HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 122/22
EN
Official Journal of the European Union
11.5.2011
COMMISSION REGULATION (EU) No 445/2011
of 10 May 2011
on a system of certification of entities in charge of maintenance for freight wagons and amending
Regulation (EC) No 653/2007
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
maintenance activities. When they operate freight wagons
for this purpose, infrastructure managers do so in the
capacity of a railway undertaking. The assessment of
Having regard to the Treaty on the Functioning of the European
the infrastructure manager’s capacity to operate freight
Union,
wagons for this purpose should be part of its assessment
for a safety authorisation under Article 11 of Directive
2004/49/EC.
Having regard to Directive 2004/49/EC of the European
Parliament and of the Council of 29 April 2004 on safety on
the Community’s railways and amending Council Directive
(5) Inspections
and
monitoring
undertaken
before
the
95/18/EC on the licensing of railway undertakings and
departure of a train or en route are generally
Directive 2001/14/EC on the allocation of railway infrastructure
performed by operational staff of the railway under
capacity and the levying of charges for the use of railway infra
takings or infrastructure managers, following the
structure and safety certification ( 1 ), and in particular Article 14a
process described in their safety management system in
thereof,
accordance with Article 4(3) of Directive 2004/49/EC.
Having regard to the Recommendation of the European Railway
(6) The
railway
undertakings
or
the
infrastructure
managers
Agency of 8 July 2010 on a System of Certification for Entities
should ensure, through their safety management system,
in Charge of Maintenance,
the control of all risks related to their activity, including
the use of contractors. To this end, a railway undertaking
should rely on contractual arrangements involving
Whereas:
entities in charge of maintenance for all wagons it
operates. This could be a contract between the railway
undertaking and the entity in charge of maintenance or a
(1) Directive
2004/49/EC
aims
to
improve
access
to
the
chain of contracts involving other parties, such as the
market for rail transport services by defining common
keeper. These contracts should be consistent with the
principles for the management, regulation and super
procedures outlined by a railway undertaking or an infra
vision of railway safety. Directive 2004/49/EC also
structure manager in its safety management system,
provides for a framework to be put in place to ensure
including for the exchange of information.
equal conditions for all entities in charge of maintenance
for freight wagons through application of the same
certification requirements across the Union.
(7)
In accordance with Directive 2004/49/EC, a certificate for
an entity in charge of maintenance (ECM certificate) is
valid throughout the Union. Certificates issued by bodies
(2)
The purpose of the certification system is to provide a
in third countries appointed under equivalent criteria and
framework for the harmonisation of requirements and
meeting equivalent requirements to those contained in
methods to assess the ability of entities in charge of
this Regulation should normally be accepted as being
maintenance across the Union.
equivalent to the ECM certificates issued in the Union.
(3) Without
prejudice
to
the
responsibility
of
railway
under
(8) The
assessment
by
a
certification
body
of
an
application
takings and infrastructure managers for the safe
for an ECM certificate is an assessment of the applicant’s
operation of trains, the entity in charge of maintenance
ability to manage maintenance activities and to deliver
should ensure that the freight wagons for which it is in
the operational functions of maintenance either by itself
charge of maintenance are in a safe state of running by
or through contracts with other bodies, such as main
means of a system of maintenance. Taking into account
tenance workshops, charged with delivering these
the wide variety of design and maintenance methods, this
functions or parts of these functions.
system of maintenance should be a process-oriented
system.
(9) A
system
of
accreditation
should
provide
a
tool
for
managing risks by assuring that accredited bodies are
(4) Infrastructure
managers
need
to
use
freight
wagons
to
competent to carry out the work they undertake.
transport materials for construction or for infrastructure
Furthermore, accreditation is regarded as a means to
secure national and international recognition of ECM
( 1 ) OJ L 164, 30.4.2004, p. 44.
certificates issued by accredited bodies.

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11.5.2011 Official
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European
Union L
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(10) In
order
to
have
a
system
allowing
certification
bodies
to
2. The purpose of the system of certification is to provide
perform checks on certified entities in charge of main
evidence that an entity in charge of maintenance has established
tenance across the Union, it is important that all bodies
its maintenance system and can meet requirements laid down in
able to award certificates to any entity in charge of main
this Regulation to ensure the safe state of running of any freight
tenance (the ‘certification bodies’) should cooperate with
wagon for which it is in charge of maintenance.
each other in order to harmonise approaches to certifi
cation. Specific requirements for accreditation should be
developed and approved in line with the provisions of
Article 2
Regulation (EC) No 765/2008 of the European
Parliament and of the Council (
Scope

