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presoja sistema kakovosti
1 Objavljeno
RS
DRUGO: TRANS
ISO 9001 - odgovornost vodstva (4.1.), sistem kakovosti (4.2.), pregled pogodb (4.3.), korektivni in preventivni ukrepi (4,14.), zapisi o kakovosti (4.6.), interne presoje kakovosti (4.17), usposabljanje, izobraževanje in motivacija za kakovost (4.18.)
ISO 9001 - management responsability (4.1.), quality system (4.2.) ts (4.3.), corrective and preventive measures (4.14.), quality records (4.16.), internal quality estimations (4.17.), training, education and motivation for quality (4.18.)
2 Končna redakcija
pravo
CELEX: 32000L0009
Proizvajalec mora vlogo za presojo svojega sistema kakovosti za zadevne elemente vložiti pri priglašenem organu, ki ga izbere sam.
The manufacturer must lodge an application for assessment of his quality system with a notified body or his choice, for the components concerned.
3 Končna redakcija
pravo
CELEX: 31999L0036
Priglašeni organ mora opravljati redne presoje, da bi se prepričal, če proizvajalec vzdržuje in uporablja sistem kakovosti, ter proizvajalcu izročiti poročilo o presoji.
The notified body must carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and provide the manufacturer with an audit report.
4 Končna redakcija
pravo
CELEX: 32000L0009
Priglašeni organ mora predlagane spremembe ovrednotiti in odločiti, ali spremenjeni sistem kakovosti še vedno izpolnjuje zahteve iz točke 3.2, ali se zahteva ponovna presoja.
The notified body must evaluate the modifications proposed and decide whether the amended quality system will still satisfy the requirements referred to in paragraph 3.2 or whether a reassessment is required.
5 Končna redakcija
pravo
CELEX: 32000L0009
Priglašeni organ mora predlagane spremembe ovrednotiti in odločiti, ali bo spremenjen sistem kakovosti še vedno izpolnjeval zahteve iz točke 3.2, ali se zahteva ponovna presoja.
The notified body must evaluate the modifications proposed and decide whether the modified quality system will still satisfy the requirements referred to in paragraph 3.2 or whether a reassessment is required.
6 Končna redakcija
CELEX: 32004R0001
do 100 % stroškov za uvedbo sistemov zagotavljanja kakovosti, kakršni sta seriji ISO 9000 ali 14000, sistemov na temelju analize nevarnosti in kritičnih kontrolnih točk (HACCP), sistemov sledljivosti, sistemov za zagotavljanje upoštevanja pristnosti in tržnih normativov ali programov presoje vplivov na okolje;
up to 100 % of the costs of the introduction of quality assurance schemes such as ISO 9000 or 14000 series, systems based on hazard analysis and critical control points (HACCP), traceability systems, systems to assure respect of authenticity and marketing norms or environmental audit systems;
7 Končna redakcija
pravo
CELEX: 31999L0036
Priglašeni organ mora opravljati redne presoje, da bi se prepričal, če lastnik ali njegov pooblaščeni zastopnik s sedežem v Skupnosti ali imetnik ali odobreni organ vzdržuje in uporablja sistem kakovosti, in bi lastniku ali njegovemu pooblaščenemu zastopniku s sedežem v Skupnosti ali imetniku ali odobrenemu organu izročil poročilo o presoji.
The notified body must carry out periodic audits to make sure that the owner or his authorised representative established in the Community or the holder or the approved body maintains and applies the quality system and provide the owner or his authorised representative established in the Community or the holder or the approved body with an audit report.
8 Pravna redakcija
DRUGO
Proizvajalec mora pri priglašenem organu vložiti prošnjo za presojo njegovega sistema kakovosti.
The manufacturer shall lodge an application for assessment of his quality system with a notified body.
9 Pravna redakcija
promet
CELEX: 21998A1016(01)
Upoštevati morata presojo po sistemu ene vloge/vrednotenja/sistema kakovosti, ki hkrati zadovoljuje zahteve obeh pogodbenic.
Consideration shall be given to a single submission/evaluation/ quality systems assessment which simultaneously satisfies the requirements of each jurisdiction.
10 Pravna redakcija
DRUGO
Proizvajalec mora pri priglašenem organu, ki ga izbere sam, vložiti prošnjo za presojo njegovega sistema kakovosti za zadevne izdelke.
The manufacturer shall lodge an application for assessment of his quality system with a notified body of his choice, for the products concerned.
