natgillin/translations-raw huggingface dataset:
A conformity assessment body shall be capable of carrying out all the conformity assessment tasks assigned to it by Annexes III to VII and Annex IX and in relation to which it has been notified, whether those tasks are carried out by the conformity assessment body itself or on its behalf and under its responsibility.
Organi za ugotavljanje skladnosti in njihovo osebje izvajajo dejavnosti ugotavljanja skladnosti z največjo strokovno neoporečnostjo in potrebno tehnično usposobljenostjo na določenem področju, brez vplivov in spodbud, zlasti finančnih, ki bi lahko vplivali na njihovo presojo ali rezultate njihovih dejavnosti ugotavljanja skladnosti, zlasti kar zadeva osebe ali skupine oseb, za katere so rezultati navedenih dejavnosti pomembni.
At all times and for each conformity assessment procedure and each kind or category of products in relation to which it has been notified, a conformity assessment body shall have at its disposal the necessary:
Organ za ugotavljanje skladnosti je zmožen izvajati vse naloge ugotavljanja skladnosti, ki so takšnemu organu dodeljene v prilogah III do VII in Prilogi IX in za katere je bil priglašen, bodisi da navedene naloge izvede sam bodisi da so izvedene v njegovem imenu in v okviru njegove odgovornosti.
personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks;
Organ za ugotavljanje skladnosti ima vedno in za vsak postopek ugotavljanja skladnosti ter za vsako vrsto ali kategorijo proizvodov, za katere je priglašen, na razpolago potrebno:
descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency and the ability of reproduction of those procedures.
osebje s tehničnim znanjem ter zadostnimi in ustreznimi izkušnjami za izvajanje nalog ugotavljanja skladnosti;
It shall have appropriate policies and procedures in place that distinguish between tasks it carries out as a notified body and other activities;
opise postopkov, po katerih se izvaja ugotavljanje skladnosti, ki zagotavljajo preglednost in zmožnost reprodukcije teh postopkov.
procedures for the performance of activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the product technology in question and the mass or serial nature of the production process.
Imeti mora ustrezno politiko in postopke za razlikovanje med nalogami, ki jih izvaja kot priglašeni organ, in drugimi dejavnostmi;
A conformity assessment body shall have the means necessary to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and shall have access to all necessary equipment or facilities.
postopke za izvajanje dejavnosti, pri katerih je ustrezno upoštevana velikost podjetja, sektor, v katerem deluje, in njegovo strukturo, stopnjo zahtevnosti tehnologije zadevnega proizvoda ter masovno ali serijsko naravo proizvodnega postopka.
The personnel responsible for carrying out conformity assessment tasks shall have the following:
Organ za ugotavljanje skladnosti ima potrebna sredstva za ustrezno izvajanje tehničnih in upravnih nalog, povezanih z dejavnostmi za ugotavljanje skladnosti, ter dostop do vse potrebne opreme ali prostorov.
sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been notified;
Osebje, pristojno za izvajanje nalog ugotavljanja skladnosti:
satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments;
je dobro tehnično in poklicno usposobljeno, kar zajema vse dejavnosti ugotavljanja skladnosti, za katere je bil organ za ugotavljanje skladnosti priglašen;
appropriate knowledge and understanding of the essential health and safety requirements set out in Annex II, of the applicable harmonised standards, of the relevant provisions of Union harmonisation legislation and of national legislation;
ima zadovoljivo znanje o zahtevah glede presoj, ki jih izvaja, in ustrezna pooblastila za izvedbo teh presoj;
the ability to draw up certificates, records and reports demonstrating that assessments have been carried out.
ima primerno znanje in razumevanje bistvenih zdravstvenih in varnostnih zahtev iz Priloge II, veljavnih harmoniziranih standardov ter ustreznih določb zakonodaje Unije o harmonizaciji in nacionalne zakonodaje;
The impartiality of the conformity assessment bodies, their top level management, and of the personnel responsible for carrying out the conformity assessment tasks shall be guaranteed.
je usposobljeno za pripravo certifikatov, zapisov in poročil, ki dokazujejo, da so bile presoje izvedene.
The remuneration of the top level management and personnel responsible for carrying out the conformity assessment tasks of a conformity assessment body shall not depend on the number of assessments carried out or on the results of those assessments.
Zagotovljena je nepristranskost organa za ugotavljanje skladnosti, njegovega najvišjega vodstva in osebja, odgovornega za izvajanje nalog ugotavljanja skladnosti.
