natgillin/translations-raw huggingface dataset:
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 subsystems or safety components concerned are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Regulation that apply to them.
Skladnost s tipom na podlagi zagotavljanja kakovosti proizvodnje je del postopka ugotavljanja skladnosti, pri katerem proizvajalec izpolni obveznosti iz točk 2 in 5 ter zagotovi in na lastno odgovornost izjavi, da so zadevni podsistemi ali varnostni elementi v skladu s tipom, opisanim v certifikatu o EU-pregledu tipa, in da izpolnjujejo zahteve iz te uredbe, ki veljajo zanje.
The manufacturer shall operate an approved quality system for production, final product inspection and testing of the subsystems or safety components concerned as specified in point 3, and shall be subject to surveillance as specified in point 4.
Proizvajalec izvaja odobren sistem kakovosti za proizvodnjo, končni pregled proizvoda in preskušanje zadevnih podsistemov ali varnostnih elementov iz točke 3 ter je pod nadzorom v skladu s točko 4.
The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice.
Proizvajalec pri priglašenem organu, ki ga izbere sam, vloži zahtevek za oceno svojega sistema kakovosti.
all relevant information for the subsystems or safety components approved under module B;
vse ustrezne informacije za podsisteme ali varnostne elemente, odobrene v skladu z modulom B;
the documentation concerning the quality system;
dokumentacijo o sistemu kakovosti;
the technical documentation of the approved type and a copy of the EU-type examination certificate(s);
tehnično dokumentacijo o odobrenem tipu in izvod certifikata (certifikatov) o EU-pregledu tipa;
details of the premises where the subsystem or the safety component is manufactured.
podrobnosti o prostorih, kjer se podsistem ali varnostni element proizvaja.
The quality system shall ensure that the subsystems or safety components are in conformity with the type(s) described in the EU-type examination certificate(s) and comply with the requirements of this Regulation that apply to them.
Sistem kakovosti zagotovi, da so podsistemi ali varnostni elementi skladni s tipom ali tipi, opisanim ali opisanimi v certifikatu o EU-pregledu tipa, in da izpolnjujejo zahteve iz te uredbe, ki veljajo zanje.
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 je sprejel proizvajalec, so sistematično in urejeno dokumentirani kot pisno dokumentirane politike, postopki in navodila.
The quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.
Dokumentacija sistema kakovosti omogoča dosledno razlago programov kakovosti, načrtov, priročnikov in zapisov.
It shall, in particular, contain an adequate description of:
Vsebuje zlasti ustrezen opis:
the quality objectives and the organisational structure, responsibilities and powers of the management with regard to the 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 opravljeni pred proizvodnjo, med njo in po njej, ter pogostost njihovega izvajanja;
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 pregledih in podatki o preskusih, podatki o umerjanjih, poročila o strokovni usposobljenosti zadevnega osebja itd.;
the means of monitoring the achievement of the required product quality and the effective operation of the quality system.
sredstev za spremljanje doseganja zahtevane kakovosti proizvodov 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 sistem izpolnjuje zahteve, navedene v točki 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 relevant harmonised standard.
Ta organ predvidi skladnost z navedenimi zahtevami glede elementov sistema kakovosti, ki so v skladu z ustreznimi specifikacijami relevantnega harmoniziranega standarda.
The audit shall include an assessment visit to the premises where the subsystems or the safety components are manufactured, inspected and tested.
Presoja vključuje ocenjevalni obisk v obratih, kjer se podsistemi ali varnostni elementi proizvajajo, pregledujejo in preskušajo.
In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the field of cableway installations and in the technology of the subsystems or safety components concerned, and knowledge of the applicable requirements of this Regulation.
Poleg izkušenj s sistemi za upravljanje kakovosti ima skupina za presojo vsaj enega člana z izkušnjami pri presojanju na področju žičniških naprav in tehnologije zadevnih podsistemov in varnostnih elementov ter znanjem o veljavnih zahtevah iz te uredbe.
The audit shall include an assessment visit to the manufacturer's premises.
Presoja vključuje ocenjevalni obisk v obratih proizvajalca.
The auditing team shall review the technical documentation referred to in point 3.1(e), to verify the manufacturer's ability to identify the relevant requirements of this Regulation and to carry out the necessary examinations with a view to ensuring compliance of the subsystems or safety components with those requirements.
