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  1. #744233

    Critéir cháilithe maidir le pearsanra

    Qualification criteria in relation to personnel

    Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. )

  2. #744237

    Saineofar critéir shonracha cháilithe ar a laghad chun measúnú a dhéanamh ar an méid seo a leanas:

    Specific qualification criteria shall be defined at least for the assessment of:

    Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. )

  3. #744252

    córas bainistithe cáilíochta an chomhlachta dá dtugtar fógra, na nósanna imeachta gaolmhara agus na critéir cháilithe atá riachtanach;

    the notified body's quality management system, related procedures and the required qualification criteria;

    Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. )

  4. #747804

    Critéir cháilithe maidir le pearsanra

    Qualification criteria in relation to personnel

    Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance. )

  5. #747808

    Saineofar critéir shonracha cháilithe ar a laghad chun measúnú a dhéanamh ar an méid seo a leanas:

    Specific qualification criteria shall be defined at least for the assessment of:

    Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance. )

  6. #747822

    córas bainistithe cáilíochta an chomhlachta dá dtugtar fógra, na nósanna imeachta gaolmhara agus na critéir cháilithe atá riachtanach;

    the notified body's quality management system, related procedures and the required qualification criteria;

    Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance. )

  7. #2440877

    na critéir cháilithe ar a raibh an roghnú bunaithe,

    the qualification criteria upon which the selection was based;

    Directive (EU) 2022/2381 of the European Parliament and of the Council of 23 November 2022 on improving the gender balance among directors of listed companies and related measures (Text with EEA relevance)

  8. #1915052

    Áiritheoidh na Ballstáit go gcomhlíonfaidh na breathnóirí na critéir cháilíochta a leagtar amach in Iarscríbhinn II a ghabhann leis an gComhaontú.

    Member States shall ensure that observers fulfil the qualification criteria set out in the Annex II to the Agreement.

    Regulation (EU) 2021/56 of the European Parliament and of the Council of 20 January 2021 laying down management, conservation and control measures applicable in the Inter-American Tropical Tuna Convention area and amending Council Regulation (EC) No 520/2007

  9. #2440740

    Le níos mó trédhearcachta i leith na gcritéar cáilithe agus an phróisis roghnúcháin do stiúrthóirí, cuirtear ar a gcumas d’infheisteoirí measúnú níos fearr a dhéanamh ar straitéis ghnó na cuideachta agus cinntí eolasacha a dhéanamh.

    More transparency in the qualification criteria and the selection process for directors enables investors to better assess the company’s business strategy and to take informed decisions.

    Directive (EU) 2022/2381 of the European Parliament and of the Council of 23 November 2022 on improving the gender balance among directors of listed companies and related measures (Text with EEA relevance)

  10. #2804034

    Féadfaidh na Ballstáit a chinneadh critéir cháilíochta a leagan síos d’ionadaithe oibrithe in imeachtaí cúirte a bhaineann le héilimh ar phá chomhionainn, chun a áirithiú go bhfuil na hionadaithe sin cáilithe go leordhóthanach.

    Member States may decide to set qualification criteria for representatives of workers in court proceedings relating to equal pay claims, in order to ensure that such representatives are adequately qualified.

    Directive (EU) 2023/970 of the European Parliament and of the Council of 10 May 2023 to strengthen the application of the principle of equal pay for equal work or work of equal value between men and women through pay transparency and enforcement mechanisms (Text with EEA relevance)

  11. #2937081

    déanann saineolaithe cáilithe nó creidiúnaithe iad ar bhealach neamhspleách i gcomhréir le critéir cháilithe; nó

    carried out in an independent manner by qualified or accredited experts in accordance with qualification criteria; or

    Directive (EU) 2023/1791 of the European Parliament and of the Council of 13 September 2023 on energy efficiency and amending Regulation (EU) 2023/955 (recast) (Text with EEA relevance)

  12. #744234

    Déanfaidh an Comhlachtaí dá dTugtar Fógra na critéir cháilithe agus na nósanna imeachta a bhunú agus a dhoiciméadú chun daoine atá bainteach le gníomhaíochtaí um measúnú comhréireachta a roghnú agus a údarú, lena n-áirítear maidir le heolas, taithí agus na hinniúlachtaí eile is gá, agus an oiliúint tosaigh agus oiliúint leanúnach is gá.

