natgillin/translations-raw huggingface dataset:
An authorised representative may not fulfil the obligations set out in points 2 and 5.1.
Pooblaščeni zastopnik ne sme izpolniti obveznosti proizvajalca iz točk 2 in 5.1.
CONFORMITY ASSESSMENT PROCEDURES FOR SUBSYSTEMS AND SAFETY COMPONENTS: MODULE G: CONFORMITY BASED ON UNIT VERIFICATION
POSTOPKI UGOTAVLJANJA SKLADNOSTI PODSISTEMOV IN VARNOSTNIH ELEMENTOV: MODUL G: SKLADNOST NA PODLAGI PREVERJANJA ENOTE
Conformity based on unit verification is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3.1 and 4, and ensures and declares on his sole responsibility that the subsystem or safety component concerned, which has been subject to the provisions of point 3, is in conformity with the requirements of this Regulation that apply to it.
Skladnost na podlagi preverjanja enote je postopek ugotavljanja skladnosti, s katerim proizvajalec izpolni obveznosti iz točk 2, 3.1 in 4 ter zagotovi in na lastno odgovornost izjavi, da je zadevni podsistem ali varnostni element, ki je predmet določb iz točke 3, v skladu z zahtevami te uredbe, ki veljajo zanj.
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured subsystem or safety component with the applicable requirements of this Regulation.
Proizvajalec sprejme vse potrebne ukrepe, da proizvodni proces in njegovo spremljanje zagotovita skladnost proizvedenih podsistemov ali varnostnih elementov z veljavnimi zahtevami te uredbe.
The manufacturer shall lodge an application for unit verification of a subsystem or a safety component with the notified body of his choice.
Proizvajalec pri priglašenem organu, ki ga izbere sam, vloži zahtevek za preverjanje enote podsistema ali varnostnega elementa.
The notified body shall examine the technical documentation for the subsystem or the safety component and shall carry out the appropriate examinations and tests set out in the relevant harmonised standards and/or equivalent tests set out in other relevant technical specifications, to check the conformity of the subsystem or the safety component with the applicable requirements of this Regulation, or have them carried out.
Priglašeni organ pregleda tehnično dokumentacijo za podsistem ali varnostni element ter izvede ali naroči ustrezne preglede in preskuse, določene v ustreznih harmoniziranih standardih, in/ali enakovredne preskuse, določene v drugih ustreznih tehničnih specifikacijah, s čimer se preveri skladnost podsistema ali varnostnega elementa z veljavnimi 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 the 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 odobreni podsistem ali varnostni element ali jo da namestiti na svojo odgovornost.
If the notified body refuses to issue a certificate of conformity, it shall state in detail the reasons for the refusal and indicate the necessary corrective measures to be taken.
Če priglašeni organ zavrne izdajo certifikata o skladnosti, podrobno utemelji zavrnitev in navede potrebne korektivne ukrepe, ki jih je treba sprejeti.
When the manufacturer reapplies for unit verification of the subsystem or the safety component concerned, he shall apply to the same notified body.
Kadar proizvajalec ponovno vloži zahtevek za preverjanje enote za zadevni podsistem ali varnostni element, zahtevek vloži pri istem priglašenem organu.
On request, the notified body shall provide the Commission and the Member States with a copy of the certificate of conformity.
Na zahtevo priglašeni organ Komisiji in državam članicam predloži izvod certifikata o skladnosti.
The manufacturer shall keep the technical documentation and the certificate 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 hrani tehnično dokumentacijo in certifikat o skladnosti za nacionalne organe še 30 let po tem, ko je bil podsistem ali varnostni element dan na trg.
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 subsystem or safety component that satisfies the applicable requirements of this Regulation.
Proizvajalec na vsak podsistem ali varnostni element, ki izpolnjuje veljavne zahteve iz te uredbe, namesti oznako CE in, v okviru odgovornosti priglašenega organa iz točke 3, identifikacijsko številko tega organa.
The manufacturer shall draw up a written EU declaration of conformity 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 sestavi pisno izjavo EU o skladnosti in jo hrani za nacionalne organe 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 the safety component for which it has been drawn up.
Izjava EU o skladnosti opredeljuje podsistem ali varnostni element, za katerega je bila sestavljena.
The manufacturer's obligations set out in points 3.1 and 4 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 in 4 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 H 1: CONFORMITY BASED ON FULL QUALITY ASSURANCE PLUS DESIGN EXAMINATION
POSTOPKI UGOTAVLJANJA SKLADNOSTI PODSISTEMOV IN VARNOSTNIH ELEMENTOV: MODUL H 1: SKLADNOST NA PODLAGI POPOLNEGA ZAGOTAVLJANJA KAKOVOSTI IN PREGLED NAČRTOVANJA
Conformity based on full quality assurance plus design examination is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on his sole responsibility that the subsystems or safety components concerned satisfy the requirements of this Regulation that apply to them.
