natgillin/translations-raw huggingface dataset:
Where the type does not satisfy the applicable requirements of this Directive, the notified body shall refuse to issue an EU-type examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.
dokazila o ustreznosti rešitve tehnične zasnove.
The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the applicable requirements of this Directive, and shall determine whether such changes require further investigation.
V teh dokazilih so navedeni vsi uporabljeni dokumenti, zlasti kadar se ustrezni harmonizirani standardi niso uporabili v celoti.
If so, the notified body shall inform the manufacturer accordingly.
Dokazila po potrebi vsebujejo rezultate preskusov, ki jih je v skladu z drugimi ustreznimi tehničnimi specifikacijami izvedel ustrezni laboratorij proizvajalca ali drug preskuševalni laboratorij v njegovem imenu in na njegovo odgovornost.
The manufacturer shall inform the notified body that holds the technical documentation relating to the EU-type examination certificate of all modifications to the approved type that may affect the conformity of the explosive with the essential safety requirements of this Directive or the conditions for validity of that certificate.
Priglašeni organ:
Such modifications shall require additional approval in the form of an addition to the original EU-type examination certificate.
v zvezi z eksplozivom:
Each notified body shall inform its notifying authority concerning the EU-type examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of such certificates and/or any additions thereto refused, suspended or otherwise restricted.
pregleda tehnično dokumentacijo in dodatna dokazila, da ugotovi ustreznost tehnične zasnove eksploziva;
Each notified body shall inform the other notified bodies concerning the EU-type examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning such certificates and/or additions thereto which it has issued.
v zvezi z vzorci:
The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU-type examination certificates and/or additions thereto.
preveri, ali je bil vzorec izdelan v skladu s tehnično dokumentacijo, ter identificira elemente, ki so bili zasnovani v skladu z veljavnimi določbami ustreznih harmoniziranih standardov, in elemente, ki so bili zasnovani v skladu z drugimi ustreznimi tehničnimi specifikacijami;
On request, the Commission and the Member States may obtain a copy of the technical documentation and the results of the examinations carried out by the notified body.
izvede ustrezne preglede in preskuse ali jih da izvesti, da preveri, ali je proizvajalec, kadar se je odločil uporabiti rešitve iz ustreznih harmoniziranih standardov, te res uporabil;
The notified body shall keep a copy of the EU-type examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, until the expiry of the validity of that certificate.
izvede ustrezne preglede in preskuse ali jih da izvesti, da bi v primeru neuporabe rešitev iz ustreznih harmoniziranih standardov preveril, ali rešitve, ki jih je sprejel proizvajalec, ki uporablja druge ustrezne tehnične specifikacije, izpolnjujejo ustrezne bistvene varnostne zahteve iz te direktive;
The manufacturer shall keep a copy of the EU-type examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the explosive has been placed on the market.
se dogovori s proizvajalcem o kraju, v katerem se bodo opravljali pregledi in preskusi.
The manufacturer’s authorised representative may lodge the application referred to in point 3 and fulfil the obligations set out in points 7 and 9, provided that they are specified in the mandate.
Priglašeni organ sestavi poročilo o vrednotenju, ki navaja ukrepe, izvedene v skladu s točko 4, in njihove rezultate.
MODULE C 2
Brez poseganja v obveznosti do priglasitvenih organov lahko priglašeni organ objavi vsebino navedenega poročila v celoti ali delno le, če se proizvajalec strinja.
Conformity to type based on internal production control plus supervised product checks at random intervals
Kadar tip izpolnjuje zahteve te direktive, ki se nanašajo na zadevni eksploziv, priglašeni organ proizvajalcu izda certifikat o EU-pregledu tipa.
Conformity to type based on internal production control plus supervised product checks at random intervals is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 4, and ensures and declares on his sole responsibility that the explosives concerned are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Directive that apply to them.
Ta certifikat vsebuje ime in naslov proizvajalca, ugotovitve pregleda, pogoje (če ti obstajajo) njegove veljavnosti in potrebne podatke za identifikacijo odobrenega tipa.
Manufacturing
Certifikatu o EU-pregledu tipa je lahko priložena ena ali več prilog.
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured explosives with the type described in the EU-type examination certificate and with the requirements of this Directive that apply to them.
Certifikat o EU-pregledu tipa in njegove priloge vsebujejo vse potrebne informacije, da se lahko ovrednoti skladnost proizvedenih eksplozivov s preskušenim tipom ter omogoči nadzor med uporabo.
Product checks
Kadar tip ne izpolnjuje veljavnih zahtev iz te direktive, priglašeni organ zavrne izdajo certifikata o EU-pregledu tipa in ustrezno obvesti vložnika s podrobno utemeljitvijo zavrnitve.
