natgillin/translations-raw huggingface dataset:
The manufacturer shall affix the conformity marking set out in the legislative instrument, and, under the responsibility of the notified body referred to in point 4, the latter's identification number to each individual product that satisfies the applicable requirements of the legislative instrument.
Proizvajalec namesti znak skladnosti, kot določa zakonodajni instrument, in na odgovornost priglašenega organa iz točke 4 identifikacijsko številko tega organa na vsak proizvod, ki izpolnjuje veljavne zahteve zakonodajnega instrumenta.
If the notified body referred to in point 5 agrees and under its responsibility, the manufacturer may also affix the notified body's identification number to the products.
Če priglašeni organ iz točke 5 to dovoli, proizvajalec na odgovornost priglašenega organa namesti na proizvode tudi identifikacijsko številko tega organa.
An authorised representative may not fulfil the manufacturer's obligations set out in points 3 and 6.1.
Pooblaščeni zastopnik ne rabi izpolniti obveznosti proizvajalca iz točk 3 in 6.1.
Conformity based on unit verification
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 and 5, and ensures and declares on his sole responsibility that the product concerned, which has been subject to the provisions of point 4, is in conformity with the requirements of the legislative instrument that apply to it.
Skladnost na podlagi preverjanja enote je postopek ugotavljanja skladnosti, pri čemer proizvajalec izpolni obveznosti iz točk 2, 3 in 5 ter zagotovi in na lastno odgovornost izjavi, da je zadevni proizvod, ki je predmet določb iz točke 4, v skladu z zahtevami zakonodajnega instrumenta, ki zanje veljajo.
The manufacturer shall establish the technical documentation and make it available to the notified body referred to in point 4.
Proizvajalec predloži tehnično dokumentacijo in jo da na voljo priglašenemu organu iz točke 4.
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured product with the applicable requirements of the legislative instrument.
Proizvajalec sprejme vse potrebne ukrepe, da proizvodni proces in njegovo spremljanje zagotovita skladnost proizvedenega proizvoda z veljavnimi zahtevami zakonodajnega instrumenta.
A notified body chosen by the manufacturer shall carry out appropriate examinations and tests, set out in the relevant harmonised standards and/or technical specifications, or equivalent tests, to check the conformity of the product with the applicable requirements of the legislative instrument, or have them carried out.
Priglašeni organ, ki ga je izbral proizvajalec, izvede ustrezne preglede in preskuse, določene v ustreznih harmoniziranih standardih in/ali tehničnih specifikacijah, ali jih da izvesti, ali enakovredne preskuse, s čimer preveri skladnost proizvoda z veljavnimi zahtevami zakonodajnega instrumenta.
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 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 odobren proizvod ali jo da namestiti na svojo odgovornost.
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 4, the latter's identification number to each 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 4 identifikacijsko številko tega organa na vsak proizvod, ki izpolnjuje veljavne zahteve zakonodajnega instrumenta.
The manufacturer shall draw up a written declaration of conformity 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 manufacturer's obligations set out in points 2 and 5 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 2 in 5 lahko v njegovem imenu in na njegovo odgovornost izpolni pooblaščeni zastopnik, pod pogojem, da je naveden v pooblastilu.
Conformity based on full quality assurance
Skladnost na podlagi popolnega zagotavljanja kakovosti
Conformity based on full quality assurance 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 products concerned satisfy the requirements of the legislative instrument that apply to them.
Skladnost na podlagi popolnega zagotavljanja kakovosti je postopek ugotavljanja skladnosti, pri čemer proizvajalec izpolni obveznosti iz točk 2 in 5 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 design, manufacture and 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 oblikovanje, proizvodnjo ter pregled in preskušanje zadevnih proizvodov iz točke 3 ter je nadzorovan v skladu s točko 4.
results of design calculations made, examinations carried out, etc.,
rezultate opravljenih projektnih izračunov, pregledov itd.,
a written declaration that the same application has not been lodged with any other notified body.
pisno izjavo, da ista vloga ni bila vložena pri nobenem drugem priglašenem organu.
That quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.
