natgillin/translations-raw huggingface dataset:
The purpose of audit systems is to verify whether official controls relating to feed and food law and animal health and animal welfare rules are effectively implemented and are suitable to achieve the objectives of the relevant legislation, including compliance with national control plans.
Namen sistemov presoj je preverjanje, ali se uradni nadzori v zvezi z zakonodajo o krmi in živilih ter s pravili o zdravstvenem varstvu živali in zaščiti živali uspešno izvajajo ter so primerni za doseganje ciljev ustrezne zakonodaje, vključno s skladnostjo z nacionalnimi načrti nadzora.
These guidelines seek to lay down principles to observe rather than stipulating detailed methods with a view to facilitating their application to the diversity of Member State control systems.
Te smernice poskušajo določiti načela, ki jih je treba upoštevati in ne predpisujejo podrobnih metod, zaradi njihove lažje uporabe v različnih nadzornih sistemih držav članic.
The methods selected for applying the principles in these guidelines may vary depending on the size, nature, number and complexity of the competent authorities responsible for official controls throughout the Member States.
Metode, izbrane za uporabo načel v teh smernicah, se lahko razlikujejo glede na velikost, naravo, število in zapletenost pristojnih organov, odgovornih za uradne nadzore v državah članicah.
Background and legal basis — Regulation (EC) No 882/2004
Ozadje in pravna podlaga – Uredba (ES) št. 882/2004
These guidelines lay down criteria for conducting the audits provided for in Article 4(6) of Regulation (EC) No 882/2004.
Te smernice določajo merila za izvajanje presoj, predvidenih v členu 4(6) Uredbe (ES) št. 882/2004.
In this connection the following extracts from that Regulation are relevant:
V zvezi s tem so pomembni naslednji izvlečki iz te uredbe:
‘Competent authorities shall carry out internal audits or may have external audits carried out, and shall take appropriate measures in the light of their results, to ensure that they are achieving the objectives of this Regulation.
„Pristojni organi izvajajo notranje presoje ali lahko dajo izvesti zunanje presoje in ob upoštevanju rezultatov presoj sprejemajo ustrezne ukrepe, da zagotovijo dosego ciljev te uredbe.
These audits shall be subject to independent scrutiny and shall be carried out in a transparent manner.’
Te presoje so predmet neodvisnega natančnega pregleda in se izvajajo pregledno.“
‘“Audit” means a systematic and independent examination to determine whether activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives.’
„‚presoja‘ pomeni sistematično in neodvisno pregledovanje, ali so aktivnosti in z njimi povezani rezultati skladni z načrtovano ureditvijo in ali se takšna ureditev uspešno izvaja in je primerna za doseganje ciljev.“
For the purposes of these guidelines, the definitions laid down in Article 2 of Regulation (EC) No 882/2004, Articles 2 and 3 of Regulation (EC) No 178/2002 of the European Parliament and of the Council [1], ISO 19011:2002 [2] 4 and ISO 9000:2000 [3] apply.
Za namene teh smernic se uporabljajo opredelitve, določene v členu 2 Uredbe (ES) št. 882/2004, v členih 2 in 3 Uredbe (ES) št. 178/2002 Evropskega parlamenta in Sveta [1], ISO 19011:2002 [2] in ISO 9000:2000 [3].
In particular the following definitions from ISO 19011:2002 and ISO 9000:2000 should be noted:
Upoštevati je treba zlasti naslednje opredelitve iz ISO 19011:2002 in ISO 9000:2000:
‘Audit criteria’
„kriteriji presoje“
means the set of policies, procedures or requirements used as a reference against which audit evidence is compared, i.e. the standard against which the auditee’s activities are assessed.
pomenijo skupek splošnih usmeritev, postopkov ali zahtev, ki se uporabljajo kot referenčna podlaga, s katero se primerja dokaz presoje, tj. standard za ocenjevanje aktivnosti presojanca;
‘Audit plan’
„načrt presoje“
means the description of the activities and arrangements for an audit.
pomeni opis aktivnosti in dogovorov za presojo;
‘Audit programme’
„program presoj“
means a set of one or more audits planned for a specific time frame and directed towards a specific purpose.
pomeni skupek ene ali več presoj, načrtovanih v določenem časovnem okviru in usmerjenih k določenemu namenu;
‘Audit team’
„presojevalna skupina“
means one or more auditors conducting an audit supported if needed by technical experts.
pomeni enega ali več presojevalcev, ki izvajajo presojo in jim po potrebi pomagajo tehnični izvedenci;
‘Auditee’
„presojanec“
means organisation being audited.
