natgillin/translations-raw huggingface dataset:
The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.
Priglašeni organ ovrednoti vsako predlagano spremembo in odloči, ali spremenjeni sistem kakovosti še vedno izpolnjuje zahteve iz točke 2.3.2 in ali je potrebno ponovno ocenjevanje.
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 2.3.2 or whether a reassessment is necessary.
Proizvajalca se obvesti o odločitvi.
It shall notify the manufacturer of its decision.
Obvestilo vsebuje ugotovitve pregleda in utemeljeno odločitev o ocenjevanju.
The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.
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, 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:
dokumentacijo o sistemu kakovosti;
the quality system documentation;
zapise kakovosti, kot so poročila o pregledih in podatki o preskusih, podatki o umerjanju, 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.
Priglašeni organ opravlja redne presoje, da ugotovi, če proizvajalec vzdržuje in uporablja sistem kakovosti, ter zagotovi poročilo o presoji proizvajalcu.
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.
Poleg tega lahko priglašeni organ nepričakovano obišče proizvajalca.
In addition, the notified body may pay unexpected visits to the manufacturer.
Oznaka skladnosti in izjava EU o skladnosti
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.
Proizvajalec namesti oznako CE in dodatno meroslovno oznako iz te direktive in na odgovornost priglašenega organa iz točke 2.3.1 identifikacijsko številko tega organa na vsako posamezno tehtnico, ki je v skladu s tipom, opisanim v certifikatu o EU-pregledu tipa, in ki izpolnjuje veljavne zahteve 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.
Proizvajalec za vsak model tehtnice sestavi pisno izjavo EU o skladnosti in nacionalnim organom omogoča dostop do nje še 10 let po tem, ko je bila tehtnica dana na trg.
Conformity marking and EU declaration of conformity
Izjava EU o skladnosti opredeljuje model tehtnice, za katerega je bila sestavljena.
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 2.3.1, 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.
Na zahtevo pristojnih organov se zagotovi izvod izjave EU o skladnosti.
The manufacturer shall draw up a written EU declaration of conformity for each instrument model and keep it at the disposal of the national authorities for 10 years after the instrument has been placed on the market.
Proizvajalec za nacionalne organe še 10 let po tem, ko je bila tehtnica dana na trg, hrani:
The EU declaration of conformity shall identify the instrument model for which it has been drawn up.
dokumentacije iz točke 2.3.1;
A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.
informacij v zvezi s spremembo iz točke 2.3.5, kot je bila odobrena;
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:
odločitev in poročil priglašenega organa iz točk 2.3.5, 2.4.3 in 2.4.4.
the documentation referred to in point 2.3.1;
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 information relating to the change referred to in point 2.3.5, as approved;
Pooblaščeni zastopnik
the decisions and reports of the notified body referred to in points 2.3.5, 2.4.3 and 2.4.4.
Obveznosti proizvajalca iz točk 2.3.1, 2.3.5, 2.5 in 2.6 lahko v njegovem imenu in na njegovo odgovornost izpolni pooblaščeni zastopnik, če so navedene v pooblastilu.
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.
Modul D1: zagotavljanje kakovosti proizvodnje
Authorised representative
Zagotavljanje kakovosti proizvodnje je postopek ugotavljanja skladnosti, s katerim proizvajalec izpolni obveznosti iz točk 3.2, 3.4 in 3.7 ter zagotovi in na lastno odgovornost izjavi, da zadevne tehtnice izpolnjujejo zahteve iz te direktive, ki veljajo zanje.
The manufacturer’s obligations set out in points 2.3.1, 2.3.5, 2.5 and 2.6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
Tehnična dokumentacija
Module D1: Quality assurance of the production process
Proizvajalec pripravi tehnično dokumentacijo.
Quality assurance of the production process is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 3.2, 3.4 and 3.7, and ensures and declares on his sole responsibility that the instruments concerned satisfy the requirements of this Directive that apply to them.
Dokumentacija omogoča ugotavljanje skladnosti tehtnice z ustreznimi zahtevami ter vključuje ustrezno analizo in oceno tveganj(a).
Technical documentation
Tehnična dokumentacija po potrebi vsebuje vsaj naslednje elemente:
The manufacturer shall establish the technical documentation.
poročila o preskusih.
The documentation shall make it possible to assess the instrument’s conformity with the relevant requirements, and shall include an adequate analysis and assessment of the risk(s).
Proizvajalec nacionalnim organom omogoča dostop do tehnične dokumentacije še 10 let po tem, ko je bila tehtnica dana na trg.
