natgillin/translations-raw huggingface dataset:
a railway undertaking or an infrastructure manager which implements risk control measures in accordance with Article 4 of Directive 2004/49/EC;
prevoznik v železniškem prometu ali upravljavec infrastrukture, ki izvaja ukrepe nadzorovanja tveganja v skladu s členom 4 Direktive 2004/49/ES;
an entity in charge of maintenance which implements measures in accordance with Article 14a(3) of Directive 2004/49/EC;
subjekt, zadolžen za vzdrževanje, ki izvaja ukrepe v skladu s členom 14a(3) Direktive 2004/49/ES;
a contracting entity or a manufacturer which invites a notified body to apply the ‘EC’ verification procedure in accordance with Article 18(1) of Directive 2008/57/EC or a designated body according to Article 17(3) of that Directive;
naročnik ali proizvajalec, ki priglašeni organ poziva k uporabi postopka za ES-verifikacijo v skladu s členom 18(1) Direktive 2008/57/ES, ali organ, imenovan v skladu s členom 17(3) navedene direktive;
an applicant for an authorisation for the placing in service of structural sub-systems;
prosilec za dovoljenje za začetek obratovanja strukturnih podsistemov;
‘assessment body’ means the independent and competent external or internal individual, organisation or entity which undertakes investigation to provide a judgement, based on evidence, of the suitability of a system to fulfil its safety requirements;
„ocenjevalni organ“ pomeni neodvisno in pristojno zunanjo ali notranjo osebo, organizacijo ali subjekt, ki na podlagi dokazov preveri, ali sistem izpolnjuje varnostne zahteve, in o tem sprejme odločitev;
‘risk acceptance criteria’ means the terms of reference by which the acceptability of a specific risk is assessed; these criteria are used to determine that the level of a risk is sufficiently low that it is not necessary to take any immediate action to reduce it further;
„merila sprejemanja tveganja“ pomeni merila za ocenjevanje sprejemljivosti določenega tveganja; ta merila se uporabljajo za to, da se ugotovi, ali je raven tveganja dovolj nizka, da niso potrebni takojšnji ukrepi za njegovo nadaljnje zmanjšanje;
‘technical system’ means a product or an assembly of products including the design, implementation and support documentation; the development of a technical system starts with its requirements specification and ends with its acceptance; although the design of relevant interfaces with human behaviour is considered, human operators and their actions are not included in a technical system; the maintenance process is described in the maintenance manuals but is not itself part of the technical system;
„tehnični sistem“ pomeni proizvod ali skupino proizvodov, vključno z zasnovo, uvedbo in podporno dokumentacijo; razvoj tehničnega sistema se prične z določitvijo zahtev, konča pa z njegovo odobritvijo; čeprav se upošteva zasnova ustreznih vmesnikov s človeškim vedenjem, človeški izvajalci in njihova dejanja niso vključeni v tehnični sistem; postopek vzdrževanja je opisan v priročnikih za vzdrževanje, vendar ni del tehničnega sistema;
‘catastrophic consequence’ means fatalities and/or multiple severe injuries and/or major damage to the environment resulting from an accident;
„katastrofalne posledice“ pomeni smrtne žrtve in/ali več težje ranjenih in/ali veliko škodo za okolje, ki jih povzroči nesreča;
‘system’ means any part of the railway system which is subjected to a change whereby the change may be of a technical, operational or organisational nature;
„sistem“ pomeni kateri koli del železniškega sistema, ki je predmet spremembe, pri čemer je sprememba lahko tehničnega, operativnega ali organizacijskega značaja;
‘notified national rule’ means any national rule notified by Member States under Council Directive 96/48/EC [7] or, Directive 2001/16/EC of the European Parliament and of the Council [8] and Directives 2004/49/EC and 2008/57/EC;
„priglašeni nacionalni predpis“ pomeni kateri koli nacionalni predpis, ki ga države članice priglasijo v skladu z Direktivo Sveta 96/48/ES [7] ali Direktivo 2001/16/ES Evropskega parlamenta in Sveta [8] ter direktivama 2004/49/ES in 2008/57/ES;
‘certification body’ means a certification body as defined in Article 3 of Regulation (EU) No 445/2011;
„certifikacijski organ“ pomeni certifikacijski organ, kakor je opredeljen v členu 3 Uredbe (EU) št. 445/2011;
‘conformity assessment body’ means a conformity assessment body as defined in Article 2 of Regulation (EC) No 765/2008;
„organ za ugotavljanje skladnosti“ pomeni organ za ugotavljanje skladnosti, kakor je opredeljen v členu 2 Uredbe (ES) št. 765/2008;
‘accreditation’ means accreditation as defined in Article 2 of Regulation (EC) No 765/2008;
„akreditacija“ pomeni akreditacijo, kakor je opredeljena v členu 2 Uredbe (ES) št. 765/2008;
‘national accreditation body’ means a national accreditation body as defined in Article 2 of Regulation (EC) No 765/2008;
„nacionalni akreditacijski organ“ pomeni nacionalni akreditacijski organ, kakor je opredeljen v členu 2 Uredbe (ES) št. 765/2008;
‘recognition’ means an attestation by a national body other than the national accreditation body that the assessment body meets the requirements set out in Annex II to this Regulation to carry out the independent assessment activity specified in Article 6(1) and (2).