1 ).
1. The
system
of
certification
shall
apply
to
any
entity
in
charge of maintenance for freight wagons to be used on the
(11) To
evaluate
the
certification
process
set
out
in
this
Regu
railway network within the Union.
lation, it is important that the European Railway Agency
(the Agency) oversees the development of the system of
certification. To be able to perform this function, the
2. Maintenance
workshops
or
any
organisation
taking
on
a
Agency needs to collect information on the nature of
subset of the functions specified in Article 4 may apply the
the certification bodies active in this field and the
system of certification on a voluntary basis, based on the prin
number of certificates issued to entities in charge of
ciples specified in Article 8 and Annex I.
maintenance. It is also important for the Agency to
facilitate coordination of the certification bodies.
3. References
to
an
infrastructure
manager
in
Articles
5,
7
and 12 shall be understood as relating to its operations with
(12) Commission
Regulation
(EC)
No
653/2007
of
13
June
freight wagons for transporting materials for construction or for
2007 on the use of a common European format for
infrastructure maintenance activities. When it operates freight
safety certificates and application documents in
wagons for this purpose, an infrastructure manager shall be
accordance with Article 10 of Directive 2004/49/EC of
deemed to do so in the capacity of a railway undertaking.
the European Parliament and of the Council and on the
validity of safety certificates delivered under Directive
2001/14/EC ( 2 ) provides the standard format for safety
Article 3
certificates. This format must be updated to include
further information on entities in charge of maintenance.
Definitions
Regulation (EC) No 653/2007 should therefore be
1. For the purposes of this Regulation, the definitions laid
amended accordingly.
down in Article 3 of Directive 2004/49/EC apply.
(13) Pending
the
full
application
of
the
certification
system
of
2. In
addition,
the
following
definitions
apply:
the entity in charge of maintenance provided for in this
Regulation, the validity of existing practices to certify
entities in charge of maintenance and maintenance
(a)
‘accreditation’ means accreditation as defined in
workshops should be recognised during a period of tran
Article 2(10) of Regulation (EC) No 765/2008;
sition in order to ensure the uninterrupted provision of
rail freight services, in particular at international level.
During this period the national safety authorities
should pay particular attention to the equivalence and
(b) ‘ECM certificate’ means a certificate issued to an entity in
the consistency of the different certification practices.
charge of maintenance for the purposes of Article 14a(4) of

Directive 2004/49/EC;
(14) The
measures
provided
for
in
this
Regulation
are
in
(c) ‘certification body’ means a body, designated in accordance
accordance with the opinion of the Committee estab
with Article 10, responsible for the certification of entities
lished by Article 27 of Directive 2004/49/EC,
in charge of maintenance, on the basis of the criteria in
Annex II;
HAS ADOPTED THIS REGULATION:
(d) ‘freight wagon’ means a non-self-propelled vehicle designed
for the purpose of transporting freight or other materials to
Article 1
be used for activities such as construction or infrastructure
Purpose
maintenance;
1. This
Regulation
establishes
a
system
of
certification
of
entities in charge of maintenance for freight wagons as
(e) ‘maintenance workshop’ means a mobile or fixed entity
referred to in Article 14a of Directive 2004/49/EC.
composed of staff, including those with management
responsibility, tools and facilities organised to deliver main
( 1 ) OJ L 218, 13.8.2008, p. 30.
tenance of vehicles, parts, components or sub-assemblies of
( 2 ) OJ L 153, 14.6.2007, p. 9.
vehicles;

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L 122/24
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Official Journal of the European Union
11.5.2011
(f) ‘release to service’ means the assurance given to the fleet
Article 5
maintenance manager by the entity delivering the main
tenance that maintenance has been delivered according to
Relationships between parties involved in the maintenance
the maintenance orders;
process
1. Each
railway
undertaking
or
infrastructure
manager
shall
ensure that the freight wagons it operates, before their
(g) ‘return to operation’ means the assurance, based on a release
departure, have a certified entity in charge of maintenance
to service, given to the user, such as a railway undertaking
and that the use of the wagon corresponds to the scope of
or a keeper, by the entity in charge of maintenance that all
the certificate.
appropriate maintenance works have been completed and
the wagon, previously removed from operation, is in a
condition to be used safely, possibly subject to temporary
2. All
parties
involved
in
the
maintenance
process
shall
restrictions of use.
exchange relevant information about maintenance in
accordance with the criteria listed in sections I.7 and I.8 of
Annex III.
Article 4
Maintenance system
3. Following
contractual
arrangements,
a
railway
undertaking
may request information for operational purposes on the main
1. The
maintenance
system
shall
be
composed
of
the tenance of a freight wagon. The entity in charge of the main
following functions:
tenance of the freight wagon shall respond to such requests
either directly or through other contracting parties.
(a) the management function, which supervises and coordinates
the maintenance functions referred to in points (b) to (d)
4. Following
contractual
arrangements,
an
entity
in
charge
of
and ensures the safe state of the freight wagon in the
maintenance may request information on the operation of a
railway system;
freight wagon. The railway undertaking or the infrastructure
manager shall respond to such requests either directly or
through other contracting parties.
(b) the maintenance development function, which is responsible
for the management of the maintenance documentation,
including the configuration management, based on design
5. All
contracting
parties
shall
exchange
information
on
and operational data as well as on performance and return
safety-related malfunctions, accidents, incidents, near-misses
on experience;
and other dangerous occurrences as well as on any possible
restriction on the use of freight wagons.
(c) the fleet maintenance management function, which manages
6. The
certificates
of
entities
in
charge
of
maintenance
shall
the freight wagon’s removal for maintenance and its return
be accepted as proof of the ability of a railway undertaking or
to operation after maintenance; and
infrastructure manager to meet the requirements governing
maintenance and the control of contractors and suppliers
specified in Annex II, points B.1, B.2, B.3 and C.1, to
(d) the maintenance delivery function, which delivers the
Commission Regulation (EU) No 1158/2010 of 9 December
required technical maintenance of a freight wagon or
2010 on a common safety method for assessing conformity
parts of it, including the release to service documentation.
with the requirements for obtaining railways safety
certificates ( 1 ) and Commission Regulation (EU) No
1169/2010 of 10 December 2010 on a common safety
2. The
entity
in
charge
of
maintenance
shall
ensure
that
the method for assessing conformity with the requirements for
functions referred to in paragraph 1 comply with the
obtaining a railways safety authorisation
( 2 ), unless the
requirements and assessment criteria set out in Annex III.
national safety authority can demonstrate the existence of a
substantial safety risk.
3. The
entity
in
charge
of
maintenance
shall
carry
out
the 7. If a contracting party, in particular a railway undertaking,
management function itself, but may outsource the maintenance
has a justified reason to believe that a particular entity in charge
functions referred to in points (b) to (d) of paragraph 1, or parts
of maintenance does not comply with the requirements of
of them, to other contracting parties subject to the provisions of
Article 14a(3) of Directive 2004/49/EC or with the certification
Article 8. Where it resorts to outsourcing, the entity in charge
requirements of this Regulation, it shall promptly inform the
of maintenance shall ensure that the principles set out in Annex
certification body thereof. The certification body shall take
I are applied.
appropriate action to check if the claim of non-compliance is
justified and shall inform the parties involved (including the
competent national safety authority if relevant) of the results
4. Regardless
of
the
outsourcing
arrangements
in
place,
the of its investigation.
entity in charge of maintenance shall be responsible for the
outcome of the maintenance activities it manages and shall
( 1 ) OJ L 326, 10.12.2010, p. 11.
establish a system to monitor performance of those activities.
( 2 ) OJ L 327, 11.12.2010, p. 13.

