natgillin/translations-raw huggingface dataset:
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 Directive, and shall determine whether such changes require further investigation.
Priglašeni organ določi število primerkov opreme za vzorec in odloči o potrebi, da organ sam opravi ali da opraviti končno presojo vzorcev tlačne opreme v celoti ali delno.
The manufacturer shall inform the notified body that holds the technical documentation relating to the EU-type examination certificate — design type of all modifications to the approved design that may affect the conformity of the pressure equipment with the essential safety requirements of this Directive or the conditions for validity of the certificate.
Kadar vzorec ne dosega sprejemljive ravni kakovosti, organ sprejme ustrezne ukrepe.
Such modifications shall require additional approval in the form of an addition to the original EU-type examination certificate — design type.
Kadar preskuse izvaja priglašeni organ, proizvajalec med proizvodnim procesom na odgovornost priglašenega organa namesti identifikacijsko številko priglašenega organa.
Each notified body shall inform its notifying authorities concerning the EU-type examination certificates — design type and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of certificates and/or any additions thereto refused, suspended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.
Proizvajalec oznako CE namesti na vsako posamezno tlačno opremo ali sklop, ki je v skladu s tipom, opisanim v certifikatu o EU-pregledu tipa, in izpolnjuje veljavne zahteve iz te direktive.
Each notified body shall inform the other notified bodies concerning the EU-type examination certificates — design type and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning the certificates and/or additions thereto which it has issued.
Proizvajalec za vzorčno tlačno opremo pripravi pisno izjavo EU o skladnosti in jo hrani skupaj s tehnično dokumentacijo, ki je nacionalnim organom na voljo še 10 let po tem, ko je bila tlačna oprema dana na trg.
The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU-type examination certificates — design type and/or additions thereto.
Izjava EU o skladnosti opredeljuje vzorec tlačne opreme, za katerega je bila sestavljena.
The notified body shall keep a copy of the EU-type examination certificate — design type, 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.
MODUL D:
The manufacturer shall keep a copy of the EU-type examination certificate — design type, its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the pressure equipment has been placed on the market.
SKLADNOST S TIPOM NA PODLAGI ZAGOTAVLJANJA KAKOVOSTI PROIZVODNEGA PROCESA
MODULE C2:
Skladnost s tipom na podlagi zagotavljanja kakovosti proizvodnega procesa je del postopka ugotavljanja skladnosti, s katerim proizvajalec izpolni obveznosti iz točk 2 in 5 ter zagotovi in na lastno odgovornost izjavi, da so zadevna tlačna oprema ali sklopi v skladu s tipom, opisanim v certifikatu o EU-pregledu tipa, in da izpolnjujejo zahteve iz te direktive, ki veljajo zanje.
CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRESSURE EQUIPMENT CHECKS AT RANDOM INTERVALS
Proizvajalec upravlja odobren sistem zagotavljanja kakovosti za proizvodnjo, končni pregled proizvoda in preskušanje zadevne tlačne opreme, kakor je določeno v točki 3, in zanj velja nadzor, kakor je določeno v točki 4.
Conformity to type based on internal production control plus supervised pressure equipment 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 pressure equipment concerned is in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Directive that apply to it.
Sistem kakovosti
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured pressure equipment with the type described in the EU-type examination certificate and with the requirements of this Directive that apply to them.
Proizvajalec za zadevno tlačno opremo vloži zahtevek za presojo svojega sistema kakovosti priglašenemu organu, ki ga izbere sam.
A notified body, chosen by the manufacturer, shall carry out checks or have them carried out at random intervals determined by the body, in order to verify the quality of the final assessment and of the internal checks on the pressure equipment, taking into account, inter alia, the technological complexity of the pressure equipment and the quantity of production.
vse informacije o načrtovanem tipu tlačne opreme,
The notified body shall establish that the manufacturer actually performs final assessment in accordance with point 3.2 of Annex I.
dokumentacijo o sistemu kakovosti,
An adequate sample of the final pressure equipment, 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 applying other technical specifications, shall be carried out to check the conformity of the pressure equipment with the relevant requirements of this Directive.
tehnično dokumentacijo o odobrenem tipu in izvod certifikata o EU-pregledu tipa.
