natgillin/translations-raw huggingface dataset:
The notified body shall not assess again the entire quality manual and all the procedures already assessed by the quality management system certification body.
Priglašeni organ ne ocenjuje ponovno celotnega priročnika kakovosti in vseh postopkov, ki jih je že ocenil organ za potrjevanje sistema vodenja kakovosti.
In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant interoperability constituent field and product technology concerned, and knowledge of the requirements of the TSI.
Revizijska skupina ima poleg izkušenj s sistemi vodenja kakovosti vsaj enega člana z izkušnjami ocenjevanja na ustreznem področju glede komponente interoperabilnosti in zadevne tehnologije proizvoda ter poznavanjem zahtev TSI.
The audit shall include an assessment visit to the manufacturer’s premises.
Revizija vključuje ocenjevalni obisk proizvajalčevih prostorov.
The auditing team shall review the technical documentation referred to in point 3.1, second paragraph, fifth indent, to verify the manufacturer’s ability to identify the requirements of the TSI and to carry out the necessary examinations with a view to ensuring compliance of the interoperability constituent with those requirements.
Revizijska skupina pregleda tehnično dokumentacijo iz pete alinee drugega odstavka točke 3.1, da preveri, ali je proizvajalec sposoben opredeliti zahteve TSI in izvesti potrebne preglede za zagotovitev skladnosti komponente interoperabilnosti s temi zahtevami.
The decision shall be notified to the manufacturer.
Odločitev je treba sporočiti proizvajalcu.
The notification shall contain the conclusions of the audit and the reasoned assessment decision.
Uradno obvestilo vsebuje ugotovitve revizije in utemeljeno odločitev o oceni.
Where the assessment of the quality management system provided satisfying evidence that the requirements referred to in point 3.2 are met, the notified body shall issue a quality management system approval to the applicant.
Če se z oceno sistema vodenja kakovosti zagotovijo zadovoljivi dokazi, da so zahteve iz točke 3.2 izpolnjene, priglašeni organ vložniku izda odobritev sistema vodenja kakovosti.
The manufacturer shall undertake to fulfil the obligations arising out of the quality management system as approved and to maintain it so that it remains adequate and efficient.
Proizvajalec se obvezuje, da bo izpolnjeval obveznosti, ki izhajajo iz odobrenega sistema vodenja kakovosti, ter da bo sistem primerno in učinkovito vzdrževal.
The manufacturer shall keep the notified body that has approved the quality management system informed of any intended change to the quality management system having impact on the interoperability constituent, including changes of quality management system certificate.
Proizvajalec obvesti priglašeni organ, ki je odobril sistem vodenja kakovosti, o kakršni koli nameravani spremembi sistema vodenja kakovosti, ki bi vplivala na komponento interoperabilnosti, vključno s spremembami certifikata sistema vodenja kakovosti.
The notified body shall evaluate any proposed changes and decide whether the modified quality management system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary.
Priglašeni organ oceni predlagane spremembe in presodi, ali bo spremenjeni sistem vodenja kakovosti še naprej izpolnjeval zahteve iz točke 3.2 ali je potrebna ponovna ocena.
The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality management system.
Namen nadzora je zagotoviti, da proizvajalec dosledno izpolnjuje obveznosti, ki izhajajo iz odobrenega sistema vodenja kakovosti.
The manufacturer shall, for periodic audits purposes, allow the notified body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular:
Proizvajalec priglašenemu organu za namene rednih revizij omogoči vstop v prostore za proizvodnjo, pregledovanje, preskušanje in skladiščenje ter mu da na voljo vse potrebne informacije, zlasti:
the quality management system documentation,
dokumentacijo o sistemu vodenja kakovosti,
The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality management system and shall provide the manufacturer with an audit report.
Priglašeni organ redno izvaja redne revizije, s čimer ugotovi, ali proizvajalec vzdržuje in uporablja sistem vodenja kakovosti, ter proizvajalcu zagotovi revizijsko poročilo.
The frequency of the periodic audits shall be at least once every 2 years.
Redne revizije se izvajajo vsaj enkrat na dve leti.
