natgillin/translations-raw huggingface dataset:
MODULE D: CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS
Sistem kakovosti zagotovi, da so naprave ali oprema skladne s tipom, ki je opisan v certifikatu o EU-pregledu tipa, in da izpolnjujejo zahteve iz te uredbe, ki se uporabljajo 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 3.2 and 3.5, and ensures and declares on his sole responsibility that the appliances or fittings 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.
Vsi elementi, zahteve in določbe, ki jih je sprejel proizvajalec, so sistematično in urejeno dokumentirani kot pisno dokumentirane politike, postopki in navodila.
The manufacturer shall operate an approved quality system for production, final product inspection and testing of the appliances or fittings concerned as specified in point 3.3, and shall be subject to surveillance as specified in point 3.4.
Dokumentacija sistema kakovosti omogoča dosledno razlago programov kakovosti, načrtov, priročnikov in zapisov.
Quality system
Vsebuje zlasti ustrezen opis:
The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the appliances or fittings concerned.
ciljev kakovosti in organizacijske strukture, odgovornosti in pooblastil uprave glede kakovosti proizvodov;
The application shall include:
ustreznih tehnik proizvodnje, nadzora kakovosti in zagotavljanja kakovosti, postopkov in sistematičnih ukrepov, ki se bodo uporabljali;
all relevant information for the appliance or the fitting approved under module B;
pregledov in preskusov, ki bodo opravljeni pred proizvodnjo, med njo in po njej, ter pogostost njihovega izvajanja,
the documentation concerning the quality system;
zapisov o kakovosti, kot so poročila o pregledu in podatki o preskusih, podatki o kalibraciji, poročila o strokovni usposobljenosti osebja itd.;
the technical documentation of the approved type and a copy of the EU type-examination certificate.
sredstev za spremljanje doseganja zahtevane kakovosti proizvoda in učinkovitega delovanja sistema kakovosti.
The quality system shall ensure that the appliances or fittings are in conformity with the type described in the EU type-examination certificate and comply with the requirements of this Regulation that apply to them.
Priglašeni organ oceni sistem kakovosti, da ugotovi, ali sistem izpolnjuje zahteve, navedene v točki 3.3.2.
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.
Priglašeni organ domneva skladnost z zahtevami glede elementov sistema kakovosti, ki so skladne z ustreznimi specifikacijami ustreznega harmoniziranega standarda.
The quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.
Poleg izkušenj s sistemi za upravljanje kakovosti ima skupina za presojo vsaj enega člana z izkušnjami pri presojanju na ustreznem področju proizvodov in njihove tehnologije ter znanjem o veljavnih zahtevah iz te uredbe.
It shall, in particular, contain an adequate description of:
Presoja vključuje ocenjevalni obisk v obratih proizvajalca.
the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality;
Skupina za presojo pregleda tehnično dokumentacijo iz točke 3.3.1(e), da ugotovi, ali je proizvajalec zmožen identificirati ustrezne zahteve iz te uredbe, in da izvede potrebne preglede za zagotovitev skladnosti naprav ali opreme z navedenimi zahtevami.
the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used;
Proizvajalec je obveščen o odločitvi.
the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out;
Obvestilo vsebuje ugotovitve presoje in utemeljeno odločitev o oceni.
the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.;
Proizvajalec ukrepa tako, da izpolni obveznosti, ki izhajajo iz odobrenega sistema kakovosti, in da ohrani njegovo primernost in učinkovitost.
the means of monitoring the achievement of the required product quality and the effective operation of the quality system.
Proizvajalec priglašeni organ, ki je odobril sistem kakovosti, obvešča o vseh načrtovanih spremembah sistema kakovosti.
The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.3.2.
Priglašeni organ oceni predlagane spremembe in ugotovi, ali bo spremenjeni sistem kakovosti še naprej izpolnjeval zahteve iz točke 3.3.2 ali pa je potrebna ponovna ocena.
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.
O svoji odločitvi obvesti proizvajalca.
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 the product technology concerned, and knowledge of the applicable requirements of this Regulation.
Obvestilo vsebuje rezultate pregleda in obrazložitev odločitve.
The audit shall include an assessment visit to the manufacturer's premises.
Nadzor, za katerega je odgovoren priglašeni organ
The auditing team shall review the technical documentation referred to in point 3.3.1(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 appliance or the fitting with those requirements.
Namen nadzora je zagotoviti, da proizvajalec ustrezno izpolnjuje obveznosti, ki izhajajo iz odobrenega sistema kakovosti.
The decision shall be notified to the manufacturer.
