NoBo’s – providing competent, independent and impartial assessments for the railway industry

Former Railway Interoperability Directives (96/48/EC and 2001/16/EC and their amendments) have been repealed on 19 July 2010 by the Directive 2008/57/EC on the interoperability of the rail system within the Community. These directives have changed the way that fixed railway infrastructure, the rolling stock that runs on it and certain components are designed, assessed and put into service. These changes have happened across Europe. Notified Bodies have a key role in these common European processes.

Notified Bodies, otherwise known as NoBo’s, are acting more-and-more in the railway field. Nevertheless, the involvement of a Notified Body at the earliest stages of a project is not yet a reflex for many manufacturers, suppliers or contracting entities.

NoBo’s – what are they?

Notified Bodies are not new. They were stated through the development of the New Approach Directives (directives providing for CE marking) in order to assess the EC conformity of products subject to specific directives before being placed on the European market.

CE marking does not indicate that a product was made in the European Economic Area, but merely states that the product is assessed before being placed on the market and thus satisfied the legislatives requirements to be sold there. It means that the manufacturer has verified that the product complies with all the relevant essential requirements (e.g. health and safety requirements) of the applicable directives or, if stipulated in the directives, has been examined by a notified conformity assessment body.

A Notified Body (NoBo) is a conformity assessment body appointed by a Member State and notified to the European Commission and other Member States authorised to carry out third-party conformity assessment tasks under Community harmonised legislation.

By notification in the railway sector, a Member State informs the Commission and the other Member States that a body, which fulfills the relevant requirements, has been appointed to carry out conformity assessment-to-assessment according to the Interoperability Directives.

The minimum criteria which are taken into account by the Member States when appointing a NoBo are described in Annex VIII of the Directive 2008/57/EC and concern the following items:

• Independence
• Impartiality
• Freedom from incentive and pressures
• Access to resources
• Competence
• Insurance
• Confidentiality
• Participation to their coordination group.

Directive 2008/57/EC

The scope of the Directive 2008/57/EC, as of the formers one’s, remains the Interoperability of the European railway systems. Interoperability means the ability of a rail system to allow the safe and uninterrupted movement of trains which accomplish the required levels of performance for the lines on which they are running. The ability depends on all the regulatory, technical and operational conditions which must be met in order to satisfy the essential requirements (conditions about safety, reliability and availability, health, environmental protection as technical compatibility stated in Annex III of the Directive 2008/57/EC).

Directive 2008/57/EC is dividing the European railway system into Conventional and High-Speed systems, both broken down into several structural (infrastructure, energy, control-command and signalling and rolling stock) and functional subsystems (traffic operation and management, maintenance and telematics applications for passenger and freight wagons).

Key components of the structural subsystems are named Interoperability Constituents.

By decisions called Technical Specifications of Interoperability (TSIs), the Commissions have defined specifications which each subsystems or part subsystems covered in order to meet the essential requirements and ensure the interoperability of the rail system.

Assessment by the Notified Body

In case of an Interoperability Constituent, when required by the corresponding TSI, the manufacturer has to contract a Notified Body in order to assess the EC conformity of his constituent. The assessment module has to be chosen by the manufacturer in function of his organisation.

In case of structural subsystem, the applicant (contracting entity or manufacturer) contracts a Notified Body in order to apply the EC verification process.

Once employed, the Notified Body:

• May explain the legislative framework
• Will scrutinise the design, manufacture, assembly, testing, commissioning and, sometimes, in service performance
• May be critical
• May refuse to edit certificate in case of e.g. non-conformity related to the product
• May delay introduction
• May make surveillance through appointed or surprise visits.

As a matter of fact, all conformity assessment activities for the EC verification of a subsystem shall begin at the design stage and shall cover the whole manufacturing period, up to the type approval stage and the testing before the system is placed into service.

The available methods are set in the TSIs as assessment modules, based on the Council Decision 93/465/EC/ repealed by 768/2008/EC. The TSIs limit the modules that can be used in certain conditions and product type. The modules do not determine what needs to be assessed but only the type of evidence that can be accepted to demonstrate conformity. Modules address either, design or production – including final testing. Modules involve either inspection based assessments or quality based assessments.

In any case, when the EC conformity is established, the Notified Body will deliver to his customer the necessary certificates according to the applied module(s) and will approve and finalise the technical file. This technical file will support the declaration of EC conformity of the product that will be written by the applicant.

Many precautions will be taken in the area of guaranteeing the safe functioning of the product or subsystem. And this not only applies to the subsystem itself, but even more to the interfaces. The Commission Regulation (EC) 352/2009 on the adoption of a common safety method on risk evaluation will have more-and-more to be taken into account. Most of the Notified Bodies will be able to help you on this subject also.

Competition between Notified Bodies

A Notified Body is governed by a fine balance. On one side, there is government regulation. Member State appointment involves rigorous and regular reassessment against the notification criteria. If a Notified Body fails to meet the defined criteria, its Member State can withdraw its appointment without appeal. This side of the balance is a rigorous, high-cost approach.

On the other side there is commercial pressure. Once appointed, a Notified Body can operate in any Member State. There are currently more than 45 Railway Interoperability Notified Bodies with various scopes of appointment. Notified Bodies are commercial organisations and must compete with their peers to win work. This side of the balance is less rigorous with reduced costs.

