Assessment bodies: NoBo, DeBo, AsBo for RA

Athens, 16th DEC 2014

Luca TRINCA, Interoperability Unit

CONTENT

1. INTRODUCTION ON ASSESSMENT BODIES

2. ACCREDITATION AND RECOGNITION

3. NOTIFIED BODIES
4. DESIGNATED BODIES

5. ASSESSMENT BODIES FOR CSM-RA

CONTENT

1. INTRODUCTION ON ASSESSMENT BODIES

2. ACCREDITATION AND RECOGNITION

3. NOTIFIED BODIES
4. DESIGNATED BODIES

5. ASSESSMENT BODIES FOR CSM-RA

CONFORMITY ASSESSMENT: GENERAL

Conformity assessment
means the process demonstrating whether specified requirements relating to
a product, process, service, system, person or body have been fulfilled
Conformity assessment body (CAB)
means a body that performs conformity assessment activities including
calibration, testing, certification and inspection;
(Reg. (EC) No. 765/2008)

The same approach is valid in all the regulated European industrial sector
(e.g. ships, toys, gas emissions)

CONFORMITY ASSESSMENT: RAILWAYS

3 types of CABs, depending on the assessment against:
- TSIs called Notified Bodies (NoBo ref. art 28 of IOD);
- NNTR (notified national technical rules) called designated Bodies (DeBo ref.
art 17 of IOD);
- Risk Assessment performed under the CSM called Assessment Bodies (AsBo
ref. 6 of Reg. 402/2013).
ATTENTION
NoBo and DeBo are related to the IOD only for the authorisation of
components, subsystems and vehicles;
AsBo has double nature: under the IOD (art 15, 2nd para, 2nd bullet point) for
the APIS (if requested by the TSI and for the safe integration) but also under
the Safety Railways Directive (49/2004/EC) for the modification to the SMS for
RU and IM (DV29bis, 38 -> 41)

CONTENT

1. INTRODUCTION ON ASSESSMENT BODIES

2. ACCREDITATION AND RECOGNITION

3. NOTIFIED BODIES
4. DESIGNATED BODIES

5. ASSESSMENT BODIES FOR CSM-RA

TWO PATHS: ACCREDITATION AND RECOGNITION

Accreditation
Means an attestation by a national accreditation body (NAB) that a conformity
assessment body (CAB) meets the requirements set by harmonised standards
and, where applicable, any additional requirements including those set out in
relevant sectoral schemes, to carry out a specific conformity assessment
activity.
Recognition
This term is not defined, however art 5(2) of Reg. (EC) No. 765/2008 allows the
Member State to select the specific CAB, giving evidence of the comparable
requirements to the accreditation.

KEY WORDS
NATIONAL ACCREDITATION BODY
national accreditation body shall mean the sole body in a Member State that performs
accreditation with authority derived from the State. (Reg. (EC) No. 765/2008)
In Greece is the E.SY.D. (http://www.esyd.gr/portal/p/esyd/en/esyd.jsp)

HARMONISED STANDARDS
A harmonised standard is a European standard elaborated on the basis of a request from
the EC to a recognised European Standards Organisation (CEN, CLC, ETSI) to develop a
European standard that provides solutions for compliance with a legal provisions
(http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/index_en.htm )
SECTORAL SCHEME
Documents containing criteria supplementary (amplified or detailed) to those contained
in Harmonised standards (ref. lev 4. to guide EA 1/06 available here:
http://www.european-accreditation.org/publication/ea-1-06re-published-november-2014).

ACCREDITATION/RECOGNITION: WHY DO THEY EXIST ?

No contractual relationship

CERTIFICATE/
REPORT

CERTIFICATE/
REPORT
CONFORMITY
ASSESSMENT
BODY
(3rd party)

Technical Activity
From other country

END USER
e.g. Authorities,
consumers
(2nd party)

MANUFACTURER/
SERVICE PROVIDER
(1st party)
APPLICATION
INFORMATION ON
ACCREDITATION
STATUS

CONFIDENCE

accredits

ACCREDITATON BODY

Mutual trust!