Skupina za presojo pregleda tehnično dokumentacijo iz točke 3.1(e), da ugotovi, ali je proizvajalec zmožen identificirati ustrezne zahteve iz te uredbe, in da izvede potrebne preglede za zagotovitev skladnosti podsistemov ali varnostnih elementov z navedenimi zahtevami.
The decision shall be notified to the manufacturer.
Proizvajalec je obveščen o odločitvi.
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 ukrepa tako, da izpolni obveznosti, ki izhajajo iz odobrenega sistema kakovosti, ter ohrani njegovo primernost in učinkovitost.
The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.
Proizvajalec priglašeni organ, ki je odobril sistem kakovosti, obvešča o vseh načrtovanih spremembah 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 odloči, ali bo spremenjeni sistem kakovosti še naprej izpolnjeval zahteve iz točke 3.2 ali pa je potrebna ponovna ocena.
It shall notify the manufacturer of the outcome of the evaluation.
Proizvajalca obvesti o rezultatih vrednotenja.
In case of a reassessment, it shall notify the manufacturer of its decision.
V primeru ponovne ocene obvesti proizvajalca o svoji odločitvi.
The notification shall contain the conclusions of the examination and the reasoned assessment decision.
Obvestilo vsebuje rezultate pregleda in obrazložitev odločitve o oceni.
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 dostop do krajev proizvodnje, pregledovanja, preskušanja in skladiščenja ter mu zagotovi vse potrebne informacije, zlasti:
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 pregledih in podatki o preskusih, podatki o umerjanjih, poročila o strokovni usposobljenosti osebja itd.
The notified body shall carry out periodic audits of at least once every two years to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report.
Priglašeni organ opravlja redne preglede vsaj enkrat na dve leti, s čimer zagotovi, da proizvajalec vzdržuje in izvaja sistem kakovosti, poročila o teh pregledih pa pošilja proizvajalcu.
In addition, the notified body may pay unexpected visits to the manufacturer.
Poleg tega lahko priglašeni organ nenapovedano obišče proizvajalca.
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 takšnimi obiski sme priglašeni organ, če je potrebno, opraviti ali naročiti preskuse proizvodov, da preveri pravilno delovanje sistema kakovosti.
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 pošlje poročilo o obisku, če so bili izvedeni preskusi, pa tudi poročilo o njih.
The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 3.1, the latter's identification number to each individual subsystem or safety component that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of this Regulation.
Proizvajalec na vsak posamezen podsistem ali varnostni element, ki je v skladu s tipom, opisanim v certifikatu o EU-pregledu tipa, in ki izpolnjuje ustrezne zahteve iz te uredbe, namesti oznako CE in, v okviru odgovornosti priglašenega organa iz točke 3.1, identifikacijsko številko tega organa.
The manufacturer shall draw up a written EU declaration of conformity for each subsystem or safety component model and keep it at the disposal of the national authorities for 30 years after the subsystem or the safety component has been placed on the market.
Proizvajalec za vsak model podsistema ali varnostnega elementa sestavi pisno izjavo EU o skladnosti in jo za nacionalne organe hrani še 30 let po tem, ko je bil podsistem ali varnostni element dan na trg.
The EU declaration of conformity shall identify the subsystem or safety component model for which it has been drawn up.
Izjava EU o skladnosti opredeljuje model podsistema ali varnostnega elementa, za katerega je bila sestavljena.
A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.
Na zahtevo se pristojnim organom predloži izvod izjave EU o skladnosti.
The manufacturer shall, for a period of 30 years after the subsystem or safety component has been placed on the market, keep at the disposal of the national authorities:
Proizvajalec za nacionalne organe še 30 let po tem, ko je bil podsistem ali varnostni element dan na trg, hrani:
the information relating to the change referred to in point 3.5, as approved;
informacije v zvezi s spremembo iz točke 3.5, kakor je bila odobrena;
Each notified body shall inform its notifying authority of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of quality system approvals refused, suspended or otherwise restricted.
