natgillin/translations-raw huggingface dataset:
The notified body shall be a third-party body that is independent of the manufacturer of the device in relation to which it performs conformity assessment activities.
nadzor nad financami priglašenega organa;
The notified body shall also be independent of any other economic operator having an interest in the device as well as of any competitors of the manufacturer.
dejavnosti in odločitve, ki jih sprejme priglašeni organ, vključno s pogodbenimi sporazumi;
This does not preclude the notified body from carrying out conformity assessment activities for competing manufacturers.
po potrebi prenos pooblastil na osebje in/ali odbore za izvedbo določenih dejavnosti;
The notified body shall be organised and operated so as to safeguard the independence, objectivity and impartiality of its activities.
komunikacijo z organom, pristojnim za priglašene organe, in obveznosti glede komunikacije z drugimi pristojnimi organi, Komisijo in drugimi priglašenimi organi.
The notified body shall document and implement a structure and procedures for safeguarding impartiality and for promoting and applying the principles of impartiality throughout its organisation, personnel and assessment activities.
Neodvisnost in nepristranskost
Such procedures shall provide for the identification, investigation and resolution of any case in which a conflict of interest may arise, including involvement in consultancy services in the field of devices prior to taking up employment with the notified body.
Priglašeni organ je organ tretje strani, ki je neodvisen od proizvajalca pripomočka, v zvezi s katerim izvaja dejavnosti ugotavljanja skladnosti.
The investigation, outcome and its resolution shall be documented.
Priglašeni organ je neodvisen tudi od katerega koli drugega gospodarskega subjekta, ki ima interes za pripomoček, in od katerih koli konkurentov proizvajalca.
The notified body, its top-level management and the personnel responsible for carrying out the conformity assessment tasks shall not:
To ne preprečuje priglašenemu organu, da opravlja dejavnosti ugotavljanja skladnosti za konkurenčne proizvajalce.
be the designer, manufacturer, supplier, installer, purchaser, owner or maintainer of devices which they assess, nor the authorised representative of any of those parties.
Priglašeni organ s svojo organizacijo in delovanjem zagotavlja neodvisnost, objektivnost in nepristranskost pri izvajanju svojih dejavnosti.
Such restriction shall not preclude the purchase and use of assessed devices that are necessary for the operations of the notified body and the conduct of the conformity assessment, or the use of such devices for personal purposes;
Priglašeni organ dokumentira in izvaja strukturo in postopke za zagotovitev nepristranskosti ter za spodbujanje in uporabo načel nepristranskosti v svoji organizaciji, med osebjem in v dejavnostih ocenjevanja.
be involved in the design, manufacture or construction, marketing, installation and use, or maintenance of the devices for which they are designated, nor represent the parties engaged in those activities;
Takšni postopki omogočajo identifikacijo, preiskovanje in rešitev v vsakem primeru, v katerem lahko pride do nasprotja interesov, vključno s sodelovanjem pri svetovalnih storitvah na področju pripomočkov pred zaposlitvijo pri priglašenem organu.
engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are designated;
Preiskava, rezultati in rešitev primerov se dokumentirajo.
offer or provide any service which may jeopardise the confidence in their independence, impartiality or objectivity.
Priglašeni organ, njegovo najvišje vodstvo in osebje, odgovorno za izvajanje nalog ugotavljanja skladnosti:
In particular, they shall not offer or provide consultancy services to the manufacturer, its authorised representative, a supplier or a commercial competitor as regards the design, construction, marketing or maintenance of devices or processes under assessment, and
niso snovalci, proizvajalci, dobavitelji, monterji, kupci, lastniki ali vzdrževalci pripomočkov, ki jih ocenjujejo, ali pooblaščeni predstavniki katere koli od navedenih strani.
be linked to any organisation which itself provides consultancy services as referred to in point (d).
