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quality assessment and assurance
1 Objavljeno
RS
DRUGO: TRANS
Quality assurance is a systematic and continuous process of quality assessment, quality control and quality improvement.
Zagotavljanje kakovosti je načrtovan pristop k ocenjevanju, nadzoru in izboljšanju kakovosti na vseh področjih.
2 Objavljeno
obramba
Ur. l. RS, št. MP 2010-74
b) Regulatory procedures and assessment methodologies related to nuclear safety, radiation protection, quality assurance, waste management, transportation, emergency planning, environmental impact evaluation of nuclear facilities,
b) postopki in metodologije ocenjevanja, povezani z jedrsko varnostjo, varstvom pred sevanjem, zagotavljanjem kakovosti, ravnanjem z odpadki, prevozi, načrtovanjem ob izrednem dogodku, presojo vpliva jedrskih objektov na okolje;
3 Objavljeno
gospodarstvo
Ur. l. RS, št. MP 2001-61
the scope of responsibilities; rights of access to the Head of the SAPARD Agency and to all records, personnel and premises (including decentralised and delegated bodies); the exclusion of members of the internal audit unit from day to day operational actions; staffing (competence, training and experience); planning (needs assessments, risk based approach, cycle of audit coverage); documentation (will the rationale for tests and conclusions be adequately recorded, are supporting papers held); audit evidence (will arrangements ensure it is sufficient, relevant and reliable); are there adequate arrangements for quality assurance; reports (are they adequate in conception and will the procedures ensure they will be timely) and conclusions as to the audit plan.
obseg odgovornosti; pravice dostopa do vodje agencije SAPARD in do vseh evidenc, zaposlenih in prostorov (vključno z decentraliziranimi enotami in inštitucijami, na katere so bile prenesene naloge); izključenost članov enote za notranjo revizijo iz vsakodnevnih operativnih nalog; kadrovanje (znanje, usposabljanje in izkušnje); načrtovanje (ocena potreb, pristop glede na oceno tveganja, revizijski ciklus); dokumentacijo (ali so utemeljitve za preskuse in sklepne ugotovitve ustrezno zapisane ali se bo hranila spremljajoča dokumentacija); revizijske dokaze (ali ureditev zagotavlja zadostne, ustrezne in zanesljive dokaze); ali je ustrezno urejeno zagotavljanje kakovosti; poročila (ali ustrezajo po svoji zasnovi in ali postopki zagotavljajo, da bodo pravočasna) in sklepne ugotovitve glede načrta revizij.
4 Končna redakcija
CELEX: 32004L0018
These characteristics shall include levels of environmental performance, design for all requirements (including accessibility for disabled persons) and conformity assessment, performance, safety or dimensions, including the procedures concerning quality assurance, terminology, symbols, testing and test methods, packaging, marking and labelling and production processes and methods.
Ti tehnični predpisi vključujejo stopnje okoljske uspešnosti, zahteve v zvezi s konstrukcijo, namenjeno vsem uporabnikom (vključno z dostopnostjo za invalidne osebe), ter ocenjevanje skladnosti, kakovosti, varnosti ali dimenzij, vključno s postopki v zvezi z zagotavljanjem kakovosti, izrazoslovjem, simboli, preskušanjem in preskusnimi metodami, pakiranjem, označevanjem ali uporabo nalepk.
5 Končna redakcija
CELEX: 32004L0017
These characteristics shall include levels of environmental performance, design for all requirements (including accessibility for disabled persons) and conformity assessment, performance, safety or dimensions, including the procedures concerning quality assurance, terminology, symbols, testing and test methods, packaging, marking and labelling, user instructions, and production processes and methods.
Te tehnične zahteve vključujejo stopnje varnosti za okolje, zahteve v zvezi s konstrukcijo, namenjeno vsem uporabnikom (vključno z dostopnostjo za invalidne osebe), ter ocenjevanje skladnosti, izvedbo, varnost ali dimenzije, vključno s postopki v zvezi z zagotavljanjem kakovosti, izrazoslovjem, simboli, preskušanjem in preskusnimi metodami, pakiranjem, označevanjem in uporabo nalepk, navodili za uporabnike, proizvodnimi postopki in metodami.
