European Union Aviation Safety Agency

Notice of Proposed Amendment 2019-05 (A)

Embodiment of safety management system (SMS) requirements into
Part-145 and Part 21
RMT.0251 PHASE II
EXECUTIVE SUMMARY
With reference to Rulemaking Task (RMT).0251 Phase II in EPAS 2019-2023, this Notice of Proposed Amendment
(NPA) proposes amendments to Annex I (Part 21) to Regulation (EU) No 748/2012 and Annex II (Part-145) to
Regulation (EU) No 1321/2014, in order to:
— introduce safety management principles that implement ICAO Annex 19; and
— foster an organisational culture for effective safety management and effective occurrence reporting in
accordance with Commission Regulation (EU) No 376/2014.
Note 1: Phase I of RMT.0251 was limited to the introduction of safety management requirements into Part-
CAMO (see Opinion No 06/2016).
Note 2: The review of the occurrence reporting system was governed by RMT.0681, but certain additional
changes are proposed through this RMT, in light of the principles of ICAO Annex 19, Chapter 5.
This NPA proposes to consider the applicability of safety management systems (SMSs) to Part-145 approved
maintenance organisations, as well as to production and design organisations that are approved in accordance
with Subparts G and J of Part 21.
By doing so, safety will be enhanced through:
— the establishment of safety policies and objectives that are associated with sufficient resources;
— the systematic identification of hazards, and a risk management system;
— the safety assurance system, including giving consideration to safety performance; and
— safety promotion.
This RMT also aims to streamline the procedures for oversight, and introduce a set of new, common
management system requirements for competent authorities to increase their efficiency.
NPA 2019-05 is divided into three parts. The present NPA 2019-05 (A) includes:
— the procedural information pertaining to the regulatory proposal;
— the explanatory note to the proposed amendments;
— the regulatory impact assessment; and
— a detailed summary of the proposed amendments (see Chapter 7 ‘Appendices’).
The draft implementing rules (IRs) as well as the draft Acceptable Means of Compliance (AMC) and Guidance
Material (GM) for Part 21 are proposed in NPA 2019-05 (B), whereas those for Part-145 are proposed in
NPA 2019-05 (C).
Action area: Systemic enablers to safety — safety management
Affected rules: Part-145 and Part 21
Affected stakeholders: AMOs (Part-145); POA holders; DOA holders; ETSOA holders; competent authorities
Driver: Safety Rulemaking group: No (but Focused Consultation Group)
Impact assessment: Full Rulemaking Procedure: Standard

12.7.2017 17.4.2019 2020/Q1 2020/Q3 2020/Q3

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Table of contents

Table of contents
1. About this NPA...................................................................................................................... 3
1.1. How this NPA was developed .................................................................................................... 3
1.2. How to comment on this NPA ................................................................................................... 4
1.3. The next steps............................................................................................................................ 4
2. In summary — why and what ................................................................................................ 5
2.1. Why we need to change the rules — issue/rationale ............................................................... 5
2.2. What we want to achieve — objectives .................................................................................... 5
2.3. How we want to achieve it — overview of the proposals......................................................... 6
2.3.1. Summary of changes to Part-145 ...................................................................................... 6
2.3.2. Summary of changes to Part 21 ........................................................................................ 7
2.3.3. Specific commonalities and differences between Part-145 and Part 21 .......................... 8
2.4. What are the expected benefits and drawbacks of the proposals ........................................... 9
3. Proposed amendments and rationale .................................................................................. 11
3.1. Draft regulation (Draft EASA opinion) for Part 21 ................................................................... 11
3.2. Draft AMC & GM (Draft EASA decision) for Part 21 ................................................................ 11
3.3. Draft regulation (Draft EASA opinion) for Part-145................................................................. 11
3.4. Draft AMC and GM (Draft EASA decision) for Part-145 .......................................................... 11
4. Impact assessment (IA)........................................................................................................ 12
4.1. What is the issue ..................................................................................................................... 12
4.1.1. Introduction .................................................................................................................... 12
4.1.2. Evidence gathering — EASA questionnaire..................................................................... 13
4.1.3. Safety risk assessment .................................................................................................... 13
4.1.4. Who is affected? ............................................................................................................. 14
4.2. What we want to achieve — objectives .................................................................................. 14
4.3. How it could be achieved — background and options............................................................ 14
4.4. What are the impacts .............................................................................................................. 17
4.4.1. Introduction to the impact analysis ................................................................................ 17
4.4.2. Relevant elements from the EASA questionnaire ........................................................... 18
4.4.3. Safety impact................................................................................................................... 19
4.4.4. Environmental impact ..................................................................................................... 20
4.4.5. Social impact ................................................................................................................... 20
4.4.6. Economic impact ............................................................................................................. 21
4.4.7. Proportionality impact .................................................................................................... 23
4.5. Conclusion ............................................................................................................................... 24
4.6. Monitoring and evaluation ...................................................................................................... 27
5. Proposed actions to support implementation ...................................................................... 29
6. References .......................................................................................................................... 31
6.1. Affected regulations ................................................................................................................ 31
6.2. Affected decisions ................................................................................................................... 31
6.3. Other reference documents .................................................................................................... 31
7. Appendices ......................................................................................................................... 33
7.1. Appendix I — Detailed summary of changes to Part 21.......................................................... 33
7.2. Appendix II — Detailed summary of changes for Part-145 ..................................................... 50
7.3. Appendix III — EASA questionnaire......................................................................................... 61

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1. About this NPA

1. About this NPA

1.1. How this NPA was developed
The European Union Aviation Safety Agency (EASA) developed this NPA in line with Regulation (EU)
2018/11391 (Basic Regulation) and the Rulemaking Procedure2. This rulemaking activity is included in
the European Plan for Aviation Safety (EPAS)3 under RMT.0251. The text of this NPA has been
developed by EASA based on the input from a focused consultation group (FCG). It is hereby submitted
to all interested parties4 for consultation.
RMT.0251 (old task number: MDM.055) was initiated in October 2010 as an ‘Agency task’; it was
originally intended to cover all airworthiness domains. Part-M (Annex I to Regulation (EU)
No 1321/20145) and Part-145 were covered by the issuing of NPA 2013-01(B) and NPA 2013-01(C)
respectively. For efficiency reasons, and due to the parallel RMT for a light Part-M (RMT.0547 in the
context of the GA roadmap), it was then decided to split the work into two phases:
— Phase I focused on the introduction of SMSs into Part-M, and its outcome was Opinion
No 06/2016 (Part-CAMO), in conjunction with the outcome of RMT.0547 — Opinion
No 05/2016 (Part-ML and Part-CAO);
— Phase II focuses on the introduction of SMSs into Part 21 ((Annex I to Regulation (EU)
No 748/20126) and Part-145 (Annex I to Regulation (EU) No 1321/2014), with a new
consultation based on the results of Phase I. Although no CRD was issued for the first NPA 2013-
01(C) on Part-145, the text proposed in this NPA takes into account the comments received on
that first NPA.
A new Terms of Reference (ToR) for Phase II document was published on 12 July 20177, which
established a FCG with competent authority and industry representatives, some of whom had already
taken part in Phase I.

1 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 (OJ L 212, 22.8.2018, p. 1) (https://eur-
lex.europa.eu/legal-content/EN/TXT/?qid=1535612134845&uri= CELEX:32018R1139).
2 EASA is bound to follow a structured rulemaking process as required by Article 115(1) of Regulation (EU) 2018/1139.
Such a process has been adopted by the EASA Management Board (MB) and is referred to as the ‘Rulemaking Procedure’.
See MB Decision No 18-2015 of 15 December 2015 replacing Decision 01/2012 concerning the procedure to be applied
by EASA for the issuing of opinions, certification specifications and guidance material (http://www.easa.europa.eu/the-
agency/management-board/decisions/easa-mb-decision-18-2015-rulemaking-procedure).
3 https://www.easa.europa.eu/document-library/general-publications?publication_type%5B%5D=2467
4 In accordance with Article 115 of Regulation (EU) 2018/1139 and Articles 6(3) and 7 of the Rulemaking Procedure.
5 Commission Regulation (EU) No 1321/2014 of 26 November 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 (OJ L 362, 17.12.2014, p. 1) (https://eur-lex.europa.eu/legal-
content/EN/TXT/?qid=1549461562202&uri=CELEX:32014R1321).
6 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) (https://eur-lex.europa.eu/legal-
content/EN/TXT/?qid=1549462558558&uri=CELEX:32012R0748).
7 https://www.easa.europa.eu/document-library/terms-of-reference-and-group-compositions/tor-rmt0251b-mdm055-
mdm060

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1. About this NPA

Since the publication of Issue 1 of the ToR, ICAO has published the fourth edition of the Safety
Management Manual (ICAO Doc 9859), which is aligned with the second issue of ICAO Annex 19. The
proposed changes to the rules in this NPA benefit, to a certain extent, from the material in that newly
edited ICAO document.
On 20 August 2018, new Basic Regulation (Regulation (EU) 2018/1139), which repealed Regulation
(EC) No 216/2008, was published. In Part-145, all references were updated since this NPA proposes
changes to all points of the Regulation. For Part 21, only the points affected by SMS have been
modified to reference the new Basic Regulation. The remaining points that are not proposed in this
NPA to be amended still refer to Regulation (EC) No 216/2008. The update of the references to
Regulation (EU) 2018/1139 should not be considered as an assessment of the impact of that
Regulation to Part 21. This will be conducted through a dedicated rulemaking task (RMT.0727).

1.2. How to comment on this NPA

Please submit your comments using the automated Comment-Response Tool (CRT) available at
http://hub.easa.europa.eu/crt/8.
The deadline for submission of comments is 17 July 2019.

1.3. The next steps

Following the closing of the public commenting period, EASA will review all the comments with the
support of the FCG.
Based on the comments received, EASA will issue opinions containing the proposed amendments to
Regulations (EU) No 748/2012 and (EU) 1321/2014. Summaries of the comments received will be
provided in the opinions. The opinions will be submitted to the European Commission, which will use
them as a technical basis in order to take a decision on whether or not to amend the Regulations.
If the Commission decides that the Regulations should be amended, EASA will issue decisions that
amend the AMC & GM to comply with the amendments introduced into the Regulation.
The comments received on this NPA and the EASA responses to them will be reflected in
comment-response documents (CRDs). This CRD will be available on the EASA website and will be the
basis for the development of the Opinions and Decisions, which will be respectively proposed for
adoption by the European Commission and approved by EASA.
The opinions will include a proposal for transition measures for organisations and authorities to adapt
to the new requirements. The European Commission, along with the EU Member States, will validate
it. At this stage of the project, a transitional period of two years after the Regulations enter into force
is suggested.

8 In case of technical problems, please contact the CRT webmaster (crt@easa.europa.eu).

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2. In summary — why and what

2. In summary — why and what

2.1. Why we need to change the rules — issue/rationale
Pursuing the objectives of the Basic Regulation regarding the development of EU rules, EASA shall
issue opinions addressed to the European Commission (proposing amendments to regulations) and
Decisions (issuing AMC & GM). When doing so, it shall consider International Civil Aviation
Organization (ICAO) Standards and Recommended Practices (SARPs) (see EASA Management Board
Decision No 18-2015, Article 6).
At the end of 2013, ICAO published the first Edition of the Safety Management Annex (here referred
to as ‘ICAO Annex 19’). Later in 2016, ICAO published the second edition of that document. According
to that document, the use of an SMS is foreseen in maintenance, design and production.
For design and production organisations, the existing legal EU framework already includes
organisational requirements that cover certain safety management aspects, but the safety
management SARPs9, which stem from ICAO Annex 19, are not consistently implemented. In
particular, Part 21 already imposes, in some cases, the necessity for an organisation to seek an
organisational approval (i.e. design organisation approval (DOA) and production organisation approval
(POA)) after demonstrating that they are able to ensure the safety of their product through the
compliance of the design with the technical specifications or the conformity of the production with
the design data. Some provisions required for such organisational approvals are similar to those
required for an SMS by ICAO Annex 19, as better explained later in this document.
For maintenance, a decision has already been taken on how to introduce SMS into Part-145 (see
Section 4.3 for further details).
No exemptions have been issued in accordance with Article 71 of the Basic Regulation that are
pertinent to the scope of Phase II of this RMT.

2.2. What we want to achieve — objectives

The overall objectives of the EASA system are defined in Article 1 of the Basic Regulation. This proposal
will contribute to the achievement of these objectives by addressing the issues outlined in Section 2.1.
The specific objectives of this proposal are to:
— further improve the level of safety with respect to Part-145 and Part 21 organisations;
— overcome obstacles related to the mutual acceptance of approvals;
— foster the principles of safety management as indicated in the ICAO Annex 19 SARPs, second
edition, taking due account of the critical elements of a State’s safety oversight system as
defined in ICAO Annex 19, Appendix 1;
— streamline the procedures for oversight and enforcement, and increase the efficiency of the
management system requirements for competent authorities; and

9 Design, production and maintenance are the last aviation domains into which safety management requirements have
not yet been introduced.

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2. In summary — why and what

— support the implementation of the 2019-2023 EPAS, notably Section 5.2 (e.g. systemic safety
enablers, safety management), as a strategic priority.

2.3. How we want to achieve it — overview of the proposals

To develop this regulatory proposal, the FCG was consulted during three meetings between December
2017 and June 2018. An additional written consultation of the draft proposal for Part 21 only, for the
sake of maturity, was organised after these three meetings.

2.3.1. Summary of changes to Part-145

For Part-145, the majority of the changes are based on Opinion No 06/2016 (Part-CAMO) and the
associated proposed AMC & GM, which are themselves based on Subparts GEN of the authority and
organisation requirements (AR/OR) in the Regulations for civil aviation air crew10 and air operations11,
and the related AMC & GM respectively.
It thus fosters alignment with the content of Regulation (EU) No 965/2012, notably in the case of
multiple approvals if an aircraft operator also holds Part-CAMO and/or Part-145 approvals. The newly
introduced SMS elements in Part-145 follow the integrated approach used in the other domains,
through the introduction of an integrated management system. As example, the new ‘management
system’ of point 145.A.200 for Part-145 is introduced; it incorporates the existing quality system of
point 145.A.65 with the ICAO SMS SARPs in an integrated management system. The resulting text
resembles ORO.GEN.200 in Regulation (EU) No 965/2012.
This process is called the ‘integrated management system’.
However, some differences may exist with imported Part-CAMO text due to regulatory constraints,
such as differences in the regulatory numbering system; or the specific needs of each of the EU
regulations. For clarity or consistency, the text could not be identical to that in Part-CAMO. In other
cases, no equivalent text existed in Part-145, in particular when the introduced changes went beyond
the straightforward introduction of a management system, dealing with other general aspects such as
applications, alternative means of compliance (AltMoC), changes, access, findings, etc. However,
these differences does not impact the intent of the regulator for that NPA.
Some minor improvements to the imported Part-CAMO text have also been proposed through this
NPA, mainly for reasons of clarity or language improvement. The text may also benefit from some
improvements proposed during the adoption of Part-CAMO being currently under review. Again these
changes should not change the meaning, notably for Section B (i.e. the authority requirements).
Several Part-145 points have also been amended to highlight certain risks related to maintenance
activities (e.g. fatigue and external working teams in 145.A.47).

10 Commission Regulation (EU) No 1178/2011 of 3 November 2011 laying down technical requirements and
administrative procedures related to civil aviation aircrew pursuant to Regulation (EC) No 216/2008 of the
European Parliament and of the Council (OJ L 311, 25.11.2011, p. 1) (https://eur-lex.europa.eu/legal-
content/EN/TXT/?qid=1549467168079&uri=CELEX:32011R1178).
11 Commission Regulation (EU) No 965/2012 of 5 October 2012 laying down technical requirements and
administrative procedures related to air operations pursuant to Regulation (EC) No 216/2008 of the
European Parliament and of the Council (OJ L 296, 25.10.2012, p. 1) (https://eur-lex.europa.eu/legal-
content/EN/TXT/?qid=1549466927988&uri=CELEX:32012R0965).

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2. In summary — why and what

In accordance with ICAO Annex 19, all Part-145 organisations should implement an SMS without
exception: the new safety management requirements introduced into the EU regulatory framework
apply to all types of Part-145 approved organisations.
A more detailed list of the proposed changes to Part-145 is provided in Appendix II to this NPA.

2.3.2. Summary of changes to Part 21

Rather than ‘organisation-centric’, the Part 21 Section A requirements are more ‘product-centric’.
Moving to an integrated management system in Part 21 would have too much diluted the importance
of the quality (management) system and the design assurance system, which are specific, integral
parts of the production and design system (see points 21.A.139 and 21.A.239). In addition, Part 21
already includes detailed organisational requirements for approved production and design
organisations that match some of the ICAO Annex 19 related SARPs.
Fully aligning Part 21 with the SMS requirements in the other domains would thus:
— entail extensive changes to Part 21, making the alignment complex; and
— potentially affect Part 21 organisations, requiring a review of their processes or procedures,
without leading to a clear safety benefit.
Consequently, the changes to Part 21 Section A (organisation requirements) have been limited to the
introduction of the ICAO SMS framework (ICAO Annex 19, Second Edition, Appendix II), based on a
gap analysis performed between the ICAO SMS framework and the existing Part 21 requirements. It is
therefore proposed in this NPA that the 12 elements of an SMS applicable to an organisation, as
defined in Appendix II to ICAO Annex 19, should be added to the Part 21 organisational requirements,
respectively in points 21.A.139 (i.e. ‘Quality system’ for ‘production’) and 21.A.239 (i.e. ‘Design
assurance system’). By doing so, the existing rule structure for Section A remains unchanged, and the
volume of changes is limited.
The new safety management requirements apply to all Part 21 approved organisations (POA holders
and DOA holders, excluding the alternative procedures to DOAs). See Chapter 4 for further details.
The concepts of hazard identification, risk management and mitigation, as well as occurrence
reporting, are already well embedded in the culture and rules associated with the design and
production of the products, parts and appliances as described in the various Certification
Specifications (CSs) and in points 21.A.3A, 21.A.139 and 21.A.239. This means that the alignment of
the occurrence reporting system required by Regulation (EU) No 376/201412 has been considered in
this NPA to be notably consistent with ICAO Annex 19, Chapter 5 and its Appendix III and the
development of RMT.0681.
For Section B, the authority requirements have been aligned with the other aviation domains, in an
approach that is similar to the one for Part-145. However, some peculiarities of the Part 21 rules had
to be kept. The main following elements have been introduced:

12 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 (https://eur-lex.europa.eu/legal-
content/EN/TXT/?qid=1532624380599&uri=CELEX:32014R0376).

