimited period of time. It shall remain valid subject to the design organisation’s compliance with all the following conditions:
    1. the design organisation continues to comply with Regulation (EU) 2018/1139 and its delegated and implementing acts; taking into account the provisions of point 21.B.433 of this Annex related to the handling of findings;

Reading this document does not replace reading the official text published in the Official Journal of the European Union. We assume no responsibility for any inaccuracies arising from the conversion of the original to this format.

This text is published under EUR-Lex's own terms of reuse, not a Legalize or public-domain licence. EUR-Lex
Creative Commons Attribution 4.0 International (CC BY 4.0)
© European Union, https://eur-lex.europa.eu — Source: EUR-Lex (Publications Office of the European Union). Reused under the Creative Commons Attribution 4.0 International (CC BY 4.0) licence. Only EU legislation published in the printed Official Journal of the European Union is deemed authentic; consolidated texts are reproduced here for documentation purposes and have been reformatted to Markdown.