The notified body shall assess the number of items of equipment to sample and whether it is necessary to perform, or have performed, all or part of final assessment on the pressure equipment samples.
Sistem kakovosti zagotavlja, da je tlačna oprema v skladu s tipom, opisanim v certifikatu o EU-pregledu tipa in z zahtevami iz te direktive, ki veljajo zanjo.
Where a sample does not conform to the acceptable quality level, the body shall take appropriate measures.
Vsi temelji, zahteve in predpisi, ki jih je prevzel proizvajalec, so sistematično in urejeno dokumentirani kot pisno dokumentirane politike, postopki in navodila.
Where the tests are carried out by a notified body, the manufacturer shall, under the responsibility of the notified body, affix the notified body’s identification number during the manufacturing process.
Dokumentacija sistema kakovosti omogoča dosledno razlago programov kakovosti, načrtov, priročnikov in evidenc.
The manufacturer shall affix the CE marking to each individual pressure equipment or assembly that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of this Directive.
Zlasti vsebuje ustrezne opise:
The manufacturer shall draw up a written EU declaration of conformity for a pressure equipment model and keep it at the disposal of the national authorities for 10 years after the pressure equipment has been placed on the market.
ciljev kakovosti in organizacijske strukture, odgovornosti in pooblastil uprave glede kakovosti tlačne opreme,
The EU declaration of conformity shall identify the pressure equipment model for which it has been drawn up.
ustreznih tehnik, procesov in sistemskih dejavnosti v proizvodnji, obvladovanju in zagotavljanju kakovosti, ki bodo uporabljani, predvsem postopkov v zvezi z stalnim spajanjem delov, odobrenih v skladu s Prilogo I, točka 3.1.2,
MODULE D:
pregledov in preskusov, ki bodo opravljeni pred proizvodnjo, med njo in po njej, ter pogostost njihovega izvajanja,
CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS
evidenc kakovosti, na primer poročil o pregledih, podatkov preskušanja, podatkov umerjanja, poročil glede kvalifikacij ali potrditev zadevnega osebja, posebej za osebje, ki izvaja stalno spajanje delov in neporušitvene preskuse v skladu s Prilogo I, točki 3.1.2 in 3.1.3, itd. ter
Conformity to type based on quality assurance of the production process 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 pressure equipment or assembly concerned is in conformity with the type described in the EU-type examination certificate and satisfies the requirements of this Directive that apply to it.
načinov nadzora doseganja zahtevane kakovosti in učinkovitosti delovanja sistema kakovosti.
The manufacturer shall operate an approved quality system for production, final product inspection and testing of the pressure equipment concerned as specified in point 3 and shall be subject to surveillance as specified in point 4.
Priglašeni organ presodi sistem kakovosti, s čimer ugotovi, ali sistem izpolnjuje zahteve, navedene v točki 3.2.
Quality system
Priglašeni organ domneva skladnost z zahtevami glede elementov sistema kakovosti, ki so skladne z ustreznimi specifikacijami ustreznega harmoniziranega standarda.
The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice for the pressure equipment concerned.
Poleg izkušenj s sistemi za upravljanje kakovosti ima skupina za presojo vsaj enega člana z izkušnjami pri ocenjevanju na ustreznem področju zadevne tlačne opreme in tehnologije ter znanjem o veljavnih zahtevah iz te direktive.
all relevant information on the pressure equipment type envisaged,
Presoja vključuje inšpekcijski obisk v obratih proizvajalca.
the documentation concerning the quality system,
Skupina za presojo pregleda tehnično dokumentacijo iz pete alinee točke 3.1, da ugotovi, ali je proizvajalec zmožen identificirati ustrezne zahteve iz te direktive, in izvede potrebne preglede za zagotovitev skladnosti proizvoda s temi zahtevami.
the technical documentation of the approved type and a copy of the EU-type examination certificate.
