natgillin/translations-raw huggingface dataset:
A conformity assessment body, its top-level management and the personnel responsible for carrying out the conformity assessment tasks shall not be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of the products which they assess, or the authorised representative of any of those parties.
Člen 32
This shall not preclude the use of assessed products that are necessary for the operations of the conformity assessment body or the use of such products for personal purposes.
Osebje organov za ocenjevanje skladnosti
A conformity assessment body, its top-level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, manufacture or construction, marketing, installation, use or maintenance of those products, or represent the parties engaged in those activities.
Osebje, odgovorno za izvajanje dejavnosti ocenjevanja skladnosti, ima naslednje kvalifikacije:
They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified.
dobro tehnično in poklicno usposobljenost, kar vključuje vse dejavnosti ocenjevanja skladnosti, za katere je bil organ za ocenjevanje skladnosti priglašen;
This prohibition shall apply, in particular, to consultancy services.
zadovoljivo znanje o zahtevah glede ocenjevanj, ki jih izvaja, in ustrezna pooblastila za njihovo izvajanje;
Conformity assessment bodies shall ensure that the activities of their subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity assessment activities.
ustrezno poznavanje in razumevanje bistvenih zahtev, veljavnih harmoniziranih standardov in zadevnih določb prava Unije;
Conformity assessment bodies and their personnel shall carry out the conformity assessment activities with the highest degree of professional integrity and the requisite technical competence in the specific field and shall be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of their conformity assessment activities, especially as regards persons or groups of persons with an interest in the results of those activities.
sposobnost pripravljati potrdila, zapise in poročila, ki dokazujejo, da je bilo ocenjevanje izvedeno.
Article 32
Prejemki najvišjega vodstva in osebja organa za ocenjevanje skladnosti niso odvisni od števila ali rezultatov opravljenih ocenjevanj.
Personnel of conformity assessment bodies
Člen 33
The personnel responsible for carrying out conformity assessment activities shall have the following skills:
Domneva o skladnosti organa za ocenjevanje skladnosti
sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been notified;
Če organ za ocenjevanje skladnosti dokaže svojo skladnost z merili, ki so določena v ustreznih harmoniziranih standardih ali njihovih delih, katerih sklicevanja so objavljena v Uradnem listu Evropske unije, se domneva, da izpolnjuje zahteve iz členov 30 do 32, kolikor veljavni harmonizirani standardi zajemajo te zahteve.
satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments;
Člen 34
appropriate knowledge and understanding of the essential requirements, of the applicable harmonised standards and of the relevant provisions of Union law;
Odvisne družbe in podizvajalci priglašenih organov
the ability to draw up certificates, records and reports demonstrating that assessments have been carried out.
Kadar priglašeni organ za določene naloge, povezane z ocenjevanjem skladnosti, sklene pogodbo s podizvajalci ali te naloge prenese na odvisno družbo, zagotovi, da podizvajalec ali odvisna družba izpolnjuje zahteve iz členov 30 do 32, ter o tem ustrezno obvesti priglasitveni organ.
The remuneration of the top-level management and assessment personnel of a conformity assessment body shall not depend on the number of assessments carried out or on the results of those assessments.
Priglašeni organi so v celoti odgovorni za naloge, ki jih izvajajo podizvajalci ali odvisne družbe, ne glede na to, kje imajo ti podizvajalci ali ta odvisne družbe sedež.
Article 33
Dejavnosti priglašenih organov se lahko prenesejo na podizvajalca ali odvisno družbo samo, če stranka s tem soglaša.
Presumption of conformity of a conformity assessment body
Priglašeni organi za priglasitveni organ hranijo zadevne dokumente v zvezi z ocenjevanjem kvalifikacij podizvajalca ali odvisne družbe ter delom, ki ga ta opravi v skladu z ustrezno TSI.
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 Articles 30 to 32, in so far as the applicable harmonised standards cover those requirements.