Skladnost na podlagi popolnega zagotavljanja kakovosti in pregleda načrtovanja je postopek ugotavljanja skladnosti, pri katerem proizvajalec izpolnjuje obveznosti iz točk 2 in 5 ter zagotovi in na lastno odgovornost izjavi, da zadevni podsistemi ali varnostni elementi izpolnjujejo zahteve iz te uredbe, ki veljajo zanje.
The manufacturer shall operate an approved quality system for the design, manufacture and final inspection and testing of subsystems or safety components as specified in point 3 and shall be subject to surveillance as specified in point 4.
Proizvajalec izvaja odobren sistem kakovosti za načrtovanje, proizvodnjo, končni pregled in preskušanje podsistemov ali varnostnih elementov iz točke 3 ter je pod nadzorom v skladu s točko 4.
The adequacy of the technical design of the subsystems or safety components shall have been examined in accordance with point 3.6.
Ustreznost tehničnega načrta podsistemov ali varnostnih elementov se pregleda v skladu s točko 3.6.
The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the subsystems or safety components concerned.
Proizvajalec pri priglašenem organu, ki ga izbere sam, vloži zahtevek za oceno svojega sistema kakovosti za zadevne podsisteme ali varnostne elemente.
all necessary information on the subsystems or safety components to be manufactured;
vse potrebne informacije o podsistemih ali varnostnih elementih, ki bodo proizvedeni;
the technical documentation in accordance with Annex VIII for one representative type of each category of subsystem or safety component to be manufactured;
tehnično dokumentacijo v skladu s Prilogo VIII za en reprezentativen tip vsake kategorije podsistema ali varnostnega elementa, ki bo proizvedena;
the address of the premises where the subsystems or safety components are designed, manufactured, inspected and tested;
naslov prostorov, kjer se podsistem ali varnostni element načrtuje, proizvaja, pregleduje in preskuša;
a written declaration that the same application has not been lodged with any other notified body.
pisno izjavo, da enak zahtevek ni bil vložen pri nobenem drugem priglašenem organu.
The quality system shall ensure compliance of the subsystems or the safety components with the requirements of this Regulation that apply to them.
Sistem kakovosti zagotavlja skladnost podsistemov ali varnostnih elementov z zahtevami iz te uredbe, ki veljajo za njih.
the quality objectives and the organisational structure, responsibilities and powers of the management with regard to the design and product quality;
ciljev kakovosti in organizacijske strukture, odgovornosti in pristojnosti vodstva glede načrtovanja in kakovosti proizvoda;
the technical design specifications, including standards, that will be applied and, where the relevant harmonised standards will not be applied in full, the means, including other relevant technical specifications, that will be used to ensure that the essential requirements of this Regulation will be met;
specifikacij tehničnih načrtov, vključno s standardi, ki bodo uporabljeni, in, kjer ustrezni harmonizirani standardi ne bodo uporabljeni v celoti, sredstev, tudi drugih ustreznih tehničnih specifikacij, ki bodo uporabljena za zagotovitev izpolnjevanja bistvenih zahtev iz te uredbe;
the design control and design verification techniques, processes and systematic actions that will be used when designing the subsystems or the safety components;
tehnik, postopkov in sistematičnih ukrepov za nadzor in preverjanje načrtovanja, ki bodo uporabljeni pri načrtovanju podsistemov ali varnostnih elementov;
the examinations and tests to 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 pogostosti njihovega izvajanja;
the means of monitoring the achievement of the required design and product quality and the effective operation of the quality system.
sredstev za spremljanje doseganja zahtevane kakovosti načrtovanja in proizvodov ter učinkovitega delovanja sistema kakovosti.
The audit shall include an assessment visit to the premises where the subsystems or the safety components are designed, manufactured, inspected and tested.
Presoja vključuje ocenjevalni obisk v obratih, kjer se podsistemi ali varnostni elementi načrtujejo, proizvajajo, pregledujejo in preskušajo.
In addition to experience in quality management systems, the auditing team shall have at least one member experienced as assessor 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 auditing team shall review the technical documentation referred to in point 3.1 to verify the manufacturer's ability to identify the applicable requirements of this Regulation and to carry out the necessary examinations with a view to ensuring compliance of the subsystems or the safety components with those requirements.
Skupina za presojo pregleda tehnično dokumentacijo iz točke 3.1, da ugotovi, ali je proizvajalec zmožen identificirati veljavne zahteve iz te uredbe, in da izvede potrebne preglede za zagotovitev skladnosti podsistemov ali varnostnih elementov z navedenimi zahtevami.
The notified body shall notify its decision to the manufacturer or his authorised representative.
