HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 179/46
EN
Official Journal of the European Union
29.6.2013
COMMISSION IMPLEMENTING REGULATION (EU) No 628/2013
of 28 June 2013
on working methods of the European Aviation Safety Agency for conducting standardisation
inspections and for monitoring the application of the rules of Regulation (EC) No 216/2008 of
the European Parliament and of the Council and repealing Commission Regulation (EC) No
736/2006
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
menting rules for the airworthiness and environmental
certification of aircraft and related products, parts and
appliances, as well as for the certification of design and
Having regard to the Treaty on the Functioning of the European
production organisations; Commission Regulation (EC)
Union,
No 2042/2003 ( 4 ) laid down implementing rules for
the continuing airworthiness of aircraft and aeronautical
products, parts and appliances, and on the approval of
Having regard to Regulation (EC) No 216/2008 of the European
organisations and personnel involved in these tasks.
Parliament and of the Council of 20 February 2008 on
common rules in the field of civil aviation and establishing a
European Aviation Safety Agency, and repealing Council
Directive 91/670/EEC, Regulation (EC) No 1592/2002 and
(6) Since
that
time,
Regulation
(EC)
No
216/2008
has
Directive 2004/36/EC (
replaced Regulation (EC) No 1592/2002 of the

1 ), and in particular Article 24(5) thereof,
European Parliament and of the Council of 15 July
2002 on common rules in the field of civil aviation
Whereas:
and establishing a European Aviation Safety Agency (


5 )
and the common rules have been extended twice: first to
include air crew, air operations and ramp inspections;
secondly to include air traffic management and air navi
(1) Article 24(1) and Article 54 of Regulation (EC) No
gations services (ATM/ANS) as well as airport safety, as a
216/2008 require the European Aviation Safety Agency
consequence of which the Commission has adopted
(hereinafter ‘the Agency’), to assist the Commission in
several implementing rules corresponding to those new
monitoring the application of its provisions, as well as
fields of competence such as Commission Regulation
its implementing rules, by Member States’ competent
(EU) No 805/2011 of 10 August 2011 laying down
authorities, by conducting standardisation inspections.
detailed rules for air traffic controllers’ licences and
certain certificates ( 6 ), Commission Implementing Regu
lation (EU) No 1034/2011 ( 7 ) laying down administrative
(2) Article
54(4)
of
Regulation
(EC)
No
216/2008
stipulates
procedures for the safety oversight of air traffic
that where an inspection of a Member State competent
management and air navigation services, Commission
authority entails an inspection of an undertaking or an
Implementing Regulation (EU) No 1035/2011 of
association of undertakings, the Agency should follow
17 October 2011 laying down common requirements
the provisions of Article 55.
for the provision of air navigation services
( 8 ),
Commission Regulation (EU) No 691/2010 of 29 July
2010 laying down a performance scheme for air navi
(3) Commission
Regulation
(EC)
No
736/2006
( 2 ) lays down
gation services and network functions and amending
the working methods of the Agency for conducting stan
Regulation (EC) No 2096/2005 laying down common
dardisation inspections (hereinafter ‘the current working
requirements for the provision of air navigation
methods’).
services ( 9 ), Council Regulation (EEC) No 3922/91 of
16 December 1991 on the harmonization of technical
requirements and administrative procedures in the field
(4)
Six years have passed since the adoption of the current
of civil aviation ( 10 ), amended by Commission Regulation
working methods. Considerable changes to the common
(EC) No 859/2008 ( 11 ), Directive 2004/36/EC of the
rules have been adopted; a number of international
European Parliament and of the Council of 21 April
agreements have also been adopted; the Agency and
2004 on the safety of third-country aircraft using
the Member States have also accumulated valuable
Community airports
( 12 ), amended by Commission
experience that needs to be accounted for.
Directive 2008/49/EC of 16 April 2008 amending
Annex II to Directive 2004/36/EC of the European
(5) When
Regulation
(EC)
No
736/2006
was
adopted,
the
( 4 ) OJ L 315, 28.11.2003, p. 1.
common rules in the field of civil aviation were limited
( 5 ) OJ L 240, 7.9.2002, p. 1.
to initial and continuing airworthiness. Commission
( 6 ) OJ L 206, 11.8.2011, p. 21.
Regulation (EC) No 1702/2003 (
(

3 ) laid down imple

7 ) OJ L 271, 18.10.2011, p. 15.
( 8 ) OJ L 271, 18.10.2011, p. 23.
( 9 ) OJ L 201, 3.8.2010, p. 1.