Conformity assessment bodies shall take out liability insurance unless liability is assumed by the State in accordance with national law, or the Member State itself is directly responsible for the conformity assessment.
Plačilo najvišjega vodstva in osebja, odgovornega za izvajanje nalog ugotavljanja skladnosti organa za ugotavljanje skladnosti, ni odvisno od števila izvedenih ugotavljanj ali rezultatov navedenih ugotavljanj.
The personnel of a conformity assessment body shall observe professional secrecy with regard to all information obtained in carrying out their tasks under Annexes III to VII and Annex IX or any provision of national law giving effect to it, except in relation to the competent authorities of the Member State in which its activities are carried out.
Organ za ugotavljanje skladnosti sklene zavarovanje odgovornosti, razen če odgovornost prevzame država v skladu z nacionalnim pravom ali če je država članica sama neposredno odgovorna za ugotavljanje skladnosti.
Proprietary rights shall be protected.
Osebje organa za ugotavljanje skladnosti je zavezano k poklicni molčečnosti v zvezi z vsemi informacijami, pridobljenimi med izvajanjem nalog v skladu s prilogami III do VII in Prilogo IX ali katero koli izvedbeno določbo nacionalnega prava, razen pred pristojnimi organi države članice, v kateri izvaja svoje dejavnosti.
Conformity assessment bodies shall participate in, or ensure that their personnel responsible for carrying out the conformity assessment tasks are informed of, the relevant standardisation activities and the activities of the notified body coordination group established under the relevant Union harmonisation legislation and shall apply as general guidance the administrative decisions and documents produced as a result of the work of that group.
Lastninske pravice so zaščitene.
Article 22
Organi za ugotavljanje skladnosti sodelujejo pri ustreznih dejavnostih standardizacije in dejavnostih skupine za usklajevanje priglašenega organa, ustanovljene v skladu z ustrezno zakonodajo Unije o harmonizaciji, ali zagotovijo, da je njihovo osebje, odgovorno za izvajanje nalog ugotavljanja skladnosti, obveščeno o teh dejavnostih, upravne odločbe in dokumente, ki izhajajo iz rezultatov dela navedene skupine, pa uporabljajo kot splošne smernice.
Presumption of conformity of notified bodies
Člen 22
Where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union, it shall be presumed to comply with the requirements set out in Article 21 in so far as the applicable harmonised standards cover those requirements.
Domneva o skladnosti priglašenih organov
Article 23
Kadar organ za ugotavljanje skladnosti dokaže skladnost z merili, določenimi v zadevnih harmoniziranih standardih ali njihovih delih, na katere so bila objavljena sklicevanja v Uradnem listu Evropske unije, se domneva, da izpolnjuje zahteve iz člena 21, če veljavni harmonizirani standardi zajemajo navedene zahteve.
Subsidiaries of and subcontracting by notified bodies
Člen 23
Where a notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements set out in Article 21 and shall inform the notifying authority accordingly.
Hčerinske družbe in podizvajalci priglašenih organov
Notified bodies shall take full responsibility for the tasks performed by subcontractors or subsidiaries wherever these are established.
Kadar priglašen organ za določene naloge, povezane z ugotavljanjem skladnosti, sklene pogodbo s podizvajalci ali jih prenese na hčerinsko podjetje, zagotovi, da podizvajalec ali hčerinsko podjetje izpolnjuje zahteve iz člena 21 ter o tem ustrezno obvesti priglasitveni organ.
Activities may be subcontracted or carried out by a subsidiary only with the agreement of the client.
Priglašeni organi v celoti prevzamejo odgovornost za naloge, ki jih izvajajo podizvajalci ali hčerinska podjetja, ne glede na njihov sedež.
Notified bodies shall keep at the disposal of the notifying authority the relevant documents concerning the assessment of the qualifications of the subcontractor or the subsidiary and the work carried out by them under Annexes III to VII and Annex IX.
Dejavnosti se lahko prenesejo na podizvajalca ali hčerinsko podjetje samo, če stranka s tem soglaša.
Article 24
Priglašeni organi za priglasitvene organe hranijo zadevne dokumente v zvezi s presojo kvalifikacij podizvajalca ali hčerinskega podjetja ter nalogami, ki jih izvaja v skladu s prilogami III do VII in Prilogo IX.
