natgillin/translations-raw huggingface dataset:
the examinations and tests that will be carried out before, during, and after manufacture, and the frequency with which they will be carried out;
sredstev za spremljanje doseganja zahtevane kakovosti proizvoda in učinkovitega delovanja sistema kakovosti.
the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned;
Priglašeni organ oceni sistem kakovosti, da določi, ali izpolnjuje zahteve iz točke 3.2.
the means of monitoring the achievement of the required product quality and the effective operation of the quality system.
Priglašeni organ domneva skladnost s tistimi zahtevami glede elementov sistema kakovosti, ki so skladni z ustreznimi specifikacijami, ki veljajo za ustrezen harmoniziran standard.
The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2.
Skupina za presojo ima poleg izkušenj s sistemi vodenja kakovosti vsaj enega člana z izkušnjami ocenjevalca na ustreznem zadevnem področju instrumenta in tehnologije instrumenta ter poznavanjem veljavnih zahtev iz te direktive.
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.
Presoja vključuje ocenjevalni obisk proizvajalčevih prostorov.
In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant instrument field and instrument technology concerned, and knowledge of the applicable requirements of this Directive.
Skupina za presojo pregleda tehnično dokumentacijo iz točke (e) točke 3.1, da preveri sposobnost proizvajalca, s čimer ugotovi ustrezne zahteve iz te direktive in izvede potrebne preglede, da se zagotovi, da instrument izpolnjuje te zahteve.
The audit shall include an assessment visit to the manufacturer’s premises.
Proizvajalca se obvesti o odločitvi.
The auditing team shall review the technical documentation referred to in point (e) of point 3.1, 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 instrument with those requirements.
Obvestilo vsebuje ugotovitve presoje in utemeljeno odločitev o oceni.
The decision shall be notified to the manufacturer.
Proizvajalec se zaveže, da bo izpolnjeval obveznosti, ki izhajajo iz sistema kakovosti, kot je bil odobren, ter ga vzdrževal, da ostane ustrezen in učinkovit.
The notification shall contain the conclusions of the audit and the reasoned assessment decision.
Proizvajalec obvešča priglašeni organ, ki je odobril sistem kakovosti, o kakršni koli nameravani spremembi sistema 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.
Priglašeni organ ovrednoti kakršno koli predlagano spremembo in odloči, ali spremenjen sistem kakovosti še vedno izpolnjuje zahteve iz točke 3.2 in ali je potrebna ponovna ocena.
The manufacturer shall keep the notified body that has approved the quality system informed of any intended change of the quality system.
Proizvajalca se obvesti o odločitvi.
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 re-assessment is necessary.
Obvestilo vsebuje ugotovitve pregleda in utemeljeno odločitev o oceni.
It shall notify the manufacturer of its decision.
Nadzor, za katerega je odgovoren priglašeni organ
The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.
dokumentacijo o sistemu kakovosti;
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:
zapise kakovosti, kot so poročila o kontrolah in podatki o preskusih, podatki o umerjanjih, poročila o strokovni usposobljenosti osebja.
the quality system documentation;
Priglašeni organ opravlja redne presoje, da ugotovi, če proizvajalec vzdržuje in uporablja sistem kakovosti, ter zagotovi poročilo o presoji proizvajalcu.
the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned.
Poleg tega lahko priglašeni organ nepričakovano obišče proizvajalca.
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.
Proizvajalec namesti oznako CE in dodatno meroslovno oznako iz te direktive ter na odgovornost priglašenega organa iz točke 3.1. svojo identifikacijsko številko na vsak posamezen merilni instrument, ki je skladen s tipom iz certifikata o EU-pregledu tipa in izpolnjuje veljavne zahteve iz te direktive.
In addition, the notified body may pay unexpected visits to the manufacturer.