( 1 ) OJ L 79, 19.3.2008, p. 1.
( 10 ) OJ L 373, 31.12.1991, p. 4.
( 2 ) OJ L 129, 17.5.2006, p. 10.
( 11 ) OJ L 254, 20.9.2008, p. 1.
( 3 ) OJ L 243, 27.9.2003, p. 6.
( 12 ) OJ L 143, 30.4.2004, p. 76.

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EN
29.6.2013 Official
Journal
of
the
European
Union L
179/47
Parliament and of the Council regarding the criteria for
(11) With
regard
to
the
States
part
of
the
EU
neighbourhood
the conduct of ramp inspections on aircraft using
and enlargement policy, including notably States Party to
Community airports ( 1 ) Commission Regulation (EU)
the European Common Aviation Area agreement, stan
No 965/2012 of 5 October 2012 laying down
dardisation inspections should be organised in
technical requirements and administrative procedures
accordance with the same working methods and in
related to air operations ( 2 ), and Commission Regulation
accordance with the same standards as for the Member
(EU) No 1178/2011 of 3 November 2011 laying down
States, subject to appropriate Agreements or Working
technical requirements and administrative procedures
Arrangements.
related to civil aviation aircrew ( 3 ).
(12) With
regard
to
the
States
having
signed
Bilateral
Air
(7) Regulation
(EC)
No
216/2008
has
also
introduced
a
Safety Agreements providing for the mutual acceptance
number of new provisions that need to be reflected in
of certain certification findings and approvals, standard
the Agency’s working methods for carrying out standard
isation inspections should support the monitoring of the
isation inspections. In particular, Article 11 establishes
implementation of the agreement and report the results
the conditions for the mutual recognition of certificates
to the appropriate bilateral oversight board in view of
issued by competent authorities of Member States, as
possible adjustments. The inspections of those Member
well as conditions for suspending this recognition,
States whose certification findings and approvals are
where standardisation inspections constitute an
accepted in the framework of the bilaterals should
important instrument for such decision-making.
include additional verifications to ensure competent auth
Article 15 establishes an information network that
orities discharge correctly their responsibilities stemming
provides useful information to be taken into account
from the bilateral agreements.
for standardisation inspections, whilst certain results of
such standardisation inspections may need to be made
available without delay to this information network.
(13) In
order
to
monitor
the
application
of
Regulation
(EC)
Article 27(3) establishes that the Agency has to
No 216/2008 and its implementing rules, as well as
support the Member States in discharging their
other aviation safety rules stemming from existing Regu
obligations towards ICAO.
lations and agreements efficiently, it is necessary to
review the current working methods, notably to ensure
they become more system oriented, follow a more
(8) Notwithstanding
further
changes
of
the
common
rules
as
continuous monitoring approach more focused on
established by Regulation (EC) No 216/2008 and its
safety performance, provide for more efficient use of
implementing rules, the Agency should support the
resources in order not to generate an undue burden on
Commission in monitoring the implementation of
the competent authorities and include a feedback loop to
other aviation safety requirements stemming, for
the Agency’s rulemaking activities. Inspection teams
instance, from the Single European Sky legislation or
should be set up with adequately trained and qualified
the legislation on accident investigation or occurrence
personnel and the Agency shall endeavour to balance the
reporting.
participation of authorised personnel from different
Member States.
(9) Since
2006,
the
European
external
aviation
policy
has
also experienced significant developments, both
(14) The
working
methods
should
reflect
the
definitions
and
principles of auditing as defined in ISO 19011.
regarding International Civil Aviation Organisation

(ICAO), States in the neighbourhood of the European
Union and certain key partners at global level.
(15) Beyond the inspection-level, the working methods should
elaborate on the monitoring at system-level and at
finding-level.
(10) A
Memorandum
of
Cooperation
with
the
International
Civil Aviation Organisation (ICAO) was signed in
2010 ( 4 ) which creates the framework for a structured
cooperation between parties, in particular regarding the
(16) The
working
methods
should
provide
more
flexibility
to
exchange of information related to safety, with a view to
the Agency in taking action where this corresponds to its
avoid duplication of tasks where possible, as a
technical competence whilst maintaining legal certainty
consequence of which the Agency’s standardisation
on the working methods.
inspection programme and the ICAO Universal Safety
Oversight Audit Programme (USOAP) should become
more inter-related. The inspection working methods
(17) Regulation (EC) No 736/2006 should therefore be
should also take into account ICAO Doc 9735 — the
repealed accordingly.
USOAP continuous Monitoring Manual.