A notified body, chosen by the manufacturer, shall carry out product checks or have them carried out at random intervals determined by that body, in order to verify the quality of the internal checks on the explosive, taking into account, inter alia, the technological complexity of the explosives and the quantity of production.
Priglašeni organ oceni vse spremembe splošno sprejetih najnovejših dosežkov, ki kažejo, da odobreni tip ne izpolnjuje več veljavnih zahtev iz te direktive, ter ugotovi, ali take spremembe zahtevajo nadaljnjo preiskavo.
An adequate sample of the final products, taken on site by the notified body before the placing on the market, shall be examined and appropriate tests as identified by the relevant parts of the harmonised standards and/or equivalent tests set out in other relevant technical specifications, shall be carried out to check the conformity of the explosive with the type described in the EU-type examination certificate and with the relevant requirements of this Directive.
V tem primeru priglašeni organ ustrezno obvesti proizvajalca.
Where a sample does not conform to the acceptable quality level, the notified body shall take appropriate measures.
Proizvajalec obvesti priglašeni organ, ki ima tehnično dokumentacijo o certifikatu o EU-pregledu tipa, o vseh spremembah odobrenega tipa, ki bi lahko vplivale na skladnost eksploziva z bistvenimi varnostnimi zahtevami iz te direktive ali pogoji veljavnosti tega certifikata.
The acceptance sampling procedure to be applied is intended to determine whether the manufacturing process of the explosive performs within acceptable limits, with a view to ensuring conformity of the explosive.
Take spremembe zahtevajo dodatno odobritev v obliki dodatka izvirnemu certifikatu o EU-pregledu tipa.
The manufacturer shall, under the responsibility of the notified body, affix the notified body’s identification number during the manufacturing process.
Vsak priglašeni organ obvesti svoj priglasitveni organ o certifikatih o EU-pregledu tipa, ki jih je izdal ali preklical, in/ali dodatkih k tem potrdilom ter redno ali na zahtevo priglasitvenega organa da na voljo seznam zavrnjenih, začasno preklicanih ali drugače omejenih certifikatov in/ali dodatkov.
CE marking and EU declaration of conformity
Vsak priglašeni organ obvesti druge priglašene organe o zavrnjenih, preklicanih, začasno preklicanih ali drugače omejenih certifikatih o EU-pregledu tipa in/ali dodatkih k tem certifikatom ter jih na zahtevo obvesti o izdanih certifikatih in/ali dodatkih.
The manufacturer shall affix the CE marking to each individual explosive that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of this Directive.
Komisija, države članice in drugi priglašeni organi lahko na zahtevo dobijo kopijo certifikata o EU-pregledu tipa in/ali dodatkov k potrdilu.
The manufacturer shall draw up a written EU declaration of conformity for each explosive type and keep it at the disposal of the national authorities for 10 years after the explosive has been placed on the market.
Komisija in države članice lahko na zahtevo dobijo kopijo tehnične dokumentacije in rezultate pregledov, ki jih je izvedel priglašeni organ.
The EU declaration of conformity shall identify the explosive type for which it has been drawn up.
Priglašeni organ kopijo certifikata o EU-pregledu tipa, njegovih prilog in dodatkov ter tehnični spis, vključno z dokumentacijo, ki jo predloži proizvajalec, hrani do poteka veljavnosti tega certifikata.
A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.
Proizvajalec nacionalnim organom omogoča vpogled v kopijo certifikata o EU-pregledu tipa ter njegovih prilog in dodatkov, vključno s tehnično dokumentacijo, še vsaj 10 let po tem, ko je bil eksploziv dan na trg.
Authorised representative
Pooblaščeni zastopnik proizvajalca lahko vloži vlogo iz točke 3 ter izpolni obveznosti iz točk 7 in 9, če so navedene v pooblastilu.
The manufacturer’s obligations set out in point 4 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
MODUL C 2
MODULE D
Skladnost s tipom na podlagi notranjega nadzora proizvodnje in nadzorovani preskusi proizvodov v naključnih časovnih presledkih
Conformity to type based on quality assurance of the production process
Skladnost s tipom na podlagi notranjega nadzora proizvodnje in nadzorovani preskusi proizvodov v naključno izbranih časovnih presledkih so del postopka ugotavljanja skladnosti, s katerim proizvajalec izpolni obveznosti iz točk 2, 3 in 4 ter zagotovi in na lastno odgovornost izjavi, da so zadevni eksplozivi skladni s tipom, opisanim v certifikatu o EU-pregledu tipa, in da izpolnjujejo zahteve te direktive, ki veljajo zanje.
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 explosives concerned are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Directive that apply to them.