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11.5.2011 Official
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European
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8. When
there
is
a
change
of
entity
in
charge
of
main
3. The
certification
body
shall
take
a
decision
no
later
than
4
tenance, the registration holder as indicated in Article 33(3)
months after all the information required and any supple
of Directive 2008/57/EC of the European Parliament and of
mentary information requested has been submitted to it by
the Council ( 1 ), shall inform in due time the registration
the entity in charge of maintenance applying for the certificate.
entity, as defined in Article 4(1) of Commission Decision
The certification body shall undertake the necessary assessment
2007/756/EC ( 2 ), so that the latter may update the national
at the site or sites of the entity in charge of maintenance prior
vehicle register.
to the award of the certificate. The decision on the award of the
certificate shall be communicated to the entity in charge of
The former entity in charge of maintenance shall deliver the
maintenance using the relevant form in Annex V.
maintenance documentation to either the registration holder or
the new entity in charge of maintenance.
4. An ECM certificate shall be valid for a period up to 5
years. The holder of the certificate shall without delay inform
The former entity in charge of maintenance is relieved of its
the certification body of all significant changes in the circum
responsibilities when it is removed from the national vehicle
stances applying at the time the original certificate was awarded
register. If on the date of de-registration of the former entity
to allow the certification body to decide whether to amend,
in charge of maintenance any new entity has not acknowledged
renew or revoke it.
its acceptance of entity in charge of maintenance status, the
registration of the vehicle is suspended.
5.
The certification body shall set out in detail the reasons on
Article 6
which each of its decisions is based. The certification body shall
notify its decision and the reasons to the entity in charge of
Certification bodies
maintenance, together with an indication of the process, time
1. ECM
certificates
shall
be
awarded
by
any
competent limit for appeal and the contact details of the appeal body.
certification body, chosen by the applicant entity in charge of
maintenance.
6. The
certification
body
shall
conduct
surveillance
at
least
once a year at selected sites, geographically and functionally
2. Member
States
shall
ensure
that
the
certification
bodies representative of all the activities of those entities in charge of
comply with the general criteria and principles set out in
maintenance it has certified, to verify that the entities still satisfy
Annex II and with any subsequent sectoral accreditation
the criteria set out in Annex III.
schemes.
3. Member
States
shall
take
the
measures
necessary
to
ensure 7. If
the
certification
body
finds
that
an
entity
in
charge
of
that decisions taken by the certification bodies are subject to
maintenance no longer satisfies the requirements on the basis of
judicial review.
which it issued the ECM certificate, it shall agree an
improvement plan with the entity in charge of maintenance,
4. In
order
to
harmonise
approaches
to
the
assessment
of or limit the scope of application of the certificate, or suspend
applications, the certification bodies shall cooperate with each
the certificate, depending on the degree of non-compliance.
other both within the Member States and across the Union.
In the event of continuous non-compliance with the certifi
5. The
Agency
shall
organise
and
facilitate
cooperation cation requirements or any improvement plan, the certification
between the certification bodies.
body shall limit the scope of or revoke the ECM certificate,
giving reasons for its decision, together with an indication of
Article 7
the process and time limit for appeal and the contact details of
the appeal body.
System of certification for entities in charge of
maintenance
1. Certification
shall
be
based
on
an
assessment
of
the
ability 8. When
a
railway
undertaking
or
an
infrastructure
manager
of the entity in charge of maintenance to meet the relevant
applies for a safety certificate or safety authorisation, the
requirements in Annex III and to apply them consistently. It
following shall apply concerning the freight wagons it uses:
shall include a system of surveillance to ensure continuing
compliance with the applicable requirements after award of
(a) where the freight wagons are maintained by the applicant,
the ECM certificate.
either the applicant shall include as part of its application a
valid ECM certificate, if available, or its capacity as entity in
2. The
entities
in
charge
of
maintenance
shall
apply
for
charge of maintenance shall be assessed as part of its appli
certification using the relevant form in Annex IV and
cation for a safety certificate or safety authorisation;
providing documentary evidence of the procedures specified
in Annex III. They shall promptly submit all supplementary
information requested by the certification body. In assessing
(b) where the freight wagons are maintained by parties other
applications, certification bodies shall apply the requirements
than the applicant, the applicant shall ensure, through its
and assessment criteria set out in Annex III.
safety management system, the control of all risks related to
its activity, including the use of such wagons, whereby, in
( 1 ) OJ L 191, 18.7.2008, p. 1.
particular, the provisions of Article 5 of this Regulation
( 2 ) OJ L 305, 23.11.2007, p. 30.
shall apply.

