natgillin/translations-raw huggingface dataset:
The national accreditation body shall not offer or provide any activities or services that conformity assessment bodies provide, nor shall it provide consultancy services, own shares in or otherwise have a financial or managerial interest in a conformity assessment body.
Nacionalni akreditacijski organ ne sme nuditi ali izvajati dejavnosti ali storitev, ki jih izvajajo organi za ugotavljanje skladnosti, kot tudi ne svetovalnih storitev, niti imeti v lasti delnic ali kakršnega koli finančnega ali upravljavskega interesa v organu za ugotavljanje skladnosti.
Each Member State shall ensure that its national accreditation body has the appropriate financial and personnel resources for the proper performance of its tasks, including the fulfilment of special tasks, such as activities for European and international accreditation cooperation and activities that are required to support public policy and which are not self-financing.
Vsaka država članica zagotovi, da ima njihov nacionalni akreditacijski organ na voljo ustrezne finančne in človeške vire za pravilno izvajanje svojih nalog, vključno za izpolnjevanje posebnih nalog, kot so dejavnosti evropskega in mednarodnega akreditacijskega sodelovanja ter dejavnosti, ki so potrebne za podporo javni politiki in ki niso samofinancirane.
The national accreditation body shall be a member of the body recognised under Article 14.
Nacionalni akreditacijski organ je član organa, priznanega na podlagi člena 14.
National accreditation bodies shall establish and maintain appropriate structures to ensure the effective and balanced involvement of all interested parties within both their organisations and the body recognised under Article 14.
Nacionalni akreditacijski organi vzpostavijo in vzdržujejo ustrezno strukturo za zagotavljanje učinkovitega in uravnoteženega vključevanja vseh interesnih skupin tako v svoje organizacije kakor v organ, priznan na podlagi člena 14.
Operation of accreditation
Izvajanje akreditacije
A national accreditation body shall, when requested by a conformity assessment body, evaluate whether that conformity assessment body is competent to carry out a specific conformity assessment activity.
Nacionalni akreditacijski organi na zahtevo organa za ugotavljanje skladnosti ocenijo, ali ima ta organ za ugotavljanje skladnosti pristojnosti za izvajanje določene dejavnosti ugotavljanja skladnosti.
Where it is found to be competent, the national accreditation body shall issue an accreditation certificate to that effect.
Če se ugotovi, da organ ima te pristojnosti, nacionalni akreditacijski organ izda certifikat o akreditaciji.
When a Member State decides not to use accreditation, it shall provide the Commission and the other Member States with all the documentary evidence necessary for the verification of the competence of the conformity assessment bodies it selects for the implementation of the Community harmonisation legislation in question.
Ko se država članica odloči, da ne bo uporabljala akreditacije, Komisiji in drugim državam članicam predloži vsa dokumentarna dokazila, potrebna za preverjanje pristojnosti organov za ugotavljanje skladnosti, ki jih država članica izbere za izvajanje zadevne usklajevalne zakonodaje Skupnosti.
National accreditation bodies shall monitor the conformity assessment bodies to which they have issued an accreditation certificate.
Nacionalni akreditacijski organi spremljajo vse organe za ugotavljanje skladnosti, ki so jim izdali certifikat o akreditaciji.
Where a national accreditation body ascertains that a conformity assessment body which has received an accreditation certificate is no longer competent to carry out a specific conformity assessment activity or has committed a serious breach of its obligations, that accreditation body shall take all appropriate measures within a reasonable timeframe to restrict, suspend or withdraw the accreditation certificate.
Kadar nacionalni akreditacijski organ ugotovi, da organ za ugotavljanje skladnosti, ki je prejel certifikat o akreditaciji, ni več pristojen za izvajanje določene dejavnosti ugotavljanja skladnosti, ali da je resno prekršil svoje obveznosti, ta akreditacijski organ v razumnem času sprejme vse ustrezne ukrepe, da omeji, začasno odvzame ali prekliče njegov certifikat o akreditaciji.
Member States shall establish procedures for the resolution of appeals, including, where appropriate, legal remedies against accreditation decisions or the absence thereof.
Države članice določijo postopke za reševanje ugovorov, vključno s pravnimi sredstvi, kjer je to primerno, zoper odločitve o akreditaciji ali njihovo odsotnost.
Principle of non-competition
Načelo nekonkurenčnosti
National accreditation bodies shall not compete with conformity assessment bodies.
Nacionalni akreditacijski organi ne konkurirajo organom za ugotavljanje skladnosti.
National accreditation bodies shall not compete with other national accreditation bodies.
