natgillin/translations-raw huggingface dataset:
A notified body chosen by the applicant shall carry out appropriate examinations and tests, set out in the relevant TSI(s), harmonised standards and/or technical specifications, or equivalent tests, to check the conformity of the subsystem with the requirements of the relevant TSI(s), or have them carried out.
Priglašeni organ, ki ga je izbral vložnik, izvede ali naroči ustrezne preglede in preskuse, določene v ustreznih TSI, harmoniziranih standardih in/ali tehničnih specifikacijah, ali enakovredne preskuse, s čimer preveri skladnost podsistema z zahtevami ustreznih TSI.
In the absence of such a harmonised standard and/or technical specification the appropriate tests to be carried out shall be decided between the applicant and the notified body concerned.
Če tak harmoniziran standard in/ali tehnična specifikacija nista na voljo, se vložnik in zadevni priglašeni organ dogovorita o izvedbi ustreznih preskusov.
The examinations, tests and checks shall be carried out at the stages provided in point 2 of Annex VI to Directive 2008/57/EC.
Pregledi, preskusi in preverjanja se izvedejo v fazah iz točke 2 Priloge VI k Direktivi 2008/57/ES.
The notified body may take into account evidence of examinations, checking or tests that have been successfully performed, under comparable conditions by other bodies [1] or, when this is specified by the relevant TSI(s), by (or on the behalf of) the applicant.
Priglašeni organ lahko upošteva dokazila o pregledih, preverjanjih ali preskusih, ki so jih v primerljivih pogojih uspešno izvedli drugi organi [1] ali vložnik (ali so bili opravljeni v njegovem imenu), kadar tako določajo ustrezne TSI.
The notified body will then decide as to whether it shall use the results of these checks or tests.
Potem se priglašeni organ odloči, ali bo uporabil rezultate teh pregledov ali preskusov.
The evidences gathered by the notified body shall be suitable and sufficient to show the conformity with the requirement of the relevant TSI(s) and that all required and appropriate checks and tests have been carried out.
Dokazila, ki jih zbere priglašeni organ, so ustrezna in zadostna, da pokažejo skladnost z zahtevami ustreznih TSI, in dokazujejo, da so bili opravljeni vsi zahtevani in ustrezni preverjanja in preskusi.
The extent to which the evidence originating from other parties is taken into account by the notified body shall be justified by documented analysis using the factors listed in the following paragraph.
Stopnja, do katere priglašeni organ upošteva dokazila drugih udeležencev, je odvisna in utemeljena z evidentirano analizo, pri kateri se upoštevajo dejavniki, navedeni v naslednjem odstavku.
The notified body shall examine:
Priglašeni organ pregleda:
the use of existing equipment and systems:
uporabo obstoječe opreme in sistemov:
used identically as before,
ki se uporabljajo popolnoma enako kot prej,
used before but adapted for use in the new work,
ki so se prej uporabljali, a so zdaj prilagojeni za uporabo,
the use of existing designs, technologies, materials and production techniques,
uporabo obstoječega projektiranja, tehnologij, materialov in proizvodnih tehnik,
the arrangements for design, production, testing and commissioning,
ureditev za projektiranje, proizvodnjo, preskušanje in zagon,
previous approvals from other competent bodies,
prejšnje odobritve s strani drugih pristojnih organov,
the accreditations of other involved bodies:
akreditacije drugih udeleženih organov:
it is permissible for the notified body to take account of valid accreditation to relevant European standards, provided that no conflict of interest exists, that accreditation covers the testing being performed and that accreditation is current,
priglašeni organ lahko upošteva veljavno akreditacijo na podlagi ustreznega evropskega standarda pod pogojem, da ne obstaja nobeno navzkrižje interesov, da akreditacija zajema preskušanje, ki se izvaja, in da je veljavna,
where no formal accreditation exists, the notified body shall confirm that the systems for control of competence, independence, testing and material handling processes, facilities and equipment and other processes relevant to the contribution to the subsystem are controlled,
kadar uradna akreditacija ne obstaja, priglašeni organ potrdi, ali so sistemi za nadzor kompetenc, neodvisnosti, preskušanja in ravnanja z materialom, prostorov in opreme ter drugih ustreznih postopkov za prispevanje k podsistemu pod nadzorom,
in all cases, the notified body shall consider the appropriateness of the arrangements and decide the level of witnessing required.
v vsakem primeru priglašeni organ preveri ustreznost ureditev in odloči o tem, koliko mora biti pri postopkih navzoč.
In all cases, the notified body keeps the responsibility of final results of the examinations, tests and checks.