When the manufacturer operates a certified quality management system, the notified body shall take this into account during the periodic audits.
Kadar proizvajalec izvaja potrjeni sistem vodenja kakovosti, priglašeni organ to upošteva pri rednih revizijah.
In addition, the notified body may pay unexpected visits to the manufacturer.
Poleg tega lahko priglašeni organ proizvajalca nenapovedano obišče.
During such visits the notified body may, if necessary, carry out interoperability constituent tests, or have them carried out, in order to verify that the quality management system is functioning correctly.
Med temi obiski lahko priglašeni organ po potrebi izvede ali naroči preskuse komponent interoperabilnosti, s čimer preveri, ali sistem vodenja kakovosti pravilno deluje.
The notified body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.
Priglašeni organ proizvajalcu predloži poročilo o obisku in, če so bili izvedeni preskusi, poročilo o preskusih.
The certificates to be referred to are:
Certifikati, na katere se lahko sklicuje, so:
the quality management system approval indicated in point 3.3 and audit reports indicated in point 4.3, if any,
odobritev sistema vodenja kakovosti iz točke 3.3 in revizijska poročila iz točke 4.3, če ta obstajajo,
The manufacturer shall, for the period defined in the relevant TSI and, where the TSI does not define this period, for a period ending at least 10 years after the last interoperability constituent has been manufactured, keep at the disposal of the national authorities:
Proizvajalec hrani naslednje dokumente, da so nacionalnim organom na voljo v obdobju, določenem v ustrezni TSI oziroma, kadar TSI tega obdobja ne določa, vsaj 10 let po tem, ko je bila proizvedena zadnja komponenta interoperabilnosti:
the change referred to in point 3.5, as approved,
dokumentacijo o spremembi iz točke 3.5, kakor je bila odobrena,
Each notified body shall inform its notifying authorities of quality management system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of quality management system approvals refused, suspended or otherwise restricted.
Vsak priglašeni organ obvesti priglasitvene organe o izdanih ali preklicanih odobritvah sistema vodenja kakovosti in redno ali na zahtevo zagotovi priglasitvenim organom seznam zavrnjenih, začasno opuščenih ali drugače omejenih odobritev sistema vodenja kakovosti.
Each notified body shall inform the other notified bodies of quality management system approvals which it has refused, suspended, withdrawn or otherwise restricted, and, upon request, of quality management system approvals which it has issued.
Vsak priglašeni organ obvesti druge priglašene organe o odobritvah sistema vodenja kakovosti, ki jih je zavrnil, začasno opustil, preklical ali drugače omejil, ter jih na zahtevo obvesti o odobritvah sistema vodenja kakovosti, ki jih je izdal.
The manufacturer’s obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
Obveznosti proizvajalca iz točk 3.1, 3.5, 5 in 6 lahko v njegovem imenu in na njegovo odgovornost izpolni pooblaščeni zastopnik, pod pogojem, da je to navedeno v pooblastilu.
Conformity to type based on product verification is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 5.1 and 6, and ensures and declares on his sole responsibility that the interoperability constituents concerned, which have been subject to the provisions of point 3, are in conformity with the type described in the EC-type examination certificate and satisfy the requirements of the technical specification for interoperability (TSI) that apply to them.
Skladnost s tipom na podlagi preverjanja proizvoda je del postopka ugotavljanja skladnosti, v okviru katerega proizvajalec izpolni obveznosti iz točk 2, 5.1. in 6 ter zagotovi in na lastno odgovornost izjavi, da so zadevne komponente interoperabilnosti, ki so predmet določb iz točke 3, v skladu s tipom, opisanim v certifikatu o ES-pregledu tipa, in da izpolnjujejo zahteve tehnične specifikacije za interoperabilnost (TSI), ki se zanje uporabljajo.
A notified body chosen by the manufacturer shall carry out appropriate examinations and tests in order to check the conformity of the interoperability constituents with the approved type described in the EC-type examination certificate and with the requirements of the TSI.