pomeni presojano organizacijo;
‘Auditor’
„presojevalec“
means a person with the competence to conduct an audit.
pomeni osebo, kompetentno za izvedbo presoje;
‘Corrective action’
„korektivni ukrep“
means action to eliminate the cause of a detected non-conformity or other undesirable situation.
pomeni ukrep za odpravo vzroka ugotovljene neskladnosti ali drugega nezaželenega stanja;
‘Preventive action’
„preventivni ukrep“
means action to eliminate the cause of a potential non-conformity or other undesirable situation.
pomeni ukrep za odpravo vzroka možne neskladnosti ali drugega nezaželenega stanja;
‘Technical expert’
„tehnični izvedenec“
means a person who provides specific knowledge or expertise to the audit team.
pomeni osebo, ki presojevalni skupini priskrbi posebno znanje ali izvedensko mnenje.
For the purposes of these Guidelines, the following definitions apply:
V teh smernicah se uporabljajo naslednje opredelitve:
‘Audit Body’
„presojevalni organ“
‘Audit process’
„proces presoje“
means the set of activities described in Section 5.1. (Systematic Approach).
pomeni niz dejavnosti, opisanih v oddelku 5.1 (Sistematični pristop);
‘Audit system’
„sistem presoj“
means the combination of one or more audit bodies carrying out an audit process within or across competent authorities.
pomeni kombinacijo enega ali več presojevalnih organov, ki izvajajo proces presoje znotraj pristojnih organov ali med njimi;
‘Production chain’
„proizvodna veriga“
means the whole production chain incorporating all ‘stages of production, processing and distribution’ as defined in Article 3(16) of Regulation (EC) No 178/2002.
pomeni celotno proizvodno verigo, ki vključuje vse „stopnje proizvodnje, predelave in distribucije“, kot je opredeljeno v členu 3(16) Uredbe (ES) št. 178/2002.
General Guidance
Splošne smernice
Where a combination of audit systems is introduced in a Member State, mechanisms should be put in place to ensure that the audit systems cover all control activities under Regulation (EC) No 882/2004, including animal health and animal welfare and at all stages of the feed and food-production chain, and including the activities of all agencies or control bodies involved.
Če je v državi članici uvedena kombinacija sistemov presoj, je treba vzpostaviti mehanizme za zagotovitev, da sistemi presoj pokrivajo vse nadzorne dejavnosti v skladu z Uredbo (ES) št. 882/2004, vključno z zdravstvenim varstvom ter zaščito živali, in na vseh stopnjah krmne verige in verige proizvodnje živil, ter vključno z dejavnostmi vseh vključenih agencij ali izvajalcev nadzora.
In particular, where control tasks are delegated to a control body, and the competent authority has chosen to audit rather than to inspect the control body, then the contractual obligations of that delegated body should include the acceptance of auditing requirements and the conditions thereof.
Zlasti kjer so nadzorne naloge prenesene na nadzorni organ in so se pristojni organi odločili za presojo in ne za inšpekcijski pregled nadzornega organa, morajo pogodbene obveznosti tega pooblaščenega organa vključevati sprejetje presojevalskih zahtev in pogojev.
In addition to the specific guidance set out in this document, ISO 19011:2002 should be referred to for general guidance.
Razen posebnih napotkov, določenih v tem dokumentu, je treba kot splošni napotek upoštevati ISO 19011:2002.
Nature of the audit process
Lastnosti procesa presoje
Systematic Approach
Sistematični pristop
A systematic approach should be applied to the planning, conduct, follow-up and management of audits.
Sistematični pristop je treba uporabiti za načrtovanje, izvajanje, spremljanje in vodenje presoj.