( 1 ) OJ L 109, 19.4.2008, p. 17.
(18) The
measures
provided
for
in
this
Regulation
are
in
( 2 ) OJ L 296, 25.10.2012, p. 1.
( 3 ) OJ L 311, 25.11.2011, p. 1.
accordance with the opinion of the Committee estab
( 4 ) Council Decision 2011/531/EU, OJ L 232, 9.9.2011, p. 8.
lished by Article 65 of Regulation (EC) No 216/2008,

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L 179/48
EN
Official Journal of the European Union
29.6.2013
HAS ADOPTED THIS REGULATION:
(6) ‘finding’ means the result of the comparison between the
available evidence and the applicable requirements;
Article 1
Subject matter and scope
(7) ‘correction’ means an action to eliminate a finding of non-
conformity with the applicable requirements;
1. This
Regulation
lays
down
the
working
methods
for:
(a) monitoring the application by competent authorities of the
(8) ‘corrective action’ means an action to eliminate the cause of
Member States of Regulation (EC) No 216/2008 and its
a finding of non-conformity with the applicable
implementing rules in the fields covered by Article 1(1) of
requirements in order to prevent recurrence;
that Regulation;
(9) ‘immediate safety concern’ means a situation where there is
(b) conducting standardisation inspections of the competent
evidence that a product, service, system, constituent,
authorities of Member States;
equipment or facility is either in such a condition, or is
being operated, supplied or maintained in such a manner
(c) verifying that the competent authorities of Member States
that harm to persons is likely to occur unless the situation
are issuing and overseeing certificates in accordance with
is corrected immediately.
Regulation (EC) No 216/2008 and its implementing rules;
Article 3
(d) contributing to the assessment of the impact of the imple
mentation by the competent authorities of Member States of
Principles applicable to monitoring
Regulation (EC) No 216/2008 and its implementing rules.
1. The
Agency
shall
monitor
the
application
by
competent
authorities of the requirements referred in Article 1 as well as
2. The
working
methods
established
in
this
Regulation
shall their uniform implementation according to the methodology
also apply, as far as practicable, when the Agency is charged
laid down in this Regulation and shall report thereon.
with the task to monitor the application of aviation safety
requirements established by other EU legislation, agreements
concluded by the Union or working arrangements concluded
2. The
monitoring
shall
be
continuous
and
risk-based,
on
the
by the Agency.
basis of the information available to the Agency. It shall entail
assessing the competent authorities’ ability to discharge their
safety oversight responsibilities, conducting inspections as
Article 2
necessary, as well as the follow-up of findings stemming from
Definitions
inspections, in order to ensure that appropriate corrections and
corrective actions are timely implemented.
For the purposes of this Regulation the following definitions
apply:
3. The
monitoring
shall
follow
a
system
approach.
It
shall
address all domains and critical elements of the safety oversight
(1) ‘inspection’ means the standardisation inspection referred to
system as defined by ICAO. Particular attention shall be given to
in Article 24(1) and Article 54 of Regulation (EC) No
interfaces between domains.
216/2008, including the inspection of undertakings or
associations of undertakings referred to in Article 54(4)
and Article 55 of that Regulation, carried out by the
4. The
monitoring
shall
be
conducted
in
a
transparent,
effi
Agency;
cient, effective, harmonised and consistent manner.
(2) ‘competent authority’ means the entity designated by the
5. The
Agency
shall
analyse
the
outcome
of
its
monitoring
Member State as competent for the implementation of
activities in order to identify the need for regulatory improve
Regulation (EC) No 216/2008 and its implementing rules;
ments.
(3) ‘authorised personnel’ means the persons authorised by the
Agency to carry out inspections, including seconded
Article 4
personnel;
Principles applicable to inspections and findings
(4) ‘seconded personnel’ means the officials made available by
1. Inspections
of
competent
authorities
shall
take
into
the competent authorities of Member States, the Inter
account the results of previous inspections and address in
national Civil Aviation Organisation (ICAO), other inter
particular changes to the regulatory requirements, to the
national aviation organisations or the competent authorities
safety oversight capability of the competent authority and be
of Third Countries having agreements with the Union or
proportionate to the level and complexity of the industry under
working arrangements with the Agency, who are nominated
their oversight, ensuring as a priority a high and uniform level
by these authorities to assist the Agency in carrying out
of safety for commercial air transport.
inspections;
2. Inspections
may
include
inspections
of
undertakings
or
(5) ‘evidence’ means records, statements of fact, or other
associations of undertakings under the oversight of the
information which are relevant and verifiable;
competent authority inspected.