11 Pravna redakcija
DRUGO
Priglašeni organ oceni predlagane spremembe in odloči, ali bo spremenjeni sistem kakovosti izpolnjeval zahteve iz odstavka 3.2 ali pa je potrebna ponovna presoja.
The notified body shall evaluate the modifications proposed and decide whether the amended quality system will still satisfy the requirements referred to in paragraph 3.2 or whether a reassessment is required.
12 Pravna redakcija
promet
CELEX: 21998A1016(01)
ugotovitev pogojev in mehanizmov za stalno vzdrževanje programa MRA (oblikovanje sistema upravljanja kakovosti, mehanizma presoj in procesa posvetovanja/stalnega dialoga).
establishment of the conditions and mechanisms for on-going maintenance of the MRA (develop quality management system, audit mechanism and a consultation/on-going dialogue process).
13 Pravna redakcija
DRUGO
Organ, ki opravlja presojo, objektivno oceni sestavne dele sistema nadzorovanja kakovosti in še zlasti preveri, ali sistem zagotavlja skladnost izdelane OZO z odobrenim modelom.
The body carrying out audits shall make all necessary objective evaluations of the components of the quality-control system and shall check in particular whether the system ensures conformity of PPE manufactured with the approved model.
14 Pravna redakcija
DRUGO
Organ periodično opravi presojo za zagotovitev, da proizvajalec vzdržuje in uporablja odobreni sistem nadzorovanja kakovosti, in proizvajalcu zagotovi izvod poročila o presoji.
The body shall periodically carry out audits to ensure that the manufacturer is maintaining and applying the approved quality-control system and shall provide the manufacturer with a copy of the audit report.
15 Pravna redakcija
promet
CELEX: 21998A1016(01)
ugotovitev pogojev in mehanizmov za stalno vzdrževanje programa certificiranja (oblikovanje sistema upravljanja kakovosti, mehanizma presoj in procesa posvetovanja/stalnega dialoga).
establishment of the conditions and mechanisms for on-going maintenance of the certification programme (develop quality management system, audit mechanism and a consultation/on-going dialogue process).
16 Pravna redakcija
promet
CELEX: 21998A1016(01)
primerjalno ocenjevanje sistemov kakovosti, ki naj obsega sodelovanje zakonodajnih organov/organov za imenovanje pri presoji, ki jih opravljajo CAB druge pogodbenice po zahtevah druge pogodbenice.
for quality systems assessments, an inter-comparison exercise which would consist of the participation of regulatory/designating authorities in audits carried out by CABs of the other Party on the basis of requirements of the other Party.
17 Pravna redakcija
DRUGO
Organ za ugotavljanje skladnosti mora presoditi o predlaganih spremembah in odločiti, ali bo spremenjen sistem kakovosti še vedno izpolnjeval zahteve, navedene v 3.2., in ali je potrebna vnovična presoja.
The notified body must assess the changes proposed an decide whether the altered quality system will still satisfy the requirements referred to in 3. 2 or whether reassessment is required.
18 Pravna redakcija
promet
CELEX: 21998A1016(01)
sistemi/postopki upravljanja/zagotavljanja kakovosti za zagotovitev trajne ustreznosti in učinkovitosti politik, postopkov, smernic in sistemov, ki se uporabljajo za uresničitev ciljev programa skladnosti z GMP, vključno z vzpostavitvijo standardov ter letnih presoj in preverjanj.
quality management/assurance system/procedures to ensure the ongoing suitability and effectiveness of policies, procedures, guidelines and systems used to achieve the objectives of the GMP compliance programme, including establishment of standards and annual audit and review.
19 Pravna redakcija
promet
CELEX: 21998A1016(01)
sistemi/postopki upravljanja/zagotavljanja kakovosti za zagotovitev trajne ustreznosti in učinkovitosti politik, postopkov, smernic in sistemov, ki se uporabljajo za uresničitev ciljev programa ugotavljanja skladnosti, vključno z vzpostavitvijo standardov ter letnih presoj in preverjanj.
quality management/assurance systems/procedures to ensure the on-going suitability and effectiveness of policies, procedures, guidelines and systems used to achieve the objectives of the conformity assessment programme, including establishment of standards and annual audit and review.
20 Prevajalska redakcija
izobraževanje
CELEX: 31995L0016
Presoja sistema zagotavljanja kakovosti
Assessment of the quality assurance system
21 Prevajalska redakcija
izobraževanje
CELEX: 31995L0016
Proizvajalec mora pri priglašenem organu vložiti zahtevek za presojo svojega sistema zagotavljanja kakovosti.
The manufacturer must lodge an application for assessment of his quality assurance system with a notified body.
22 Prevajalska redakcija
izobraževanje
CELEX: 31995L0016
Proizvajalec mora pri priglašenem organu vložiti zahtevek za presojo svojega sistema zagotavljanja kakovosti.
The installer of a lift must lodge an application for assessment of his quality assurance system with a notified body.
23 Prevajalska redakcija
izobraževanje
CELEX: 31997L0023
Proizvajalec mora vložiti zahtevek za presojo svojega sistema kakovosti priglašenemu organu, ki ga izbere sam.
The manufacturer must lodge an application for assessment of his quality system for the pressure equipment with a notified body of his choice.
24 Prevajalska redakcija
izobraževanje
CELEX: 31990L0384
Priglašeni organ periodično izvaja presoje, da se prepriča, ali proizvajalec vzdržuje in uporablja sistem kakovosti;
The notified body shall periodically carry out audits in order to ensure that the manufacturer is maintaining and applying the quality system;
25 Prevajalska redakcija
izobraževanje
CELEX: 21998A1016(01)
Upoštevati morata presojo po sistemu ene vloge/vrednotenja/sistema kakovosti, ki hkrati zadovoljuje zahteve obeh pogodbenic.
Consideration shall be given to a single submission/evaluationquality systems assessment which simultaneously satisfies the requirements of each jurisdiction.
26 Prevajalska redakcija
izobraževanje
CELEX: 31995L0016
Proizvajalec mora pri priglašenem organu, katerega izbere sam, vložiti zahtevek za presojo svojega sistema zagotavljanja kakovosti.
The installer must lodge an application for assessment of his quality assurance system with a notified body of his choice.
27 Prevajalska redakcija
izobraževanje
CELEX: 31998L0079
vse ustrezne informacije, ki so na voljo iz postopkov opazovanja in informiranja in iz sistemov zunanje presoje kakovosti iz člena 11;
any relevant information available from the vigilance procedures and from external quality assessment schemes as referred to in Article 11;
28 Prevajalska redakcija
izobraževanje
CELEX: 31995L0016
Monter dvigala mora zahtevek za presojo svojega sistema zagotavljanja kakovosti za dvigala vložiti pri priglašenem organu, katerega izbere sam.
The installer of a lift must lodge an application for assessment of his quality assurance system for the lifts concerned with a notified body of his choice.
29 Prevajalska redakcija
izobraževanje
CELEX: 31998L0079
ker so informacije, pridobljene s postopkom budnosti, pa tudi s sistemi zunanje presoje kakovosti, koristne za odločanje o razvrstitvi pripomočkov;
whereas information obtained from the vigilance procedure as well as from external quality assessment schemes is useful for decision-making on classification of devices;
30 Prevajalska redakcija
izobraževanje
CELEX: 31994L0009
Priglašeni organ periodično opravlja presoje za zagotovitev, da proizvajalec vzdržuje in uporablja sistem kakovosti, ter o njih izdaja poročila o presoji proizvajalcu.
The notified body shall periodically carry out audits to ensure that the manufacturer maintains and applies the quality system and shall provide an audit report to the manufacturer.
31 Prevajalska redakcija
izobraževanje
CELEX: 31996L0098
Priglašeni organ mora redno izvajati presoje za zagotovitev, da proizvajalec vzdržuje in uporablja sistem kakovosti, in mora proizvajalcu predložiti poročilo o presoji.
The notified body must periodically carry out audits to make sure that the manufacturer maintains and applies the quality system and must provide the manufacturer with audit reports.
32 Prevajalska redakcija
RS
EMEA
sistem zagotavljanja kakovosti bo okrepljen z izvedbo priporočil, ki izhajajo iz presoje Odbora za zdravila za uporabo v veterinarski medicini (CVMP), opravljene oktobra 2005.
The quality-assurance system will be strengthened by implementing recommendations resulting from the audit of the Committee for Medicinal Products for Veterinary Use (CVMP) conducted in October 2005.
33 Prevajalska redakcija
izobraževanje
CELEX: 31992L0042
Priglašeni organ mora presoditi o predlaganih spremembah in odločiti, ali bo spremenjeni sistem kakovosti še vedno izpolnjeval zahteve iz 3.2 in ali je potrebna vnovična presoja.
The notified body must assess the changes proposed and decide whether the altered quality system will still satisfy the requirements referred to in 3.2 or whether reassessment in required.
34 Prevajalska redakcija
izobraževanje
CELEX: 32003L0044
Priglašeni organ mora oceniti predlagane spremembe in odločiti, ali bo spremenjeni sistem kakovosti še naprej izpolnjeval zahteve iz točke 3.2 ali pa je potrebna ponovna presoja.
The notified body must evaluate the modifications proposed and decide whether the modified quality system will still satisfy the requirements referred to in point 3.2 or whether a reassessment is required.
35 Prevajalska redakcija
izobraževanje
CELEX: 31995L0016
Proizvajalec varnostnega sestavnega dela mora zahtevek za presojo svojega sistema zagotavljanja kakovosti za varnostne sestavne dele vložiti pri priglašenem organu, katerega izbere sam.
The manufacturer of the safety component must lodge an application for assessment of his quality assurance system for the safety components concerned with a notified body of his choice.
36 Prevajalska redakcija
izobraževanje
CELEX: 32004R0001
do 100 % stroškov za uvedbo sistemov zagotavljanja kakovosti, kakršni sta seriji ISO 9000 ali 14000, sistemov na temelju analize nevarnosti in kritičnih kontrolnih točk (HACCP), sistemov sledljivosti, sistemov za zagotavljanje upoštevanja pristnosti in tržnih normativov ali programov presoje vplivov na okolje;
up to 100 % of the costs of the introduction of quality assurance schemes such as ISO 9000 or 14000 series, systems based on hazard analysis and critical control points (HACCP), traceability systems, systems to assure respect of authenticity and marketing norms or environmental audit systems;
37 Prevajalska redakcija
izobraževanje
CELEX: 32004D0192
Prednost bo imelo zunanje zagotavljanje kakovosti mikrobioloških laboratorijev, izboljšanje kakovosti, presoja strokovne usposobljenosti in akreditacijski sistemi za razvoj mreže referenčnih laboratorijev in povečanje sposobnosti javnozdravstvenih laboratorijev.
Priority will be given to external quality assurance of microbiological laboratories, quality improvement, proficiency assessment and accreditation schemes to develop networks of reference laboratories and enhance the capabilities of public health laboratories.
38 Prevajalska redakcija
izobraževanje
CELEX: 31995L0016
Priglašeni organ mora predlagane spremembe presoditi in odločiti, ali spremenjeni sistem zagotavljanja kakovosti še vedno izpolnjuje zahteve, navedene v oddelku 3.2 in ali je potrebna ponovna presoja.
The notified body must assess the modifications proposed and decide whether the modified quality assurance system still satisfies the requirements referred to in Section 3.2 or whether a reassessment is required.
39 Prevajalska redakcija
izobraževanje
CELEX: 31993L0015
Organ za ugotavljanje skladnosti mora presoditi o predlaganih spremembah in odločiti, ali bo spremenjen sistem kakovosti še vedno izpolnjeval zahteve, navedene v 3.2, in ali je potrebna vnovična presoja.
The notified body must assess the changes proposed an decide whether the altered quality system will still satisfy the requirements referred to in 3.2 or whether reassessment is required.
40 Prevajalska redakcija
izobraževanje
CELEX: 31995L0016
Priglašeni organ mora predlagane spremembe presoditi in odločiti, ali bo spremenjeni sistem zagotavljanja kakovosti še vedno izpolnjeval zahteve, navedene v oddelku 3.2, in ali je potrebna ponovna presoja.
The notified body must assess the modifications proposed and decide whether the modified quality assurance system will still satisfy the requirements referred to in Section 3.2 or whether a reassessment is required.
41 Prevajalska redakcija
izobraževanje
CELEX: 31995L0016
Priglašeni organ mora predlagane spremembe presoditi in odločiti, ali bo spremenjeni sistem zagotavljanja kakovosti še vedno izpolnjeval zahteve, navedene v oddelku 3.2, in ali je potrebna ponovna presoja.
The notified body must assess the modifications proposed and decide whether the modified quality assurance system will still satisfy the requirements referred to in Section 3.2 or whether a re-assessment is required.
42 Prevajalska redakcija
izobraževanje
CELEX: 31995L0016
Priglašeni organ mora redno opravljati presoje, s katerimi zagotovi, da proizvajalec varnostnih sestavnih delov vzdržuje in uporablja sistem, s katerim zagotovi kakovost, ter proizvajalcu varnostnih sestavnih delov zagotoviti poročilo o presoji.