- Repetition of activities (tests!)

-Technical Barriers to Trade
+ Costs
9

TRIANGLE OF ROLES (GENERAL)

MANUFACTURER/
SERVICE PROVIDER
(1st party)

CONFORMITY
ASSESSMENT
BODY
rd
(3 party)

END USER
(2nd party)
e.g. Authorities,
consumers

10

CONTENT

1. INTRODUCTION ON ASSESSMENT BODIES

2. ACCREDITATION AND RECOGNITION

3. NOTIFIED BODIES
4. DESIGNATED BODIES

5. ASSESSMENT BODIES FOR CSM-RA

11

NOBOs IN EU

In EU there are 58 NoBos (source NANDO @May 2014) under the

Interoperability Directive 2008/57/EC.

NoBos can work in the whole Europe

40 accredited and 18 recognised:

The accredited NoBos have been assessed according several ISO standards, mainly
17020, 17021 and 17065

In some cases the competence of the recognised NoBos has been assessed
according to ISO standards OR according the requirements of Annex VIII to IOD

12

TWO PATHS for NOBOs IN DETAILS

RECOGNITION

ACCREDITATION
European co-operation for
Accreditation (EA)

National Accreditation Body

Non-Accredited Conformity
Assessment Body

Accredited Conformity
Assessment Body

Member State
(Recognition and Notification)

Member State
(Notification)

Today in EU there are

several way of apply the EN
ISO standards.

RAILWAY
PECULIARITIES
ERA accreditation
scheme (with EA)

The scope description

of the accreditation
must be the same
scope description as
the notification.

HERE THE CABS

BECOME NoBoS
Notified Body (IOD 2008/57/EC)

EC Declaration of Conformity for IC // EC Declaration of Suitability for

Use for IC // EC Declaration of Verification of the Subsystem

The accreditation scheme

will harmonise them

Modules
Decision
2010/713/EU)

13

SECTORAL SCHEME FOR NOBOs

ERA is developing, with EA (European cooperation for accreditation), a

specific sectoral accreditation scheme for notified bodies for railways
under the interoperability directive 2008/57/EC.

This scheme would facilitate the trust amongst EU NoBos and the
notification process (accreditation -> Notification)

The scheme must cover the technical capacity necessary for the NoBos
to properly perform their duties. (ERA WP 2014: ABS 4.5(2)
http://www.era.europa.eu/Document-Register/Pages/Work-progamme-2014.aspx)

14

SECTORAL SCHEME FOR NOBOs

Bilateral meetings with EA-European cooperation for accreditation and

NAB-National accreditation bodies (art. 14(6) and 4 of 765/2008). Meetings
with EA, BELAC, COFRAC, RVA, SWEDAC, UKAS, EBA and PCA until
beginning 2015.
Ad hoc task force with external members (EA, NB-Rail) + NSAs, OTIF (as
observers): active from February to December 2015

Kick off:
Progress:
Intermediate:
Final:

11 FEB 2015
29 MAY 2015
22 SEP 2015
04 DEC 2015

FINAL DELIVERABLE ACCREDITATION SCHEME: DEC 2015

15

SECTORAL SCHEME FOR NOBOs

THE SCHEME WOULD BE BASED ON

EN ISO/IEC 17065
Focus on the product certifications the main activity of NoBo in IOD
Allow the use of the tools and techniques described in 17020 and
17021 details on surveillance and witnessing
Provide clear identification of resources tasks allocations
Mechanism to safeguard the impartiality (flexible)
EN ISO/IEC 17011
Possibility to have as external experts staff from NSA and/or from
ERA -> linked to the expertise in field for the assessment team
Duration of accreditation -> linked to overall cost