„priznanje“ pomeni potrdilo nacionalnega organa, ki ni nacionalni akreditacijski organ, da ocenjevalni organ izpolnjuje zahteve iz Priloge II k tej uredbi, da lahko opravlja neodvisno dejavnost ocene iz člena 6(1) in (2).
If the proposed change has no impact on safety, the risk management process described in Article 5 need not be applied.
Če predlagana sprememba ne vpliva na varnost, ni treba uporabiti postopka upravljanja s tveganji iz člena 5.
If the proposed change has an impact on safety, the proposer shall decide, by expert judgement, on the significance of the change based on the following criteria:
Če predlagana sprememba vpliva na varnost, predlagatelj strokovno oceni pomembnost spremembe na podlagi naslednjih meril:
failure consequence: credible worst-case scenario in the event of failure of the system under assessment, taking into account the existence of safety barriers outside the system under assessment;
posledice odpovedi: verjeten najslabši možni potek dogodkov v primeru odpovedi ocenjevanega sistema, pri čemer se upoštevajo obstoječi varnostni ukrepi zunaj ocenjevanega sistema;
novelty used in implementing the change: this concerns both what is innovative in the railway sector, and what is new for the organisation implementing the change;
novosti, ki se uvede s spremembo: to se nanaša tako na inovacije v železniškem sektorju kot tudi na novosti v organizaciji, ki uvaja spremembo;
monitoring: the inability to monitor the implemented change throughout the system life-cycle and intervene appropriately;
spremljanja: nezmožnost spremljanja uvedenih sprememb v življenjskem ciklu sistema in ustrezne intervencije;
additionality: assessment of the significance of the change taking into account all recent safety-related changes to the system under assessment and which were not judged to be significant.
dodatnosti: ocena pomembnosti spremembe, pri čemer se upoštevajo vse nedavne z varnostjo povezane spremembe ocenjevanega sistema, ki ne veljajo za pomembne.
The proposer shall keep adequate documentation to justify its decision.
Predlagatelj vodi ustrezno dokumentacijo, ki vsebuje utemeljitev njegove odločitve.
The proposer shall be responsible for applying this Regulation, including the assessment of the significance of the change based on the criteria in Article 4, and for conducting the risk management process set out in Annex I.
Predlagatelj je odgovoren za uporabo te uredbe, vključno z oceno pomembnosti spremembe na podlagi meril iz člena 4, in za izvajanje postopka upravljanja s tveganji iz Priloge I.
The proposer shall ensure that risks introduced by its suppliers and its service providers, including their subcontractors, are also managed in compliance with this Regulation.
Predlagatelj zagotovi, da so tveganja, ki jih ustvarijo njegovi dobavitelji in ponudniki storitev, vključno z njihovimi podizvajalci, prav tako upravljana v skladu s to uredbo.
To this end, the proposer may require through contractual arrangements that its suppliers and its service providers, including their subcontractors, participate in the risk management process set out in Annex I.
V ta namen lahko predlagatelj prek pogodbenih dogovorov zahteva, naj dobavitelji in ponudniki storitev, vključno z njihovimi podizvajalci, sodelujejo v postopku upravljanja s tveganji iz Priloge I.
An 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.
Ocenjevalni organ opravi neodvisno oceno ustreznosti uporabe postopka upravljanja s tveganji iz Priloge I in rezultatov uporabe tega postopka.
This assessment body shall meet the criteria listed in Annex II.
Ta ocenjevalni organ izpolnjuje merila iz Priloge II.
Where the assessment body is not already designated by existing Union or national legislation, the proposer shall appoint its own assessment body at the earliest appropriate stage of the risk assessment process.
Kadar ocenjevalni organ ni imenovan že z obstoječo zakonodajo Unije ali nacionalno zakonodajo, predlagatelj imenuje svoj ocenjevalni organ v najzgodnejši ustrezni fazi postopka ocene tveganja.