Proizvodnja
The manufacturer shall operate an approved quality system for production, final product inspection and testing of the explosives concerned as specified in point 3, and shall be subject to surveillance as specified in point 4.
Proizvajalec sprejme vse potrebne ukrepe, da s proizvodnim procesom in njegovim spremljanjem zagotovi skladnost proizvedenih eksplozivov s tipom, ki je opisan v certifikatu o EU-pregledu tipa, in z zahtevami te direktive, ki veljajo zanj.
Quality system
Preskusi proizvoda
The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the explosives concerned.
Priglašeni organ, ki ga izbere proizvajalec, izvaja ali da izvesti preskuse proizvoda v naključno izbranih časovnih presledkih, ki jih določi ta organ, da bi preveril kakovost notranje kontrole eksploziva, upoštevajoč med drugim tehnološko zapletenost eksplozivov in obseg proizvodnje.
all relevant information for the explosive category envisaged;
Priglašeni organ na ustreznem vzorcu končnih proizvodov, odvzetih na kraju samem, pred dajanjem na trg izvede pregled in primerne preskuse, kakor so opredeljeni v ustreznih delih harmoniziranega standarda, in/ali enakovredne preskuse, ki so določeni v drugih ustreznih tehničnih specifikacijah, da preveri skladnost eksploziva s tipom, opisanim v certifikatu o EU-pregledu tipa, ter z ustreznimi zahtevami iz te direktive.
the documentation concerning the quality system;
V primerih, ko vzorec ne dosega sprejemljive ravni kakovosti, priglašeni organ sprejme ustrezne ukrepe.
the technical documentation of the approved type and a copy of the EU-type examination certificate.
Postopek vzorčenja za sprejemljivost, ki se uporablja, je zasnovan za presojo, ali se proizvodni proces eksploziva izvaja v sprejemljivih mejah s ciljem zagotavljanja skladnosti eksploziva.
The quality system shall ensure that the explosives are in conformity with the type described in the EU-type examination certificate and comply with the requirements of this Directive that apply to them.
Proizvajalec med proizvodnim procesom na odgovornost priglašenega organa na proizvode namesti identifikacijsko številko tega organa.
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.
Oznaka CE in izjava EU o skladnosti
The quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.
Proizvajalec namesti oznako CE na vsak posamezni eksploziv, ki je skladen s tipom, opisanim v certifikatu o EU-pregledu tipa, in izpolnjuje veljavne zahteve iz te direktive.
It shall, in particular, contain an adequate description of:
Proizvajalec za vsak tip eksploziva sestavi pisno izjavo EU o skladnosti in nacionalnim organom omogoči dostop do nje v obdobju 10 let po tem, ko je bil eksploziv dan na trg.
the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality;
Izjava EU o skladnosti opredeljuje tip eksploziva, za katerega je bila sestavljena.
the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used;
Na zahtevo se pristojnim organom predloži kopijo izjave EU o skladnosti.
the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out;
Pooblaščeni zastopnik
the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.;
Obveznosti proizvajalca iz točke 4 lahko v njegovem imenu in na njegovo odgovornost izpolni pooblaščeni zastopnik, če so navedene v pooblastilu.
the means of monitoring the achievement of the required product quality and the effective operation of the quality system.
MODUL D
The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2.
Skladnost s tipom na podlagi zagotavljanja kakovosti proizvodnega procesa
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.
Skladnost s tipom na podlagi zagotavljanja kakovosti proizvodnje je del postopka ugotavljanja skladnosti, s katerim proizvajalec izpolni obveznosti iz točk 2 in 5 ter zagotovi in na lastno odgovornost izjavi, da so zadevni eksplozivi skladni s tipom, opisanim v certifikatu o EU-pregledu tipa, in da izpolnjujejo zahteve iz te direktive, ki veljajo zanje.
In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant product field and product technology concerned, and knowledge of the applicable requirements of this Directive.
Proizvajalec upravlja odobren sistem zagotavljanja kakovosti za proizvodnjo, končni pregled proizvoda in preskušanje zadevnih eksplozivov, kakor je določeno v točki 3, in je predmet nadzora iz točke 4.
The audit shall include an assessment visit to the manufacturer’s premises.
Sistem kakovosti
The notification shall contain the conclusions of the audit and the reasoned assessment decision.
dokumentacijo, ki se nanaša na sistem kakovosti;
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.
tehnično dokumentacijo odobrenega tipa in kopijo certifikata o EU-pregledu tipa.
The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.
Sistem kakovosti zagotovi skladnost eksplozivov s tipom, opisanim v certifikatu o EU-pregledu tipa, in z zahtevami iz te direktive, ki veljajo zanje.
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.