    The Notified Body shall establish and document qualification criteria and procedures for selection and authorisation of persons involved in conformity assessment activities, including as regards knowledge, experience and other competence required, and the required initial and ongoing training.

    Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. )

  13. #744235

    Leis na critéir cháilithe, tabharfar aghaidh ar na feidhmeanna éagsúla laistigh den phróiseas um measúnú comhréireachta, amhail iniúchóireacht, meastóireacht nó tástáil táirgí, athbhreithniú ar an doiciméadacht theicniúil agus ar chinnteoireacht, chomh maith leis na feistí, na teicneolaíochtaí agus na réimsí amhail bith-chomhoiriúnacht, steiriliú, fíocháin agus cealla de bhunús daonna agus ainmhíoch agus meastóireacht chliniciúil, a chumhdaítear le raon an ainmniúcháin.

    The qualification criteria shall address the various functions within the conformity assessment process, such as auditing, product evaluation or testing, technical documentation review and decision-making, as well as the devices, technologies and areas, such as biocompatibility, sterilisation, tissues and cells of human and animal origin and clinical evaluation, covered by the scope of designation.

    Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. )

  14. #744236

    Leis na critéir cháilithe dá dtagraítear i Roinn 3.2.1, déanfar tagairt do raon ainmniúcháin comhlachta dá dtugtar fógra i gcomhréir leis an tuairisc raoin arna húsáid ag an mBallstát don fhógra dá dtagraítear in Airteagal 42(3), lena soláthraítear leibhéal leordhóthanach sonraí don cháilíocht is gá laistigh d'fhoranna na tuairisce raoin.

    The qualification criteria referred to in Section 3.2.1 shall refer to the scope of a notified body's designation in accordance with the scope description used by the Member State for the notification referred to in Article 42(3), providing a sufficient level of detail for the required qualification within the subdivisions of the scope description.

    Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. )

  15. #744247

    Maidir leis an bpearsanra atá freagrach as critéir cháilithe a bhunú agus as pearsanra eile a údarú chun gníomhaíochtaí sonracha um measúnú comhréireachta a chomhlíonadh, fostóidh an comhlacht féin dá dtugtar fógra iad agus ní saineolaithe seachtracha a bheidh i gceist ná ní ligfear obair ar fochonradh dóibh.

    The personnel responsible for establishing qualification criteria and for authorising other personnel to perform specific conformity assessment activities shall be employed by the notified body itself and shall not be external experts or subcontracted.

    Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. )

  16. #744290

    Beidh próiseas ar bun ag an gcomhlacht dá dtugtar fógra chun doiciméadú iomlán a dhéanamh ar cháiliú gach baill foirne atá bainteach le gníomhaíochtaí um measúnú comhréireachta agus comhlíonadh na gcritéar cáilithe dá dtagraítear i Roinn 3.2.

    The notified body shall have a procedure in place to fully document the qualification of each member of personnel involved in conformity assessment activities and the satisfaction of the qualification criteria referred to in Section 3.2.

    Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. )

  17. #744291

    Más rud é, in imthosca eisceachtúla nach féidir comhlíonadh na gcritéar cáilithe a leagtar amach i Roinn 3.2 a thaispeáint go hiomlán, tabharfaidh an comhlacht dá dtugtar fógra údar don údarás náisiúnta atá freagrach as comhlachtaí dá dtugtar fógra, is é sin an t-údar atá le húdarú an phearsanra sin chun gníomhaíochtaí um measúnú comhréireachta a chur i gcrích.

    Where in exceptional circumstances the fulfilment of the qualification criteria set out in Section 3.2. cannot be fully demonstrated, the notified body shall justify to the authority responsible for notified bodies the authorisation of those members of personnel to carry out specific conformity assessment activities.

    Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. )

  18. #747805

    Déanfaidh an comhlacht dá dtugtar fógra na critéir cháilithe agus na nósanna imeachta a bhunú agus a dhoiciméadú chun daoine atá bainteach le gníomhaíochtaí um measúnú comhréireachta a roghnú agus a údarú, lena n-áirítear maidir le heolas, taithí agus na hinniúlachtaí eile is gá, agus maidir leis an oiliúint tosaigh agus an oiliúint leanúnach is gá.