Priglašeni organ obvesti proizvajalca ali njegovega pooblaščenega zastopnika o svoji odločitvi.
It shall notify the manufacturer or the authorised representative of its decision.
Proizvajalca ali pooblaščenega zastopnika obvesti o svoji odločitvi.
Design examination
Pregled načrtovanja
The manufacturer shall lodge an application for examination of the design with the notified body referred to in point 3.1.
Proizvajalec vloži zahtevek za pregled načrtovanja pri priglašenem organu iz točke 3.1.
The application shall make it possible to understand the design, manufacture and operation of the subsystem or safety component, and to assess the conformity with the requirements of this Regulation that apply to it.
Zahtevek omogoča razumevanje načrtovanja, proizvodnje in obratovanja podsistema ali varnostnega elementa ter oceno njegove skladnosti z zahtevami iz te uredbe, ki veljajo zanj.
the technical documentation as described in Annex VIII.
tehnično dokumentacijo, opisano v Prilogi VIII.
The notified body shall examine the application and, where the design meets the requirements of this Regulation that apply to the subsystem or safety component, it shall issue an EU design examination certificate to the manufacturer.
Priglašeni organ pregleda zahtevek in, če načrtovanje izpolnjuje zahteve iz te uredbe, ki veljajo za podsistem ali varnostni element, proizvajalcu izda certifikat o EU-pregledu tipa za načrtovanje.
That certificate shall give the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the data necessary for identification of the approved design.
Na certifikatu so navedeni ime in naslov proizvajalca, rezultati pregleda, morebitni pogoji njegove veljavnosti in potrebni podatki za identifikacijo odobrenega načrtovanja.
That certificate may have one or more annexes attached.
Certifikatu je lahko priložena ena ali več prilog.
That certificate and its annexes shall contain all relevant information to allow the conformity of manufactured subsystems or safety components with the examined design to be evaluated and to allow for in-service control, where applicable.
Navedeni certifikat in njegove priloge vsebujejo vse potrebne informacije, da se lahko oceni skladnost proizvedenih podsistemov ali varnostnih elementov s pregledanim načrtovanjem ter omogoči nadzor med uporabo, kjer je to ustrezno.
Where the design does not satisfy the applicable requirements of this Regulation, the notified body shall refuse to issue an EU design examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.
Če načrtovanje ne izpolnjuje veljavnih zahtev iz te uredbe, priglašeni organ zavrne izdajo certifikata o EU-pregledu tipa za načrtovanje in ustrezno obvesti vložnika s podrobno utemeljitvijo zavrnitve.
The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved design may no longer comply with the applicable requirements of this Regulation, and shall determine whether such changes require further investigation.
Priglašeni organ spremlja kakršne koli spremembe splošno sprejetih najnovejših tehnoloških dosežkov, ki kažejo, da odobreno načrtovanje morda ne izpolnjuje več veljavnih zahtev iz te uredbe, ter določi, ali take spremembe zahtevajo nadaljnje preiskave.
The manufacturer shall keep the notified body that has issued the EU design examination certificate informed of any modification to the approved design that may affect the conformity with the essential requirements of this Regulation or the conditions for validity of the certificate.
Proizvajalec redno obvešča priglašeni organ, ki je izdal certifikat o EU-pregledu tipa za načrtovanje, o kakršnih koli spremembah odobrenega načrtovanja, ki bi lahko vplivale na skladnost z bistvenimi zahtevami te uredbe, ali o pogojih veljavnosti certifikata.
Such modifications shall require additional approval from the notified body that issued the EU design examination certificate in the form of an addition to the original EU design examination certificate.
Za take spremembe je potrebna dodatna odobritev – priglašenega organa, ki je izdal certifikat o EU-pregledu tipa za načrtovanje – v obliki dodatka k izvirniku certifikata o EU-pregledu tipa za načrtovanje.
Each notified body shall inform its notifying authority of the EU design examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of certificates and/or any additions thereto refused, suspended or otherwise restricted.
Vsak priglašeni organ obvesti svoj priglasitveni organ o izdanih ali preklicanih certifikatih o EU-pregledu tipa za načrtovanje in/ali dodatkih k tem certifikatom ter redno ali na zahtevo priglasitvenemu organu predloži seznam zavrnjenih, začasno preklicanih ali drugače omejenih certifikatov in/ali dodatkov.
Each notified body shall inform the other notified bodies of the EU design examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, of the certificates and/or additions thereto which it has issued.
Vsak priglašeni organ obvesti druge priglašene organe o certifikatih o EU-pregledu tipa za načrtovanje in/ali dodatkih k tem certifikatom, ki jih je zavrnil, umaknil, začasno preklical ali drugače omejil, na zahtevo pa tudi 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 EU design examination certificates and/or additions thereto.
