Background explanation:
This question relates to the notified bodies (NoBos) in the railway sector according to Interoperability Directive (EU) 2016/797 (IOD). When these NoBos are notified based on accreditation then they have to comply with requirements from IOD chapter VI and EN ISO/IEC 17065 in conjunction with ERA Assessment Scheme 000MRA1044 Ver. 1.1 according to EA Resolution 2017 (40) 16 (sectorial certification scheme for NoBos).
According to section 2.1 of Annex IV of the IOD, the NoBos perform verification (evaluation and certification) by reference to technical specifications for interoperability (TSI). Some of these TSIs request the NoBos to accept safety assessment reports of an AsBo (CSM-RA assessment body as defined in Regulation (EU) No 402/2013) as part of the evaluation work.
Question:
The aim of this question is to clarify the requirements which shall be used by a NoBo to accept a safety assessment report of an AsBo in the case when requested by the applicable TSI.
To allow the NoBo to take responsibility for the results, 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 as an input to the verification by reference to TSI?
September 2021
Applicable requirements:
EN ISO/IEC 17065, section 7.4.5 states: “The certification body shall only rely on evaluation results related to certification completed prior to the application for certification, where it takes responsibility for the results and satisfies itself that the body that performed the evaluation fulfils the requirements contained in 6.2.2 and those specified by the certification scheme.”
EN ISO/IEC 17065, section 6.2.2.1 states: “The certification body shall outsource evaluation activities only to bodies that meet the applicable requirements of the relevant International Standards and, as specified by the certification scheme, of other documents. […]”
ERA Assessment scheme states in 6.2.2.1: “In case the CAB outsources inspection activities and QMS approval under its responsibility as NoBo, according to the module or modules chosen by the client, the outsourced bodies shall be accredited according to:
- ISO/IEC 17020 type A as described in Point A.1 of Annex A if providing inspections,
- ISO/IEC 17021 if providing QMS approval.”
Answer:
NB-Rail assumes that the NoBo shall evaluate that the following acceptance criteria are met:
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) 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 (e.g. see TSI CCS section 3.2.1).
Independence:
There are two possibilities:
- 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.
- 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 at project level the relevant independence requirements of ISO 17020 Annex A.1 (Type A).