To perform the independent assessment, the assessment body shall:
Da bi opravil neodvisno oceno ocenjevalni organ:
ensure it has a thorough understanding of the significant change based on the documentation provided by the proposer;
zagotovi, da ima poglobljeno razumevanje pomembne spremembe na podlagi dokumentacije, ki mu jo je predložil predlagatelj;
conduct 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;
opravi oceno postopkov, ki se uporabljajo za upravljanje varnosti in kakovosti med načrtovanjem in izvajanjem pomembne spremembe, če teh postopkov ni že potrdil ustrezni pristojni organ za ugotavljanje skladnosti;
conduct an assessment of the application of those safety and quality processes during the design and implementation of the significant change.
opravi oceno uporabe teh postopkov varnosti in kakovosti med načrtovanjem in izvajanjem pomembne spremembe.
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.
Po koncu ocene v skladu s točkami (a), (b) in (c) ocenjevalni organ poda poročilo o oceni varnosti, ki je predvideno v členu 15 in Prilogi III.
Duplication of work between the following assessments shall be avoided:
Podvajanju dela se je treba izogniti v naslednjih ocenah:
the assessment of conformity of the safety management system and of the system of maintenance of entities in charge of maintenance as required by Directive 2004/49/EC; and
ocena skladnosti sistema varnega upravljanja in sistema vzdrževanja subjektov, zadolženih za vzdrževanje v skladu z zahtevami iz Direktive 2004/49/ES, in
the conformity assessment carried out by a notified body as defined by Article 2(j) of Directive 2008/57/EC or a body designated in accordance with Article 17 of that Directive; and
ocena skladnosti, ki jo opravi priglašeni organ, kakor je opredeljeno v členu 2(j) Direktive 2008/57/ES, ali organ, imenovan v skladu s členom 17 navedene direktive, in
any independent assessment carried out by the assessment body in accordance with this Regulation.
vse neodvisne ocene, ki jih opravi ocenjevalni organ v skladu s to uredbo.
Without prejudice to Union legislation, the 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:
Predlagatelj lahko brez poseganja v zakonodajo Unije izbere nacionalni varnostni organ kot ocenjevalni organ, če nacionalni varnostni organ ponuja to storitev in če pomembne spremembe zadevajo naslednje primere:
a vehicle needs an authorisation for placing in service, as referred to in Articles 22(2) and 24(2) of Directive 2008/57/EC;
vozilo potrebuje dovoljenje za začetek obratovanja v skladu s členom 22(2) in členom 24(2) Direktive 2008/57/ES;
a vehicle needs an additional authorisation for placing in service, as referred to in Articles 23(5) and 25(4) of Directive 2008/57/EC;
vozilo potrebuje dodatno dovoljenje za začetek obratovanja v skladu s členom 23(5) in členom 25(4) Direktive 2008/57/ES;
the safety certificate has to be updated due to alteration of the type or extent of the operation, as referred to in Article 10(5) of Directive 2004/49/EC;
varnostno spričevalo je treba podaljšati zaradi spremembe vrste ali obsega dejavnosti v skladu s členom 10(5) Direktive 2004/49/ES;
the safety certificate has to be revised due to substantial changes to the safety regulatory framework, as referred to in Article 10(5) of Directive 2004/49/EC;
varnostno spričevalo je treba zaradi bistvenih sprememb varnostnega regulativnega okvira revidirati v skladu s členom 10(5) Direktive 2004/49/ES;
the 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, as referred to in Article 11(2) of Directive 2004/49/EC;
varnostno pooblastilo je treba podaljšati zaradi bistvene spremembe železniške infrastrukture, signalizacije, oskrbe z energijo ali načel za njeno delovanje in vzdrževanje v skladu s členom 11(2) Direktive 2004/49/ES;
the safety authorisation has to be revised due to substantial changes to the safety regulatory framework, as referred to in Article 11(2) of Directive 2004/49/EC.
varnostno pooblastilo je treba zaradi bistvenih sprememb varnostnega regulativnega okvira revidirati v skladu s členom 11(2) Direktive 2004/49/ES.
Where a significant change concerns a structural subsystem that needs an authorisation for placing in service as referred to in Article 15(1) or Article 20 of Directive 2008/57/EC, 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 a notified body in accordance with Article 18(2) of that Directive.
Če pomembna sprememba zadeva strukturni podsistem, za katerega je potrebno dovoljenje za začetek obratovanja v skladu s členom 15(1) ali členom 20 Direktive 2008/57/ES, lahko predlagatelj izbere nacionalni varnostni organ kot ocenjevalni organ, če nacionalni varnostni organ ponuja to storitev, razen če je predlagatelj za to nalogo že zadolžil priglašeni organ v skladu s členom 18(2) navedene direktive.
