GUIDANCE ON THE APPLICATION OF ISO/IEC 17020 - · PDF fileguidance on the application of...

GUIDANCE ON THE APPLICATION OF ISO/IEC 17020 - IAF/ILAC-A4:2004 -

VODILO ZA UPORABO STANDARDA ISO/IEC 17020

- IAF/ILAC-A4:2004 -

Guidance on the aplication of ISO/IEC 17020 - ILAC/IAF A4:2004

Vodilo za uporabo standarda ISO/IEC 17020 - ILAC/IAF A4:2004

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© Copyright ILAC/IAF 2004

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Mednarodno združenje za akreditacijo laboratorijev ILAC (International Laboratory Accreditation Cooperation) in Mednarodni akreditacijski forum IAF (International Accreditation Forum) spodbujata dovoljeno razmnoževanje te publikacije ali njenih delov v organizacijah, ki želijo to gradivo uporabljati na področjih, povezanih z izobraževanjem, standardizacijo, akreditacijo, dobro prakso ugotavljanja skladnosti ali za druge namene, pomembne za področje strokovnega znanja in izkušenj ali ustvarjanja ILAC/IAF. Organizacije, ki želijo pridobiti dovoljenje za razmnoževanje gradiva iz te publikacije, naj se pisno ali po elektronski pošti obrnejo na Sekretariat ILAC ali Sekretariat IAF:

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ali se bo dokument, ki vsebuje omenjeno gradivo, razdeljevali v tržne namene, kje se bo razdeljeval oziroma prodajal in v kakšnih količinah;

morebitne druge informacije, ki bi ILAC in IAF lahko pomagale pri izdaji dovoljenja.

ILAC in IAF si pridržujeta pravico do zavrnitve dovoljenja brez navedbe razlogov. Dokument, v katerem izide razmnoženo gradivo, mora vsebovati izjavo, s katero se ILAC/IAF priznava njun prispevek k dokumentu. Dovoljenje za razmnoževanje zajema samo gradivo, navedeno v prvotni prošnji. Morebitne spremembe navedene uporabe gradiva je treba v naprej pisno priglasiti in pridobiti dodatno dovoljenje. ILAC in IAF ne odgovarjata za nobeno uporabo svojega gradiva v drugem dokumentu. Vsaka kršitev zgornjega dovoljenja za razmnoževanje ali nedovoljena uporaba tega gradiva je strogo prepovedana in ima lahko za posledico pravni spor. Za dovoljenje in nadaljnjo pomoč se obrnite na:

The ILAC Secretariat, c/o NATA, PO Box 7507, Silverwater NSW 2128, Australia, Faks: +61 2 9743 5311, E-pošta: [email protected]

The IAF Secretariat, 53 Manuka Circle, Cherrybrook NSW 2126, Australia, Faks: +61 2 9481 7343, E-pošta: [email protected]



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Contents

Vsebina

1. Scope 4 1. Predmet standarda 4

2. Definitions 4 2. Definicije 4

3. Administrative requirements 5 3. Upravne zahteve 5

4. Independence, impartiality and integrity 6 4. Neodvisnost, nepristranost in poštenost 6

5. Confidentiality 8 5. Zaupnost 8

6. Organisation and management 8 6. Organizacija in vodenje 8

7. Quality system 10 7. Sistem kakovosti 10

8. Personnel 11 8. Osebje 11

9. Facilities and equipment 11 9. Zmogljivosti in oprema 11

10. Inspection methods and procedures 13 10. Metode in postopki kontrole 13

11. Handling inspection samples and items 14 11. Ravnanje z vzorci in primerki za kontrolo 14

12. Records 14 12. Zapisi 14

13. Inspection reports and inspection certificates 14 13. Poročila o kontroli in potrdila oziroma certifikato kontroli

14

14. Sub-contracting 15 14. Sklepanje podpogodb 15

15. Complaints and appeals 16 15. Pritožbe in prizivi 16

16. Co-operation 16 16. Sodelovanje 16

Appendix 1 18 Dodatek 1 19





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Uvod Introduction

1. Scope

1. Predmet standarda

1.1a When using ISO/IEC 17020 and this guidance document the accreditation body should neither add to, nor subtract from the requirements of the standard. The application of legal, governmental or other normative requirements shall be reflected in the scope of accreditation granted.