6 Pravna redakcija
delo in sociala
CELEX: 32003R2151
System quality assurance assessment and review services
Storitve ocenjevanja in preučevanja sistemskega zagotavljanja kakovosti
7 Pravna redakcija
promet
CELEX: 21997A1205(01)
undertaking activities in the fields of standardization, quality assessment, metrology and quality-assurance in order to promote international standards and quality assessment procedures and to facilitate trade.
izvajanje dejavnosti na področju standardizacije, ocenjevanja kakovosti, meroslovja in zagotavljanja kakovosti z namenom spodbujanja mednarodnih standardov in postopkov ocenjevanja kakovosti ter olajšanja trgovine.
8 Pravna redakcija
obramba
CELEX: 32000L0069
The following data quality objectives, for allowed uncertainty of assessment methods, and of minimum time coverage and of data capture of measurement are provided to guide quality-assurance programmes.
Za vodenje programov zagotavljanja kakovosti se določijo naslednji cilji kakovosti podatkov v zvezi z dovoljeno negotovostjo ocenjevalnih metod ter najmanjšo časovno pokritostjo in razpoložljivostjo podatkov meritve.
9 Pravna redakcija
promet
CELEX: 21998A1016(01)
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.
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.
10 Strokovna redakcija
CELEX: 32002L0098
(16) Blood establishments should establish and maintain quality systems involving all activities that determine the quality policy objectives and responsibilities and implement them by such means as quality planning, quality control, quality assurance, and quality improvement within the quality system, taking into account the principles of good manufacturing practice as well as the EC conformity assessment system.
(16) Transfuzijske ustanove morajo uvesti in vzdrževati sisteme kakovosti, ki vključujejo vse dejavnosti, ki opredeljujejo cilje politike kakovosti in odgovornosti, in jih izvajati v smislu načrtovanja kakovosti, nadzora kakovosti, zagotavljanja kakovosti ter izboljševanja kavosti znotraj sistema kakovosti, ob upoštevanju načel dobre proizvodne prakse, kot tudi sistema ES za ugotavljanje skladnosti.
11 Prevajalska redakcija
izobraževanje
CELEX: 31997L0023
(full quality assurance with design examination and special surveillance of the final assessment)
(celovito zagotavljanje kakovosti s pregledovanjem načrtovanja in posebnim nadzorom končne presoje)
12 Prevajalska redakcija
izobraževanje
CELEX: 31997L0043
appropriate quality assurance programmes including quality control measures and patient dose or administered activity assessments are implemented by the holder of the radiological installation, and
da imetnik radiološkega objekta izvaja ustrezne programe zagotavljanja kakovosti, vključno z ukrepi preverjanja kakovosti ter oceno obsevanosti bolnika ali uporabljenega radioaktivnega odmerka in
13 Prevajalska redakcija
izobraževanje
CELEX: 31999L0030
The following data-quality objectives for the required accuracy of assessment methods, of minimum time coverage and of data capture of measurement are laid down to guide quality-assurance programmes.
Za izvajanje programov zagotavljanja kakovosti se za zahtevano natančnost ocenjevalnih metod ter najmanjšo časovno pokritost in za zajetost podatkov meritve določijo naslednji cilji kakovosti podatkov.
14 Prevajalska redakcija
izobraževanje
CELEX: 32002L0098
Blood establishments should establish and maintain quality systems involving all activities that determine the quality policy objectives and responsibilities and implement them by such means as quality planning, quality control, quality assurance, and quality improvement within the quality system, taking into account the principles of good manufacturing practice as well as the EC conformity assessment system.