The technical documentation shall, wherever applicable, contain at least the following elements:
Proizvajalec upravlja odobreni sistem zagotavljanja kakovosti za proizvodnjo, končni pregled proizvoda in preskušanje zadevnih tehtnic, kakor je določeno v točki 3.5, in zanj velja nadzor iz točke 3.6.
test reports.
dokumentacijo o sistemu kakovosti;
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.
tehnično dokumentacijo iz točke 3.2.
the documentation concerning the quality system;
Priglašeni organ oceni sistem kakovosti, da določi, ali izpolnjuje zahteve iz točke 3.5.2.
the technical documentation referred to in point 3.2.
Skupina za presojo pregleda tehnično dokumentacijo iz točke 3.2, da preveri sposobnosti proizvajalca, da prepozna ustrezne zahteve iz te direktive in izvede potrebne preglede, da zagotovi, da tehtnica izpolnjuje te zahteve.
The quality system shall ensure compliance of the instruments with the requirements of this Directive that apply to them.
Priglašeni organ ovrednoti vsako predlagano spremembo in odloči, ali spremenjeni sistem kakovosti še vedno izpolnjuje zahteve iz točke 3.5.2 in ali je potrebno ponovno ocenjevanje.
The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.5.2.
tehnično dokumentacijo iz točke 3.2;
The auditing team shall review the technical documentation referred to in point 3.2 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.
Proizvajalec namesti oznako CE in dodatno meroslovno oznako iz te direktive in na odgovornost priglašenega organa iz točke 3.5.1 identifikacijsko številko tega organa na vsako posamezno tehtnico, ki izpolnjuje veljavne zahteve iz te direktive.
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 3.5.2 or whether reassessment is necessary.
dokumentacijo iz točke 3.5.1;
the technical documentation referred to in point 3.2;
informacije v zvezi s spremembo iz točke 3.5.5, kot je bila odobrena;
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.
odločitve in poročila priglašenega organa iz točk 3.5.5, 3.6.3 in 3.6.4.
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 3.5.1, the latter’s identification number to each individual instrument that satisfies the applicable requirements of this Directive.
Obveznosti proizvajalca iz točk 3.3, 3.5.1, 3.5.5, 3.7 in 3.8 lahko v njegovem imenu in na njegovo odgovornost izpolni pooblaščeni zastopnik, če so navedene v pooblastilu.
the documentation referred to in point 3.5.1;
Modul F: skladnost s tipom na podlagi overitve proizvoda
the information relating to the change referred to in point 3.5.5, as approved;
Skladnost s tipom na podlagi overitve proizvoda je del postopka ugotavljanja skladnosti s katerim proizvajalec izpolni obveznosti iz točk 4.2, in 4.5 ter zagotovi in na lastno odgovornost izjavi, da so zadevne tehtnice, ki so predmet določb iz točke 4.3, v skladu 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 3.5.5, 3.6.3 and 3.6.4.
Proizvajalec sprejme vse potrebne ukrepe, da proizvodni proces in njegovo spremljanje zagotovita skladnost proizvedenih tehtnic z odobrenim tipom, kot je opisan v certifikatu o EU-pregledu tipa, in z zahtevami iz te direktive, ki veljajo zanje.
The manufacturer’s obligations set out in points 3.3, 3.5.1, 3.5.5, 3.7 and 3.8 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
Overitev
Module F: Conformity to type based on product verification
Priglašeni organ, ki ga je izbral proizvajalec, izvede ustrezne preglede in preskuse, da preveri skladnost tehtnic z odobrenim tipom, kot je opisan v certifikatu o EU-pregledu tipa, in ustreznimi zahtevami iz te direktive.
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 4.2 and 4.5 and ensures and declares on his sole responsibility that the instruments concerned, which have been subject to the provisions of point 4.3, are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Directive that apply to them.
Pregledi in preskusi za pregled skladnosti tehtnic z ustreznimi zahtevami se izvedejo s pregledom in preskusom vsake tehtnice, kot je določeno v točki 4.4.
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured instruments with the approved type described in the EU-type examination certificate and with the requirements of this Directive that apply to them.
Overitev skladnosti s pregledom in preskusom vsake tehtnice
Verification
Za overitev skladnosti tehtnic s tipom, opisanim v certifikatu o EU-pregledu tipa, in z ustreznimi zahtevami iz te direktive se pregleda vsaka posamezna tehtnica, opravijo pa se tudi ustrezni preskusi iz zadevnih harmoniziranih standardov in/ali enakovredni preskusi iz drugih zadevnih tehničnih specifikacij.
A notified body chosen by the manufacturer shall carry out appropriate examinations and tests in order to check the conformity of the instruments with the approved type described in the EU-type examination certificate and with the appropriate requirements of this Directive.
