http://www.legislation.gov.uk/eur/2013/402/article/6Commission Implementing Regulation (EU) No 402/2013 of 30 April 2013 on the common safety method for risk evaluation and assessment and repealing Regulation (EC) No 352/2009 (Text with EEA relevance)Commission Implementing Regulation (EU) No 402/2013Commission Implementing Regulation (EU) No 402/2013 of 30 April 2013 on the common safety method for risk evaluation and assessment and repealing Regulation (EC) No 352/2009 (Text with EEA relevance)King's Printer of Acts of Parliamenthttps://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02013R0402-20150803texttext/xmlen2024-10-09Expert Participation2020-12-31 Independent assessmentArticle 61An assessment body shall carry out an independent assessment of the suitability of both the application of the risk management process as set out in Annex I and of its results. This assessment body shall meet the criteria listed in Annex II. Where the assessment body is not already designated by existing ... national legislation, the proposer shall appoint its own assessment body at the earliest appropriate stage of the risk assessment process.2To perform the independent assessment, the assessment body shall:aensure it has a thorough understanding of the significant change based on the documentation provided by the proposer;bconduct an assessment of the processes used for managing safety and quality during the design and implementation of the significant change, if those processes are not already certified by a relevant conformity assessment body;cconduct an assessment of the application of those safety and quality processes during the design and implementation of the significant change.Having completed its assessment in accordance with points (a), (b) and (c), the assessment body shall deliver the safety assessment report provided for in Article 15 and Annex III.3Duplication of work between the following assessments shall be avoided:athe assessment of conformity of the safety management system and of the system of maintenance of entities in charge of maintenance as required by regulation 18A of the Railways and Other Guided Transport Systems (Safety) Regulations 2006 or paragraph 55A of the Schedule to the Channel Tunnel (Safety) (Amendment) Order 2013 regulation 16AA of the Railways (Safety Management) Regulations (Northern Ireland) 2006; andbthe conformity assessment carried out by an EU notified body or an approved body; andcany independent assessment carried out by the assessment body in accordance with this Regulation.4The proposer may choose the national safety authority as assessment body where that national safety authority offers this service and where the significant changes concern the following cases:aa vehicle needs an authorisation for placing in service ...ba vehicle needs an additional authorisation for placing in service ...cthe safety certificate has to be updated due to alteration of the type or extent of the operation ...dthe safety certificate has to be revised due to substantial changes to the safety regulatory framework ...ethe safety authorisation has to be updated due to substantial changes to the infrastructure, signalling or energy supply, or to the principles of their operation and maintenance ...fthe safety authorisation has to be revised due to substantial changes to the safety regulatory framework ...Where a significant change concerns a structural subsystem that needs an authorisation for placing in service ..., the proposer may choose the national safety authority as assessment body, where that national safety authority offers this service, unless the proposer has already given that task to an approved body.Words in Art. 6(4) omitted (E.W.S.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(7)(j)(i) (as substituted by S.I. 2019/1310, regs. 1(2)(c), 7(4)(c)(ii)); 2020 c. 1, Sch. 5 para. 1(1); and words in words in Art. 6(4) omitted (N.I.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(7)(j)(i) (as substituted by S.I. 2019/1310, regs. 1(2)(c), 7(7)(c)(ii)); 2020 c. 1, Sch. 5 para. 1(1)Words in Art. 6(4) substituted (E.W.S.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(7)(j)(ii) (as substituted by S.I. 2019/1310, regs. 1(2)(c), 7(4)(c)(ii)); 2020 c. 1, Sch. 5 para. 1(1); and words in words in Art. 6(4) substituted (N.I.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(7)(j)(ii) (as substituted by S.I. 2019/1310, regs. 1(2)(c), 7(7)(c)(ii)); 2020 c. 1, Sch. 5 para. 1(1)Words in Art. 6(3)(a) substituted (E.W.S.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(7)(b); 2020 c. 1, Sch. 5 para. 1(1)Words in Art. 6(1) omitted (E.W.S) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(7)(a); 2020 c. 1, Sch. 5 para. 1(1); and words in Art. 6(1) omitted (N.I.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(7)(a); 2020 c. 1, Sch. 5 para. 1(1)Words in Art. 6(3)(b) substituted (E.W.S) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(7)(c) (as substituted by S.I. 2019/1310, regs. 1(2)(c), 7(4)(c)(i)); 2020 c. 1, Sch. 5 para. 1(1)); and words in Art. 6(3)(a) substituted (N.I.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(7)(c) (as substituted by S.I. 2019/1310, regs. 1(2)(c), 7(7)(c)(i)); 2020 c. 1, Sch. 5 para. 1(1)Word in Art. 6(4) substituted (E.W.S) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(7)(d); 2020 c. 1, Sch. 5 para. 1(1); and word in Art. 6(4) substituted (N.I.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(7)(d); 2020 c. 1, Sch. 5 para. 1(1)Words in Art. 6(4)(a) omitted (E.W.S) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(7)(e); 2020 c. 1, Sch. 5 para. 1(1); and words in Art. 6(4)(a) omitted (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(7)(e); 2020 c. 1, Sch. 5 para. 1(1)Words in Art. 6(4)(b) omitted (E.W.S) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(7)(e); 2020 c. 1, Sch. 5 para. 1(1); and words in Art. 6(4)(b) omitted (N.I.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(7)(e); 2020 c. 1, Sch. 5 para. 1(1)Words in Art. 6(4)(c) omitted (E.W.S) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(7)(f); 2020 c. 1, Sch. 5 para. 1(1); and words in Art. 6(4)(c) omitted (N.I.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(7)(f); 2020 c. 1, Sch. 5 para. 1(1)Words in Art. 6(4)(d) omitted (E.W.S) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(7)(g); 2020 c. 1, Sch. 5 para. 1(1); and words in Art. 6(4)(d) omitted (N.I.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(7)(g); 2020 c. 1, Sch. 5 para. 1(1)Words in Art. 6(4)(e) omitted (E.W.S) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(7)(h); 2020 c. 1, Sch. 5 para. 1(1); and words in Art. 6(4)(e) omitted (N.I.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(7)(h); 2020 c. 1, Sch. 5 para. 1(1)Words in Art. 6(4)(f) omitted (E.W.S) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(7)(i); 2020 c. 1, Sch. 5 para. 1(1); and words in Art. 6(4)(f) omitted (N.I.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(7)(i); 2020 c. 1, Sch. 5 para. 1(1)Words in Art. 6(3)(b) substituted (N.I.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(7)(b); 2020 c. 1, Sch. 5 para. 1(1)