Application for notification
Člen 24
A conformity assessment body shall submit an application for notification to the notifying authority of the Member State in which it is established.
Vloga za priglasitev
The application for notification shall be accompanied by a description of the conformity assessment activities, the conformity assessment module or modules and the product or products for which that body claims to be competent, as well as by an accreditation certificate, where one exists, issued by a national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in Article 21.
Organ za ugotavljanje skladnosti predloži vlogo za priglasitev priglasitvenemu organu države članice, v kateri ima sedež.
Where the conformity assessment body concerned cannot provide an accreditation certificate, it shall provide the notifying authority with all the documentary evidence necessary for the verification, recognition and regular monitoring of its compliance with the requirements laid down in Article 21.
Vlogi za priglasitev je priložen opis dejavnosti ugotavljanja skladnosti, modul ali moduli ugotavljanja skladnosti in proizvod ali proizvodi, za katere navedeni organ trdi, da je pristojen, ter certifikat o akreditaciji, če obstaja, ki ga izda nacionalni akreditacijski organ, ki potrjuje, da organ za ugotavljanje skladnosti izpolnjuje zahteve iz člena 21.
Article 25
Kadar zadevni organ za ugotavljanje skladnosti ne more predložiti certifikata o akreditaciji, priglasitvenemu organu predloži vsa dokazila, potrebna za preverjanje, priznavanje in redno spremljanje njegovega izpolnjevanja zahtev iz člena 21.
Notification procedure
Člen 25
Notifying authorities may notify only conformity assessment bodies which have satisfied the requirements laid down in Article 21.
Priglasitveni postopek
They shall notify the Commission and the other Member States using the electronic notification tool developed and managed by the Commission.
Priglasitveni organi lahko priglasijo samo tiste organe za ugotavljanje skladnosti, ki izpolnjujejo zahteve iz člena 21.
The notification shall include full details of the conformity assessment activities, the conformity assessment module or modules and the product or products concerned and the relevant attestation of competence.
Komisijo in druge države članice obvestijo z uporabo elektronskega orodja za priglasitev, ki ga je razvila in ga upravlja Komisija.
Where a notification is not based on an accreditation certificate as referred to in Article 24(2), the notifying authority shall provide the Commission and the other Member States with documentary evidence which attests to the conformity assessment body’s competence and the arrangements in place to ensure that that body will be monitored regularly and will continue to satisfy the requirements laid down in Article 21.
Priglasitev vključuje vse podrobnosti o dejavnostih ugotavljanja skladnosti, modul ali module ugotavljanja skladnosti in zadevni proizvod ali proizvode ter ustrezno potrdilo o usposobljenosti.
The body concerned may perform the activities of a notified body only where no objections are raised by the Commission or the other Member States within two weeks of a notification where an accreditation certificate is used or within two months of a notification where accreditation is not used.
Kadar priglasitev ne temelji na certifikatu o akreditaciji iz člena 24(2), priglasitveni organ Komisiji in drugim državam članicam predloži dokumentirana dokazila, ki potrjujejo pristojnost organa za ugotavljanje skladnosti in uvedene ukrepe, ki zagotavljajo, da bo organ pod rednim nadzorom in da bo še naprej izpolnjeval zahteve iz člena 21.
Only such a body shall be considered a notified body for the purposes of this Directive.
Zadevni organ lahko izvaja dejavnosti priglašenega organa le, kadar Komisija ali druge države članice ne predložijo ugovora v dveh tednih od priglasitve v primeru uporabe certifikata o akreditaciji oziroma v dveh mesecih od priglasitve v primeru, da akreditacija ni uporabljena.
The notifying authority shall notify the Commission and the other Member States of any subsequent relevant changes to the notification.
Za namene te direktive za priglašeni organ šteje samo tak organ.
Article 26
Priglasitveni organ obvesti Komisijo in druge države članice o vseh naknadnih spremembah priglasitve.
Identification numbers and lists of notified bodies
Člen 26
The Commission shall assign an identification number to a notified body.
Identifikacijske številke in seznami priglašenih organov
It shall assign a single such number even where the body is notified under several Union acts.
Komisija priglašenemu organu dodeli identifikacijsko številko.
The Commission shall make publicly available the list of the bodies notified under this Directive, including the identification numbers that have been assigned to them and the activities for which they have been notified.
Dodeli mu samo eno številko, tudi kadar je organ priglašen v skladu z različnimi akti Unije.
