natgillin/translations-raw huggingface dataset:
The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the applicable requirements of the legislative instrument, and shall determine whether such changes require further investigation.
Priglašeni organ oceni kakršne koli spremembe splošno sprejetih najnovejših dosežkov, ki kažejo, da odobreni tip ne izpolnjuje več veljavnih zahtev zakonodajnega instrumenta, ter določi, ali te spremembe zahtevajo nadaljnje preiskave.
If so, the notified body shall inform the manufacturer accordingly.
V tem primeru priglašeni organ ustrezno obvesti proizvajalca.
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 product with the essential requirements of the legislative instrument or the conditions for validity of the certificate.
Proizvajalec obvesti priglašeni organ, ki hrani tehnično dokumentacijo o certifikatu o ES-pregledu tipa, o kakršnih koli spremembah odobrenega tipa, ki bi lahko vplivale na skladnost proizvoda z bistvenimi zahtevami zakonodajnega instrumenta ali s pogoji veljavnosti certifikata.
Such modifications shall require additional approval in the form of an addition to the original EC-type examination certificate.
Take spremembe zahtevajo dodatno odobritev v obliki dodatka k izvirnemu certifikatu o ES-pregledu tipa.
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authorities concerning the EC-type examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of certificates and/or any additions thereto refused, suspended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 druge priglašene organe o izdanih ali preklicanih certifikatih o ES-pregledu tipa in/ali dodatkih k certifikatom ter redno ali na zahtevo da na voljo priglašenim 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notified bodies concerning the EC-type examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning the certificates and/or additions thereto which it has issued.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 zavrnjenih, začasno opuščenih ali drugače omejenih certifikatih o ES-pregledu tipa ter jih na zahtevo obvesti o izdanih certifikatih in/ali dodatkih.
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 prejmejo izvode certifikatov o ES-pregledu tipa in/ali njihovih dodatkov.
On request, the Commission and the Member States may obtain a copy of the technical documentation and the results of the examinations carried out by the notified body.
Komisija in države članice lahko na zahtevo dobijo izvod tehnične dokumentacije in rezultatov pregledov, ki jih je izvedel priglašeni organ.
The notified body shall keep a copy of the EC-type examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, until the expiry of the validity of the certificate.
Priglašeni organ ima izvod certifikata o ES-pregledu tipa, njegovih prilog in dodatkov ter tehnični spis, vključno z dokumentacijo, ki jo predloži proizvajalec, do izteka veljavnosti certifikata.
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 10 years after the product has been placed on the market.
Proizvajalec da nacionalnim organom izvod certifikata o ES-pregledu tipa, njegovih prilog in dodatkov, vključno s tehnično dokumentacijo, na voljo 10 let po tem, ko je bil na trg dan proizvod.
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 vlogo iz točke 3 ter izpolni obveznosti iz točk 7 in 9, pod pogojem, da je naveden v pooblastilu.
Conformity to type based on internal production control
Skladnost s tipom na podlagi notranjega nadzora proizvodnje
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 that the products concerned are in conformity with the type described in the EC-type examination certificate and satisfy the requirements of the legislative instrument that apply to them.
Skladnost s tipom na podlagi notranjega nadzora proizvodnje je del postopka ugotavljanja skladnosti, pri čemer proizvajalec izpolni obveznosti iz točk 2 in 3 ter zagotovi in izjavi, da so zadevni proizvodi v skladu s tipom, opisanim v certifikatu o ES-pregledu tipa, in da izpolnjujejo zahteve zakonodajnega instrumenta, ki zanje veljajo.
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured products with the approved type described in the EC-type examination certificate and with the requirements of the legislative instrument that apply to them.
Proizvajalec sprejme vse potrebne ukrepe, da proizvodni proces in njegovo spremljanje zagotovita skladnost proizvedenih proizvodov z odobrenim tipom, opisanim v certifikatu o ES-pregledu tipa, in z zahtevami zakonodajnega instrumenta, ki zanje veljajo.
The manufacturer shall affix the required conformity marking set out in the legislative instrument to each individual product that is in conformity with the type described in the EC-type examination certificate and satisfies the applicable requirements of the legislative instrument.
Proizvajalec namesti zahtevani znak skladnosti, kot določa zakonodajni instrument, na vsak posamezni proizvod, ki je v skladu s tipom, opisanim v certifikatu o ES-pregledu tipa, in izpolnjuje veljavne zahteve zakonodajnega instrumenta.
