natgillin/translations-raw huggingface dataset:
The notified body shall issue an EC certificate of conformity in respect of 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 available for inspection by 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.
The manufacturer’s obligations set out in point 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 točke 6 lahko v njegovem imenu in na njegovo odgovornost izpolni pooblaščeni zastopnik pod pogojem, da je naveden v pooblastilu.
Internal production control plus product verification at random intervals is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3, 4, and 6, 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.
Notranji nadzor proizvodnje in preverjanje proizvodov v naključno izbranih časovnih presledkih je postopek ocenjevanja skladnosti, pri katerem proizvajalec izpolni obveznosti iz točk 2, 3, 4 in 6 ter zagotovi in na lastno odgovornost izjavi, da zadevne komponente interoperabilnosti izpolnjujejo zahteve tehničnih specifikacij za interoperabilnost (TSI), ki se zanje uporabljajo.
At the choice of the manufacturer, either an accredited in-house body or a notified body, chosen by the manufacturer, shall carry out product checks or have them carried out at random intervals.
Po proizvajalčevi izbiri izvede preskuse proizvodov ali jih izvaja v naključno izbranih časovnih presledkih pooblaščeni interni organ ali priglašeni organ, ki ga izbere proizvajalec.
The manufacturer shall present his products in the form of homogeneous lots and shall take all measures necessary in order that the manufacturing process ensures the homogeneity of each lot produced.
Proizvajalec predloži svoje proizvode v obliki homogenih serij in sprejme vse potrebne ukrepe, da proizvodni proces zagotovi homogenost vsake od proizvedenih serij.
All interoperability constituents shall be available for verification in the form of homogeneous lots.
Vse komponente interoperabilnosti so na voljo za preverjanje v obliki homogenih serij.
A random sample shall be drawn from each lot.
Iz vsake serije se vzame naključni vzorec.
All interoperability constituents in a sample shall be individually examined and appropriate tests shall be carried out to ensure the product conformity with the type described in the technical documentation and the requirements of the TSI that apply to it and to determine whether the lot is accepted or rejected.
Vsaka komponenta interoperabilnosti v vzorcu se posamično pregleda in opravijo se ustrezni preskusi za zagotavljanje skladnosti proizvoda s tipom, opisanim v tehnični dokumentaciji, in zahtevami TSI, ki se zanj uporablja, ter za odločanje, ali je serija sprejeta ali zavrnjena.
EC-type examination is the part of a conformity assessment procedure in which a notified body examines the technical design of an interoperability constituent and verifies and attests that the technical design of the interoperability constituent meets the requirements of the technical specification for interoperability (TSI) that apply to it.
ES-pregled tipa je del postopka ugotavljanja skladnosti, pri katerem priglašeni organ pregleda tehnično projektiranje komponente interoperabilnosti ter preveri in potrdi, da tehnično projektiranje komponente interoperabilnosti izpolnjuje zahteve tehnične specifikacije za interoperabilnost (TSI), ki se zanjo uporabljajo.
examination of a specimen, representative of the production envisaged, of the interoperability constituent (production type),
pregled vzorca komponente interoperabilnosti, reprezentativnega za predvideno proizvodnjo (tip proizvodnje),
assessment of the adequacy of the technical design of the interoperability constituent through examination of the technical documentation and supporting evidence referred to in point 3, plus examination of specimens, representative of the production envisaged, of one or more critical parts of the interoperability constituent (combination of production type and design type),
ocena ustreznosti tehničnega projektiranja komponente interoperabilnosti s pregledovanjem tehnične dokumentacije in dodatnih dokazil iz točke 3 ter pregled vzorcev, reprezentativnih za predvideno proizvodnjo, za enega ali več kritičnih delov komponente interoperabilnosti (kombinacija tipa proizvodnje in tipa projektiranja),
assessment of the adequacy of the technical design of the interoperability constituent through examination of the technical documentation and supporting evidence referred to in point 3, without examination of a specimen (design type).
ocena ustreznosti tehničnega projektiranja komponente interoperabilnosti s pregledovanjem tehnične dokumentacije in dodatnih dokazil iz točke 3 brez pregleda vzorca (tip projektiranja).
The manufacturer shall lodge an application for EC-type examination with a notified body of his choice.
Proizvajalec vloži zahtevek za ES-pregled tipa pri priglašenem organu, ki ga izbere sam.
The application shall include:
Zahtevek vključuje:
the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well,
ime in naslov proizvajalca in, če je zahtevek vložil pooblaščeni zastopnik, tudi njegovo ime in naslov,
a written declaration that the same application has not been lodged with any other notified body,
pisno izjavo, da isti zahtevek ni bila vložen še pri kakem drugem priglašenem organu,
The technical documentation shall make it possible to assess the interoperability constituent’s conformity with the applicable requirements of the TSI.