Proizvajalec priglašenemu organu za namene ocenjevanja omogoči dostop do prostorov za proizvodnjo, kontrole, preskušanje in skladiščenje ter mu zagotovi vse potrebne informacije, še zlasti:
The notification shall contain the conclusions of the audit and the reasoned assessment decision.
dokumentacijo o sistemu 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.
zapise o kakovosti, kot so poročila o pregledih in podatki o preskusih, podatki o kalibraciji, poročila o strokovni usposobljenosti osebja itd.
The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.
Priglašeni organ opravlja redne presoje vsaj enkrat na dve leti, s čimer zagotovi, da proizvajalec vzdržuje in izvaja sistem kakovosti, poročila o teh presojah pa pošilja proizvajalcu.
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 3.3.2 or whether a reassessment is necessary.
Poleg tega lahko priglašeni organ nenapovedano obišče proizvajalca.
It shall notify the manufacturer of its decision.
Med takšnimi obiski sme priglašeni organ, če je potrebno, opraviti ali naročiti preskuse proizvodov, da preveri pravilno delovanje sistema kakovosti.
The notification shall contain the conclusions of the examination and the reasoned assessment decision.
Priglašeni organ proizvajalcu pošlje poročilo o obisku, če so bili izvedeni preskusi, pa tudi poročilo o njih.
Surveillance under the responsibility of the notified body
Proizvajalec na vsako posamezno napravo ali opremo, ki je v skladu s tipom, opisanim v certifikatu o EU-pregledu tipa, in ki izpolnjuje ustrezne zahteve iz te uredbe, namesti oznako CE ter, v okviru odgovornosti priglašenega organa iz točke 3.3.1, identifikacijsko številko tega organa.
The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.
Proizvajalec za vsak model naprave ali opreme sestavi pisno izjavo EU o skladnosti in za obdobje 10 let po tem, ko je bila naprava ali oprema dana na trg, nacionalnim organom omogoča dostop do nje.
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 za nacionalni organ še vsaj deset let po tem, ko je bila naprava ali oprema dana na trg, hrani:
the quality system documentation;
dokumentacijo iz točke 3.3.1;
the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.
informacije v zvezi s spremembo iz točke 3.3.5, kot je bila odobrena;
The notified body shall carry out periodic audits 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.
odločitve in poročila priglašenega organa iz točk 3.3.5, 3.4.3 in 3.4.4.
In addition, the notified body may pay unexpected visits to the manufacturer.
Vsak priglašeni organ obvesti svoj priglasitveni organ o izdanih ali preklicanih odobritvah sistemov kakovosti in mu redno ali na zahtevo zagotovi seznam zavrnjenih, začasno preklicanih ali drugače omejenih odobritev sistemov kakovosti.
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.
Vsak priglašeni organ druge priglašene organe obvesti o odobritvah sistemov kakovosti, ki jih je zavrnil, začasno preklical, preklical ali kako drugače omejil, in, na zahtevo, o odobritvah sistemov kakovosti, ki jih je izdal.
The notified body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.
Obveznosti proizvajalca iz točk 3.3.1, 3.3.5, 3.5 in 3.6 lahko v njegovem imenu in na njegovo odgovornost izpolni pooblaščeni zastopnik, če so navedene v pooblastilu.
The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 3.3.1, the latter's identification number to each individual appliance or fitting that is in conformity with the type described in the EU type-examination certificate and satisfies the applicable requirements of this Regulation.
MODUL E: SKLADNOST S TIPOM NA PODLAGI ZAGOTAVLJANJA KAKOVOSTI PROIZVODA
The manufacturer shall draw up a written EU declaration of conformity for each appliance or fitting model and keep it at the disposal of the national authorities for 10 years after the appliance or the fitting has been placed on the market.
Skladnost s tipom na podlagi zagotavljanja kakovosti proizvoda je del postopka ugotavljanja skladnosti, pri katerem proizvajalec izpolni obveznosti iz točke 4.2 in 4.5 ter zagotovi in na lastno odgovornost izjavi, da so zadevne naprave ali oprema v skladu s tipom, opisanim v certifikatu o EU-pregledu tipa, in da izpolnjujejo zahteve iz te uredbe.
The manufacturer shall, for a period ending at least 10 years after the appliance or the fitting has been placed on the market, keep at the disposal of the national authorities:
Proizvajalec upravlja odobren sistem kakovosti za pregled končnega proizvoda in preskušanje zadevnih naprav ali opreme iz točke 4.3 ter je pod nadzorom v skladu s točko 4.4.
the documentation referred to in point 3.3.1;
vse ustrezne informacije za predvideno kategorijo proizvoda;
the information relating to the change referred to in point 3.3.5, as approved;
dokumentacijo o sistemu kakovosti ter
the decisions and reports of the notified body referred to in points 3.3.5, 3.4.3 and 3.4.4.