Proizvajalec je obveščen o odločitvi.
The quality system shall ensure that the pressure equipment is in conformity with the type described in the EU-type examination certificate and comply with the requirements of this Directive that apply to it.
Obvestilo vsebuje rezultate presoje in obrazložitev odločitve.
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.
Proizvajalec ukrepa tako, da izpolni obveznosti, ki izhajajo iz odobrenega sistema kakovosti, in da ohrani njegovo primernost in učinkovitost.
This quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.
Proizvajalec priglašeni organ, ki je odobril sistem kakovosti, obvešča o vseh načrtovanih spremembah sistema kakovosti.
It shall, in particular, contain an adequate description of:
Priglašeni organ presodi predlagane spremembe in odloči, ali bo spremenjeni sistem kakovosti še naprej izpolnjeval zahteve, navedene v točki 3.2, ali pa je potrebna vnovična presoja.
the quality objectives and the organisational structure, responsibilities and powers of the management with regard to the quality of the pressure equipment,
Svojo odločitev sporoči proizvajalcu.
the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used, particularly the procedures used for the permanent joining of parts as approved in accordance with point 3.1.2 of Annex I,
Obvestilo vsebuje rezultate preiskave in obrazložitev odločitve.
the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,
Nadzor, za katerega je odgovoren priglašeni organ
the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications or approvals of the personnel concerned, particularly those of the personnel undertaking the permanent joining of parts and the non-destructive tests in accordance with points 3.1.2 and 3.1.3 of Annex I, etc., and
Namen nadzora je zagotoviti, da proizvajalec ustrezno izpolnjuje obveznosti, ki izhajajo iz odobrenega sistema kakovosti.
the means of monitoring the achievement of the required quality and the effective operation of the quality system.
Proizvajalec priglašenemu organu za namene ocene omogoči dostop do krajev proizvodnje, pregledovanja, preskušanja in skladiščenja ter mu zagotovi vse potrebne informacije, zlasti:
The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2.
dokumentacijo o sistemu kakovosti,
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.
evidence kakovosti, na primer poročila o pregledih in podatke preskušanja, podatke umerjanja, kvalifikacijska poročila zadevnega osebja itd.
In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant pressure equipment field and pressure equipment technology concerned, and knowledge of the applicable requirements of this Directive.
Priglašeni organ opravlja redne preglede, s čimer zagotovi, da proizvajalec vzdržuje in izvaja sistem kakovosti, poročila o teh pregledih pa pošilja proizvajalcu.
The audit shall include an inspection visit to the manufacturer’s premises.
Pogostost teh rednih pregledov je tolikšna, da je v treh letih opravljena popolna vnovična presoja.
The auditing team shall review the technical documentation referred to in point 3.1, fifth indent, to verify the manufacturer’s ability to identify the relevant requirements of this Directive and to carry out the necessary examinations with a view to ensuring compliance of the product with those requirements.
Poleg tega lahko priglašeni organ nenapovedano obišče proizvajalca.
The decision shall be notified to the manufacturer.
Potrebnost in pogostost takih dodatnih obiskov sta določeni na podlagi sistema vodenja obiskov, ki ga uporablja priglašeni organ.
The notification shall contain the conclusions of the audit and the reasoned assessment decision.
V tem sistemu se upoštevajo zlasti naslednji dejavniki:
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.
kategorija tlačne opreme,
The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.
rezultati prejšnjih nadzornih obiskov,
The notified body shall evaluate the 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.
potreba po izvajanju korektivnih ukrepov,
It shall notify the manufacturer of its decision.
posebni pogoji, povezani z odobritvijo sistema, kadar je ustrezno,
The notification shall contain the conclusions of the examination and the reasoned assessment decision.
pomembne spremembe v organizaciji, politiki ali tehnikah proizvodnje.