    The notified body shall establish and document qualification criteria and procedures for selection and authorisation of persons involved in conformity assessment activities, including as regards knowledge, experience and other competence required, and the required initial and ongoing training.

    Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance. )

  19. #747806

    Leis na critéir cháilithe, tabharfar aghaidh ar na feidhmeanna éagsúla laistigh den phróiseas um measúnú comhréireachta, amhail iniúchóireacht, meastóireacht nó tástáil táirgí, athbhreithniú ar an doiciméadacht theicniúil, cinnteoireacht agus scaoileadh baisceanna, chomh maith leis na feistí, na teicneolaíochtaí agus na réimsí amhail bith-chomhoiriúnacht, steiriliú, féintástáil nó tástáil neas-othair, feistí diagnóiseacha coimhdeachta agus meastóireacht feidhmíochta, a chumhdaítear le raon an ainmniúcháin.

    The qualification criteria shall address the various functions within the conformity assessment process, such as auditing, product evaluation or testing, technical documentation review, decision-making, and batch release, as well as the devices, technologies and areas, such as biocompatibility, sterilisation, self and near patient-testing, companion diagnostics and performance evaluation, covered by the scope of designation.

    Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance. )

  20. #747807

    Leis na critéir cháilithe dá dtagraítear i Roinn 3.2.1, déanfar tagairt do raon ainmniúcháin an chomhlachta dá dtugtar fógra i gcomhréir leis an tuairisc raoin arna húsáid ag an mBallstát don fhógra dá dtagraítear in Airteagal 38(3), lena soláthraítear leibhéal leordhóthanach sonraí don cháilíocht is gá laistigh d'fhoranna na tuairisce raoin.

    The qualification criteria referred to in Section 3.2.1 shall refer to the scope of the notified body's designation in accordance with the scope description used by the Member State for the notification referred to in Article 38(3), providing a sufficient level of detail for the required qualification within the subdivisions of the scope description.

    Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance. )

  21. #747817

    Maidir leis an bpearsanra atá freagrach as critéir cháilithe a bhunú agus as pearsanra eile a údarú chun gníomhaíochtaí sonracha um measúnú comhréireachta a chomhlíonadh, fostóidh an comhlacht féin dá dtugtar fógra iad agus ní saineolaithe seachtracha a bheidh iontu ná ní ligfear dóibh obair ar fochonradh.

    The personnel responsible for establishing qualification criteria and for authorising other personnel to perform specific conformity assessment activities shall be employed by the notified body itself and shall not be external experts or subcontracted.

    Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance. )

  22. #747860

    Beidh nós imeachta ar bun ag an gcomhlacht dá dtugtar fógra chun doiciméadú iomlán a dhéanamh ar cháiliú gach baill den phearsanra atá bainteach le gníomhaíochtaí um measúnú comhréireachta agus comhlíonadh na gcritéar cáilithe dá dtagraítear i Roinn 3.2.

    The notified body shall have a procedure in place to fully document the qualification of each member of personnel involved in conformity assessment activities and the satisfaction of the qualification criteria referred to in Section 3.2.

    Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance. )

  23. #747861

    Más rud é, in imthosca eisceachtúla, nach féidir comhlíonadh na gcritéar cáilithe a leagtar amach i Roinn 3.2 a thaispeáint go hiomlán, tabharfaidh an comhlacht dá dtugtar fógra bonn cirt don údarás atá freagrach as comhlachtaí dá dtugtar fógra, leis an údarú atá ag na baill sin den phearsanra chun gníomhaíochtaí um measúnú comhréireachta a chur i gcrích.

    Where, in exceptional circumstances, the fulfilment of the qualification criteria set out in Section 3.2 cannot be fully demonstrated, the notified body shall justify to the authority responsible for notified bodies the authorisation of those members of personnel to carry out specific conformity assessment activities.

    Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance. )

  24. #1985798

    Leis an ionstraim nua, sholáthrófaí creat cuimsitheach a chlúdódh príomhghnéithe uile an ábhair (prionsabail toghcháin, critéir cháilíochta, glao ar iarratas, tíolacadh agus scrúdú iarratas, trédhearcacht, vótáil, coinníollacha seirbhíse, etc.).