The notified body must periodically carry out audits to make sure that the manufacturer of the safety components maintains and applies the quality assurance system and must provide an audit report to the manufacturer of the safety components.
43 Prevajalska redakcija
izobraževanje
CELEX: 31997L0023
Če ima proizvajalec materiala vzpostavljen ustrezen sistem zagotavljanja kakovosti, potrjen od pristojnega organa s sedežem v Skupnosti, in če je opravil posebno presojo materialov, veljajo certifikati, ki jih izda proizvajalec, kakor certifikati skladnosti z ustreznimi zahtevami iz tega oddelka.
Where a material manufacturer has an appropriate quality-assurance system, certified by a competent body established within the Community and having undergone a specific assessment for materials, certificates issued by the manufacturer are presumed to certify conformity with the relevant requirements of this section.
44 Prevajalska redakcija
izobraževanje
CELEX: 31998L0079
ker so - čeprav mednarodno potrjeni referenčni materiali in materiali, ki se uporabljajo za zunanje sisteme presoje kakovosti, niso urejeni v tej direktivi - umerjevalci in kontrolni materiali, ki jih uporabnik potrebuje za določitev delovanja pripomočkov, in vitro diagnostični medicinski pripomočki;
Whereas, although internationally certified reference materials and materials used for external quality assessment schemes are not covered by this Directive, calibrators and control materials needed by the user to establish or verify performances of devices are in vitro diagnostic medical devices;
45 Prevajalska redakcija
izobraževanje
CELEX: 31998L0079
Če država članica zahteva, da splošni zdravniki, zdravstvene ustanove ali organizatorji sistemov zunanje presoje kakovosti obvestijo pristojne organ o vseh zapletih iz odstavka 1, mora storiti vse potrebno za zagotovitev, da je tudi proizvajalec določenega pripomočka ali njegov pooblaščeni zastopnik o dogodku obveščen.
Where a Member State requires medical practitioners, the medical institutions or the organisers of external quality assessment schemes to inform the competent authorities of any incidents referred to in paragraph 1, it shall take the necessary steps to ensure that the manufacturer of the device concerned, or his authorised representative, is also informed of the incident.
46 Prevajalska redakcija
izobraževanje
CELEX: 31997L0023
Za zagotovitev skladnosti z zahtevami direktive, ki zadevajo tlačno opremo, mora biti v okviru sistema kakovosti pregledan vsak primerek tlačne opreme in opravljeni ustrezni preskusi, opredeljeni v zadevnih standardih, navedenih v oddelku 5, ali enakovredni preskusi, predvsem pa končna presoja, navedena v Prilogi I, oddelek 3.2.
Under the quality system, each item of pressure equipment must be examined and appropriate tests as set out in the relevant standard(s) referred to in Article 5, or equivalent tests, particularly final assessment as referred to in section 3.2 of Annex I, must be carried out in order to ensure its conformity with the requirements of the Directive which apply to it.
47 Prevajalska redakcija
izobraževanje
CELEX: 31997L0023
Za zagotovitev skladnosti z zahtevami direktive, ki zadevajo tlačno opremo, mora biti v okviru sistema kakovosti pregledan vsak primerek tlačne opreme in opravljeni ustrezni preskusi, opredeljeni v zadevnih standardih, navedenih v oddelku 5, ali enakovredni preskusi, predvsem pa končna presoja, navedena v Prilogi I, oddelek 3.2.
Under the quality system, each item of pressure equipment must be examined and appropriate tests as set out in the relevant standard(s) referred to in Article 5, or equivalent tests, and particularly final assessment as referred to in section 3.2 of Annex I, must be carried out in order to ensure its conformity with the requirements of the Directive which apply to it.
48 Prevajalska redakcija
izobraževanje
CELEX: 32001L0025
se vse izobraževalne dejavnosti, dejavnosti za presojo usposobljenosti, izdajanje spričeval, overitev in ponovno potrditev veljavnosti, ki jih izvajajo nevladne službe ali entitete z njenim dovoljenjem, nenehno preverjajo s sistemom standardov kakovosti, da bi zagotovila doseganje zastavljenih ciljev, vključno s tistimi v zvezi s kvalifikacijami in delovnimi izkušnjami vodij izobraževanja in ocenjevalcev;
all training, assessment of competence, certification, endorsement and revalidation activities carried out by non-governmental agencies or entities under its authority are continuously monitored through a quality standards system to ensure the achievement of defined objectives, including those concerning the qualifications and experience of instructors and accessors;
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presoja sistema kakovosti