Komisija, države članice in drugi priglašeni organi lahko na zahtevo dobijo izvode certifikatov o EU-pregledu tipa za načrtovanje in/ali njihovih dodatkov.
The notified body shall keep a copy of the EU design 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 hrani izvod certifikata o EU-pregledu tipa za načrtovanje, njegovih prilog in dodatkov ter tehnični dosje, vključno z dokumentacijo, ki jo predloži proizvajalec, do izteka veljavnosti certifikata.
The manufacturer shall keep a copy of the EU design examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for 30 years after the subsystem or safety component has been placed on the market.
Proizvajalec hrani izvod certifikata o EU-pregledu tipa za načrtovanje, njegovih prilog in dodatkov, vključno s tehnično dokumentacijo, za nacionalne organe še 30 let po tem, ko je bil podsistem ali varnostni element dan na trg.
The manufacturer shall, for assessment purposes, allow the notified body access to the design, manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular:
Proizvajalec priglašenemu organu za namene ocene omogoči dostop do krajev načrtovanja, izdelave, pregledovanja, preskušanja in skladiščenja ter mu zagotovi vse potrebne informacije, zlasti:
the quality records provided for by the design part of the quality system, such as results of analyses, calculations, tests, etc.;
zapise o kakovosti, predvidene pri postopku načrtovanja v sistemu kakovosti, na primer rezultate analiz, izračunov, preskusov itd.;
the quality records as provided for by the manufacturing part of the quality system, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.
zapise o kakovosti, kakor so predvideni pri proizvodnem postopku v sistemu kakovosti, na primer poročila o preverjanju in podatke o preskusih, podatke o umerjanjih, poročila o usposobljenosti zadevnega 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 opravlja redne preglede, s čimer zagotovi, da proizvajalec vzdržuje in izvaja sistem kakovosti, poročila o teh pregledih pa pošilja proizvajalcu.
The frequency of periodic audits shall be such that a full reassessment is carried out every three years.
Pogostost rednih pregledov je takšna, da se popoln ponovni pregled opravi vsaka tri leta.
During such visits, the notified body may, if necessary, carry out product tests, or have them carried out, in order to check the proper functioning of the quality system.
Med takšnimi obiski sme priglašeni organ, če je potrebno, opraviti ali naročiti preskuse proizvodov, da preveri pravilno delovanje sistema kakovosti.
It 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.
CE marking and EU declaration of conformity.
Oznaka CE in izjava EU o skladnosti
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 satisfies the applicable requirements of this Regulation.
Proizvajalec na vsak podsistem ali varnostni element, ki izpolnjuje veljavne zahteve iz te uredbe, namesti oznako CE in, v okviru odgovornosti priglašenega organa iz točke 3.1, identifikacijsko številko tega organa.
The EU declaration of conformity shall identify the subsystem or the safety component model for which it has been drawn up and shall refer to the number of the EU design examination certificate.
Izjava EU o skladnosti opredeljuje model podsistema ali varnostnega elementa, za katerega je bila sestavljena, v njej pa je navedena tudi številka certifikata o EU-pregledu tipa za načrtovanje.
the technical documentation referred to in point 3.1(c);
tehnično dokumentacijo iz točke 3.1(c);
the documentation concerning the quality system referred to in point 3.1(d);
dokumentacijo v zvezi s sistemom kakovosti iz točke 3.1(d);
the information relating to the change referred to in point 3.5 as approved;
informacije v zvezi s spremembo iz točke 3.5, kot je bila odobrena;
the decisions and reports of the notified body referred to in points 3.3, 3.5, 4.3 and 4.4.
odločitve in poročila priglašenega organa iz točk 3.3, 3.5, 4.3 in 4.4.
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 preklical ali umaknil, ter, na zahtevo, 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 the quality system approval decision(s) issued.
Na zahtevo priglašeni organ Komisiji in državam članicam predloži izvod odločitve oz. odločitev o odobritvi sistema kakovosti.
The notified body shall keep a copy of the quality system approval decision(s) issued, its annexes and additions, as well as the technical file, for a period of 30 years from the date of their issue.
Priglašeni organ hrani izvode odločitev o odobritvi sistema kakovosti, njenih prilog in dodatkov ter tehnični dosje še 30 let po njihovi izdaji.
The manufacturer's obligations set out in points 3.1, 3.6.4, 3.6.6, 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, 3.6.4, 3.6.6, 5 in 6 lahko v njegovem imenu in na njegovo odgovornost izpolni pooblaščeni zastopnik, če so navedene v pooblastilu.
TECHNICAL DOCUMENTATION FOR SUBSYSTEMS AND SAFETY COMPONENTS
TEHNIČNA DOKUMENTACIJA ZA PODSISTEME IN VARNOSTNE ELEMENTE