To that end, the audit process should:
V ta namen:
be the result of a transparent planning process identifying risk-based priorities in line with the competent authority’s responsibilities under Regulation (EC) No 882/2004,
mora biti proces presoje rezultat preglednega procesa načrtovanja, ki ugotavlja prednostne naloge na podlagi tveganja skladno z odgovornostmi pristojnega organa v skladu z Uredbo (ES) št. 882/2004,
form part of an audit programme that ensures adequate coverage of all relevant areas of activity and all relevant competent authorities within the sectors covered by Regulation (EC) No 882/2004 at an appropriate risk-based frequency over a period not exceeding five years,
mora biti proces presoje del programa presoj, ki zagotavlja ustrezno pokrivanje vseh ustreznih področij dejavnosti in vseh ustreznih pristojnih organov v sektorjih, ki jih pokriva Uredba (ES) št. 882/2004, ob ustrezni pogostosti na podlagi tveganja v obdobju, ki ne presega pet let,
be supported by documented audit procedures and records to ensure consistency between auditors and to demonstrate that a systematic approach is followed,
morajo proces presoje podpirati dokumentirani postopki presoje in zapisi, da se zagotovi usklajenost med presojevalci in dokaže uporaba sistematičnega pristopa,
include procedures for generating audit findings, including the identification of evidence of compliance and non-compliance, as appropriate, and for preparing, approving and distributing audit reports,
mora proces presoje vključevati postopke za pridobivanje ugotovitev presoje, vključno z ugotavljanjem skladnosti in neskladnosti, kot je ustrezno, ter za pripravljanje, odobravanje in razdeljevanje poročil o presojah,
include procedures to review audit conclusions, in order to identify system-wide strengths and weaknesses in the control system, disseminate best practice and ensure the monitoring of corrective and preventive actions,
mora proces presoje vključevati postopke za pregled sklepov presoje, za ugotavljanje sistemskih prednosti in slabosti nadzornega sistema, razširjanje najboljše prakse ter zagotavljanje spremljanja korektivnih in preventivnih ukrepov,
be monitored and reviewed to ensure the audit programme's objectives have been met and to identify opportunities for improvement.
je treba proces presoje spremljati in pregledovati, da se zagotovi izpolnitev ciljev programa presoj in ugotovijo možnosti za izboljšave.
Where more than one audit programme is envisaged within a Member State, steps should be taken to ensure that such programmes are effectively coordinated, so as to ensure a seamless audit process across the relevant competent authorities.
Če je v državi članici predviden več kot en program presoj, je treba sprejeti ukrepe za zagotovitev učinkovite uskladitve takšnih programov, da se zagotovi celostni proces presoje v vseh ustreznih pristojnih organih.
The audit programme(s) should also cover all relevant levels of the competent authority’s hierarchy.
Program(-i) presoj mora(-jo) pokrivati tudi vse ustrezne stopnje hierarhije pristojnega organa.
In order to demonstrate the audit process is transparent, documented procedures should, in particular, include a clearly defined audit planning process, audit criteria and audit report approval and distribution mechanisms.
Da bi dokazali preglednost procesa presoje, morajo dokumentirani postopki vključevati zlasti jasno opredeljen proces načrtovanja presoje, kriterije presoje ter mehanizme za odobritev in razdeljevanje poročila o presoji.
Management and implementation of the audit process should be transparent to all relevant stakeholders.
Vodenje in izvajanje procesa presoje morata biti pregledna za vse pomembne interesne skupine.
In particular, there should be full transparency between the audit body and the auditee.
Popolna preglednost mora biti zlasti med presojevalnim organom in presojancem.
Ensuring the audit process is transparent in the eyes of other stakeholders will assist in the dissemination of information, and in particular in the sharing of best practice within and between competent authorities.
Zagotovitev preglednega procesa presoje v očeh drugih interesnih skupin bo pomagala pri razširjanju informacij in zlasti pri izmenjavi najboljše prakse znotraj pristojnih organov in med njimi.
The Member States should adopt the appropriate measures to ensure their audit systems are transparent, taking national legal and other requirements into account.
Države članice morajo sprejeti primerne ukrepe za zagotovitev preglednosti svojih sistemov presoj, ob upoštevanju nacionalnih pravnih in drugih zahtev.
To that end, the Member States should consider encouraging practices that improve the transparency of the process.
V ta namen morajo države članice razmisliti o spodbujanju praks, ki izboljšajo preglednost procesa.
Some examples of such practices are listed in the Table below.
Nekaj primerov takšnih praks je navedenih v Preglednici 1.
When deciding on such measures, the Member States should balance the need for transparency against the risk of undermining the audit system's ability to achieve its objectives.
Pri odločanju o takšnih ukrepih morajo države članice uravnotežiti potrebo po preglednosti z nevarnostjo ogrozitve sposobnosti sistema presoj za dosego njegovih ciljev.
In order to optimise the benefits of transparency, it should be combined with balanced reporting, that is a proper mixture of verified compliance (positive findings) and areas for improvement (negative findings).
Za povečanje koristi preglednosti je treba preglednost združiti z uravnoteženim poročanjem, ki je ustrezna mešanica preverjene skladnosti (pozitivne ugotovitve) in področij, ki jih je treba izboljšati (negativne ugotovitve).
Table
Preglednica:
Examples of practices improving the transparency of an audit process
Primeri praks, ki izboljšujejo preglednost procesa presoje
Note: Member States should select the practices (first column) and the extent to which they are applied (remaining columns) which are appropriate to their particular circumstances.