Tehnična dokumentacija omogoča ocenjevanje skladnosti komponente interoperabilnosti z zahtevami TSI.
descriptions and explanations necessary for the understanding of those drawings and schemes and the operation (including conditions for use) and maintenance of the interoperability constituent,
opis in potrebne razlage za razumevanje načrtov in shematskih prikazov ter delovanja (vključno s pogoji za uporabo) in vzdrževanja komponent interoperabilnosti,
The notified body may request further specimens if needed for carrying out the test programme,
Priglašeni organ lahko zahteva nadaljnje vzorce, če je to potrebno za izvedbo programa preskusov,
the supporting evidence for the adequacy of the technical design solution.
dodatna dokazila o ustreznosti rešitve tehničnega projektiranja.
This supporting evidence shall mention any documents that have been used, in particular where the relevant harmonised standards and/or technical specifications have not been applied in full.
Ta dodatna dokazila navajajo kakršne koli uporabljene dokumente, zlasti če se ustrezni harmonizirani standardi in/ali tehnične specifikacije niso uporabljali v celoti.
For the interoperability constituent:
za komponento interoperabilnosti:
examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the interoperability constituent with the requirements of the relevant TSI.
pregleda tehnično dokumentacijo in dodatna dokazila, da oceni skladnost tehničnega projektiranja komponente interoperabilnosti z zahtevami iz ustrezne TSI;
For the specimen(s):
za vzorce:
verify that the specimen(s) have been manufactured in conformity with the requirements of the TSI and the technical documentation, and identify the elements which have been designed in accordance with the applicable provisions of the relevant harmonised standards and/or technical specifications, as well as the elements which have been designed without applying the relevant provisions of those standards;
preveri, ali so bili vzorci proizvedeni v skladu z zahtevami TSI in tehnične dokumentacije, ter določi elemente, ki so bili projektirani v skladu z določbami ustreznih harmoniziranih standardov in/ali tehničnih specifikacij, in elemente, ki so bili projektirani, ne da bi bile upoštevane ustrezne določbe teh standardov;
carry out appropriate examination and test, or have them carried out, to check whether requirements of the TSI have been applied correctly;
izvede ali naroči ustrezne preglede in preskuse, s katerimi preveri, ali so bile zahteve TSI pravilno upoštevane;
carry out appropriate examinations and tests, or have them carried out, to check whether, where the manufacturer has chosen to apply the solutions in the relevant harmonised standards and/or technical specifications, these have been applied correctly;
izvede ali naroči ustrezne preglede in preskuse, s katerimi preveri, ali je proizvajalec, kadar se je odločil za uporabo rešitev iz ustreznih harmoniziranih standardov in/ali tehničnih specifikacij, te pravilno upošteval;
carry out appropriate examinations and tests, or have them carried out, to check whether, where the solutions in the relevant harmonised standards and/or technical specifications have not been applied, the solutions adopted by the manufacturer meet the corresponding requirements of the TSI;
izvede ali naroči ustrezne preglede in preskuse, da v primeru neuporabe rešitev iz ustreznih harmoniziranih standardov in/ali tehničnih specifikacij preveri, ali rešitve, ki jih je sprejel proizvajalec, izpolnjujejo ustrezne zahteve TSI;
agree with the manufacturer on a location where the examinations and tests will be carried out.
se dogovori s proizvajalcem za kraj, kjer bodo izvedeni pregledi in preskusi.
The notified body shall draw up an evaluation report that records the activities undertaken in accordance with point 4 and their outcomes.
Priglašeni organ sestavi poročilo o oceni, ki navaja dejavnosti, izvedene v skladu s točko 4, in njihove rezultate.
Without prejudice to its obligations vis-à vis the notifying authorities, the notified body shall release the content of that report, in full or in part, only with the agreement of the manufacturer.
Ne glede na obveznosti do priglasitvenih organov lahko priglašeni organ objavi vsebino poročila v celoti ali delno le, če se proizvajalec strinja.
Where the type meets the requirements of the TSI that apply to the interoperability constituent concerned, the notified body shall issue an EC-type examination certificate to the manufacturer.
Če tip izpolnjuje zahteve TSI, ki se uporablja za zadevno komponento interoperabilnosti, priglašeni organ proizvajalcu izda certifikat o ES-pregledu tipa.
The certificate shall contain the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the necessary data for identification of the approved type.
Certifikat vsebuje ime in naslov proizvajalca, ugotovitve pregleda, pogoje (če ti obstajajo) njegove veljavnosti in potrebne podatke za identifikacijo odobrenega tipa.