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2. In summary — why and what

— risk-based oversight and the recognition of organisations that have good performance through
the use of flexible oversight planning cycles and extensions to 36 and 48 months;
— the concept of AltMoC for production organisations; and
— instead of 36 months currently applied, the text proposed a DOA basic oversight cycle of 24
months with the option to extend it to 36 or 48 months when conditions are met, as already
regulated in the other domains [see ARO.GEN.305]. Once the proposed regulation becomes
applicable, EASA will immediately apply a 36 months cycle to all existing DOAs already meeting
the conditions to be eligible for a 36 month oversight cycle.
Finally, a set of AMC & GM has been developed, consistent with those provided in other domains, to
demonstrate compliance with the SMS requirement. In this way, an organisation that already holds
several approval certificates may reuse the evidence already produced for the other domains or in the
case of an integrated management system.
A more detailed list of the proposed changes to Part 21 is provided in Appendix I to this NPA.

2.3.3. Specific commonalities and differences between Part-145 and Part 21

As mentioned earlier, the volume of changes to Part 21 has been kept as low as possible, by building
on the existing Part 21 structure. On the contrary, it was easier to reshape and align Part-145 with the
Air OPS rules: by doing so, the common regulatory framework is fostered when a CAMO-approved
aircraft operator also holds a Part-145 approval.
Although the two Regulations are considered to be aligned with the SMS principles that stem from
ICAO Annex 19, they might be different in their wording and regulatory structures. As a result, some
SMS principles in Part-145 may have a different regulatory status from that in Part 21. This is inherent
in the fact that the two pieces of legislation have evolved in different manners over time. Notably, for
Section A, Part 21 focuses more on the ‘product’, whereas Part-145 focuses more on the
organisational requirements. The future roadmap for OR/AR should resolve that difference.
Unlike the proposed changes for Part-145, the Part 21 approach does not foster an ‘integrated
management system’. However, the Part 21 organisation may go for an integrated management
system especially when several approvals are held.
All in all, although the approach taken for Part 21 and for Part-145 differ, the proposed changes do
not bring any incompatibility as they basically follow the SMS framework and the spirit of ICAO Annex
19 or ICAO Doc 9859.
Lastly, AMC have been introduced for points 21.A.139 (see AMC1 21.A.139(c)) and 21.A.239 (see
AMC1 21.A.239(c)) for the acceptability of the SMS Industry Standard ‘Implementing a Safety
Management System in Design, Manufacturing and Maintenance Organizations’ SM001 Issue A -
September 17th, 201813 to demonstrate compliance with the EU SMS requirements in Part 21.These
AMC identify some gaps between this SMS industry standard and the SMS elements of the
management system defined in Part 21.
— SMS Industry Standard SM-0001 has been developed by the Aerospace and Defence Industries
Association of Europe (ASD), the Aerospace Industries Association of America (AIA), the

13 https://www.asd-europe.org/sites/default/files/atoms/files/SMS%20Standard_final%20issue%20A_20180917.pdf

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2. In summary — why and what

Aerospace Industries Association of Brazil (AIAB), the Aerospace Industries Association of

Canada (AIAC) and the General Aviation Manufacturers Association (GAMA).
— Intended to improve safety performance and enhance safety culture, this document provides
explanations and some guidance material for compliance with the provisions of ICAO Annex 19,
Appendix II ‘Framework for a Safety Management System’. It essentially contains:
 some Part 21 best practices to identify hazards and to conduct safety risk management
(SRM);
 sources of data for safety assurance as well as safety performance indicators (SPIs);
 interfaces between organisations, notably within consortiums (i.e. corporate SMS) or
with suppliers or organisations that have not implemented an SMS;
 considerations regarding other management systems (e.g. quality management system,
security management system); and
 an SMS implementation plan and an SMS assessment tool based on the one developed
by SM ICG14.
— However, SMS Industry Standard SM-0001 at Issue A is not found suitable for introduction into
the AMC to Part-145.

2.4. What are the expected benefits and drawbacks of the proposals
The proposed changes:
— implement ICAO Annex 19, notably through the introduction of SMS principles, safety risk
management and continuous improvement;
— foster an organisational safety culture for effective safety management and effective
occurrence reporting, whether it is mandatory or voluntary, to be coherent with Regulation (EU)
No 376/2014; and
— streamline as much as possible the Section B oversight requirements for Part-145 and Part 21
organisations, due to an approach that is common with other domains.
The intended effects would be the:
— enhancement of safety by contributing to effective hazard identification, risk management
capabilities and error reduction, and by improving transparency;
— promotion of a positive safety culture; and
— improvement in terms of flexibility and proportionality, in particular regarding management
system requirements.
Despite the difference in approach between Section A for Part 21 (i.e. gap analysis with ICAO Annex
19) and that of Part-145 (i.e. integrated management system), the alignment of the SMS principles
will facilitate the reuse of activities and documentation that has been already developed for

14 The Safety Management International Collaboration Group (SM ICG) is a group of 18 aviation regulatory bodies,
established in 2009 to promote a common understanding of safety management principles and requirements, facilitating
their application across the international aviation community. A repository of SMICG products can be accessed free of
charge at https://www.skybrary.aero/index.php/Safety_Management_International_Collaboration_Group_(SM_ICG).

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2. In summary — why and what

compliance demonstration in other domains. This is further supported at the AMC & GM level, where
the same material has been used in the two domains, insofar as this was possible. This drawback is
therefore mitigated for Part-145-organisations that hold a DOA or a POA, and vice versa.

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3. Proposed amendments and rationale in detail

3. Proposed amendments and rationale

A detailed summary of the regulatory changes can be found:
— for Part 21 in Appendix 7.1; and
— for Part-145 in Appendix 7.2.

3.1. Draft regulation (Draft EASA opinion) for Part 21

Refer to NPA 2019-05 (B)

3.2. Draft AMC & GM (Draft EASA decision) for Part 21

Refer to NPA 2019-05 (B)

3.3. Draft regulation (Draft EASA opinion) for Part-145

Refer to NPA 2019-05 (C)

3.4. Draft AMC and GM (Draft EASA decision) for Part-145

Refer to NPA 2019-05 (C)

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4. Impact assessment (IA)

4.1. What is the issue

4.1.1. Introduction
The first edition of ICAO Annex 19 became applicable on 14 November 2013 for design, production
and maintenance activities. Without waiting for the EU rules to embed ICAO Annex 19, some
organisations that hold multiple approvals, for which an SMS is already mandatory, or that have
branches or conduct business in non-EU States where an SMS is already mandatory, have already
extended the safety management principles to their design, production and maintenance activities,
for the sake of coherence or business needs. Some major organisations, such as large production or
maintenance organisations, have also felt the benefit of having a risk management system and a
robust occurrence reporting system embedded in their corporate safety culture. Finally, a number of
EASA Member States such as France, Switzerland, and the United Kingdom have already mandated
the implementation of SMSs for maintenance organisations. Some other EASA Member States have
encouraged the implementation of SMSs on a voluntary basis. For all these reasons, an SMS is not a
novelty, and the overall impact is limited, notably for the maintenance organisations.
Pursuing the objectives of the Basic Regulation regarding the development of the EU rules, EASA
proposes to implement the ICAO safety management SARPs for the design, production and
maintenance organisation and authority requirements. Additionally, the Basic Regulation calls for a
management system, for continuous improvement of this system, and an occurrence reporting system
that supports that management system (see its Annex I, Section 3.1).
Design, production and maintenance are the last aviation domains into which safety management
requirements have not yet been introduced.
Failure to implement an SMS as an ICAO international standard will:
(a) pose obstacles for the mutual acceptance of approvals under bilateral agreements;
(b) be detrimental to the objective of continuous improvement of the overall level of safety, as a
significant segment of the air transportation system would not implement the safety
management principles;
(c) minimise the safety role of a reinforced occurrence reporting system as described in Chapter 5
of ICAO Annex 19 and in Regulation (EU) No 376/2014;
(d) not streamline the management system requirements for the competent authorities of the
EASA Member States, which are already required to upgrade their systems and procedures in
accordance with the new authority requirements introduced in Regulations (EU)
Nos 1178/2011, 290/2012 and 965/2012; and
(e) deny the need to consider the critical elements of a state safety oversight system as defined in
ICAO Annex 19, Appendix I.
The way forward is thus the proper consideration of the safety management principles in coherence
with what has been already done for the other aviation domains. Later in this document, the reader
will see that no options have been proposed for Part-145 (for reasons explained further in the text),
whereas for Part 21 some options are proposed to achieve that objective.

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The working method adopted for this IA is a qualitative assessment of the possible impacts, supported
by a questionnaire, as explained in the next section. It is recognised that this is not easy to precisely
quantify the impacts, notably with regard to the real costs. However, the EASA questionnaire helped
to identify the most significant contributors to safety and costs (see Section 4.1.2 and Appendix III).

4.1.2. Evidence gathering — EASA questionnaire

EASA sent out a survey in order to gather evidence for this IA from stakeholders. The input supported
the analysis of the problem definition and the analysis of the options. The survey was sent on 15
February 2018, and it collected specific SMS data related to the design, production and maintenance
domains.
The survey was responded to by 293 organisations (285 organisations with a single or multiple
approval(s); 8 associations or individuals) and 11 competent authorities. The organisations that hold
multiple approvals were invited to provide a consolidated response, representing all the parts of the
organisation that hold approvals.
The details of the survey can be found in Appendix III to this document. Wherever needed, the
outcome of the survey is used throughout this IA by referring to the appropriate figures in Appendix
III. The most relevant ones are repeated in Section 4.4.2.

4.1.3. Safety risk assessment

Several safety recommendations (SRs) that were addressed to EASA by safety investigation authorities
are of interest for this RMT, as they are related to the subject of ICAO Annex 19:
— SR UNKG-2015-001, following the accident to British Airways A319 G-EUOE, which occurred on
24 May 2013, recommends that ‘EASA publishes amended AMCs/GM in Part 145.A.47(b) of
European Commission Regulation (EC) No 2042/2003, containing requirements for the
implementation of an effective fatigue risk management system within approved maintenance
organisations’;
— SR UNKG-2011-018 following the serious incident to Bombardier DHC-8, SX-BIO, which occurred
on 24 April 2010, recommends ‘that the European Aviation Safety Agency expand the advisory
or guidance material in Annex II (Part 145) of European Commission Regulation (EC)
No 2042/2003 on how approved maintenance organisations should manage and monitor the
risk of maintenance engineer fatigue as part of their requirement to take human performance
limitations into account.’;
— According to SR UNKG 2010-072, pertaining to the serious incident to Boeing 737-73V, G-EZJK,
which occurred on 12 January 2009 West of Norwich, Norfolk, ‘It is recommended that the
European Aviation Safety Agency review the regulations and guidance in OPS 1, Part M and
Part-145 to ensure they adequately address complex, multi-tier, sub-contract maintenance and
operational arrangements. The need for assessment of the overall organisational structure,
interfaces, procedures, roles, responsibilities and qualifications/competency of key personnel
across all subcontract levels within such arrangements should be highlighted.’.
These SRs, together with their identified risks, have been properly considered in the proposed changes
to the Part-145 rules.

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4.1.4. Who is affected?

Part-145 maintenance organisations, Part 21 production and design organisations, competent
authorities and EASA are affected by the proposal in this NPA.

4.2. What we want to achieve — objectives

Please refer to Section 2.2.

4.3. How it could be achieved — background and options

Part-145
ICAO Annex 19 states that all approved maintenance organisations that provide services to operators
or aeroplanes or helicopters engaged in international commercial air transport, in accordance with
Annex 6, Parts I or III, should implement an SMS. In the current EASA system, the term ‘approved
maintenance organisations’ refers to either Part-M Subpart F organisations or Part-145 organisations.
With Opinions No 05/2016 ‘Task force for the review of Part-M for General Aviation (PHASE II)’ and
No 06/2016 ‘Embodiment of safety management system (SMS) requirements into Commission
Regulation (EU) No 1321/2014 — SMS in Part-M’, a new structure for Regulation (EU) No 1321/2014
was proposed, in which technical requirements and organisational requirements (e.g. Part-CAMO,
Part-CAO, Part-145) would be addressed in separate Annexes (so Part-M Subparts F and G would
eventually disappear). The technical requirements for General Aviation would be provided in a
separate Annex (Part-ML/Part-M). The organisations with a General Aviation scope (Part-CAO) would
not be required to implement an SMS, whereas other organisations would (i.e. Part-CAMO, and
Part-145), but Part-147 organisations were excluded.
This means that a decision has been already taken to limit the introduction of SMSs into Part-145
organisations. No SMS principles will be requested for future Part-CAO approved maintenance
organisations, which will address General Aviation activities. Only a Part-145 approved organisation
can maintain aircraft operated by licensed air carriers and complex motor-powered aircraft (CMPA),
in line with the spirit of ICAO Annex 19 (SMSs required for organisations that maintain aircraft engaged
in commercial air transport).
Additionally, ICAO Annex 19 does not make any differentiation in the type of maintenance
organisation (e.g. engaged in the maintenance of aeroplanes, helicopters or components, including
engines or propellers). The safety management principles have applied without exception to all Part-
145 maintenance organisations since 14 November 2013.
The implementation of ICAO Annex 19 is thus expected to be straightforward. For Part-145, it has
been decided to proceed without proposing options (i.e. full compliance with Annex 19). This has
also been well received by the FCG. Furthermore, the results of the questionnaire shown below
demonstrate that the majority of the replies are in favour of the implementation of ICAO Annex 19 for
all Part-145 activities (see Figure 16 in Appendix III).
However, the proposed changes introduce flexibility provisions regarding an SMS that should be
commensurate with the size of the organisation and complexity of the operations, so it will limit the
impact on small Part-145 organisations, or organisations with a limited scope of work.

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For further details, the reader can also review the regulatory impact assessment (RIA) in NPA 2013-
01(A), which resulted in Opinion No 06/2016.
Part 21
ICAO Annex 19 defines the applicability of SMSs to all organisations that are responsible for the design
and production of:
— aircraft in accordance with ICAO Annex 8, applicable from 14 November 2013; and
— engines and propellers in accordance with ICAO Annex 8, applicable from 7 November 2019.
Unlike the requirements on maintenance organisations, ICAO Annex 19 does not distinguish between
approved and non-approved organisations. This is because, in some regions of the world, the concept
of ‘approved’ organisations for design and production is not systematically used, even for products.
In addition, ICAO Annex 19 does not make SMSs applicable for the design and production of ‘parts &
appliances’.
Note: Regulation (EU) No 376/2014 already imposes a mandatory and voluntary occurrence reporting
system on all aviation organisations, independently of their approval status and of what they design
or produce. This can be considered a first element that stems from ICAO Annex 19, encouraging
organisations to develop a just culture. Therefore, this element will not be subject to options or to
analysis.
Starting from the scope defined by ICAO Annex 19, explained in Section 4.1.2, three options have been
developed to define the applicability of SMSs to Part 21.
Option 0 — mirroring the scope of ICAO Annex 19
The scope of this option strictly follows that of ICAO Annex 19 (all organisations that design and
produce aircraft, engines and propellers). Therefore Option 0 is considered to implement ICAO Annex
19 without any adaptation, and to mandate SMSs for all organisations, whether they are approved or
not, that design and produce aircraft, engines and propellers.
Option 1 — approved organisations that produce or design only aircraft, engines and propellers
This option would require the implementation of ICAO Annex 19 by all approved organisations that
design and produce only aircraft, engines and propellers (under Subparts J and G). All organisations
that design and produce ‘parts and appliances’ are excluded even when Part 21 requires an approval
[i.e. in the case of a European Technical Standard Order (ETSO) or an auxiliary power unit (APU)].
Under this option, this would exclude SMS for:
— Part 21 Subpart F production organisations15;
— design organisations that are entitled to demonstrate their design capabilities with the
acceptance of procedures that are alternative to DOA;

15 On the basis that the manufacturer of a product, part, or appliance without a POA has convinced the competent authority
that a POA was not needed due to a low volume of production; simple technology; the very small size of the organisation;
or production for a limited period of time; or starting production activities before achieving full compliance with
Subpart G [see point 21.A.124 (b)].