Proizvajalec za nacionalni organ 10 let po tem, ko je bil instrument dan na trg, hrani:
During such visits the notified body may, if necessary, carry out instrument tests, or have them carried out, in order to verify that the quality system is functioning correctly.
dokumentacije iz točke 3.1,
The notified body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.
podatke v zvezi s spremembo iz točke 3.5, kakor je bila odobrena;
The manufacturer shall affix the CE marking and the supplementary metrology marking set out in this Directive, and, under the responsibility of the notified body referred to in point 3.1, the latter’s identification number to each individual measuring instrument that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of this Directive.
odločitve in poročila priglašenega organa iz točk 3.5, 4.3 in 4.4.
The manufacturer shall, for a period ending 10 years after the instrument has been placed on the market, keep at the disposal of the national authorities:
Vsak priglašeni organ obvesti svoj priglasitveni organ o izdanih ali umaknjenih odobritvah sistema kakovosti in redno ali na zahtevo zagotovi svojemu priglasitvenemu organu seznam zavrnjenih, začasno preklicanih ali drugače omejenih odobritev sistema kakovosti.
the documentation referred to in point 3.1,
Pooblaščeni zastopnik proizvajalca lahko v njegovem imenu in na njegovo odgovornost izpolni obveznosti iz točk 3.1, 3.5, 5 in 6, če so navedene v pooblastilu.
the information relating to the change referred to in point 3.5, as approved;
MODUL D1: ZAGOTAVLJANJE KAKOVOSTI PROIZVODNEGA POSTOPKA
the decisions and reports from the notified body referred to in points 3.5, 4.3 and 4.4.
Zagotavljanje kakovosti proizvodnega postopka je postopek ugotavljanja skladnosti, s katerim proizvajalec izpolni svoje obveznosti iz točk 2, 4 in 7 ter na lastno odgovornost zagotovi in izjavi, da zadevni merilni instrumenti izpolnjujejo zahteve te direktive, ki veljajo zanje.
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.
Proizvajalec nacionalnim organom omogoči dostop do tehnične dokumentacije še 10 let po tem, ko je bil instrument dan na trg.
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.
Proizvajalec upravlja odobren sistem zagotavljanja kakovosti za proizvodnjo, končno kontrolo proizvoda in preskušanje zadevnega merilnega instrumenta, kakor je določeno v točki 5, in zanj velja nadzor iz točke 6.
MODULE D1: QUALITY ASSURANCE OF THE PRODUCTION PROCESS
tehnično dokumentacijo iz točke 2.
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 measuring instruments concerned satisfy the requirements of this Directive that apply to them.
Sistem kakovosti zagotovi skladnost merilnih instrumentov z zahtevami iz te direktive, ki se nanašajo nanje.
The manufacturer shall keep the technical documentation at the disposal of the national authorities for 10 years after the instrument has been placed on the market.
Priglašeni organ oceni sistem kakovosti, da določi, ali izpolnjuje zahteve iz točke 5.2.
The manufacturer shall operate an approved quality system for production, final product inspection and testing of the measuring instruments concerned as specified in point 5 and shall be subject to surveillance as specified in point 6.
Skupina za presojo pregleda tehnično dokumentacijo iz točke 2 za preverjanje sposobnosti proizvajalca, s čimer ugotovi ustrezne zahteve iz te direktive in izvede potrebne preglede, da se zagotovi, da instrument izpolnjuje te zahteve.
the technical documentation referred to in point 2.
Priglašeni organ ovrednoti kakršno koli predlagano spremembo in odloči, ali spremenjen sistem kakovosti še vedno izpolnjuje zahteve iz točke 5.2 in ali je potrebna ponovna ocena.
The quality system shall ensure compliance of the measuring instruments with the requirements of this Directive that apply to them.
tehnično dokumentacijo iz točke 2;
The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 5.2.
Proizvajalec namesti oznako CE in dodatno meroslovno oznako iz te direktive in na odgovornost priglašenega organa iz točke 5.1 identifikacijsko številko tega organa na vsak posamezen merilni instrument, ki izpolnjuje veljavne zahteve iz te direktive.