Vsak priglašeni organ obvesti svoj priglasitveni organ o izdanih ali umaknjenih odobritvah sistema kakovosti in redno ali na zahtevo zagotovi svojemu priglasitvenemu organu seznam zavrnjenih, začasno preklicanih 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, giving the reasons for its decision, 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 preklical, umaknil ali drugače omejil, ter navede razloge za svojo odločitev, na zahtevo pa tudi o odobritvah sistema kakovosti, ki jih je izdal.
On request, the notified body shall provide the Commission and the Member States with a copy of quality system approval decision(s) issued.
Na zahtevo priglašeni organ Komisiji in državam članicam predloži izvod izdane odločitve oz. izdanih odločitev o odobritvi sistema kakovosti.
The notified body shall keep a copy of each approval decision issued and its annexes and additions.
Priglašeni organ hrani izvod vsake izdane odločitve o odobritvi ter njenih prilog in dodatkov.
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, če so navedene v pooblastilu.
CONFORMITY ASSESSMENT PROCEDURES FOR SUBSYSTEMS AND SAFETY COMPONENTS: MODULE F: CONFORMITY TO TYPE BASED ON SUBSYSTEM OR SAFETY COMPONENT VERIFICATION
POSTOPKI UGOTAVLJANJA SKLADNOSTI PODSISTEMOV IN VARNOSTNIH ELEMENTOV: MODUL F: SKLADNOST S TIPOM NA PODLAGI PREVERJANJA PODSISTEMA ALI VARNOSTNEGA ELEMENTA
Conformity to type based on subsystem or safety component 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 subsystems or safety components concerned, which have been subject to the provisions of point 3, are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Regulation that apply to them.
Skladnost s tipom na podlagi preverjanja podsistema ali varnostnega elementa je del postopka ugotavljanja skladnosti, pri katerem proizvajalec izpolni obveznosti iz točk 2, 5.1 in 6 ter zagotovi in na lastno odgovornost izjavi, da so zadevni podsistemi ali varnostni elementi, ki so predmet določb iz točke 3, v skladu s tipom, opisanim v certifikatu o EU-pregledu tipa, in da izpolnjujejo zahteve iz te uredbe, ki veljajo zanje.
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured subsystems or safety components with the approved type described in the EU-type examination certificate and with the requirements of this Regulation that apply to them.
Proizvajalec sprejme vse potrebne ukrepe, da proizvodni proces in njegovo spremljanje zagotovita skladnost proizvedenih podsistemov ali varnostnih elementov z odobrenim tipom, ki je opisan v certifikatu o EU-pregledu tipa, in z zahtevami iz te uredbe, ki veljajo zanje.
The manufacturer shall lodge an application for subsystem or safety component verification with the notified body of his choice.
Proizvajalec pri priglašenem organu, ki ga izbere sam, vloži zahtevek za preverjanje podsistema ali varnostnega elementa.
details of the premises where the subsystem or the safety component can be examined.
podrobnosti o prostorih, kjer se podsistem ali varnostni element lahko pregleda.
The notified body shall carry out appropriate examinations and tests, or have them carried out, in order to check the conformity of the subsystems or safety components with the approved type described in the EU-type examination certificate and with the appropriate requirements of this Regulation.
Priglašeni organ izvede ali naroči ustrezne preglede in preskuse, da preveri skladnost podsistemov ali varnostnih elementov z odobrenim tipom, ki je opisan v certifikatu o EU-pregledu tipa, in z ustreznimi zahtevami iz te uredbe.
The examinations and tests to check the conformity of the subsystems or safety components with the appropriate requirements shall be carried out, at the choice of the manufacturer, either by examination and testing of every subsystem or safety component as specified in point 4 or by examination and testing of the subsystems or safety components on a statistical basis as specified in point 5.
Pregledi in preskusi za preverjanje skladnosti podsistemov ali varnostnih elementov z ustreznimi zahtevami se po izbiri proizvajalca izvedejo bodisi s pregledom in preskusom vsakega podsistema ali varnostnega elementa v skladu s točko 4 ali s pregledom in preskusom podsistemov ali varnostnih elementov na statistični podlagi v skladu s točko 5.