The Commission shall ensure that the list is kept up to date.
Komisija javno objavi seznam organov, priglašenih v skladu s to direktivo, vključno z identifikacijskimi številkami, ki so jim bile dodeljene, in dejavnostmi, za katere so bili priglašeni.
Article 27
Komisija zagotovi, da se seznam posodablja.
Changes to notifications
Člen 27
Where a notifying authority has ascertained or has been informed that a notified body no longer meets the requirements laid down in Article 21, or that it is failing to fulfil its obligations, the notifying authority shall restrict, suspend or withdraw notification as appropriate, depending on the seriousness of the failure to meet those requirements or fulfil those obligations.
Spremembe priglasitev
It shall immediately inform the Commission and the other Member States accordingly.
Kadar priglasitveni organ ugotovi ali je obveščen, da priglašeni organ ne izpolnjuje več zahtev iz člena 21 ali da ne more izpolniti svojih obveznosti, priglasitveni organ omeji, začasno prekliče ali umakne priglasitev, kot je primerno, glede na resnost neizpolnjevanja navedenih zahtev ali nespoštovanja navedenih obveznosti.
In the event of restriction, suspension or withdrawal of notification, or where the notified body has ceased its activity, the notifying Member State shall take appropriate steps to ensure that the files of that body are either processed by another notified body or kept available for the responsible notifying and market surveillance authorities at their request.
O tem takoj obvesti Komisijo in druge države članice.
Article 28
V primeru omejitve, začasnega preklica ali umika priglasitve ali če je priglašeni organ prenehal z dejavnostjo, država članica priglasiteljica sprejme ustrezne ukrepe za zagotovitev, da dokumente navedenega organa obravnava drug priglašeni organ ali da so na zahtevo na voljo pristojnim priglasitvenim organom in organom za nadzor trga.
Challenge of the competence of notified bodies
Člen 28
The Commission shall investigate all cases where it doubts, or doubt is brought to its attention regarding, the competence of a notified body or the continued fulfilment by a notified body of the requirements and responsibilities to which it is subject.
Izpodbijanje pristojnosti priglašenih organov
The notifying Member State shall provide the Commission, on request, with all information relating to the basis for the notification or the maintenance of the competence of the notified body concerned.
Komisija razišče vse primere, pri katerih dvomi oziroma je bila seznanjena z dvomom v pristojnost priglašenega organa ali njegovo stalno izpolnjevanje zahtev in obveznosti, ki veljajo zanj.
The Commission shall ensure that all sensitive information obtained in the course of its investigations is treated confidentially.
Država članica priglasiteljica Komisiji na zahtevo predloži vse informacije v zvezi s podlago za priglasitev ali ohranjanjem pristojnosti zadevnega priglašenega organa.
Where the Commission ascertains that a notified body does not meet or no longer meets the requirements for its notification, it shall adopt an implementing act requesting the notifying Member State to take the necessary corrective measures, including withdrawal of notification if necessary.
Komisija zagotovi, da se vse informacije občutljive narave, pridobljene v okviru njenih preiskav, obravnavajo zaupno.
That implementing act shall be adopted in accordance with the advisory procedure referred to in Article 39(2).
Kadar Komisija ugotovi, da priglašeni organ ne izpolnjuje ali ne izpolnjuje več zahtev za priglasitev, sprejme izvedbeni akt, s katerim zahteva od države članice priglasiteljice, da sprejme potrebne korektivne ukrepe, po potrebi vključno s preklicem priglasitve.
Article 29
Ta izvedbeni akt se sprejme v skladu s svetovalnim postopkom iz člena 39(2).
Operational obligations of notified bodies
Člen 29
Notified bodies shall carry out conformity assessments in accordance with the conformity assessment procedures provided for in Annexes III to VII and Annex IX.
Operativne obveznosti priglašenih organov
Conformity assessments shall be carried out in a proportionate manner, avoiding unnecessary burdens for economic operators.
Priglašeni organi izvajajo ugotavljanje skladnosti v skladu s postopki ugotavljanja skladnosti iz prilog III do VII in Priloge IX.
Conformity assessment bodies shall perform their activities taking due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the product technology in question and the mass or serial nature of the production process.
Ugotavljanje skladnosti se izvaja sorazmerno, tako da se prepreči nepotrebna obremenitev gospodarskih subjektov.
In so doing they shall nevertheless respect the degree of rigour and the level of protection required for the compliance of the product with the requirements of this Directive.