Opomba: Države članice morajo izbrati prakse (prvi stolpec) in obseg njihove uporabe (ostali stolpci), ki ustrezajo njihovemu položaju
Audit body practices
Prakse presojevalnega organa
Auditee
Presojanec
Within competent authority
Znotraj pristojnega organa
Across competent authorities (within Member States)
Med pristojnimi organi (znotraj držav članic)
Public and other stakeholders
Javnost in druge interesne skupine
Access to documented audit body procedures
Dostop do dokumentiranih postopkov presojevalnega organa
Consultation on planning of audit programme
Posvetovanje o načrtovanju programa presoj
Publication of audit programme
Objava programa presoj
Submission of audit plan
Predložitev načrta presoje
Opportunity to comment on draft audit report
Priložnost izražanja mnenja o osnutku poročila o presoji
Distribution of final audit report
Razdeljevanje končnega poročila o presoji
Publication of auditee’s comments on draft report
Objava pripomb presojanca na osnutek poročila
Publication of final audit report
Objava končnega poročila o presoji
Publication of summaries of final audit reports and of annual report
Objava povzetkov končnih poročil o presojah in letnega poročila
Publication of auditee’s action plan
Objava akcijskega načrta presojanca
Publication of follow-up results
Objava rezultatov aktivnosti po presoji
Audit bodies should be free from any commercial, financial, hierarchical, political or other pressures that might affect their judgment or the outcome of the audit process.
Presojevalni organi ne smejo biti pod kakršnimi koli trgovinskimi, finančnimi, hierarhičnimi, političnimi ali drugimi pritiski, ki bi lahko vplivali na njihovo mnenje ali izid procesa presoje.
The audit system, audit body and auditors should be independent of the activity being audited and free from bias and conflicts of interest.
Sistem presoj, presojevalni organ in presojevalci morajo biti neodvisni od aktivnosti, ki jo pregledujejo, nepristranski in brez navzkrižja interesov.
Auditors should not audit areas or activities for which they have direct responsibility.
Presojevalci ne smejo presojati področij ali aktivnosti, za katere so neposredno odgovorni.
All relevant competent authorities should introduce safeguards to ensure that responsibility and accountability for audit and control activities, such as the management and supervision of official control systems, are kept sufficiently distinct.
Vsi ustrezni pristojni organi morajo zagotoviti, da so odgovornost za presoje in aktivnosti nadzora, kot sta vodenje in nadzorovanje uradnih nadzornih sistemov, v zadostni meri ločene.
Where the audit team makes recommendations for corrective and preventive action, the auditee should choose the methods to be applied for such action.
Kadar presojevalna skupina oblikuje priporočila za korektivno in preventivno ukrepanje, mora presojanec izbrati metode za takšno ukrepanje.
Active audit team involvement in follow-up should be limited to assessing the suitability of the action plan and the effectiveness of the corrective and preventive action.
Dejavno sodelovanje presojevalne skupine pri aktivnostih po presoji mora biti omejeno na ocenjevanje primernosti akcijskega načrta ter učinkovitosti korektivnega in preventivnega ukrepanja.
Auditees should not be in a position to impede the audit programme, findings or conclusions.
Presojanci ne smejo ovirati programa presoj, ugotovitev ali zaključkov.
They should be consulted on the draft report and their comments should be considered by the audit body.
Z njimi se je treba posvetovati o osnutku poročila in presojevalni organ mora obravnavati njihove pripombe.
Where appropriate, those comments should be taken into account in a transparent manner.
Kadar je to primerno, se morajo te pripombe upoštevati na pregleden način.
The following points may help ensure that the audit process safeguards the independence of both the audit body and the audit team:
Naslednje točke lahko pripomorejo k temu, da proces presoje zagotavlja neodvisnost presojevalnega organa in presojevalne skupine:
a clear, documented mandate affording adequate power to conduct the audits should be provided,
zagotoviti je treba jasen, dokumentiran mandat, ki podeljuje ustrezna pooblastila za izvedbo presoj,
neither the audit body nor the audit team should be involved in managing or supervising the control systems being audited,
presojevalni organ in presojevalna skupina ne smeta sodelovati pri vodenju ali nadzorovanju nadzornih sistemov, ki se presojajo,
for external audits, the audit body and audit team should be external to, and independent of, the organisational hierarchy of the auditee,
pri zunanjih presojah morata biti presojevalni organ in presojevalna skupina zunaj organizacijske hierarhije presojanca in neodvisna od nje,
for internal audits, the following general principles should apply to ensure the process is independent and transparent:
pri notranjih presojah je treba spoštovati naslednja splošna načela, da se zagotovi neodvisnost in preglednost procesa:
the audit body and audit team should be appointed by top management,
presojevalni organ in presojevalno skupino mora imenovati najvišje vodstvo,
the audit body and/or the audit team should report to top management,
presojevalni organ in/ali presojevalna skupina morata poročati najvišjemu vodstvu,
a check should be carried out to ensure no conflict of interest exists for either the audit body or the audit team.
treba je preveriti, da pri presojevalnem organu ali presojevalni skupini ne obstaja navzkrižje interesov.