Though the competition between NoBo’s is supposed to be on a European scale, it seems that at present Notified Bodies compete either nationally or in some cases on regional levels. This is partly because Notified Bodies work in the language of the country where they are established and possibly in one or two more languages.

Cost and choice of the assessment module

The client has to determine the physical scope of and method of assessment that the Notified Body must use. The applicant may choose any permitted combination of modules. The most effective choice is that which would result in the lowest cost of assessment. Often, the cost of implementing and assessing a quality insurance system for a simple project or small production would be greater than an inspection based approach.

For larger or more complex projects, the sampling permitted by a quality assurance approach may lead to a lower cost option. The Notified Body can provide advice on the choice of module, but the final decision remains that of the applicant.

Certification costs have to be budgeted from the beginning as Investment costs with Return on Investment and not as belated add-on or extra costs. They will make the system widely accepted, with quality guarantee and interoperable.

Costs have to be considered by the Client during the project tender phase: for budget and definition of the scope of work.

Added value

NoBo’s provide competent, independent and impartial assessments which can lead to a smooth entry into service or placing on the market.

They also give ensured independent, competent assurance that a product is indeed compliant with the essential requirements of the Interoperability Directives, including safety. They are fair but firm.

The main targets of NoBo assessments are to guarantee safety and technical compatibility. The depth and rigorous analyses made by teams of Experts represent added value to mitigate safety and technical risks and to avoid future expensive products retrofits.

The cross acceptance principle at a European level gives the chance for Industrials to develop Interoperability Standardised Constituents (products).

Notified Bodies look for evidence of compliance, not fault. Where deficiencies are present, the Notified Body can provide constructive criticism and help their client to meet its obligation under the Interoperability Directives. As a side effect of their close involvement, Notified Bodies can provide their clients with an insight to help them to identify emerging project risks and assist effective project management.

NB-Rail

The Commission has set up a coordination group of Notified Bodies known as NB-Rail, which is a Forum for sharing experience and exchanging views on the conformity assessment procedures in order to understand better and apply more consistently the Interoperability Directives.

NB-Rail acts as a coordination group of the NoBo’s and discusses any matter related to conformity assessment and verification procedures as well as TSI applications.

NoBo’s shall participate in the relevant activities of NB-Rail according to his notification scope and shall apply the administrative decisions, Recommendation for Use (RFU) and Question & Clarification (Q&C) produced by coordination group.

The FAQ documents are available to the public available on the NB-RAIL website at: http://circa.europa.eu/irc/nbg/nbrail/info/data/ en/information/nbrail/00NB%20Rail%20Home page.htm.

NB-Rail participates in the Conformity Survey Group of the European Railway Agency (ERA) where it gives expertise on conformity assessment and verification procedures of the TSIs which are being drafted or revised.

NB-Rail is also inviting ERA to participate in its activities in order to provide feedback regarding TSI applications.

Challenges for the future

The EU legislation does not require a common accreditation scheme to be applied to Notified Bodies. An important instrument, which is not yet mandatory, is the accreditation according to the EN 45000 series. The accreditation makes requirements and processes more transparent and the result is that successful candidates are more likely to meet the criteria for the Notified Body defined in the Annex of the Interoperability Directive.

Contracting Entities and Manufactures need to be fully open, honest and frank about the works under assessment. Often, a Notified Body can help if difficulties arise, for example, where errors or omissions in a TSI affect a project.

New railway projects in Europe are today confronted with a situation that did not exist before in the time the railways were integrated companies. In the past it was normal to develop and put new infrastructure into operation with a prior knowledge of the rolling stock that would later run on it. This also applied to the procurement of rolling stock.

Nowadays, the open market makes this less certain. Infrastructure Managers and rolling stock owners must now, design and build their projects according to specifications. These specifications must guarantee interoperability and this is the only way. The TSIs must be completely unambiguous to serve this purpose and support interoperability and the verification and certification of the products and systems then guarantees that the products and systems comply with the specifications.

Notified Bodies are prepared to assist parties with its gained know-how and expertise and are prepared to play their role in this field.

Useful References:

• OJEU L191/1 of 18.7.2008 – Directive 2008/57/EC of the European Parliament and of the Council of 17 June 2008 on the interoperability of the rail systems within the Community.
• Biennial Report of the Progress with Railway Interoperability in the European Union
• http://ec.europa.eu/enterprise/ newapproach/nando/index.cfm?fuseaction =directive.main
• http://ec.europa.eu/enterprise/ policies/european-standards/documents/ harmonised-standards-legislation/ list-references/

About the Authors

Jean-Marc Dupas

Jean-Marc Dupas currently serves as Chairman of NB-Rail as well as Managing Director of Belgorail in Brussels. He is a civil engineer from the Faculté Polytechnique of Mons. He also became a post – graduate in business administration at the Solvay Business School of Brussels. Prior to joining Belgorail, Jean-Marc Dupas assumed different responsibilities in the railway sector at national and international levels.

Francis Parmentier

Francis Parmentier is Quality & Information Manager of Belgorail. He represents NB-Rail at the Conformity Survey Group of the European Railway Agency. Prior to joining Belgorail, Francis Parmentier assumed responsibilities (academy and quality) at the Belgian coordination agency of the vehicle inspection and driving licence bodies (GOCA).