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— design organisations that are required to submit only a certification programme, as per points
21.A.14 (b) or (c)16; and
— natural/legal persons that hold an ETSO authorisation (or ETSO authorisations), even if they are
required to hold a POA.
Since this option would imply that, in some cases, an organisation may be required to be approved
even without having an SMS in place (i.e. in the case of an ETSO), two types of DOA and POA would
be needed: those who are required to implement an SMS and those who are exempted. This leads to
Option 2.
Option 2— all approved organisations
The implementation of ICAO Annex 19 would be limited to all approved organisations that design and
produce aircraft, engines and propellers (under Subparts J and G), and to organisations that design
and produce parts and appliances when a DOA or POA is required (i.e. a POA is required for an ETSO
or a POA/DOA is required for an APU).
Table 1: Part 21 — selected options

Option Title Description

No
0 Full implementation of Full compliance with and implementation of ICAO
ICAO Annex 19 by all Annex 19 (i.e. for approved and non-approved
organisations that are organisations that design and produce products)
responsible for the design
and production of products
1 Implementation of ICAO Implementation of ICAO Annex 19 is limited to approved
Annex 19 is limited to organisations that only design and produce products
approved organisations that (parts and appliances are excluded)
are responsible for the It falls short of the requirements of ICAO Annex 19, as
design and production of it excludes organisations for General Aviation (i.e. ELA1
products & 2, engines, etc.), small organisations for which a POA
is not needed, and organisations that are seeking a DOA
but to which it has not yet been granted.
This approach is coherent with the General Aviation
approach adopted for continuing airworthiness
organisations. (see Opinions No 05/2016 and
No 06/2016)
2 Implementation of ICAO The implementation of ICAO Annex 19 is limited to
Annex 19 is limited to approved organisations that design and produce
approved organisations that products as well as parts and appliances under ETSO
are responsible for the authorisation.
design and production of Built on Option 1, it falls short of the requirements of
products and for ‘parts and ICAO Annex 19, except for organisations that are
appliances’ when an responsible for the design of APUs and the production
organisational approval is of ETSO articles, for which an SMS is an additional
requirement.

16 For ELA 1 or ELA2; or for engine or propeller installed on ELA 1 or 2; or for a piston engine; or a fixed or adjustable
pitch propeller; a robust quality system and assurance design system is supposed to be sufficient.

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4. Impact assessment

required under ETSO

authorisation.

Note: the term ‘product’ means aircraft, engines, or propellers

Compared with Option 0, Option 1 in Europe:

— excludes around 250 organisations that design ELA1/ELA2 (the number of Subpart F
organisations is negligible);
— accounts for around 320 EU DOA holders, 30 DOA holders outside EU, and 500 POA holders.
Compared with Option 1, Option 2 would require some additional organisations in Europe to
implement SMSs, as follows:
— 3 approved design organisations for the design of APUs;
— around 300 POA holders for the production of parts and appliances that are covered by ETSOs.

Discarded option: ‘No action’

Failing to introduce the safety management principles from ICAO Annex 19 into the design, production
and maintenance rules would be neither acceptable nor coherent with what has been achieved in the
other aviation domains. The implications of this option have been clarified in Section 4.1. Therefore,
this option has been discarded.

4.4. What are the impacts

Note: no option has been identified for Part-145. The section below compares the three options for
Part 21 that are identified in Section 4.3.

4.4.1. Introduction to the impact analysis

A detailed analysis of the costs and benefits of implementing an SMS is quite challenging due to the
very nature of ‘safety’. Intangible benefits, such as those from having an improved safety culture,
effective regulatory compliance, a management commitment to safety, shareholder value, and public
confidence, are difficult to quantify. Also, an effective management system that includes safety risk
management results from the interactions of many different organisational elements, actions, and

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processes that are ideally embedded within the organisation’s existing system. Therefore, the effects
of individual elements of the management system framework are not always easy to isolate for the
purpose of the analysis of costs and benefits. It is also acknowledged that an SMS creates immediate
and direct costs, while its benefits are likely to take time to materialise. This view negates the potential
of an SMS, not only to address the risks of major occurrences, but also to identify and tackle
production inefficiencies, improve communication, foster a better company culture, and more
effectively control contractors and suppliers. Building up risk management capabilities that are not
only limited to aviation safety risks will contribute to the adoption of better management strategies.
In addition, through an improved relationship with the competent authorities, the implementation of
a management system that includes safety risk management could result in a reduced oversight
burden. Thus, by considering an SMS as something that is implemented not solely to prevent incidents
and accidents, but also to ensure the success of as many elements of an organisation’s business as
possible, any investment in safety should be seen as an investment in productivity and organisational
success.

4.4.2. Relevant elements from the EASA questionnaire

The results of the EASA questionnaire (see Appendix III) with regard to the main safety benefits
obtained from the implementation of an SMS are shown below. By far the two clearest benefits are:
— a better safety culture; and
— a better hazard identification, which leads to better control of risks.

Figure A - The most significant benefits in SMS implementation (by

those who implemented SMS)
Better safety culture 106
Better hazard identification leading to better risk control 100
Improved communication on safety issues within the company 53
Improved internal reporting (number and types of reports) 50
Better management of changes 31
Faster resolution of safety issues 29
Improved senior management commitment 18
Improved compliance (e.g. lower number of findings in internal or… 14
Improved efficiency of internal processes in general terms 10
Improved communication on safety issues with other parties 9
More efficient allocation of resources 8
Improved relationship with the competent authority 7
Other (please specify)3 6

0 20 40 60 80 100 120

The EASA questionnaire highlighted the following elements regarding the main cost drivers in the
implementation of an SMS:
— additional staff training;

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— organisational changes, such as the creation of new working groups (e.g. a safety review board);
— documentation (e.g. new procedures/manuals); and
— software and other tools (e.g. a reporting system).

Figure B - The main cost drivers in SMS implementation (by all

organisations)

Additional staff Training (e.g. safety training development) 190

Organisational changes, such as creation of additional working groups
(e.g. Safety Review Board, Safety Action Group) 143
Documentation (e.g. new procedures/manuals and updates to existing
ones) 113
Software & other tools (e.g. reporting system, risk analysis tools, risk
registers) 103

Oversight (authority fees, time spent in audits & assessments) 73

Safety investigations 63

Safety promotion & communication 62

Internal audits 42

Consultancy 23

Other 15

0 20 40 60 80 100 120 140 160 180 200

The cost drivers highlighted involved both organisations and authority.

4.4.3. Safety impact

Part 21 | Option 0 — ICAO Annex 19 (all product organisations)
Fully implementing Annex 19 would bring significant positive safety impacts, since all organisations,
irrespective of the type of aircraft they produce, would be required to have an SMS in place, whether
or not the organisation holds an approval. Figure A in Section 4.4.2 clearly highlights the safety
benefits.
However, with this option, organisations that design and produce parts and appliances would not be
required to implement an SMS. Some parts, such as APUs, are considered to have a major impact on
safety.
Part 21 | Option 1 — all approved organisations (products)
Regulation (EU) No 376/2014 is applicable to all organisations (including the non-approved ones) that
are located in Europe, and it mandates some basic elements of an SMS, such as mandatory and
voluntary reporting and the development of a safety culture. It should be noticed that these elements
are the most important safety benefits that were identified by organisations in their responses to the
questionnaire as shown in Figure A in Section 4.4.2. This is why limiting the implementation of SMSs

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to approved organisations that produce products would not significantly decrease the resulting safety
benefits.
Therefore, even if this option provides less safety benefit than Option 0, the difference can be
considered to be negligible. Overall, a positive safety impact is expected.
Part 21 | Option 2 — all approved organisations (products and parts and appliances)
In addition to the organisations defined in Option 1, this option mandates the implementation of an
SMS by those organisations that design and produce parts and appliances under ETSO authorisation,
but only when an approval is already required by Part 21.
Therefore, organisations that design critical elements such as APUs, and which produce parts and
appliances that are covered by ETSO authorisations (i.e. when the organisations are not allowed to
produce under Part 21 Subpart F), will be required to implement an SMS. The risks related to the
design and production of these ETSO articles would be captured and assessed by those organisations.
The aircraft manufacturer would rely on the ETSO authorisation, and would only be responsible for
the proper installation of the article. This would be the additional positive safety effect of adopting
Option 2.
Concerning the design of an APU (which is a major component of an aircraft), having an SMS in place
is considered necessary and appropriate, not only in terms of the ‘complexity’ or ‘criticality’ of APUs,
but also when considering the privileges associated with the design approval for the modifications and
repair designs of those articles. Several accidents, such as uncontained explosions, or the one on 20
January 2015 at Nürnberg airport17 (i.e. that involve the intake and combustion of de-icing fluid),
remind us of how the operation of APUs can pose risks and may endanger human beings if there is a
failure, should it be at product safety level or organisational level.
Safety awareness and safety culture will be also enhanced by more safety training, communication
and safety promotion for the organisations that design and produce parts and appliances.
Finally, most of the organisations that produce parts and appliances under ETSO authorisations or
design/produce APUs, also hold Part-145 approvals for which an SMS will be also required. An
integrated (safety) management system will benefit from a safety perspective.
Compared with Option 1, a higher positive safety impact is thus expected, as more organisations
would be covered.

4.4.4. Environmental impact

No environmental impact is identified, therefore this aspect is not analysed.

4.4.5. Social impact

The following elements are considered in the social impacts for this proposal: better communication,
higher management commitment, fatigue, working conditions, lack of resources, and the level of
subcontracting activities. Two of the essential elements of an SMS as defined by ICAO Annex 19 are
the development of a safety culture and the provision of better safety training for all staff. The social
impact is commensurate with the number of organisations for which an SMS is mandatory.

17 https://aviation-safety.net/database/record.php?id=20150120-2

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Part 21 | Option 0 — ICAO Annex 19 (all product organisations)

Since this option is applicable to all organisations that design and produce aircraft engines and
propellers, the largest number of companies will be affected by this option, so it has a positive social
impact.
Part 21 | Option 1 — approved organisations (products)
This option excludes non-approved organisations that design and produce aircraft engines and
propellers; therefore, its social impact is slightly lower than that of Option 0, but it is still positive.
Overall, the difference in comparison with Option 0 can be considered to be negligible.
Part 21 | Option 2 — all approved organisations (products as well as parts and appliances)
This option includes those organisations that design and produce parts and appliances under ETSO
authorisation, but only when an approval is already required by Part 21. Therefore, the level of social
impact is lower than with Option 0, but higher than with Option 1. Overall, the difference in
comparison with Option 0 can be considered to be negligible.

4.4.6. Economic impact

For the organisations who have not yet implemented safety management principles, there would be
an economic impact.
The organisations and authorities who have already engaged in this proactive strategy to
systematically address safety risks have usefully pinpointed several areas in response to the EASA
survey, as shown in Figure B in Section 4.4.2. These elements need to be kept in mind for this analysis.
The following general features can be highlighted:
Positive impact
Some elements of an SMS, such as a positive safety culture or an internal reporting system, have the
potential to contribute significantly to the overall safety at little or no cost. For certain elements of an
SMS, the implementation will be gradual, which should spread the overall costs over time. The same
applies to the authorities, which should progressively deploy SMS management systems over time.
The effective implementation of SMSs will also improve productivity and efficiency, through the
adoption of better management strategies and the build-up of risk management capabilities that are
not limited to only aviation safety risks. Moreover, the causes of incidents and the contributing factors
to them often also cause or contribute to production losses or inefficiencies. The management system
framework of an SMS provides an organisational structure that supports managers in taking informed
decisions. Without such a framework to manage operational risks, trade-offs between commercial
pressures and safety objectives may not be managed effectively, and decisions may not be justified
objectively. The effective implementation of a management system could, therefore, contribute to a
decrease in insurance costs, to an improved reputation, and to commercial success.
For large, well established production and design organisations, it can be expected that a certain
percentage have already implemented SMSs according to the ICAO framework, on a voluntary basis,
sometimes under contractual obligations imposed on them by their customers.
The level of involvement (LOI) of an authority might be reduced due to an improvement in the
performance of an organisation, as the level of safety might be higher.

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Negative impact
The main elements of an SMS that may initially be missing from an organisation, and for which a
negative economic impact is expected when they are incorporated, stem from:
(a) developing a safety policy and its related objectives;
(b) appointing key safety personnel to execute the safety policy;
(c) establishing, implementing and maintaining a safety risk management process;
(d) establishing, implementing and maintaining a safety assurance process; and
(e) promoting safety in the organisation.
To mitigate this negative impact, the reader is invited to review the proportionality provisions laid
down in the next paragraph, as they contribute to a significant reduction of the costs, notably for small
organisations or when the risks associated with the business are limited.

Part 21 |Option 0 — ICAO Annex 19 (all product organisations)

— Negative impact
Organisations for which Part 21 currently mandates an approval (DOA holders and POA holders) will
have to adapt their structures, and update their policies, plans, procedures and expositions or
handbooks. For them, the economic impact may be considered to be limited because they can build
on their existing structures. Nevertheless, training costs and some organisational changes remain as
major contributors, as identified in the replies to the EASA questionnaire.
Since all organisations that design and produce aircraft, engines and propellers will be mandated to
apply SMSs, each organisation that is currently not required to have an approval will be required to
define an organisational structure and to document their procedures in order to be compliant with
ICAO Annex 19. For all other organisations that are not required to hold a Part 21 approval (i.e. those
that design ELA 1 or ELA and produce according to Subpart F), and which are ‘small’ by definition, the
implementation of SMSs will have a greater economic impact. They might be required to hire new
personnel, to create some new management positions, or to extend the scope of their existing
management positions, and to develop policies, plans, procedures and expositions or handbooks.
— Positive impact
In terms of economic benefits, the implementation of Annex 19 would ensure that there is a level
playing field with consistent airworthiness requirements for aircraft that participate in international
air transport, and for products for which foreign states accept certificates issued by EASA. In addition,
further efficiency/effectiveness would be fostered thanks to:
— more efficient allocation of resources;
— more efficient internal processes;
— greater senior management commitment; and
— faster resolution of safety issues.

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4. Impact assessment

For competent authorities, the impact is significant, since the implementation of SMSs by a large
number of organisations would be required to be assessed, and some of the competent authorities
might not initially have the necessary resources to do this.
Overall, considering that there are both significant positive and negative economic impacts, as
highlighted above, an overall neutral effect is expected.

Part 21 | Option 1 — approved organisations (products)

This option excludes non-approved organisations, so the general costs may therefore be much lower
than with Option 0; however, fewer safety benefits are expected, as fewer organisations would be
affected.
For competent authorities, there will be less impact than with Option 0.
Considering both the negative and positive impacts, which should be of smaller absolute values than
with Option 0, an overall neutral impact is expected over time.

Part 21 |Option 2 — all approved organisations (products as well as parts and appliances)
As mentioned earlier, the changes to these additional approved organisations will be limited because
the organisations will build on their existing procedures and structures. The flexibility provisions would
also apply to make the design/production management system proportionate to the size of the
organisation and complexity of the services. The additional costs incurred are considered rather
limited, keeping in mind the expected safety benefits.
It is also expected that most of the organisations that produce ‘parts and appliances’ under ETSO
authorisation, and those that design and produce APUs, will also already hold a Part-145 approval for
which an SMS will be required; so this will limit the overall economic impact for them.
Overall, neutral impacts are expected, although both the positive and negative impacts may be of
greater magnitude than with Option 1.

4.4.7. Proportionality impact

In all these Part 21 options, the following elements have been introduced in order to reduce the
implementation costs, which are more significant for smaller organisations:
(a) The acceptance that the design/production management system shall correspond to the size
of the organisation, as well as to the nature and complexity of its activities, taking into account
the hazards and associated risks that are inherent to these activities (see the proposed
changes to 21.A.139(b) and 21.A.239(b));
(b) Flexibility provisions contained in the AMC & GM, which allow different scenarios that are
proportionate to the size and complexity of the operations (e.g. a full-time equivalent safety
manager is not required as long as the function of a ‘safety manager’ is properly discharged
by another person, or by a group. The same applies for a formal safety review board. Both
cases must be subject to a risk assessment and must be agreed by the competent authority);

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4. Impact assessment

(c) The planned recognition of SMS Industry Standard SM-0001 as an AMC, which will allow a
level playing field with the Federal Aviation Administration (FAA) SMS approach because the
recognition of that SMS Industry Standard by the FAA is also planned. The implementation
costs could be further reduced by encouraging the implementation of common tools and data-
sharing agreements for safety management at the level of industry associations; and
(d) The changes for Part 21 Section A (requirements on organisations) are limited to the
introduction of the ICAO SMS framework based on an analysis of the gap between the ICAO
SMS framework and the existing Part 21 requirements (see further details in Section 2.3.2).
By reducing the complexity of the changes, an organisation can decide to build its SMS on its
existing exposition manual, or to produce a separate SMS manual, which limits the impact on
their documentation.
Part 21 |Option 0 — ICAO Annex 19 (all product organisations)
Significant negative disproportionate impacts are expected, since small organisations would face
implementation costs that would include, but would not be limited to, additional staff, organisational
changes, and new manuals. These changes might have significant negative repercussions for their
businesses.

Part 21 | Option 1 — approved organisations (products)

Unlike Option 0, SMSs would not be applicable to small organisations that produce or design small
aircraft (notably for General Aviation, as ELA1, and ELA2 aircraft, and their engines would be
excluded). This is very similar to the approach taken in Opinions Nos 05/2016 and 06/2016 in order to
sustain the GA Roadmap.
Therefore, significant positive proportionality impacts are expected.

Part 21 | Option 2 — all approved organisations (products as well as parts and appliances)
This option would maintain the same consistency that is identified in Option 1. Since SMSs would be
applicable to organisations that design APUs and that produce parts and appliances covered by ETSO
authorisations, some additional small organisations would be impacted. For them, the proportionality
provisions mentioned above would significantly reduce the burden. In the same vein, as most of them
would also hold a Part-145 approval, the same proportionality provisions are proposed in Part-145 for
the sake of coherence.
As for Option 1, significant positive proportionality impacts are expected.