The certificate and its annexes shall contain all relevant information to allow the conformity of interoperability constituents with the examined type to be evaluated.
Certifikati in priloge vsebujejo vse ustrezne informacije, da se lahko oceni skladnost komponent interoperabilnosti s preskušenim tipom.
Where the type does not satisfy the requirements of the TSI, the notified body shall refuse to issue an EC-type examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.
Če tip ne izpolnjuje veljavnih zahtev TSI, priglašeni organ zavrne izdajo certifikata o ES-pregledu tipa in ustrezno seznani vložnika s podrobno utemeljitvijo zavrnitve.
The manufacturer shall inform the notified body that holds the technical documentation relating to the EC-type examination certificate of all modifications to the approved type that may affect the conformity of the interoperability constituent with the requirements of the TSI or the conditions for validity of the certificate.
Proizvajalec obvesti priglašeni organ, ki hrani tehnično dokumentacijo v zvezi s certifikatom o ES-pregledu tipa, o kakršnih koli spremembah odobrenega tipa, ki bi lahko vplivale na skladnost komponente interoperabilnosti z zahtevami TSI ali s pogoji veljavnosti certifikata.
Only those examinations and tests that are relevant and necessary to the changes shall be performed.
Opravijo se samo tisti pregledi in preskusi, ki so ustrezni in potrebni glede na spremembe.
Each notified body shall inform its notifying authorities concerning the EC-type examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of certificates and/or any additions thereto refused, suspended or otherwise restricted.
Vsak priglašeni organ obvesti svoje priglasitvene organe o izdanih ali preklicanih certifikatih o ES-pregledu tipa in/ali dodatkih k certifikatom ter redno ali na zahtevo da na voljo priglasitvenim organom seznam zavrnjenih, začasno opuščenih ali drugače omejenih certifikatov in/ali dodatkov.
Each notified body shall inform the other notified bodies concerning the EC-type examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning the certificates and/or additions thereto which it has issued.
Vsak priglašeni organ obvesti druge priglašene organe o certifikatih o ES-pregledu tipa, ki jih je zavrnil, začasno opustil ali drugače omejil, ter jih na zahtevo obvesti o certifikatih in/ali dodatkih, ki jih je izdal.
The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EC-type examination certificates and/or additions thereto.
Komisija, države članice in drugi priglašeni organi lahko na zahtevo dobijo izvode certifikatov o ES-pregledu tipa in/ali njihovih dodatkov.
The notified body shall keep a copy of the EC-type examination certificate, its annexes and additions, including the documentation submitted by the manufacturer, until the expiry of the validity of the certificate.
Priglašeni organ do izteka veljavnosti certifikata hrani izvod certifikata o ES-pregledu tipa, njegovih prilog in dodatkov, vključno z dokumentacijo, ki jo predloži proizvajalec.
The manufacturer shall keep a copy of the EC-type examination certificate, its annexes and additions together with the technical documentation 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 izvod certifikata o ES-pregledu tipa, njegove priloge in dodatke skupaj s tehnično dokumentacijo, ki 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 manufacturer’s authorised representative may lodge the application referred to in point 3 and fulfil the obligations set out in points 7 and 9, provided that they are specified in the mandate.
Pooblaščeni zastopnik proizvajalca lahko vloži zahtevek iz točke 3 ter izpolni obveznosti iz točk 7 in 9, če je naveden v pooblastilu.
Conformity to type based on internal production control is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 3, and ensures and declares on his sole responsibility that the interoperability constituents concerned 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 notranjega nadzora proizvodnje je del postopka ugotavljanja skladnosti, v okviru katerega proizvajalec izpolni obveznosti iz točk 2 in 3 ter na lastno odgovornost zagotovi in izjavi, da so zadevne komponente interoperabilnosti v skladu s tipom, opisanim v certifikatu o ES-pregledu tipa, in da izpolnjujejo zahteve tehnične specifikacije za interoperabilnost (TSI), ki se zanje uporabljajo.
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the interoperability constituents with the approved type described in the EC-type examination certificate and with the requirements of the TSI that apply to them.
Proizvajalec sprejme vse potrebne ukrepe, da proizvodni proces in njegovo spremljanje zagotovita skladnost komponent interoperabilnosti z odobrenim tipom, opisanim v certifikatu o ES-pregledu tipa, in z zahtevami TSI, ki se zanje uporabljajo.
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 certificate to be referred to is:
Certifikat, na katerega se sklicuje, je:
the EC type-examination certificate and its additions.
ES-certifikat o pregledu tipa in njegovi dodatki.
