During times of universal deceit,
telling the truth becomes a revolutionary act

George Orwell

Certification


A "certification" is an attestation, issued by a suitably competent third party, relating to the fact that, for the product to which it refers, the fulfillment of specified requirements has been suitably demonstrated.

The activities implemented by the Body are based on the technical specification of the requirements that the product must ensure, and on the implementation of a combination of conformity assessment methods, which include inspection, test and audit activities, aimed at ascertaining, through the acquisition of appropriate evidence, its ability to continuously satisfy these requirements.

Due to the typical peculiarities of the products connected to the safety of the subsystems and constituent components of the railway system, the inspection component, based on the formulation of summary professional judgments on the set of all applicable reference requirements, including those of a more general and / or of a mandatory nature, it normally has a significant weight and gives the most significant added value to the certificates issued, since it is the most tangible expression of the competence and professionalism of the Body with its organization.

In order to ensure the market the utmost confidence in the conformity assessment system implemented, which is called upon to assess and certify the conformity of products, processes and systems capable of influencing the safety of the railway system, the recognitions and accreditations held by ISARail SpA have always combined inspection activities with certification activities.

The main types of services provided under accreditation, recognition or notification, divided by type, are summarized below.

Other types of certification can also be issued, outside of accreditations, on a voluntary basis and / or schemes defined internally by ISARail SpA or by third-party clients (eg voluntary certification of maintenance workshops, Skills Management Systems, etc.) .

Notified Body (identification NoBo 2424)

Pursuant to the Ministerial Decree of MIT n ° 37 of 28.06.19, ISARail SpA is qualified to assume the role of NoBo "Conformity Assessment Body" responsible for conformity assessment activities, pursuant to art. 37 of the Directive ( EU) No. 797/2016 "Interoperability of the railway system", with Ministerial Decree MIT No. 5 of 04.04.2020.

Therefore ISARail SpA is authorized to carry out the conformity assessment procedure or the suitability for use of the interoperability constituents, as well as the EC verification procedure with reference to the subsystems of trans-European high-speed and conventional rail systems, as follows:

Carrying out the EC verification procedure of railway structural subsystems, as well as the conformity assessment procedure or the suitability for use of the interoperability constituents connected to them. The EC verification procedure of a subsystem, carried out by the notified body, starts from the design phase and continues throughout the construction period up to the approval phase, prior to the subsystem's entry into service, also including the verification of the interfaces of the subsystem concerned with respect to the system into which it is integrated, based on the information available in the relevant TSI and in the registers of the infrastructure and types of vehicles authorized. A substantial part of the activity of the Notified Body consists of the verification of compliance of the subsystem and / or of the interoperability constituents involved in the procedure with the relevant Technical Specifications for Interoperability (TSI), according to the procedures provided for by them and codified in the modules referred to in Decision 713/2010 / EU. An updated list of the subsystems and TSIs for which ISARail SpA is entitled to issue the required certificates can be consulted on the EU NANDO portal (New Approach Notified and Designated Organizations) Information System (http://ec.europa.eu/growth/tools-databases / nando / index.cfm? fuseaction = notifiedbody.notifiedbody & refe_cd = NANDO% 5FINPUT% 5F198861).

The ON ISARail SpA is also authorized to carry out the conformity assessment procedures, with the issue of the corresponding certificates, for the functional subsystems of the conventional and high-speed rail system, with the related components:

• traffic operation and management;
• maintenance;
• telematic applications for passengers and freight transport

Designated Conformity Assessment Body ("DeBo")

Pursuant to the Ministerial Decree of MIT n ° 37 of 28.06.19, ISARail SpA is qualified to assume the role of DeBo (Designated Body) - "Conformity Assessment Body" responsible for conformity assessment activities, pursuant to art . 15 paragraph 8 of the Directive (EU) No. 797/2016 "Interoperability of the railway system", with Ministerial Decree MIT No. 28 of 05.05.2020, in the following areas:

 Structural subsystems

 Functional subsystems and sectors

 and in the sectors:

Carrying out the national verification procedure of railway structural subsystems, as well as the conformity assessment procedure or the suitability for use of components connected to them. Assessment of the conformity of railway subsystems and components with the safety-related approval requirements applicable to them, in compliance with the Italian national safety regulations.

The national verification procedure is aimed at certifying the conformity, and the safe integration into the national railway system, of structural subsystems subject to Authorization for Commissioning (AMIS) by the ANSF. The assessment activities carried out by the VIS are implemented in a manner regulated by the ANSF, aimed at certifying the compliance of the subsystem (or, of the component) with the essential requirements applicable to it, with particular but not exclusive reference to those corresponding to open points and / or specific cases provided for by the applicable TSI (s), not covered by any TSI conformity certifications already issued for the same product.

Certifications of conformity referring to specific subsystems, vehicles and / or "types" of vehicle (including work and maneuvering vehicles), can also be issued with reference to national technical specifications (RFI, ANSF, etc. ..) and / or technical standards and / or international fiches (EN, UNI, UIC standards, etc.).

SRM Certification Body (OC-ECM)

Pursuant to the Ministerial Decree of MIT n ° 37 of 28.06.19, ISARail SpA is qualified to assume the role of OC-ECM Certification Body (OC) of the Entities in charge of Maintenance (ECM) accredited pursuant to EU Regulation n ° 779 / 2019 (valid for wagons and vehicles other than wagons) with DM MIT n ° 6 of 04.04.2020.

The certification is issued according to the scheme prepared by the ERA (European Railway Agency), defined by EU Regulation No. 779/2019, which constitutes its legal basis, and by the Guidelines prepared by ERA itself, as "scheme owner" , to harmonize the procedures for verifying requirements and managing certifications.

The services that the ISARail SpA CB is able to offer cover the issue of the entire range of certifications provided for in the scheme:

- maintenance development,

- fleet maintenance management,

- execution of maintenance;

as well as all types of vehicles to which the maintenance system can be applied, including:

A certification issued within the framework of the scheme provides a demonstration, recognizable at European level, that the maintenance system to which it refers is:

and therefore confers on it a presumption of conformity with the regulatory requirements for the safety of railway operations.

ISO / IEC 17065 Product Certification Body (accreditation n ° 227B)

Conformity assessment activity as a Product Certification Body (accreditation n ° 227B) accredited by ACCREDIA pursuant to Directive (EU) 2016/797 "Interoperability of the railway system"

Notified Body for Conformity Assessment ("NoBo"), pursuant to art. 37, in the following areas:

Structural subsystems

Body designated for conformity assessment ("DeBo"), pursuant to art. 15, c. 8, in the following areas:

Structural subsystems

Functional subsystems and sectors

and in the sectors:

Implementing Regulation (EU) 2019/779 Certification of entities responsible for vehicle maintenance pursuant to Directive (EU) 2016/798:

References to standards and specifications:

 Decisions of the European Commission "Technical Specifications for Interoperability (TSI)" applicable to the trans-European high-speed and conventional rail system;

 Decrees and Guidelines of the National Agency for the Safety of Italian Railways (ANSF);

 EN 50126 (IEC 62278) - RAMS;

 EN 50128 (IEC 62279) - Software;

 EN 50129 (IEC 62425) - Safety systems.