4.5. Conclusion
The table below provides a summary of the qualitative assessments made for the various criteria,
which should be read from left to right, comparing Option 0 with Options 1 and 2. The table includes
‘0’ values for Option 0 in order to allow an easy comparison with the other options. However, Option
0 might have both positive and negative impacts, as described in the text. Therefore, the reader should

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4. Impact assessment

check the values of Option 1 and 2 in terms of the differences when they are compared with
Option 0.
Table 2: Conclusions for the options

Criteria Option 0 (basis) Option 1 Option 2

Full implementation Implementation of Implementation of
of ICAO Annex 19 ICAO Annex 19 is ICAO Annex 19 is
affects all limited to approved limited to approved
organisations that organisations that are organisations that are
are responsible for responsible for the responsible for the
the design and design and production design and production
production of of products. of products and also for
products. parts and appliances
when an organisational
approval is required
under ETSO
authorisation.

Safety 0 - -/+
Better safety culture. The impact remains The impact remains
Introduction of a positive, but it is less positive, but is less
systematic hazard than with Option 0 than with Option 0 but
identification because SMSs are not higher than with
process, risk controls applicable for non- Option 1, as SMSs are
and measurement of approved also applicable to parts
safety performance. organisations. and appliances under
ETSO authorisations, as
well as for APUs.

Economic 0 -/+ -/+

The implementation Lower costs but also Lower costs but also
of an SMS will add fewer safety benefits fewer benefits than
costs. The cost- than with Option 0. with Option 0. Non-
safety-analysis shows Non-approved approved organisations
that the burden is on organisations are not are not impacted.
smaller impacted. However, for ETSO
organisations. articles, there are
higher costs than with
Option 1, but these are
mitigated by the fact
that these
organisations hold a
maintenance approval
for which an SMS is
required.

Social 0+ 0+ 0+

Proportionality 0 + +

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4. Impact assessment

Significant Small production (i.e. Some small production

implementation non-approved) organisations are
costs for small organisations are not impacted in a
organisations impacted. proportionate manner.

Total 0 -/+ +
Option 0 would promote the highest level of safety and the most positive social impact. The economic
impact is confirmed for small organisations for which a formal approval is not needed.
Option 1, which falls short of the scope of ICAO Annex 19, has a less negative economic impact.
— It is considered to be an approach that is proportionate for the General Aviation segment (i.e.
consistent with the applicability chosen for continuing airworthiness organisations —
continuing airworthiness management organisations (CAMOs) and approved maintenance
organisations (AMOs)).
— It limits the impact for smaller organisations if an approval is not needed. In addition, this impact
is reduced by the fact that approved organisations can build on their existing structures,
processes, procedures and exposition manuals or handbooks.
— The costs will be further reduced by including proportionality in the requirements, based on the
size of the organisation and on the risks of the activities.
Option 2, which builds on Option 1, would also require approved organisations that design APUs to
implement SMSs, (for which Part 21 currently mandates a DOA), as well as organisations that produce
parts and appliances covered by an ETSO authorisation when a POA is required.
— It goes slightly beyond the scope of Annex 19.
— The implementation of SMSs for these additional organisations would certainly induce costs,
but would also increase the level of safety and the social impact.
— To reduce the costs, the proportionality provisions should be used when the production
activities for these parts and appliances bear fewer risks.
— In addition, for most of these organisations, synergies will be achieved through the use of an
integrated SMS for their Part 21 and Part-145 activities.
In comparison with Option 2, Option 1 has the drawback that it defines two levels of DOAs and POAs:
those that are required to implement the elements of an SMS that were missing (for products) and
those that are not required to do so (for parts and appliances). Option 2 would avoid that
differentiation in Part 21 (i.e. by avoiding the confusion introduced by compliance with two sets of
procedures within the EU regulatory framework or within an organisation). It would also ensure that
there is a level playing field and consistent airworthiness requirements for aircraft that participate in
international air transport, including the assurance that EU certificates will still be accepted by third
countries (therefore there would be a positive economic impact, as shown in the table).
Finally, the EASA questionnaire shows that among the organisations that have an ETSO authorisation,
two out of three respondents considered that SMSs should also be applicable to parts and appliances.
The rationale certainly stems from the fact that most of these organisations also hold Part-145
approvals, for which an SMS will be required, irrespective of the scope of the approval.

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4. Impact assessment

For all these reasons, Option 2 is the preferred option, as the applicability of SMSs would be extended
to all design and production organisations for which Part 21 currently requires an approval (i.e. DOA
holders or POA holders) that design or produce aircraft, engines or propellers, as well as parts and
appliances under ETSO authorisation. This is fully in line with the outcome of the last ICAO Air
Navigation Conference held in October 2018, urging organisations and authorities to develop robust
risk management capabilities. The same conclusion can be drawn from the recent issuance of the Basic
Regulation.
Note: the FAA also recommends SMSs for organisations in charge of TSO articles.

Question to stakeholders
Stakeholders are invited to comment on the IA and to provide any qualitative or quantitative
information that they may find necessary to bring to the attention of EASA.
As a result, EASA might adjust the selection of the best option, as well as the relevant parts of the
impact assessment on a case-by-case basis.

4.6. Monitoring and evaluation

Monitoring is a continuous and systematic process of data collection and analysis about the
implementation/application of a rule/activity. It generates factual information for future possible
evaluations and impact assessments; it also helps to identify actual implementation problems. With
respect to this proposal, EASA would suggest to monitor various elements looking at short and
medium term. Indeed, there are elements that should be monitored as soon as the rules are
implemented and others for which some years would need to pass before the outcome could be
measured. A proposal on indicators to check is presented below:

What to monitor How to monitor Who should monitor How often to

monitor
Number of occurrences ECCAIRS — the split in EASA/competent On a recurrent basis
reported by organisations severity/risk should authority - with the e.g. once a year
affected by this initiative, allow to distinguish the support of the Network
split by severity/risk improvement of of Analyst (NoA)
reporting versus the
improvement of safety
performance
Number of occurrences ECCAIRS — the split in EASA/competent On a recurrent basis
reported by organisations severity/risk should authority - with the e.g. once a year
affected by this initiative allow distinguish the support of the Network
on topics directly related to improvement of of Analyst (NoA)
SMS or safety reporting vs the
performance split by improvement of safety
severity/risk performance

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4. Impact assessment

Number of DOA/POA Surveys, interviews, competent On a recurrent basis

holders applying SMS as audits authorities/EASA e.g. once a year
defined in Part 21

Number and level of

findings related to SMS
requirements per audit on
Part 21 organisations at
state level; effectiveness of
SMS implementation (SMS
maturity indicator)
Number of AMOs applying Surveys, interviews, competent On a recurrent basis
SMS as defined in Part-145 audits authorities/EASA e.g. once a year

Number and level of

findings related to SMS
requirements per audit on
Part-145 organisations at
state level; effectiveness of
SMS implementation (SMS
maturity indicator)

This monitoring will have to be fine-tuned in accordance with the outcome of MST.026 from EPAS
2019-2023, for which the Safety Management Member States Technical bodies (SM.TeB) currently try
to establish markers to assess the effective implementation of SMS throughout the European Union.

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5. Proposed actions to support implementation

5. Proposed actions to support implementation

A number of actions took place during the preparation of this NPA, which helped to foster the
understanding and implementation of the proposed new rules. It is also understood that more actions
will come, notably for Design, Production and Maintenance insofar as the SMS-associated Opinions
will reach the final stage (i.e. adoption and entry into force):
— Workshops
A series of thematic SMS workshops were organised, as follows:
— ACAM implementation for the competent authorities on 27 September 2018, as part of Part-M,
point M.B.303, where a risk-based approach was discussed with the Member States;
— A ‘Product certification & DOA workshop’ on 29-31 October 2018, where this NPA was
presented; a video is available here;
— An SM ICG Industry day on 13 November 2018 where the topic was ‘SMSs made simple’; and
— An SMS workshop on 12-13 February 2019, to which competent authority Air Ops inspectors
were invited - SMS implementation was extensively discussed and there are lessons learned to
use in the Design, Production and Maintenance domains. The presentations and takeaways are
available here.
EASA is also regularly in contact with the Certification Committee (C.COM); the Design and
Manufacturing Technical Committee (DM.TeC); Production and Continuing Airworthiness Committee
(P & CA) TeB; or Engineering and Maintenance Committee (EM.TeC).
Speakers who would like to propose SMS presentations in the fields of Production, Design and
Maintenance can contact EASA at safety.management@easa.europa.eu. This may serve the
preparation of an EASA SMS workshop in the fields of Production, Design and Maintenance, once the
final text is known, after this consultation.
— SMS industry standards
SMS Industry Standard SM-000118 ‘Implementing a SMS for Design, Manufacturing and Maintenance
Providers’ as earlier described in Section 2.3.3 is intended to improve safety and to enhance safety
culture.

— Safety promotion and SMS

There is a significant volume of material that promotes SMSs on the EASA website here. An EASA
‘safety promotion’ policy is currently being developed to better support that activity in the future.
EASA also intends to develop, as appropriate, safety promotion material to better explain SMSs in the
fields of design, production and maintenance; several targeted actions are already envisaged.
As part of the introduction of the ‘safety risk management’ in this NPA, ‘fatigue’ is a risk to be carefully
mitigated, notably for Part-145 maintenance organisations (see Section 4.1.3). Guidelines on how to

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5. Proposed actions to support implementation

introduce an effective fatigue risk management system (FRMS) within approved maintenance
organisations will be developed.
Two safety promotion bulletins are being developed about:
— the risks associated with deviation from the use of maintenance data; and
— the risks associated with recurrent defects in aircraft or components.
— When it is ready, this material will be posted and promoted on the EASA website.
— Baines Simmons published a paper on ‘Hazard Identification and Risk Management challenges
throughout the Supply Chain’.
— Anyone can also propose SMS examples, tools and supporting educational material on the ICAO
safety management implementation website (ICAO SMI), which is a repository of SMS
documents to support the implementation of SMS and to complement the 4th edition of the
ICAO Safety Management Manual (ICAO Doc 9859).
— Finally, SMS experts, who would like to propose safety promotion material or presentations, or
SMS implementation cases in the fields of production, design and maintenance, can contact
EASA at safety.management@easa.europa.eu.

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6. References

6. References
6.1. Affected regulations
— Commission Regulation (EU) No 1321/2014 of 26 November 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 (OJ L 362, 17.12.2014, p. 1)
— 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)

6.2. Affected decisions

— ED Decision 2012/020/R of the Executive Director of the Agency of 30th October 2012 on
Acceptable Means of Compliance and Guidance Material 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 (‘AMC and GM to Part 21’) repealing
Decision No 2003/01/RM of the Executive Director of the Agency of 17 October 2003
— ED Decision 2015/029/R of 17 December 2015 issuing acceptable means of compliance and
guidance material to Part-M, Part-145, Part-66, and Part-147 of Regulation (EU) No 1321/2014
and repealing Decision 2003/19/RM of the Executive Director of the Agency of 28 November
2003 ‘AMC and GM to the Annexes to Regulation (EU) No 1321/2014 — Issue 2’
— ED Decision 2016/011/R of 11 July 2016 amending the Acceptable Means of Compliance and
Guidance Material to Annex I (Part-M), Annex II (Part-145) and Annex III (Part-66) to
Commission Regulation (EU) No 1321/2014 in order to support the implementation of
Commission Regulation (EU) 2015/1536, and issuing the Acceptable Means of Compliance and
Guidance Material to Annex Va (Part-T) ‘Amendments to the AMC & GM to Annex I to
Commission Regulation (EU) No 1321/2014 “Issue 2 — Amendment 1”, amendments to the
AMC & GM to Annex II to Commission Regulation (EU) No 1321/2014 “Issue 2 — Amendment
1”, amendments to the AMC & GM to Annex III to Commission Regulation (EU) No 1321/2014
“Issue 2 — Amendment 1”, and issue of the AMC & GM to Annex Va to Commission Regulation
(EU) No 1321/2014 “Issue 1”’

6.3. Other reference documents

— 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
— ICAO Annex 19 ‘Safety Management’, Edition 2, July 2016.
— ICAO Documentation 9859 ‘Safety Management Manual’ (SMM), Edition 4; June 2018.

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6. References

— Opinions Nos 05/2016 ‘Task force for the review of Part-M for General Aviation (PHASE II)’ and
06/2016 ‘Embodiment of safety management system (SMS) requirements into Commission
Regulation (EU) No 1321/2014 - SMS in Part-M’
— Common, general authority and organisation requirements already published in the areas of air
operations (see Regulation (EU) No 965/2012), aircrew (see Regulation (EU) No 1178/2011),
aerodromes (see Regulation (EU) No 139/2014), air traffic controller training (see Regulation
(EU) 2015/340), and ATM/ANS (see. Regulation (EU) 2017/373).
— Opinion No 07/2016 ‘Embodiment of level of involvement (LOI) requirements into Part 21’

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7. Appendices

7. Appendices
7.1. Appendix I — Detailed summary of changes to Part 21
NPA 2019-05 (B) includes the draft implementing rules (IRs) as well the draft Acceptable Means of
Compliance (AMC) and Guidance Material (GM) for Part 21. The following text is just a summary of
the SMS-related changes to Part-21.
As mentioned in Section 2.1, Part 21 already includes organisational requirements for design and
production organisations ensuring the safety of their products. Some of these requirements may be
easily traced to the ICAO Annex 19 SARPs, such as:
— the identification of an accountable manager or, in the case of a DOA holder, of a head of the
design organisation, ultimate responsible for the activities of the organisation;
— a system to ensure safety (i.e. the design assurance system for the DOA and the quality system
for the POA are elements to ensure the safety of the product, part or appliance);
— independent monitoring of compliance with, and the adequacy of, the documented procedures;
— a system to record the activities;
— an exposition or handbook to document the procedures; and
— the management of changes.
A gap analysis was therefore performed first. Where gaps were identified, EASA developed draft text
that inserted the missing elements and focused on the final goal of improving safety, without imposing
requirements on how organisations should structure themselves in order to reach the final goal.
Moreover, it was decided to keep the structure of Section A unchanged, and to reduce the changes as
much as possible, keeping the current text if it achieves the goals of ICAO Annex 19.
The majority of changes were made to points 21.A.139 and 21.A.239, which were renamed
respectively ‘production management organisation’ and ‘design management organisation’. The
management system will include two elements:
(a) a safety management system; and
(b) a quality system for production organisations, or a design assurance system for design
organisations.
The requirements related to the second element were not changed. In this way, organisations may
keep their current structure and procedures. To build a safety management system, organisations will
be required to do the following (ICAO Annex 19 SARPs missing in the current Part 21):
— develop a safety policy and the related objectives;
— appoint key safety personnel to execute the safety policy;
— establish, implement and maintain a safety risk management process;
— establish, implement and maintain a safety assurance process; and
— promote safety in the organisation.

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7. Appendices

If an organisation holds more than one organisational certificate that was issued on the basis of EU
legislation, it is possible to integrate the different management systems into one single system.
A set of AMC & GM is proposed in this NPA that is consistent with the AMC & GM provided in other
domains to demonstrate compliance with the SMS requirements. In this way, an organisation that
already holds an organisational certificate (e.g. CAMO, Part-145, etc.) may reuse most of the evidence
that it has already produced to demonstrate compliance with that regulation.
In this NPA, EASA proposes alternative AMC with which an organisation may also demonstrate
compliance with ‘SMS Industry Standard SM-0001’19 which was developed by AIA-USA, AIA-B, AIA-C,
ASD and GAMA (see the tables included in AMC1 21.A.139(c) and AMC1 21.A.239(c)). An organisation
that intends to demonstrate compliance through the use of the SMS Industry Standard should thus
additionally demonstrate compliance through the elements listed in those AMC in order to
demonstrate compliance with the EU SMS requirements in Part 21.
The AMC contain proportionality elements that allow an organisation to adapt its management system
according to its size and to the nature and complexity of its activities.
Whenever a point in Part 21 was amended to address an SMS requirement, the opportunity was taken
to:
— enhance, when possible, the consistency between the requirements in the various subparts
(e.g. point 21.A.245 has been amended to harmonise its content with the requirements defined
for POA holders in point 21.A.145);
— keep in Section A only organisational requirements, thus separating them from the authority
requirements that have been transferred into Section B:
 the classification of findings in points 21.A.125B, 21.A.158 and 21.A.has been
moved to Section B; and
 some EASA forms pertaining to applicants, such as EASA Form 50, have been
moved to Section A;
— move to Subpart A all the general requirements that are valid for all applicants:
 in point 21.A.3A, requirements related to occurrence reports for production
organisations were moved from points 21.A.129 and 21.A.165;
 two new points 21.A.5 for ‘record-keeping’ and 21.A.9 for ‘investigations’
have been added, which replace all the similar requirements that were in
different subparts;
— expand point 21.1 to generally define the competent authority; and
— incorporate some improvements, as proposed by the ASD task force 3 (TF3), to add clarity to
the text of some points.
Moreover, a new process was included in Subparts F and G (production) for an applicant or for a
competent authority to use an AltMoC. This new process is similar to what is already included in other
aviation domains. The new point added defines the procedure to be applied by organisations to
propose such AltMoC, and by competent authorities to inform EASA and other Member States about

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7. Appendices

it. It was considered that for design organisations, such a process is not required, since there is only
one competent authority (EASA), and the process for an organisation to propose AltMoC is already
available as part of EASA procedures. It has been used for a long time with positive results.
Changes in Section B were, in contrast, more extensive. In this case, it was considered beneficial to
align the authority requirements with those defined in other aviation domains, and to also include the
requirements that are applicable when EASA is the competent authority (which today are contained
in EASA procedures). Therefore, several new points have been added to Subpart A of Section B
(‘General’, applicable to all competent authorities) to include requirements for the authority’s
management system, the management of changes, record-keeping, and the use of qualified entities.
Subparts F and G have been amended to harmonise the requirements for the oversight of
organisations, while in Subpart J, requirements similar to Subpart G, applicable to EASA when issuing
a DOA, and to oversight of organisations, have been included.
Point 21.B.40(b), resolution of disputes, has been deleted since EASA does not have any mandate for
mediation of internal disputes in national organisations.
Finally, all the existing AMC and GM that were affected by changes introduced through this RMT were
reviewed and aligned as much as possible with those that are anticipated to cover Part-CAMO and
Part-145. In several cases, it was noticed that GM did not provide explanations or examples, but rather
means of compliance. It was then decided to redefine them as AMC, or to split them into two parts,
keeping explanations as GM and means of compliance as AMC.
List of changes to Part 21 IR
Only new, deleted or modified points are listed. Unmodified points are not reported.