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29.6.2013 Official
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3. Inspections
may
include,
when
so
agreed
by
the
parties
Article 6
concerned, inspections of military facilities open to public use
or of services provided by military personnel to the public, for
National Standardisation Coordinator
the purpose of verifying that the requirements of Article 1(3) of
1. Member
States
shall
designate
a
national
standardisation
Regulation (EC) No 216/2008 are complied with.
coordinator, acting as their primary point of contact for all
standardisation activities and in particular to coordinate the
exchange of information provided for in Article 5(1). The
4. Inspections
shall
be
carried
out
by
a
team
composed
of national standardisation coordinator shall be responsible for:
personnel authorised by the Agency, which shall be qualified
and trained in their respective domain(s). Authorised personnel
shall apply the principles of independence, integrity, ethical
(a) maintaining and updating the information provided to the
conduct, due diligence, fair presentation and confidentiality.
Agency on an on-going basis, including information
requested in accordance with Articles 3, 4 and 5,
corrections and corrective action plans and evidence of
5. Where
the
Agency
finds
that
one
or
more
certificates
do
implementation of the agreed corrective actions;
not comply with Regulation (EC) No 216/2008 and its Imple
menting Rules, that finding of non-conformity shall be reported
(b) assisting the Agency at all stages of an inspection and
to the competent authority concerned. Where the finding of
ensuring that the inspection team is accompanied
non-conformity is not corrected in a timely manner the
throughout the on-site inspections.
Agency shall make recommendations pursuant to Article 11(2)
of Regulation (EC) No 216/2008 in order to allow a decision
2. Competent
authorities
shall
ensure
that
there
are
clear
on the mutual recognition of the said certificate(s).
lines of communication between the national standardisation
coordinator designated and their internal organisation, in
order for him/her to properly discharge his/her responsibilities.
6. The
Agency
shall
classify
and
follow-up
the
findings
of
non-conformity identified during inspections referred to in para
Article 7
graphs 1, 2 and 3 depending on their impact on safety and
safety related findings shall be prioritised. The Agency shall also
Continuous monitoring
inform without delay the competent authorities of Member
States when the correction of an immediate safety concern
1. The
continuous
monitoring
referred
to
in
Article
3
shall
has not been satisfactorily addressed.
comprise the following:
(a) the collection and analysis of data and information provided
7. This
Regulation
is
without
prejudice
to
Articles
15
and
58
by the competent authorities of Member States, the Inter
of Regulation (EC) No 216/2008, to Commission Decision
national Civil Aviation Organisation (ICAO), the
2001/844/EC, ECSC, Euratom
( 1 ), to Regulation (EC) No
Commission or other relevant sources;
2111/2005 of the European Parliament and of the Council ( 2 )
and Commission Regulation (EC) No 473/2006 ( 3 ).
(b) the assessment of the competent authority’s ability to
discharge its safety oversight responsibilities;
Article 5
(c) depending on the assessment referred to in point (b), the
Exchange of information
prioritisation, planning and determination of the scope of
inspections;
1. Competent
authorities
of
Member
States
shall
provide
the
Agency with all necessary information relevant to their safety
(d) the conduct of such inspections, including the related
oversight, addressing all the critical elements of their safety
reporting;
oversight system, including the undertakings or associations of
undertakings under their oversight. The information shall be
provided in a form and a manner specified by the Agency,
(e) the follow-up and closure of findings of non-conformity
taking into account the information that has been made
stemming from the inspections.
available to ICAO.
2. For
the
assessment
referred
to
in
point
(b)
of
paragraph
1,
the Agency shall establish, develop and maintain a single model
2. The
Agency
may
also
request
ad-hoc
information
from taking into account at least the following elements:
the competent authorities of Member States. When submitting
such a request for information the Agency shall state its legal
(a) the size and complexity of the aviation industry;
basis and purpose, specify what information is required and set
the time-limit within which the information is to be provided.
(b) serious incidents, accidents, fatal accidents and related fatal
ities;
3. The
Agency
shall
provide
competent
authorities
of
Member States with relevant information to support the
(c) the results of ramp inspections;
uniform implementation of the applicable requirements.
(d) the results of previous inspections;
( 1 ) OJ L 317, 3.12.2001, p. 1.
( 2 ) OJ L 344, 27.12.2005, p. 15.