Sistem kakovosti zagotovi skladnost naprav ali opreme s tipom, opisanim v certifikatu o EU-pregledu tipa, in veljavnimi zahtevami iz te uredbe.
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 systems approvals refused, suspended or otherwise restricted.
pregledov in preskusov, ki bodo opravljeni po koncu proizvodnje;
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.
načinov nadzora učinkovitosti delovanja sistema kakovosti.
The manufacturer's obligations set out in points 3.3.1, 3.3.5, 3.5 and 3.6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
Priglašeni organ oceni sistem kakovosti, da ugotovi, ali izpolnjuje zahteve iz točke 4.3.2.
MODULE E: CONFORMITY TO TYPE BASED ON PRODUCT QUALITY ASSURANCE
Poleg izkušenj s sistemi za upravljanje kakovosti ima skupina za presojo vsaj enega člana z izkušnjami pri presojanju na ustreznem področju proizvodov in njihove tehnologije ter znanjem o veljavnih zahtevah iz te uredbe.
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 4.2 and 4.5, and ensures and declares on his sole responsibility that the appliances or fittings 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.
Skupina za presojo pregleda tehnično dokumentacijo iz točke 4.3.1(e), da ugotovi, ali je proizvajalec zmožen identificirati ustrezne zahteve iz te uredbe, in da izvede potrebne preglede za zagotovitev skladnosti naprav ali opreme z navedenimi zahtevami.
The manufacturer shall operate an approved quality system for final product inspection and testing of the appliances or fittings concerned as specified in point 4.3 and shall be subject to surveillance as specified in point 4.4.
Priglašeni organ oceni predlagane spremembe in ugotovi, ali bo spremenjeni sistem kakovosti še naprej izpolnjeval zahteve iz točke 4.3.2 ali pa je potrebna ponovna ocena.
all relevant information for the product category envisaged;
Proizvajalec na vsako posamezno napravo ali opremo, ki je v skladu s tipom, opisanim v certifikatu o EU-pregledu tipa, in ki izpolnjuje ustrezne zahteve iz te uredbe, namesti oznako CE ter, v okviru odgovornosti priglašenega organa iz točke 4.3.1, identifikacijsko številko tega organa.
the documentation concerning the quality system; and
dokumentacijo iz točke 4.3.1;
The quality system shall ensure compliance of the appliances or the fittings with the type described in the EU type-examination certificate and with the applicable requirements of this Regulation.
informacije v zvezi s spremembo iz točke 4.3.5, kot je bila odobrena;
the examinations and tests that will be carried out after manufacture;
odločitve in poročila priglašenega organa iz točk 4.3.5, 4.4.3 in 4.4.4.
the means of monitoring the effective operation of the quality system.
Vsak priglašeni organ obvesti svoj priglasitveni organ o izdanih ali umaknjenih odobritvah sistemov kakovosti in mu redno ali na zahtevo zagotovi seznam zavrnjenih, začasno preklicanih ali drugače omejenih odobritev sistemov kakovosti.
The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 4.3.2.
Obveznosti proizvajalca iz točk 4.3.1, 4.3.5, 4.5 in 4.6 lahko v njegovem imenu in na njegovo odgovornost izpolni pooblaščeni zastopnik, če so navedene v pooblastilu.
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 Regulation.
MODUL F: SKLADNOST S TIPOM NA PODLAGI PREVERJANJA PROIZVODOV
The auditing team shall review the technical documentation referred to in point 4.3.1(e), in order 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 appliance or the fitting with those requirements.
Skladnost s tipom na podlagi preverjanja proizvodov je del postopka ugotavljanja skladnosti, pri katerem proizvajalec izpolni obveznosti iz točk 5.2, 5.5.1 in 5.6 ter zagotovi in na lastno odgovornost izjavi, da so zadevne naprave ali oprema, ki so predmet točke 5.3, v skladu s tipom, opisanim v certifikatu o EU-pregledu tipa, in da izpolnjujejo zahteve iz te uredbe, 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 4.3.2 or whether a reassessment is necessary.
Proizvajalec sprejme vse potrebne ukrepe, da proizvodni proces in njegovo spremljanje zagotovita skladnost izdelanih naprav ali opreme z odobrenim tipom, ki je opisan v certifikatu o EU-pregledu tipa, in z zahtevami iz te uredbe, ki veljajo zanje.
The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 4.3.1, the latter's identification number to each individual appliance or fitting that is in conformity with the type described in the EU type-examination certificate and satisfies the applicable requirements of this Regulation.
