natgillin/translations-raw huggingface dataset:
Той не може да предлага или извършва каквито и да било дейности или услуги, които се предоставят от органите за оценка на съответствието, да предоставя търговски консултантски услуги, да притежава дялове или да има по друг начин финансов или управленски интерес в орган за оценка на съответствието .
It may not offer or provide any activities or services that conformity assessment bodies provide, provide commercial consultancy services , own shares or otherwise have a financial or managerial interest in a conformity assessment body .
Measures must be taken to ensure independence of both the national accreditation body and the conformity assessment bodies; and the list of these measures has to be completed with the one guaranteeing financial and managerial separation.
Measures must be taken to ensure independence of both the national accreditation body and the conformity assessment bodies; and the list of these measures has to be completed with the one guaranteeing financial and managerial separation.
Член 4, параграф 8
Article 4, paragraph 8
Националният орган по акредитация кандидатства за членство в Европейската организация за акредитация (EA).
The national accreditation body shall seek membership of European co-operation for Accreditation (EA) .
Националният орган по акредитация е член на органа, признат съгласно член 12а.
The national accreditation body shall be a member of the body recognised under Article 12a .
Voluntary membership in the recognised body is not sufficient because it would make the entire concept of European accreditation inconsistent.
Voluntary membership in the recognised body is not sufficient because it would make the entire concept of European accreditation inconsistent.
The change in Article 4(8) is in line with the general view on the desirability of identifying the EA as the one and only body to be granted special status under the Regulation expressed in the amendment to Recital 18.
The change in Article 4(8) is in line with the general view on the desirability of identifying the EA as the one and only body to be granted special status under the Regulation expressed in the amendment to Recital 18.
Член 4, параграф 8 a (нов)
Article 4, paragraph 8 a (new)
Националните органи по акредитация създават и поддържат подходящи структури, за да гарантират ефикасно и балансирано участие на всички заинтересовани страни както в техните организации, така и в Европейската мрежа за акредитация.
National accreditation bodies shall establish and maintain appropriate structures to ensure the effective and balanced involvement of all interested parties both within their organisations and the European accreditation network.
In order to balance the proposed non-competition status of accreditation and to ensure the safeguard of the required impartiality of national accreditation bodies, stakeholder interests should be adequately represented, both within the national accreditation bodies and the European accreditation network.
In order to balance the proposed non-competition status of accreditation and to ensure the safeguard of the required impartiality of national accreditation bodies, stakeholder interests should be adequately represented, both within the national accreditation bodies and the European accreditation network.
Когато нотифицирането на орган за оценка на съответствието не се основава на сертификат за акредитация, нотифициращият орган предоставя на Комисията и на другите държави-членки всички документни доказателства, нужни за проверката на компетентността на органа за оценка на съответствието.
Where a notification of a conformity assessment body is not based on an accreditation certificate, the notifying authority shall provide the Commission and the other Member States with all documentary evidence necessary for the verification of the competence of the conformity assessment body.
An important aim of the Regulation is to encourage the use of accreditation.
An important aim of the Regulation is to encourage the use of accreditation.
Where a Member State nevertheless opts to not use accreditation, it should be obliged to demonstrate conclusively to the other Member States and the Commission that the competence of the conformity assessment body has been verified to the same level as if an accreditation body had been used.
Where a Member State nevertheless opts to not use accreditation, it should be obliged to demonstrate conclusively to the other Member States and the Commission that the competence of the conformity assessment body has been verified to the same level as if an accreditation body had been used.
The text is carried over from the proposed Decision with some adjustments.
The text is carried over from the proposed Decision with some adjustments.
Когато националният орган по акредитация констатира, че органът за оценка на съответствието, който е получил сертификат за акредитация, не е вече компетентен да извършва специфична дейност по оценка на съответствието или извършва сериозно нарушение на задълженията си, националният орган по акредитация взема всички подходящи мерки, за да ограничи, прекрати или отнеме неговия сертификат за акредитация.
Where the 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 commits a serious breach of its obligations, the national accreditation body shall take all appropriate measures to restrict, suspend or withdraw its accreditation certificate.
Когато националният орган по акредитация констатира, че органът за оценка на съответствието, който е получил сертификат за акредитация, не е вече компетентен да извършва специфична дейност по оценка на съответствието или извършва сериозно нарушение на задълженията си, националният орган по акредитация в разумни срокове взема всички подходящи мерки, за да ограничи, прекрати или отнеме неговия сертификат за акредитация.
Where the 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 commits a serious breach of its obligations, the national accreditation body shall take all appropriate measures within a reasonable timeframe to restrict, suspend or withdraw its accreditation certificate.
