Notified Body - NoBo

Notified Body – NoBo

SIQ is, as a Notified Body (NoBo), your partner in the common goal to a unified European railway network. We are registered in NANDO database under number NB 1304, for the (EU) 2016/797 Directive. With our daughter company DIS RAIL (NB 2508) we cover the following:

Energy subsystems (ENE TSI);
Trackside control-command and signalling subsystems (CCS TSI);
On-board control-command and signalling subsystems (CCS TSI)
Locomotives and passenger rolling stock subsystems (RST TSI)
Infrastructure subsystems (INF TSI)
Wagon (WAG TSI)
Noise (NOI TSI);
Persons with disabilities and with reduced mobility (PRM TSI)
Safety in railway tunnels (SRT TSI).

We cover

EC Verification for Subsystems

EC verification for constituents

QMS inspection and production audit (SD, CD, modul H)

Railway Quality Management System (QMS) Inspections and Production Audits

Railway Quality Management System (QMS) inspections and production audits are key processes that ensure the manufacturing and maintenance of railway components and systems comply with regulatory standards for safety, quality, and performance. These audits and inspections help maintain consistency in production, reduce the risk of defects, and ensure compliance with both industry standards and European Union (EU) regulations, particularly regarding interoperability and safety.

Railway QMS Inspections include:

Document Control: Verifying that all technical documents, including designs, procedures, and operational manuals, are accurate, up to date, and accessible.
Risk Management: Assessing procedures for identifying and mitigating risks in production and maintenance to ensure the safety and reliability of railway components.
Process Control: Ensuring the consistency of manufacturing processes, with a focus on materials, tools, and machinery used during production.
Traceability: Confirming that components and systems can be traced throughout the production and supply chain, enabling the identification of defects or issues at any stage.
Supplier Evaluation: Ensuring that suppliers and contractors involved in the production process meet the required quality standards.

Railway Production Audits include:

Production Line Inspection: Reviewing the entire production process, from raw material procurement to final assembly, to ensure compliance with approved procedures.
Product Testing: Conducting tests on components or subsystems during or after production to verify that they meet the required technical specifications and safety standards. This may include functional tests, stress tests, and endurance tests.
Process Efficiency: Evaluating the efficiency and effectiveness of the production process, identifying any bottlenecks, defects, or areas for improvement.
Compliance Monitoring: Ensuring that the production process complies with both internal QMS standards and external regulations, such as EU directives for railway safety and interoperability.
Non-Conformance Handling: Reviewing how non-conformities (issues that arise during production) are addressed, including corrective actions, re-testing, and preventive measures to avoid recurrence.

Importance of QMS Inspections and Production Audits in Railways:

Safety: These inspections and audits ensure that railway components and systems are safe for public use.
Consistency: Regular audits help maintain consistent quality in production and service delivery.
Compliance: They ensure compliance with international and EU standards, which is critical for market access and interoperability across borders.
Risk Reduction: By identifying potential problems early, these processes help mitigate the risk of defects or failures in service.

NB-RAIL coordination group

SIQ Ljubljana is also an active member of the European Coordination Group of Notified Bodies for Railway Products and Systems (NB-RAIL), established by the Commission. NB-RAIL serves as a platform for sharing experiences and exchanging views on conformity assessment procedures. We contribute to drafting and issuing documents, such as recommendations for use and questions and clarifications, as well as discussing interoperability-related legislation and addressing common challenges arising from the practical application of interoperability directives.

Directive (EU) 2016/797

To ensure the best possible integration of European countries in rail transport and to uphold high safety standards, the EU has adopted Directive (EU) 2016/797 on rail interoperability within the Community.

This Directive, along with the associated technical guidelines for individual subsystems and corresponding harmonised standards, provides the foundation for enabling manufacturers of railway equipment and infrastructure to design and produce their products in accordance with uniform requirements across the Community. The conformity of these products can then be assessed by notified bodies, whose certifications are recognised throughout the Community.

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