The manufacturer’s obligations set out in point 3 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 točke 3 lahko v njegovem imenu in na njegovo odgovornost izpolni pooblaščeni zastopnik pod pogojem, da je naveden v pooblastilu.
Conformity to type based on quality management system of the production process is the part of a 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 constituent concerned 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 it.
Skladnost s tipom na podlagi sistema vodenja kakovosti proizvodnje je del postopka ugotavljanja skladnosti, v okviru katerega proizvajalec izpolni obveznosti iz točk 2 in 5 ter na lastno odgovornost zagotovi in izjavi, da je zadevna komponenta interoperabilnosti v skladu s tipom, opisanim v certifikatu o ES-pregledu tipa, in da izpolnjuje zahteve tehnične specifikacije za interoperabilnost (TSI), ki se zanjo uporabljajo.
The manufacturer shall operate an approved quality management system for production, 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 upravlja odobren sistem vodenja kakovosti za proizvodnjo, pregled končnega proizvoda in preskušanje zadevnih komponent interoperabilnosti iz točke 3 ter je nadzorovan v skladu s točko 4.
Quality management system
Sistem vodenja kakovosti
The manufacturer shall lodge an application for assessment of his quality management system with the notified body of his choice, for the interoperability constituents concerned.
Proizvajalec za zadevne komponente interoperabilnosti vloži zahtevek za ocenitev svojega sistema vodenja kakovosti pri priglašenem organu po svoji izbiri.
all relevant information for the interoperability constituent category envisaged,
vse ustrezne informacije v zvezi s predvideno kategorijo komponente interoperabilnosti,
the documentation concerning the quality management system,
dokumentacijo v zvezi s sistemom vodenja kakovosti,
The quality management system shall ensure that the interoperability constituents are in conformity with the type described in the EC-type examination certificate and comply with the requirements of the TSI that apply to them.
S sistemom vodenja kakovosti se zagotovi skladnost komponent interoperabilnosti s tipom, opisanim v certifikatu o ES-pregledu tipa, in z zahtevami TSI, ki se zanje uporabljajo.
All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions.
Vsi elementi, zahteve in določbe, ki jih proizvajalec sprejme, so sistematično in organizirano dokumentirani v obliki pisnih usmeritev, postopkov in navodil.
The quality management system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.
Dokumentacija v zvezi s sistemom vodenja kakovosti omogoča enotno razlago programov, načrtov, priročnikov in evidenc kakovosti.
It shall, in particular, contain an adequate description of:
Vsebovati mora zlasti ustrezen opis:
the corresponding manufacturing, quality control and quality management system techniques, processes and systematic actions that will be used,
ustreznih metod, postopkov in sistematičnih ukrepov, ki se bodo uporabljali pri proizvodnji, kontroli kakovosti in v okviru sistema vodenja kakovosti,
the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,
pregledov in preskusov, ki bodo opravljeni pred, med in po proizvodnji, in pogostosti njihovega opravljanja,
the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc., and
zapisov o kakovosti, kot so poročila o pregledu in podatki o preskusih, podatki o umerjanjih opreme, poročila o strokovni usposobljenosti zadevnega osebja itd., in
the means of monitoring the achievement of the required product quality and the effective operation of the quality management system.
načinov spremljanja doseganja zahtevane kakovosti proizvoda in učinkovitega delovanja sistema vodenja kakovosti.
The notified body shall assess the quality management system to determine whether it satisfies the requirements referred to in point 3.2.
Priglašeni organ oceni sistem vodenja kakovosti, da ugotovi, ali izpolnjuje zahteve iz točke 3.2.
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 standard that implements the relevant quality management standard, harmonised standard and/or technical specification.
Organ predvidi skladnost s temi zahtevami glede elementov sistema vodenja kakovosti, ki so v skladu z ustreznimi specifikacijami nacionalnega standarda, ki temelji na ustreznem standardu vodenja kakovosti, harmoniziranem standardu in/ali tehnični specifikaciji.
When the manufacturer operates a certified quality management system certified by an accredited certification body, for the manufacturing of the relevant interoperability constituent, the notified body shall take this into account in the assessment.
Kadar proizvajalec pri proizvodnji ustrezne komponente interoperabilnosti izvaja sistem vodenja kakovosti, ki je potrjen pri akreditiranem organu za potrjevanje, priglašeni organ to upošteva v oceni.
In this case, the notified body will make a detailed assessment of quality management system specific documents and records of the interoperability constituent only.
V tem primeru priglašeni organ pripravi podrobno oceno dokumentacije in zapisov v okviru sistema vodenja kakovosti samo za komponento interoperabilnosti.