EVERYTHING TO BE DISCUSSED IN THE TASK FORCE IN 2015

16

SECTORAL SCHEME FOR NOBOs

ACCREDITATION
Project
start

2014

ERA analysis of
current status

Today

MAR 2014

OCT 2014

2015
Proposal for
accreditation scheme
Kick off meeting

APR 2015

Outcome of the ad hoc

task force + Advice to EC
Ad hoc task force

DEC 2015

17

MODULES WHAT THEY ARE

On the basis of international standards, Europe developed conformity

assessment procedures and rules for their selection and use.
Those procedures are called the modules.
The modules are set out in a manner to favour their selection from the
lightest (internal control of production) for simple products or products
not necessarily presenting serious risks, moving to the most comprehensive
(full quality assurance), where the risks are more severe or the
products/technologies more complex.
In most of the industrial sectors the modules are the same, described by
ANNEX II of the Decision 768/2008.
The

blue

guide

2014

provides

also

an

interesting

reading

(http://ec.europa.eu/DocsRoom/documents/4942)

18

MODULES IN RAILWAYS

However, the specificities of sectoral needs may provide grounds for recourse
to other regulatory solutions or specific adaptation of the common principles.

THIS IS THE CASE FOR RAILWAYS DUE TO TSIs (ICs & SS) with the Decision
713/2010.

This Decision provides for a menu of modules for railways, enabling the
legislator to choose in proportion to the level of risk involved and the level of
safety required.
Those modules are identified by the TSIs and shall be followed by the
manufacturer with the collaboration of NoBos.

19

MODULES FOR ICs

Defined in the TSIs from the Decision 713/2010

The C at the
beginning indicates the
reference to the
constituents.
The modules are in
principle the same as
the general modules
for other industrial
sectors.

20

MODULES FOR SUBSYSTEMS

Defined in the TSIs from the Decision 713/2010

The S at the
beginning indicates the
reference to the
subsystems.
The modules are in
principle the same as
the general modules
for other industrial
sectors.

21

HOW TO CHOSE A MODULE

According to the choice given in the TSI, there are always two possibilities:
with QMS or without QMS.
The choice of the module
Cost
may have an important
SG
SB+SF
impact on the cost and
SB+SD or SH1
time.

QMS

SB

Size of serial
production

The choice depends on the

particular situation of each
company and specific
characteristics of the
products.

Balance between fixed cost, mass production and marginal cost.

As a rule of thumb, SB modules for mass production (vehicles) and SG for
specific developments (fixed installation).
(http://www.era.europa.eu/Document-Register/Pages/TSI-Application-Guide-Conformity-assessment-and-EC-verification.aspx )
22

CONTENT

1. INTRODUCTION ON ASSESSMENT BODIES

2. ACCREDITATION AND RECOGNITION

3. NOTIFIED BODIES
4. DESIGNATED BODIES

5. ASSESSMENT BODIES FOR CSM-RA

23

DeBos & NoBos

The NoBo approach should be used for DeBo mutatis mutandi
The same general requirements should apply (e.g. accreditation against
17065, ).
The detailed technical competence should be related to the NNTR and
not to the TSIs -> specific for each MS!

Modules apply only to TSIs, not to NNTR (maybe in the future?)

NOTE
the IOD mention in 26(5) the possibility to use modules D and E for the declaration of conformity to type
(see definition 2(w) in IOD).

Today not monitored at EU level (maybe in the future?)

24

CONTENT

1. INTRODUCTION ON ASSESSMENT BODIES

2. ACCREDITATION AND RECOGNITION

3. NOTIFIED BODIES
4. DESIGNATED BODIES

5. ASSESSMENT BODIES FOR CSM-RA

25

OVERALL VISION ON SAFETY - 1

Please for any communication refer to: csm.risc_assessment@era.europa.eu

Maintain at least the existing level of safety in the EU railways, and increase
it when reasonably practicable
Create a basis for mutual trust

with many new railway actors and interfaces

It is necessary to set up a common approach for:
Safety regulation: WHO does WHAT
Safety management: CSM
Safety supervision: check of compliance with the applicable legislation