(e) the ability of the competent authorities to implement effec
( 3 ) OJ L 84, 23.3.2006, p. 8.
tively corrections and corrective actions;

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Official Journal of the European Union
29.6.2013
(f) the result of audits carried out under international
(f) ATM/ANS and air traffic controllers, as defined in Articles
conventions or State safety assessment programmes;
8b and 8c of the said Regulation;
(g) the existence of measures pursuant to Article 11(2) of Regu
Further domains may be defined depending on the evolutions of
lation (EC) No 216/2008 or to Article 258 of the Treaty.
Regulation (EC) No 216/2008 or upon the request of the
Commission.
3. The
outcome
of
the
model
as
established
in
paragraph
2
and the input data and results of the assessment shall be made
2. The
Agency
shall
ensure
that
its
resources
are
appro
available to the national standardisation coordinator of the
priately allocated to monitoring and inspecting the different
Member State concerned.
domains depending on the results of the continuous monitoring
referred to in Article 7.
4. The Agency shall adapt the inspection programme in the
light of its continuous monitoring, reflecting both
Article 10
improvements and deteriorations in safety performance. The
Agency shall take appropriate action when there is evidence
Types of inspections
that the safety performance deteriorates.
1. The
Agency
shall
conduct:
Article 8
(a) comprehensive inspections, for the purpose of inspecting
Inspection programme
one or more domains; these inspections shall be
performed at intervals determined based on the results of
1. The
Agency
shall
establish,
in
coordination
with
the
the continuous monitoring;
Commission, a multi-annual programme, indicating the
inspections referred to in Article 10(1)(a), as well as an
annual programme indicating the inspections referred to in
(b) focused inspections, for the purpose of inspecting specific
Article 10(1)(a) and (b).
areas within one or more domains, and/or for the purpose
of assessing the implementation status of agreed corrections
and corrective actions;
2. The
inspection
programmes
shall
specify
the
Member
State(s) concerned, the type of inspection, the domains to be
inspected and the foreseen timeframe for the on-site phase,
(c) ad hoc inspections, for the purpose of investigating specific
taking into account the model referred to in Article 7.
concerns arising from the Agency’s continuous monitoring
or upon request from the Commission.
3. The
inspection
programmes
may
be
adjusted
by
the
Agency to take into account emerging risks stemming from
2. Notwithstanding
the
inspections
referred
to
in
paragraph
the continuous monitoring referred to in Article 7.
1, the Agency may raise off-site findings when it has collected
sufficient evidence of non-conformity.
4. The
annual
programme
shall
be
communicated
to
the
Commission, to the members of the Management Board of
Article 11
the Agency as part of the Agency’s work programme
Training, qualification and authorisation criteria for
pursuant to Article 33(2)(c) of Regulation (EC) No 216/2008,
inspection teams
and to the national standardisation coordinator of the Member
State concerned.
1. The
Agency
shall
establish
qualification
criteria
for
the
personnel who participate in inspection teams.
Article 9
2. The
qualification
criteria
shall
include:
Inspection domains
1. The Agency shall carry out inspections addressing each
(a) knowledge of the institutional and regulatory framework, in
domain defined in Chapter II of Regulation (EC) No
particular of this Regulation as well as on the relevant inter
216/2008. These domains shall include:
national agreements;
(a) airworthiness, as defined in Article 5 and environmental
(b) knowledge and experience of auditing techniques;
protection, as defined in Article 6 of the said Regulation
(c) technical competence and practical experience in the
(b) Air crew, as defined in Articles 7 and 8 of the said Regu
relevant domain(s) referred to in Article 9.
lation;
3. Team
leaders
shall
be
personnel
employed
by
the
Agency.
(c) Air operations, as defined in Articles 8 and 9 of the said
Their qualification criteria shall include in addition to those
Regulation;
referred to in paragraph 2, team management and communi
cation capabilities in an international environment and in
(d) Ramp inspections, as defined in Article 10 of the said
sensitive situations.
Regulation;
4. Team
members
shall
be
personnel
employed
by
the
(e) Aerodromes, as defined in Article 8a of the said Regulation;
Agency or seconded personnel.

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5. Both
team
leaders
and
team
members
shall
be
trained
on
3. Findings
of
non-conformity
identified
during
inspections
the applicable requirements and the Agency’s procedures. The
referred to in Article 10 shall be reported in accordance with
Agency shall ensure the continued competence of team leaders
Article 16, followed-up and closed in accordance with Article 17
and team members in order to participate in inspections as
and classified in accordance with Article 18.
authorised personnel. The Agency shall establish appropriate
continuous training programmes for that purpose.
Article 14
6. Personnel
who
meet
the
qualification
criteria
and
have
Preparatory phase
received appropriate training may be authorised by the
1. During
the
preparatory
phase
of
an
inspection,
the
Agency to participate in inspection teams.