1.1a Kadar akreditacijski organ uporablja standard ISO/IEC 17020 skupaj s temi napotki, naj zahtevam standarda ničesar ne dodaja niti odvzema. Veljavnost zakonskih, vladnih ali drugih normativnih zahtev se mora odražati v obsegu podeljene akreditacije.

1.4a Testing performed by an inspection body may fall into one of two categories namely functional and analytical. Functional testing, for example load testing of a crane, forms a normal part of the activities of an inspection body and is therefore within the scope of ISO/IEC 17020. Analytical testing, (which must be performed inside a laboratory under well-controlled environmental conditions and using more sophisticated equipment or testing procedures) is a laboratory activity and therefore does not come within the scope of ISO/IEC 17020. Inspection bodies wishing to undertake such laboratory type analytical testing as part of an inspection will need to do so in accordance with the relevant requirements in ISO/IEC 17025.

1.4a Preskušanje, ki ga izvaja kontrolni organ, je lahko funkcionalno ali analizno. Funkcionalno preskušanje, na primer preskušanje obtežbe dvigala, sodi med običajne dejavnosti kontrolnega organa in je zato zajeto v standardu ISO/IEC 17020. Analizno preskušanje (ki se izvaja v laboratoriju v dobro obvladovanih okoljskih razmerah in s pomočjo kompleksnejše opreme ali preskusnih postopkov) pa je dejavnost laboratorija in zato ni zajeto v standardu ISO/IEC 17020. Kontrolni organi, ki želijo v okviru kontrole izvajati analizno preskušanje v laboratoriju, morajo to izvajati v skladu z ustreznimi zahtevami standarda ISO/IEC 17025.

2. Definitions

2. Definicije

2.1a Throughout these guidelines the word “product” should be understood to include the words “product design”, “service”, “process” and “plant” as specified in clause 2.1.of the standard.

2.1a Izraz "proizvod", ki se pojavlja v teh smernicah, naj obsega izraze "načrtovanje proizvoda", "storitev", "proces" in "obrat", kot je določeno v poglavju 2.1 standarda.

2.1b In recognition of the wide range of industries represented by inspection bodies alternative terminology could be used for what is inspected.

2.1b Glede na široko paleto dejavnosti, ki jih izvajajo kontrolni organi, se lahko za predmet kontrole uporablja tudi drugo izrazje.

2.1c The definition of inspection overlaps with that of testing and product certification where these activities have common characteristics. However, an important difference is that many types of inspection involve professional judgement to determine acceptability against general requirements and thus the inspection body will have to demonstrate that it has the necessary competence to perform the task.

2.1c Definicija kontrole se prekriva z definicijo preskušanja in certificiranja proizvodov, če imajo te dejavnosti skupne značilnosti. Pomembna razlika pa je v tem, da gre pri mnogih vrstah kontrole za strokovno razsojanje, s katerim se ugotavlja sprejemljivost glede na splošne zahteve, pri čemer mora kontrolni organ dokazati, da je ustrezno usposobljen za izvajanje naloge.

2.1d The scope of ISO/IEC 17020 does not cover quality

management system certification. It may, however, be necessary for inspection bodies to examine certain aspects of the quality management system or other documented systems, in order to justify the inspection results, for example, the examination of processes. See Note 1 following Clause 2.1.

2.1d Standard ISO/IEC 17020 ne obsega certificiranja sistema vodenja kakovosti. Lahko pa da bodo morali kontrolni organi pregledati nekatere vidike sistema vodenja kakovosti ali drugih dokumentiranih sistemov, da bi lahko utemeljilirezultate kontrole, na primer preiskave procesov. Glej Opombo 1 k poglavju 2.1.

2.1e Generally, inspection involves direct determination of the conformity with specific or general requirements of unique - often complex or critical - products or small series of products, whereas product certification primarily involves indirect determination of the conformance of products manufactured in long series to specific requirements. While inspection of products in use (in-service inspection) is a well-established discipline, certification (ISO/IEC

2.1e Na splošno gre pri kontroli za neposredno ugotavljanje skladnosti enotnih – pogosto kompleksnih ali kritičnih proizvodov ali manjših serij proizvodov s posebnimi ali splošnimi zahtevami, medtem ko gre pri certificiranju proizvodov predvsem za posredno ugotavljanje skladnosti proizvodov, izdelanih v večjih serijah, s posebnimi zahtevami. Medtem ko je kontrola proizvodov v uporabi



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Guide 65) of products in use does not occur. Some further differences are shown in the following table.