Člen 35
Article 34
Akreditirani interni organi
Subsidiaries of, and subcontracting by, notified bodies
Prosilci lahko uporabijo akreditirani interni organ za izvajanje dejavnosti ocenjevanja skladnosti za namene izvajanja postopkov iz modulov A1, A2, C1 ali C2 iz Priloge II k Sklepu št. 768/2008/ES ter modulov CA1 in CA2 iz Priloge I k Sklepu 2010/713/EU.
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 Articles 30 to 32 and shall inform the notifying authority accordingly.
Ta organ je ločen in samostojen del zadevnega prosilca in ne sodeluje pri oblikovanju, proizvodnji, dobavi, vgradnji, uporabi ali vzdrževanju proizvodov, ki jih ocenjuje.
Notified bodies shall take full responsibility for the tasks performed by subcontractors or subsidiaries wherever these are established.
Akreditirani interni organ izpolnjuje naslednje zahteve:
Activities of notified bodies may be subcontracted or carried out by a subsidiary only with the agreement of the client.
akreditiran je v skladu z Uredbo (ES) št. 765/2008;
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 the relevant TSI.
organ in njegovo osebje sta znotraj matične organizacije organizacijsko razpoznavna in uporabljata metode poročanja, ki zagotavljajo njuno nepristranskost, ki jo dokazujeta pristojnemu nacionalnemu akreditacijskemu organu;
Article 35
organ in osebje nista odgovorna za obliko, proizvodnjo, dobavo, vgradnjo, delovanje ali vzdrževanje proizvodov, ki jih ocenjujeta, niti ne sodelujeta pri dejavnostih, ki bi lahko vplivale na njuno neodvisno presojo ali integriteto v zvezi z njunimi dejavnostmi ocenjevanja;
Accredited in-house bodies
organ opravlja svoje storitve izključno za podjetje, katerega del je.
Applicants may use an accredited in-house body to carry out conformity assessment activities for the purpose of implementing the procedures set out in modules A1, A2, C1 or C2 laid down in Annex II to Decision No 768/2008/EC and modules CA1 and CA2 laid down in Annex I to Decision 2010/713/EU.
Akreditirani interni organ se ne priglasi državam članicam ali Komisiji, vendar podjetje, katerega del je, ali nacionalni akreditacijski organ priglasitvenemu organu na njegovo zahtevo posreduje informacije o akreditaciji tega akreditiranega internega organa.
That body shall constitute a separate and distinct part of the applicant concerned and shall not participate in the design, production, supply, installation, use or maintenance of the products it assesses.
Člen 36
An accredited in-house body shall meet the following requirements:
Zahtevek za priglasitev
it shall be accredited in accordance with Regulation (EC) No 765/2008;
Organ za ocenjevanje skladnosti predloži zahtevek za priglasitev priglasitvenemu organu države članice, v kateri ima sedež.
the body and its personnel shall, within the undertaking of which they form a part, be organisationally identifiable and have reporting methods which ensure their impartiality, and shall demonstrate it to the competent national accreditation body;
Navedenemu zahtevku se priložijo opis dejavnosti ocenjevanja skladnosti ter opis modula ali modulov za ocenjevanje skladnosti in proizvoda ali proizvodov, za katere naj bi bil navedeni organ po lastnih trditvah pristojen, ter morebitno potrdilo o akreditaciji, ki ga izda nacionalni akreditacijski organ in ki potrjuje, da organ za ocenjevanje skladnosti izpolnjuje zahteve iz členov 30 do 32.
neither the body nor its personnel shall be responsible for the design, manufacture, supply, installation, operation or maintenance of the products they assess, nor shall they engage in any activity that might conflict with their independence of judgement or integrity in relation to their assessment activities;
Kadar zadevni organ za ocenjevanje skladnosti ne more zagotoviti potrdila o akreditaciji, priglasitvenemu organu predloži vsa dokazila, potrebna za verifikacijo, priznavanje in redno spremljanja njegovega izpolnjevanja zahtev iz členov 30 do 32.
the body shall supply its services exclusively to the undertaking of which it forms a part.