Agency shall:
Article 12
(a) give notice of the inspection to the competent authority at
least 10 weeks before the on-site phase, including the
Setting up teams for inspections
intended type, domain(s) and areas for inspection;
1. Inspections shall be carried out by teams set up by the
Agency composed by authorised personnel pursuant to
(b) collect the necessary information for the preparation of the
Article 11.
inspection, taking duly into account the information
available from continuous monitoring;
2. The
Agency
shall
determine
the
team
composition
in
order to establish the minimum team size necessary to cover
(c) define the scope, the extent and the programme of the
the required technical competencies and workload, taking into
inspection, including the inspection of undertakings or
account the type of inspection, the scope, the number of
association of undertakings, taking into account the
domains considered and the expected programme. Each team
information from continuous monitoring;
shall have a team leader and one team member as a minimum.
In all cases, the Agency shall ensure the size of the teams
(d) determine the size and the composition of the inspection
remains commensurate to the scope.
team.
3. The
Agency
shall
ensure
that,
in
setting
up
the
teams, 2. Upon notice of the inspection, the competent authority
there shall be no conflict of interests either with the
shall cooperate with the Agency in order to prepare the on-site
competent authorities inspected or with the undertakings or
phase swiftly. If deemed necessary, a preliminary meeting may
associations of undertakings inspected.
be organised between the inspection team and the national
standardisation coordinator.
4. The
Agency
shall
request
in
due
time
before
an
inspection
information from seconding authorities or organisations as to
3. The
Agency
shall
provide
the
inspection
programme
and
the availability of team members for participating in the on-site
the composition of the team to the competent authority at least
phase.
2 weeks before the on-site phase.
5. Expenses
arising
from
the
participation
of
national
stan
Article 15
dardisation coordinators as provided for in Article 14(2),
On-site phase
Article 19(2) and of seconded personnel to inspections carried
out by the Agency shall be borne by the Agency, in compliance
1. During the on-site phase of an inspection, the Agency
with Union rules and without prejudice to the annual budgetary
shall:
procedure of the Union.
(a) organise an opening meeting with the national standard
Article 13
isation coordinator and the competent authority inspected;
Conduct of inspections
(b) follow up findings of non-conformity identified in previous
1. Inspections
referred
to
in
Article
10(1)(a)
and
(b)
shall
inspections and that remain open, and review the
include the following phases:
corresponding corrections and corrective actions;
(c) notify the competent authority of any immediate safety
(a) a preparatory phase, lasting a minimum of 10 weeks prior
concern, where such concern is identified during the
to the inspection;
inspection;
(b) an on-site phase;
(d) at a closing session, present to the competent authority
inspected a list of preliminary findings of non-conformity
(c) a reporting phase, lasting a maximum of 10 weeks
identified or followed up in the course of the inspection.
following the end of the on-site phase.
2. In
addition,
the
Agency
may:
2. Ad hoc inspections referred to in Article 10(1)(c) shall be
announced to the competent authority concerned with a notice
(a) inspect the main offices and to the extent deemed necessary,
of two weeks but need not to comply with the deadlines and
any regional offices of the competent authority and of the
the procedures provided for in Articles 14, 15 and 16, except
qualified entities to which the competent authority may
for the need of a final report.
have allocated tasks;

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(b) inspect undertakings or associations of undertakings under
Article 17
the oversight of the competent authority as part of the
inspection of this competent authority; in that case, the
Findings follow-up and closure
competent authority may accompany the inspection team;
1. For
all
findings
of
non-conformity
classified
under
Article 18(1)(b) and (c), the competent authority shall propose
(c) carry out interviews with the staff of the competent
a correction and a corrective action no later than four weeks
authority inspected and qualified entities, if any, and of
after receipt of the notification from the Agency.
undertakings or association of undertakings visited, if any;
2. For
all
findings
of
non-conformity
classified
under
(d) examine legislation, procedures, certificates, records, data
Article 18(1)(a), the competent authority shall propose a
and any other relevant material.
corrective action no later than 10 weeks after receipt of the
notification from the Agency;
Article 16
Reporting phase
3. The
competent
authority
shall
report
to
the
Agency
in
due
time on the completion of corrective actions and provide
1. During
the
reporting
phase
of
an
inspection,
the
Agency evidence thereof.
shall, within 6 weeks after the closing session of the on-site
phase, review the preliminary findings, classify them and
4. The
Agency
shall:
establish on this basis a draft report addressed to the
competent authority inspected.