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7. Appendices

Part 21 reference Action

Change of the title in harmonisation with the
content of the rule; all requirements currently
21.1 General Competent authority
spread in Part 21 and defining the competent
authority, have been moved to this point
SECTION A — TECHNICAL REQUIREMENTS
SUBPART A — GENERAL PROVISIONS
21.A.1 Scope Improvement of the text

21.A.3A Failures, malfunctions and defects Requirements for production organisations have
Occurrence reporting been moved from points 21.A.129 and 21.A.165
21.A.5 Record-keeping Replacement of all the record-keeping
requirements spread in Section A
21.A.9 Investigations Replacement of all the investigation requirements
spread in Section A
SUBPART B — TYPE CERTIFICATES AND RESTRICTED TYPE CERTIFICATES
21.A.44 Obligations of the holder References have been updated
21.A.55 Record-keeping The requirement has been moved to 21.A.5
SUBPART D — CHANGES TO TYPE CERTIFICATES AND RESTRICTED TYPE CERTIFICATES
21.A.105 Record-keeping The requirement has been moved to 21.A.5
21.A.109 Obligations and EPA marking References have been updated
SUBPART E — SUPPLEMENTAL TYPE CERTIFICATES
21.A.118A Obligations and EPA marking References have been updated
SUBPART F — PRODUCTION WITHOUT PRODUCTION ORGANISATION APPROVAL
21.A.124A Alternative means of compliance New point to introduce AltMoC
21.A.125B Findings Update to move classification and requirements
for competent authority to Section B
21.A.125C Duration and continued validity Text improvement and harmonisation with similar
requirements in other Subparts
21.A.126 Production inspection system The record-keeping requirements have been
moved to 21.A.5
21.A.129 Obligations of the manufacturer The reporting requirements have been moved to
21.A.3A
SUBPART G — PRODUCTION ORGANISATION APPROVAL
21.A.134A Alternative means of compliance New point to introduce AltMoC
21.A.139 Quality Production management Introduction of the 12 elements of the safety
system management system as defined by ICAO Annex 19
21.A.143 Exposition Improvement of text
21.A.145 Approval requirements Resources Improvement of text
21.A.147 Changes to the approved production Improvement of text
management system organisation
21.A.157 Investigations The requirement has been moved to 21.A.9
21.A.158 Findings Update to move classification and requirements
for competent authority to Section B
21.A.159 Duration and continued validity References have been updated

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21.A.165 Obligations of the holder Reporting requirements have been moved to

21.A.3A
SUBPART H — CERTIFICATES OF AIRWORTHINESS AND RESTRICTED CERTIFICATES OF AIRWORTHINESS
21.A.180 Inspections The requirement has been moved to 21.A.9
21.A.181 Duration and continued validity References have been updated
SUBPART I — NOISE CERTIFICATES
21.A.210 Inspections The requirement has been moved to 21.A.9
21.A.211 Duration and continued validity References have been updated
SUBPART J — DESIGN ORGANISATION APPROVAL
21.A.239 Design assurance management system Introduction of the 12 elements of the safety
management system as defined by ICAO Annex 19
21.A.243 Data Handbook Improvement of text
21.A.245 Approval requirements Resources The requirement has been made consistent with
requirement 21.A.145
21.A.247 Changes in to the design management Improvement of text
assurance system
21.A.257 Investigations The requirement has been moved to 21.A.9
21.A.258 Findings Update to move classification and requirements
for competent authority to Section B
21.A.259 Duration and continued validity References have been updated
21.A.263 Privileges Minor changes proposed by this NPA, based on
the text proposed with Opinion No 07/2016 (LOI),
replacing ‘design assurance system’ with ‘design
management system’
21.A.265 Obligations of the holder Minor changes proposed by this NPA, based on
the text proposed with Opinion No 07/2016 (LOI)
SUBPART M — REPAIRS
21.A.447 Record-keeping The requirement has been moved to 21.A.5
21.A.451 Obligations and EPA marking References have been updated
SUBPART O — EUROPEAN TECHNICAL STANDARD ORDER AUTHORISATIONS
21.A.604 ETSO Authorisation for an Auxiliary References have been updated
Power Unit (APU)
21.A.609 Obligations of holders of ETSO References have been updated
authorisations
21.A.613 Record-keeping The requirement has been moved to 21.A.5
21.A.615 Inspection by the Agency The requirement has been moved to 21.A.9
21.A.619 Duration and continued validity Improvement of text
SUBPART P — PERMIT TO FLY
21.A.705 Competent authority The requirement has been moved to 21.1
21.A.721 Inspections The requirement has been moved to 21.A.9
21.A.723 Duration and continued validity Improvement of text
21.A.729 Record-keeping The requirement has been moved to 21.A.5

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SECTION B — PROCEDURES FOR COMPETENT AUTHORITIES

SUBPART A — GENERAL PROVISIONS
21.B.5 Scope The text has been improved to better specify scope of
Section B and aligned with Part-CAMO Section B
21.B.10 Oversight documentation New point aligned with Part-CAMO Section B
21.B.15 Information to EASA New point aligned with Part-CAMO Section B
21.B.20 Obligations of the competent authority Deleted to align with Part-CAMO Section B
21.B.20 Immediate reaction to a safety problem New point aligned with Part-CAMO Section B
21.B.25 Requirements for the organisation of the Deleted to align with Part-CAMO Section B
competent authority
21.B.25 Management system New point aligned with Part-CAMO Section B
21.B.30 Allocation of tasks to qualified entities New point aligned with Part-CAMO Section B
21.B.30 Documented procedures Deleted to align with Part-CAMO Section B
21.B.35 Changes in organisation and procedures Deleted to align with Part-CAMO Section B
21.B.35 Changes in the management system New point aligned with Part-CAMO Section B
21.B.40 Resolution of disputes Paragraph b was deleted
21.B.45 Reporting/coordination Deleted to align with Part-CAMO Section B
21.B.55 Record-keeping The text has been aligned with Part-CAMO Section B
21.B.65 Suspension, limitation and revocation New point aligned with Part-CAMO Section B
SUBPART F — PRODUCTION WITHOUT PRODUCTION ORGANISATION APPROVAL
21.B.115 Alternative means of compliance New point aligned with Part-CAMO Section B
21.B.120 Investigation Deleted to align with Part-CAMO Section B
21.B.120 Initial certification procedure New point aligned with Part-CAMO Section B
21.B.125 Findings and corrective actions Updated to include classification and requirements
for competent authority, previously in Section A
21.B.130 Issue of letter of agreement The content has been moved to 21.B.120, to be
consistent with Part-CAMO Section B
21.B.145 Limitation, suspension and revocation of The requirement has been moved to 21.B.65
a letter of agreement
21.B.150 Record-keeping The requirement has been moved to 21.B.55
SUBPART G — PRODUCTION ORGANISATION APPROVAL
21.B.215 Alternative means of compliance New point aligned with Part-CAMO Section B
21.B.220 Investigation Deleted to align with Part-CAMO Section B
21.B.220 Initial certification procedure New point aligned with Part-CAMO Section B
21.B.221 Oversight principles New point aligned with Part-CAMO Section B
21.B.222 Oversight programme New point aligned with Part-CAMO Section B
21.B.225 Findings and corrective actions Updated to include classification and requirements
for competent authority, previously in Section A
21.B.230 Issue of letter of agreement The content has been moved to 21.B.220, to be
consistent with Part-CAMO Section B
21.B.235 Continued surveillance The content has been moved to 21.B.221 and
21.B.222 to align with Part-CAMO Section B

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21.B.240 Amendment of a production organisation Deleted to align with Part-CAMO Section B

approval
21.B.240 Changes to a production organisation New point aligned with Part-CAMO Section B
approval
21.B.245 Suspension and revocation of a The requirement has been moved to 21.B.65
production organisation approval
21.B.260 Record-keeping The requirement has been moved to 21.B.55
SUBPART H — AIRWORTHINESS CERTIFICATES AND RESTRICTED CERTIFICATES OF AIRWORTHINESS
21.B.330 Suspension and revocation of a noise The requirement has been moved to 21.B.65
certificate
21.B.345 Record-keeping The requirement has been moved to 21.B.55
SUBPART I — NOISE CERTIFICATES
21.B.430 Suspension and revocation of a noise The requirement has been moved to 21.B.65
certificate
21.B.445 Record-keeping The requirement has been moved to 21.B.55
SUBPART J — DESIGN ORGANISATION APPROVAL
21.B.430 Initial certification procedure New point aligned with Part-CAMO Section B
21.B.431 Oversight principles New point aligned with Part-CAMO Section B
21.B.432 Oversight programme New point aligned with Part-CAMO Section B
21.B.433 Findings and corrective actions New point aligned with Part-CAMO Section B
21.B.435 Changes to a design organisation New point aligned with Part-CAMO Section B
approval
SUBPART P — PERMIT TO FLY
21.B.530 Revocation of permits to fly The requirement has been moved to 21.B.65
21.B.545 Record-keeping The requirement has been moved to 21.B.55

APPENDICES
Appendix VIII EASA Form 52 — Aircraft statement of conformity References updated
Appendix X EASA Form 55 — Production organisation approval certificate References updated
Appendix XI EASA Form 65 — Letter of agreement for production without References updated
production organisation approval

List of changes to Part 21 AMC & GM

GENERAL
GM1 Annex 1 Definitions New
GM1 21.1 Competent authority — Responsibility for implementation former GM 21.B.20
GM1 21.1(c) Competent authority — Permit to fly former GM 21.A.705
SECTION A — TECHNICAL REQUIREMENTS
Subpart A — General provisions
AMC1 21.A.3A(a)(1) Occurrence reporting — Collection, investigation and Amended to make it also
analysis of data related to flammability reduction means (FRM) reliability applicable to applicants for a
certificate

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AMC2 21.A.3A(a)(1) Occurrence reporting — Collection, investigation and Amended to make it also
analysis of data related to ETOPS significant occurrences applicable to applicants for a
certificate
GM1 21.A.3A(a) and 21.A.3A(b) Occurrence reporting — Collecting system The title has been amended
The system for collection, investigation and analysis of data
GM2 21.A.3A(b)(a) and (b) Occurrence reporting The reference in the title has
been amended
GM1 21.A.3A(a)(1) and (b)(1) Occurrence reporting — Mandatory and New to provide an overview of
voluntary occurrence reporting Regulation (EU) No 376/2014
GM1 21.A.3A(a)(1)(ii) and (b)(1)(i) Occurrence reporting — Internal safety New, based on
reporting scheme GM1 ORO.GEN.200(a)(3)
AMC1 21.A.3A(b)(2)(d) Occurrence reporting — Reporting to EASA The reference has been
amended and the text improved
AMC1 21.A.5 Record-keeping New, based on
AMC1 ORO.GEN.220(b)
GM1 21.A.5 Record-keeping New proposed by ASD TF3
AMC1 21.A.5(a) and 21.A.433(a) Record-keeping — Repair design former AMC 21.A.433(a) and
21.A.447
GM1 21.A.5(a) and (b) Record-keeping — Recording and archiving system Former GM 21.A.165(d) and (h),
adapted to cover also design
organisations
AMC1 21.A.5(e) Record-keeping — Record of personnel involved in design Former AMC 21.A.145(d)(2),
or production adapted to cover also design
organisations
GM1 21.A.9 Investigations — Arrangements Former GM 21.A.157,
improvement of text
SUBPART F — PRODUCTION WITHOUT PRODUCTION ORGANISATION APPROVAL
AMC1 21.A.122 Eligibility — Link between design and production References have been amended
AMC1 21.A.124 Application Text moved form from
AMC 21.B.120(c)(1)
GM 21.A.124(a) Application – Application form Deleted, its content has been
moved to AMC3 21.B.120(a)
AMC1 21.A.124A Alternative means of compliance New based on
AMC1 ORO.GEN.120(a)
GM No 1 to 21.A.125(b) Uncontrolled non-compliance with applicable design Deleted, its content has been
data moved to GM1 21.B.125(b)(1),
21.B.225(b)(1) and
21.B430(b)(1)
GM No 2 to 21.A.125(b) Examples of level one findings Deleted, its content has been
moved to GM1 21.B.125(b)
GM1 21.A.125B(a), 21.A.158(a) and 21.A.258(a) Findings — Causal analysis New, as proposed in NPA 2013-
01(C)
GM 21.A.126(b)(6) Production inspection system – Recording and record Deleted, its content has been
keeping moved to GM1 21.A.5 (a) and (b)

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SUBPART G — PRODUCTION ORGANISATION APPROVAL FOR PRODUCTS, PARTS AND APPLIANCES

GM 21.A.134 Application – Application form and manner Deleted, its content has been
moved to AMC1 21.A.134
AMC1 21.A.134 Application Former AMC21.B.220(c) and GM
21.A.134
AMC1 21.A.134A Alternative means of compliance New, based on
AMC1 ORO.GEN.120(a)
GM1 21.A.139(c) Production management system — Safety management New, based on
element GM2 ORO.GEN.200(a)(1)
AMC1 21.A.139(c) Production management system — Safety management New to define the acceptability
element of the SMS industry standard
AMC1 21.A.139(c)(1) Production management system — Safety policy & New, based on
objectives AMC1 ORO.GEN.200(a)(2)
GM1 21.A.139(c)(1) Production management system — Safety policy New, based on
GM1 ORO.GEN.200(a)(2)
AMC1 21.A.139(c)(2) Production management system — Safety New, based on
management element — Organisation and accountabilities AMC1 ORO.GEN.200(a)(1)
GM1 21.A.139(c)(2) Production management system — Safety management New, based on
element — Organisation and accountabilities AMC1 ORO.GEN.200(a)(1)
AMC1 21.A.139(c)(3) Production management system — Safety risk New, based on
management — Interfaces between organisations GM1 ORO.GEN.200(a)(3)
AMC1 21.A.139(c)(3) and (4) Production management system — Safety New, based on
management key processes AMC1 ORO.GEN.200(a)(3)

GM1 21.A.139(c)(4)(ii) Production management system — Management of New, as proposed in NPA 2013-
change 01(C)
AMC1 21.A.139(c)(4)(ii) Production management system — Management of New, as proposed in NPA 2013-
change 01(C)
AMC1 21.A.139(c)(5) Production management system — Safety New, based on
communication AMC1 ORO.GEN.200(a)(4)
GM1 21.A.139(c)(5) Production management system — Safety promotion New GM on safety promotion
AMC1 21.A.139(c)(5)(i) Production management system — Safety training New, dedicated to safety
training
GM1 21.A.139(c)(5)(i) Production management system — Safety training New, dedicated to safety
training
AMC1 GM no1 to 21.A.139(a)(d) Production management system — Quality Amended to be extended to the
system element production management system
AMC1 GM 21.A.139(d)(2)(b)(1) Production management system Quality References have been amended
System — Elements of the quality system
GM1 No2 21.A.139(d)(1)(a) Production management system — Conformity References have been amended
of supplied parts or appliances
AMC1 21.A.139(d)(2)(ii) (b)(1)(ii) Production management system — Vendor References have been amended
and subcontractor assessment, audit and control — Production Organisation

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Approval (POA) holder using documented arrangements with other parties

for assessment and surveillance of a supplier
AMC2 21.A.139(d)(2)(ii) (b)(1)(ii) Production management system — Vendor References have been amended;
and sub-contractor assessment, audit and control — Production the text in the note and the point
Organisation Approval (POA) holder using other party supplier certification on competent authority
approval have been moved to
GM1 21.A.139(d)(2)(ii)
GM1 21.A.139(d)(2)(ii) Production management system — Vendor and sub- The text has been derived from
contractor assessment, audit and control the note and the point on
competent authority approval in
AMC No2 to 21.A.139(b)(1)(ii)
AMC1 21.A.139(e) Production management system — Documentation New, based on
GM1 ORO.GEN.200(a)(5)
AMC1 21.A.139(f) Production management system — Independent New, based on
monitoring of compliance and adequacy AMC1 ORO.GEN.200(a)(6))
GM No 1 to 21.A.139(b)(2) Quality System – Independent quality assurance Deleted
function
GM1 No2 21.A.139(f)(b)(2) Production management system — Adequacy of References have been amended
procedures and monitoring function
GM1 21.A.143 Exposition - Production Organisation Exposition (POE) Amended to improve the text
AMC1 21.A.143(a)(1) Exposition New, to include the commitment
statement
AMC1 21.A.145(a) Resources Text derived from
GM 21.A.145(a)
GM1 21.A.145(a) Resources Approval Requirements Amended to move text
containing means of compliance
in AMC1 21.A.145(a)
GM1 21.A.145(b)(2) Approval requirements Resources — Airworthiness, Amended to improve the text
noise, fuel venting and exhaust emissions /production data procedures
AMC1 21.A.145(c)(1) Resources — Accountable manager New, based on CAMO.A.305 and
on GM 21.A.145(c)(1)
GM1 21.A.145(c)(1) Approval requirements Resources — Accountable Amended, some of the text has
manager been moved to
AMC1 21.A.145(c)(1)
AMC1 GM21.A.145(c)(2) Approval requirements Resources — Responsible Amended to improve the text
managers and include text based on
AMC1 ORO.GEN.200(a)(6)
AMC2 21.A.145(c)(2) Resources — Competency of personnel New, to define competency of
personnel
AMC1 21.A.145(d)(1) Approval requirements Resources — Certifying staff Amended to improve the text
AMC 21.A.145(d)(2) Approval requirements – Record of certifying staff Deleted, its content has been
moved to AMC1 21.A.5(e)
AMC1 21.A.145(d)(2)(3) Approval requirements Resources – Evidence of Amended to improve the text
authorisation