V vsakem primeru je priglašeni organ odgovoren za končne rezultate pregledov, preskusov in preverjanja.
The notified body shall agree with the applicant the locations where the tests will be carried out and shall agree that final subsystem tests and, whenever required in the TSI, tests under full operating conditions, are carried out by the applicant under direct supervision and attendance of the notified body.
Priglašeni organ se z vložnikom dogovori o krajih, kjer se bodo preskusi izvajali, in da bo končne preskuse podsistema, in kadar koli tako zahtevajo TSI, preskuse v pogojih polnega obratovanja izvedel vložnik pod neposrednim nadzorom in ob navzočnosti priglašenega organa.
When the subsystem referred to in point 2 is subject to derogation(s) procedure according to Article 9 of Directive 2008/57/EC, the applicant shall inform the notified body thereof.
Če se za podsistem iz točke 2 uporabijo postopki v zvezi z odstopanji v skladu s členom 9 Direktive 2008/57/ES, vložnik o tem obvesti priglašeni organ.
Where the subsystem referred to in point 2 is subject to derogation, upgrade, renewal or specific case the EC certificate shall also indicate the precise reference to the TSI(s) or their parts to which conformity has not been examined during EC verification procedure.
Če se za podsistem iz točke 2 uporabijo postopki v zvezi z odstopanji, nadgradnjo, obnovo ali v posebnih primerih, ES-certifikat navaja tudi natančno referenco na TSI ali njihove dele, v zvezi s katerimi med postopkom ES-verifikacije skladnost ni bila preverjena.
Where the subsystem referred to in point 2 is subject to derogation, upgrade, renewal or specific case, the EC declaration for the subsystem shall also indicate the reference to the TSI(s) or their parts to which conformity has not been examined during EC verification procedure.
Če se za podsistem iz točke 2 uporabijo postopki v zvezi z odstopanji, nadgradnjo, obnovo ali v posebnih primerih, ES-izjava za podsistem navaja tudi natančno referenco na TSI ali njihove dele, v zvezi s katerimi med postopkom ES-verifikacije skladnost ni bila preverjena.
A copy of the EC declaration of verification and/or EC ISV declarations, if any, shall be made available to the relevant authorities upon request.
Izvodi ES-izjave o verifikaciji in/ali ES-izjav o ISV, če te obstajajo, so na zahtevo na voljo pristojnim organom.
The technical file accompanying the EC certificate of verification shall be lodged with the applicant.
Tehnični dosje, ki spremlja ES-certifikat o verifikaciji, hrani vložnik.
A copy of the EC certificate of verification and the technical file shall be made available to the Commission, the Member States and the relevant authorities upon request.
Izvoda ES-certifikata o verifikaciji in tehničnega dosjeja sta na voljo Komisiji, državam članicam in ustreznim organom, če ju ti zahtevajo.
The applicant shall keep a copy of the technical file throughout the service life of the subsystem; it shall be sent to any other Member State which so requests.
Vložnik hrani izvod tehničnega dosjeja do konca obratovanja podsistema; na zahtevo ga pošlje kateri koli drugi državi članici.
The applicant’s obligations set out in points 2, 3, 5.3, 5.4, 6.2 and 6.4 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
Obveznosti vložnika iz točk 2, 3, 5.3, 5.4., 6.2 in 6.4 lahko v njegovem imenu in na njegovo odgovornost izpolni pooblaščeni zastopnik, pod pogojem, da je naveden v pooblastilu.
EC verification based on full quality management system plus design examination is the EC verification procedure whereby the applicant fulfils the obligations laid down in points 2 and 6, and ensures and declares on his sole responsibility that the subsystem concerned satisfies the requirements of the relevant TSI(s) as well as any other regulations deriving from the Treaty that apply to it.
ES-verifikacija na podlagi celovitega sistema vodenja kakovosti in pregleda projektiranja je del postopka ES-verifikacije, v okviru katerega vložnik izpolni obveznosti iz točk 2 in 6 ter zagotovi in na lastno odgovornost izjavi, da zadevni podsistem izpolnjuje zahteve ustreznih TSI in drugih predpisov, ki izhajajo iz Pogodbe in se zanj uporabljajo.
The design, manufacture and final subsystem inspection and testing of the subsystem concerned shall be covered by approved quality management system(s) as specified in point 3 and shall be subject to surveillance as specified in point 5.
Projektiranje, proizvodnjo, končni pregled podsistema in preskušanje zadevnega podsistema zajemajo odobreni sistemi vodenja kakovosti iz točke 3 ter so nadzorovani v skladu s točko 5.
