1. Conformity Assessment Activities of the IOD-NoBos
Maik Wuttke
Vice-Chairman of NB-Rail Association & Leader of the RST-Group at NB-Rail
QM-Representative for three Organisations accredited to perform NoBo/ DeBo/ AsBo/ ECM-CB/ ISA activities:
TÜV Rheinland InterTraffic, Cologne
TÜV Rheinland Rail Certification (previously Luxcontrol Nederland), Utrecht
TÜV Rheinland UK, Solihull

2. Conformity Assessment (incl. Conformity Certification)
Step C - Certification
2a Inspection of Design/Product(s)
relevant aspects of (third party independence)
Step B - Evaluation
2b Audit on Design/Production Processes
relevant aspects of (third party independence)
Step A - Evidence 3a
Selfassessed Design Evidence
(Drawing / Calc / Simulation) 3b
Type Test / Product Test Reports
17025 for the RELEVANT Scope of Testing
or RFU-STR
(independent to pt4.1.4) 3c
Selfassessed Series Testing Evidence 9001 3d
ISA Reports
50126series
Fig. 5 ISA-independance
+ often also A or B for
the RELEVANT ISA Scope 3e
Selfassessed Commissioning Evidence 9001 3f
V&V Reports
50126series
Fig. 5 V&V- independance
+ often also A or B/17025 for this V&V Scope)

3. Conformity Assessment (incl. Conformity Certification)
Step C C
Certification
Evaluation
2a Inspection of Design/Product(s)
relevant aspects of (third party independence)
Step B
2a Inspection of Design/Product(s)
relevant aspects of (third party independence) B
2b Audit on Design/Production Processes
relevant aspects of (third party independence)
2b Audit on Design/Production Processes
relevant aspects of (third party independence)
Evidence
Selfassessed Design Evidence
(Drawing / Calc / Simulation)
Type Test / Product Test Reports to
ISO 17025
or RFU-STR ISO9001
(independence to ISO17025 pt4.1.4)
Selfassessed Series Testing Evidence
ISA Reports to EN 50126series
+ EN Fig. 5 ISA-independance
(+ often also ISO17020 Type A or B)
Selfassessed Commissioning Evidence
V&V Reports to EN50126series
Fig. 5 V&V- independance
(+ often also EN17020 type A or B)

4. Conformity Assessment (incl. Conformity Certification)
Step C C
Certification
Evaluation
Inspection of Design/ Product to ISO17020
Audit on Design/Production Processes ISO17021
Evidence
Selfassessed Design Evidence
(Drawing / Calc / Simulation)
Type Test / Product Test Reports to
ISO 17025
or RFU-STR ISO9001
(independence to ISO17025 pt4.1.4)
Selfassessed Series Testing Evidence
ISA Reports to EN 50126series
+ EN Fig. 5 ISA-independence
(+ often also ISO17020 Type A or B)
Selfassessed Commissioning Evidence
V&V Reports to EN50126series
Fig. 5 V&V- independence
(+ often also EN17020 type A or B)

5. Conformity Assessment (incl. Conformity Certification)
Certification Review & Desicition ISO17065
Certification
Evaluation
Inspection of Design/ Product to ISO17020
Audit on Design/Production Processes ISO17021
Evidence
Selfassessed Design Evidence
(Drawing / Calc / Simulation)
Type Test / Product Test Reports to
ISO 17025
or RFU-STR ISO9001
(independence to ISO17025 pt4.1.4)
Selfassessed Series Testing Evidence
ISA Reports to EN 50126series
+ EN Fig. 5 ISA-independance
(+ often also ISO17020 Type A or B)
Selfassessed Commissioning Evidence
V&V Reports to EN50126series
Fig. 5 V&V- independance
(+ often also EN17020 type A or B)