Kadar takšen harmonizirani standard ni na voljo, se zadevni priglašeni organ odloči za izvedbo ustreznih preskusov.
The examinations and tests to check the conformity of the instruments with the appropriate requirements shall be carried out by examination and testing of every instrument as specified in point 4.4.
Priglašeni organ izda certifikat o skladnosti ob upoštevanju izvedenih pregledov in preskusov ter namesti svojo identifikacijsko številko na vsako odobreno tehtnico ali jo da namestiti na svojo odgovornost.
Verification of conformity by examination and testing of every instrument
Proizvajalec nacionalnim organom omogoča dostop do potrdil o skladnosti še 10 let po tem, ko je bila tehtnica dana na trg.
All instruments 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 Directive.
Proizvajalec namesti oznako CE in dodatno meroslovno oznako iz te direktive in na odgovornost priglašenega organa iz točke 4.3 identifikacijsko številko tega organa na vsako posamezno tehtnico, ki je v skladu z odobrenim tipom, opisanim v certifikatu o EU-pregledu tipa, in ki izpolnjuje veljavne zahteve iz te direktive.
In the absence of such a harmonised standard, the notified body concerned shall decide on the appropriate tests to be carried out.
Proizvajalec za vsak model tehtnice sestavi pisno izjavo EU o skladnosti in nacionalnim organom omogoča dostop do nje še 10 let po tem, ko je bila tehtnica dana na trg.
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.
Če priglašeni organ iz točke 4.3 to dovoli, lahko proizvajalec na odgovornost priglašenega organa namesti na tehtnice tudi identifikacijsko številko tega organa.
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.
Če priglašeni organ to dovoli, lahko proizvajalec na odgovornost priglašenega organa namesti identifikacijsko številko tega organa na tehtnice v času proizvodnega postopka.
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 4.3, the latter’s identification number to each individual instrument that is in conformity with the approved type described in the EU-type examination certificate and satisfies the applicable requirements of this Directive.
Obveznosti proizvajalca lahko v njegovem imenu in na njegovo odgovornost izpolni pooblaščeni zastopnik, če so navedene v pooblastilu.
The manufacturer shall draw up a written EU declaration of conformity for each instrument model and keep it at the disposal of the national authorities, for 10 years after the instrument has been placed on the market.
Pooblaščenemu zastopniku ni treba izpolniti obveznosti proizvajalca iz točke 4.2.
If the notified body referred to in point 4.3 agrees and under its responsibility, the manufacturer may also affix the notified body’s identification number to the instruments.
Modul F1: skladnost na podlagi overitve proizvoda
If the notified body agrees and under its responsibility, the manufacturer may affix the notified body’s identification number to the instruments during the manufacturing process.
Skladnost na podlagi overitve proizvoda je postopek ugotavljanja skladnosti, pri čemer proizvajalec izpolni obveznosti iz točk 5.2, 5.3 in 5.6 ter zagotovi in na lastno odgovornost izjavi, da so zadevne tehtnice, ki so predmet določb iz točke 5.4, v skladu z zahtevami iz te direktive, ki veljajo zanje.
The manufacturer’s obligations may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
Proizvajalec sprejme vse potrebne ukrepe, da proizvodni proces in njegovo spremljanje zagotovita skladnost proizvedene tehtnice z veljavnimi zahtevami iz te direktive.
An authorised representative may not fulfil the manufacturer’s obligations set out in point 4.2.
Priglašeni organ, ki ga izbere proizvajalec, izvede ustrezne preglede in preskuse, da preveri skladnost tehtnic z veljavnimi zahtevami iz te direktive.
Module F1: Conformity based on product verification
Pregledi in preskusi za pregled skladnosti z navedenimi zahtevami se izvedejo s pregledom in preskusom vsake tehtnice, kot je določeno v točki 5.5.
Conformity based on product verification is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 5.2, 5.3 and 5.6 and ensures and declares on his sole responsibility that the instruments concerned, which have been subject to the provisions of point 5.4, are in conformity with the requirements of this Directive that apply to them.
Pregleda se vsaka posamezna tehtnica in opravijo se ustrezni preskusi iz zadevnih harmoniziranih standardov in/ali enakovredni preskusi iz drugih zadevnih tehničnih specifikacij, da se preveri skladnost z zahtevami, ki zanje veljajo.
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured instruments with the applicable requirements of this Directive.
Kadar takšen harmonizirani standard ni na voljo, se zadevni priglašeni organ odloči za izvedbo ustreznih preskusov.
A notified body chosen by the manufacturer shall carry out appropriate examinations and tests to check the conformity of the instruments with the applicable requirements of this Directive.
