natgillin/translations-raw huggingface dataset:
the decisions and reports of the notified body referred to in points 3.5, 4.3 and 4.4.
odločbe in poročila priglašenega organa iz točk 3.5, 4.3 in 4.4.
Each notified body shall inform its notifying authorities of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or otherwise restricted.
Vsak priglašeni organ obvesti druge priglašene organe o izdanih ali preklicanih odobritvah sistema kakovosti in redno ali na zahtevo zagotovi priglašenim organom seznam zavrnjenih, začasno opuščenih ali drugače omejenih odobritev sistema kakovosti.
Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended, withdrawn or otherwise restricted, and, upon request, of quality system approvals which it has issued.
Vsak priglašeni organ obvesti druge priglašene organe o odobritvah sistema kakovosti, ki jih je zavrnil, začasno opustil, preklical ali drugače omejil, ter jih na zahtevo obvesti o odobritvah sistema 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 točke 3.1, 3.5, 5 in 6 lahko v njegovem imenu in na njegovo odgovornost izpolni pooblaščeni zastopnik, pod pogojem, da je naveden v pooblastilu.
Quality assurance of the production process
Zagotavljanje kakovosti proizvodnje
Quality assurance of the production process is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 4 and 7, and ensures and declares on his sole responsibility that the products concerned satisfy the requirements of the legislative instrument that apply to them.
Zagotavljanje kakovosti proizvodnje je postopek ugotavljanja skladnosti, pri katerem proizvajalec izpolni obveznosti iz točk 2, 4 in 7 ter zagotovi in na lastno odgovornost izjavi, da zadevni proizvodi izpolnjujejo zahteve zakonodajnega instrumenta, ki zanje veljajo.
The manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for 10 years after the product has been placed on the market.
Proizvajalec nacionalnim organom da na voljo tehnično dokumentacijo 10 let po tem, ko je bil na trg dan proizvod.
The manufacturer shall operate an approved quality system for production, final product inspection and testing of the products concerned as specified in point 5, and shall be subject to surveillance as specified in point 6.
Proizvajalec upravlja odobren sistem kakovosti za proizvodnjo, pregled končnega proizvoda in preskušanje zadevnih proizvodov iz točke 5 ter je nadzorovan v skladu s točko 6.
the technical documentation referred to in point 2.
tehnično dokumentacijo iz točke 2.
The quality system shall ensure compliance of the products with the requirements of the legislative instrument that apply to them.
Sistem kakovosti zagotovi skladnost proizvodov z zahtevami zakonodajnega instrumenta, ki zanje veljajo.
the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.,
zapisov 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 assess the quality system to determine whether it satisfies the requirements referred to in point 5.2.
Priglašeni organ oceni sistem kakovosti, da ugotovi, ali izpolnjuje zahteve iz točke 5.2.
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 specification.
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 tehnično specifikacijo.
The auditing team shall review the technical documentation referred to in point 2 in order 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 točke 2 za preverjanje sposobnosti proizvajalca, s čimer ugotovi ustrezne zahteve zakonodajnega instrumenta in izvede potrebne preglede za zagotovitev skladnosti proizvoda s temi zahtevami.
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 5.2 or whether reassessment is necessary.
Priglašeni organ oceni predlagane spremembe in se odloči, ali bo spremenjeni sistem kakovosti še naprej izpolnjeval zahteve iz točke 5.2 ali pa je potrebna ponovna ocena.
the technical documentation referred to in point 2,
tehnično dokumentacijo iz točke 2,
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 5.1, the latter's identification number to each individual product that satisfies the applicable requirements of the legislative instrument.
Proizvajalec namesti zahtevani znak skladnosti, kot določa zakonodajni instrument, in na odgovornost priglašenega organa iz točke 5.1 identifikacijsko številko tega organa na vsak proizvod, ki izpolnjuje veljavne zahteve zakonodajnega instrumenta.
the documentation referred to in point 5.1,
dokumentacijo iz točke 5.1,
the change referred to in point 5.5, as approved,
spremembo iz točke 5.5, kot je bila odobrena,
the decisions and reports of the notified body referred to in points 5.5, 6.3 and 6.4.
odločbe in poročila priglašenega organa iz točk 5.5, 6.3 in 6.4.
Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued.