The manufacturer shall draw up a written declaration of conformity for a product model and keep it at the disposal of the national authorities for 10 years after the product has been placed on the market.
Proizvajalec za vzorčni proizvod sestavi pisno izjavo o skladnosti in jo da na voljo nacionalnim organom 10 let po tem, ko je bil na trg dan proizvod.
The declaration of conformity shall identify the product model for which it has been drawn up.
Izjava o skladnosti opredeljuje vzorčni proizvod, za katerega je bila sestavljena.
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 internal production control plus supervised product testing
Skladnost s tipom na podlagi notranjega nadzora proizvodnje in nadzorovani preskusi proizvodov
Conformity to type based on internal production control plus supervised product testing is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 4, and ensures and declares on his sole responsibility that the products concerned are in conformity with the type described in the EC-type examination certificate and satisfy the requirements of the legislative instrument that apply to them.
Skladnost s tipom na podlagi notranjega nadzora proizvodnje in nadzorovani preskusi proizvodov so del postopka ugotavljanja skladnosti, pri čemer proizvajalec izpolni obveznosti iz točk 2, 3 in 4 ter zagotovi in na lastno odgovornost izjavi, da so zadevni proizvodi v skladu s tipom, opisanim v certifikatu o ES-pregledu tipa, in da izpolnjujejo zahteve zakonodajnega instrumenta, ki zanje veljajo.
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured products with the type described in the EC-type examination certificate and with the requirements of the specific legislative instrument that apply to them.
Proizvajalec sprejme vse potrebne ukrepe, da se s proizvodnim procesom in njegovim spremljanjem zagotovi skladnost proizvedenih proizvodov s tipom, opisanim v certifikatu o ES-pregledu tipa, in z zahtevami posebnega zakonodajnega instrumenta, ki zanje veljajo.
For each individual product manufactured one or more tests on one or more specific aspects of the product shall be carried out by the manufacturer or on his behalf, in order to verify conformity with the corresponding requirements of the legislative instrument.
Za vsak proizveden proizvod proizvajalec sam ali kdo drug v njegovem imenu izvede enega ali več preskusov glede enega ali več posebnih vidikov proizvoda, da preveri skladnost z ustreznimi zahtevami zakonodajnega instrumenta.
At the choice of the manufacturer, the tests shall be carried out either by an accredited in-house body or under the responsibility of a notified body, chosen by the manufacturer.
Po zbiri proizvajalca preskuse izvede bodisi pooblaščeni interni organ bodisi je za izvedbo teh preskusov odgovoren priglašeni organ, ki ga izbere proizvajalec.
Conformity to type based on internal production control plus supervised product checks at random intervals
Skladnost s tipom na podlagi notranjega nadzora proizvodnje in nadzorovani preskusi proizvodov v naključno izbranih časovnih presledkih
Conformity to type based on internal production control plus supervised product checks at random intervals is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 4, and ensures and declares on his sole responsibility that the products concerned are in conformity with the type described in the EC-type examination certificate and satisfy the requirements of the legislative instrument that apply to them.
Skladnost s tipom na podlagi notranjega nadzora proizvodnje in nadzorovani preskusi proizvodov v naključno izbranih časovnih presledkih so del postopka ugotavljanja skladnosti, pri čemer proizvajalec izpolni obveznosti iz točk 2, 3 in 4 ter zagotovi in na lastno odgovornost izjavi, da so zadevni proizvodi v skladu s tipom, opisanim v certifikatu o ES-pregledu tipa, in da izpolnjujejo zahteve zakonodajnega instrumenta, ki zanje veljajo.
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 determined by the body, in order to verify the quality of the internal checks on the product, taking into account, inter alia, the technological complexity of the products and the quantity of production.
Na proizvajalčevo izbiro pooblaščeni interni organ ali priglašeni organ, ki ga izbere proizvajalec, izvede preskuse proizvodov ali jih da izvesti v naključno izbranih časovnih presledkih, ki jih določi organ, da preveri kakovost notranjega preskušanja proizvodov, pri čemer se med drugim upoštevata tehnološka zahtevnost proizvodov in količina proizvodnje.
An adequate sample of the final products, taken on site by the notified body before the placing on the market, shall be examined and appropriate tests as identified by the relevant parts of the harmonised standards and/or technical specifications, or equivalent tests, shall be carried out to check the conformity of the product with the relevant requirements of the legislative instrument.