Some differences between Inspection (ISO/IEC 17020) and

Product Certification (ISO/IEC Guide 65) Note: see page 17

že ustaljena strokovna disciplina, pa se certificiranje (ISO/IEC Vodilo 65) proizvodov v uporabi ne izvaja. V naslednji tabeli je prikazanih nekaj nadaljnjih razlik.

Nekaj razlik med kontrolo (ISO/IEC 17020) in certificiranjem

proizvodov (ISO/IEC Vodilo 65) Opomba: glej stran 17

3. Administrative Requirements

3. Upravne zahteve

3.2a An organisational diagram is a useful means of illustrating the position of the inspection body in relation to a larger organisation. Diagrams showing relationships with related companies or organisations and relationships between departments within the same organisation are useful support for claims of independence.

3.2a Koristen pripomoček za prikaz položaja kontrolnega organa v okviru večje organizacije je organigram. Diagrami, ki kažejo odnose s povezanimi podjetji ali organizacijami ali odnose med oddelki znotraj iste organizacije, pa so koristna podpora zahtevam za neodvisnost.

3.3a Accreditation bodies present the scope of activity for which accreditation of inspection bodies is granted in a formal statement, called, for example, the Accreditation Schedule that accompanies the Accreditation Certificate. The Accreditation Schedule is produced by the accreditation body in consultation with the assessor(s) involved in the assessment of the inspection body. It is based on the information provided by the inspection body in connection with the application for accreditation and the demonstrated and verified competence of the inspection body. The Accreditation Certificate and Schedule should indicate the type of body as defined in sub-clause 4.2 of ISO/IEC 17020. An example of a layout of an Accreditation Certificate is given at Appendix 1 and of an Accreditation Schedule at Appendix 2.

3.3a Obseg dejavnosti, za katero je kontrolnemu organu podeljena akreditacija, navedejo akreditacijski organi v formalni izjavi, imenovani npr. obseg akreditacije, ki je priložen akreditacijski listini. Akreditacijski organ izdela obseg akreditacije po posvetovanju z ocenjevalcem(-i), vključenim (-i) v ocenjevanje kontrolnega organa. Obseg temelji na podatkih, ki jih v prijavi za akreditacijo navede kontrolni organ, ter na dokazani in preverjeni usposobljenosti kontrolnega organa. V akreditacijski listini in njeni prilogi naj bo navedena vrsta organa, kot je določeno v podpoglavju 4.2 standarda ISO/IEC 17020. V dodatku 1 je naveden primer akreditacijske listine, v dodatku 2 pa primer priloge k akreditacijski listini.

3.3b The scope of accreditation should be defined in the schedule in sufficiently precise terms that potential clients may establish accurately and unambiguously the general field of inspection, the type and range of inspection and, where applicable, the regulations, standards or specifications containing the requirements against which the inspection will be performed.

3.3b V prilogi naj bo dovolj natančno opredeljen obseg akreditacije, da bodo možni naročniki lahko točno in nedvoumno ugotovili področje kontrole, vrsto in obseg kontrole ter morebitne predpise, standarde ali specifikacije, ki vsebujejo zahteve, po katerih se bo kontrola izvajala.

3.3c Contracts or work orders for inspection should ensure that there is a clear and demonstrable understanding between the inspection body and its customer of the scope of the inspection work to be undertaken by the inspection body. In many inspection areas (e.g. in-service inspection based on national regulations) individual contracts are not signed with clients. In these cases the work order must becontained in some underlying documentation, e.g. regulations issued by regulatory authorities.

3.3c V pogodbah ali delovnih nalogih naj se zagotovi jasno in dokazljivo razumevanje med kontrolnim organom in njegovim odjemalcem glede obsega kontrole, ki jo bo kontrolni organ izvajal. Na mnogih področjih kontrole (npr. kontrola v uporabi, ki ima podlago v nacionalnih predpisih) se z odjemalci ne podpišejo posamezne pogodbe. V takih primerih mora delovni nalog vsebovati osnovno dokumentacijo, npr. predpise, ki jih izdajo upravni organi.