Nacionalni akreditacijski organi ne konkurirajo drugim nacionalnim akreditacijskim organom.
National accreditation bodies shall be permitted to operate across national borders, within the territory of another Member State, either at the request of a conformity assessment body in the circumstances set out in Article 7(1), or, if they are asked to do so by a national accreditation body in accordance with Article 7(3), in cooperation with the national accreditation body of that Member State.
Nacionalnim akreditacijskim organom se dovoli delovanje prek nacionalnih meja na ozemlju druge države članice, bodisi na zahtevo organa za ugotavljanje skladnosti v okoliščinah, določenih v členu 7(1), bodisi če jih za to zaprosi nacionalni akreditacijski organ v skladu s členom 7(3), v sodelovanju z nacionalnim akreditacijskim organom te države članice.
Cross-border accreditation
Čezmejna akreditacija
Where a conformity assessment body requests accreditation it shall do so with the national accreditation body of the Member State in which it is established or with the national accreditation body to which that Member State has had recourse in accordance with Article 4(2).
Kadar organ za ugotavljanje skladnosti zaprosi za akreditacijo, to stori pri nacionalnem akreditacijskem organu države članice, v kateri ima sedež, ali pri nacionalnem akreditacijskem organu, ki ga ta država članica uporablja v skladu s členom 4(2).
However, a conformity assessment body may request accreditation by a national accreditation body other than those referred to in the first subparagraph in any one of the following situations:
Vendar pa lahko organ za ugotavljanje skladnosti zaprosi za akreditacijo tudi nacionalni akreditacijski organ, ki ni naveden v prvem pododstavku, in sicer v naslednjih primerih:
where the Member State in which it is established has decided not to establish a national accreditation body and has not had recourse to the national accreditation body of another Member State in accordance with Article 4(2);
kadar se država članica, v kateri ima sedež, ni odločila ustanoviti nacionalni akreditacijski organ in ne uporablja nacionalnega akreditacijskega organa druge države članice v skladu s členom 4(2);
where the national accreditation bodies referred to in the first subparagraph do not perform accreditation in respect of the conformity assessment activities for which accreditation is sought;
kadar nacionalni akreditacijski organi iz prvega pododstavka ne izvajajo akreditacije za dejavnosti ugotavljanja skladnosti, za katere se zahteva akreditacija;
where the national accreditation bodies referred to in the first subparagraph have not successfully undergone peer evaluation under Article 10 in respect of the conformity assessment activities for which accreditation is sought.
kadar so bili nacionalni akreditacijski organi iz prvega pododstavka v medsebojnem strokovnem vrednotenju v okviru člena 10 glede dejavnosti ugotavljanja skladnosti, za katere se zahteva akreditacija, negativno ovrednoteni.
Where a national accreditation body receives a request pursuant to paragraph 1(b) or (c), it shall inform the national accreditation body of the Member State in which the requesting conformity assessment body is established.
Kadar nacionalni akreditacijski organ prejme zahtevo iz odstavka 1(b) ali (c), obvesti nacionalni akreditacijski organ države članice, v kateri ima organ za ugotavljanje skladnosti, ki je dal zahtevo, sedež.
In such cases, the national accreditation body of the Member State in which the requesting conformity assessment body is established may participate as an observer.
V teh primerih lahko nacionalni akreditacijski organ države članice, v kateri ima organ za ugotavljanje skladnosti, ki je dal zahtevo, sedež, sodeluje kot opazovalec.
A national accreditation body may request another national accreditation body to carry out part of the assessment activity.
Nacionalni akreditacijski organ lahko zaprosi drugi nacionalni akreditacijski organ, da izvede del dejavnosti ocenjevanja.
In such a case, the accreditation certificate shall be issued by the requesting body.
V tem primeru certifikat o akreditaciji izda organ prosilec.