Organ na ustreznem vzorcu končnih proizvodov, odvzetih na sami lokaciji, pred dajanjem na trg izvede pregled in primerne preskuse, ki so opredeljeni v ustreznih delih harmoniziranega standarda, katerega sklicevanja so bila objavljena v Uradnem listu Evropske unije, ali podobne preskuse, s katerimi preveri skladnost proizvoda z ustreznimi zahtevami zakonodajnega instrumenta.
Where a sample does not conform to the acceptable quality level, the body shall take appropriate measures.
V primerih, ko vzorec ne dosega sprejemljive ravni kakovosti, organ sprejme ustrezne ukrepe.
Where the tests are carried out by notified body, the manufacturer shall, under the responsibility of the notified body, affix the notified body's identification number during the manufacturing process.
Če preskuse izvede priglašeni organ, mora proizvajalec med proizvodnim procesom na odgovornost priglašenega organa namestiti identifikacijsko številko priglašenega organa.
Conformity to type based on quality assurance of the production process
Skladnost s tipom na podlagi zagotavljanja kakovosti proizvodnje
Conformity to type based on quality assurance 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 products concerned are in conformity with the type described in the EC-type examination certificate and satisfy the requirements of the legislative instrument that apply to them.
Skladnost s tipom na podlagi zagotavljanja kakovosti proizvodnje je del postopka ugotavljanja skladnosti, pri čemer proizvajalec izpolni obveznosti iz točk 2 in 5 ter zagotovi in na lastno odgovornost izjavi, da so zadevni proizvodi v skladu s tipom, opisanim v certifikatu o ES-pregledu tipa, in da izpolnjujejo zahteve zakonodajnega instrumenta, ki veljajo zanje.
The manufacturer shall operate an approved quality system for production, final product inspection and testing of the products concerned as specified in point 3, and shall be subject to surveillance as specified in point 4.
Proizvajalec upravlja odobren sistem kakovosti za proizvodnjo, pregled končnega proizvoda in preskušanje zadevnih proizvodov iz točke 3 ter je nadzorovan v skladu s točko 4.
The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the products concerned.
Proizvajalec pri priglašenem organu, ki ga izbere sam, vloži vlogo za ocenitev svojega sistema kakovosti za zadevne proizvode.
all relevant information for the product category envisaged,
vse ustrezne podatke za predvideno kategorijo proizvoda,
the documentation concerning the quality system,
dokumentacijo o sistemu kakovosti,
the technical documentation of the approved type and a copy of the EC-type examination certificate.
tehnično dokumentacijo o odobrenem tipu in izvod certifikata o ES-pregledu tipa.
The quality system shall ensure that the products are in conformity with the type described in the EC-type examination certificate and comply with the requirements of the legislative instrument that apply to them.
S sistemom kakovosti se zagotovi skladnost proizvodov s tipom, opisanim v certifikatu o ES-pregledu tipa, in z zahtevami zakonodajnega instrumenta, ki zanje veljajo.
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, morajo biti sistematično in organizirano dokumentirani v obliki pisnih usmeritev, postopkov in navodil.
The quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.
Dokumentacija o sistemu kakovosti mora omogočati enotno razlago programov, načrtov, priročnikov in zapisov o kakovosti.
It shall, in particular, contain an adequate description of:
Zlasti mora vsebovati ustrezne opise za:
the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality,
ciljev kakovosti in organizacijske strukture, odgovornosti in pristojnosti vodstva glede kakovosti proizvodov,
the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used,
ustreznih tehnik proizvodnje, nadzora kakovosti in zagotavljanja kakovosti, postopkov in sistematičnih ukrepov, ki se bodo uporabljali,
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 izvedeni pred proizvodnjo, med njo in po njej, ter pogostnost njihovega izvajanja,
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 osebja itd.,
the means of monitoring the achievement of the required product quality and the effective operation of the quality system.
načinov spremljanja doseganja zahtevane kakovosti proizvoda in učinkovitega delovanja sistema kakovosti.
The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2.
Priglašeni organ oceni sistem 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 system that comply with the corresponding specifications of the national standard that implements the relevant harmonised standard and/or technical specifications.
Ta organ predvidi skladnost s temi zahtevami glede elementov sistema kakovosti, ki so v skladu z ustreznimi specifikacijami nacionalnega standarda, ki veljajo za ustrezni harmonizirani standard in/ali tehnične specifikacije.
In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant product field and product technology concerned, and knowledge of the applicable requirements of the legislative instrument.
Pregledovalna skupina ima poleg izkušenj pri sistemih vodenja kakovosti vsaj enega člana z izkušnjami iz ocenjevanja na ustreznem področju proizvodov in zadevne tehnologije proizvoda ter poznavanjem veljavnih zahtev zakonodajnega instrumenta.