Accreditation/recognition of the assessment body
Akreditacija/priznanje ocenjevalnega organa
The assessment body provided for in Article 6 shall be either:
Ocenjevalni organ iz člena 6 je lahko:
accredited by the national accreditation body referred to in Article 13(1) using the criteria defined in Annex II; or
akreditiran s strani nacionalnega akreditacijskega organa iz člena 13(1) v skladu z merili iz Priloge II ali
recognised by the recognition body referred to in Article 13(1) using the criteria defined in Annex II; or
priznan s strani organa za priznavanje iz člena 13(1) v skladu z merili iz Priloge II ali
the national safety authority under the requirement of Article 9(2).
nacionalni varnostni organ v skladu z zahtevo iz člena 9(2).
Acceptance of accreditation/recognition
Sprejetje akreditacije/priznanja
When granting the safety certificate or the safety authorisation in accordance with Commission Regulation (EU) No 1158/2010 [9] or Commission Regulation (EU) No 1169/2010 [10], a national safety authority shall accept accreditation or recognition by a Member State in accordance with Article 7, as proof of the ability of the railway undertaking or infrastructure manager to act as an assessment body.
Pri podeljevanju varnostnega spričevala ali varnostnega pooblastila v skladu z Uredbo Komisije (EU) št. 1158/2010 [9] oziroma Uredbo Komisije (EU) št. 1169/2010 [10] nacionalni varnostni organ sprejme akreditacijo ali priznanje s strani države članice v skladu s členom 7 kot dokazilo o sposobnosti prevoznika v železniškem prometu ali upravljavca infrastrukture, da deluje kot ocenjevalni organ.
When granting the certificate to an entity in charge of maintenance in accordance with Regulation (EU) No 445/2011, the certification body shall accept such accreditation or recognition by a Member State, as proof of the ability of the entity in charge of maintenance to act as assessment body.
Pri izdaji spričevala subjektu, zadolženemu za vzdrževanje v skladu z Uredbo (EU) št. 445/2011, certifikacijski organ od države članice tako akreditacijo ali priznanje sprejme kot dokazilo o sposobnosti subjekta, zadolženega za vzdrževanje, da deluje kot ocenjevalni organ.
Types of recognition of the assessment body
Vrste priznanj ocenjevalnega organa
The following types of recognition of the assessment body may be used:
Uporabijo se lahko naslednje vrste priznanj ocenjevalnega organa:
recognition by the Member State of an entity in charge of maintenance, an organisation or a part of it or an individual;
priznanje države članice subjektu, zadolženemu za vzdrževanje, organizaciji ali delu organizacije ali posamezniku;
recognition by the national safety authority of the ability of an organisation or a part of it or an individual to conduct independent assessment through the assessment and supervision of the safety management system of a railway undertaking or an infrastructure manager;
priznanje nacionalnega varnostnega organa o zmožnosti organizacije ali dela organizacije ali posameznika, da opravi neodvisno oceno z ocenjevanjem in nadzorom sistema varnega upravljanja prevoznika v železniškem prometu ali upravljavca infrastrukture;
when the national safety authority is acting as certification body in conformity with Article 10 of Regulation (EU) No 445/2011, recognition by the national safety authority of the ability of an organisation or a part of it or an individual to conduct independent assessment through assessment and surveillance of the system of maintenance of an entity in charge of maintenance;
kadar nacionalni varnostni organ deluje kot certifikacijski organ v skladu s členom 10 Uredbe (EU) št. 445/2011, priznanje nacionalnega varnostnega organa o zmožnosti organizacije ali dela organizacije ali posameznika, da opravi neodvisno oceno z ocenjevanjem in nadzorom sistema vzdrževanja subjekta, zadolženega za vzdrževanje;
recognition by a recognition body designated by the Member State of the ability of an entity in charge of maintenance, an organisation or a part of it or an individual to conduct independent assessment.
priznanje s strani organa za priznavanje, ki ga imenuje država članica, da je subjekt, zadolžen za vzdrževanje, organizacija ali del organizacije ali posameznik sposoben opravljati neodvisno oceno.
When the Member State recognises the national safety authority as an assessment body, it is the responsibility of that Member State to ensure that the national safety authority fulfills the requirements set out in Annex II; In this case, the assessment body functions of the national safety authority shall be demonstrably independent of the other functions of the national safety authority.
