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

Conformity Assessment (incl. Conformity Certification) Step C - Certification 2a Inspection of Design/Product(s) relevant aspects of 17020 (third party independence) Step B - Evaluation 2b Audit on Design/Production Processes relevant aspects of 17021 (third party independence) Step A - Evidence 3a Selfassessed Design Evidence 9001 (Drawing / Calc / Simulation) 3b Type Test / Product Test Reports 17025 for the RELEVANT Scope of Testing or RFU-STR-022 + 9001 (independent to 17025 pt4.1.4) 3c Selfassessed Series Testing Evidence 9001 3d ISA Reports 50126series + 50128 Fig. 5 ISA-independance + often also 17020 A or B for the RELEVANT ISA Scope 3e Selfassessed Commissioning Evidence 9001 3f V&V Reports 50126series +50128 Fig. 5 V&V- independance + often also 17020 A or B/17025 for this V&V Scope) 18.09.2018

Conformity Assessment (incl. Conformity Certification) Step C C Certification Evaluation 2a Inspection of Design/Product(s) relevant aspects of 17020 (third party independence) Step B 2a Inspection of Design/Product(s) relevant aspects of 17020 (third party independence) B 2b Audit on Design/Production Processes relevant aspects of 17021 (third party independence) 2b Audit on Design/Production Processes relevant aspects of 17021 (third party independence) Evidence Selfassessed Design Evidence (Drawing / Calc / Simulation) Type Test / Product Test Reports to ISO 17025 or RFU-STR-022 + ISO9001 (independence to ISO17025 pt4.1.4) Selfassessed Series Testing Evidence ISA Reports to EN 50126series + EN 50128 Fig. 5 ISA-independance (+ often also ISO17020 Type A or B) Selfassessed Commissioning Evidence V&V Reports to EN50126series +50128 Fig. 5 V&V- independance (+ often also EN17020 type A or B) 18.09.2018

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-022 + ISO9001 (independence to ISO17025 pt4.1.4) Selfassessed Series Testing Evidence ISA Reports to EN 50126series + EN 50128 Fig. 5 ISA-independence (+ often also ISO17020 Type A or B) Selfassessed Commissioning Evidence V&V Reports to EN50126series +50128 Fig. 5 V&V- independence (+ often also EN17020 type A or B) 18.09.2018

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-022 + ISO9001 (independence to ISO17025 pt4.1.4) Selfassessed Series Testing Evidence ISA Reports to EN 50126series + EN 50128 Fig. 5 ISA-independance (+ often also ISO17020 Type A or B) Selfassessed Commissioning Evidence V&V Reports to EN50126series +50128 Fig. 5 V&V- independance (+ often also EN17020 type A or B) 18.09.2018

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-022 + ISO9001 (independence to ISO17025 pt4.1.4) Selfassessed Series Testing Evidence ISA Reports to EN 50126series + EN 50128 Fig. 5 ISA-independance (+ often also ISO17020 Type A or B) Selfassessed Commissioning Evidence V&V Reports to EN50126series +50128 Fig. 5 V&V- independance (+ often also EN17020 type A or B) 18.09.2018

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? 18.09.2018

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) 18.09.2018

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) 18.09.2018

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? 18.09.2018

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) 18.09.2018

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. 18.09.2018

General Issues for Step B – Evaluation & Step C -Certification Q4:How is the NoBo Evaluation performed? 18.09.2018 Overview Conformity Assessment

Step B - NoBo-Evaluation Often expected – but not like this… 18.09.2018

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) 18.09.2018

Step B - NoBo-Evaluation Audit ISO17021 Audit of the Seriesproduction of THIS TYPE of Product. 18.09.2018

General Issues for Step B – Evaluation & Step C -Certification Q5: What is the result of the NoBo Activities? 18.09.2018

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) 18.09.2018

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 18.09.2018

Webpage: NB-Rail.eu 18.09.2018