The adequacy of the technical design of the subsystem shall have been examined in accordance with point 4.
Ustreznost tehničnega projektiranja podsistema se pregleda v skladu z določbami iz točke 4.
copy of EC ISV declaration(s) issued for the subsystem, if any, and
izvode ES-izjav o ISV, ki so bile izdane za podsistem (če obstajajo), in
The quality management system shall ensure compliance of the subsystem with the requirements of the relevant TSI(s) that apply to it.
Sistem vodenja kakovosti zagotavlja skladnost podsistema z zahtevami ustreznih TSI, ki se zanj uporabljajo.
the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design and subsystem quality,
ciljev kakovosti in organizacijske strukture, odgovornosti in pooblastil, ki jih ima vodstvo glede projektiranja in kakovosti podsistema,
the technical design specifications, including standards, that will be applied and, where the relevant harmonised standards and/or technical specifications will not be applied in full, the means that will be used to ensure that the requirements of the relevant TSI(s) that apply to the subsystem will be met,
tehničnih specifikacij projektiranja, vključno s standardi, ki se bodo uporabljali, in kadar se ustrezni harmonizirani standardi in/ali tehnične specifikacije ne bodo uporabljali v celoti, sredstev, ki se bodo uporabljala za zagotavljanje izpolnjevanja zahtev ustreznih TSI, ki se uporabljajo za podsistem,
the design control and design verification techniques, processes and systematic actions that will be used when designing the subsystem pertaining to the product category covered,
tehnik nadzora projektiranja in načinov preverjanja projektiranja, postopkov in sistematičnih ukrepov, ki se bodo uporabljali pri projektiranju podsistema, ki spadajo v to kategorijo proizvodov,
the means of monitoring the achievement of the required design and subsystem quality and the effective operation of the quality management system.
načinov spremljanja doseganja zahtevane kakovosti projektiranja in podsistema ter učinkovitega delovanja sistema kakovosti.
It shall presume conformity with those requirements in respect of the elements of the quality management system that comply with the corresponding specifications of the national standards that implements the relevant quality management standard, harmonised standard and/or technical specifications.
Organ predvidi skladnost s temi zahtevami glede elementov sistema vodenja kakovosti, ki so v skladu z ustreznimi specifikacijami nacionalnih standardov, ki temelji na ustreznem standardu vodenja kakovosti, harmoniziranem standardu in/ali tehničnih specifikacijah.
When the applicant operates a certified quality management system certified by an accredited certification body for the design, manufacturing and final testing of the relevant subsystem, the notified body shall take this into account in the assessment.
Kadar vložnik pri projektiranju in končnem preskušanju zadevnega podsistema izvaja sistem vodenja kakovosti, ki je potrjen pri akreditiranem organu za potrjevanje, priglašeni organ to upošteva v oceni.
In addition to experience in quality management systems, the auditing team shall have at least one member experienced as an assessor in the relevant subsystem field and product technology concerned, and knowledge of the requirements of the relevant TSI(s).
Revizijska skupina ima poleg izkušenj s sistemi vodenja kakovosti vsaj enega člana z izkušnjami ocenjevanja na ustreznem področju glede podsistema in zadevne tehnologije proizvoda ter poznavanjem zahtev ustreznih TSI.
The applicant or his authorised representative shall be notified of the decision.
Vložnika ali pooblaščenega zastopnika se obvesti o odločitvi.
The applicant shall lodge an application for EC verification of the subsystem (through full quality management system plus examination of the design) with the notified body referred to in point 3.1.
Vložnik vloži zahtevek za ES-verifikacijo podsistema (na podlagi celovitega sistema vodenja kakovosti in pregleda projektiranja) pri priglašenem organu iz točke 3.1.
The application shall make it possible to understand the design, manufacture, maintenance and operation of the subsystem, and to assess the conformity with the requirements of the TSI(s) that apply to it.
Zahtevek omogoča razumevanje projektiranja, proizvodnje, vzdrževanja in delovanja podsistema ter oceno njene skladnosti z zahtevami TSI, ki se zanjo uporabljajo.
the name and address of the applicant,
ime in naslov vložnika,
The technical documentation shall specify the requirements of the relevant TSI(s) and cover, as far as relevant for the assessment, the design and operation of the subsystem.
Tehnična dokumentacija opredeljuje zahteve ustreznih TSI in v obsegu, ki je pomemben za oceno, zajema projektiranje in delovanje podsistema.
a general description of subsystem, its overall design and structure,
splošen opis podsistema, njegovega celovitega projektiranja in strukture,
The supporting evidence shall include, where necessary, the results of tests (including those in operational conditions) carried out by the appropriate testing body of the applicant, or by another testing body on his behalf and under his responsibility.