The auditing team shall review the technical documentation referred to in point 2 in order 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 instrument with those requirements.
dokumentacijo iz točke 5.1;
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 5.2 or whether a re-assessment is necessary.
podatke v zvezi s spremembo iz točke 5.5, kakor je bila odobrena;
the technical documentation referred to in point 2;
odločitve in poročila priglašenega organa iz točk 5.5, 6.3 in 6.4.
The manufacturer shall affix the CE marking, the supplementary metrology marking set out in this Directive, and, under the responsibility of the notified body referred to in point 5.1, the latter’s identification number to each individual measuring instrument that satisfies the applicable requirements of this Directive.
Pooblaščeni zastopnik proizvajalca lahko v njegovem imenu in na njegovo odgovornost izpolni obveznosti iz točk 3, 5.1, 5.5, 7 in 8, če so navedene v pooblastilu.
the documentation referred to in point 5.1;
MODUL E: SKLADNOST S TIPOM NA PODLAGI ZAGOTAVLJANJA KAKOVOSTI INSTRUMENTA
the information relating to the change referred to in point 5.5, as approved;
Skladnost s tipom na podlagi zagotavljanja kakovosti instrumenta je del postopka ugotavljanja skladnosti, pri čemer proizvajalec izpolni obveznosti iz točk 2 in 5 ter zagotovi in na lastno odgovornost izjavi, da so zadevni merilni instrumenti skladni s tipom, opisanim v certifikatu o EU-pregledu tipa, in da izpolnjujejo zahteve iz te direktive, ki veljajo zanje.
the decisions and reports of the notified body referred to in points 5.5, 6.3 and 6.4.
Proizvajalec upravlja odobren sistem zagotavljanja kakovosti za končno kontrolo proizvoda in preskušanje zadevnega merilnega instrumenta, kakor je določeno v točki 3, in zanj velja nadzor iz točke 4.
The manufacturer’s obligations set out in points 3, 5.1, 5.5, 7 and 8 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
Sistem kakovosti zagotovi skladnost merilnih instrumentov s tipom, opisanim v certifikatu o EU-pregledu tipa, in da izpolnjujejo ustrezne zahteve iz te direktive.
MODULE E: CONFORMITY TO TYPE BASED ON INSTRUMENT QUALITY ASSURANCE
pregledov in preskusov, ki bodo opravljeni po koncu proizvodnje;
Conformity to type based on instrument 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 measuring instruments 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.
sredstev nadzorovanja učinkovitega delovanja sistema kakovosti.
The manufacturer shall operate an approved quality system for final product inspection and testing of the measuring instruments concerned as specified in point 3 and shall be subject to surveillance, as specified in point 4.
Skupina za presojo pregleda tehnično dokumentacijo iz točke (e) točke 3.1 za preverjanje sposobnosti proizvajalca, s čimer ugotovi ustrezne zahteve iz te direktive in izvede potrebne preglede, da se zagotovi, da instrument izpolnjuje te zahteve.
The quality system shall ensure compliance of the measuring instruments with the type described in the EU-type examination certificate and with the applicable requirements of this Directive.
Obvestilo vsebuje ugotovitve presoje in utemeljeno odločitev o oceni.
the examinations and tests that will be carried out after manufacture;
Proizvajalec obvešča priglašeni organ, ki je odobril sistem kakovosti, o kakršni koli nameravani spremembi sistema kakovosti.
the means of monitoring the effective operation of the quality system.
Proizvajalec namesti oznako CE, dodatno meroslovno oznako iz te direktive in na odgovornost priglašenega organa iz točke 3.1. svojo identifikacijsko številko na vsak posamezen instrument, ki je skladen s tipom iz certifikata o EU-pregledu tipa in izpolnjuje veljavne zahteve iz te direktive.
The auditing team shall review the technical documentation referred to in point (e) of point 3.1, in order 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 instrument with those requirements.
dokumentacijo iz točke 3.1;
The notification shall contain the conclusions of audit and the reasoned assessment decision.
odločitve in poročila priglašenega organa iz točk 3.5, 4.3 in 4.4.
The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.