Dokumentacija o sistemu kakovosti dovoljuje dosledno razlago programov, načrtov, priročnikov in zapisov o kakovosti.
the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design and product quality,
ciljev kakovosti in organizacijske strukture, odgovornosti in pristojnosti vodstva glede oblikovanja in kakovosti proizvodov,
the technical design specifications, including standards, that will be applied and, where the relevant harmonised standards and/or technical specifications will not be applied in full, the means that will be used to ensure that the essential requirements of the legislative instrument that apply to the products will be met,
tehničnih specifikacij oblikovanja, vključno s standardi, ki se bodo uporabljali, in kadar se ustrezni harmonizirani standardi in/ali tehnične specifikacije ne bodo uporabljali v celoti, sredstva, ki se bodo uporabljala za zagotavljanje izpolnjevanja bistvenih zahtev zakonodajnega instrumenta, ki veljajo za proizvode,
the design control and design verification techniques, processes and systematic actions that will be used when designing the products pertaining to the product category covered,
tehnik nadzora oblikovanja in preverjanje oblikovanja, postopkov in sistematičnih ukrepov, ki se bodo uporabljali pri oblikovanju proizvodov, ki spadajo v to kategorijo proizvodov,
the means of monitoring the achievement of the required design and product quality and the effective operation of the quality system.
načinov spremljanja doseganja zahtevane kakovosti oblikovanja in kakovosti proizvodov ter učinkovitega delovanja sistema kakovosti.
In addition to experience in quality management systems, the auditing team shall have at least one member experienced as an assessor 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 pri presojanju ustreznega področja proizvodov in zadevne tehnologije proizvoda ter poznavanjem veljavnih zahtev zakonodajnega instrumenta.
The auditing team shall review the technical documentation referred to in point 3.1, second indent, to verify the manufacturer's ability to identify the applicable 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 druge alinee točke 3.1 za preverjanje sposobnosti proizvajalca, da ugotovi veljavne zahteve zakonodajnega instrumenta in izvede potrebne preglede za zagotovitev skladnosti proizvoda s temi zahtevami.
The manufacturer or his authorised representative shall be notified of the decision.
Proizvajalec ali pooblaščeni zastopnik sta obveščena o odločitvi.
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 vstop v prostore za oblikovanje, proizvodnjo, pregled, preskušanje in skladiščenje ter mu posreduje vse potrebne informacije, zlasti:
the quality records as provided for by the design part of the quality system, such as results of analyses, calculations, tests, etc.,
zapise o kakovosti, predvidene v načrtovalnem delu sistema kakovosti, kot so rezultati 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, predvidene v proizvodnem delu sistema kakovosti, kot so poročila o pregledu in podatki o preskusih, podatki o umerjanjih opreme, poročila o strokovni usposobljenosti osebja itd.
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 lahko priglašeni organ po potrebi izvede preskus proizvodov ali jih da izvesti, s čimer 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.
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 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 izpolnjuje veljavne zahteve zakonodajnega instrumenta.
the technical documentation referred to in point 3.1,
tehnično dokumentacijo iz točke 3.1,
the documentation concerning the quality system referred to in point 3.1,
dokumentacijo o sistemu kakovosti iz točke 3.1,
Conformity based on full quality assurance plus design examination
Skladnost na podlagi popolnega zagotavljanja kakovosti in pregleda oblikovanja
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 6, and ensures and declares on his sole responsibility that the products concerned satisfy the requirements of the legislative instrument that apply to them.
Skladnost na podlagi popolnega zagotavljanja kakovosti in pregleda oblikovanja je postopek ugotavljanja skladnosti, pri čemer proizvajalec izpolni obveznosti iz točk 2 in 6 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 design, manufacture and final product inspection and testing of the products concerned as specified in point 3 and shall be subject to surveillance as specified in point 5.
Proizvajalec upravlja odobren sistem kakovosti za oblikovanje, proizvodnjo ter pregled in preskušanje zadevnih proizvodov iz točke 3 ter je nadzorovan v skladu s točko 5.
The adequacy of the technical design of the products shall have been examined in accordance with point 4.
Ustreznost tehničnega oblikovanja proizvodov se pregleda v skladu z določbami iz točke 4.
This quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.
Dokumentacija o sistemu kakovosti dovoljuje dosledno razlago programov, načrtov, priročnikov in zapisov o kakovosti.