Proizvajalec nacionalnim organom omogoča dostop do potrdil o skladnosti še 10 let po tem, ko je bila tehtnica dana na trg.
The examinations and tests to check the conformity with those requirements shall be carried out by examination and testing of every instrument as specified in point 5.5.
Proizvajalec namesti oznako CE in dodatno meroslovno oznako iz te direktive in na odgovornost priglašenega organa iz točke 5.4 identifikacijsko številko tega organa na vsako posamezno tehtnico, ki izpolnjuje veljavne zahteve iz te direktive.
All instruments shall be individually examined and appropriate tests, set out in the relevant harmonised standards and/or equivalent tests set out in other relevant technical specifications, shall be carried out to verify conformity with the requirements that apply to them.
Če priglašeni organ iz točke 5.5 to dovoli, lahko proizvajalec na odgovornost priglašenega organa namesti na tehtnice tudi identifikacijsko številko tega organa.
In the absence of such a harmonised standard the notified body concerned shall decide on the appropriate tests to be carried out.
Pooblaščenemu zastopniku ni treba izpolniti obveznosti proizvajalca iz točk 5.2.1 in 5.3.
The manufacturer shall keep the certificates of conformity at the disposal of the national authorities for 10 years after the instrument has been placed on the market.
Modul G: skladnost na podlagi neposredne overitve posamičnega merila
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 5.4, the latter’s identification number to each individual instrument that satisfies the applicable requirements of this Directive.
Skladnost na podlagi neposredne overitve posamičnega merila je postopek ugotavljanja skladnosti, s katerim proizvajalec izpolni obveznosti iz točk 6.2, 6.3 in 6.5 ter zagotovi in na lastno odgovornost izjavi, da je zadevna tehtnica, ki je predmet določb iz točke 6.4, v skladu z zahtevami iz te direktive, ki veljajo zanjo.
If the notified body referred to in point 5.5 agrees and under its responsibility, the manufacturer may also affix the notified body’s identification number to the instruments.
Proizvajalec predloži tehnično dokumentacijo in jo da na voljo priglašenemu organu iz točke 6.4.
An authorised representative may not fulfil the manufacturer’s obligations set out in points 5.2.1 and 5.3.
Proizvajalec sprejme vse potrebne ukrepe, da proizvodni proces in njegovo spremljanje zagotovita skladnost proizvedene tehtnice z veljavnimi zahtevami iz te direktive.
Module G: Conformity based on unit verification
Priglašeni organ, ki ga je izbral proizvajalec, izvede ali da izvesti ustrezne preglede in preskuse, določene v ustreznih harmoniziranih standardih, in/ali enakovredne preskuse, določene v drugih ustreznih tehničnih specifikacijah, s čimer preveri skladnost tehtnice z veljavnimi zahtevami iz te direktive.
Conformity based on unit verification is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 6.2, 6.3 and 6.5, and ensures and declares on his sole responsibility that the instrument concerned, which has been subject to the provisions of point 6.4, is in conformity with the requirements of this Directive that apply to it.
Priglašeni organ izda certifikat o skladnosti ob upoštevanju izvedenih pregledov in preskusov ter namesti svojo identifikacijsko številko na odobreno tehtnico ali jo da namestiti na svojo odgovornost.
The manufacturer shall establish the technical documentation and make it available to the notified body referred to in point 6.4.
Proizvajalec namesti oznako CE in dodatno meroslovno oznako iz te direktive in na odgovornost priglašenega organa iz točke 6.4 identifikacijsko številko tega organa na vsako tehtnico, ki izpolnjuje veljavne zahteve iz te direktive.
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured instrument with the applicable requirements of this Directive.
Proizvajalec sestavi pisno izjavo EU o skladnosti in nacionalnim organom omogoča dostop do nje še 10 let po tem, ko je bila tehtnica dana na trg.
A notified body chosen by the manufacturer shall carry out appropriate examinations and tests, set out in the relevant harmonised standards and/or equivalent tests set out in other relevant technical specifications, to check the conformity of the instrument with the applicable requirements of this Directive, or have them carried out.
Izjava EU o skladnosti opredeljuje tehtnico, za katero je bila sestavljena.
The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out and shall affix its identification number to the approved instrument, or have it affixed under its responsibility.
Obveznosti proizvajalca iz točk 6.2.2. in 6.5 lahko v njegovem imenu in na njegovo odgovornost izpolni pooblaščeni zastopnik, če so navedene v pooblastilu.
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 6.4, the latter’s identification number to each instrument that satisfies the applicable requirements of this Directive.
Skupne določbe