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AMC1 21.A.147 Changes to the production management system — New to include the text deleted
Application for variation of scope and terms of the POA from point 21.A.147 and the text
from AMC No1 to 21.B.240
GM1 21.A.147(a) Changes to the approved production management system Amended to improve the text
organisation — Significant changes
GM1 21.A.149 Transferability References have been amended
AMC1 21.A.153 Changes to the terms of approval — Application for a change References have been amended
to the terms of approval
GM 21.A.157 Investigations – Arrangements deleted
GM No 1 to 21.A.158(a) Uncontrolled non-compliance with applicable design Deleted, its content has been
data moved to GM1 21.B.125(b)(1),
21.B.225(b)(1) and
21.B430(b)(1)
GM No 2 to 21.A.158(a) Examples of level one findings Deleted, its content has been
moved to GM1 21.B.125(b)
GM 21.A.165(d) and (h) Obligations of the holder – Recording and archiving Deleted, its content has been
system moved to GM1 21.A.5(a) and (b))
GM1 21.A.125B(a), 21.A.158(a) and 21.A.258(a) Findings — Causal analysis New, as proposed in NPA 2013-
01(C)
SUBPART J — DESIGN ORGANISATION APPROVAL
GM1 21.A.239(c) Design management system — Safety management New, based on
element GM2 ORO.GEN.200(a)(1)
AMC1 21.A.239(c) Design management system — Safety management New to define acceptability of
element SMS industry standard
AMC1 21.A.239(c)(1) Design management system — Safety policy & New, based on
objectives AMC1 ORO.GEN.200(a)(2)
GM1 21.A.239(c)(1) Design management system — Safety policy New, based on
GM1 ORO.GEN.200(a)(2)
AMC1 21.A.239(c)(2) Design management system — Safety management New, based on
element — Organisation and accountabilities AMC1 ORO.GEN.200(a)(1)

GM1 21.A.239(c)(2) Design management system — Safety management New, based on

element — Organisation and accountabilities AMC1 ORO.GEN.200(a)(1)
AMC1 21.A.239(c)(3) and (4) Design management system — Safety New, based on
management key processes AMC1 ORO.GEN.200(a)(3)
AMC1 21.A.239(c)(3) Design management system — Safety risk management New, based on
— Interfaces between organisations GM1 ORO.GEN.200(a)(3)
AMC1 21.A.239(c)(4)(ii) Design management system — Management of New, as proposed in NPA 2013-
change 01(C)
GM1 21.A.239(c)(4)(ii) Design management system — Management of New, as proposed in NPA 2013-
change 01(C)

AMC1 21.A.239(c)(5) Design management system — Safety communication New, based on

AMC1 ORO.GEN.200(a)(4)

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GM1 21.A.239(c)(5) Design management system — Safety Promotion New GM on safety promotion
AMC1 21.A.239(c)(5)(i) Design management system — Safety training New, dedicated to safety
training
GM1 21.A.239(c)(5)(i) Design management system — Safety training New, dedicated to safety
training
GM1 21.A.239(d)(a) Design management system — Design assurance system Part of the text has been moved
element to AMC1 21.A.239(d)
AMC1 21.A.239(d) Design management system — Design assurance element Former GM1 21.A.239(d)
AMC2 GM21.A.239(d)(a) Design management system — Design assurance Change of title to reflect the
element system for minor changes to type design or minor repairs to content
products
AMC1 21.A.239(a)(3) Design assurance system – Independent system Deleted
monitoring
AMC1 21.A.239(d)(2)(b) Design management assurance system — References have been amended
Independent verification checking function of the demonstration of
compliance
GM1 21.A.239(d)(3)(c) Design management system — Design assurance References have been amended
element system
AMC1 21.A.239(e) Design management system — Documentation New, based on
GM1 ORO.GEN.200(a)(5)
AMC1 21.A.239(f) Design management system — Independent monitoring of New, based on
compliance and adequacy AMC1 ORO.GEN.200(a)(6))
AMC1 21.A.243(a) Data Handbook Amended to improve the text,
change references and include
the commitment statement
AMC2 21.A.243(a) Data Handbook — Model content of handbook for References have been amended
organisations designing minor changes to type design or minor repairs to
products
AMC1 21.A.243(d) Handbook — Statement of qualifications and experience Text from GM No 1 to
21.A.243(d)
GM1 21.A.243(d) Handbook — Statement of qualifications and experience Amended to update references,
to include safety functions, and
to delete means of compliance
and move them to
AMC1 21.A.243(d)
AMC2 21.A.243(d) Handbook Data requirements — Statement of the Amended to improve the text
qualification and experience – Organisations designing minor changes to type
design or minor repairs to products
AMC GM No1 21.A.245 Resources Requirements for approval Amended to improve the text
and update references
AMC GM No 2 21.A.245 Resources Requirements for approval — Amended to improve the text
Organisations designing minor changes to type design or minor repairs to
products

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AMC1 21.A.245(a) Resources — Head of the design organisation New, based on CAMO.A.305 and
on GM 21.A.145(c)(1)
AMC1 21.A.245(b) Resources — Responsible managers New text based on
AMC1 ORO.GEN.200(a)(6) and
AMC1 21.A.145(c)(2)
AMC2 21.A.245(b) Resources — Competency of personnel New, to define competency of
personnel
AMC1 21.A.247 Changes to the design management system — Application New, text derived from the
for a significant change or a variation of scope and terms of the DOA deleted point 21.A.247
GM1 21.A.247 Changes to in the design management assurance system Amended to improve the text
GM 21.A.257(a) Investigations Deleted, its content has been
moved to GM1 21.A.9
GM1 21.A.125B(a), 21.A.158(a) and 21.A.258(a) Findings — Causal analysis New, as proposed in NPA 2013-
01(C)
SUBPART M — REPAIRS

AMC1 AMC 21.A.433(a) and 21.A.447 Repair design and record keeping Deleted, its content has been
moved to AMC1 21.A.5(a) and
21.A.433(a)
SUBPART P — PERMIT TO FLY
GM 21.A.705 Competent authority Deleted, its content has been
moved to GM1 21.1(c)
SECTION B PROCEDURES FOR COMPETENT AUTHORITIES
SUBPART A — GENERAL
GM 21.B.20 Responsibility for implementation Deleted, its content has been
moved to 21.1(a)(2) and (3)
AMC1 21.B.25 Management system — General New, based on
AMC1 ARO.GEN.120(e)
AMC2 GM21.B.25 Organisation Management System — General Amended to improve the text
GM 21.B.25(b)– Resources deleted
GM 21.B.25(c) Qualification and training deleted
AMC1 21.B.25(a)(1) Management system — Documented procedures former AMC 21.B.30(a)
GM1 21.B.25(a)(2) Management system — Personnel New, based on
GM1 ARO.GEN.200(a)(2)
AMC1 21.B.25(a)(3) Management system — Qualification and training — New, based on
General AMC1 ARO.GEN.200(a)(2)
AMC2 21.B.25(a)(3) Management system — Qualification and training — New, based on the current
Technical personnel including inspectors AMC 145.B.10(3)
AMC3 21.B.25(a)(3) Management system — Initial and recurrent training — New, based on
Inspectors AMC2 ARO.GEN.200(a)(2)
AMC1 21.B.25(a)(5) Management system — Safety risk management process New AMC on safety risk
management as part of the
management system framework
for competent authorities

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GM1 21.B.25(a)(5) Management system — Safety risk management process New GM on the same subject
AMC1 21.B.25(d) Management system — Procedures available to EASA New AMC based on
AMC1 ARO.GEN.200(d)
AMC 21.B.30(a) Documented procedures Deleted, its content has been
moved to AMC1 21.B.25(a)(1)
GM1 21.B.30 Allocation of tasks to qualified entities — Certification tasks New, based on
GM1 ARO.GEN.205
AMC 21.B.35(a) Changes deleted
GM No 1 to 21.B.45 Co-ordination with other related activities deleted
GM No 2 to 21.B.45 Co-ordination deleted
GM No 3 to 21.B.45 Reporting – Information relevant to registers established deleted
by the Agency
AMC1 21.B.55(a) Record-keeping — General New, based on
AMC1 ARO.GEN.220(a)
AMC1 21.B.55(a)(1) Record-keeping — Competent authority management New, based on
system AMC1 ARO.GEN.220(a)(1);(2);(3)
GM1 21.B.55 Record-keeping — Design approvals transferred to the Agency References have been amended
GM1 21.B.55(e) Record-keeping — Traceability of release certificates former GM 21.B.150(d)
AMC1 21.B.65 Suspension, limitation and revocation — Corrective action former AMC 21.B.245
plan
AMC1 21.B.65(c) Suspension, limitation and revocation — Information on New AMC, as proposed in NPA
security situation 2013-01(C)
GM1 21.B.65 Suspension, limitation and revocation former GM 21.B.245
SUBPART F — PRODUCTION WITHOUT PRODUCTION ORGANISATION APPROVAL
GM1 21.B.115 and 21.B.215 Alternative means of compliance New, based on
GM1 ARO.GEN.120
AMC1 21.B.115(d) and 21.B.215(d) Alternative means of compliance — New, based on
Demonstration of compliance AMC1 ARO.GEN.120(e)
AMC1 21.B.120(a) Initial certification procedure — Investigation team New, based on the curent
21.B.120
AMC2 21.B.120(a) Initial certification procedure — Investigation team Amended to improve the text
Qualification criteria for the investigation team members
AMC3 21.B.120(a)(c)(1) Initial certification procedure — Evaluation of Amended to improve the text
applications and remove Form 60 that has
been moved to AMC1 21.A.124
AMC4 GM 21.B.120(a)(c)(3) Initial certification procedure — Investigation Amended to improve the text
preparation and planning and update references
GM1 21.B.120(c) Initial certification procedure — Auditing and investigation The title has been updated
findings
AMC1 21.B.120(d) Initial certification procedure — Issue of the letter of Former AMC 21.B.130 and
agreement GM 21.B.130(b)
GM1 21.B.125(a) 21.B.125(b), 21.B.225(b) and 21.B430(b) Findings and former GM 21.B.125(a)
corrective actions — Objective evidence

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GM1 21.B.125(b) Findings and corrective actions — Examples of level 1 Former GM No 2 to 21.A.125B(a)
findings
GM1 21.B.125(b)(1) and 21.B.225(b)(1) Findings and corrective actions — Former GM No1 to 21.A.125B(a)
Uncontrolled non-compliance with applicable design data
AMC1 21.B.125(d) Findings and corrective actions — Notification of findings New, based on AMC 21.B.225(a)
AMC 21.B.130 Issue of the letter of agreement Deleted, its content has been
oved to AMC1 21.B.120(d)
GM 21.B.130(b) Issue of the letter of agreement Deleted, its content has been
oved to AMC1 21.B.120(d)
AMC1 21.B.140 Amendment of a letter of agreement The text has been improved and
references have been amended
GM 21.B.150(d) Record keeping – Traceability of release certificates Deleted, its content has been
oved to GM1 21.B.55(e)
SUBPART G — PRODUCTION ORGANISATION APPROVAL
GM1 21.B.115 and 21.B.215 Alternative means of compliance New, based on
GM1 ARO.GEN.120
AMC1 21.B.115(d) and 21.B.215(d) Alternative means of compliance — New, based on
Demonstration of compliance AMC1 ARO.GEN.120(e)
AMC1 21.B.220 and 21.B.430 Initial certification procedure — Verification of New, based on
compliance AMC1 ARO.GEN.310(a)
AMC1 GM No 1 to 21.B.220(c) Procedures for investigation Initial Amended to improve the text
certification procedure — Investigation preparation and planning
AMC1 21.B.220 and 21.B.221 Initial certification procedure — Investigation New text, based on 21.B.220
team
AMC1GM 21.B.220(a) Initial certification procedure — Investigation team Amended to improve the text
AMC 21.B.220(c) Procedures for investigation – Evaluation of applications Deleted, its content has been
oved to AMC1 21.A.134
GM1 No 2 to 21.B.220(c) Initial certification procedure — Organisation Amended to improve the text
approval Procedures for investigation — General and update references
GM2 No 3 to 21.B.220(c) Initial certification procedure — Procedures for Amended to update references
investigation – POA applications Application received from organisations
with facilities/partners/suppliers/subcontractors located in a third country
GM3 No 4 to 21.B.220(c) Initial certification procedure Procedures for Amended to update references
investigation — Competent authority surveillance of suppliers of a POA
holder located in other Member States
AMC1 21.B.220(d)(1) Initial certification procedure — Issuance of the former AMC No1 to 21.B.230
certificate
AMC1 21.B.221(a), (b) and (c) Oversight principles — Management system New, based on
assessment GM1 ARO.GEN.300(a);(b);(c)
AMC1 21.B.222 and 21.B.432 Oversight programme — Annual review New, as proposed in NPA 2013-
01(C)
GM1 21.B.222(a) Oversight programme — Maintenance of the POA — Work former GM 21.B.235(b)
allocation within the competent authority

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AMC1 21.B.222(b) and 21.B.432(b) Oversight programme — Specific nature New, based on
and complexity of the organisation — results of past oversight AMC1 ARO.GEN.305(b);(d);(d1)
AMC2 21.B.222(b) and 21.B.432(b) Oversight programme — Subcontracted New AMC added for determine
activities the need for oversight for
subcontracted organisations
GM1 21.B.222(b) Oversight programme former GM 21.B.235(b) and (c)
AMC1 21.B.222(b)(1) Oversight programme — Audit New, based on
AMC1 ARO.GEN.305(b)(1)
GM1 21.B.222(b)(1)(ii) Oversight programme — Guide to the conduct of Former GM 21.B.235(a)(4)
monitoring production standards
AMC1 21.B.222(c) Oversight programme — Oversight planning cycle audit New, based on
and inspection AMC1 ARO.GEN.305(c)
AMC1 21.B.222(c) and 21.B.432(c) Oversight programme — Oversight New, based on
planning cycle — Audit AMC1 ARO.GEN.305(c)
AMC1 21.B.222(d) Oversight programme — Extension of the oversight New, as proposed in NPA 2013-
planning cycle beyond 24 months 01(C)
GM1 21.B.125(a) 21.B.125(b), 21.B.225(b) and 21.B430(b) Findings and former GM 21.B.125(a)
corrective actions — Objective evidence
AMC1 21.B.225(d)(a) Findings and corrective actions — Notification of Amended to improve the text
findings
GM1 21.B.125(b)(1) and 21.B.225(b)(1) Findings and corrective actions — Former GM No1 to 21.A.125B(a)
Uncontrolled non-compliance with applicable design data
AMC No 1 to 21.B.230 Issue of the certificate Deleted, its content has been
moved to AMC1 21.B.220(d)(1)
GM 21.B.235(a)(4) Guide to the conduct of monitoring production standards. Deleted, its content has been
moved to GM1 21.B.222(b)(1)(ii)
GM 21.B.235(b) Maintenance of the POA - Work allocation within the Deleted, its content has been
competent authority moved to GM1 21.B.222(a)
GM 21.B.235(b) and (c) Continued surveillance Deleted, its content has been
moved to GM1 21.B.222(b)
AMC 21.B.235(c) Continuation of POA Deleted, its content has been
moved to AMC1 21.B.222(b)(1)
and 21.B.432(b)(1)
AMC1 No 1 to 21.B.240 Changes to a production organisation approval — Amended, based on
Application for significant changes or a variation of scope and terms of the AMC1 ARO.GEN.33 and removal
POA of Form 51 that has been moved
to AMC1 21.A.147
GM 21.B.245 Continued validity Deleted, its content has been
moved to GM1 21.B.65
AMC 21.B.245 Corrective action plan Deleted, its content has been
moved to AMC1 21.B.65
SUBPART J — DESIGN ORGANISATION APPROVAL

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AMC1 21.B.220 and 21.B.430 Initial certification procedure — Verification of New, based on
compliance AMC1 ARO.GEN.310(a)

AMC1 21.B.430 and 21.B.431 Initial certification procedure — Investigation New, based on AMC1 21.B.220
team and 21.B.221

AMC1 21.B.430(a) Initial certification procedure — Organisation approval New, based on

team AMC1 21.B.220(a)
AMC1 21.B.430(d)(1) Initial certification procedure — Issuance of the New based on
certificate AMC1 21.B.220(d)(1)
AMC1 21.B.431(a), (b) and (c) Oversight principles — Management system New, based on
assessment GM1 ARO.GEN.300(a);(b);(c)
AMC1 21.B.222 and 21.B.432 Oversight programme — Annual review New, as proposed in NPA 2013-
01(C)
AMC1 21.B.222(b) and 21.B.432(b) Oversight programme — Specific nature New, based on
and complexity of the organisation — results of past oversight AMC1 ARO.GEN.305(b);(d);(d1)
AMC2 21.B.222(b) and 21.B.432(b) Oversight programme — Subcontracted New AMC, added for determine
activities the need for oversight for
subcontracted organisations
AMC1 21.B.432(b)(1) Oversight programme — Audit New, based on
AMC1 ARO.GEN.305(b)(1)
AMC1 21.B.432(c) Oversight programme — Oversight planning cycle audit New, based on
and inspection AMC1 ARO.GEN.305(c)
AMC1 21.B.222(c) and 21.B.432(c) Oversight programme — Oversight New, based on
planning cycle — Audit AMC1 ARO.GEN.305(c)
AMC1 21.B.432(d) Oversight programme — Extension of the oversight New, as proposed in NPA 2013-
planning cycle beyond 24 months 01(C)
GM1 21.B.125(b), 21.B.225(b) and 21.B4.30(b) Findings and corrective former GM 21.B.125(a)
actions — Objective evidence

AMC1 21.B.433(d) Findings and corrective actions — Notification of findings New, based on AMC1
21.B.225(d) Findings and
corrective actions - Notification
of findings
AMC1 21.B.435 Changes to a design organisation approval — Application for New, based on on
significant changes or A variation of scope and terms of the DOA AMC1 ARO.GEN.33

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7.2. Appendix II — Detailed summary of changes for Part-145

NPA 2019-05 (C) includes the draft implementing rules (IRs) as well the draft Acceptable Means of
Compliance (AMC) and Guidance Material (GM) for Part-145. The following text is just a summary of
the SMS-related changes to Part-145.
General changes to Part-145 text (IR/AMC/GM Section A and Section B):
— All references to a ‘quality system’ are replaced by a ‘management system’ or ‘compliance
monitoring’ (depending on the context).
— All references to ‘continuation training’ are replaced by ‘recurrent training’.
— All references to a ‘surveyor’ are replaced by ‘inspector’.
— All references to personnel ‘competence’ are replaced by ‘competency’.
— All references to personnel ‘human factors training’ are replaced by ‘safety training’.
— General linguistic improvement.
— All references to ‘approval schedule’ are replaced by ‘terms of approval’. Several changes were
made to clarify the use of the terms ‘approval’ (in the sense of approval process) and ‘certificate’
(in the sense of the output of an approval process).
— References to Regulation (EC) No 216/2008 have been changed to Regulation (EU) 2018/1139.
— References to ‘indirect approval’ are adapted, where applicable, to the concept of ‘change not
requiring prior approval’ (see 145.A.85).
— References to Flight Engineer (FE) licences are deleted, as these are no longer foreseen in
Part-FCL (Commission Regulation (EU) No 1178/2011). The existing authorisation is to be
‘grandfathered’ through the amendment of Article 4.
— References to EASA Form 4 are deleted, as also discussed for Part-CAMO, and this is for all cases
(nominated post holders, safety manager, compliance monitoring manager). The relevant
points are amended to define the acceptance process through oversight and formal acceptance
through approving the exposition.
— When the content of existing AMC or GM is amended or for new AMC or GM, the title of the
AMC or GM takes a sequential number (e.g. AMC1, GM2, etc.).
— Remark: at the AMC & GM level, similarly to the approach taken for Part-CAMO and explained
in Opinion No 06/2016, no distinction will be made between complex and non-complex
organisations, and a single set of AMC & GM will be applicable to all Part-145 organisations.
List of changes to the Cover Regulation
COVER REGULATION
Article 4 New paragraph 9 to ensure that any existing
certification authorisation issued on the basis of a
flight engineer licence continues to remain valid.
New paragraph 10 for the adaptation of the
organisation with the management system
List of changes to Part-145 IR*

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* For Section B, because it is replaced by a new content aligned with Part-CAMO, the deleted rule
points are not listed. For Section A, to give a complete picture, also the unchanged points are
indicated.
Numbering convention:
Section A: any existing/amended point keeps the current numbering; any ‘new’ point takes the CAMO
numbering.
Section B: full alignment with the Part-CAMO numbering

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Part-145 reference Action

Change of the title in harmonisation with CAMO.A.105;
consideration of new Basic Regulation Article 65 on
reallocation of competent authority responsibility to EASA
145.1 General Competent authority upon request of organisations operating in more than one
Member State; consideration of new Basic Regulation Article
64 on reallocation of responsibility upon request of Member
States
SECTION A — TECHNICAL AND ORGANISATION REQUIREMENTS
145.A.10 Scope Alignment with CAMO.A.005 (Scope)
145.A.15 Application for an organisation Alignment with CAMO.A.115 (Application for an organisation
certificate certificate)
Alignment with part of CAMO.A.125 (Terms of approval and
145.A.20 Terms of approval
privileges of the organisation)
145.A.25 Facility requirements No change
Alignment of with CAMO.A.305 (Personnel requirements) for
the accountable manager and nominated persons
145.A.30 Personnel requirements
The reference to flight engineer has been deleted in (j); the
reference to 145.A.37 has been introduced in (k)
See ‘General changes’; point (j) is moved to 145.A.55 (Record-
145.A.35 Certifying staff and support staff
keeping)
145.A.36 Records of airworthiness review Deleted, its content has been moved to 145.A.55 (Record-
staff keeping)
New, based on CAO.A.045 (Airworthiness review staff)
145.A.37 Airworthiness review staff
(Opinion No 05/2016)
145.A.40 Equipment and tools No change
145.A.42 Components No change
see ‘General changes’; the reference to 145.A.202 has been
145.A.45 Maintenance data introduced in (c); the reference to HF has been introduced in
(e)
Points (b) and (d) have been amended to introduce the risks
145.A.47 Production planning related to (respectively) personnel fatigue and external
working teams
Alignment with M.A.201(c) and 145.A.80; adaptation to
145.A.48 Performance of maintenance
management system
145.A.50 Certification of maintenance Alignment with M.A.801 as amended by Opinion No 05/2016
Alignment with CAMO.A.220 (Record-keeping), former
145.A.55 Maintenance and airworthiness
145.A.35(j) and 145.A.36; alignment with ML.A.904(d)
review records Record-keeping
(Opinion No 05/2016) for airworthiness review records;
Alignment with CAMO.A.160; elements of internal reporting
145.A.60 Occurrence reporting
to be covered by 145.A.202
Delete ‘safety/quality’ elements (see 145.A.200); keep
145.A.65 Safety and quality policy,
145.A.65(b) with minor alignment to CAMO.A.315(e)
Maintenance procedures and quality system
(Continuing airworthiness management)

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Clarification on the MOE objective; certain alignment with

145.A.70 Maintenance organisation
CAMO.A.300 (CAME); deletion of ‘where applicable’ when not
exposition (MOE)
referring to a given implementing rule requirement
Simplification of (b) to prevent the interpretation that
subcontracting maintenance to approved organisation is
145.A.75 Privileges of the organisation prohibited; the limitation of airworthiness review privilege
inside the Member States has been added (see
CAMO.A.125(e))
145.A.80 Limitations on the organisation Deleted, its content has been moved to 145.A.48
145.A.85 Changes to the organisation Alignment with CAMO.A.130 (Changes to the organisation)
145.A.90 Continued validity Alignment with CAMO.A.135 (Continued validity)
145.A.95 Findings Alignment with CAMO.A.150 (Findings)
145.A.120 Means of compliance Alignment with CAMO.A.120 (Means of compliance)
145.A.140 Access Alignment with CAMO.A.140 (Access)
145.A.155 Immediate reaction to a safety Alignment with CAMO.A.155 (Immediate reaction to a safety
problem problem)
145.A.200 Management system Alignment with CAMO.A.200 (Management system)
Alignment with CAMO.A.202 (Internal safety reporting
145.A.202 Internal safety reporting scheme
scheme)
Based on CAMO.A.205 (Contracting and subcontracting) and
145.A.205 Contracting and subcontracting ORO.GEN.205 (contracted activities) for purchased
equipment or services

SECTION B — AUTHORITY REQUIREMENTS PROCEDURES FOR COMPETENT AUTHORITIES

145.B.005 Scope New/aligned with Part-CAMO Section B
145.B.115 Oversight documentation New/aligned with Part-CAMO Section B
New/aligned with Part-CAMO Section B with a minor
145.B.120 Means of compliance
clarification in point (a)
145.B.125 Information to EASA New/aligned with Part-CAMO Section B
145.B.135 Immediate reaction to a safety New/aligned with Part-CAMO Section B
problem
New/aligned with Part-CAMO Section B with a minor
145.B.200 Management system
difference in point (d)
New/aligned with Part-CAMO Section B with a minor change
145.B.205 Allocation of tasks to qualified
in point (a) to remove the reference to the Member State,
entities
because the regulated entity is the Competent Authority.
145.B.210 Changes in the management New/aligned with Part-CAMO Section B
system
145.B.220 Record-keeping New/aligned with Part-CAMO Section B
New/aligned with Part-CAMO Section B with a minor
145.B.300 Oversight principles
improvement in points (d) and (e)
145.B.305 Oversight programme New/aligned with Part-CAMO Section B

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New/aligned with Part-CAMO Section B with a minor

145.B.310 Initial certification procedure
clarification in point (b)
New/aligned with Part-CAMO Section B with a clarification in
145.B.330 Changes — organisations
point (e)
145.B.350 Findings and corrective actions New/aligned with Part-CAMO Section B
145.B.355 Suspension, limitation, and New/aligned with Part-CAMO Section B
revocation

APPENDICES TO PART-145
Appendix I — Authorised Release Certificate — EASA
No change
Form 1
Appendix II — Class and Rratings Ssystem used for the Incorporate the content from Appendix IV to Part-M;
Aapproval of Mmaintenance Oorganisations referred adapt indirect approval of capability list with the
to in Annex I (Part-M) Subpart F and Annex II (Part-145) approach of change not requiring prior approval
Appendix III — Maintenance Oorganisation certificate Alignment with Appendix I to Part-CAMO
Approval referred to in Annex II (Part-145) — EASA (Certificate); Change related to the airworthiness
Form 3-145 review privilege (modified by Opinion No 06/2016)
Appendix IV — Conditions for the use of staff not
qualified in accordance with Annex III (Part-66) No change
referred to in points 145.A.30(j)1 and 2

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7. Appendices

List of changes to Part-145 AMC & GM*

*For Section A, only AMC & GM affected by this RMT are listed. For Section B, because it is
replaced by a new content aligned with Part-CAMO, the deleted AMC & GM are not listed.

GENERAL
GM1 to Annex II (Part-145) Definitions New
SECTION A — TECHNICAL AND ORGANISATION REQUIREMENTS
AMC1 145.A.10 Scope Minor adaptation to management system
GM1 145.A.10 Scope Adaptation to management system; clarification that the
external organisation performing the independent audit is
subcontracted.
AMC1 145.A.15 Application for an organisation Alignment with AMC M.A.702 (to become AMC1 CAMO.A.115)
certificate
AMC2 145.A.15 Application for an organisation New; information on ‘pre-audit’
certificate
GM1 145.A.15(b) Application for an organisation New; the purpose is to explain that the ‘shall’ in 145.A.15(b)
certificate does not mean that ‘changes not requiring prior approval’
(145.A.85(c)) is a privilege and can be used from the start of
operation
AMC1 145.A.25(a) Facility requirements New point (5), introduced to clarify that, considering a risk
assessment, flexibility is allowed for certain base maintenance
tasks to be carried in facility other than a hangar enclosing the
whole aircraft (EM.TEC input).
AMC1 145.A.30(a) Personnel requirements Alignment with AMC M.A.706(a) (to become
AMC1 CAMO.A.305(a))
AMC1 145.A.30(b) Personnel requirements Partial alignment with AMC M.A.706 (to become
AMC1 CAMO.A.305(a)(3)) and adaptation to management
system; quality and safety manager are not subject of this AMC
GM1 145.A.30(b) Personnel requirements New; explanation of the purpose of ‘ensuring compliance’ (as
opposed to ‘monitoring compliance’)
AMC1 145.A.30(c) Personnel requirements Adaptation to management system
AMC1 145.A.30(c);(ca) Personnel requirements New AMC for the safety management and compliance
monitoring function (based on AMC1 ORO.GEN.200(a)(1) and
AMC1 ORO.GEN.200(a)(6))
GM1 145.A.30(ca) Personnel requirements New GM for the safety manager, based on
GM1 ORO.GEN.200(a)(1)
AMC1 145.A.30(cc) Personnel requirements New AMC for nominated persons, based on AMC M.A.706 (to
become AMC1 CAMO.A.305(c))
AMC1 145.A.30(d) Personnel requirements Adaptation to management system
AMC1 145.A.30(e) Personnel requirements Adaptation to management system
AMC2 145.A.30(e) Personnel requirements Adaptation to management system and change from HF
training to safety training
AMC3 145.A.30(e) Personnel requirements Simplification and update of reference

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AMC4 145.A.30(e) Personnel requirements Simplification and ‘general change’

AMC5 145.A.30(e) Personnel requirements New AMC, based on the current GM2 145.A.30(e),
AMC M.A.706(k) (to become AMC3 CAMO.A.305(g)) and
AMC M.A.607
GM1 145.A.30(e) Personnel requirements Adaptation to management system as safety training
GM2 145.A.30(e) Personnel requirements Elements moved to new AMC5 145.A.30(e); Adaptation to
management system and safety training
GM3 145.A.30(e) Personnel requirements Adaptation to management system
GM4 145.A.30(e) Personnel requirements New GM, based on EHFAG (former HF CAG) inputs
GM5 145.A.30(e) Personnel requirements New GM, based on HF CAG inputs
GM6 145.A.30(e) Personnel requirements New GM, added to clarify the scope of safety training
depending on the complexity of the organisation.
AMC1 145.A.30(f) Personnel requirements See ‘general changes’
AMC1 145.A.30(h) Personnel requirements See ‘general changes’
AMC1 145.A.30(j)(4) Personnel requirements Deletion of the point relevant to flight engineer which no
longer exists under Part-FCL.
GM 145.A.30(j)(4) Personnel requirements (Flight Deleted because it is relevant to flight engineer which no
crew) longer exist under Part-FCL.
AMC1 145.A.30(j)(5) Personnel requirements Adaptation to management system
AMC1 145.A.30(j)(5)(i) Personnel requirements Adaptation to management system
AMC1 145.A.30(j)(5)(ii) Personnel requirements Adaptation to management system
AMC1 145.A.35(a) Certifying staff and support See ‘general changes’ and update of reference
staff
AMC1 145.A.35(d) Certifying staff and support See ‘general changes’ and adaptation to management system
staff
AMC1 145.A.35(e) Certifying staff and support See ‘general changes’ and update of reference
staff
AMC1 145.A.35(f) Certifying staff and support See ‘general changes’ and update of reference
staff
AMC1 145.A.45(c) Maintenance data Use of internal safety reporting scheme (145.A.202)
AMC1 145.A.45(d) Maintenance data Adaptation to management system
AMC1 145.A.45(e) Maintenance data New point linked to the risk when using a work card system
provided by the operator/CAMO
AMC1 145.A.47(b) Production planning New AMC related to fatigue risk management
AMC GM1 145.A.47(b) Production planning AMC changed to GM and expanded with fatigue information
GM1 145.A.47(d) Production planning New GM to explain the meaning of ‘external working teams’
AMC1 145.A.48(a) AMC 145.A.80 Limitations on Provision extended to component maintenance organisation;
the organisation Performance of maintenance see also ‘general changes’
AMC1 145.A.48(c)(2) AMC1 145.A.48(b) Reference of the AMC amended to reflect the revised
Performance of maintenance implementing rule
AMC2 145.A.48(c)(2) AMC2 145.A.48(b) Reference of the AMC amended; clarification provided on the
Performance of maintenance source used for critical task identification

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AMC3 145.A.48(c)(2) AMC3 145.A.48(b) Reference of the AMC amended

Performance of maintenance
AMC4 145.A.48(c)(2) AMC4 145.A.48(b) Reference of the AMC amended
Performance of maintenance
AMC1 145.A.48(c)(3) Performance of Amended references
maintenance
GM1 145.A.48(c)(3) Performance of maintenance Amended references; correct the term ‘duplicate’ by
‘independent’
GM1 145.A.48(c)(4) GM 145.A.48(d) Performance Amended references
of maintenance — critical design configuration
control limitations (CDCCL)
GM1 AMC 145.A.50(a) Certification of AMC changed into GM; clarification of the responsibilities
maintenance linked to the issue of a CRS
AMC1 145.A.50(b) Certification of maintenance Alignment with ICAO Annex 6, Part I, Paragraph 8.8.
AMC1 145.A.50(e) Certification of maintenance Change relevant to the convention for referencing the rule
AMC1 145.A.55 Record-keeping New AMC; alignment with AMC1 ORO.GEN.220(b)
GM1 145.A.55 Record-keeping New GM; alignment with GM1 ORO.GEN.220(b)
GM1 145.A.55(a)(1) Record-keeping Maintenance Amended to limit to ‘maintenance records’; general points 4.,
and airworthiness review records 5. and 6. covered by AMC1 145.A.55
AMC1 145.A.55(a)(3) AMC 145.A.55(c) Record- Amended reference and title
keeping Maintenance and airworthiness review
records
AMC1 145.A.55(d) AMC 145.A.35(j) Certifying Amended to limit to certifying staff and support staff records;
staff and support staff Record-keeping See ‘general changes’
AMC2 145.A.55(d) AMC 145.A.36 Record-keeping AMC 145.A.36 relocated under 145.A.55(d)
Records of airworthiness review staff
AMC 145.A.60(b) Occurrence reporting Deleted; intent covered by the new AMC1 145.A.202
AMC 145.A.65(a) Safety and quality policy, Deleted; covered by AMC1 145.A.200(a)(2)
maintenance procedures and quality system
AMC1 145.A.65(b) Safety and quality policy, Amended reference and use of internal safety reporting
mMaintenance procedures and quality system scheme (145.A.202)
GM1 145.A.65 Maintenance procedures New GM added to provide guidance on the design and
presentation of technical procedures in line with human
factors principles.
GM2 145.A.65(b)(1) Safety and quality policy, Amended references
mMaintenance procedures and quality system
AMC1 145.A.65(b)(2) Safety and quality policy, Amended references
mMaintenance procedures and quality system
AMC1 145.A.70(a) Maintenance organisation Amended to reflect the change to the implementing rule and
exposition (MOE) adaptation to management system
GM1 145.A.70(a) Maintenance organisation Same as above ; point 9 transferred to new
exposition (MOE) AMC1 145.A.70(a)(1)