The manufacturer shall lodge an application for examination of the design with the notified body referred to in point 3.1.
Vlogo za pregled oblikovanja vloži proizvajalec pri priglašenem organu iz točke 3.1.
The application shall make it possible to understand the design, manufacture and operation of the product, and to assess the conformity with the requirements of the legislative instrument that apply to it.
Vloga omogoča razumevanje oblikovanja, proizvodnje in delovanja proizvoda ter oceno skladnosti proizvodov z zahtevami zakonodajnega instrumenta, ki zanje veljajo.
The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design and operation of the product. The technical documentation shall, wherever applicable, contain at least the following elements:
Tehnična dokumentacija opredeljuje veljavne zahteve in v obsegu, ki je pomemben za tako ugotavljanje, zajema oblikovanje in delovanje proizvoda; Tehnična dokumentacija mora, kjer je to ustrezno, vsebovati vsaj naslednje elemente:
the supporting evidence for the adequacy of the technical design.
dodatna dokazila o ustreznosti tehničnega oblikovanja.
This supporting evidence shall mention any documents that have been used, in particular where the relevant harmonised standards and/or technical specifications have not been applied in full, and shall include, where necessary, the results of tests carried out by the appropriate laboratory of the manufacturer, or by another testing laboratory on his behalf and under his responsibility.
Ta dokazila navajajo dokumente, ki so se uporabljali, zlasti če se ustrezni harmonizirani standardi in/ali tehnične specifikacije niso uporabljali v celoti, ter vključujejo, če je potrebno, rezultate preskusov, ki jih je izvedel ustrezni laboratorij proizvajalca ali drug preskuševalni laboratorij v njegovem imenu in na njegovo odgovornost.
The notified body shall examine the application, and where the design meets the requirements of the legislative instrument that apply to the product it shall issue an EC design examination certificate to the manufacturer.
Priglašeni organ pregleda vlogo in, če oblikovanje izpolnjuje določbe zakonodajnega instrumenta, ki veljajo za proizvod, proizvajalcu izda certifikat o ES-pregledu oblikovanja.
The 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.
Certifikat vsebuje ime in naslov proizvajalca, rezultate pregleda, pogoje (če so) njegove veljavnosti in potrebne podatke za identifikacijo odobrenega oblikovanja.
The certificate and its annexes shall contain all relevant information to allow the conformity of manufactured products with the examined design to be evaluated, and to allow for in-service control, where applicable.
Certifikati in priloge vsebujejo vse potrebne informacije, da se lahko oceni skladnost proizvedenih proizvodov s preskušenim tipom ter po potrebi omogoči nadzor med uporabo.
Where the design does not satisfy the applicable requirements of the legislative instrument, the notified body shall refuse to issue a design examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.
Če oblikovanje ne izpolnjuje veljavnih zahtev zakonodajnega instrumenta, priglašeni organ zavrne izdajo certifikata o pregledu oblikovanja in ustrezno obvesti vlagatelja 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 the legislative instrument, and shall determine whether such changes require further investigation.
Priglašeni organ odobri kakršne koli spremembe splošno sprejetih najnovejših dosežkov, ki kažejo, da odobreno oblikovanje ne izpolnjuje več veljavnih zahtev zakonodajnega instrumenta, ter določi, ali te spremembe zahtevajo nadaljnje preiskave.
The manufacturer shall keep the notified body that has issued the EC design examination certificate informed of any modification to the approved design that may affect the conformity with the essential requirements of the legislative instrument or the conditions for validity of the certificate.
Proizvajalec obvesti priglašeni organ, ki je izdal certifikat o ES-pregledu oblikovanja, o kakršnih koli spremembah odobrenega oblikovanja, ki bi lahko vplivale na skladnost z bistvenimi zahtevami zakonodajnega instrumenta in s pogoji veljavnosti certifikata.
Such modifications shall require additional approval — from the notified body that issued the EC design examination certificate — in the form of an addition to the original EC design examination certificate.
Priglašeni organ, ki je izdal certifikat o ES-pregledu oblikovanja, mora te spremembe dodatno odobriti v obliki dodatka k izvirnemu certifikatu o ES-pregledu oblikovanja.