Dodatna dokazila po potrebi vsebujejo rezultate preskusov (vključno s pridobljenimi v pogojih delovanja), ki jih je izvedel ustrezni preskuševalni organ vložnika ali drug preskuševalni organ v njegovem imenu in na njegovo odgovornost.
When the subsystem referred to in point 4.1 is subject to derogation(s) procedure according to Article 9 of Directive 2008/57/EC, the applicant shall inform the notified body thereof.
Če se za podsistem iz točke 4.1 uporabijo postopki v zvezi z odstopanji v skladu s členom 9 Direktive 2008/57/ES, vložnik o tem obvesti priglašeni organ.
The applicant shall also provide the notified body with a precise reference to the TSI(s) or their parts for which the derogation is requested.
Vložnik za priglašeni organ pripravi tudi natančne navedbe TSI ali njihovih delov, za katere se prosi odstopanje.
The notified body shall examine the application, and where the design meets the requirements of the relevant TSI(s) that apply to the subsystem it shall issue an EC design examination certificate to the applicant.
Priglašeni organ pregleda zahtevek in, če projektiranje izpolnjuje zahteve ustreznih TSI, ki se uporabljajo za podsistem, vložniku izda certifikat o ES-pregledu projektiranja.
The certificate shall give the name and address of the applicant, the conclusions of the examination, the conditions (if any) for its validity and the data necessary for identification of the approved design.
Certifikat vsebuje ime in naslov vložnika, izsledke pregleda, pogoje (če ti obstajajo) njegove veljavnosti in podatke, potrebne za identifikacijo odobrenega projektiranja.
The certificate and its annexes shall contain all relevant information to allow the conformity of the subsystem with the examined design to be evaluated.
Certifikati in priloge vsebujejo vse ustrezne informacije, da se lahko oceni skladnost podsistema s pregledanim projektiranjem.
Where the subsystem referred to in point 4.1 is subject to derogation, upgrade, renewal or specific case, the EC design examination certificate shall also indicate the precise reference to the TSI(s) or their parts to which conformity has not been examined during EC verification procedure.
Če se za podsistem iz točke 4.1 uporabijo postopki v zvezi z odstopanji, nadgradnjo, obnovo ali v posebnih primerih, certifikat o ES-pregledu projektiranja navaja tudi natančno referenco na TSI ali njihove dele, v zvezi s katerimi med postopkom ES-verifikacije skladnost ni bila preverjena.
If only certain parts are covered and they meet the requirements of the relevant TSI(s), the notified body shall issue an EC ISV certificate in compliance with Article 18(4) of Directive 2008/57/EC.
Če se pregledajo le nekateri deli in ti izpolnjujejo zahteve ustreznih TSI, priglašeni organ izda ES-certifikat o ISV v skladu s členom 18(4) Direktive 2008/57/ES.
Where the design does not satisfy the requirements of the relevant TSI(s), the notified body shall refuse to issue an EC design examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.
Če projekt ne izpolnjuje zahtev ustreznih TSI, priglašeni organ zavrne izdajo certifikata o pregledu projektiranja in ustrezno obvesti vložnika s podrobno utemeljitvijo zavrnitve.
The applicant shall keep the notified body that has issued the EC design examination certificate informed of any modification to the approved design that may affect the conformity with the requirements of the relevant TSI(s) or the conditions for validity of the certificate until the expiry of the validity of the certificate.
Vložnik obvesti priglašeni organ, ki je izdal certifikat o ES-pregledu projektiranja, o kakršnih koli spremembah odobrenega projekta, ki bi lahko vplivale na skladnost z zahtevami ustreznih TSI in s pogoji veljavnosti certifikata do izteka veljavnosti certifikata.
The notified body shall keep a copy of the EC design examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the applicant until the expiry of the validity of the certificate.
Priglašeni organ hrani izvod certifikata o ES-pregledu projektiranja, njegovih prilog in dodatkov ter tehnični dosje, vključno z dokumentacijo, ki jo predloži vložnik do izteka veljavnosti certifikata.
The applicant shall keep a copy of the EC design examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities throughout the service life of the subsystem.
Vložnik hrani izvod certifikata o ES-pregledu projektiranja, njegovih prilog in dodatkov, vključno s tehnično dokumentacijo, ki so nacionalnim organom na voljo ves čas obratovanja podsistema.