MODUL E1: ZAGOTAVLJANJE KAKOVOSTI KONČNE KONTROLE IN PRESKUŠANJA INSTRUMENTA
The manufacturer shall affix the CE marking, the supplementary metrology marking set out in this Directive, and, under the responsibility of the notified body referred to in point 3.1, the latter’s identification number to each individual instrument that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of this Directive.
Zagotavljanje kakovosti končne kontrole in preskušanja instrumenta je postopek ugotavljanja skladnosti, s katerim proizvajalec izpolni obveznosti iz točk 2, 4 in 7 ter na lastno odgovornost zagotovi in izjavi, da zadevni merilni instrumenti izpolnjujejo zahteve te direktive, ki veljajo zanje.
the documentation referred to in point 3.1;
Proizvajalec nacionalnim organom omogoči dostop do tehnične dokumentacije še 10 let po tem, ko je bil instrument dan na trg.
the decisions and reports of the notified body referred to in points 3.5, 4.3 and 4.4.
Proizvajalec upravlja odobren sistem zagotavljanja kakovosti za končno kontrolo proizvoda in preskušanje zadevnega merilnega instrumenta, kakor je določeno v točki 5, in zanj velja nadzor iz točke 6.
MODULE E1: QUALITY ASSURANCE OF FINAL INSTRUMENT INSPECTION AND TESTING
Proizvajalec vloži vlogo za ocenitev svojega sistema kakovosti v zvezi z zadevnimi merilnimi instrumenti pri priglašenem organu, ki ga sam izbere.
Quality assurance of final instrument inspection and testing 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 measuring instruments concerned satisfy the requirements of this Directive that apply to them.
Dokumentacija sistema kakovosti mora omogočati dosledno razlago programov, načrtov, priročnikov in zapiskov.
The manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for 10 years after the instrument has been placed on the market.
dokumentacijo iz točke 5.1;
The manufacturer shall operate an approved quality system for final product inspection and testing of the measuring instruments concerned as specified in point 5 and shall be subject to surveillance as specified in point 6.
odločitve in poročila priglašenega organa iz točk 5.5, 6.3 in 6.4.
The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the measuring instruments concerned.
Pooblaščeni zastopnik proizvajalca lahko v njegovem imenu in na njegovo odgovornost izpolni obveznosti iz točk 3, 5.1, 5.5, 7 in 8, če so navedene v pooblastilu.
The quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.
MODUL F: SKLADNOST S TIPOM NA PODLAGI OVERITVE PROIZVODOV
the documentation referred to in point 5.1,
Skladnost s tipom na podlagi overitve proizvodov je del postopka ugotavljanja skladnosti, s katerimi proizvajalec izpolni obveznosti iz točk 2, 5.1 in 6 ter zagotovi in na lastno odgovornost izjavi, da so zadevni merilni instrumenti, za katere se uporablja točka 3, skladni s tipom, opisanim v certifikatu o EU-pregledu tipa, in da izpolnjujejo zahteve iz te direktive, ki veljajo zanje.
the decisions and reports from the notified body referred to in points 5.5, 6.3 and 6.4.
Overitev
The manufacturer’s obligations set out in points 3, 5.1, 5.5, 7 and 8 may be fulfilled his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
Priglašeni organ, ki ga je izbral proizvajalec, izvede ali da izvesti ustrezne preglede in preskuse, da preveri skladnost instrumentov s tipom, opisanim v certifikatu o EU-pregledu tipa, in z ustreznimi zahtevami iz te direktive.
MODULE F: CONFORMITY TO TYPE BASED ON PRODUCT VERIFICATION
Pregledi in preskusi za preverjanje skladnosti merilnih instrumentov z ustreznimi zahtevami se po izbiri proizvajalca izvedejo bodisi s pregledom in preskusom vsakega instrumenta v skladu s točko 4 ali s pregledom in preskusom merilnih instrumentov na statistični podlagi v skladu s točko 5.