(a) evaluate the corrections and the corrective actions submitted
by the competent authority or request further clarification in
2. The
draft
report
shall
contain
at
least:
a timely manner;
(a) an executive summary presenting the conclusions;
(b) agree with or reject the corrections and/or corrective actions
submitted within 16 weeks after the notification;
(b) details on the conduct of the inspection, including the type
of the inspection, domains covered, scope and composition
of the team;
(c) monitor the satisfactory implementation of corrective
actions;
(c) an analysis by critical element focusing on the main
findings;
(d) identify any need for supplementary actions in accordance
with Article 22;
(d) a list of findings of non-conformity identified or followed
up during the inspection together with their classification;
(e) report on a regular basis to the competent authority and to
the Commission the status of findings of non-conformity
(e) recommendations, including where necessary on the mutual
and the related corrections/corrective actions by means of
recognition of certificates.
status reports;
3. Findings
of
non-conformity
shall
be
notified
by
means
of
(f) close the findings of non-conformity once satisfied with the
the draft report referred to in paragraph 2, except if already
completion of the corrective actions and the evidence
notified in writing by the Agency by other means.
provided, record the closure of the findings of non-
conformity and inform the competent authority accordingly.
4. The
competent
authority
may
submit
written
comments
to the Agency within two weeks from the notification.
5. For the purposes of point (c), the Agency may request
evidence or clarifications to the competent authority. The
5. The
Agency
shall,
within
10
weeks
after
the
closing Agency may also decide to verify the implementation on site
session, issue a final report on the basis of the draft report
by means of an inspection.
mentioned in paragraph 2, reflecting the comments of the
competent authority inspected, if any. The Agency may adapt
6. When
findings
of
non-conformity
are
subject
to
an
the description of the finding of non-conformity, its legal basis,
infringement action pursuant to Article 11(2) of Regulation
its classification or its status as appropriate to take into account
(EC) No 216/2008 or to the Treaties, the Agency shall ensure
the comments as well as the corrections or corrective actions
appropriate follow-up in consultation with the Commission and
submitted during the reporting phase.
shall not close any such finding without prior coordination with
the Commission.
6. The
Agency
shall
establish
and
maintain
a
continuous
monitoring status for each Member State which shall be
Article 18
provided on request to the Member State concerned and to
the Commission.
Classification of findings
1. All
findings
of
non-conformity
identified
by
the
Agency
in
7. The
final
report
shall
be
addressed
to
the
competent the framework of the inspections referred to in Article 10 shall
authority inspected and to the Commission, who may
be classified and reported by the Agency, whether they pertain
subsequently transmit this report to the Member State
to administrative requirements or to technical requirements, in
concerned and other competent authorities as appropriate.
one of the following classes:

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EN
29.6.2013 Official
Journal
of
the
European
Union L
179/53
(a) Class C: non-conformity with the applicable requirements,
Article 21
raising mainly standardisation concerns;
Access to information contained in inspection reports
(b) Class D: non-conformity with the applicable requirements,
1. Where information contained in an inspection report
raising standardisation concerns and safety concerns if not
concerns an undertaking or association of undertakings under
timely corrected;
the safety oversight of a third country and falls within the scope
of application of a Union agreement concluded pursuant to
(c) Class G: immediate safety concern.
Article 12 of Regulation (EC) No 216/2008, that information
shall be made available to the third country as a party to such
2. The
reporting,
follow-up
and
closure
shall
be
prioritised an agreement in accordance with its relevant provisions.
depending on their classification.
2. Where
information
contained
in
an
inspection
report
falls
Article 19
within the scope of application of the Memorandum of
Cooperation between the Union and ICAO, that information
Immediate safety concern
shall be made available to ICAO in accordance with the
1. When
an
immediate
safety
concern
has
been
notified
by provisions of this Memorandum of Cooperation and the
the Agency:
corresponding safety annex.
(a) the Agency shall request the competent authority to take
3. Where information contained in an inspection report
adequate corrective actions, including immediate correc
relates to ongoing safety investigations conducted in accordance
tions;
with Regulation (EU) No 996/2010 of the European Parliament
and of the Council ( 1 ), that information shall be made available
(b) the competent authority shall apply effective corrections to
without delay to the authority in charge of the safety investi
remove the finding and shall provide the Agency with
gation.
evidence thereof.
4. For the purpose of Regulation (EC) No 1049/2001 of the
2. The
Agency
may
request
within
two
weeks
from
the European Parliament and of the Council ( 2 ), the decision-making
notification of the immediate safety concern the competent
process related to an inspection report shall not be deemed to
authority to attend a meeting to assess the implementation of
be concluded before the related findings of non-conformity are
the immediate corrections.
closed.