Surveillance under the responsibility of the notified body
Med takimi obiski lahko priglašeni organ po potrebi opravi preskuse proizvodov ali da takšne preskuse opraviti, da ugotovi, ali sistem kakovosti deluje pravilno.
The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.
Priglašeni organ proizvajalcu pošlje poročilo o obisku, če so bili izvedeni preskusi, pa tudi poročilo o njih.
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 namesti oznake CE in na odgovornost priglašenega organa iz točke 3.1 identifikacijsko številko tega organa na vsako posamezno tlačno opremo, ki je v skladu s tipom, opisanim v certifikatu o EU-pregledu tipa, in ki izpolnjuje veljavne zahteve iz te direktive.
the quality system documentation,
Proizvajalec za vzorčno tlačno opremo pripravi pisno izjavo EU o skladnosti in jo hrani skupaj s tehnično dokumentacijo, ki je nacionalnim organom na voljo še 10 let po tem, ko je bila tlačna oprema dana na trg.
the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.
Proizvajalec še 10 let po tem, ko je bila tlačna oprema dana na trg, omogoča državnim organom dostop do:
The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and provide the manufacturer with an audit report.
dokumentacije, navedene v točki 3.1,
The frequency of periodic audits shall be such that a full reassessment is carried out every three years.
odobrenih sprememb iz točke 3.5,
In addition the notified body may pay unexpected visits to the manufacturer.
odločitev in poročil priglašenih organov, navedenih v točkah 3.3, 3.5, 4.3 in 4.4.
The need for such additional visits, and the frequency thereof, will be determined on the basis of a visit control system operated by the notified body.
Vsak priglašeni organ obvesti svoje priglasitvene organe o izdanih ali preklicanih odobritvah sistemov kakovosti in redno ali na zahtevo svojim priglasitvenim organom omogoča dostop do seznama zavrnjenih, začasno preklicanih ali drugače omejenih odobritvah sistemov kakovosti.
In particular, the following factors shall be considered in the visit control system:
Vsak priglašeni organ druge priglašene organe obvesti o odobritvah sistemov kakovosti, ki jih je zavrnil, začasno preklical, preklical ali drugače omejil, in, na zahtevo, o odobritvah sistemov kakovosti, ki jih je izdal.
the category of the pressure equipment,
Obveznosti proizvajalca iz točk 3.1, 3.5, 5 in 6 lahko v njegovem imenu in na njegovo odgovornost izpolni pooblaščeni zastopnik, če so navedene v pooblastilu.
the results of previous surveillance visits,
MODUL D1:
the need to follow up corrective actions,
ZAGOTAVLJANJE KAKOVOSTI PROIZVODNEGA PROCESA
special conditions linked to the approval of the system, where applicable,
Zagotavljanje kakovosti proizvodnega postopka je postopek ugotavljanja skladnosti, s katerim proizvajalec izpolni obveznosti iz točk 2, 4 in 7 ter zagotovi in na lastno odgovornost izjavi, da zadevna tlačna oprema izpolnjuje zahteve iz te direktive, ki veljajo zanjo.
significant changes in manufacturing organisation, policy or techniques.
Dokumentacija omogoča ugotavljanje skladnosti tlačne opreme z ustreznimi zahtevami ter vključuje ustrezno analizo in oceno tveganja.
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.
Tehnična dokumentacija opredeljuje zahteve, ki se uporabljajo, in zajema, če je to pomembno za oceno, načrt, proizvodnjo in delovanje proizvoda.
The notified body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.
Proizvajalec pristojnim nacionalnim organom omogoči dostopnost do tehnične dokumentacije za obdobje 10 let po tem, ko je bila tlačna oprema dana na trg.