3.4a The inspection body is expected to be able to show what

factors have been taken into account when determining the necessary level of the contracted insurance. One of the factors that should be taken in to account is the risks associated with the performance of inspection activities.

3.4a Od kontrolnega organa se pričakuje, da bo sposoben pokazati, katere dejavnike je upošteval pri določanju potrebne ravni zavarovanja v pogodbi. Eden od dejavnikov, ki bi jih bilo treba upoštevati, so tveganja, povezana z izvajanjem dejavnosti kontrole.

3.4b It is not the role of accreditation bodies to approve the level of insurance cover held by their clients. The types of liability covered by insurance, for example, may include employers’ liability, public liability and professional indemnity.

3.4.b Ni vloga akreditacijskih organov, da bi odobravali raven obsega zavarovanja, ki ga imajo njihovi naročniki. Vrste jamstva ki so zajete v zavarovanju, lahko npr. vključujejo obveznosti delodajalca, javnopravno odgovornost in zavarovanje proti napakam pri opravljanju poklica.



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Note: Inspection bodies should pay particular attention to insurance cover when undertaking inspection work in another country, where legal requirements may differ from those in the body’s home country.

Opomba: Kontrolni organi naj bodo še posebej pozorni na obseg zavarovanja, kadar izvajajo kontrolo v drugi državi, saj se lahko zakonske zahteve tam razlikujejo od domačih.

3.5a The conditions referred to in clause 3.5 are contractual

and business conditions, not physical conditions, of inspection sites.

3.5a Pogoji iz poglavja 3.5 so pogodbeni in poslovni pogoji, ne pa fizični pogoji na lokacijah, kjer se kontrola izvaja.

3.6a It is not the role of accreditation bodies to judge the adequacy of the financial acccounts.

3.6a Vloga akreditacijskih organov ni razsojanje ustreznosti finančnih poročil.

4. Independence, impartiality and integrity 4. Neodvisnost, nepristranost in poštenost

4.1a Procedures should be documented to assure inspection body staff are free from commercial, financial or other pressures which might affect their judgement.

4.1a Dokumentiran postopki naj zagotavljajo da je osebje kontrolnega organa prosto komercialnih, finančnih ali drugih pritiskov, ki bi lahko vplivali na njegovo razsojanje.

4.2a The categorisation of inspection bodies as Type A, B or C

is essentially a measure of their independence. Demonstrable independence of an inspection body may strengthen the confidence of the inspection body’s customers in the body’s ability to carry out inspection work with impartiality and objectivity. The terms first party and second party, as defined in ISO/IEC Guide 2, are not used in ISO/IEC 17020, because application of them would not be helpful. However, since conventional thinking has been in terms of first, second or third parties for many years, it is necessary to offer some explanation on the relationship between the two sets of categories, asincluded below.

4.2a Razvrstitev kontrolnih organov v tipe A, B ali C je v bistvu merilo njihove neodvisnosti. Izkazljiva neodvisnost kontrolnega organa, lahko poveča zaupanje odjemalcev v njegovo sposobnost nepristranskega in objektivnega izvajanja kontrole. Izraza prva stranka in druga stranka, kot sta definirana v ISO/IEC Vodilu 2, se v standardu ISO/IEC 17020 ne uporabljata, saj njuna uporaba ne bi pomagala. Vendar pa je glede na to, da se je dolga leta konvencionalno razmišljalo v smislu prvih, drugih ali tretjih strank, treba nekako razložiti povezavo med obema sklopoma kategorij. Ta razlaga je vključena v nadaljevanju.

4.2.1a A Type A Inspection Body, to claim to be independent of

the parties involved, shall demonstrate that it is not linked to a party directly involved in design, manufacture, supply, installation, purchase, ownership, use or maintenance of the items inspected or similar competitive items by

o common ownership (except where the owners have no ability to influence the outcome of an inspection), Note 1

o common ownership appointees on the boards (or equivalent) of the organisations (except where these have functions that have no influence on the outcome of an inspection) Note 2

o directly reporting to the same higher level of management

o contractual arrangements, informal understandings or other means that may have an ability to influence the outcome of an inspection.

In addition to the above, an Inspection Body shall not

become a Type A Inspection Body if another part of the same organisation is directly involved in design, manufacture, supply, installation, purchase, ownership, use or maintenance of the items inspected or similar competitive items, when such other parts of the organisation do not have a separate legal identity.