Člen 37
An accredited in-house body shall not be notified to the Member States or the Commission, but information concerning its accreditation shall be given by the undertaking of which it forms a part or by the national accreditation body to the notifying authority at the request of that authority.
Postopek priglasitve
Article 36
Priglasitveni organi priglasijo samo tiste organe za ocenjevanje skladnosti, ki izpolnjujejo zahteve iz členov 30 do 32.
Application for notification
Priglasitveni organi Komisiji in drugim državam članicam priglasijo organe iz odstavka 1 z uporabo elektronskega orodja za priglasitev, ki ga razvije in upravlja Komisija.
A conformity assessment body shall submit an application for notification to the notifying authority of the Member State in which it is established.
Priglasitev vključuje vse podrobnosti o dejavnostih ocenjevanja skladnosti ter o modulu ali modulih za ocenjevanje skladnosti in zadevnem proizvodu ali proizvodih ter ustrezno potrdilo o akreditaciji ali drugo potrdilo o usposobljenosti iz odstavka 4.
That application 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 Articles 30 to 32.
Kadar priglasitev ne temelji na potrdilu o akreditaciji iz člena 36(2), priglasitveni organ Komisiji in drugim državam članicam predloži dokazila, ki potrjujejo usposobljenost organa za ocenjevanje skladnosti, in uvedene ukrepe, ki zagotavljajo, da bo organ pod rednim nadzorom in bo še naprej izpolnjeval zahteve iz členov 30 do 32.
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 Articles 30 to 32.
Zadevni organ lahko izvaja dejavnosti priglašenega organa le, če Komisija ali druge države članice ne ugovarjajo v dveh tednih od priglasitve, če je uporabljeno potrdilo o akreditaciji, ali v dveh mesecih od priglasitve, če to potrdilo ni uporabljeno.
Article 37
Komisija in druge države članice so uradno obveščene o vseh nadaljnjih pomembnih spremembah priglasitve.
Notification procedure
Člen 38
Notifying authorities shall only notify conformity assessment bodies which comply with the requirements laid down in Articles 30 to 32.
Identifikacijske številke in seznami priglašenih organov
Notifying authorities shall notify the bodies referred to in paragraph 1 to the Commission and the other Member States using the electronic notification tool developed and managed by the Commission.
Komisija priglašenemu organu dodeli identifikacijsko številko.
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 accreditation certificate or other attestation of competence provided for in paragraph 4.
Dodeli mu eno identifikacijsko številko, tudi če je organ priglašen na podlagi več pravnih aktov Unije.
Where a notification is not based on an accreditation certificate as referred to in Article 36(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 periodically and will continue to satisfy the requirements laid down in Articles 30 to 32.
Komisija 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.
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.
Komisija zagotovi, da se navedeni seznam posodablja.
The Commission and the other Member States shall be notified of any subsequent relevant changes to the notification.
Člen 39
Article 38
Spremembe priglasitev
Identification numbers and lists of notified bodies
Kadar priglasitveni organ ugotovi ali je obveščen, da priglašeni organ ne izpolnjuje več zahtev iz členov 30 do 32 ali da ne izpolnjuje svojih obveznosti, omeji, začasno prekliče ali umakne priglasitev, če je ustrezno, skladno z resnostjo neizpolnjevanja teh zahtev ali obveznosti.
The Commission shall assign an identification number to a notified body.
O tem takoj ustrezno obvesti Komisijo in druge države članice.
A notified body shall be assigned a single identification number even where it is notified under several legal acts of the Union.
Če pride do omejitve, začasnega preklica ali umika priglasitve ali če priglašeni organ preneha dejavnost, priglasitvena država članica sprejme ustrezne ukrepe, s katerimi zagotovi, da zadeve tega organa obravnava drug priglašeni organ ali da so te zadeve pristojnim priglasitvenim organom in organom za nadzor trga na njihovo zahtevo še naprej na voljo.