The audit shall include an assessment visit to the manufacturer's premises.
Pregled vključuje ocenjevalni obisk proizvajalčevih prostorov.
The auditing team shall review the technical documentation referred to in point 3.1, fifth indent, to verify the manufacturer's ability to identify the relevant requirements of the legislative instrument and to carry out the necessary examinations with a view to ensuring compliance of the product with those requirements.
Pregledovalna skupina pregleda tehnično dokumentacijo iz pete alinee drugega odstavka točke 3.1 za preverjanje sposobnosti proizvajalca, s čimer ugotovi ustrezne zahteve zakonodajnega instrumenta in izvede potrebne preglede za zagotovitev skladnosti proizvoda s temi zahtevami.
The decision shall be notified to the manufacturer.
Sklep je treba sporočiti proizvajalcu.
The notification shall contain the conclusions of the audit and the reasoned assessment decision.
Obvestilo vsebuje ugotovitve revizije in utemeljeno odločitev o oceni.
The manufacturer shall undertake to fulfil the obligations arising out of the quality 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 kakovosti, ter da bo sistem kakovosti primerno in učinkovito vzdrževal.
The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.
Proizvajalec obvesti priglašeni organ, ki je odobril sistem kakovosti, o kakršni koli nameravani spremembi sistema kakovosti.
The notified body shall evaluate any proposed changes and decide whether the modified quality 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 se odloči, ali bo spremenjeni sistem kakovosti še naprej izpolnjeval zahteve iz točke 3.2 ali pa je potrebna ponovna ocena.
The notification shall contain the conclusions of the examination and the reasoned assessment decision.
Uradno obvestilo vsebuje ugotovitve pregleda in utemeljitev odločitve o oceni.
Surveillance under the responsibility of the notified body
Nadzor s strani priglašenega organa
The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.
Namen nadzora je zagotoviti, da proizvajalec ustrezno izpolnjuje obveznosti, ki izhajajo iz odobrenega sistema kakovosti.
The manufacturer shall, for assessment 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 ocene omogoči vstop v prostore za proizvodnjo, pregled, preskušanje in skladiščenje ter mu posreduje vse potrebne informacije, zlasti:
the quality system documentation,
dokumentacijo o sistemu kakovosti,
the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.
zapise o kakovosti, kot so poročila o pregledu in podatki o preskusih, podatki o umerjanjih opreme, poročila o strokovni usposobljenosti osebja itd.
The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report.
Priglašeni organ redno izvaja preglede, s čimer ugotovi, ali proizvajalec vzdržuje in uporablja sistem kakovosti, ter proizvajalcu zagotovi poročilo o pregledu.
In addition, the notified body may pay unexpected visits to the manufacturer.
Razen tega lahko priglašeni organ proizvajalca nenapovedano obišče.
During such visits the notified body may, if necessary, carry out product tests, or have them carried out, in order to verify that the quality system is functioning correctly.
Med temi obiski lahko priglašeni organ po potrebi izvede preskuse proizvodov ali jih da izvesti, s čimer preveri, ali sistem 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 preskusu.
The manufacturer shall affix the required conformity marking set out in the legislative instrument, and, under the responsibility of the notified body referred to in point 3.1, the latter's identification number to each individual product that is in conformity with the type described in the EC-type examination certificate and satisfies the applicable requirements of the legislative instrument.
Proizvajalec namesti zahtevani znak skladnosti, kot določa zakonodajni instrument, in na odgovornost priglašenega organa iz točke 3.1 identifikacijsko številko tega organa na vsak proizvod, ki je v skladu s tipom, opisanim v certifikatu o ES-pregledu tipa, in ki izpolnjuje veljavne zahteve zakonodajnega instrumenta.
The manufacturer shall draw up a written declaration of conformity for each product model and keep it at the disposal of the national authorities for 10 years after the product has been placed on the market.
Proizvajalec za vsak vzorčni proizvod sestavi pisno izjavo o skladnosti in jo da na voljo nacionalnim organom 10 let po tem, ko je bil na trg dan proizvod.
The manufacturer shall, for a period ending at least 10 years after the product has been placed on the market, keep at the disposal of the national authorities:
Proizvajalec za nacionalne organe še vsaj deset let po tem, ko je bil na trg dan proizvod, hrani:
the documentation referred to in point 3.1,
dokumentacijo iz točke 3.1,
the change referred to in point 3.5, as approved,
spremembo iz točke 3.5, kot je bila odobrena,