6. Conformity Assessment (incl. Conformity Certification)
Certification Review & Desicition ISO17065
Certification
Evaluation
Inspection of Design/ Product to ISO17020
Audit on Design/Production Processes ISO17021
Evidence
Selfassessed Design Evidence
(Drawing / Calc / Simulation)
Type Test / Product Test Reports to
ISO 17025
or RFU-STR ISO9001
(independence to ISO17025 pt4.1.4)
Selfassessed Series Testing Evidence
ISA Reports to EN 50126series
+ EN Fig. 5 ISA-independance
(+ often also ISO17020 Type A or B)
Selfassessed Commissioning Evidence
V&V Reports to EN50126series
Fig. 5 V&V- independance
(+ often also EN17020 type A or B)

7. General Issues for Step B – Evaluation & Step C -Certification
NoBos may only certify, AFTER ALL APPLICABLE TSIs for the Product/ Installation have been evaluated with positive outcome.
Q1: What is the Product/ Installation to be certified?
Q2: Which TSIs & which parameters in them apply?

8. What is the Product to be certified?
Consider:
This may be a variant of previous authorised type
This may be a modified vehicle
There may be derogations
(2008/57/EC Art. 9 & Art.20)

9. What is the Installation to be certified?
Consider:
The bridge may have been „maintained“ + the track is new.
Only the bridge may have been replaced.
There may be derogations.
(2008/57/EC Art. 9 & Art.20)

10. General Issues for Step B – Evaluation & Step C -Certification
Before starting any Evaluation, the NoBo must create a complete Requirements-Check-List and demonstarte the related competence of the Team.
Q3: How are these Requirements defined?

11. Requirements:
Level1: „Essential Requirements“ from 2008/57/EC: Safety, Health, Environmental Protection,
Reliability and Availability, Technical compatibility,
Accessability (but limited to how they are contained in the TSIs)
Level2: Text in TSI- if directly containing an assessable requirement: direct TSI requirement, may include a reference to a ‚Mandatory Standard‘ (or part of it)
Level3: Text in TSI- not containing an assessable requirement:
in-direct TSI requirement
>>>> must be supported by a ‚Voluntary applied Standart‘ or ‚Alternative Solution‘ at the choice of the applicant
Level4: Apply supporting information (ERA TO/ ERA TD/ ERA Mandatory Documents/ ERA Guides/ RFUs/ FAQs)

12. Requirements Check-List
Make a systematic Assessment Check-List to list all applicable Requirements.
Update the list as required throughout the project > to have a complete and true list at the end.

13. General Issues for Step B – Evaluation & Step C -Certification
Q4:How is the NoBo Evaluation performed?
Overview Conformity Assessment

14. Step B - NoBo-Evaluation
Often expected – but not like this…

15. Step B - NoBo-Evaluation Inspection ISO17020
Design-Inspection of Evidence documents Prototype-/ Installation-Inspection
Depending on the Moduls chosen by the Applicant, this may vary in focus
Some TSIs/ Moduls have anomalies! (e.g. no Installation-Inspection)

16. Step B - NoBo-Evaluation Audit ISO17021
Audit of the Seriesproduction of THIS TYPE of Product.

17. General Issues for Step B – Evaluation & Step C -Certification
Q5: What is the result of the NoBo Activities?

18. Results of Step B – Evaluation & Step C -Certification
These include:
Check List of applied Requirements, Reports on the Evaluation (Inspection & Audit), Results of Evaluation, References to the Evidence documents, Conditions for Use
These do not include: Assessements of Requirements, Conditions for Use, which were not in the Scope of the Assessment (as legally defined by IOD)

19. In Summary Identify all mandatory and applicant-defined Requirements
Prepare Checklist and define competent Team of NoBo-Inspectors and –Auditors (competent= knowledge& ability)
Perform Evaluation = Inspection of Evidence + Inspection of Product/ Installation + Audit of Series Production
Report on all Results
Submit all Reporting to an independent Certification Review & Decision
Prepare Certificate + Reports + References to Evidence Documents in the NoBo Technical File
> Process must be documented, repeatable, traceable and should create the same result regardless of which NoBo is performing it

20. Webpage: NB-Rail.eu