Priglašeni organ, ki ga je izbral proizvajalec, izvede ustrezne preglede in preskuse, da preveri skladnost komponent interoperabilnosti z odobrenim tipom, opisanim v certifikatu o ES-pregledu tipa, in zahtevami TSI.
The examinations and tests to check the conformity of the interoperability constituents with the requirements of the TSI shall be carried out, at the choice of the manufacturer either by examination and testing of every interoperability constituent as specified in point 4 or by examination and testing of the interoperability constituents on a statistical basis as specified in point 5.
Pregledi in preskusi za ugotovitev skladnosti komponent interoperabilnosti z zahtevami TSI se na izbiro proizvajalca izvedejo s pregledom in preskušanjem vsake komponente interoperabilnosti, kot je določeno v točki 4, ali s pregledom in preskušanjem komponent interoperabilnosti na statistični podlagi, kot je določeno v točki 5.
Verification of conformity by examination and testing of every interoperability constituent.
Preverjanje skladnosti s pregledom in preskusom vsake komponente interoperabilnosti
All interoperability constituents shall be individually examined and appropriate tests set out in the relevant TSI, harmonised standard(s) and/or technical specifications, or equivalent tests, shall be carried out in order to verify conformity with the approved type described in the EC-type examination certificate and with the requirements of the TSI.
Vse komponente interoperabilnosti se pregledajo posamezno, na njih pa se izvedejo primerni preskusi, določeni v ustreznih TSI, harmoniziranih standardih in/ali tehničnih specifikacijah, ali enakovredni preskusi, s čimer se preveri njihova skladnost z odobrenim tipom, opisanim v certifikatu o ES-pregledu tipa, in zahtevami TSI.
When a test is not set out in the TSI, harmonised standard(s) and technical specification(s), the appropriate tests to be carried out shall be decided between the manufacturer and the notified body concerned.
Če preskus ni določen v TSI, harmoniziranih standardih in tehničnih specifikacijah, se o ustreznih preskusih, ki se opravijo, dogovorita proizvajalec in zadevni priglašeni organ.
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure the homogeneity of each lot produced, and shall present his interoperability constituents for verification in the form of homogeneous lots.
Proizvajalec sprejme vse potrebne ukrepe, da proizvodni proces in njegovo spremljanje zagotovita homogenost vsake proizvedene serije, ter predloži svoje komponente interoperabilnosti za preverjanje v obliki homogenih serij.
A random sample shall be taken from each lot according to the requirements of the TSI.
Iz vsake serije se izbere naključni vzorec v skladu z zahtevami TSI.
All interoperability constituents in a sample shall be individually examined and appropriate tests set out in the relevant TSI, harmonised standard(s) and/or technical specifications, or equivalent tests, shall be carried out in order to ensure their conformity with the requirements of the TSI and to determine whether the lot is accepted or rejected.
Vse vzorčne komponente interoperabilnosti se pregledajo posamezno, na njih pa se izvedejo ustrezni preskusi, določeni v ustreznih TSI, harmoniziranih standardih in/ali tehničnih specifikacijah, ali enakovredni preskusi, s čimer se preveri njihova skladnost z veljavnimi zahtevami TSI in določi, ali se serija sprejme ali zavrne.
When a test is not set out in the relevant TSI, harmonised standard(s) and/or technical specification(s), the appropriate tests to be carried out shall be decided between the manufacturer and the notified body concerned.
Če preskus ni določen v ustreznih TSI, harmoniziranih standardih in/ali tehničnih specifikacijah, se o ustreznih preskusih, ki se opravijo, dogovorita proizvajalec in zadevni priglašeni organ.
If a lot is accepted, all interoperability constituents of the lot shall be considered approved, except for those interoperability constituents from the sample that have been found not to satisfy the tests.
Če je serija sprejeta, se odobrijo vse komponente interoperabilnosti iz serije razen tistih komponent interoperabilnosti iz vzorca, za katere je bilo ugotovljeno, da ne izpolnjujejo zahtev preskusa.
The notified body shall issue an EC certificate of conformity in respect to the examinations and tests carried out.
Priglašeni organ izda ES-certifikat o skladnosti na podlagi opravljenih pregledov in preskusov.