Vsi elementi, zahteve in določbe, ki jih je sprejel proizvajalec, se sistematično in metodično dokumentirajo v obliki pisnih ukrepov, postopkov in navodil.
It shall notify the manufacturer of its decision.
Dokumentacija sistema kakovosti mora omogočati dosledno razlago programov, načrtov, priročnikov in zapiskov.
The notification shall contain the conclusions of the examination and the reasoned assessment decision.
Vsebuje zlasti ustrezen opis:
Surveillance under the responsibility of the notified body
ciljev kakovosti in organizacijske strukture, odgovornosti in pristojnosti vodstva glede kakovosti proizvodov;
The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.
ustreznih tehnik, postopkov in sistematičnih ukrepov za proizvodnjo, nadzor in zagotavljanje kakovosti, ki se bodo uporabljali;
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:
pregledov in preskusov, ki bodo opravljeni pred proizvodnjo, med njo in po njej, ter pogostost njihovega izvajanja;
the quality system documentation;
zapisov kakovosti, kot so poročila o pregledih in podatki o preskusih, podatki o umerjanju opreme, poročila o strokovni usposobljenosti osebja itd.;
the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.
sredstev za spremljanje doseganja zahtevane kakovosti proizvoda in učinkovitega delovanja sistema kakovosti.
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 oceni sistem kakovosti, da ugotovi, ali izpolnjuje zahteve iz točke 3.2.
In addition, the notified body may pay unexpected visits to the manufacturer.
Domneva skladnost s tistimi zahtevami glede elementov sistema kakovosti, ki so skladni z ustreznimi specifikacijami, ki veljajo za ustrezen harmonizirani standard.
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.
Skupina za presojo ima poleg izkušenj pri sistemih vodenja kakovosti vsaj enega člana z izkušnjami vrednotenja na ustreznem zadevnem področju proizvodov in tehnologije proizvoda ter poznavanjem veljavnih zahtev iz te direktive.
The notified body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.
Presoja vključuje ocenjevalni obisk proizvajalčevih prostorov.
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 explosive that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of this Directive.
Skupina za presojo pregleda tehnično dokumentacijo iz podtočke (e) točke 3.1 za preverjanje sposobnosti proizvajalca, s čimer ugotovi ustrezne zahteve iz te direktive in izvede potrebne preglede, da se zagotovi, da eksploziv izpolnjuje te zahteve.
The manufacturer shall, for a period ending 10 years after the explosive has been placed on the market, keep at the disposal of the national authorities:
Proizvajalca se obvesti o odločitvi.
the documentation referred to in point 3.1;
Obvestilo vsebuje ugotovitve presoje in utemeljeno odločitev o oceni.
the information relating to the change referred to in point 3.5, as approved;
Proizvajalec se zaveže, da bo izpolnjeval obveznosti, ki izhajajo iz sistema kakovosti, kot je bil odobren, in ga ohranjal, da ostane ustrezen in učinkovit.
the decisions and reports of the notified body referred to in points 3.5, 4.3 and 4.4.
Proizvajalec obvešča priglašeni organ, ki je odobril sistem kakovosti, o vseh nameravanih spremembah sistema kakovosti.
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.
Priglašeni organ vse predlagane spremembe ovrednoti in odloči, ali bo spremenjeni sistem kakovosti še vedno izpolnjeval zahteve iz točke 3.2 in ali je potrebna ponovna ocena.
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.
O svoji odločitvi obvesti proizvajalca.
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.
Obvestilo vsebuje ugotovitve pregleda in utemeljeno odločitev o oceni.
MODULE E
Nadzor, za katerega je odgovoren priglašeni organ
Conformity to type based on product quality assurance
Namen nadzora je zagotoviti, da proizvajalec ustrezno izpolnjuje zahteve iz odobrenega sistema kakovosti.
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 explosives concerned are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Directive that apply to them.
Proizvajalec priglašenemu organu za namene ocenjevanja omogoči dostop do prostorov za proizvodnjo, pregledovanje, preskušanje in skladiščenje ter mu zagotovi vse potrebne informacije, še zlasti:
The manufacturer shall operate an approved quality system for final product inspection and testing of the explosives concerned as specified in point 3 and shall be subject to surveillance as specified in point 4.
dokumentacijo o sistemu kakovosti;
The quality system shall ensure compliance of the explosives with the type described in the EU-type examination certificate and with the applicable requirements of this Directive.
zapise kakovosti, kot so poročila o pregledih in podatki o preskusih, podatki o umerjanju opreme, poročila o strokovni usposobljenosti osebja itd.
This quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.
Priglašeni organ opravlja redne presoje, da ugotovi, ali proizvajalec vzdržuje in uporablja sistem kakovosti, ter proizvajalcu posreduje poročilo o presoji.