Requirements for national accreditation bodies
Zahteve za nacionalne akreditacijske organe
A national accreditation body shall fulfil the following requirements:
Nacionalni akreditacijski organ mora izpolnjevati naslednje zahteve:
it shall be organised in such a manner as to make it independent of the conformity assessment bodies it assesses and of commercial pressures, and to ensure that no conflicts of interest with conformity assessment bodies occur;
organiziran je tako, da je neodvisen od organov za ugotavljanje skladnosti, ki jih ocenjuje, in od tržnih pritiskov ter da zagotavlja, da z organi za ugotavljanje skladnosti ne pride do navzkrižja interesov;
it shall be organised and operated so as to safeguard the objectivity and impartiality of its activities;
organiziran in voden je tako, da zagotavlja objektivnost in nepristranskost svojih dejavnosti;
it shall ensure that each decision relating to the attestation of competence is taken by competent persons different from those who carried out the assessment;
zagotavlja, da vse odločitve o potrditvi pristojnosti sprejmejo pristojne osebe, različne od tistih, ki so izvedle ocenjevanje;
it shall have adequate arrangements to safeguard the confidentiality of the information obtained;
z ustreznimi dogovori zagotavlja zaupnost pridobljenih podatkov;
it shall identify the conformity assessment activities for which it is competent to perform accreditation, referring, where appropriate, to relevant Community or national legislation and standards;
opredeli dejavnosti ugotavljanja skladnosti, za katere ima pristojnost izvajanja akreditacije, pri čemer se, kjer je to primerno, sklicuje na ustrezno nacionalno zakonodajo ali zakonodajo Skupnosti in na standarde;
it shall set up the procedures necessary to ensure efficient management and appropriate internal controls;
določi potrebne postopke za zagotovitev učinkovitega upravljanja in ustreznega notranjega kontroliranja;
it shall have a number of competent personnel at its disposal sufficient for the proper performance of its tasks;
razpolaga z zadostnim številom strokovnega osebja za pravilno izvajanje svojih nalog;
it shall document the duties, responsibilities and authorities of personnel who could affect the quality of the assessment and of the attestation of competence;
dokumentira dolžnosti, odgovornosti in pooblastila osebja, ki bi lahko vplivali na kakovost ocenjevanja in potrditev pristojnosti;
it shall establish, implement and maintain procedures for monitoring the performance and competence of the personnel involved;
določi, izvaja in vzdržuje postopke spremljanja storilnosti in usposobljenosti zadevnega osebja;
it shall verify that conformity assessments are carried out in an appropriate manner, meaning that unnecessary burdens are not imposed on undertakings and that due account is taken 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;
preveri, da se ugotavljanje skladnosti izvaja na primeren način, kar pomeni, da se podjetjem ne nalagajo nepotrebna bremena in da se ustrezno upoštevajo velikost podjetja, sektor, v katerem deluje, njegova struktura, stopnja zapletenosti zadevne proizvodne tehnologije in množična narava proizvodnega postopka;
it shall publish audited annual accounts prepared in accordance with generally accepted accounting principles.
objavi letne revidirane računovodske izkaze, pripravljene v skladu s splošno sprejetimi računovodskimi načeli.
Compliance with requirements
Skladnost z zahtevami
Where a national accreditation body does not meet the requirements of this Regulation or fails to fulfil its obligations hereunder, the Member State concerned shall take appropriate corrective action or shall ensure that such corrective action is taken, and shall inform the Commission thereof.
Kadar nacionalni akreditacijski organ ne izpolnjuje zahtev ali obveznosti iz te uredbe, zadevna država članica sprejme ustrezni korektivni ukrep ali pa poskrbi, da se tak korektivni ukrep sprejme, o čemer obvesti tudi Komisijo.
Member States shall monitor their national accreditation bodies at regular intervals in order to ensure that they fulfil the requirements laid down in Article 8 on a continuing basis.
Države članice v rednih časovnih presledkih spremljajo svoje nacionalne akreditacijske organe, da bi zagotovile njihovo nenehno izvajanje zahtev iz člena 8.
Member States shall take the utmost account of the results of peer evaluation under Article 10 when carrying out the monitoring referred to in paragraph 2 of this Article.
Države članice pri izvajanju spremljanja iz odstavka 2 tega člena kar najbolj upoštevajo oceno medsebojnega strokovnega vrednotenja iz člena 10.
National accreditation bodies shall have in place the necessary procedures to deal with complaints against the conformity assessment bodies they have accredited.
Nacionalni akreditacijski organi lahko uporabljajo potrebne postopke za obravnavo pritožb zoper organe za ugotavljanje skladnosti, ki so jih pooblastili.
Peer evaluation
Medsebojno strokovno vrednotenje
National accreditation bodies shall subject themselves to peer evaluation organised by the body recognised under Article 14.
Nacionalni akreditacijski organi morajo opraviti medsebojno strokovno vrednotenje, ki ga organizira organ, priznan na podlagi člena 14.
Stakeholders shall have the right to participate in the system set up for the supervision of peer evaluation activities, but not in individual peer evaluation procedures.
Interesne skupine imajo pravico, da sodelujejo v sistemu, ki je ustanovljen za nadzor dejavnosti medsebojnega strokovnega vrednotenja, ne pa v posameznih postopkih medsebojnega strokovnega vrednotenja.