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AMC1 145.A.70(a)(1) Maintenance organisation New AMC, based on point 9 of GM 145.A.70(a); the text of the
exposition (MOE) accountable manager statement is simplified.
AMC1 145.A.75(b) Privileges of the organisation See ‘general changes’ and adaptation to management system
and change to 145.A.75; note in paragraph 1 on the FAR
Part 145 deleted, because relevant to foreign regulation.
GM1 145.A.75(b) Privileges of the organisation New GM to clarify that it is not prohibited to subcontract
certain activities to an approved organisation. The rule does
neither foresee an AMO to work solely as subcontractor (they
should exercise their privilege).
AMC1 145.A.85 Changes to the organisation New AMC; alignment with AMC1 ORO.GEN.130
AMC2 145.A.85 Changes to the organisation New AMC, based on AMC1 ORO.GEN.130(b)
GM1 145.A.85 Changes to the organisation New GM to clarify that 145.A.85 is also applicable to MOE
changes
GM1 145.A.85(a)(1) Changes to the organisation New GM to provide example for changes that may affect the
scope of the certificate or the terms of approval
GM2 145.A.85(a)(1) Changes to the organisation New GM; alignment with GM2 ORO.GEN.130(a)
GM1 145.A.85(b) Changes to the organisation New GM in the spirit of GM1 ORO.GEN.130(b)
GM1 145.A.85(c) Changes to the organisation New GM clarifying the intent of ‘changes not requiring prior
approval’
AMC1 145.A.95 Findings New AMC, based on AMC1 ORO.GEN.150(b)
GM1 145.A.95 Findings New GM, as proposed in NPA 2013-01(C), also to be used for
compliance monitoring (145.A.200(a)(6))
AMC1 145.A.120 Means of compliance New GM, based on AMC1 ORO.GEN.120(a)
GM1 145.A.200 Management system New GM explaining the management system concept
AMC1 145.A.200(a)(1) Management system New AMC, based on AMC1 ORO.GEN.200(a)(1)
GM1 145.A.200(a)(1) Management system New GM, based on GM2 ORO.GEN.200(a)(1)
GM2 145.A.200(a)(1) Management system New GM, aligned with GM3 ORO.GEN.200(a)(1)
AMC1 145.A.200(a)(2) Management system New AMC, based on AMC1 ORO.GEN.200(a)(2)
GM1 145.A.200(a)(2) Management system New GM, based on GM1 ORO.GEN.200(a)(2) and extended to
safety culture and just culture
AMC1 145.A.200(a)(3) Management system New AMC, based on AMC1 ORO.GEN.200(a)(3)
GM1 145.A.200(a)(3) Management system New GM, based on GM4 ORO.GEN.200(a)(3)
GM2 145.A.200(a)(3) Management system New GM, as proposed in NPA 2013-01(C)
AMC1 145.A.200(a)(4) Management system New AMC, based on AMC1 ORO.GEN.200(a)(4)
GM1 145.A.200(a)(4) Management system New GM on safety promotion
GM1 145.A.200(a)(5) Management system New GM, based on GM1 ORO.GEN.200(a)(5)
AMC1 145.A.200(a)(6) Management system New AMC, based on AMC 145.A.65(c)(1) point 1
AMC2 145.A.200(a)(6) AMC 145.A.65(c)(1) Safety AMC based on AMC 145.A.65(c)(1) points 2. to 11.
and quality policy, maintenance procedures and
quality system Management system
AMC3 145.A.200(a)(6) Management system New AMC, based on GM1 ORO.GEN.200(a)(6)

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AMC4 145.A.200(a)(6) AMC 145.A.65(c)(2) Safety AMC based on AMC 145.A.65(c)(2)

and quality policy, maintenance procedures and
quality system Management system
GM1 145.A.200(a)(6) Management system New GM to clarify that the compliance monitoring function
itself needs to be monitored for compliance.
GM2 145.A.200(a)(6) GM 145.A.65(c)(1) Safety GM based on GM 145.A.65(c)(1), but extensively revised to
and quality policy, maintenance procedures and provide better guidance and an example on compliance
quality system Management system monitoring audit plan.
AMC1 145.A.202 Internal safety reporting scheme New AMC, based on NPA 2013-01(C)
GM1 145.A.202 Internal safety reporting scheme New GM, based on GM1 ORO.GEN.200(a)(3)
GM1 145.A.205 Contracting and subcontracting New GM, based on GM2 ORO.GEN.205 and extended to
address particular maintenance aspects
GM2 145.A.205 Contracting and subcontracting New GM to explain the difference between contracting and
subcontracting maintenance
SECTION B — AUTHORITY REQUIREMENTS PROCEDURE FOR COMPETENT AUTHORITIES
GM1 145.B.120 Means of compliance New GM, based on GM1 ARO.GEN.120
AMC1 145.B.120(e) Means of compliance New AMC, based on AMC1 ARO.GEN.120(e)
AMC1 145.B.200 Management system New AMC, based on current AMC 145.B.10(1)
AMC2 145.B.200 Management system New AMC, based on GM1 ARO.GEN.200(a)
AMC1 145.B.200(a)(1) Management system New AMC, aligned with AMC1 ARO.GEN.200(a)(1)
GM1 145.B.200(a)(2) Management system New GM, based on GM1 ARO.GEN.200(a)(2)
AMC1 145.B.200(a)(3) Management system New AMC, based on AMC1 ARO.GEN.200(a)(2)
AMC2 145.B.200(a)(3) Management system New AMC, based on the current AMC 145.B.10(3)
AMC3 145.B.200(a)(3) Management system New AMC, based on AMC2 ARO.GEN.200(a)(2)
AMC1 145.B.200(a)(5) Management system New AMC on safety risk management as part of the
management system framework for competent authorities
GM1 145.B.200(a)(5) Management system New GM on the same subject
AMC1 145.B.200(d) Management system New AMC, based on AMC1 ARO.GEN.200(d)
GM1 145.B.205 Allocation of tasks to qualified New GM, based on GM1 ARO.GEN.205
entities
AMC1 145.B.220(a) Record-keeping AMC based on AMC1 ARO.GEN.220(a) and the current AMC
145.B.55
AMC1 145.B.220(a)(1) Record-keeping New AMC, based on AMC1 ARO.GEN.220(a)(1);(2);(3)
AMC1 145.B.300(a);(b);(c) Oversight principles New AMC, based on GM1 ARO.GEN.300(a);(b);(c) and AMC2
ARO.GEN.300(a);(b);(c)
AMC1 145.B.300(f) Oversight principles New AMC on information deemed useful for oversight
AMC1 145.B.305(a);(b) Oversight programme New AMC, as proposed in NPA 2013-01(C)
AMC1 145.B.305(b) Oversight programme New AMC, based on AMC1 ARO.GEN.305(b);(d);(d1)
AMC2 145.B.305(b) Oversight programme New AMC added for determine the need of oversight for
subcontracted organisations
AMC1 145.B.305(b)(1) Oversight programme New AMC, based on AMC1 ARO.GEN.305(b)(1)
AMC1 145.B.305(c) Oversight programme New AMC, based on AMC1 ARO.GEN.305(c)

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AMC2 145.B.305(c) Oversight programme New AMC, based on AMC2 ARO.GEN.305(c)

AMC1 145.B.305(d) Oversight programme New AMC, as proposed in NPA 2013-01(C)
AMC1 145.B.310 Initial certification procedure New AMC, based on AMC1 ARO.GEN.310(a)
AMC1 145.B.310(a) Initial certification procedure AMC based on the current AMC 145.B.20(3)
AMC1 145.B.310(c) Initial certification procedure AMC based on the current AMC 145.B.20(6)
AMC2 145.B.310(c) Initial certification procedure AMC based on the current AMC 145.B.20(5)
AMC1 145.B.310(d) Initial certification procedure AMC based on the current AMC 145.B.20(6)
AMC1 145.B.310(e)(2) Initial certification AMC based on the current AMC 145.B.20(1) and AMC
procedure 145.B.25(1)
AMC1 145.B.330 Changes — organisations AMC based on AMC1 ARO.GEN.330 and the current AMC
145.B.35
GM1 145.B.330 Changes — organisations New GM, based on GM1 ARO.GEN.330
GM1 145.B.350(b);(c) Findings and corrective GM, based on the current AMC 145.B.50(a)
actions
AMC1 145.B.355(c) Suspension, limitation and New AMC, as proposed in NPA 2013-01(C)
revocation
APPENDICES TO AMC TO ANNEX II (PART-145)
Appendix I to AMC 145.B.20(1) EASA Form 4 Deleted because EASA Form 4 is not used any more
Appendix II to AMC2 145.B.310(c) AMC Update of reference
145.B.20(5) EASA Form 6
Update of reference (Part-M Subpart G is deleted with Opinion
Appendix III to AMC 145.A.15 EASA Form 2 No 06/216)
Appendix IV to AMC3 145.A.30(e) and See ‘general changes’
AMC2 145.B.200(a)(3) 145.B.10(3) Fuel Ttank
Ssafety Ttraining

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7. Appendices

7.3. Appendix III — EASA questionnaire

In the context of the preparation of the RIA for RMT.0251 Phase II, EASA launched a survey to the
competent authorities and industry.
The aim of the survey was to gather evidence to support the applicability of SMSs, and to identify
where proportionality is needed, as well as to collect data on potential impacts, difficulties and
opportunities in the implementation of SMSs.
The input supported the analysis of the problem definition and the analysis of the options. The survey
was run from 21 December 2017 until 15 February 2018, and it collected specific SMS data related to
the design, production and maintenance domains. Some key results of the survey, including a
description of the respondents, are as follows:
The survey was responded to by 293 organisations [285 organisations with a single or multiple
approval(s) and 8 associations/individual representatives] and 11 competent authorities. The
organisations that hold multiple approvals were invited to provide a consolidated response,
representing all parts of the organisation that hold approvals.
The organisations were classified into 12 groups according to their business areas or the approvals
they hold.

The following provides a more detailed overview of the organisations that replied to the
questionnaire, grouped according to Part 21 and Part-145 and the number of employees:

Part 21 organisations by product design/manufacture

120
101
100

80

60
45
40

20 14
9 5 3
0
Part and Other aircraft Engine Aircraft ELA 1 Aircraft ELA 2 Propeller
appliance (other than ELA
1)

Figure 1: Part 21 organisations by product design/manufacture

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Part-145 organisations by class rating

120 112
95
100
80 64
56 50
60 44
35
40
19 15
20 7
0

Figure 2: Part-145 organisations by class rating

Organisations by company size (number of

employees for all activities)
no data
501-1000 5%
5%

101-500
18%
51-100
11%

26-50 1-10
13% 18%

11-25
14% >1000
16%

Figure 3: Organisations by company size (number of employees for all activities)

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The following are some of the responses to the survey questions on the implementation of SMSs.

Have you already implemented SMS in your company?

no reply
6%

No
40% No
Yes
no reply
Yes
54%

Figure 4: Reply to the question ‘Have you already implemented an SMS in your company?’

Have you already implemented SMS in your company? (answers by

group of organisations )

group 13 Other 26
10
group 12 AOC 26
0
group 11 Approved Training Organisation (ATO) 32
1
group 10 Part-147 Maintenance Training… 23
1
group 9 CAMO 56
11
group 8 Part-145 Maintenance organisation 132
76
group 7 Approved Design Organisation (DOA) 82
39
group 6 Approved Production Organisation (POA) 50
45
group 5 Production organisation without Approval 0
1
group 4 Approved Design Organisation (DOA)… 1
1
group 3 Design Organisation with certification… 7
3
group 2 Alternative Procedures to Approved Design… 7
12
group 1 ETSO approval holder (other than APU) 9
6

0 20 40 60 80 100 120 140

Yes No

Figure 5: Replies to the question ‘Have you already implemented SMS in your company?’ (Answers
by group of organisations)

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The decision to implement SMS was made

due to multiple approvals held by

7% the organisation (e.g. organisation
21% also holding an AOC)
other (please specify)

10%
on a voluntary basis
41%

21% due to national aviation

regulations mandating SMS

Figure 6: Reasons for implementing an SMS

Breakdown of the organisations that have implemented SMS on a

voluntary basis (by type of organisation)

group 13 Other 11

group 12 AOC 5

group 11 ATO 14

group 10 Part-147 13

group 9 CAMO 17

group 8 Part-145 39

group 7 DOA 48

group 6 POA 20

group 5 Production organisation without Approval 0

group 4 DOA (Subpart J) ETSO approval holder (for APU) 1

group 3 Design Organisation with certification programme 5

group 2 ADOA 5

group 1 ETSO approval holder (other than APU) 4

0 10 20 30 40 50 60

Figure 7: Implementation of an SMS on a voluntary basis

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7. Appendices

SMS applicability for Part 21

Regarding Part 21, the first question addressed the applicability of SMSs. The following charts show
the answers aggregated by organisations, by groups and by the types of product. In all cases, the
majority of respondents believed that some SMS requirements should be imposed on all
organisations. The questions also allowed respondents to provide comments in support of their
answers. In many cases, respondents that were not in favour of the application of SMSs to all
organisations, also included comments that proposed the exclusion of small organisations, especially
those that only deal with minor changes or that produce products, parts and appliances under
Subpart F. In general, several respondents proposed the application of proportional requirements,
and even the definition of a minimum set of common requirements, to encourage organisations to
develop safety cultures. The following are some of the comments that were received:
— ‘In small companies, informal communication can lead to an equivalent level of safety.
However, I would still encourage voluntary adoption. E.g. provide suitable templates that they
can use and explanations of benefits.’
— ‘Some applicable SMS elements (e.g. visible management commitment to safety, safety risk
assessment or safety promotion to increase safety awareness among staff) should apply to all
aviation parties, as we all work together in one aviation network.’
— ‘Safety culture must be in all part of the process.’

In your opinion, are there any

organisations/activities/products addressed in Part 21 that
should not be subject to any SMS requirements? (answers
by Part 21 organisations)
no reply
2%

Yes
29%

No
69%

Figure 8: Replies to the question ‘In your opinion, are there any organisations/activities/products
addressed in Part 21 that should not be subject to any SMS requirements?’ (Answers by Part 21
organisations)

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In your opinion, are there any

organisations/activities/products addressed in Part 21 that
should not be subject to any SMS requirements? (answers
by groups of Part 21 organisations)

group 7 Approved Design Organisation (DOA) 86 35

group 6 Approved Production Organisation (POA) 66 30

group 5 Production organisation without Approval 1

group 4 Approved Design Organisation (DOA)… 2

group 3 Design Organisation with certification… 8 3

group 2 Alternative Procedures to Approved Design… 13 6

group 1 ETSO approval holder (other than APU) 10 5

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

No Yes

Figure 09: Replies to the question ‘In your opinion, are there any organisations/activities/products
addressed in Part 21 that should not be subject to any SMS requirements?’ (answers by groups of
Part 21 organisations)

In your opinion, are there any organisations/activities/products

addressed in Part 21 that should not be subject to any SMS
requirements? (answers by Part 21 organisations type of product)

0
Propeller 0
3
0
Engine 3
11
2
Other aircraft 18
25
1
Aircraft ELA 2 (other than ELA 1) 3
1
1
Aircraft ELA 1 4
4
2
Part and appliance 28
71

0 10 20 30 40 50 60 70 80

no reply Yes No

Figure 10: Replies to the question ‘In your opinion, are there any organisations/activities/products
addressed in Part 21 that should not be subject to any SMS requirements?’ (Answers divided by the
type of product produced by Part 21 organisations)

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SMS applicability for Part-145

Given the decision to apply SMSs to Part-145 (see Section 4.1), the questionnaire was developed to
collect feedback on the extent of SMSs within Part-145.

Figure 11: Replies to question ‘In your opinion, are there any categories of Part-145 organisations
that should not be subject to any SMS requirements?’ and the corresponding rationale for the ‘no’
answers.

Figure 12: Categories of Part-145 organisations proposed to be excluded from SMS requirements

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In your opinion, are there any categories of Part-145 organisations

that should not be subject to any SMS requirements? (responses by
Part-145 maintenance organisations by class rating)

Engines B2 03 16
Engines B3 0 4 11
Engines B1 0 11
33
D1 NDT 2 10
44
C components to be installed on complex motor-powered aircraft (CMPA) 3 23
86
C components to be installed on other than CMPA 4 18
42
Aircraft A4 02 5
Aircraft A3 1 12
22
Aircraft A2 1 18
31
Aircraft A1 3 22
70
0 10 20 30 40 50 60 70 80 90 100

Yes no reply No

Figure 13: Replies to the question ‘In your opinion are there any categories of EASA Part-145
organisations that should not be subject to any SMS requirements?’ (Replies by Part-145
Maintenance organisation by class rating.)
Opinions of competent authorities
The same question regarding the applicability of SMSs was addressed to competent authorities. For
Part 21, the distribution of answers and justifications is similar to what was provided by organisations
and explained above.

In your opinion are there any

organisations/activities/products
addressed in EASA Part 21 that should
not be subject to any SMS
requirements? (answers from the
competent authorities)

No
36%

Yes
64%

Figure 14: Replies to the question ‘In your opinion, are there any organisations/activities/products
addressed in Part 21 that should not be subject to any SMS requirements?’ (Answers from the
competent authorities.)

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In your opinion, are there any categories

of Part-145 organisations that should
not be subject to any SMS
requirements? (answers from the
competent authorities)

Yes
27%

No
73%

Figure 15: Replies to the question ‘In your opinion, are there any categories of Part-145
organisations that should not be subject to any SMS requirements?’ (Answers by the competent
authorities)

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