Transfuzijske ustanove morajo uvesti in vzdrževati sisteme kakovosti, ki vključujejo vse dejavnosti, ki opredeljujejo cilje politike kakovosti in odgovornosti, in jih izvajati v smislu načrtovanja kakovosti, nadzora kakovosti, zagotavljanja kakovosti ter izboljševanja kakovosti znotraj sistema kakovosti, ob upoštevanju načel dobre proizvodne prakse, kot tudi sistema ES za ugotavljanje skladnosti.
15 Prevajalska redakcija
izobraževanje
CELEX: 31997L0043
Special attention shall be given to the quality assurance programmes, including quality control measures and patient dose or administered activity assessment, as mentioned in Article 8, for these practices.
Pri teh posegih je treba posvetiti posebno pozornost programom zagotavljanja kakovosti, vključno z ukrepi preverjanja kakovosti in oceno obsevanosti bolnika ali uporabljenega radioaktivnega odmerka, kakor je omenjeno v členu 8.
16 Prevajalska redakcija
izobraževanje
CELEX: 32004D0192
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.
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.
17 Prevajalska redakcija
izobraževanje
CELEX: 21998A0403(01)
comply with quality assurance prescriptions and participate in intercalibration exercises; (c) use and develop, individually or preferably jointly, other duly validated scientific assessment tools, such as modelling, remote sensing and progressive risk assessment strategies;
uporabljajo in razvijajo, posamezno ali po možnosti skupaj, druga ustrezno potrjena orodja znanstvenega ocenjevanja, kot so modeliranje, daljinsko zaznavanje in progresivne strategije ocene tveganja;
18 Prevajalska redakcija
izobraževanje
CELEX: 31995L0016
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.
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.
19 Prevajalska redakcija
izobraževanje
CELEX: 31997L0043
The optimization process shall include the selection of equipment, the consistent production of adequate diagnostic information or therapeutic outcome as well as the practical aspects, quality assurance including quality control and the assessment and evaluation of patient doses or administered activities, taking into account economic and social factors.
Optimizacijski postopek mora vključevati izbiro opreme, zadovoljivo raven diagnostičnih informacij ali izida zdravljenja, pa tudi praktične vidike, zagotavljanje kakovosti, vključno s preverjanjem kakovosti ter oceno in ovrednotenje obsevanosti bolnika ali izvedenih dejavnosti, ob upoštevanju ekonomskih in socialnih dejavnikov.
20 Prevajalska redakcija
izobraževanje
CELEX: 31997L0023
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.
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.
21 Prevajalska redakcija
izobraževanje
CELEX: 32001L0025
the fields of application of the quality standards cover the administration of the certification systems, all training courses and programmes, examinations and assessments carried out by or under the authority of each Member State and the qualifications and experience required of instructors and assessors, having regard to the policies, systems, controls and internal quality-assurance reviews established to ensure achievement of the defined objectives.
področje uporabe standardov kakovosti zajema upravljanje sistemov za izdajanje spričeval, vse izobraževalne tečaje in programe, izpitno preverjanje in ocenjevanje, ki ga izvaja vsaka država članica ali se izvaja z njenim pooblastilom, ter kvalifikacije in izkušnje, ki jih morajo imeti vodje izobraževanja in ocenjevalci ob upoštevanju strategij, sistemov, nadzora in notranje kontrole zagotavljanja kakovosti, ki so bili uvedeni, da bi zagotovili doseganje zastavljenih ciljev.
22 Prevajalska redakcija
izobraževanje
CELEX: 32002D1786
supporting the network's operation, in the Member States and the countries participating on the basis of Article 10 of this decision, in particular in relation to common investigations, training, continuous assessment, quality assurance and, where appropriate, in relation to its contribution to the actions described in the Annex, points 1.2 and 1.3;
podpora delovanju mrež v državah članicah in državah, ki sodelujejo na podlagi člena 10 tega sklepa, zlasti v zvezi s skupnimi raziskavami, usposabljanjem, nenehnim ocenjevanjem, zagotavljanjem kakovosti in, kadar je to primerno, v zvezi s prispevkom k ukrepom, opisanim v točkah 1.2 in 1.3 Priloge;
23 Prevajalska redakcija
izobraževanje
CELEX: 32004L0018
These characteristics shall include levels of environmental performance, design for all requirements (including accessibility for disabled persons) and conformity assessment, performance, safety or dimensions, including the procedures concerning quality assurance, terminology, symbols, testing and test methods, packaging, marking and labelling and production processes and methods.