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Certification bodies and national safety authorities shall conduct
inform the Agency of the certification bodies accredited. Any
an active exchange of views in all circumstances in order to
change shall also be notified to the Agency within 1 month of
avoid any duplication of assessment.
the change.
Article 8
3. Certification
bodies
shall
notify
the
Agency
of
all
issued,
System of certification for outsourced maintenance
amended, renewed or revoked ECM certificates or certificates for
functions
specific functions according to Article 4(1), within 1 week from
its decision, using the forms in Annex V.
1. Where the entity in charge of maintenance decides to
outsource one or more of the functions referred to in
Article 4(1)(b), (c) and (d), or parts of them, voluntary certifi
cation of the contractor under the certification system of this
4. The Agency shall keep a record of all information notified
Regulation shall create a presumption of conformity of the
under paragraphs 2 and 3 and shall make it publicly available.
entity in charge of maintenance with the relevant requirements
set out in Annex III, as far as these requirements are covered by
the voluntary certification of the contractor. In the absence of
such certification, the entity in charge of maintenance shall
Article 11
demonstrate to the certification body how it complies with all
Amendment to Regulation (EC) No 653/2007
the requirements set out in Annex III with regard to the
functions it decides to outsource.
Annex I to Regulation (EC) No 653/2007 is replaced by the text
set out in Annex VI to this Regulation.
2. Certification in respect of outsourced maintenance
functions, or parts of them, shall be issued by the certification
Article 12
bodies, following the same procedures in Articles 6, 7, and
10(3), adapted to the specific case of the applicant. They shall
Transitional provisions
be valid throughout the Union.
1. The
following
transitional
provisions
shall
apply
without
prejudice to Article 9.
In assessing applications for certificates in respect of outsourced
maintenance functions, or parts of them, certification bodies
shall follow the principles set out in Annex I.
2. Starting
from
31
May
2012,
any
ECM
certificate
shall
be
issued in accordance with this Regulation to entities in charge
of maintenance for freight wagons, without prejudice to
Article 14a(8) of Directive 2004/49/EC.
Article 9
Role of the supervision regime
If a national safety authority has a justified reason to believe
3. Certificates
issued
by
a
certification
body
by
no
later
than
that a particular entity in charge of maintenance does not
31 May 2012 on the basis of principles and criteria equivalent
comply with the requirements of Article 14a(3) of Directive
to those of the Memorandum of Understanding establishing the
2004/49/EC or with the certification requirements of this Regu
basic principles of a common system of certification of entities
lation, it shall immediately take the necessary decision and
in charge of maintenance for freight wagons, signed by Member
inform the Commission, the Agency, other competent
States on 14 May 2009, shall be recognised as being equivalent
authorities, the certification body and other interested parties
to ECM certificates issued under this Regulation for their
of its decision.
original validity period until at the latest 31 May 2015.
Article 10
4. Certificates
issued
by
a
certification
body
to
entities
in
charge of maintenance by no later than 31 May 2012 on the
Provision of information to the Commission and the
basis of national laws existing before the entry into force of this
Agency
Regulation and equivalent to this Regulation, in particular
1. By
no
later
than
30
November
2011,
Member
States
shall Articles 6 and 7 and Annexes I and III, shall be recognised as
inform the Commission whether the certification bodies are
being equivalent to ECM certificates issued under this Regu
accredited bodies, recognised bodies or national safety
lation for their original period of validity until at the latest
authorities. They shall also notify any change in this situation
31 May 2015.
to the Commission within 1 month of the change.
5. Certificates
issued
to
maintenance
workshops
by
no
later
2. By
no
later
than
31
May
2012,
Member
States
shall
notify than 31 May 2014 on the basis of national laws existing before
the Agency of the certification bodies recognised. The accredi
the entry into force of this Regulation and equivalent to this
tation bodies as defined in Regulation (EC) No 765/2008 shall
Regulation shall be recognised as being equivalent to certificates

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of
the
European
Union L
122/27
for maintenance workshops taking on the maintenance delivery
14 May 2009 shall be recognised as being equivalent to ECM
function issued under this Regulation for their original period of
certificates issued under this Regulation.
validity until at the latest 31 May 2017.
7. Railway
undertakings
and
infrastructure
managers
which
are already certified in accordance with Articles 10 and 11 of
Directive 2004/49/EC by no later than 31 May 2012 need not
6. Without prejudice to paragraphs 3 to 5, entities in charge
apply for an ECM certificate for the original period of validity of
of maintenance for freight wagons registered in the national
their certificates for maintaining the wagons they are
vehicle register by no later than 31 May 2012 shall be
responsible for as entity in charge of maintenance.
certified in accordance with this Regulation by no later than
31 May 2013. During this period, self declarations of
Article 13
conformity of entities in charge of maintenance to the
Entry into force
relevant requirements of the present Regulation or of the
Memorandum of Understanding establishing the basic principles
This Regulation shall enter into force on the 20th day following
of a common system of certification of entities in charge of
the date of its publication in the Official Journal of the European
maintenance for freight wagons, signed by Member States on
Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 10 May 2011.
For the Commission
The President
José Manuel BARROSO

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ANNEX I
Principles to be used for organisations applying for a certificate in respect of maintenance functions outsourced
by an entity in charge of maintenance
1. For certification of an entity or organisation taking on one or more maintenance functions of an entity in charge of
maintenance (maintenance development, fleet maintenance management, maintenance delivery) or parts of them, the
following requirements and assessment criteria contained in Annex III apply:
(a) requirements and assessment criteria set out in section I of Annex III, adapted to the organisation’s type and extent
of service;
(b) requirements and assessment criteria describing the specific maintenance function or functions.
2. For certification of a maintenance workshop taking on the maintenance delivery function, the following requirements
and assessment criteria contained in Annex III apply:
(a) the requirements and assessment criteria set out in section I of Annex III, which must be adapted to the specific
activity of a maintenance workshop providing the maintenance delivery function;
(b) the processes describing the maintenance delivery function.

