Railway sector
All the engineering and documentation a manufacturer needs to go before a notified body with a file that holds up.
From assessor to preparer
The studio worked for two years in independent conformity assessment at a certification body: review of technical files, checking of test reports, findings, audits and closure of non-conformities on locomotives, wagons, on-track machines and interoperability constituents.
That work teaches one thing, but a decisive one: most files don't get stuck on a technical problem, they get stuck on a missing piece of evidence. The calculation exists but isn't traceable, the test was done but the report doesn't reference the requirement, the drawing is right but doesn't match what was built. Today we put that knowledge on the manufacturer's side, to build the evidence before anyone asks for it.
Conformity assessment remains the task of the notified body: the studio does not certify or issue declarations on behalf of the manufacturer. We prepare the technical evidence and documentation, and for the same product we never take on both the designer's and the assessor's role.
The framework we work in
Before producing a single line of documentation, the scope is set: what the vehicle is from a regulatory point of view, which technical specifications for interoperability apply, which assessment module is chosen and which national rules remain in play.
The TSIs are amended fairly often. The first task in every job is to check which version applies at the date the application is submitted and which transitional provisions are active: starting from the wrong revision is the most expensive and most common mistake.
Structural analysis of the frame and carbody
It's the heart of the file and the part that produces the most findings. Each verification must be set up on the correct vehicle category, with loads, combinations and acceptance criteria stated and traceable by the reader.
What we actually produce
Interoperability constituents
For constituents the route differs from a subsystem: EC declaration of conformity or suitability for use, module chosen according to the applicable TSI, and a file that must stand on its own because the constituent is fitted to different vehicles.
As assessors, we followed files on very different families of constituents, and the documentation needed always follows the same pattern:
Design and as-built
On-track machines, locomotives and wagons
The work isn't limited to on-track machines: the method is the same for a locomotive being renewed, a freight wagon and a track maintenance machine. What changes are the applicable standards and the relative weight of the verifications.
Tests: preparation and support
Tests are carried out in accredited laboratories or in the field, with calibrated instruments. Our role is upstream and downstream: defining what to test and why, and turning the result into evidence the assessor accepts.
- Test planWhich requirements are closed by a test rather than a calculation, which quantities are measured, with what uncertainty and under what conditions.
- Specification for the laboratoryTest document with configuration, required instrumentation, measurement points, acceptance criteria and precise reference to the standard.
- Support during executionPresence in the laboratory or in the field, setup check, verification that the instruments' calibration certificates are valid and attached.
- Reading and correlationComparison between measured and calculated, explanation of deviations, and incorporation of the result into the report and the file.
The most common types: static and fatigue tests on carbody and frame, axle qualification and fatigue, residual stresses, vibration and shock tests on equipment, functional and stability tests, non-destructive testing of welded joints.
How you get to certification
- Gap analysisComparison between what you already have and what the TSI and applicable standards require. The result is a precise list of what's missing, requirement by requirement.
- Documentation planWho produces what, in what order and by which deadlines, aligned with the notified body's assessment plan.
- Producing the evidenceCalculations, FEM analyses, reports, reference drawings, data sheets and justifications for requirements closed by analysis.
- Tests and reportsExecution at accredited laboratories and incorporation of the reports into the file, with an explicit link to the requirement they close.
- Technical fileIndex, numbering, revisions and traceability. A well-organised file is assessed in weeks; a disorganised one in months.
- Findings and close-outResponding to findings, revising documents and support up to the manufacturer's declaration and entry into service.
What you receive
Images
FAQ
Can you issue the certification yourselves?
No, and no consultant can. Conformity verification is the job of the notified body and the declaration is signed by the manufacturer. We prepare the technical evidence and documentation the body will assess, and follow the file until the findings are closed.
We've already received findings: can you step in halfway through?
Yes, it's one of the most frequent requests. We start by reading the findings and the assessment plan, work out which are formal and which substantive, and produce only what's needed to close them. Often the problem isn't redoing the calculation but making it traceable.
Do we need to redo everything if we modify an existing vehicle?
It depends on the significance of the change. Assessing it is precisely the first task: if it isn't significant the route is much shorter; if it is, the risk assessment must be set up and the scope of the verifications to redo identified. Doing this before designing avoids doing the work twice.
Do you also do the design or only the documentation?
Both, and often together: designing while knowing the requirement that will have to be demonstrated costs much less than adapting afterwards. On the same product, however, we don't take on the dual role of designer and independent assessor.
Do you also work for component suppliers, not just vehicle manufacturers?
Yes. For an interoperability constituent the file must stand on its own, regardless of the vehicle it will be fitted to, and this requires a different approach from a subsystem.
In what language do you produce the documentation?
Italian and English. The language is agreed at the start depending on the notified body and the target market, because changing it halfway means redoing the revisions.
Go before the notified body with the evidence already in place
An initial gap analysis costs a fraction of discovering halfway through that a calculation or a test report is missing.