Member States shall ensure that their national accreditation bodies regularly undergo peer evaluation as required by paragraph 1.
Države članice zagotavljajo, da njihove nacionalne akreditacijske organe redno strokovno vrednotijo, kakor je predpisano v odstavku 1.
Peer evaluation shall be operated on the basis of sound and transparent evaluation criteria and procedures, in particular concerning structural, human resource and process requirements, confidentiality and complaints.
Medsebojno strokovno vrednotenje se izvaja na podlagi zanesljivih in preglednih meril in postopkov vrednotenja, zlasti v zvezi z zahtevami glede strukture, človeških virov in postopkov, zaupnosti ter pritožb.
Appropriate appeal procedures against decisions taken as a result of such evaluation shall be provided for.
Določiti je treba ustrezne pritožbene postopke zoper odločitve, ki so bili sprejeti kot posledica takega vrednotenja.
Peer evaluation shall ascertain whether the national accreditation bodies meet the requirements laid down in Article 8, taking into account the relevant harmonised standards referred to in Article 11.
Iz medsebojnega strokovnega vrednotenja je razvidno, ali nacionalni akreditacijski organi izpolnjujejo zahteve iz člena 8, upoštevajoč ustrezne harmonizirane standarde iz člena 11.
The outcome of peer evaluation shall be published and communicated by the body recognised under Article 14 to all Member States and the Commission.
Rezultate medsebojnega strokovnega vrednotenja organ, priznan na podlagi člena 14, objavi in posreduje vsem državam članicam in Komisiji.
The Commission shall, in cooperation with the Member States, oversee the rules and the proper functioning of the peer evaluation system.
Komisija v sodelovanju z državami članicami nadzira pravila in pravilno delovanje sistema medsebojnega strokovnega vrednotenja.
Presumption of conformity for national accreditation bodies
Domneva skladnosti za nacionalne akreditacijske organe
National accreditation bodies that demonstrate conformity with the criteria laid down in the relevant harmonised standard, the reference of which has been published in the Official Journal of the European Union, by having successfully undergone peer evaluation under Article 10 shall be presumed to fulfil the requirements laid down in Article 8.
Domneva se, da nacionalni akreditacijski organi, ki dokažejo skladnost z merili, navedenimi v ustreznem harmoniziranem standardu, sklicevanje na katerega je bilo objavljeno v Uradnem listu Evropske unije, tako da uspešno prestane medsebojno strokovno vrednotenje iz člena 10, izpolnjujejo zahteve iz člena 8.
National authorities shall recognise the equivalence of the services delivered by those accreditation bodies which have successfully undergone peer evaluation under Article 10, and thereby accept, on the basis of the presumption referred to in paragraph 1 of this Article, the accreditation certificates of those bodies and the attestations issued by the conformity assessment bodies accredited by them.
Nacionalni akreditacijski organi priznajo enakovrednost storitev, ki jih opravijo tisti akreditacijski organi, ki so uspešno prestali medsebojno strokovno vrednotenje iz člena 10, in s tem na podlagi domneve iz odstavka 1 tega člena sprejmejo certifikate o akreditaciji teh organov in certifikate, ki jih izdajo organi za ugotavljanje skladnosti, ki so jih akreditirali.
Information obligation
Obveznost obveščanja
Each national accreditation body shall inform the other national accreditation bodies of the conformity assessment activities in respect of which it operates accreditation and of any changes thereto.
Vsak nacionalni akreditacijski organ ostale nacionalne akreditacijske organe obvesti o dejavnostih ugotavljanja skladnosti, za katere izvaja akreditacijo, ter o vseh morebitnih spremembah.
Each Member State shall inform the Commission and the body recognised under Article 14 of the identity of its national accreditation body and of all conformity assessment activities in respect of which that body operates accreditation in support of Community harmonisation legislation, and of any changes thereto.
Vsaka država članica Komisijo in organ, priznan na podlagi člena 14, obvesti o identiteti svojega nacionalnega akreditacijskega organa in o vseh dejavnostih ugotavljanja skladnosti, za katere ta organ izvaja akreditacijo v korist usklajevalne zakonodaje Skupnosti, in o vseh morebitnih spremembah.
Each national accreditation body shall regularly make publicly available information concerning the results of its peer evaluation, the conformity assessment activities in respect of which it operates accreditation and any changes thereto.
Vsak nacionalni akreditacijski organ redno objavlja informacije o rezultatih medsebojnega strokovnega vrednotenja, dejavnostih ugotavljanja skladnosti, za katere izvaja akreditacijo, in o vseh morebitnih spremembah.
Requests to the body recognised under Article 14
Zaprosila organu, priznanemu na podlagi člena 14
The Commission may, after consulting the Committee set up by Article 5 of Directive 98/34/EC, request the body recognised under Article 14 to contribute to the development, maintenance and implementation of accreditation in the Community.
Komisija lahko po posvetovanju z odborom, ustanovljenim s členom 5 Direktive 98/34/ES, zahteva od organa, priznanega na podlagi člena 14, da prispeva k razvoju, ohranjanju in izvajanju akreditacije v Skupnosti.
The Commission may also, following the procedure laid down in paragraph 1:
Prav tako lahko Komisija po postopku iz odstavka 1:
request the body recognised under Article 14 to lay down evaluation criteria and procedures for peer evaluation and to develop sectoral accreditation schemes;
zahteva od organa, priznanega na podlagi člena 14, da določi merila in postopke za medsebojno strokovno vrednotenje in oblikuje sheme sektorske akreditacije;
accept any existing scheme that already lays down evaluation criteria and procedures for peer evaluation.
sprejme vse obstoječe sheme, ki že določajo merila in postopke za medsebojno strokovno vrednotenje.
The Commission shall ensure that sectoral schemes identify the technical specifications necessary to meet the level of competence required by Community harmonisation legislation in fields with specific requirements relating to technology, health and safety or environment related requirements or any other aspect of public interest protection.
Komisija zagotovi, da sektorske sheme opredeljujejo tehnične specifikacije, potrebne za doseganje take ravni usposobljenosti, kot jo zahteva usklajevalna zakonodaja Skupnosti na področjih s posebnimi zahtevami glede tehnologije, varovanja zdravja ali okolja ali kakšnega drugega vidika zaščite javnih interesov.
European accreditation infrastructure
Evropska akreditacijska infrastruktura
The Commission shall, after consulting the Member States, recognise a body which satisfies the requirements set out in Annex I to this Regulation.
Komisija po posvetovanju z državami članicami prizna organ, ki izpolnjuje zahteve, določene v Prilogi I k tej uredbi.
A body which is to be recognised pursuant to paragraph 1 shall conclude an agreement with the Commission.
Organ, ki naj bi se ga priznalo po odstavku 1, sklene sporazum s Komisijo.
That agreement shall specify, inter alia, the detailed tasks of the body, funding provisions and provisions for its supervision.
Ta sporazum med drugim določa natančne naloge organa, določbe o financiranju in določbe o nadzorovanju organa.
Both the Commission and the body shall be able to terminate the agreement without cause at the expiry of a reasonable period of notice to be defined therein.
Komisija in organ imata možnost prekiniti sporazum brez razloga ob poteku razumnega odpovednega roka, ki se določi v tem sporazumu.
The Commission and the body shall make the agreement public.
Sporazum med Komisijo in organom je javen.
The Commission shall communicate the recognition of a body pursuant to paragraph 1 to the Member States and to national accreditation bodies.
Komisija o priznanju organa na podlagi odstavka 1 obvesti države članice in nacionalne akreditacijske organe.
The Commission may not recognise more than one body at a time.
Komisija istočasno ne more priznati več kot en organ.
The first body recognised under this Regulation shall be the European cooperation for accreditation, provided that it has concluded an agreement as specified in paragraph 2.
Prvi organ, priznan na podlagi te uredbe, je Evropsko združenje za akreditacijo, pod pogojem, da sklene sporazum, določen v odstavku 2.
COMMUNITY MARKET SURVEILLANCE FRAMEWORK AND CONTROLS OF PRODUCTS ENTERING THE COMMUNITY MARKET
OKVIR NADZORA TRGA SKUPNOSTI IN NADZOR PROIZVODOV, KI VSTOPAJO NA TRG SKUPNOSTI
Articles 16 to 26 shall apply to products covered by Community harmonisation legislation.
Členi 16 do 26 se uporabljajo za proizvode, ki so zajeti v usklajevalni zakonodaji Skupnosti.
Each of the provisions of Articles 16 to 26 shall apply in so far as there are no specific provisions with the same objective in Community harmonisation legislation.
Vsaka določba iz členov 16 do 26 se uporablja, kadar v usklajevalni zakonodaji Skupnosti ni posebnih določb z istim ciljem.
The application of this Regulation shall not prevent market surveillance authorities from taking more specific measures as provided for in Directive 2001/95/EC.
Uporaba te uredbe organom za nadzor trga ne preprečuje sprejemanja bolj specifičnih ukrepov, kakor je predvideno v Direktivi 2001/95/ES.