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European
Union L
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ANNEX II
Criteria for accreditation or recognition of certification bodies involved in the assessment and award of ECM
certificates
1. ORGANISATION
The certification body must document its organisational structure, showing the duties, responsibilities and authorities of
management and other certification staff and any committees. Where the certification body is a defined part of a legal
entity, the structure must include the line of authority and the relationship to other parts within the same legal entity.
2. INDEPENDENCE
The certification body must be organisationally and functionally independent in its decision-making from railway under
takings, infrastructure managers, keepers, manufacturers and entities in charge of maintenance and shall not provide
similar services.
The independence of the staff responsible for the certification checks must be guaranteed. No official must be remu-
nerated on the basis of either the number of checks performed or the results of those checks.
3. COMPETENCE
The certification body and the staff deployed must have the required professional competence, in particular regarding the
organisation of the maintenance of freight wagons and the appropriate maintenance system.
The certification body must demonstrate:
(a) sound experience in assessing management systems;
(b) knowledge of the applicable requirements of the legislation.
The team established for surveillance of the entities in charge of maintenance must be experienced in the relevant fields,
and in particular must demonstrate:
(a) appropriate knowledge and understanding of the applicable European legislation;
(b) relevant technical competence;
(c) a minimum of 3 years of relevant experience in maintenance in general;
(d) sufficient experience in freight wagon maintenance or at least in maintenance in equivalent industrial sectors.
4. IMPARTIALITY
The certification body’s decisions must be based on objective evidence of conformity or non-conformity obtained by the
certification body, and must not be influenced by other interests or by other parties.
5. RESPONSIBILITY
The certification body is not responsible for ensuring ongoing conformity with the requirements for certification.
The certification body has the responsibility to assess sufficient objective evidence upon which to base a certification
decision.
6. OPENNESS
A certification body needs to provide public access to, or disclosure of, appropriate and timely information about its audit
process and certification process. It also needs to provide information about the certification status (including the
granting, extension, maintenance, renewal, suspension, reduction in scope, or withdrawal of certification) of any organi
sation, in order to develop confidence in the integrity and credibility of certification. Openness is a principle of access to,
or disclosure of, appropriate information.
7. CONFIDENTIALITY
To gain the privileged access to information needed to assess conformity with the requirements for certification
adequately, a certification body must keep confidential any commercial information about a client.

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8. RESPONSIVENESS TO COMPLAINTS
The certification body must establish a procedure to handle complaints about decisions and other certification-related
activities.
9. LIABILITY AND FINANCING
The certification body must be able to demonstrate that it has evaluated the risks arising from its certification activities
and that it has adequate arrangements (including insurance or reserves) to cover liabilities arising from its operations in
each field of its activities and the geographic areas in which it operates.

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EN
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of
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European
Union L
122/31
ANNEX III
Requirements and assessment criteria for organisations applying for an ECM certificate or for a certificate in
respect of maintenance functions outsourced by an entity in charge of maintenance
I. Management
function
requirements
and
assessment
criteria
1. Leadership
— commitment to the development and implementation of the maintenance system of the organisation and to the
continuous improvement of its effectiveness
The organisation must have procedures for:
(a) establishing a maintenance policy appropriate to the organisation’s type and extent of service and approved by
the organisation’s chief executive or his or her representative;
(b) ensuring that safety targets are established, in line with the legal framework and consistent with an organisation’s
type, extent and relevant risks;
(c) assessing its overall safety performance in relation to its corporate safety targets;
(d) developing plans and procedures for reaching its safety targets;
(e) ensuring the availability of the resources needed to perform all processes to comply with the requirements of
this Annex;
(f) identifying and managing the impact of other management activities on the maintenance system;
(g) ensuring that senior management is aware of the results of performance monitoring and audits and takes overall
responsibility for the implementation of changes to the maintenance system;
(h) ensuring that staff and staff representatives are adequately represented and consulted in defining, developing,
monitoring and reviewing the safety aspects of all related processes that may involve staff.
2. Risk
assessment
— a structured approach to assess risks associated with the maintenance of freight wagons, including those
directly arising from operational processes and the activities of other organisations or persons, and to identify the appropriate risk
control measures
2.1. The organisation must have procedures for:
(a) analysing risks relevant to the extent of operations carried out by the organisation, including the risks arising
from defects and construction non-conformities or malfunctions throughout the lifecycle;
(b) evaluating the risks referred to in point (a);
(c) developing and putting in place risk control measures.
2.2. The organisation must have procedures and arrangements in place to recognise the need and commitment to
collaborate with keepers, railway undertakings, infrastructure managers, or other interested parties.
2.3. The organisation must have risk assessment procedures to manage changes in equipment, procedures, organisation,
staffing or interfaces, and to apply Commission Regulation (EC) No 352/2009 ( 1 ).
2.4. When assessing risk, an organisation must have procedures to take into account the need to determine, provide and
sustain an appropriate working environment which conforms to Union and national legislation, in particular
Council Directive 89/391/EEC ( 2 ).
3. Monitoring
— a structured approach to ensure that risk control measures are in place, working correctly and achieving the
organisation’s objectives
3.1. The organisation must have a procedure to regularly collect, monitor and analyse relevant safety data, including:
(a) the performance of relevant processes;
(b) the results of processes (including all contracted services and products);
( 1 ) OJ L 108, 29.4.2009, p. 4.
( 2 ) OJ L 183, 29.6.1989, p. 1.