Preverjanje
the documentation referred to in point 4.3.1;
Priglašeni organ, ki ga izbere proizvajalec, izvede ali naroči ustrezne preglede in preskuse, da preveri skladnost naprav ali opreme z odobrenim tipom, ki je opisan v certifikatu o EU-pregledu tipa, in z ustreznimi zahtevami iz te uredbe.
the information relating to the change referred to in point 4.3.5, as approved;
Pregledi in preskusi za preverjanje skladnosti naprav ali opreme z ustreznimi zahtevami se po izbiri proizvajalca izvedejo bodisi s pregledom in preskusom vsake naprave ali opreme v skladu s točko 5.4 ali s pregledom in preskusom naprav ali opreme na statistični podlagi v skladu s točko 5.5.
the decisions and reports of the notified body referred to in points 4.3.5, 4.4.3 and 4.4.4.
Preverjanje skladnosti s pregledom in preskusom vsake naprave ali opreme.
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.
Vse naprave ali oprema 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.
The manufacturer's obligations set out in points 4.3.1, 4.3.5, 4.5 and 4.6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
Kadar harmoniziran standard ni na voljo, se zadevni priglašeni organ odloči glede izvedbe ustreznih preskusov.
MODULE F: CONFORMITY TO TYPE BASED ON PRODUCT VERIFICATION
Priglašeni organ izda certifikat o skladnosti v zvezi z izvedenimi pregledi in preskusi ter namesti ali da v okviru svoje odgovornosti namestiti svojo identifikacijsko številko na vsako odobreno napravo ali opremo.
Conformity to type based on product verification is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 5.2, 5.5.1 and 5.6, and ensures and declares on his sole responsibility that the appliances or fittings concerned, which have been subject to point 5.3, are in conformity with the type described in the EU type-examination certificate and satisfy the requirements of this Regulation that apply to them.
Proizvajalec nacionalnim organom omogoči pregled certifikatov o skladnosti za obdobje 10 let po tem, ko je bila naprava ali oprema dana na trg.
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured appliances or fittings with the approved type described in the EU type-examination certificate and with the requirements of this Regulation that apply to them.
Statistično preverjanje skladnosti
Verification
Proizvajalec sprejme vse potrebne ukrepe, da proizvodni proces in njegovo spremljanje zagotovita homogenost vsake proizvedene serije, ter predloži svoje naprave ali opremo za preverjanje v obliki homogenih serij.
A notified body chosen by the manufacturer shall carry out appropriate examinations and tests, or have them carried out, in order to check the conformity of the appliances or fittings with the approved type described in the EU type-examination certificate and with the appropriate requirements of this Regulation.
Naključno izbrani vzorec se odvzame iz vsake partije v skladu z zahtevami iz točke 5.5.3.
The examinations and tests to check the conformity of the appliances or fittings with the appropriate requirements shall be carried out, at the choice of the manufacturer, either by examination and testing of every appliance or fitting as specified in point 5.4 or by examination and testing of the appliances or fittings on a statistical basis as specified in point 5.5.
Vse naprave ali oprema 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 veljavnimi zahtevami te uredbe in določi, ali se serija sprejme ali zavrne.
Verification of conformity by examination and testing of every appliance or fitting
Priglašeni organ uporabi sistem vzorčenja, ki ima naslednje značilnosti:
All appliances or fittings 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.
raven kakovosti, ki ustreza 95-odstotni verjetnosti sprejemljivosti, pri čemer je delež neskladnosti med 0,5 % in 1,5 %,
In the absence of such a harmonised standard, the notified body concerned shall decide on the appropriate tests to be carried out.
mejna kakovost, ki ustreza 5-odstotni verjetnosti sprejemljivosti, pri čemer je delež neskladnosti med 5 % in 10 %.
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 appliance or fitting, or have it affixed under its responsibility.
Če je serija sprejeta, se šteje, da so odobrene vse naprave ali oprema iz serije, razen tistih naprav ali opreme iz vzorca, za katere je ugotovljeno, da imajo nezadovoljive rezultate preskusa.
The manufacturer shall keep the certificates of conformity available for inspection by the national authorities for 10 years after the appliance or the fitting has been placed on the market.
Priglašeni organ izda certifikat o skladnosti v zvezi z izvedenimi pregledi in preskusi ter namesti ali da v okviru svoje odgovornosti namestiti svojo identifikacijsko številko na vsako odobreno napravo ali opremo.
Statistical verification of conformity
Proizvajalec nacionalnim organom omogoči dostop do certifikatov o skladnosti za obdobje 10 let po tem, ko so bile naprave ali oprema dani na trg.