Takšna omejitev ne izključuje nakupa in uporabe ocenjenih pripomočkov, ki so nujni za delovanje priglašenega organa in izvajanje ugotavljanja skladnosti, ali uporabe takih izdelkov za osebne namene;
Such restriction does not preclude general training activities that are not client specific and that relate to regulation of devices or to related standards.
ne sodelujejo pri zasnovi, izdelavi ali zgradbi, trženju, montaži in uporabi ali vzdrževanju pripomočkov, za katere so imenovani, in ne zastopajo strani, ki se ukvarjajo z navedenimi dejavnostmi;
Involvement in consultancy services in the field of devices prior to taking up employment with a notified body shall be fully documented at the time of employment and potential conflicts of interest shall be monitored and resolved in accordance with this Annex.
ne sodelujejo pri dejavnostih, ki bi lahko bile v nasprotju z njihovo neodvisno presojo ali integriteto v zvezi z dejavnostmi ugotavljanja skladnosti, za katere so imenovani;
Personnel who were formerly employed by a specific client, or provided consultancy services in the field of devices to that specific client prior to taking up employment with a notified body, shall not be assigned for conformity assessment activities for that specific client or companies belonging to the same group for a period of three years.
ne nudijo ali izvajajo nobenih storitev, ki bi lahko ogrozile zaupanje v njihovo neodvisnost, nepristranskost ali objektivnost.
The impartiality of notified bodies, of their top-level management and of the assessment personnel shall be guaranteed.
Zlasti ne ponujajo ali izvajajo svetovalnih storitev za proizvajalca, njegovega pooblaščenega predstavnika, dobavitelja ali tržnega konkurenta v zvezi z zasnovo, zgradbo, trženjem ali vzdrževanjem pripomočkov ali postopki, ki se ocenjujejo, in
The level of the remuneration of the top-level management and assessment personnel of a notified body and subcontractors, involved in assessment activities shall not depend on the results of the assessments.
niso povezani z nobeno organizacijo, ki sama zagotavlja svetovalne storitve, kot je navedeno v točki (d).
Notified bodies shall make publicly available the declarations of interest of their top-level management.
Takšna omejitev ne izključuje dejavnosti splošnega usposabljanja, ki se ne osredotočajo na potrebe stranke in ki se nanašajo na predpise o pripomočkih ali povezane standarde.
If a notified body is owned by a public entity or institution, independence and absence of any conflict of interest shall be ensured and documented between, on the one hand, the authority responsible for notified bodies and/or the competent authority and, on the other hand, the notified body.
Sodelovanje pri svetovalnih storitvah na področju pripomočkov pred zaposlitvijo pri priglašenem organu se ob zaposlitvi v celoti dokumentira, morebitna nasprotja interesov pa se spremljajo in rešujejo v skladu s to prilogo.
The notified body shall ensure and document that the activities of its subsidiaries or subcontractors, or of any associated body, including the activities of its owners do not affect its independence, impartiality or the objectivity of its conformity assessment activities.
Osebju, ki je bilo pred zaposlitvijo pri priglašenem organu zaposleno pri določeni stranki ali je tej stranki zagotavljalo svetovalne storitve na področju pripomočkov, se tri leta ne dodeljujejo dejavnosti ugotavljanja skladnosti za to določeno stranko ali podjetja, ki pripadajo isti skupini.
The notified body shall operate in accordance with a set of consistent, fair and reasonable terms and conditions, taking into account the interests of small and medium-sized enterprises as defined in Recommendation 2003/361/EC in relation to fees.
Zagotovljena je nepristranskost priglašenih organov, njihovega najvišjega vodstva in osebja za ugotavljanje skladnosti.
The requirements laid down in this Section in no way preclude exchanges of technical information and regulatory guidance between a notified body and a manufacturer applying for conformity assessment.
Višina prejemkov za najvišje vodstvo, osebje priglašenega organa za ugotavljanje skladnosti in podizvajalce, vključene v dejavnosti ugotavljanja skladnosti, ni odvisna od rezultatov ugotavljanja skladnosti.
The notified body shall have documented procedures in place ensuring that its personnel, committees, subsidiaries, subcontractors, and any associated body or personnel of external bodies respect the confidentiality of the information which comes into its possession during the performance of conformity assessment activities, except when disclosure is required by law.
Priglašeni organi omogočijo javni dostop do izjav svojega najvišjega vodstva o interesih.
The personnel of a notified body shall observe professional secrecy in carrying out their tasks under this Regulation or any provision of national law giving effect to it, except in relation to the authorities responsible for notified bodies, competent authorities for medical devices in the Member States or the Commission.
Če je priglašeni organ v lasti javne osebe ali ustanove, sta zagotovljeni in dokumentirani neodvisnost in odsotnost morebitnega nasprotja interesov med organom, pristojnim za priglašene organe, in/ali pristojnim organom na eni strani ter priglašenim organom na drugi strani.
Proprietary rights shall be protected.