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 2, 5.1 and 6, and ensures and declares on his sole responsibility that the measuring instruments concerned, which have been subject to the provisions of point 3, are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Directive that apply to them.
Overitev skladnosti s pregledovanjem in preskušanjem vsakega instrumenta
Verification
Vsak merilni instrument se posamezno pregleda in izvedejo se ustrezni preskusi, ki so navedeni v ustreznih harmoniziranih standardih in/ali normativnih dokumentih, in/ali enakovredni preskusi, ki so določeni v drugih ustreznih tehničnih specifikacijah, da se preveri njegova skladnost z odobrenim tipom, opisanim v certifikatu o EU-pregledu tipa, in ustreznimi zahtevami iz te direktive.
A notified body chosen by the manufacturer shall carry out the appropriate examinations and tests, or have them carried out, to verify the conformity of the instruments with the type as described in the EU-type examination certificate and the appropriate requirements of this Directive.
Kadar harmoniziranega standarda ali normativnega dokumenta ni na voljo, se zadevni priglašeni organ odloči za izvedbo ustreznih preskusov.
The examinations and tests to verify the conformity of the measuring instruments with the appropriate requirements shall be carried out, at the choice of the manufacturer, either by examination and testing of every instrument as specified in point 4, or by examination and testing of the measuring instruments on a statistical basis as specified in point 5.
Priglašeni organ izda certifikat o skladnosti ob upoštevanju izvedenih pregledov in preskusov ter namesti svojo identifikacijsko številko na vsak odobren instrument ali jo da namestiti na svojo odgovornost.
Verification of conformity by examination and testing of every instrument
Proizvajalec nacionalnim organom omogoči dostop do certifikatov o skladnosti še 10 let po tem, ko je bil instrument dan na trg.
All measuring instruments shall be individually examined and appropriate tests set out in the relevant harmonised standard(s) and/or normative documents, and/or equivalent tests set out in other relevant technical specifications, shall be carried out in order to verify their conformity with the approved type described in the EU-type examination certificate and with the appropriate requirements of this Directive.
Statistično preverjanje skladnosti.
In the absence of a harmonised standard or normative document, the notified body concerned shall decide on the appropriate tests to be carried out.
Proizvajalec sprejme vse potrebne ukrepe, da se v proizvodnem procesu in pri njegovem spremljanju zagotovi homogenost vsake proizvedene partije, ter da svoje merilne instrumente preveriti v obliki homogenih partij.
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 instrument or have it affixed under its responsibility.
Naključno izbrani vzorec se odvzame iz vsake partije v skladu z zahtevami iz točke 5.3.
The manufacturer shall keep the certificates of conformity available for inspection by the national authorities for 10 years after the instrument has been placed on the market.
Vsak merilni instrument v vzorcu se posamezno pregleda in izvedejo se ustrezni preskusi, ki so navedeni v ustreznih harmoniziranih standardih in/ali normativnih dokumentih in/ali enakovrednih preskusih, ki so določeni v tehničnih specifikacijah, da se preveri skladnost s tipom, opisanim v certifikatu o EU-pregledu tipa, in z veljavnimi zahtevami iz te direktive ter določi, ali se partija sprejme ali zavrne.
Statistical verification of conformity
Kadar harmoniziranega standarda ali normativnega dokumenta ni na voljo, se zadevni priglašeni organ odloči za izvedbo ustreznih preskusov.
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure the homogeneity of each lot produced, and shall present his measuring instruments for verification in the form of homogeneous lots.
Statistični postopek izpolnjuje naslednje zahteve:
A random sample shall be taken from each lot according to the requirements of point 5.3.
Statistična kontrola temelji na spodaj navedenih lastnostih.
All measuring instruments in a sample shall be individually examined and appropriate tests set out in the relevant harmonised standard(s) and/or normative document(s), and/or equivalent tests set out in other relevant technical specifications, shall be carried out in order to verify their conformity with the type described in the EU-type examination certificate and with the applicable requirements of this Directive, and to determine whether the lot is accepted or rejected.
Sistem za vzorčenje zagotavlja: