natgillin/translations-raw huggingface dataset:
Če nacionalni akreditacijski organi ne izpolnjujejo svojih obveznosti, je treba zagotoviti, da so v nacionalni zakonodaji na voljo učinkoviti pravni ukrepi, da bi se položaj lahko izboljšal.
In case national accreditation bodies fail to meet their obligations it has to be guaranteed that effective legal measures are available under national law so that the situation can be remedied.
Države članice imajo na področju zdravil ne glede na določbe te uredbe pravico, da naložijo dodatne zahteve priglašenim organom, za katere menijo, da so bistvene za zagotavljanje aktivnega, preventivnega in sistematičnega nadzora trga ter za dosego aktivnega varstva bolnikov, uporabnikov in drugih tretjih strani ter skladnosti s predpisi, ki urejajo zdravila, določenimi v direktivi 93/42/EGS.
Notwithstanding the provisions of this Regulation, in the area of medicinal products Member States shall have the right to impose additional requirements on notified bodies which they regard as essential to guarantee active, preventive and systematic market surveillance, and to achieve the active protection of patients, users and other third parties and compliance with the rules governing medicinal products laid down in Directive 93/42/EEC.
(Ta ustni predlog spremembe temelji na predlogu spremembe 174)
(This oral AM is based on AM 174)
Člen 5 a (novo), naslov in odstavek 1
Article 5 a (new), title and paragraph 1
Člen 5a Načelo nekonkurenčnosti
Article 5a Principle of non-competition
Nacionalni akreditacijski organi ne konkurirajo organom za ugotavljanje skladnosti.
National accreditation bodies shall not compete with conformity assessment bodies.
Člen 5 a (novo), odstavek 2
Article 5 a (new), paragraph 2
Nacionalni akreditacijski organi ne konkurirajo drugim nacionalnim akreditacijskim organom na ozemlju Evropske unije v zvez z akreditacijo za dejavnosti obveznega ugotavljanja skladnosti.
National accreditation bodies shall not compete with other national accreditation bodies within the territory of the European Union with respect to accreditation for compulsory conformity assessment activities.
Člen 5 a (novo), odstavek 3
Article 5 a (new), paragraph 3
Vendar se nacionalnim akreditacijskim organom dovoli delovanje prek meja držav članic na ozemlju druge države članice na zahtevo organa za ugotavljanje skladnosti v zvezi z akreditacijo za dejavnost obveznega ugotavljanja skladnosti v okoliščinah iz člena 6(1) ali če jih za to zaprosi nacionalni akreditacijski organ iz člena 6(3) v sodelovanju z nacionalnim akreditacijskim organom te države članice.
National accreditation bodies, however, shall be permitted to operate across Member State borders, within the territory of another Member State, at the request of a conformity assessment body in respect of accreditation for a compulsory conformity assessment activity in the circumstances specified in Article 6(1) or if they are asked to do so by a national accreditation body under Article 6(3) in co-operation with the national accreditation body of that Member State.
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 na podlagi člena 4(2).
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 pursuant to Article 4(2).
Kadar organ za ugotavljanje skladnosti zaprosi za akreditacijo za dejavnost obveznega ugotavljanja skladnosti , to stori pri nacionalnem akreditacijskem organu države članice, v kateri ima sedež, ali pri nacionalnem akreditacijskem organu, ki ga ta država članica uporablja na podlagi člena 4(2).
Where a conformity assessment body requests accreditation for a compulsory conformity assessment activity , 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 pursuant to Article 4(2).
Evropski organi za ugotavljanje skladnosti morajo konkurirati organom za ugotavljanje skladnosti izven Evrope.
European conformity assessment bodies have to compete with conformity assessment bodies from outside Europe .
Čezmejna akreditacijska politika za organe za ugotavljanje skladnosti izven Evrope je določena v smernicah Mednarodnega akreditacijskega foruma.
The cross-frontier accreditation policy for conformity assessment bodies from outside Europe is specified in Guidance by the International Accreditation Forum (IAF).
Zahteve za čezmejno akreditacijo na prostovoljnem področju ne smejo biti bolj omejevalne kot politike Mednarodnega akreditacijskega foruma in Mednarodnega združenja za akreditacijo laboratorijev, da se izognemo neugodnemu položaju (stroški, birokracija) za evropske organe.
The requirements for cross-frontier accreditation in the voluntary field should not be more restrictive than the policies by the IAF and by the International Laboratory Accreditation Co-operation (ILAC) to avoid unnecessary disadvantages (costs, bureaucracy) for the European bodies.
Člen 7, točka 9 a (novo)
Article 7, point 9 a (new)
(9a) omogoči in jamči, 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.
(9a) it shall make it possible and guarantee 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 the undertaking, the sector in which it operates, the structure of the undertaking, the degree of complexity of the product technology in question and the mass nature of the production process.
Države članice lahko pozitivno oceno strokovnega vrednotenja iz člena 9 štejejo kot izpolnjevanje potreb po spremljanju, določenih v prvem odstavku.
Member States may choose to accept successful peer evaluation under Article 9 as fulfilling the needs of the monitoring provided for in the first paragraph.
Države članice štejejo pozitivno oceno strokovnega vrednotenja iz člena 9 kot izpolnjevanje potreb po spremljanju, določenih v prvem odstavku.
Member States shall choose to accept successful peer evaluation under Article 9 as fulfilling the needs of the monitoring provided for in the first paragraph.
Nacionalni akreditacijski organi uvedejo pritožbene postopke, da bi gospodarskim subjektom zagotovili pravna sredstva, če lahko dokažejo, da akreditacijski organ nima najmanjših zahtevanih znanj ali pristojnosti, ali da predstavlja pristranskost.
National accreditation bodies shall have in place appeal procedures to provide economic operators with a means of redress where they can demonstrate that an accredited body does not have the minimum required skills or competence, or that it is exhibiting bias.
Vendar, ker imajo ukrepi nacionalnih akreditacijskih organov in organov, ki jih akreditirajo, neposreden vpliv na gospodarske subjekte, morajo slednji imeti na voljo določeno pravno sredstvo.
However, since the actions of national accreditation bodies, and the bodies they accredit, have a direct impact on economic operators, the latter should have an explicit means of redress.
Nacionalni akreditacijski organi izvajajo sistem strokovnega vrednotenja in v njem sodelujejo .
National accreditation bodies shall operate a peer evaluation system and participate in it .
Nacionalni akreditacijski organi morajo opraviti strokovno vrednotenje, ki ga organizira organ, priznan v členu 12a.
National accreditation bodies shall subject themselves to peer evaluation as organised by the body recognised under Article 12a .
Interesne skupine imajo pravico, da sodelujejo v sistemu, ki je bil ustanovljen za nadzor dejavnosti strokovnega vrednotenja.
Stakeholders shall have the right to participate in the system set up for the supervision of peer evaluation activities.
Da bi bil verodostojno neodvisen, sistem ne sme biti zaprti krog "prijateljev", ki se medsebojno akreditirajo znotraj majhnega "kluba".
To be credibly independent the system should not be a closed loop among ‘peers’ accrediting themselves within a small ‘club’.
Nacionalni organi, ki sodelujejo pri strokovnem vrednotenju, si ne smejo odvzeti pristojnosti uporabnikov sistema: industrije.
National authorities participating in peer assessment should not deprive themselves of the competence of the users of the system: the industry.
Mednarodna shema za potrditev električnih proizvodov v skladu s standardi IEC se nanaša na strokovno vrednotenje in je odprta za interesne skupine na vodstveni ravni: enako velja tudi v Evropi v združenju evropskih certifikacijskih organov, ki so dejavni na področju direktive o nizki napetosti.
The international scheme for the approval of electrical products according to IEC standards relies on peer assessment and is open to interested stakeholders at the management level: the same is also true in Europe within the association of the European Certification bodies active in the Low Voltage Directive area.
Države članice zagotavljajo, da njihove nacionalne akreditacijske organe redno strokovno vrednotijo.
Member States shall ensure that their national accreditation bodies regularly undergo peer evaluation.
Države članice zagotavljajo, da njihove nacionalne akreditacijske organe redno strokovno vrednotijo , kot je predpisano v odstavku 1 .
Member States shall ensure that their national accreditation bodies regularly undergo peer evaluation , as required by paragraph 1 .
Strokovno vrednotenje se izvaja na podlagi zanesljivih in preglednih meril in postopkov vrednotenja.
The peer evaluation shall be operated on the basis of sound and transparent evaluation criteria and procedures.
Določiti je treba ustrezne pritožbene postopke zoper sklepe, ki so bili sprejeti kot posledica vrednotenja.
Appropriate appeals procedures against decisions taken as a result of the evaluation shall be provided for.
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 .
The peer evaluation shall be operated on the basis of sound and transparent evaluation criteria and procedures , especially concerning structural, human resource and process requirements, confidentiality and complaints .
Dodatek nekaterih elementov kot del obvezne podlage za strokovno vrednotenje.
To add certain elements as part of the obligatory basis of the peer evaluation.
Poročila o strokovnem vrednotenju morajo zadevati ta področja, pa tudi druga ustrezna področja pod ločenimi naslovi in v formatu, ki omogoča primerno primerjavo vseh poročil.
The reports on the peer evaluation should address these areas, as well any other relevant areas, under separate headings in a format enabling convenient comparison of all reports.
Iz strokovnega vrednotenja je razvidno, ali nacionalni akreditacijski organi izpolnjujejo zahteve iz člena 7.
The peer evaluation shall ascertain whether the national accreditation bodies meet the requirements laid down in Article 7.
Nacionalni akreditacijski organi, ki so uspešno opravili strokovno vrednotenje, priznajo enakovrednost medsebojnih akreditacij in rezultatov ugotavljanja skladnosti, izdanih s strani organov, ki so jih akreditirali.
National accreditation bodies that have successfully undergone peer evaluation shall recognise the equivalence of each others’ accreditations and the conformity assessment results issued by bodies accredited by them.
Članstvo v organu, priznanem v členu 12a, ne pomeni obveznosti za nacionalne akreditacijske organe, da sodelujejo pri strokovnem vrednotenju, ki je ključni instrument za dosego enakovrednosti, preglednosti in doslednosti akreditacijske prakse.
Membership to the body recognized under Article 12a does not imply the obligation for national accreditation bodies to participate in the peer evaluation, which is the key instrument to achieve equivalence, transparency and consistency of accreditation practice.
Sistem strokovnega vrednotenja bi bilo treba organizirati na evropski ravni in izvajati po usklajenih predpisih.
The peer evaluation system should be organised at European level and be operated according to harmonised rules.
Rezultate strokovnega vrednotenja se posreduje vsem državam članicam in Komisiji.
The results of the peer evaluation shall be communicated to all Member States and the Commission.
Končne rezultate strokovnega vrednotenja se objavi in posreduje vsem državam članicam in Komisiji.
The final results of the peer evaluation shall be published and communicated to all Member States and the Commission.
Z rezultati vrednotenja morajo biti seznanjene ne le države članice in Komisija, ampak morajo do njih imeti dostop tudi vse interesne skupine.
The results of the evaluation must not only be made known to the Member States and the Commission but must also be accessible to all interested parties.
Komisija nadzira pravila in pravilno delovanje sistema strokovnega vrednotenja.
The Commission shall oversee the rules and the proper functioning of the peer evaluation system.
Komisija v sodelovanju z državami članicami nadzira pravila in pravilno delovanje sistema strokovnega vrednotenja.
The Commission shall , in co-operation with the Member States, oversee the rules and the proper functioning of the peer evaluation system.
Domneva skladnosti
Presumption of conformity
Domneva skladnosti za nacionalne akreditacijske organe
Presumption of conformity for national accreditation bodies
Skladnost s standardom je treba dokazati s postopkom strokovnega vrednotenja, uvedenega v okviru Evropskega združenja za akreditacijo.
Compliance with the standard is to be demonstrated through the peer evaluation process established within EA.
Če se akreditacija uporablja za učinkovito podporo ustreznemu delovanju notranjega trga, tako da povečuje medsebojno zaupanje, potem je treba od samih akreditacijskih organov zahtevati dejavno dokazilo, da je zaupanje vanje upravičeno.
If the use of accreditation is to support efficiently the proper functioning of the internal market by increasing mutual confidence, then the accreditation bodies themselves need to be required to actively demonstrate that the confidence placed in them is justified.
Domneva se, da nacionalni akreditacijski organi, ki izpolnjujejo merila, navedena v ustreznem usklajenem standardu, sklicevanje na katerega je bilo objavljeno v Uradnem listu Evropske unije, izpolnjujejo zahteve iz člena 7.
National accreditation bodies that comply 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, shall be presumed to fulfil the requirements set out in Article 7.
Domneva se, da nacionalni akreditacijski organi, ki dokažejo skladnost z merili , navedenimi v ustreznem usklajenem standardu, sklicevanje na katerega je bilo objavljeno v Uradnem listu Evropske unije, tako da uspešno sodelujejo v sistemu strokovnega vrednotenja, določenem v členu 9, izpolnjujejo zahteve iz člena 7.
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 successful participation in the peer evaluation system set out in Article 9, shall be presumed to fulfil the requirements set out in Article 7.
Skladnost s standardom je treba dokazati s postopkom strokovnega vrednotenja, uvedenega v okviru organa, priznanega v členu 12a.
Compliance with the standard is to be demonstrated through the peer evaluation process established within the body recognized under Article 12a.
Nacionalni akreditacijski organ pristojne nacionalne organe in Komisijo obvesti o vseh dejavnostih ugotavljanja skladnosti, za katere izvaja akreditacijo v korist zakonodaje Skupnosti, in o vseh morebitnih spremembah.
A national accreditation body shall inform the competent national authorities and the Commission of all conformity assessment activities in respect of which it operates accreditation in support of Community legislation and of any changes thereto.
Nacionalni akreditacijski organ pristojne nacionalne organe , Komisijo in priznani organ iz člena 12a te uredbe obvesti o vseh dejavnostih ugotavljanja skladnosti, za katere izvaja akreditacijo v korist zakonodaje Skupnosti, in o vseh morebitnih spremembah.
A national accreditation body shall inform the competent national authorities , the Commission and the body recognised under Article 12a of this Regulation of all conformity assessment activities in respect of which it operates accreditation in support of Community legislation and of any changes thereto.
Vključitev "priznani organ iz člena 12a te uredbe" med obveznosti obveščanja nacionalnega akreditacijskega organa bo povečala preglednost med različnimi akterji.
The inclusion of “the body recognised under Article 12A of this regulation” into the information obligation for national accreditation bodies will increase the transparency among the various actors.
Nacionalni akreditacijski organ javno objavi informacije o rezultatih strokovnega vrednotenja, dejavnostih ugotavljanja skladnosti, za katere izvaja akreditacijo, in o vseh morebitnih spremembah.
A national accreditation body shall make publicly available information about the results of its peer evaluation, the conformity assessment activities in respect of which it operates accreditation and about any changes thereto.
Nacionalni akreditacijski organ redno in javno objavlja informacije o rezultatih strokovnega vrednotenja, dejavnostih ugotavljanja skladnosti, za katere izvaja akreditacijo, in o vseh morebitnih spremembah.
A national accreditation body shall make regularly and publicly available information about the results of its peer evaluation, the conformity assessment activities in respect of which it operates accreditation and about any changes thereto.
Informacije o rezultatih strokovnega vrednotenja morajo biti redno na voljo javnosti.
The information about the results of the peer evaluation should be publicly available and on a regular basis.
Prav tako lahko Komisija, po postopku iz prvega odstavka , zaprosi EA, da oblikuje sheme sektorske akreditacije.
The Commission may also, following the procedure laid down in the first paragraph , request the EA to develop sectoral accreditation schemes.
Prav tako lahko Komisija, po postopku iz prvega odstavka :
The Commission may also, following the procedure laid down in the first paragraph :
(a) sprejme vse obstoječe sheme, ki že določajo merila in postopke za strokovno vrednotenje;
(a) accept any such existing schemes that already lay down evaluation criteria and procedures for peer evaluation;
(b) od priznanega organa iz člena 12a zahteva, da določi merila in postopke za strokovno vrednotenje in oblikuje sheme sektorske akreditacije.
(b) request the body recognised under Article 12a to lay down evaluation criteria and procedures for peer evaluation and to develop sectoral accreditation schemes.
Uredba podeljuje priznanemu organu iz člena 12a pomembno vlogo pri zagotavljanju homogenosti in povečevanju kakovosti akreditacije v Evropi.
The Regulation gives the body recognised under Article 12a a major role to ensure the homogeneity and further the quality of accreditation within Europe .
Zato morajo sistem strokovnega vrednotenja, ki je v odgovornosti priznanega organa iz člena 12a, nadzorovati tudi države članice in Komisija.
Therefore the system of peer evaluation, under the responsibility of the body recognised under Article 12a, should also be under the control of the Member States and the Commission.
Take sheme opredeljujejo sektorske tehnične specifikacije, potrebne za zagotavljanje take ravni usposobljenosti, kot jo zahteva usklajevalna zakonodaja Skupnosti na področjih s posebnimi zahtevami glede tehnologije ali varovanja zdravja.
Such schemes shall identify the sectoral technical specifications necessary to ensure the level of competence required by Community harmonisation legislation in fields with specific technology or health and safety related requirements.
Take sheme opredeljujejo sektorske tehnične specifikacije, potrebne za zagotavljanje take ravni usposobljenosti, kot jo zahteva usklajevalna zakonodaja Skupnosti na področjih s posebnimi zahtevami glede tehnologije , okolja ali varovanja zdravja.
Such schemes shall identify the sectoral technical specifications necessary to ensure the level of competence required by Community harmonisation legislation in fields with specific technology or health , environment and safety related requirements.
Sklicevanje na varovanje okolja je bilo vključeno že v prejšnjih členih, zlasti zato, ker je treba rešiti primere neskladnosti z obstoječo zakonodajo EU na področju okolja.
The reference to the protection of the environment has been made already under previous articles not the least because cases of non-conformity with existing EU legislation in the environmental field also have to be dealt with.
Člen 12 a (novo), naslov in odstavek 1
Article 12 a (new), title and paragraph 1
Evropska akreditacijska infrastruktura
European accreditation infrastructure
Komisija po posvetovanju z državami članicami prizna organ, ki izpolnjuje zahteve iz priloge te uredbe.
The Commission shall, after consultation with the Member States, recognise a body which satisfies the requirements of the Annex to this Regulation.
Ta cilj je namenjen zagotavljanju vrste osnovnih zahtev za imenovanje priznanega organa in za sprejetje okvirnega sporazuma, ki se z njim sklene, obenem pa prekinitev sporazuma zaradi kršitve ali brez razloga, v zadnjem primeru na primer, če alternativni organ učinkoviteje izpolnjuje iste ali višje zahteve, je bil nadgrajen in bi zato moral prevzeti vlogo prvega, ali preprosto zaradi ponovnih pogajanj.
The objective is to provide a set of basic requirements for the appointment of the recognised body, and for the framework agreement to be concluded with it, while ensuring that the agreement can be terminated whether due to breach or without cause, in the latter case for example if an alternative body meeting the same requirements more effectively, or meeting higher requirements, has developed and therefore should be used instead, or simply for renegotiation.
Člen 12 a (novo), odstavek 2
Article 12 a (new), paragraph 2
Da bi bil priznan, organ s Komisijo sklene okvirni sporazum.
In order for a body to be recognised, it shall conclude a framework agreement with the Commission.
Ta sporazum med drugim vsebuje natančne naloge organa, katerih kršitev omogoči Komisiji prekinitev sporazuma, določbe o financiranju in določbe o nadzorovanju priznanega organa, pa tudi druge določbe, ki so običajne za tovrstni sporazum.
That agreement shall contain, inter alia, the detailed tasks of the body, breach of which will entitle the Commission to terminate the agreement, funding provisions and provisions for the supervision of the recognised body, as well as other provisions customary for an agreement of its type.
Okvirni sporazum med Komisijo in ustreznim organom je javen.
The Commission and the body concerned shall make the framework agreement public.
Komisija in ustrezni organ imata možnost prekiniti sporazum brez razloga ob poteku razumnega odpovednega roka, ki je določen v sporazumu.
Both the Commission and the body concerned shall be able to terminate the agreement without cause at the expiry of a reasonable notice period to be defined in the agreement.
Glej obrazložitev člena 12 a (novo), odstavek 1.
See justification to Article 12 a (new), paragraph 1.
Člen 12 a (novo), odstavek 3
Article 12 a (new), paragraph 3
Komisija o priznanju iz odstavka 1 obvesti države članice in nacionalne akreditacijske organe.
The Commission shall communicate recognition under paragraph 1 to Member States and the national accreditation bodies.
Člen 12 a (novo), odstavek 4
Article 12 a (new), paragraph 4