Each notified body shall inform its notifying authorities of the EC 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 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 oblikovanja 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 of the EC 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 zavrnjenih, začasno opuščenih ali drugače omejenih certifikatih o ES-pregledu oblikovanja 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 design examination certificates and/or additions thereto.
Komisija, države članice in drugi priglašeni organi lahko na zahtevo prejmejo izvode certifikatov o ES-pregledu oblikovanja in/ali njihovih dodatkov.
On request, the Commission and the Member States may obtain a copy of the technical documentation and of 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 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 ima izvod certifikata o ES-pregledu oblikovanja, 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 design 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 na voljo izvod certifikata o ES-pregledu oblikovanja, njegovih prilog in dodatkov, vključno s tehnično dokumentacijo,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 and shall mention the number of the design examination certificate.
Izjava o skladnosti opredeljuje vzorčni proizvod, za katerega je bila sestavljena, in navaja številko certifikata o pregledu oblikovanja.
the decisions and reports of the notified body referred to in points 3.5, 5.3 and 5.4.
odločbe in poročila priglašenega organa iz točk 3.5, 5.3 in 5.4.
The manufacturer's authorised representative may lodge the application referred to in points 4.1 and 4.2 and fulfil the obligations set out in points 3.1, 3.5, 4.4, 4.6, 6 and 7, on his behalf and under his responsibility, provided that they are specified in the mandate.
Pooblaščeni zastopnik proizvajalca lahko vloži vlogo iz točk 4.1 in 4.2 ter izpolni obveznosti iz točk 3.1., 3.5., 4.4., 4.6., 6 in 7 v svojem imenu in na lastno odgovornost, pod pogojem, da je naveden v pooblastilu.
TABLE: CONFORMITY ASSESSMENT PROCEDURES IN COMMUNITY LEGISLATION
TABELA: POSTOPKI ZA UGOTAVLJANJE SKLADNOSTI V ZAKONODAJI SKUPNOSTI
DESIGN
OBLIKOVANJE
Type examination
Pregled tipa
Unit verification
Preverjanje enote
keeps technical documentation at the disposal of national authorities
hrani tehnično dokumentacijo na razpolago nacionalnim organom
Manufacturer submits to notified body
Proizvajalec predloži priglašenemu organu
technical documentation
tehnično dokumentacijo
supporting evidence for the adequacy of the technical design solution
dodatna dokazila o ustreznosti rešitve tehničnega oblikovanja
specimen(s), representative of the production envisaged, as required
vzorce, reprezentativne za predvideno proizvodnjo (po potrebi)
submits technical documentation
predloži tehnično dokumentacijo
operates an approved quality system for design
izvaja odobren sistem zagotavljanja kakovosti za načrtovanje
Notified body
Priglašeni organ
ascertains conformity with essential requirements
preverja skladnost z bistvenimi zahtevami
examines technical documentation and supporting evidence to assess adequacy of the technical design
pregleduje tehnično dokumentacijo in dodatna dokazila, da ugotovi ustreznost tehničnega oblikovanja
for specimen(s): carries out tests, if necessary
Za vzorce: po potrebi izvaja preskuse
issues EC-type examination certificate
izdaja certifikate o ES-pregledu tipa
carries out surveillance of the QS
izvaja nadzor nad sistemom kakovosti
verifies conformity of design [1]issues EC-design examination certificate [1]
preverja skladnost oblikovanja [1]izdaja certifikate o ES-pregledu tipa [1]
Conformity to type
Skladnost s tipom
Production quality assurance
Zagotavljanje kakovosti proizvodnje
Product quality assurance
Zagotavljanje kakovosti proizvoda
Product verification
Preverjanje proizvoda
declares conformity with essential requirements
razglasi skladnost z bistvenimi zahtevami
affixes required conformity marking
pritrdi zahtevano oznako skladnosti
declares conformity with approved type
razglasi skladnost z odobrenim tipom
operates an approved quality system for production, final inspection and testing
upravlja odobren sistem kakovosti za proizvodnjo, pregled končnega proizvoda in preskušanje
operates an approved quality system for final inspection and testing
upravlja odobren sistem kakovosti za pregled končnega proizvoda in preskušanje
submits product
predloži proizvod
declares conformity
razglasi skladnost
aAffixes required conformity marking
pritrdi zahtevano oznako skladnosti