Priglašeni organ zagotavlja in dokumentira, da dejavnosti njegovih odvisnih družb ali podizvajalcev ali katerega koli povezanega organa, tudi dejavnosti njegovih lastnikov, ne vplivajo na njegovo neodvisnost, nepristranskost ali objektivnost njegovih dejavnosti ugotavljanja skladnosti.
The notified body shall have documented procedures in place in respect of the requirements of this Section.
Priglašeni organ deluje v skladu z vrsto doslednih, poštenih in razumnih pogojev, ob upoštevanju interesov malih in srednjih podjetij, kot so opredeljena v Priporočilu 2003/361/ES v zvezi s pristojbinami.
Liability
Zahteve iz tega oddelka nikakor ne izključujejo izmenjave tehničnih informacij in regulativnih navodil med priglašenim organom in proizvajalcem, ki vloži zahtevo za ugotavljanje skladnosti.
The notified body shall take out appropriate liability insurance for its conformity assessment activities, unless liability is assumed by the Member State in question in accordance with national law or that Member State is directly responsible for the conformity assessment.
Priglašeni organ vzpostavi dokumentirane postopke za zagotovitev, da njegovo osebje, odbori, odvisne družbe, podizvajalci, kateri koli povezan organ ali osebje zunanjih organov spoštuje zaupnost informacij, pridobljenih med opravljanjem dejavnosti ugotavljanja skladnosti, razen kadar njihovo razkritje zahteva zakon.
The scope and overall financial value of the liability insurance shall correspond to the level and geographic scope of activities of the notified body and be commensurate with the risk profile of the devices certified by the notified body.
Osebje priglašenega organa je zavezano k poklicni molčečnosti glede vseh informacij, pridobljenih pri opravljanju nalog v skladu s to uredbo ali katero koli izvedbeno določbo nacionalnega prava, ki uredbo uveljavlja, razen v zvezi z organi, pristojnimi za priglašene organe, pristojnimi organi za medicinske pripomočke v državah članicah ali Komisijo.
The liability insurance shall cover cases where the notified body may be obliged to withdraw, restrict or suspend certificates.
Pravice iz lastništva so zaščitene.
Financial requirements
Priglašeni organ vzpostavi dokumentirane postopke v zvezi z zahtevami iz tega oddelka.
The notified body shall have at its disposal the financial resources required to conduct its conformity assessment activities within its scope of designation and related business operations.
Odgovornost
It shall document and provide evidence of its financial capacity and its long-term economic viability, taking into account, where relevant, any specific circumstances during an initial start-up phase.
Priglašeni organ sklene zavarovanje odgovornosti za svoje dejavnosti ugotavljanja skladnosti, razen če odgovornost prevzame zadevna država članica v skladu z nacionalnim pravom ali če je ta država članica neposredno pristojna za ugotavljanje skladnosti.
Participation in coordination activities
Obseg in skupna finančna vrednost zavarovanja odgovornosti ustrezata ravni in geografskemu obsegu dejavnosti priglašenega organa in sta sorazmerna s profilom tveganja pripomočkov, ki jih je certificiral priglašeni organ.
The notified body shall participate in, or ensure that its assessment personnel is informed of, any relevant standardisation activities and in the activities of the notified body coordination group referred to in Article 49 and that its assessment and decision-making personnel are informed of all relevant legislation, guidance and best practice documents adopted in the framework of this Regulation.
Zavarovanje odgovornosti krije primere, v katerih je lahko priglašeni organ dolžan preklicati, omejiti ali začasno preklicati certifikate.
The notified body shall take into consideration guidance and best practice documents.
Finančne zahteve
QUALITY MANAGEMENT REQUIREMENTS
Priglašeni organ ima na razpolago finančna sredstva, potrebna za izvajanje dejavnosti ugotavljanja skladnosti v okviru njegovega področja, za katero je imenovan, in z njim povezanih poslovnih dejavnosti.
The notified body shall establish, document, implement, maintain and operate a quality management system that is appropriate to the nature, area and scale of its conformity assessment activities and is capable of supporting and demonstrating the consistent fulfilment of the requirements of this Regulation.
Dokumentira in predloži dokaze o svoji finančni zmogljivosti in dolgoročni ekonomski sposobnosti, ob upoštevanju, kjer je to ustrezno, posebnih okoliščin v začetni zagonski fazi.