National accreditation bodies shall take all appropriate measures within a reasonable timeframe to restrict, suspend or withdraw the accreditation certificate of a conformity assessment body in cases of incompetence of the latter.
National accreditation bodies shall take all appropriate measures within a reasonable timeframe to restrict, suspend or withdraw the accreditation certificate of a conformity assessment body in cases of incompetence of the latter.
The evaluation of whether the measure has been taken with reasonable promptness would ultimately be for the courts but should depend on the seriousness of the problem in the individual case.
The evaluation of whether the measure has been taken with reasonable promptness would ultimately be for the courts but should depend on the seriousness of the problem in the individual case.
A delay of even a short period could be deemed unreasonable if the circumstances and effects are sufficiently grave.
A delay of even a short period could be deemed unreasonable if the circumstances and effects are sufficiently grave.
Държавите-членки въвеждат процедури за обезпечаване на искове и жалби, предявени срещу решение за акредитацията или срещу липсата на такова решение .
Member States shall establish procedures for the resolution of appeals and complaints made against accreditation decisions, or the absence thereof .
Държавите-членки гарантират въвеждането на процедури за обезпечаване на искове, предявени срещу решение за акредитацията или срещу липсата на такова решение , и за произнасяне по жалби.
Member States shall ensure the establishment of procedures for the resolution of appeals made against accreditation decisions, or the absence thereof, and for the resolution of complaints.
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.
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.
Член 5, параграф 4 a (нов)
Article 5, paragraph 4 a (new)
Държавите-членки имат правото, в допълнение към разпоредбите на настоящия регламент, да поставят в областта "медицински изделия" допълнителни изисквания към нотифицираните органи, които смятат за уместни, за да се гарантира активно, превантивно и систематично наблюдение на пазара и да се постигне активна защита на пациентите, потребителите и други трети страни и съответствие със залегналите в Директива 93/42/ЕИО правила относно медицинските изделия.
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.
(Това устно изменение се основава на изменение 174)
(This oral AM is based on AM 174)
Член 5 а (нов), заглавие и параграф 1
Article 5 a (new), title and paragraph 1
Член 5a Принцип за неконкуренция
Article 5a Principle of non-competition
Националните органи по акредитация не конкурират органите за оценка на съответствието.
National accreditation bodies shall not compete with conformity assessment bodies.
Член 5 а (нов), параграф 2
Article 5 a (new), paragraph 2
Националните органи по акредитация не конкурират други национални органи по акредитация в рамките на ЕС по отношение на задължителни дейности по оценка на съответствието, за които се изисква акредитация.
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.
Член 5 а (нов), параграф 3
Article 5 a (new), paragraph 3
Все пак на националните органи по акредитация е разрешено да извършват дейност извън границите на държавата-членка, на територията на друга държава-членка, по искане на орган за оценка на съответствието по отношение на акредитация за задължителна дейност по оценка на съответствието при обстоятелствата, посочени в член 6, параграф 1, или ако тяхното съдействие е потърсено от национален орган по акредитация съгласно член 6, параграф 3 в сътрудничество с националния орган по акредитация на тази държава-членка.
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.
Член 6, параграф 1, алинея 1
Article 6, paragraph 1, subparagraph 1
Органът за оценка на съответствието трябва да подаде заявление за акредитация в националния орган по акредитация на държавата-членка, в която е създаден или в националния орган по акредитация, до чиито услуги държавата-членка се е позовала съгласно член 4, параграф 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).
Органът за оценка на съответствието трябва да подаде заявление за акредитация за задължителна дейност по оценка на съответствието в националния орган по акредитация на държавата-членка, в която е създаден или в националния орган по акредитация, до чиито услуги държавата-членка се е позовала съгласно член 4, параграф 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).
European conformity assessment bodies have to compete with conformity assessment bodies from outside Europe.
European conformity assessment bodies have to compete with conformity assessment bodies from outside Europe .
The cross-frontier accreditation policy for conformity assessment bodies from outside Europe is specified in Guidance by the International Accreditation Forum (IAF).
The cross-frontier accreditation policy for conformity assessment bodies from outside Europe is specified in Guidance by the International Accreditation Forum (IAF).
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.
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.
Член 7, точка 9 a (нова)
Article 7, point 9 a (new)
(9а) той разрешава и гарантира, че оценките на съответствието се извършват по подходящ начин, като се избягва ненужно обременяване на предприятията и се взема предвид размерът, браншът, организационната структура на предприятието, относителната сложност на производствената технология и серийният характер на производството.
(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.
Член 8, параграф 1, алинея 2
Article 8, paragraph 1, subparagraph 2
Държавите-членки могат да изберат да приемат, че необходимостта от наблюдение, предвидено в първи параграф, е задоволена от успешната партньорска проверка съгласно член 9.