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(c) the effectiveness of risk control arrangements;
(d) information on experience, malfunctions, defects and repairs arising from day-to-day operation and main
tenance.
3.2. The organisation must have procedures to ensure that accidents, incidents, near-misses and other dangerous
occurrences are reported, logged, investigated and analysed.
3.3. For a periodic review of all processes, the organisation must have an internal auditing system which is independent,
impartial and acts in a transparent way. This system must have procedures in place to:
(a) develop an internal audit plan, which can be revised depending on the results of previous audits and monitoring
of performance;
(b) analyse and evaluate the results of the audits;
(c) propose and implement specific corrective measures/actions;
(d) verify the effectiveness of previous measures/actions.
4. Continuous
improvement
— a structured approach to analyse the information gathered through regular monitoring, auditing,
or other relevant sources and to use the results to learn and to adopt preventive or corrective measures in order to maintain or
improve the level of safety
The organisation must have procedures to ensure that:
(a) identified shortcomings are rectified;
(b) new safety developments are implemented;
(c) internal audit findings are used to bring about improvement in the system;
(d) preventive or corrective actions are implemented, when needed, to ensure compliance of the railway system with
standards and other requirements throughout the lifecycle of equipment and operations;
(e) relevant information relating to the investigation and causes of accidents, incidents, near-misses and other
dangerous occurrences is used to learn and, where necessary, to adopt measures in order to improve the
level of safety;
(f) relevant recommendations from the national safety authority, from the national investigation body and from
industry or internal investigations are evaluated and implemented if appropriate;
(g) relevant reports/information from railway undertakings/infrastructure managers and keepers or other relevant
sources are considered and taken into account.
5. Structure
and
responsibility
— a structured approach to define the responsibilities of individuals and teams for secure delivery
of the organisation’s safety objectives
5.1. The organisation must have procedures to allocate responsibilities for all relevant processes throughout the organi
sation.
5.2. The organisation must have procedures to clearly define safety-related areas of responsibility and the distribution of
responsibilities to specific functions associated with them as well as their interfaces. These include the procedures
indicated above between the organisation and the keepers and, where appropriate, railway undertakings and infra
structure managers.
5.3. The organisation must have procedures to ensure that staff with delegated responsibilities within the organisation
have the authority, competence and appropriate resources to perform their functions. Responsibility and
competence should be coherent and compatible with the given role, and delegation must be in writing.
5.4. The organisation must have procedures to ensure the coordination of activities related to relevant processes across
the organisation.
5.5. The organisation must have procedures to hold those with a role in the management of safety accountable for their
performance.
6. Competence
management
— a structured approach to ensure that employees have the competences required in order to
achieve the organisation’s objectives safely, effectively and efficiently in all circumstances
6.1. The organisation must set up a competence management system providing for:
(a) the identification of posts with responsibility for performing within the system all the processes necessary for
compliance with the requirements of this Annex;
(b) the identification of posts involving safety tasks;

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(c) the allocation of staff with the appropriate competence to relevant tasks.
6.2. Within the organisation’s competence management system, there must be procedures to manage the competence of
staff, including at least:
(a) identification of the knowledge, skills and experience required for safety-related tasks as appropriate for the
responsibilities;
(b) selection principles, including basic educational level, mental aptitude and physical fitness;
(c) initial training and qualification or certification of acquired competence and skills;
(d) assurance that all staff are aware of the relevance and importance of their activities and how they contribute to
the achievement of safety objectives;
(e) ongoing training and periodical updating of existing knowledge and skills;
(f) periodic checks of competence, mental aptitude and physical fitness where appropriate;
(g) special measures in the case of accidents/incidents or long absences from work, as required.
7. Information
— a structured approach to ensure that important information is available to those making judgments and
decisions at all levels of the organisation
7.1. The organisation must have procedures to define reporting channels to ensure that, within the entity itself and in its
dealings with other actors, including infrastructure managers, railways undertakings and keepers, information on all
relevant processes is duly exchanged and submitted to the person having the right role both within its own
organisation and in other organisations, in a prompt and clear way.
7.2. To ensure an adequate exchange of information, the organisation must have procedures:
(a) for the receipt and processing of specific information;
(b) for the identification, generation and dissemination of specific information;
(c) for making available reliable and up-to-date information.
7.3. The organisation must have procedures to ensure that key operational information is:
(a) relevant and valid;
(b) accurate;
(c) complete;
(d) appropriately updated;
(e) controlled;
(f) consistent and easy to understand (including the language used);
(g) made known to staff before it is applied;
(h) easily accessible to staff, with copies provided to them where required.
7.4. The requirements set out in points 7.1, 7.2 and 7.3 apply in particular to the following operational information:
(a) checks of the accuracy and completeness of national vehicle registers regarding the identification (including
means) and registration of the freight wagons maintained by the organisation;
(b) maintenance documentation;
(c) information on support provided to keepers and, where appropriate, to other parties, including railway under
takings/infrastructure managers;
(d) information on the qualification of staff and subsequent supervision during maintenance development;
(e) information on operations (including mileage, type and extent of activities, incidents/accidents) and requests of
railway undertakings, keepers and infrastructure managers;
(f) records of maintenance performed, including information on deficiencies detected during inspections and
corrective actions taken by railway undertakings or by infrastructure managers such as inspections and moni
toring undertaken before the departure of the train or en route;
(g) release to service and return to operation;
(h) maintenance orders;