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 pressure equipment that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of this Directive.
Proizvajalec upravlja odobren sistem zagotavljanja kakovosti za proizvodnjo, končni pregled proizvoda in preskušanje zadevne tlačne opreme, kakor je določeno v točki 5, in zanj velja nadzor, kakor je določeno v točki 6.
The manufacturer shall draw up a written EU declaration of conformity for each pressure equipment model and keep it at the disposal of the national authorities for 10 years after the pressure equipment has been placed on the market.
tehnično dokumentacijo iz točke 2.
The manufacturer shall, for a period ending 10 years after the pressure equipment has been placed on the market, keep at the disposal of the national authorities:
Sistem kakovosti zagotavlja skladnost tlačne opreme z zahtevami iz te direktive, ki veljajo zanjo.
the documentation referred to point 3.1,
ustreznih tehnik, procesov in sistemskih ukrepov v proizvodnji, vodenju kakovosti in zagotavljanju kakovosti, ki bodo uporabljani, predvsem postopkov, uporabljenih v zvezi s stalnim spajanjem delov, odobrenih v skladu s Prilogo I, točka 3.1.2,
the change referred to in point 3.5, as approved,
evidenc kakovosti, na primer poročil o pregledih, podatkov preskušanja, podatkov umerjanja, poročil o kvalifikacijah ali potrditvi zadevnega osebja, posebej za osebje, ki izvaja stalno spajanje delov in neporušitvene preskuse v skladu s Prilogo I, točka 3.1.2, itd.,
the decisions and reports of the notified body referred to in points 3.3, 3.5, 4.3 and 4.4.
načinov nadzora doseganja zahtevane kakovosti proizvodov in učinkovitosti delovanja sistema kakovosti.
Each notified body shall inform its notifying authorities of the quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or otherwise restricted.
Priglašeni organ presodi sistem kakovosti, s čimer ugotovi, ali sistem izpolnjuje zahteve, navedene v točki 5.2.
Each notified body shall inform the other notified bodies of the quality system approvals which it has refused, suspended, withdrawn or otherwise restricted, and, upon request, of quality system approvals which it has issued.
Elementi sistema kakovosti, ki so skladni z ustreznim harmoniziranim standardom, štejejo za skladne z ustreznimi zahtevami iz točke 5.2.
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.
Poleg izkušenj s sistemi za upravljanje kakovosti ima skupina za presojo vsaj enega člana z izkušnjami pri presojanju zadevne tehnologije tlačne opreme in znanjem o veljavnih zahtevah iz te direktive.
MODULE D1:
Presoja vključuje ocenjevalni obisk v obratih proizvajalca.
QUALITY ASSURANCE OF THE PRODUCTION PROCESS
Skupina za presojo pregleda tehnično dokumentacijo iz točke 2, da ugotovi, ali je proizvajalec zmožen identificirati ustrezne zahteve iz te direktive, in izvede potrebne preglede za zagotovitev skladnosti tlačne opreme s temi zahtevami.
Quality assurance of the production process is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 4 and 7, and ensures and declares on his sole responsibility that the pressure equipment concerned satisfy the requirements of this Directive that apply to it.
Priglašeni organ presodi vse predlagane spremembe in odloči, ali bo spremenjeni sistem kakovosti še naprej izpolnjeval zahteve, navedene v točki 5.2, ali pa je potrebna vnovična presoja.
The documentation shall make it possible to assess the conformity of the pressure equipment with the relevant requirements and shall include an adequate analysis and assessment of the risk(s).
tehnično dokumentacijo iz točke 2,
The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the product.
potreba po izvajanju korektivnih ukrepov,
The manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for 10 years after the pressure equipment has been placed on the market.
Med takimi obiski lahko priglašeni organ po potrebi opravi preskuse proizvodov, ali da takšne preskuse opraviti, da ugotovi, ali sistem kakovosti deluje pravilno.