The quality management system of the notified body shall address at least the following:
Sodelovanje pri usklajevalnih dejavnostih
management system structure and documentation, including policies and objectives for its activities;
Priglašeni organ sodeluje pri ustreznih dejavnostih standardizacije in dejavnostih koordinacijske skupine priglašenega organa iz člena 49, ali zagotovi, da je njegovo osebje za ugotavljanje skladnosti o tem obveščeno, ter prav tako zagotovi, da je njegovo osebje za ugotavljanje skladnosti in odločanje obveščeno o vseh zadevnih zakonodajnih dokumentih, smernicah in dokumentih o najboljših praksah, ki so bili sprejeti v okviru te uredbe.
policies for assignment of activities and responsibilities to personnel;
Priglašeni organ upošteva smernice in dokumente o najboljših praksah.
assessment and decision-making processes in accordance with the tasks, responsibilities and role of the notified body's personnel and top-level management;
ZAHTEVE GLEDE VODENJA KAKOVOSTI
the planning, conduct, evaluation and, if necessary, adaptation of its conformity assessment procedures;
Priglašeni organ vzpostavi, dokumentira, izvaja, vzdržuje in upravlja sistem vodenja kakovosti, ustrezen naravi, področju in obsegu njegovih dejavnosti ugotavljanja skladnosti ter je zmožen podpirati in dokazovati dosledno izpolnjevanje zahtev iz te uredbe.
control of documents;
Sistem vodenja kakovosti priglašenega organa obravnava vsaj naslednje:
control of records;
strukturo in dokumentacijo sistema upravljanja, vključno s politikami in cilji za njegove dejavnosti;
management reviews;
politike za dodelitev dejavnosti in odgovornosti osebju;
internal audits;
ocenjevanje in postopek odločanja v skladu z nalogami, odgovornostmi in vlogo osebja in najvišjega vodstva priglašenega organa;
corrective and preventive actions;
načrtovanje, izvajanje, ocenjevanje in po potrebi prilagajanje njegovih postopkov ugotavljanja skladnosti;
complaints and appeals; and
kontrola dokumentov;
continuous training.
kontrola evidenc;
Where documents are used in various languages, the notified body shall ensure and control that they have the same content.
vodstveni pregledi;
The top-level management of the notified body shall ensure that the quality management system is fully understood, implemented and maintained throughout the notified body organisation including subsidiaries and subcontractors involved in conformity assessment activities pursuant to this Regulation.
notranje presoje;
The notified body shall require all personnel to formally commit themselves by a signature or equivalent to comply with the procedures defined by the notified body.
korektivni in preventivni ukrepi;
That commitment shall cover aspects relating to confidentiality and to independence from commercial and other interests, and any existing or prior association with clients.
pritožbe in
The personnel shall be required to complete written statements indicating their compliance with confidentiality, independence and impartiality principles.
nadaljnje usposabljanje.
RESOURCE REQUIREMENTS
Če se dokumenti uporabljajo v različnih jezikih, priglašeni organ zagotovi in preveri, da je njihova vsebina enaka.
Notified bodies shall be capable of carrying out all the tasks falling to them under this Regulation with the highest degree of professional integrity and the requisite competence in the specific field, whether those tasks are carried out by notified bodies themselves or on their behalf and under their responsibility.
Najvišje vodstvo priglašenega organa zagotovi, da celotna organizacija priglašenega organa, vključno z odvisnimi družbami in podizvajalci, ki so udeleženi pri dejavnostih ugotavljanja skladnosti v skladu s to uredbo, v celoti razume, izvaja in vzdržuje sistem vodenja kakovosti.
In particular, notified bodies shall have the necessary personnel and possess or have access to all equipment, facilities and competence needed to perform properly the technical, scientific and administrative tasks entailed in the conformity assessment activities in relation to which they have been designated.
Priglašeni organ od celotnega osebja zahteva, da se s podpisom ali na enakovreden način formalno zaveže k spoštovanju postopkov, ki jih določi priglašeni organ.
Such requirement presupposes at all times and for each conformity assessment procedure and each type of devices in relation to which they have been designated, that the notified body has permanent availability of sufficient administrative, technical and scientific personnel who possess experience and knowledge relating to the relevant devices and the corresponding technologies.
Pri tem so vključeni vidiki zaupnosti in neodvisnosti od gospodarskih in drugih interesov ter trenutna ali predhodna povezava s strankami.