    The new instrument would provide a comprehensive framework covering all main aspects of the subject matter (election principles, qualification criteria, call for application, submission and examination of applications, transparency, voting, conditions of service, etc.).

    Council Decision (EU) 2021/1744 of 28 September 2021 establishing the position to be adopted on behalf of the European Union at the 15th General Assembly of the Intergovernmental Organisation for International Carriage by Rail (OTIF)

  25. #2440737

    An easpa trédhearcachta atá ann faoi láthair sa phróiseas roghnúcháin agus i leith na gcritéar cáilithe do phoist stiúrthóra i bhformhór na mBallstát, is bacainn mhór é ar chomhionannas inscne níos fearr i measc stiúrthóirí agus bíonn tionchar diúltach aige ar ghairmréim agus ar shaoirse gluaiseachta na n-iarrthóirí ar phoist bhoird, agus ar chinntí infheisteoirí.

    The current lack of transparency in the selection process and qualification criteria for director positions in most Member States represents a significant barrier to greater gender balance among directors and negatively affects both the board candidates’ careers and freedom of movement and investor decisions.

    Directive (EU) 2022/2381 of the European Parliament and of the Council of 23 November 2022 on improving the gender balance among directors of listed companies and related measures (Text with EEA relevance)

  26. #2440742

    Cé nach bhfuil sé d’aidhm ag an treoir seo comhchuibhiú mionsonraithe a dhéanamh ar dhlíthe náisiúnta maidir leis an bpróiseas roghnúcháin agus na critéir cháilithe do phoist stiúrthóra, is gá, chun an chothromaíocht inscne a bhaint amach, ceanglais íosta áirithe a thabhairt isteach ar chuideachtaí liostaithe nach bhfuil ionadaíocht chothrom inscne acu a bhaineann le hiarrthóirí a roghnú lena gceapadh chuig poist stiúrthóra nó lena dtoghadh do phoist stiúrthóra ar bhonn próiseas roghnúcháin atá trédhearcach agus sainithe go soiléir agus mheasúnú comparáideach oibiachtúil ar a gcáilíochtaí i dtéarmaí oiriúnachta, inniúlachta agus feidhmíocht ghairmiúil de.

    While this Directive does not aim to harmonise national laws on the selection process and qualification criteria for director positions in detail, the introduction of certain minimum requirements for listed companies without balanced gender representation relating to the selection of candidates for appointment or election to director positions on the basis of a transparent and clearly defined selection process and an objective comparative assessment of their qualifications in terms of suitability, competence and professional performance is necessary for achieving gender balance.

    Directive (EU) 2022/2381 of the European Parliament and of the Council of 23 November 2022 on improving the gender balance among directors of listed companies and related measures (Text with EEA relevance)

  27. #2440789

    I bhfianaise chuspóirí na Treorach seo a mhéid a bhaineann le cothromaíocht inscne, ba cheart a cheangal ar chuideachtaí liostaithe, arna iarraidh sin d’iarrthóir atá roghnaithe lena cheapadh nó lena ceapadh chuig poist stiúrthóra nó lena thoghadh nó lena toghadh do phoist stiúrthóra, an t-iarrthóir sin a chur ar an eolas faoi na critéir cháilithe ar a raibh an roghnú bunaithe, faoin measúnú comparáideach oibiachtúil ar na hiarrthóirí faoi na critéir sin agus, i gcás inarb ábhartha, faoi na breithnithe sonracha lenar cinneadh go heisceachtúil tosaíocht a thabhairt d’iarrthóir nach duine den ghnéas thearcionadaithe é nó í.

    In view of the objectives of this Directive as regards gender balance, listed companies should be required at the request of a candidate for appointment or election to a director position, to inform that candidate of the qualification criteria upon which the selection was based, the objective comparative assessment of the candidates under those criteria and, where relevant, the specific considerations exceptionally tilting the balance in favour of a candidate who is not of the underrepresented sex.

    Directive (EU) 2022/2381 of the European Parliament and of the Council of 23 November 2022 on improving the gender balance among directors of listed companies and related measures (Text with EEA relevance)