Independent audit bodies should be external to or separate from the management of audited activities.
Neodvisni presojevalni organi morajo biti zunaj vodstva presojanih aktivnosti ali ločeni od njega.
Internal audit bodies should report to the most senior management within the organisational structure.
Notranji presojevalni organi morajo poročati najvišjemu vodstvu v organizacijski strukturi.
Where technical expertise required for the audit is available only within a competent authority, measures should be taken to ensure the audit team remains independent.
Kjer je tehnično strokovno znanje, ki ga zahteva presoja, na voljo le v pristojnem organu, je treba sprejeti ukrepe za ohranjanje neodvisnosti presojevalne skupine.
Where control activities are organised on a regional basis, technical specialists could be exchanged in order to ensure they are independent.
Kjer so nadzorne dejavnosti organizirane na regionalni ravni, se lahko tehnični strokovnjaki izmenjujejo, da se zagotovi njihova neodvisnost.
Independent Scrutiny of the Audit Process
Neodvisni natančni pregled procesa presoje
In order to check whether it is achieving its objectives, the audit process should be subject to scrutiny by an independent person or body.
Da bi preverili, ali proces presoje dosega svoje cilje, ga mora natančno pregledati neodvisna oseba ali organ.
Such independent person or body should have sufficient authority, expertise and resources to carry out this task effectively.
Taka neodvisna oseba ali organ mora imeti ustrezno pristojnost, strokovno znanje in vire za učinkovito izvajanje te naloge.
The approaches to independent scrutiny may vary, depending on the activity or the competent authority.
Pristopi k neodvisnemu natančnemu pregledu so lahko različni, odvisni od aktivnosti ali pristojnega organa.
Where a body or a committee has been established with a view to independent scrutiny of the audit process, one or more independent persons should be members of such body or committee.
Kadar je oblikovan organ ali odbor za neodvisni natančni pregled procesa presoje, mora v takem organu ali odboru sodelovati ena ali več neodvisnih oseb.
Such independent persons should have access to the audit process and be empowered to contribute fully to it.
Takim neodvisnim osebam morata biti zagotovljena dostop do procesa presoje in pooblastilo, da sodelujejo v največji možni meri.
Action should be taken to remedy any shortcomings identified in the audit process by the independent person or body.
Če neodvisna oseba ali organ v procesu presoje ugotovi kakršne koli pomanjkljivosti, je treba sprejeti vse potrebne ukrepe za njihovo odpravo.
Implementation of the Audit Process
Izvajanje procesa presoje
Guiding Principles: (a) Compliance with planned arrangements; (b) Effective implementation; (c) Suitability to achieve objectives
Vodilna načela: (a) skladnost z načrtovano ureditvijo; (b) učinkovito izvajanje; (c) primernost za doseganje ciljev
To comply with the requirements of Article 4(6) of Regulation (EC) No 882/2004, the audit system should cover the following three points set out in Article 2(6):
Za izpolnjevanje zahtev člena 4(6) Uredbe (ES) št. 882/2004, mora sistem presoj zajemati naslednje tri točke iz člena 2(6):
Verification of compliance with planned arrangements in order to provide assurances that official controls are carried out as intended and that any instructions or guidelines given to staff carrying out the controls are followed.
preverjanje skladnosti z načrtovano ureditvijo za zagotovitev, da se uradni nadzor izvaja, kot je bilo predvideno, in da se spoštujejo navodila ali smernice, dane osebju, ki izvaja nadzor.
This may largely be addressed by document review, but will also require on-site verification.
To se lahko v veliki meri izvede s pregledom dokumentov, vendar bo potrebno tudi preverjanje na kraju samem.
The audit team will require good generic audit knowledge and skills to address this audit objective.
Presojevalna skupina mora imeti dobro splošno presojevalsko znanje in veščine za doseganje tega cilja presoje.
Verification of the effective implementation of planned arrangements.
Preverjanje uspešnega izvajanja načrtovane ureditve.
In order to assess effectiveness, that is the extent to which planned results are achieved, on-site operational implementation must be included.
Za ocenjevanje uspešnosti, tj. obsega uresničitve načrtovanih rezultatov, je treba vključiti operativno izvajanje na kraju samem.