QUESTION / CLARIFICATION

(1)

Supported by NB-Rail Association

QUESTION / CLARIFICATION

Co-funded by the European Union

NB-R^AILCOORDINATION G^ROUP

INTEROPERABILITY DIRECTIVE OF THE RAIL SYSTEM WITHIN THE E^UROPEANU^NION

QC-STR-010 ^{Issue 01}Date 17/06/2021

T^ITLE

ACCEPTANCE OF CSM-RAASSESSMENT REPORTS WHEN REQUESTED BY TSI

O^RIGINATOR S^UBJECTR^{ELATED TO}

SGSTR (EU)2016/797,(EU)2016/798

CSM-RA(EU)N^O402/2013

TSILÔC&PÂS(EU)NÔ1302/2014ÂS

AMENDED BY (EU)2019/776

TSICCS(EU)2016/919 AS AMENDED BY

(EU)2019/776

AMENDMENT RECORD:

DESCRIPTION AND B^ACKGROUNDE^XPLANATION

The aim of this Q&C is to clarify the legal background which shall be used by a NoBo to accept a safety assessment (inspection) report of an AsBo (CSM-RA assessment body as defined in Regulation (EU) No 402/2013) only in the case when requested by the applicable TSI, as an input to the verification by reference to the TSI (short: “TSI- verification”; see section 2.1 of Annex IV of IOD (EU) 20167/797).

Note: The assessment of the requirement capture and safe integration performed by an AsBo are out of scope of this Q&C. Other aspects where CSM-RA has to be applied exist, but are also out of scope of this Q&C.

Background information:

According to the IOD (EU) 2016/797, safety is an essential requirement. The TSI define requirements, which are always based on and linked to the essential requirements (see chapter 3 of each TSI, except TSI CCS). By means of the EC Certificate of Verification that is based on the requirements of the applicable TSIs, the NoBo confirms the conformity with the essential requirements as far as covered by the requirements of the applicable TSIs. The assessment of requirements related to safety is part of the evaluation carried out by the NoBo. The NoBo is therefore responsible and liable for the evaluation of the requirements as defined in the TSI of the object of assessment in the frame of its role as NoBo. Consequently, also the requirements related to safety are also covered by the EC Certificate of Verification of the NoBo.

Some TSIs request for the purpose of the assessment of one or several basic requirement(s), the applicant to deliver an inspection report by applying the procedure specified in the CSM-RA. Such an inspection report is a safety assessment report that is to be issued by an AsBo. In such a case, the safety assessment report from the AsBo has to be considered as part of the EVALUATION stage by the NoBo, who is responsible for the Verification by reference to TSIs, as explained above.

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QUESTION / CLARIFICATION

QC-STR-010 ^{Issue 01}Date 17/06/2021

Note: The distinction between the ‘EVALUATION’ stage and the ‘EVIDENCE technical documentation’ stage is described by Figure 3 flow chart of the ERA Assessment Scheme [3].

If the NoBo is to accept reports from other bodies, then clause 7.4 of the ISO 17065:2012 together with section 6.2.2.1 of the ERA Assessment Scheme [3] apply. This is based on the clause 7.4.5 of ISO 17065:2012.

Note: The ERA Assessment Scheme is based on ISO 17065:2012 standard and all the requirements included in that standard apply.

In such cases, the safety assessment report of the AsBo shall support the subsequent work performed by the NoBo, provided the applicable criteria for competence, independence and impartiality are fulfilled at project level.

Art. 15 (4) of CSM- RA [2] calls for an acceptance of safety assessment reports by notified bodies in the case when a TSI requires the use of the CSM-RA. However,

“acceptance” does not mean that the NoBo has to accept without any further checks before certifying the product. It also has to be taken into account that the legal framework for EC Verification (IOD (EU) 2016/797 and ERA Assessment Scheme [3]) has been updated, voted and published at a later stage than the CSM-RA. Therefore, the requirements of the IOD and ERA Assessment Scheme have to be applied first by the NoBo before any other requirements such as requirements from CSM-RA.

Consequence:

Because the overall responsibility for the verification by reference to the TSI remains with the NoBo, it must be ensured that such evidence assessment reports are fully consistent with the relevant requirements.

The NoBo is the sole decision maker for any issues of relevance whether a subsystem / an IC or part thereof complies with the applicable requirements of the TSIs.

Consequently, if the NoBo is accepting reports from other bodies as part of the evaluation stage, then these reports have to fulfil the requirements defined in clause 6.2.2.1 of the ISO 17065:2012 standard, as specified in the ERA Assessment Scheme [3]. Even when the AsBo is contracted by the applicant and not by the NoBo, the requirements from clause 6.2.2 of the ISO 17065:2012 standard shall also apply to the AsBo, as the AsBo is providing evaluation results that the NoBo has to rely on.

Requirements:

The related requirements on competence, independence and impartiality of NoBos are defined in the IOD (EU) 2016/797 in Articles 31 and 32, as well as in in chapters 4.1 and 4.2. of the ERA Assessment Scheme [3].

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QUESTION / CLARIFICATION

QC-STR-010 ^{Issue 01}Date 17/06/2021

The related requirements for competence, independence and impartiality for inspection activities are specified in the standard EN ISO/IEC 17020 [1]. Independence level Type A equals the same independence requirements of the IOD for NoBos and DeBos.