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(i) technical information to be provided to railway undertakings/infrastructure managers and keepers for main
tenance instructions;
(j) emergency information concerning situations where the safe state of running is impaired, which may consist of:
(i) the imposition of restrictions of use or specific operating conditions for the freight wagons maintained by
the organisation or other vehicles of the same series even if maintained by other entities in charge of
maintenance, whereby this information should also be shared with all involved parties;
(ii) urgent information on safety-related issues identified during maintenance, such as deficiencies detected in a
component common to several types or series of vehicles;
(k) all relevant information/data needed to submit the annual maintenance report to the certification body and to
the relevant customers (including keepers), whereby this report must also be made available upon request to
national safety authorities.
8. Documentation
— a structured approach to ensure the traceability of all relevant information
8.1. The organisation must have adequate procedures in place to ensure that all relevant processes are duly documented.
8.2. The organisation must have adequate procedures in place to:
(a) regularly monitor and update all relevant documentation;
(b) format, generate, distribute and control changes to all relevant documentation;
(c) receive, collect and archive all relevant documentation.
9. Contracting
activities
— a structured approach to ensure that subcontracted activities are managed appropriately in order for
the organisation’s objectives to be achieved
9.1. The organisation must have procedures in place to ensure that safety related products and services are identified.
9.2. When making use of contractors and/or suppliers for safety related products and services, the organisation must
have procedures in place to verify at the time of selection that:
(a) contractors, subcontractors and suppliers are competent;
(b) contractors, subcontractors and suppliers have a maintenance and management system that is adequate and
documented.
9.3. The organisation must have a procedure to define the requirements that such contractors and suppliers have to
meet.
9.4. The organisation must have procedures to monitor the awareness of suppliers and/or contractors of risks they entail
to the organisation’s operations.
9.5. When the maintenance/management system of a contractor or supplier is certified, the monitoring process described
in point 3 may be limited to the results of the contracted operational processes referred to in point 3.1(b).
9.6. At least the basic principles for the following processes must be clearly defined, known and allocated in the contract
between the contracting parties:
(a) responsibilities and tasks relating to railway safety issues;
(b) obligations relating to the transfer of relevant information between both parties;
(c) the traceability of safety-related documents.
II. Requirements
and
assessment
criteria
for
the
maintenance
development
function
1. The organisation must have a procedure to identify and manage all maintenance activities affecting safety and safety-
critical components.
2. The
organisation
must
have
procedures
to
guarantee
conformity
with
the
essential
requirements
for
interoperability,
including updates throughout the lifecycle, by:
(a) ensuring compliance with the specifications related to the basic parameters for interoperability as set out in the
relevant technical specifications for interoperability (TSIs);
(b) verifying in all circumstances the consistency of the maintenance file with the authorisation of placing-in-service
(including any national safety authority requirements), the declarations of conformity to TSIs, the declarations of
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(c) managing any substitution in the course of maintenance in compliance with the requirements of the Directive
2008/57/EC and the relevant TSIs;
(d) identifying the need for risk assessment regarding the potential impact of the substitution in question on the
safety of the railway system;
(e) managing the configuration of all technical changes affecting the system integrity of the vehicle.
3. The organisation must have a procedure to design and to support the implementation of maintenance facilities,
equipment and tools specifically developed and required for maintenance delivery. The organisation must have a
procedure to check that these facilities, equipment and tools are used, stored and maintained according to their
maintenance schedule and in conformity with their maintenance requirements.
4. When
freight
wagons
start
operations,
the
organisation
must
have
procedures
to:
(a) obtain the initial documentation and to collect sufficient information on planned operations;
(b) analyse the initial documentation and to provide the first maintenance file, also taking into account the
obligations contained in any associated guarantees;
(c) ensure that the implementation of the first maintenance file is done correctly.
5. To keep the maintenance file updated throughout the lifecycle of a freight wagon, the organisation must have
procedures to:
(a) collect at least the relevant information in relation to:
(i) the type and extent of operations effectively performed, including, but not limited to, operational incidents
with a potential to affect the safety integrity of the freight wagon;
(ii) the type and extent of operations planned;
(iii) the maintenance effectively performed;
(b) define the need for updates, taking into account the limit values for interoperability;
(c) make proposals for and approve changes and their implementation, with a view to a decision based on clear
criteria, taking into account the findings from risk assessment;
(d) ensure that the implementation of changes is done correctly.
6. When the competence management process is applied to the maintenance development function, at least the
following activities affecting safety must be taken into account:
(a) assessment of the significance of changes for the maintenance file and proposed substitutions in the course of
maintenance;
(b) engineering disciplines required for managing the establishment and the changes of maintenance file and the
development, assessment, validation and approval of substitutions in the course of maintenance;
(c) joining techniques (including welding and bonding), brake systems, wheel sets and draw gear, non-destructive
testing techniques and maintenance activities on specific components of freight wagons for the transport of
dangerous goods such as tanks and valves.
7. When the documentation process is applied to the maintenance development function, the traceability of at least the
following elements needs to be guaranteed:
(a) the documentation relating to the development, assessment, validation and approval of a substitution in the
course of maintenance;
(b) the configuration of vehicles, including, but not limited to, components related to safety;
(c) records of the maintenance performed;
(d) results of studies concerning return on experience;
(e) all the successive versions of the maintenance file, including risk assessment;
(f) reports on the competence and supervision of maintenance delivery and fleet maintenance management;
(g) technical information to be provided to support keepers, railway undertakings and infrastructure managers.