Vsak priglašeni organ obvesti druge priglašene organe o odobritvah sistema kakovosti, ki jih je zavrnil, začasno opustil ali preklical, ter jih na zahtevo obvesti o odobritvah sistema kakovosti, ki jih je izdal.
The manufacturer's obligations set out in points 3, 5.1, 5.5, 7 and 8 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, 5.1, 5.5, 7 in 8 lahko v njegovem imenu in na njegovo odgovornost izpolni pooblaščeni zastopnik, pod pogojem, da je naveden v pooblastilu.
Conformity to type based on product quality assurance
Skladnost s tipom na podlagi zagotavljanja kakovosti proizvoda
Conformity to type based on product quality assurance is that 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 proizvoda 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 zanje veljajo.
The manufacturer shall operate an approved quality system for 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 pregled končnega proizvoda in preskušanje zadevnih proizvodov iz točke 3 ter je nadzorovan v skladu s točko 4.
the documentation concerning the quality system, and
dokumentacijo o sistemu kakovosti ter
The quality system shall ensure compliance of the products with the type described in the EC-type examination certificate and with the applicable requirements of the legislative instrument.
Sistem kakovosti zagotovi skladnost proizvodov s tipom, opisanim v certifikatu o ES-pregledu tipa, in ustreznimi zahtevami zakonodajnega instrumenta.
the examinations and tests that will be carried out after manufacture,
pregledov in preskusov, ki bodo opravljeni po proizvodnji,
the means of monitoring the effective operation of the quality system.
načinov spremljanja učinkovitega delovanja sistema kakovosti.
The auditing team shall review the technical documentation referred to in point 3.1, fifth indent, in order 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.
Quality assurance of final product inspection and testing
Zagotavljanje kakovosti za nadzor in preskušanje končnega proizvoda
Quality assurance of final product inspection and testing is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 4 and 7, and ensures and declares on his sole responsibility that the products concerned satisfy the requirements of the legislative instrument that apply to them.
Zagotavljanje kakovosti za pregled in preskušanje končnega proizvoda sta postopek ugotavljanja skladnosti, pri katerem proizvajalec izpolni obveznosti iz točk 2, 4 in 7 ter zagotovi in na lastno odgovornost izjavi, da zadevni proizvodi izpolnjujejo zahteve zakonodajnega instrumenta, ki zanje veljajo.
The manufacturer shall operate an approved quality system for final product inspection and testing of the products concerned as specified in point 5 and shall be subject to surveillance as specified in point 6.
Proizvajalec upravlja odobren sistem kakovosti za pregled končnega proizvoda in preskušanje zadevnih proizvodov iz točke 5 ter je nadzorovan v skladu s točko 6.
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 5.2 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 5.2 ali pa je potrebna ponovna ocena.
Conformity to type based on product verification
Skladnost s tipom na podlagi preverjanja proizvoda
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 products 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 legislative instrument that apply to them.
Skladnost s tipom na podlagi preverjanja proizvoda je del postopka ugotavljanja skladnosti, pri čemer proizvajalec izpolni obveznosti iz točk 2, 5.1. in 6 ter zagotovi in na lastno odgovornost izjavi, da so proizvodi, ki so predmet določb iz točke 3, v skladu s tipom, opisanim v certifikatu o ES-pregledu tipa, in da izpolnjujejo zahteve zakonodajnega instrumenta, ki zanje veljajo.
A notified body chosen by the manufacturer shall carry out appropriate examinations and tests in order to check the conformity of the products with the approved type described in the EC-type examination certificate and with the appropriate requirements of the legislative instrument.
Priglašeni organ, ki ga je izbral proizvajalec, izvede ustrezne preglede in preskuse, da preveri skladnost proizvodov z odobrenim tipom, opisanim v certifikatu o ES-pregledu tipa, in ustreznimi zahtevami zakonodajnega instrumenta.
The examinations and tests to check the conformity of the products with the appropriate requirements shall be carried out, at the choice of the manufacturer either by examination and testing of every product as specified in point 4 or by examination and testing of the products on a statistical basis as specified in point 5.
Pregledi in preskusi za pregled skladnosti proizvodov z ustreznimi zahtevami se po presoji proizvajalca izvedejo s pregledom in preskušanjem vsakega proizvoda, kot je določeno v točki 4, ali s pregledom in preskušanjem proizvodov na statistični podlagi, kot je določeno v točki 5.