Some TSIs explicitly require the applicant to use Regulation (EU) No 402/2013 [2]. Article 6(3) of that Regulation (EU) No 402/2013 on independent assessment, explicitly states that the duplication of work between the conformity assessments carried out by a NoBo and an AsBo shall be avoided. In such a case the Regulation (EU) 402/2013 shall be applied according to its Article 2(3)(a).

Regulation (EU) No 402/2013 [2] defines the criteria in Annex II and refers to the ISO/IEC 17020:2012 standard. This standard requires impartiality, competence but also independence of the AsBo for all types A, B and C as defined in Annex A. Regarding independence criteria this standard requests to assure independence of the company (Type A) and independence of the personnel performing the inspection (Type B or C) with regard to the product under inspection concerning the design, manufacture, supply, installation, servicing and maintenance of that product. It is considered that verification, validation, testing activities, risk assessment and risk management of that product form part of the activities mentioned above.

References:

[1] ISO / IEC 17020:2012 (Conformity assessment – Requirements for the operation of various types of bodies performing inspection)

[2] Commission Implementing Regulation (EU) No 402/2013 on the common safety method for risk evaluation and assessment

[3] ERA Assessment Scheme, Technical document Requirements for Conformity Assessment Bodies seeking Notification, 000MRA1044 Ver. 1.1

[4] Register of CSM-RA Assessment Bodies ERADIS:

https://eradis.era.europa.eu/safety_docs/assessments/bodies/default.aspx

S^UGGESTEDR^ESOLUTION/INTERPRETATION

Question 1:

Is it correct that the NoBo takes over the full responsibility and liability for the correct conformity assessment of the object under assessment against the TSI requirements (TSI CCS Annex section 4.2.1, TSI Loc&Pas Annex section 4.2.3.4.2, 4.2.3.5.3, 4.2.4.2.2, 4.2.5.3.5, 4.2.5.5.8 and 4.2.5.5.9) based on the own assessment and on the safety assessment report of the AsBo?

Yes, NB-Rail assumes that the NoBo is taking over the full responsibility and liability of the content of the ‘NoBo-File’ (section 2.3.4 and 2.4 c) of Annex IV of IOD).

(4)

QUESTION / CLARIFICATION

QC-STR-010 ^{Issue 01}Date 17/06/2021

Note: Consequently, question 2 is raised. If the answer to question 1 is “No”, then the NoBo would be required to reduce the scope of assessment accordingly and would definitely exclude the safety assessment report of the AsBo. The certificates (see regulation (EU) 2019/250 and also RFU-STR-001 from NB-Rail) of the NoBo will then in turn also exclude those requirements, where the TSI calls for an assessment by an AsBo.

Question 2:

Which acceptance criteria shall be used by a NoBo to accept a safety assessment (inspection) report of an AsBo when requested by the applicable TSI (TSI CCS Annex section 4.2.1, TSI Loc&Pas Annex section 4.2.3.4.2, 4.2.3.5.3, 4.2.4.2.2, 4.2.5.3.5, 4.2.5.5.8 and 4.2.5.5.9), as an input to the verification by reference to TSI?

NB-Rail assumes that the NoBo shall evaluate that the following acceptance criteria are met and asks for confirmation by the legal services of the European Commission:

Competence, Independence and Impartiality:

The AsBo shall be accredited or recognised for the relevant technical area (as defined in the “Classification” field of the ERADIS database [4]) in relation to the relevant structural subsystem of the object under assessment.

Competence and Impartiality:

The requirement on competence and impartiality shall be deemed to be fully covered by the corresponding accreditation / recognition and by ad-hoc registration as AsBo in the ERADIS database [4] (e.g. see TSI CCS section 3.2.1).

Independence:

There are two possibilities:

1. The AsBo fulfils the same independence requirements as the NoBo via an accreditation / recognition for ISO 17020 type A. The AsBo safety assessment report shall be accepted by the NoBo as an inspection report part of the EVALUATION stage without additional checks on the criteria to be met by the AsBo assessment team.

2. The AsBo is not fulfilling the same independence requirements as the NoBo, i.e. the AsBo is accredited / recognised according to ISO 17020 type B or C. To enable the NoBo to accept the AsBo safety assessment report as part of the EVALUATION stage the NoBo at least

• shall be involved since the beginning of the design stage of the object under assessment according to IOD (EU) 2016/797 art. 15.3, and

• shall be allowed to verify if the AsBo assessment team meets for each project the relevant independence requirements.

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QUESTION / CLARIFICATION

QC-STR-010 ^{Issue 01}Date 17/06/2021

Besides competence, independence and impartiality the NoBo shall always check that:

• The safety assessment report contains correctly and fully the relevant requirements of the TSI for the object under assessment,

• The safety assessment report contains all relevant conditions and limit of use,

• The safety assessment report contains the conclusions of the independent assessment.

ORGANISATION(^S)REQUESTED TO RÊSPOND(Ê.^G.TSIG^ROUP,RISC,ERAÊTC.) RISC

D^{ATE OF}AGREEMENT AT NBR^AILP^LENARYM^EETING PLE 062, 17/06/2021

RESPONSE FROM ORGANISATION A^BOVE

Disclaimer: ERA TO always supersedes NB-Rail suggested solution in case of difference.