Ti tehnični predpisi vključujejo stopnje okoljske uspešnosti, zahteve v zvezi s konstrukcijo, namenjeno vsem uporabnikom (vključno z dostopnostjo za invalidne osebe), ter ocenjevanje skladnosti, kakovosti, varnosti ali dimenzij, vključno s postopki v zvezi z zagotavljanjem kakovosti, izrazoslovjem, simboli, preskušanjem in preskusnimi metodami, pakiranjem, označevanjem ali uporabo nalepk.
24 Prevajalska redakcija
izobraževanje
CELEX: 32004L0017
These characteristics shall include levels of environmental performance, design for all requirements (including accessibility for disabled persons) and conformity assessment, performance, safety or dimensions, including the procedures concerning quality assurance, terminology, symbols, testing and test methods, packaging, marking and labelling, user instructions, and production processes and methods.
Te tehnične zahteve vključujejo stopnje varnosti za okolje, zahteve v zvezi s konstrukcijo, namenjeno vsem uporabnikom (vključno z dostopnostjo za invalidne osebe), ter ocenjevanje skladnosti, izvedbo, varnost ali dimenzije, vključno s postopki v zvezi z zagotavljanjem kakovosti, izrazoslovjem, simboli, preskušanjem in preskusnimi metodami, pakiranjem, označevanjem in uporabo nalepk, navodili za uporabnike, proizvodnimi postopki in metodami.
25 Prevajalska redakcija
izobraževanje
CELEX: 31997L0023
In the framework of quality assurance procedures for equipment in categories III and IV referred to in Article 3, section 1.1 (a), section 1.1 (b) first indent and section 1.2, the notified body shall, when performing unexpected visits, take a sample of equipment from the manufacturing or storage premises in order to perform, or have performed, the final assessment as referred to in Annex I, section 3.2.2.
V okviru postopkov za zagotavljanje kakovosti opreme iz razredov III in IV, navedenih v prvi alinei oddelka 1.1(b), oddelku 1.1.(a) in oddelku 1.2 člena 3, priglašeni organ ob nenapovedanih obiskih vzame vzorec opreme iz proizvodnih ali skladiščnih prostorov, da pripravi ali da pripraviti končno oceno, kakor je navedeno v oddelku 3.2.2
26 Prevajalska redakcija
izobraževanje
CELEX: 31993L0099
Member States shall take all measures necessary to ensure that the laboratories referred to in Article 7 of Directive 89/397/EEC comply with the general criteria for the operation of testing laboratories laid down in European Standard EN 45001 supplemented by standard operating procedures and the random audit of their compliance by quality assurance personnel, in accordance with the OECD principles No 2 and 7 of good laboratory practice as set out in Section II of Annex 2 to the Decision of the Council of the OECD of 12 May 1981 concerning the mutual acceptance of data in the assessment of chemicals.
Države članice sprejmejo ustrezne ukrepe za zagotovitev, da so laboratoriji iz člena 7 Direktive 89/397/EGS v skladu s splošnimi merili za delovanje preskusnih laboratorijev, predpisanimi z evropskim standardom EN 45001, dopolnjenim s standardnimi operativnimi postopki (SOP) in naključno presojo njihove ustreznosti s strani osebja za zagotavljanje kakovosti, v skladu z načeloma OECD št. 2 in 7 dobre laboratorijske prakse, kakor je predpisano v razdelku II Priloge 2 k Sklepu Sveta OECD z dne 12. maja 1981 o medsebojnem priznavanju podatkov pri ocenjevanju kemikalij.
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quality assessment and assurance