The manufacturer shall keep the EC certificates of conformity at the disposal of the national authorities for the period defined in the relevant TSI and, where the TSI does not define this period, for 10 years after the last interoperability constituent has been manufactured.
Proizvajalec hrani ES-certifikat o skladnosti, ki je za pregled na voljo nacionalnim organom v obdobju, določenem v ustrezni TSI oziroma, kadar TSI tega obdobja ne določa, 10 let po tem, ko je bila proizvedena zadnja komponenta interoperabilnosti.
If a lot is rejected, the notified body or the competent authority shall take appropriate measures to prevent that lot is being placed on the market.
Če se serija zavrne, mora priglašeni organ ali pristojni organ sprejeti ustrezne ukrepe, da prepreči dajanje te serije na trg.
In the event of the frequent rejection of lots the notified body may suspend the statistical verification and take appropriate measures.
Če so zavrnitve serij pogoste, lahko priglašeni organ opusti statistično preverjanje in sprejme ustrezne ukrepe.
The manufacturer shall draw up a written EC declaration of conformity for the interoperability constituent and keep it at the disposal of the national authorities, for the period defined in the relevant TSI and, where the TSI does not define this period, for 10 years after the last interoperability constituent has been manufactured.
Proizvajalec za komponento interoperabilnosti sestavi pisno ES-izjavo o skladnosti in jo hrani, da je nacionalnim organom na voljo v obdobju, določenem v ustrezni TSI oziroma, kadar TSI tega obdobja ne določa, 10 let po tem, ko je bila proizvedena zadnja komponenta interoperabilnosti.
the EC type-examination certificate and its additions,
ES-certifikat o pregledu tipa in njegovi dodatki,
the EC certificate of conformity referred to in point 4.2 or point 5.3.
ES-certifikat o skladnosti iz točke 4.2 ali točke 5.3.
The manufacturer’s obligations may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
Obveznosti proizvajalca lahko v njegovem imenu in na njegovo odgovornost izpolni pooblaščeni zastopnik, pod pogojem, da je naveden v pooblastilu.
An authorised representative may not fulfil the manufacturer’s obligations set out in points 2, 5.1 and 5.2.
Pooblaščeni zastopnik ne more izpolniti obveznosti proizvajalca iz točk 2, 5.1 in 5.2.
Conformity based on full quality management system is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on his sole responsibility that the interoperability constituents concerned satisfy the requirements of the technical specification for interoperability (TSI) that apply to them.
Skladnost na podlagi celovitega sistema vodenja kakovosti je postopek ocenjevanja skladnosti, v okviru katerega proizvajalec izpolni obveznosti iz točk 2 in 5 ter zagotovi in na lastno odgovornost izjavi, da zadevne komponente interoperabilnosti izpolnjujejo zahteve tehničnih specifikacij za interoperabilnost (TSI), ki se zanje uporabljajo.
The manufacturer shall operate an approved quality management system for design, manufacture and final product inspection and testing of the interoperability constituents concerned as specified in point 3 and shall be subject to surveillance as specified in point 4.
Proizvajalec izvaja odobren sistem vodenja kakovosti za projektiranje, proizvodnjo ter končni pregled in preskušanje zadevnih komponent interoperabilnosti iz točke 3 ter je nadzorovan v skladu s točko 4.
the technical documentation for one model of each category of interoperability constituents intended to be manufactured.
tehnično dokumentacijo za en model iz vsake kategorije komponent interoperabilnosti, ki bodo proizvedeni.
The technical documentation shall, wherever applicable, contain at least the following elements:
Tehnična dokumentacija, kjer je to ustrezno, vsebuje vsaj naslednje elemente:
the documentation concerning the quality management system, and
dokumentacijo v zvezi s sistemom vodenja kakovosti,
a written declaration that the same application has not been lodged with any other notified body.
pisno izjavo, da isti zahtevek ni bil vložen pri nobenem drugem priglašenem organu.
The quality management system shall ensure compliance of the interoperability constituents with the requirements of the TSI that apply to them.