Verification of conformity by examination and testing of every product
Preverjanje skladnosti s pregledom in preskusom vsakega proizvoda.
All products shall be individually examined and appropriate tests set out in the relevant 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 appropriate requirements of the legislative instrument.
Vsi proizvodi se pregledajo posamezno, na njih pa se izvedejo primerni preskusi, določeni v ustreznem(-ih) standardu(-ih) in/ali tehničnih specifikacijah, ali enakovredni preskusi, s čimer se preveri njihova skladnost z odobrenim tipom, opisanim v certifikatu o ES-pregledu tipa, in ustreznimi zahtevami zakonodajnega instrumenta.
In the absence of such a harmonised standard, the notified body concerned shall decide on the appropriate tests to be carried out.
Kadar takšen harmonizirani standard ni na voljo, se zadevni priglašeni organ odloči za izvedbo ustreznih preskusov.
The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out, and shall affix its identification number to each approved product or have it affixed under its responsibility.
Priglašeni organ izda certifikat o skladnosti ob upoštevanju izvedenih pregledov in preskusov ter namesti svojo identifikacijsko številko na vsak odobren proizvod ali jo da namestiti na svojo odgovornost.
The manufacturer shall keep the certificates of conformity available for inspection by the national authorities for 10 years after the product has been placed on the market.
Proizvajalec da nacionalnim organom na voljo certifikate o skladnosti za pregled 10 let po tem, ko je bil dan na trg proizvod.
Statistical verification of conformity
Statistično preverjanje skladnosti
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 products for verification in the form of homogeneous lots.
Proizvajalec sprejme vse potrebne ukrepe, da proizvodni proces in njegovo spremljanje zagotovita homogenost vsakega proizvedenega lota, ter predloži svoje proizvode za preverjanje v obliki homogenih lotov.
A random sample shall be taken from each lot according to the requirements of the legislative instrument.
Iz vsakega lota se odvzame naključni vzorec v skladu z zahtevami iz zakonodajnega instrumenta.
All products in a sample shall be individually examined and appropriate tests set out in the relevant harmonised standard(s) and/or technical specifications, or equivalent tests, shall be carried out in order to ensure their conformity with the applicable requirements of the legislative instrument and to determine whether the lot is accepted or rejected.
Vsi vzorčni proizvodi se pregledajo posamezno, na njih pa se izvedejo ustrezni preskusi, določeni v ustreznem(-ih) harmoniziranem(-ih) standardu(-ih) in/ali tehničnih specifikacijah, ali enakovredni preskusi, s čimer se preveri njihova skladnost z veljavnimi zahtevami zakonodajnega instrumenta in določi, ali se lot sprejme ali zavrne.
If a lot is accepted, all products of the lot shall be considered approved, except for those products from the sample that have been found not to satisfy the tests.
Če je lot sprejet, se odobrijo vsi proizvodi iz lota, razen tisti proizvodi iz vzorca, za katere je bilo ugotovljeno, da ne izpolnjujejo zahtev preskusa.
The notified body shall issue a certificate of conformity in respect to the examinations and tests carried out, and shall affix its identification number to each approved product or have it affixed under its responsibility.
Priglašeni organ izda certifikat o skladnosti ob upoštevanju izvedenih pregledov in preskusov ter namesti svojo identifikacijsko številko na vsak odobren proizvod ali jo da namestiti na svojo odgovornost.
The manufacturer shall keep the certificates of conformity at the disposal of the national authorities for 10 years after the product has been placed on the market.
Proizvajalec da nacionalnim organom na voljo certifikate o skladnosti 10 let po tem, ko je bil dan na trg proizvod.
If a lot is rejected, the notified body or the competent authority shall take appropriate measures to prevent that lot's being placed on the market.
Če se lot zavrne, mora priglašeni organ ali pristojni organ sprejeti ustrezne ukrepe, da prepreči vpeljavo tega lota v promet.
In the event of the frequent rejection of lots the notified body may suspend the statistical verification and take appropriate measures.
Če so zavrnitve lotov pogoste, lahko priglašeni organ opusti statistično preverjanje in sprejme ustrezne ukrepe.
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, the latter's identification number to each individual product that is in conformity with the approved 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 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.
If the notified body referred to in point 3 agrees and under its responsibility, the manufacturer may also affix the notified body's identification number to the products.