26

OVERALL VISION ON SAFETY - 2

EU railway
legislation
Safety
Regulation

Definition by EU legislation of Roles and Responsibilities

of railway stakeholders
Responsibility for safety of railway system put on those who
OPERATE and MAINTAIN railways:

Safety
Management

Safety
Supervision

RUs, IMs must manage and monitor safely their activities

through a Safety Management System (SMS)
ECMs must manage and monitor maintenance activities
through a System of Maintenance

NSAs & other bodies (e.g. ECM Certification Body, NoBo,

DeBo, etc.) guarantee RUs, IMs and ECMs comply with their
obligations

CSM-RA and SMS

The implementation of a Safety Management System (SMS)
requires the application of the CSM for Risk Assessment for any
modification.
The APIS requires also the application of the CSM-RA.

BOTH PROCESSES ARE CONTROLLED BY

THE ASBO DESCRIBED IN THE CSM-RA

CSM for Risk Assessment

Regulations 402/2013 (replacing Regulation 352/2009)

Common: harmonised method at the European level ensuring equal

treatment for all railway actors

Safety: it is to be used by railway actors to manage safely changes made

to the European railway system

Method: tool to be applied for controlling risks in a harmonised way. It is

not replacing the technical railway knowledge

CSM for risk assessment is a European regulation it is legally binding and

there is no need of national transposition

AsBo for CSM-RA

AsBo is the body who checks the correct application of the CSM-RA
It shall be either (Article 7):
(a)

ACCREDITED by the national accreditation body

using the criteria defined in Annex II, or;

(b)

RECOGNISED by the recognition body

using the criteria defined in Annex II, or;

(c)

the NATIONAL SAFETY AUTHORITY designated by the Member State as

able to conduct independent assessment

When Member State recognises NSA as an assessment body, it is the responsibility

of that Member State to ensure that NSA fulfils requirements set out in Annex II.
In this case, Assessment Body functions of NSA shall be demonstrably independent
of the other functions of NSA (art 9.2 of the 402/2013)

PROCESS FOR ASSESSMENT

An assessment body shall carry out an independent assessment of both the

suitability of the application of the risk management process described in Annex I
and of the appropriateness of its results.

The proposer (of the change) shall appoint its own assessment body at the earliest
appropriate stage of the risk assessment process.

ACTIVITIES PERFORMED BY AsBo

To perform the independent assessment, the assessment body shall:

(a) ensure it has a thorough understanding of the significant change based on
the documentation;
(b) conduct an assessment of the processes used for managing the safety and
quality;
(c) conduct an assessment of the application of those safety and quality
processes

32

CRITERIA FOR AsBo FOR CSM-RA

Fulfil all requirements of ISO/IEC 17020 standard
Exercise professional judgement in performing the inspection work defined in that
standard
Fulfil the general criteria concerning competence and independence in that
standard and the following specific competence criteria:

(a)

competence in risk management: knowledge and experience of the

standard safety analysis techniques and of the relevant standards;

(b)

all relevant competences for assessing the parts of the railway system
affected by the change
( i.e. for assessing change + its integration in railway system);

(c)

competence in the correct application of safety and quality management

systems or in auditing management systems.

SCOPE OF THE ACCREDITATION

By analogy to Article 28 of Directive 2008/57/EC on NoBos, AsBo shall be accredited
or recognised for the different areas of competence within the railway system, or
parts of it for which an essential safety requirement exists, including the area of
competence involving the operation and maintenance of the railway system.
For example, possible classifications of competence can be:

Infrastructure
Energy
Control command and signalling
Rolling Stock
Braking components
Operation and Traffic management
Overall consistency and system approach (System Level)

AN HARMONISATION WITH THE ACCREDITATION OF NOBOs IS ENVISAGED (not yet

planned)

Making the railway system work better for society.

era.europa.eu