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.
Държавите-членки избират да приемат, че необходимостта от наблюдение, предвидено в първи параграф, е задоволена от успешната партньорска проверка съгласно член 9.
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.
Националните органи по акредитация следва да разполагат с процедури за обжалване, за да осигурят на икономическите оператори правни средства за защита в случаи, при които те могат да докажат, че съответният орган по акредитация не разполага с минимума от изискваните умения или компетенции, или че не е безпристрастен.
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.
The existing proposal provides for a procedure whereby Member States are required to monitor their national accreditation bodies at regular intervals.
The existing proposal provides for a procedure whereby Member States are required to monitor their national accreditation bodies at regular intervals.
This protects the general public interest.
This protects the general public interest.
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.
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.
Националните органи по акредитация поддържат система за партньорска проверка и участват в нея .
National accreditation bodies shall operate a peer evaluation system and participate in it .
Националните органи по акредитация са подложени на партньорска проверка, организирана от органа, признат по член 12а .
National accreditation bodies shall subject themselves to peer evaluation as organised by the body recognised under Article 12a .
Член 9, параграф 1 a (нов)
Article 9, paragraph 1 a (new)
Заинтересованите страни имат правото да участват в системата, създадена за контрол на дейностите по партньорски проверки.
Stakeholders shall have the right to participate in the system set up for the supervision of peer evaluation activities.
To be credibly independent the system should not be a closed loop among ‘peers’ accrediting themselves within a small ‘club’.
To be credibly independent the system should not be a closed loop among ‘peers’ accrediting themselves within a small ‘club’.
National authorities participating in peer assessment should not deprive themselves of the competence of the users of the system: the industry.
National authorities participating in peer assessment should not deprive themselves of the competence of the users of the system: the industry.
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.
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.
Държавите-членки гарантират, че националните органи по акредитация извършват редовно партньорска проверка.
Member States shall ensure that their national accreditation bodies regularly undergo peer evaluation.
Държавите-членки гарантират, че националните органи по акредитация извършват редовно партньорска проверка според изискванията на параграф 1 .
Member States shall ensure that their national accreditation bodies regularly undergo peer evaluation , as required by paragraph 1 .
Партньорската проверка се извършва на базата на добре обосновани и прозрачни критерии за оценка и процедури.
The peer evaluation shall be operated on the basis of sound and transparent evaluation criteria and procedures.
Предвиждат се подходящи процедури за обжалване срещу решенията, взети в резултат на проверката.
Appropriate appeals procedures against decisions taken as a result of the evaluation shall be provided for.
Партньорската проверка се извършва на базата на добре обосновани и прозрачни критерии за оценка и процедури, особено по отношение на структурните изисквания, изискванията относно човешките ресурси и технологичните изисквания, по отношение на поверителността и жалбите .
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 .
To add certain elements as part of the obligatory basis of the peer evaluation.
To add certain elements as part of the obligatory basis of the peer evaluation.
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.
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.
Партньорската проверка констатира дали националните органи по акредитация отговарят на изискванията, посочени в член 7.
The peer evaluation shall ascertain whether the national accreditation bodies meet the requirements laid down in Article 7.
Националните органи по акредитация, успешно преминали партньорската проверка, признават взаимно еквивалентността на акредитациите и на резултатите от проверката на съответствието, извършени от акредитирани от тях органи.
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.
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.
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.
The peer evaluation system should be organised at European level and be operated according to harmonised rules.
The peer evaluation system should be organised at European level and be operated according to harmonised rules.
Резултатите от партньорската проверка се съобщават на всички държави-членки и на Комисията.
The results of the peer evaluation shall be communicated to all Member States and the Commission.
Окончателните резултати от партньорската проверка се публикуват и съобщават на всички държави-членки и на Комисията.
The final results of the peer evaluation shall be published and communicated to all Member States and the Commission.
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.
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.
Комисията осъществява надзор над правилата и правилното функциониране на системата за партньорска проверка.
The Commission shall oversee the rules and the proper functioning of the peer evaluation system.
Комисията , в сътрудничество с държавите-членки, осъществява надзор над правилата и правилното функциониране на системата за партньорска проверка.
The Commission shall , in co-operation with the Member States, oversee the rules and the proper functioning of the peer evaluation system.
Член 10, заглавие
Article 10, title
Презумпция за съответствие
Presumption of conformity
Презумпция за съответствие за националните органи по акредитация
Presumption of conformity for national accreditation bodies
Compliance with the standard is to be demonstrated through the peer evaluation process established within EA.
Compliance with the standard is to be demonstrated through the peer evaluation process established within EA.
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.
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.