The Commission shall make publicly available the list of the bodies notified under this Directive, including the identification numbers that have been allocated to them and the activities for which they have been notified.
Člen 40
The Commission shall ensure that that list is kept up to date.
Izpodbijanje usposobljenosti priglašenih organov
Article 39
Komisija razišče vse primere, za katere kakor koli dvomi ali je bila opozorjena na dvom v pristojnost priglašenega organa ali v njegovo dosledno izpolnjevanje zanj veljavnih zahtev in zadolžitev.
Changes to notifications
Priglasitvena država članica Komisiji na zahtevo predloži vse informacije z zvezi z osnovo za priglasitev ali ohranjanjem pristojnosti zadevnega organa.
Where a notifying authority has ascertained or has been informed that a notified body no longer meets the requirements laid down in Articles 30 to 32, 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.
Komisija zagotovi, da se vse informacije občutljive narave, pridobljene v okviru njenih preiskav, obravnavajo zaupno.
It shall immediately inform the Commission and the other Member States accordingly.
Kadar Komisija ugotovi, da priglašeni organ ne izpolnjuje ali ne izpolnjuje več zahtev za priglasitev, o tem obvesti priglasitveno državo članico in od nje zahteva, da sprejme ustrezne popravljalne ukrepe, vključno z umikom priglasitve, če je to potrebno.
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.
Člen 41
Article 40
Operativne obveznosti priglašenih organov
Challenges to the competence of notified bodies
Priglašeni organi izvajajo ocenjevanje skladnosti v skladu s postopki ocenjevanja skladnosti iz ustrezne TSI.
The Commission shall investigate all cases where it has any doubt, or where a 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.
Ocenjevanje skladnosti se izvaja sorazmerno, pri čemer se prepreči nepotrebna obremenitev gospodarskih subjektov.
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 body concerned.
Priglašeni organi pri izvajanju svojih dejavnosti upoštevajo velikost podjetja, gospodarski sektor, v katerem posluje, njegovo strukturo, stopnjo zahtevnosti zadevne tehnologije proizvoda ter masovno ali serijsko naravo proizvodnega postopka.
The Commission shall ensure that all sensitive information obtained in the course of its investigations is treated confidentially.
Pri tem kljub temu delujejo z namenom oceniti, ali je proizvod skladen s to direktivo.
Where the Commission ascertains that a notified body does not meet, or no longer meets, the requirements for its notification, it shall inform the notifying Member State accordingly and request it to take the necessary corrective measures, including withdrawal of notification if necessary.
Kadar priglašeni organ ugotovi, da proizvajalec ni izpolnil zahtev, določenih v ustrezni TSI ali zadevnih harmoniziranih standardih ali tehničnih specifikacijah, od njega zahteva, da sprejme ustrezne popravljalne ukrepe, in ne izda potrdila o skladnosti.
Article 41
Kadar med nadzorovanjem skladnosti po izdaji potrdila priglašeni organ ugotovi, da proizvod ni več skladen z ustrezno TSI ali zadevnimi harmoniziranimi standardi ali tehničnimi specifikacijami, od proizvajalca zahteva, da sprejme ustrezne popravljalne ukrepe, in po potrebi začasno prekliče ali odvzame potrdilo.
Operational obligations of notified bodies
Kadar popravljalni ukrepi niso sprejeti ali nimajo zahtevanega učinka, priglašeni organ omeji, začasno prekliče ali odvzame katera koli potrdila, kakor je primerno.
Notified bodies shall carry out conformity assessments in accordance with the conformity assessment procedures provided for in the relevant TSI.
Člen 42
Conformity assessments shall be carried out in a proportionate manner, avoiding unnecessary burdens for economic operators.
Obveznost priglašenih organov o zagotavljanju informacij
Notified bodies, when performing their activities, shall 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.