Organi za ugotavljanje skladnosti pri izvajanju svojih postopkov upoštevajo velikost podjetja, sektor, v katerem deluje, in njegovo strukturo, stopnjo zahtevnosti zadevne tehnologije ter masovno ali serijsko naravo proizvodnega postopka.
Where a notified body finds that the essential health and safety requirements set out in Annex II or corresponding harmonised standards or other technical specifications have not been met by a manufacturer, it shall require that manufacturer to take appropriate corrective measures and shall not issue a certificate of conformity.
Pri tem spoštujejo stopnjo zahtevnosti in zaščite, potrebne za to, da proizvod izpolnjuje zahteve iz te direktive.
Where, in the course of the monitoring of conformity following the issue of a certificate, a notified body finds that a product no longer complies, it shall require the manufacturer to take appropriate corrective measures and shall suspend or withdraw the certificate if necessary.
Kadar priglašeni organ ugotovi, da proizvajalec ne izpolnjuje bistvenih zdravstvenih in varnostnih zahtev iz Priloge II ali ustreznih harmoniziranih standardov ali drugih tehničnih specifikacij, od proizvajalca zahteva, da sprejme ustrezne korektivne ukrepe, in ne izda certifikata o skladnosti.
Where corrective measures are not taken or do not have the required effect, the notified body shall restrict, suspend or withdraw any certificates, as appropriate.
Kadar med spremljanjem skladnosti po izdaji certifikata priglašeni organ ugotovi, da proizvod ne izpolnjuje več zahtev, od proizvajalca zahteva, da izvede ustrezne korektivne ukrepe, in po potrebi začasno prekliče ali prekliče certifikat.
Article 30
Kadar korektivni ukrepi niso sprejeti ali nimajo zahtevanega učinka, priglašeni organ po potrebi omeji, začasno prekliče ali prekliče vse certifikate.
Appeal against decisions of notified bodies
Člen 30
Member States shall ensure that an appeal procedure against decisions of the notified bodies is available.
Pritožba zoper odločitve priglašenih organov
Article 31
Države članice zagotovijo, da je na voljo pritožbeni postopek zoper odločitve priglašenih organov.
Information obligation on notified bodies
Člen 31
Notified bodies shall inform the notifying authority of the following:
Obveznost obveščanja za priglašene organe
any refusal, restriction, suspension or withdrawal of a certificate;
Priglašeni organi obveščajo priglasitveni organ o:
any circumstances affecting the scope of or conditions for notification;
vseh zavrnitvah, omejitvah, začasnih preklicih ali preklicih certifikata;
any request for information which they have received from market surveillance authorities regarding conformity assessment activities;
vseh okoliščinah, ki vplivajo na obseg uporabe priglasitve ali pogoje zanjo;
on request, conformity assessment activities performed within the scope of their notification and any other activity performed, including cross-border activities and subcontracting.
vseh zahtevah po informacijah, ki so jih prejeli od organov za nadzor trga v zvezi z dejavnostmi ugotavljanja skladnosti;
Notified bodies shall provide the other bodies notified under this Directive carrying out similar conformity assessment activities covering the same products with relevant information on issues relating to negative and, on request, positive conformity assessment results.
na zahtevo o vseh dejavnostih ugotavljanja skladnosti, izvedenih v okviru njihove priglasitve, in o vseh drugih izvedenih dejavnostih, vključno s čezmejnimi dejavnostmi in sklepanjem pogodb s podizvajalci.
Article 32
Priglašeni organi drugim organom, ki so priglašeni v okviru te direktive ter izvajajo podobne dejavnosti ugotavljanja skladnosti in zajemajo enake proizvode, zagotavljajo zadevne informacije o vprašanjih v zvezi z negativnimi in na zahtevo pozitivnimi rezultati ugotavljanja skladnosti.
Exchange of experience
Člen 32
The Commission shall provide for the organisation of exchange of experience between the Member States’ national authorities responsible for notification policy.
Izmenjava izkušenj
Article 33
Komisija omogoči izmenjavo izkušenj med nacionalnimi organi držav članic, ki so pristojni za politiko glede priglasitev.
Coordination of notified bodies
Člen 33
The Commission shall ensure that appropriate coordination and cooperation between bodies notified under this Directive are put in place and properly operated in the form of a sectoral group of notified bodies.
Usklajevanje priglašenih organov