Verification of conformity by examination and testing of every subsystem or safety component
Preverjanje skladnosti s pregledom in preskusom vsakega podsistema ali varnostnega elementa
All subsystems or safety components shall be individually examined and appropriate tests set out in the relevant harmonised standard(s), and/or equivalent tests set out in other relevant technical specifications, shall be carried out in order to verify conformity with the approved type described in the EU-type examination certificate and with the appropriate requirements of this Regulation.
Vsi podsistemi ali varnostni elementi se pregledajo posamezno, na njih pa se izvedejo ustrezni preskusi, določeni v ustreznih harmoniziranih standardih, in/ali enakovredni preskusi, določeni v drugih ustreznih tehničnih specifikacijah, s čimer se preveri njihova skladnost z odobrenim tipom, opisanim v certifikatu o EU-pregledu tipa, in ustreznimi zahtevami iz te uredbe.
In the absence of such a harmonised standard, the notified body concerned shall decide on the appropriate tests to be carried out.
Kadar tak harmoniziran 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 subsystem or safety component 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 podsistem ali varnostni element ali jo da namestiti na svojo odgovornost.
The manufacturer shall keep the certificates of conformity available for inspection by the national authorities for 30 years after the subsystem or safety component has been placed on the market.
Proizvajalec za nacionalne organe certifikate o skladnosti hrani še 30 let po tem, ko je bil podsistem ali varnostni element dan na trg.
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 subsystem or safety component 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 svoj podsistem ali varnostni element za preverjanje v obliki homogenih serij.
A random sample shall be taken from each lot.
Iz vsake serije se odvzame naključni vzorec.
All the subsystems or safety components in the sample shall be individually examined and appropriate tests set out in the relevant harmonised standard(s) and/or equivalent tests set out in other relevant technical specifications, shall be carried out in order to verify their conformity with the approved type described in the EU-type examination certificate and with the applicable requirements of this Regulation and to determine whether the lot is accepted or rejected.
Vsi podsistemi ali varnostni elementi iz vzorca se pregledajo posamezno, na njih pa se izvedejo ustrezni preskusi, določeni v ustreznih harmoniziranih standardih, in/ali enakovredni preskusi, določeni v drugih ustreznih tehničnih specifikacijah, s čimer se preveri njihova skladnost z odobrenim tipom, ki je opisan v certifikatu o EU-pregledu tipa, in z veljavnimi zahtevami iz te uredbe ter določi, ali se serija sprejme ali zavrne.
If a lot is accepted, all the subsystems or safety components of the lot shall be considered approved, except for those subsystems or safety components from the sample that have been found not to satisfy the tests.
Če je serija sprejeta, se šteje, da so odobreni vsi podsistemi ali varnostni elementi iz serije, razen tistih podsistemov ali varnostnih elementov iz vzorca, za katere je 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 subsystem or safety component 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 podsistem ali varnostni element ali jo da namestiti na svojo odgovornost.
The manufacturer shall keep the certificates of conformity at the disposal of the national authorities for 30 years after the subsystem or the safety component has been placed on the market.
Proizvajalec za nacionalne organe certifikate o skladnosti hrani še 30 let po tem, ko je bil podsistem ali varnostni element dan na trg.
If a lot is rejected, the notified body or the competent authority shall take appropriate measures to prevent the placing on the market of that lot.
Če se serija zavrne, priglašeni organ ali pristojni organ sprejme 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 affix the CE marking and, under the responsibility of the notified body referred to in point 3, the latter's identification number to each individual subsystem or safety component that is in conformity with the approved type described in the EU-type examination certificate and satisfies the applicable requirements of this Regulation.
Proizvajalec na vsak posamezen podsistem ali varnostni element, ki je v skladu z odobrenim tipom, opisanim v certifikatu o EU-pregledu tipa, in ki izpolnjuje ustrezne zahteve iz te uredbe, namesti oznako CE in, v okviru odgovornosti priglašenega organa iz točke 3, identifikacijsko številko tega organa.
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 subsystems or safety components.
Če priglašeni organ iz točke 3 to dovoli, lahko proizvajalec na odgovornost priglašenega organa na podsisteme ali varnostne elemente namesti 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 subsystems or safety components during the manufacturing process.
Proizvajalec lahko na podlagi dovoljenja priglašenega organa in na njegovo odgovornost namesti identifikacijsko številko tega organa na podsisteme ali varnostne elemente 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, če so navedene v pooblastilu.