Priglašeni organi priglasitveni organ obvestijo o:
In so doing, they shall nevertheless operate with the aim of assessing the compliance of the product with this Directive.
vsaki zavrnitvi, omejitvi, začasnem preklicu ali odvzemu potrdila;
Where a notified body finds that requirements laid down in the relevant TSI or corresponding harmonised standards or technical specifications have not been met by a manufacturer, it shall require that manufacturer to take appropriate corrective measures and shall not issue a conformity certificate.
vseh okoliščinah, ki vplivajo na področje uporabe in pogoje priglasitve;
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 with the relevant TSI or corresponding harmonised standards or technical specifications, it shall require the manufacturer to take appropriate corrective measures and shall suspend or withdraw the certificate if necessary.
vsaki zahtevi po informacijah, ki so jo prejeli od organov za nadzor trga, v zvezi z dejavnostmi ocenjevanja 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.
dejavnostih ocenjevanja skladnosti, izvedenih v okviru njihove priglasitve, in o kakršnih koli drugih izvedenih dejavnostih, vključno s čezmejnimi dejavnostmi in sklepanjem pogodb s podizvajalci, če se od njih to zahteva.
Article 42
Pristojni nacionalni varnostni organi so tudi obveščeni o vsaki zavrnitvi, omejitvi, začasnem preklicu ali odvzemu potrdil na podlagi točke (a).
Obligation of notified bodies to provide information
Priglašeni organi drugim organom, ki so priglašeni v okviru te direktive in izvajajo podobne dejavnosti ocenjevanja skladnosti, ki zajemajo enake proizvode, zagotavljajo zadevne informacije o vprašanjih v zvezi z negativnimi in, na zahtevo, pozitivnimi rezultati ocenjevanja skladnosti.
Notified bodies shall inform the notifying authority of the following:
Priglašeni organi Agenciji posredujejo potrdila ES o verifikaciji podsistemov, potrdila ES o skladnosti komponent interoperabilnosti in potrdila ES o primernosti komponent interoperabilnosti za uporabo.
any refusal, restriction, suspension or withdrawal of a certificate;
Člen 43
any circumstances affecting the scope of, and conditions for, notification;
Izmenjava najboljših praks
any request for information which they have received from market surveillance authorities regarding conformity assessment activities;
Komisija omogoči izmenjavo najboljših praks med nacionalnimi organi držav članic, ki so pristojni za politiko glede priglasitev.
on request, conformity assessment activities performed within the scope of their notification and any other activity performed, including cross-border activities and subcontracting.
Člen 44
The competent national safety authorities shall also be informed of any refusal, restriction, suspension or withdrawal of a certificate under point (a).
Koordinacija priglašenih organov
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.
Komisija z vzpostavitvijo sektorske skupine priglašenih organov zagotovi ustrezno koordinacijo in sodelovanje med organi, ki so bili priglašeni v skladu s to direktivo.
Notified bodies shall provide the Agency with ‘EC’ certificates of verification of subsystems, ‘EC’ certificates of conformity of interoperability constituents and ‘EC’ certificates of suitability of use of interoperability constituents.
Agencija podpira dejavnosti priglašenih organov v skladu s členom 24 Uredbe (EU) 2016/796.
Article 43
Države članice zagotovijo, da organi, ki jih priglasijo, neposredno ali po pooblaščenih zastopnikih sodelujejo pri delu navedene skupine.
Exchanges of best practice
Člen 45
The Commission shall provide for the organisation of exchanges of best practices between the Member States' national authorities responsible for notification policy.
Imenovani organi
Article 44
Zahteve glede organov za ocenjevanje skladnosti iz členov 30 do 34 se uporabljajo tudi za organe, imenovane v skladu s členom 15(8), razen:
Coordination of notified bodies
v primeru kvalifikacij, ki se zahtevajo od osebja v skladu s točko (c) člena 32(1), ko mora imenovani organ ustrezno poznati in razumeti nacionalno pravo;