Such personnel shall be in sufficient numbers to ensure that the notified body in question can perform the conformity assessment tasks, including the assessment of the medical functionality, clinical evaluations and the performance and safety of devices, for which it has been designated, having regard to the requirements of this Regulation, in particular, those set out in Annex I.
Osebje mora izpolniti pisne izjave, ki potrjujejo njegovo spoštovanje načel zaupnosti, neodvisnosti in nepristranskosti.
A notified body's cumulative competences shall be such as to enable it to assess the types of devices for which it is designated.
ZAHTEVE GLEDE VIROV
The notified body shall have sufficient internal competence to critically evaluate assessments conducted by external expertise.
Priglašeni organi so sposobni izvajati vse naloge, ki jim pripadajo v skladu s to uredbo, z najvišjo stopnjo profesionalne integritete in potrebnimi kompetencami na določenem področju, ne glede na to, ali navedene naloge izvajajo priglašeni organi sami ali se izvajajo v njihovem imenu in pod njihovo odgovornostjo.
Tasks which a notified body is precluded from subcontracting are set out in Section 4.1.
Priglašeni organi imajo zlasti zaposleno potrebno osebje, v posesti oziroma dostop pa imajo tudi do vse opreme, objektov in zmogljivosti, potrebnih za pravilno izvajanje tehničnih, znanstvenih in upravnih nalog, povezanih z dejavnostmi ugotavljanja skladnosti, za katere so imenovani.
Personnel involved in the management of the operation of a notified body's conformity assessment activities for devices shall have appropriate knowledge to set up and operate a system for the selection of assessment and verification staff, for verification of their competence, for authorisation and allocation of their tasks, for organisation of their initial and ongoing training and for the assignment of their duties and the monitoring of those staff, in order to ensure that personnel who carry out and perform assessment and verification operations are competent to fulfil the tasks required of them.
Pri takšni zahtevi se predpostavlja, da ima priglašeni organ vedno in za vsak postopek ugotavljanja skladnosti ter za vsako vrsto pripomočkov, za katere je imenovan, stalno na voljo zadostno število administrativnega, tehničnega in znanstvenega osebja, ki ima dovolj izkušenj in znanja v zvezi z zadevnimi pripomočki in ustrezno tehnologijo.
The notified body shall identify at least one individual within its top-level management as having overall responsibility for all conformity assessment activities in relation to devices.
Takšnega osebja je dovolj, da lahko zadevni priglašeni organ opravlja naloge ugotavljanja skladnosti, vključno z ocenjevanjem medicinske funkcionalnosti, kliničnimi ocenami ter učinkovitostjo in varnostjo pripomočkov, za katere je bil imenovan, ob upoštevanju zahtev iz te uredbe in zlasti tistih iz Priloge I.
The notified body shall ensure that personnel involved in conformity assessment activities maintain their qualification and expertise by implementing a system for exchange of experience and a continuous training and education programme.
Priglašeni organ ima takšne skupne pristojnosti, da lahko oceni vrste pripomočkov, za katere je imenovan.
The notified body shall clearly document the extent and limits of duties and responsibilities and the level of authorisation of the personnel, including any subcontractors and external experts, involved in conformity assessment activities and inform those personnel accordingly.
Ima zadostne notranje pristojnosti za kritično oceno ocenjevanja, ki ga izvajajo zunanji strokovnjaki.
Qualification criteria in relation to personnel
Naloge, v zvezi s katerimi priglašeni organ ne more skleniti podizvajalske pogodbe, so navedene v oddelku 4.1.
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.
Osebje priglašenega organa, vključeno v vodenje njegovih dejavnosti ugotavljanja skladnosti za pripomočke, ima ustrezno znanje za vzpostavitev in upravljanje sistema za izbiro osebja za ocenjevanje in preverjanje, preverjanje njihovih kompetenc, izdajanje dovoljenj za njihove naloge in razporeditev teh nalog, organizacijo njihovega začetnega in nadaljnjega usposabljanja ter dodeljevanje njihovih nalog in spremljanje tega osebja, s čimer se zagotovi, da je osebje, ki izvaja in opravlja ocenjevanja in preverjanja, usposobljeno za opravljanje zahtevanih nalog.
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.
Priglašeni organ med svojim najvišjim vodstvom določi vsaj eno osebo, ki je v celoti odgovorna za vse dejavnosti ugotavljanja skladnosti pripomočkov.