Če priglašeni organ iz točke 3 to dovoli, proizvajalec na odgovornost priglašenega organa namesti na proizvode tudi identifikacijsko številko tega organa.
If the notified body agrees and under its responsibility, the manufacturer may affix the notified body's identification number to the products during the manufacturing process.
Proizvajalec lahko na podlagi dovoljenja priglašenega organa in na njegovo odgovornost namesti identifikacijsko številko tega organa na proizvode med proizvodnim procesom.
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 and 5.1.
Pooblaščeni zastopnik ne rabi izpolniti obveznosti proizvajalca iz točk 2 in 5.1.
Conformity based on product verification
Skladnost na podlagi preverjanja proizvoda
Conformity based on product verification is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3, 6.1 and 7 and ensures and declares on his sole responsibility that the products concerned, which have been subject to the provisions of point 4, are in conformity with the requirements of the legislative instrument that apply to them.
Skladnost na podlagi preverjanja proizvoda je postopek ugotavljanja skladnosti, pri čemer proizvajalec izpolni obveznosti iz točk 2, 3, 6.1. in 7 ter zagotovi in na lastno odgovornost izjavi, da so proizvodi, ki so predmet določb iz točke 4, v skladu z zahtevami 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 applicable requirements of the legislative instrument.
Proizvajalec sprejme vse ukrepe, da proizvodni proces in njegovo spremljanje zagotovita skladnost proizvedenih proizvodov z veljavnimi zahtevami zakonodajnega instrumenta.
A notified body chosen by the manufacturer shall carry out appropriate examinations and tests to check the conformity of the products with the applicable requirements of the legislative instrument.
Priglašeni organ, ki ga je izbral proizvajalec, izvede ustrezne preglede in preskuse, s čimer preveri skladnost proizvodov z veljavnimi zahtevami zakonodajnega instrumenta.
The examinations and tests to check the conformity with those requirements shall be carried out, at the choice of the manufacturer, either by examination and testing of every product as specified in point 5, or by examination and testing of the products on a statistical basis as specified in point 6.
Pregledi in preskusi za pregled skladnosti s temi zahtevami se po presoji proizvajalca izvedejo s pregledom in preskušanjem vsakega proizvoda, kot je določeno v točki 5, ali s pregledom in preskušanjem proizvodov na statistični podlagi, kot je določeno v točki 6.
All products shall be individually examined and appropriate tests, set out in the relevant harmonised standards and/or technical specifications, or equivalent tests, shall be carried out to verify conformity with the requirements that apply to them.
Vsi proizvodi se pregledajo posamezno, na njih pa se izvedejo ustrezni preskusi, določeni v ustreznem(-ih) harmoniziranem(-ih) standardu(-ih) in/ali tehničnih specifikacijah, ali enakovredni preskusi, s čimer se preveri njihova skladnost z zahtevami, ki zanje veljajo.
In the absence of such a harmonised standard and/or technical specification the notified body concerned shall decide on the appropriate tests to be carried out.
Kadar takšen harmonizirani standard in/ali tehnična specifikacija nista na voljo, se zadevni priglašeni organ odloči za izvedbo ustreznih preskusov.
The manufacturer shall take all measures necessary so that the manufacturing process ensures the homogeneity of each lot produced, and shall present his products for verification in the form of homogeneous lots.
Proizvajalec sprejme vse potrebne ukrepe, da se s proizvodnim procesom zagotovi homogenost vsakega proizvedenega lota, ter predloži svoje proizvode za preverjanje v obliki homogenih lotov.
All products in the sample shall be individually examined and appropriate tests set out in the relevant harmonised standards and/or technical specifications, or equivalent tests, to establish conformity with the requirements that apply to them, shall be carried out to determine whether the lot is accepted or rejected.
Vsi vzorčni proizvodi se pregledajo posamezno, na njih pa se izvedejo ustrezni preskusi, določeni v ustreznem(-ih) harmoniziranem(-ih) standardu(-ih) in/ali tehničnih specifikacijah, ali enakovredni preskusi, s čimer se preveri njihova skladnost z zahtevami, ki zanje veljajo, in določi, ali se lot sprejme ali zavrne.
If a lot is rejected, the notified body shall take appropriate measures to prevent that lot being placed on the market.
Če je lot zavrnjen, priglašeni organ sprejme ustrezne ukrepe, da prepreči dajanje v promet tega lota.