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III. Requirements
and
assessment
criteria
for
the
fleet
maintenance
management
function
1. The organisation must have a procedure to check the competence, availability and capability of the entity
responsible for maintenance delivery before placing maintenance orders. This requires that the maintenance
workshops are duly qualified to decide upon the requirements for technical competences in the maintenance
delivery function.
2. The organisation must have a procedure for the composition of the work package and for the issue and release of
the maintenance order.
3. The
organisation
must
have
a
procedure
to
send
freight
wagons
for
maintenance
in
due
time.
4. The
organisation
must
have
a
procedure
to
manage
the
removal
of
freight
wagons
from
operation
for
maintenance
or when defects have been identified.
5. The organisation must have a procedure to define the necessary control measures applied to the maintenance
delivered and the release to service of the freight wagons.
6. The organisation must have a procedure to issue a notice to return to operation, taking into account the release to
service documentation.
7. When the competence management (CM) process is applied to the fleet maintenance management function, at least
the return to operation must be taken into account.
8. When the information process is applied to the fleet maintenance management function, at least the following
elements need to be provided to the maintenance delivery function:
(a) applicable rules and technical specifications;
(b) the maintenance plan for each freight wagon;
(c) a list of spare parts, including a sufficiently detailed technical description of each part to allow like-for-like
replacement with the same guarantees;
(d) a list of materials, including a sufficiently detailed description of their use and the necessary health and safety
information;
(e) a dossier that defines the specifications for activities affecting safety and contains intervention and in-use
restrictions for components;
(f) a list of components or systems subject to legal requirements and a list of these requirements (including brake
reservoirs and tanks for the transport of dangerous goods);
(g) all additional relevant information related to safety according to the risk assessment performed by the organi
sation.
9. When the information process is applied to the fleet maintenance management function, at least the return to
operation, including restrictions on use relevant to users (railway undertakings and infrastructure managers), needs
to be communicated to interested parties.
10. When the documentation process is applied to the fleet maintenance management function, at least the following
elements need to be recorded:
(a) maintenance orders;
(b) return to operation, including restrictions on use relevant to railway undertakings and infrastructure managers.
IV. Requirements
and
assessment
criteria
for
the
maintenance
delivery
function
1. The
organisation
must
have
procedures
to:
(a) check the completeness and appropriateness of the information delivered by the fleet maintenance management
function in relation to the activities ordered;
(b) control the use of the required, relevant maintenance documents and other standards applicable to the delivery
of maintenance services in accordance with maintenance orders;
(c) ensure that all relevant maintenance specifications in the maintenance orders are available to all involved staff
(e.g. they are contained in internal working instructions);
(d) ensure that all relevant maintenance specifications, as defined in applicable regulations and specified standards
contained in the maintenance orders, are available to all involved staff (e.g. they are contained in internal
working instructions).
2. The
organisation
must
have
procedures
to
ensure
that:
(a) components (including spare parts) and materials are used as specified in the maintenance orders and supplier
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(b) components and materials are stored, handled and transported in a manner that prevents wear and damage and
as specified in the maintenance orders and supplier documentation;
(c) all components and materials, including those provided by the customer, comply with relevant national and
international rules as well as with the requirements of relevant maintenance orders.
3. The
organisation
must
have
procedures
to
determine,
identify,
provide,
record
and
keep
available
suitable
and
adequate facilities, equipment and tools to enable it to deliver the maintenance services in accordance with main
tenance orders and other applicable specifications, ensuring:
(a) the safe delivery of maintenance, including the health and safety of maintenance staff;
(b) ergonomics and health protection, also including the interfaces between users and information technology
systems or diagnostic equipment.
4. Where necessary to ensure valid results, the organisation must have procedures to ensure that its measuring
equipment is:
(a) calibrated or verified at specified intervals, or prior to use, against international, national or industrial
measurement standards — where no such standards exist, the basis used for calibration or verification must
be recorded;
(b) adjusted or re-adjusted as necessary;
(c) identified to enable the calibration status to be determined;
(d) safeguarded from adjustments that would invalidate the measurement result;
(e) protected from damage and deterioration during handling, maintenance and storage.
5. The
organisation
must
have
procedures
to
ensure
that
all
facilities,
equipment
and
tools
are
correctly
used,
calibrated, preserved and maintained in accordance with documented procedures.
6. The
organisation
must
have
procedures
to
check
that
the
performed
maintenance
tasks
are
in
accordance
with
the
maintenance orders and to issue the notice to release to service that includes eventual restrictions of use.
7. When the risk assessment process (in particular point 2.4 of section I) is applied to the maintenance delivery
function, the working environment includes not only the workshops where maintenance is done but also the tracks
outside the workshop buildings and all places where maintenance activities are performed.
8. When the competence management process is applied to the maintenance delivery function, at least the following
activities affecting safety must be taken into account:
(a) joining techniques (including welding and bonding);
(b) non-destructive testing;
(c) final vehicle testing and release to service;
(d) maintenance activities on brake systems, wheel sets and draw gear and maintenance activities on specific
components of freight wagons for the transport of dangerous goods, such as tanks, valves, etc.;
(e) other identified specialist areas affecting safety.
9. When the information process is applied to the maintenance delivery function, at least the following elements must
be provided to the fleet maintenance management and maintenance development functions:
(a) works performed in accordance with the maintenance orders;
(b) any possible fault or defect regarding safety which is identified by the organisation;
(c) the release to service.
10. When the documentation process is applied to the maintenance delivery function, at least the following elements
must be recorded:
(a) clear identification of all facilities, equipments and tools related to activities affecting safety;
(b) all maintenance works performed, including personnel, tools, equipment, spare parts and materials used and
taking into account:

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(i) relevant national rules where the organisation is established;
(ii) requirements laid down in the maintenance orders, including requirements regarding records;
(iii) final testing and decision regarding release to service;
(c) the control measures required by maintenance orders and the release to service;
(d) the results of calibration and verification, whereby, for computer software used in the monitoring and
measurement of specified requirements, the ability of the software to perform the desired task must be
confirmed prior to initial use and reconfirmed as necessary;
(e) the validity of the previous measuring results when a measuring instrument is found not to conform to
requirements.

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ANNEX IV

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ANNEX V

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ANNEX VI
‘ANNEX I

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