3. When the corrections do not satisfy the Agency, the
Article 22
Agency shall make recommendations to the Commission,
Supplementary actions
including where necessary a request with regard to the mutual
recognition of the certificate(s) issued by the competent auth
1. The
Agency
shall
identify
any
failure
to
follow
up
a
ority. The Agency shall also inform the competent authorities of
finding of non-conformity such as:
the Member States immediately.
(a) corrective action not submitted within the period referred to
Article 20
in Article 17(1);
Records
(b) corrective action not agreed by the Agency within the
1. The
Agency
shall
establish
a
system
of
record-keeping
period referred to in Article 17(4)(b);
providing for adequate storage, accessibility and reliable tracea
bility of changes for:
(c) corrective action not duly implemented.
2. In the cases referred to in paragraph 1, the Agency shall
(a) training, qualification and authorisation of team leaders and
request the competent authority to provide clarifications on the
team members;
failure and to submit supplementary actions, setting a time-limit
for the response.
(b) inspection programmes;
3. The Agency shall assess the consequence of the failure
(c) reports;
together with the response provided by the competent
authority within the set time-limit. Based on the outcome of
(d) findings and related evidence;
such assessment, the Agency may:
(e) agreed corrections and corrective actions;
(a) agree with the supplementary actions submitted; or
(f) closure of findings of non-conformity and related evidence;
(b) issue a supplementary report to the competent authority
concerned and to the Commission. That report shall
(g) recommendations regarding the mutual recognition of
include the Agency’s assessment and recommendations to
certificates;
the Commission, including when deemed necessary recom
mendations on the mutual recognition of certificate(s) issued
(h) assessments referred to in Article 7(1)(b).
by the competent authority.
2. All
records
shall
be
kept
for
a
minimum
period
of
15
( 1 ) OJ L 295, 12.11.2010, p. 35.
years, subject to applicable data protection law.
( 2 ) OJ L 145, 31.5.2001, p. 43.

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4. Without
prejudice
to
Regulation
(EC)
No
2111/2005,
Article 24
following receipt of the supplementary report referred to in
paragraph 3(b), the Commission may take any of the
Working procedures
following steps:
The Agency shall revise its working procedures in order to
implement the tasks conferred upon it under Articles 3 to 23
(a) address comments to the Member State concerned or
within six months following the entry into force of this Regu
request further explanation to clarify all or part of the
lation at the latest.
findings of non-conformity;
Article 25
Transitional arrangements
(b) require the Agency to carry out an ad-hoc inspection to
check the satisfactory implementation of corrections and
1. Findings
of
non-conformity
identified
by
the
Agency
corrective actions;
pursuant to Regulation (EC) No 736/2006 and for which
evidence of closure has not been submitted to the Agency at
the time of entry into force of this Regulation shall be deemed
(c) initiate the procedure referred to in Article 11(2) of Regu
to have been made in accordance with this Regulation and shall
lation (EC) No 216/2008 to decide whether certificates
be treated accordingly.
issued by the competent authority comply with the
applicable requirements;
2. Corrective
action
plans
agreed
by
the
Agency
pursuant
to
Regulation (EC) No 736/2006 shall be deemed to have been
(d) initiate a procedure under Article 258 of the Treaty.
agreed in accordance with this Regulation.
3. Team
members
and
team
leaders
authorised
by
the
Article 23
Agency pursuant to Regulation (EC) No 736/2006 shall be
deemed authorised personnel according to this Regulation.
Annual report
The Agency shall submit to the Commission, no later than 31
Article 26
March of each year, an annual report on the continuous moni
Repeal
toring activities and the inspections carried out in the previous
year. The report shall include an analysis of the results of the
Regulation (EC) No 736/2006 is repealed.
activities and inspections, reflecting the competent authorities’
ability to discharge their safety oversight responsibilities, as well
Article 27
as recommendations for possible improvements. The recom
Entry into force and application
mendations shall in particular identify those technical rules
that would need to be established or amended pursuant to
This Regulation shall enter into force on the twentieth day
Article 17(2)(b) of Regulation (EC) No 216/2008 as well as
following the date of its publication in the Official Journal of
those Agency measures that would need to be established or
the European Union.
amended pursuant to Article 18(c) of Regulation (EC) No
216/2008.
It shall apply from 1 January 2014.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 28 June 2013.
For the Commission
The President
José Manuel BARROSO

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