Sistem vodenja kakovosti zagotavlja skladnost komponent interoperabilnosti z zahtevami TSI, ki se zanje uporabljajo.
the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design and product quality,
ciljev kakovosti in organizacijske strukture, odgovornosti in pristojnosti vodstva glede kakovosti projektiranja in proizvodov,
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 TSI that apply to the interoperability constituents 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 TSI, ki se uporabljajo za komponente interoperabilnosti,
the design control and design verification techniques, processes and systematic actions that will be used when designing the interoperability constituents pertaining to the product category covered,
metod, postopkov in sistematičnih ukrepov za kontrolo in preverjanje projektiranja, ki se bodo uporabljali pri projektiranju komponent interoperabilnosti, ki se nanašajo na zajeto kategorijo proizvoda,
the means of monitoring the achievement of the required design and product quality and the effective operation of the quality management system.
načinov spremljanja doseganja zahtevane kakovosti projektiranja in proizvodov ter učinkovitega delovanja sistema kakovosti.
When the manufacturer operates a certified quality management system certified by an accredited certification body, for the design and manufacturing of the relevant interoperability constituent, the notified body shall take this into account in the assessment.
Kadar proizvajalec pri projektiranju in proizvodnji ustrezne komponente interoperabilnosti 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 interoperability constituent field and product technology concerned, and knowledge of the requirements of the TSI.
Revizijska skupina ima poleg izkušenj s sistemi vodenja kakovosti vsaj enega člana z izkušnjami ocenjevanja na ustreznem področju glede komponente interoperabilnosti in zadevne tehnologije proizvoda ter poznavanjem zahtev TSI.
The auditing team shall review the technical documentation referred to in point 3.1, second indent, to verify the manufacturer’s ability to identify the requirements of the TSI and to carry out the necessary examinations with a view to ensuring compliance of the interoperability constituent with those requirements.
Revizijska skupina pregleda tehnično dokumentacijo iz druge alinee točke 3.1, da preveri, ali je proizvajalec sposoben opredeliti zahteve TSI in izvesti potrebne preglede za zagotovitev skladnosti komponente interoperabilnosti s temi zahtevami.
The manufacturer 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:
Proizvajalec 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 quality records as provided for by the design part of the quality management system, such as results of analyses, calculations, tests, etc., and
zapise o kakovosti, predvidene v projektnem delu sistema vodenja kakovosti, kot so rezultati analiz, izračunov, preskusov itd., in
the quality records as provided for by the manufacturing part of the quality management system, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.
zapise o kakovosti, predvidene v proizvodnem delu sistema vodenja kakovosti, kot so poročila o pregledih in podatki o preskusih, podatki o umerjanju opreme, poročila o strokovni usposobljenosti osebja itd.
During such visits, the notified body may, if necessary, carry out interoperability constituent tests, or have them carried out, in order to check the proper functioning of the quality management system.
Med temi obiski lahko priglašeni organ po potrebi opravlja ali naroči preskuse komponent interoperabilnosti, s čimer preveri pravilno delovanje sistema vodenja kakovosti.
It shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.
Proizvajalcu predloži poročilo o obisku in, če so bili izvedeni preskusi, poročilo o preskusih.
the quality management system approval indicated in point 3.3 and audit reports indicated in point 4.3, if any.
odobritev sistema vodenja kakovosti iz točke 3.3 in revizijska poročila iz točke 4.3, če ta obstajajo.
the documentation concerning the quality management system referred to in point 3.1,
dokumentacijo v zvezi s sistemom vodenja kakovosti iz točke 3.1,
the change referred to in point 3.5, as approved, and
dokumentacijo o spremembi iz točke 3.5, kakor je bila odobrena, ter
Each notified body shall inform the other notified bodies of quality management system approvals which it has refused, suspended or withdrawn, and, upon request, of quality management system approvals which it has issued.
Vsak priglašeni organ obvesti druge priglašene organe o odobritvah sistema vodenja kakovosti, ki jih je zavrnil, začasno opustil ali preklical, ter jih na zahtevo obvesti o odobritvah sistema vodenja kakovosti, ki jih je izdal.