The applicant shall, for periodic audits purposes, allow the notified body access to the design, manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular:
Vložnik priglašenemu organu za namene rednih revizij omogoči vstop v prostore za projektiranje, proizvodnjo, pregled, preskušanje in skladiščenje ter mu posreduje vse potrebne informacije, zlasti:
The frequency of the periodic audits shall be at least once every 2 years, with at least one audit during the time period of performing the relevant activities (design, manufacture, assembly or installation) for the subsystem being the subject of the EC design examination referred to in point 4.4.
Revizije se izvajajo najmanj enkrat na dve leti z najmanj eno revizijo v obdobju izvajanja pomembnih dejavnosti (projektiranje, proizvodnja, montaža ali namestitev) za podsistem, ki je predmet postopka pregleda projektiranja ES iz točke 4.4.
During such visits, the notified body may, if necessary, carry out subsystem tests, or have them carried out, in order to check the proper functioning of the quality management systems.
Med temi obiski lahko priglašeni organ po potrebi opravlja ali naroči preskuse podsistema, s čimer preveri pravilno delovanje sistemov vodenja kakovosti.
It shall provide the applicant with a visit report and, if tests have been carried out, with a test report.
Vložniku predloži poročilo o obisku in, če so bili izvedeni preskusi, poročilo o preskusih.
to witness the surveillance audits referred to in point 5.2,
do navzočnosti pri nadzornih revizijah iz točke 5.2,
to initiate additional audits referred to in point 5.3 under its responsibility and together with the other notified body(ies).
do izvedbe dodatnih revizij iz točke 5.3 v okviru svoje odgovornosti in v sodelovanju z drugimi priglašenimi organi.
Where the subsystem referred to in point 4.1 is subject to derogation, upgrade, renewal or specific case, the EC certificate shall also indicate the precise reference to the TSI(s) or their parts to which conformity has not been examined during EC verification procedure.
Če se za podsistem iz točke 4.1 uporabijo postopki v zvezi z odstopanji, nadgradnjo, obnovo ali v posebnih primerih, ES-certifikat navaja tudi natančno referenco na TSI ali njihove dele, v zvezi s katerimi med postopkom ES-verifikacije skladnost ni bila preverjena.
The EC declaration of verification shall identify the subsystem for which it has been drawn up and shall mention the number of the design examination certificate.
ES-izjava o verifikaciji opredeljuje podsistem, za katerega je bila sestavljena, in navaja številko certifikata o pregledu projektiranja.
Where the subsystem referred to in point 4.1 is subject to derogation, upgrade, renewal or specific case, the EC declaration for the subsystem shall also indicate the reference to the TSI(s) or their parts to which conformity has not been examined during EC verification procedure.
Če se za podsistem iz točke 4.1 uporabijo postopki v zvezi z odstopanji, nadgradnjo, obnovo ali v posebnih primerih, ES-izjava za podsistem navaja tudi natančno referenco na TSI ali njihove dele, v zvezi s katerimi med postopkom ES-verifikacije skladnost ni bila preverjena.
the quality management system approval referred to in point 3.3 and audit reports indicated in point 5.3, if any,
odobritev sistema vodenja kakovosti iz točke 3.3 in revizijska poročila iz točke 5.3, če ta obstajajo,
the EC design examination certificate referred to in point 4.4 and its additions.
ES-certifikat o pregledu projektiranja iz točke 4.4 in njegovi dodatki.
the decisions and reports of the notified body referred to in points 3.5, 5.3 and 5.4, and
odločbe in poročila priglašenega organa iz točk 3.5, 5.3 in 5.4, ter
the technical file referred to in 6.3.
tehnični dosje iz točke 6.3.
The applicant’s authorised representative may lodge the application referred to in points 4.1 and 4.2 and fulfil the obligations set out in points 3.1, 3.5, 4.3, 4.5, 4.7, 6.2 and 7, on his behalf and under his responsibility, provided that they are specified in the mandate.
Pooblaščeni zastopnik lahko v imenu vložnika in na njegovo odgovornost vloži zahtevek iz točk 4.1 in 4.2 ter izpolni obveznosti iz točk 3.1, 3.5, 4.3., 4.5, 4.7, 6.2 in 7, pod pogojem, da je naveden v pooblastilu.
The conditions to entrust checking and test must be similar to the conditions, respected by a notified body to subcontract activities (see §6.5 of the Blue Guide on the New Approach).
Da bi lahko zaupali pregledom in preskusom, morajo biti pogoji podobni pogojem, ki jih pri podizvajalskih dejavnostih upošteva priglašeni organ (glej odstavek 6.5 „modrega vodnika za novi pristop“).