Ko država članica prizna nacionalni varnostni organ kot ocenjevalni organ, je ta država članica odgovorna, da zagotovi, da nacionalni varnostni organ izpolnjuje zahteve iz Priloge II; v tem primeru morajo biti funkcije nacionalnega varnostnega organa kot ocenjevalnega organa dokazljivo neodvisne od drugih funkcij nacionalnega varnostnega organa.
Validity of recognition
Veljavnost priznanja
In the cases referred in Article 9(1)(a) and (d) and Article 9(2), the period of validity of recognition shall not exceed 5 years from the date it is granted.
V primerih iz člena 9(1)(a) in (d) ter člena 9(2) obdobje veljavnosti priznanja ne sme presegati 5 let od dneva, ko se podeli.
In the case referred in Article 9(1)(b):
V primerih iz člena 9(1)(b):
the statement of recognition for a railway undertaking or an infrastructure manager shall be displayed on the relevant safety certificate in field 5 ‘Additional Information’ of the harmonised format of safety certificates provided in Annex I to Commission Regulation (EC) No 653/2007 [11] and in an appropriate part of the safety authorisations;
mora biti izjava o priznanju za prevoznika v železniškem prometu ali upravljavca infrastrukture navedena na ustreznem varnostnem spričevalu v polju 5 „Dodatne informacije“ usklajenega obrazca varnostnih spričeval iz Priloge I k Uredbi Komisije (ES) št. 653/2007 [11] in v ustreznem delu varnostnih dovoljenj;
the period of validity of recognition shall be limited to the validity of the safety certificate or authorisation under which it is granted.
je obdobje veljavnosti priznanja treba omejiti na veljavnost varnostnega spričevala ali pooblastila, v okviru katerega je podeljeno.
In this case, the request of recognition shall be made at the next application for renewal or update of the safety certificate or authorisation.
V tem primeru je treba v naslednji vlogi za obnovitev ali posodobitev varnostnega spričevala ali pooblastila vključiti zahtevek za priznanje.
In the cases referred in Article 9(1)(c):
V primerih iz člena 9(1)(c):
the statement of recognition for an entity in charge of maintenance shall be displayed on the relevant certificate in field 5 ‘Additional Information’ of the harmonised format of certificates for entities in charge of maintenance provided in Annex V, or in Annex VI where relevant, of Regulation (EU) No 445/2011;
se izjava o priznanju za subjekt, zadolžen za vzdrževanje, navede na ustreznem spričevalu v polju 5 „Dodatne informacije“ usklajenega obrazca spričeval za subjekte, zadolžene za vzdrževanje, iz Priloge V ali, če je primerno, Priloge VI k Uredbi (EU) št. 445/2011;
the period of validity of recognition shall be limited to the validity of the certificate issued by the certification body under which it is granted.
obdobje veljavnosti priznanja je omejeno na veljavnost spričevala, ki ga je izdal certifikacijski organ, v okviru katerega je bilo izdano.
In this case, the request of recognition shall be made at the next application for renewal or update of that certificate.
V tem primeru je treba v naslednji vlogi za obnovitev ali posodobitev navedenega spričevala vključiti zahtevek za priznanje.
Surveillance by recognition body
Nadzor s strani organa za priznavanje
By analogy to the requirements in Article 5(3) and (4) of Regulation (EC) No 765/2008 for accreditation, the recognition body shall conduct periodic surveillance in order to verify that the assessment body it recognised continues to satisfy the criteria set out in Annex II during the validity of the recognition.
Po analogiji z zahtevami iz člena 5(3) in (4) Uredbe (ES) št. 765/2008 glede akreditacije organ za priznavanje opravlja redni nadzor, da se preveri, ali ocenjevalni organ, ki ga je priznal, še naprej izpolnjuje merila iz Priloge II v obdobju veljavnosti priznanja.
If the assessment body no longer satisfies the criteria set out in Annex II, the recognition body shall limit the scope of application of the recognition, suspend or withdraw the recognition, depending on the degree of non-compliance.
Če ocenjevalni organ ne izpolnjuje več meril iz Priloge II, organ za priznavanje omeji področje uporabe priznanja, odloži ali prekliče priznanje, odvisno od stopnje neskladnosti.
Relaxed criteria where a significant change is not to be mutually recognised
Opuščena merila, kadar pomembne spremembe ni treba vzajemno priznati
Where the risk assessment for a significant change is not to be mutually recognised, the proposer shall appoint an assessment body meeting at least the competency, independency and impartiality requirements of Annex II.
Kadar ocene tveganja pomembne spremembe ni treba vzajemno priznati, predlagatelj imenuje ocenjevalni organ, ki izpolnjuje vsaj zahteve glede usposobljenosti, neodvisnosti in nepristranskosti iz Priloge II.