The Chief Executive of the legal entity of which the

Inspection Body is a part shall define and document its policy for maintaining the Type A status of the Inspection

4.2.1a Da bi lahko izjavil, da je neodvisen od vključenih strank, mora kontrolni organ tipa A dokazati, da ni povezan s stranko, ki je neposredno vpletena v načrtovanje, proizvodnjo, dobavo, montažo, nabavo, lastništvo, uporabo ali vzdrževanje predmetov, ki jih kontrolira, ali podobnih konkurenčnih predmetov, preko:

o skupnega lastništva (razen če lastniki nimajo vpliva na izid kontrole), Opomba 1

o imenovanja v upravo (ali enakovredno telo) skupnega lastništva organizacij (razen če te funkcije nimajo vpliva na izid kontrole) Opomba 2

o neposredne odgovornosti isti, višji ravni vodstva o pogodbenih dogovorov, neformalnih sporazumov ali

drugih načinov, ki bi lahko vplivali na izid kontrole. Poleg zgoraj omenjenega kontrolni organ ne sme

postati kontrolni organ tipa A, če je drugi del iste organizacije neposredno vpleten v načrtovanje, proizvodnjo, dobavo, montažo, nabavo, lastništvo, uporabo ali vzdrževanje predmetov kontrole ali podobnih konkurenčnih predmetov, če taki drugi deli organizacije nimajo ločene pravne identitete.

Glavni izvršni direktor pravne osebe, katere del je

kontrolni organ, mora opredeliti in dokumentirati politiko te pravne osebe glede vzdrževanja statusa kontrolnega organa tipa A. Akreditacijski organ bo pregledal dokaze o izvajanju te politike glede na



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Body. The Accreditation Body will examine the evidence of implementation of this policy in respect of ownership interests, constitution of board of directors, means of financing, decision making methods and other such factors that may have an influence on the impartiality, independence and integrity of a Type A Inspection Body.

Note 1 An example of this is a cooperative type of structure where

there are large numbers of stakeholders but they (individually or as a group) have no formal means of influencing the policies, strategies or operation of the inspection body.

Note 2 An example of this is where a bank financing a company

may insist on an appointee to the board to overview how the company is managed but will not be involved in any decision-making.

interese lastništva, sestavo nadzornega odbora, načine financiranja, metode odločanja in druge dejavnike, ki bi lahko vplivali na nepristranost, neodvisnost in poštenost kontrolnega organa tipa A.

Opomba 1: Tak primer je zadružni tip strukture, z velikim

številom deleženikovi, ki pa (posamično ali kot skupina) nimajo formalnih sredstev za vplivanje na politiko, strategijo ali delovanje kontrolnega organa.

Opomba 2: Tak primer je, če banka, ki financira podjetje,

vztraja pri imenovanju v upravo svojega predstavnika, ki bo nadziral vodenje podjetja, ne bo se pa vključeval v odločanje.

4.2.2a The two characteristics by which inspection bodies can be identified as Type B inspection bodies are the following:

Type B inspection bodies form a demonstrably separate

and identifiable part of an organisation that is involved in the design, manufacture, supply, installation, use or maintenance of items that they inspect;

Type B inspection bodies supply inspection services only

to their parent organisation. A Type B inspection body may form a part of a user

organisation or of a supplier organisation. When a Type B inspection body that forms a part of a

supplier organisation inspects items that are manufactured by or for its parent organisation and are to be supplied to the market or to any other party, it carries out first party inspection.

When a Type B inspection body that forms a part of a

user organisation inspects items to be supplied for use by its parent organisation by a supplier organisation that is not its parent organisation and not related to it, it carries out second party inspection.

4.2.2a Dve značilnosti po katerih so prepoznavni kontrolni organi tipa B, sta:

Kontrolni organi tipa B so dokazljivo ločeni in

prepoznaven del organizacije, ki je vpletena v načrtovanje, proizvodnjo, dobavo, montažo, uporabo ali vzdrževanja predmetov, ki jih ti kontrolni organi kontrolirajo;

Kontrolni organi tipa B opravljajo kontrolne storitve

samo za matično organizacijo. Kontrolni organ tipa B je lahko del organizacije

uporabnika ali organizacije dobavitelja. Kadar kontrolni organ tipa B, ki je del organizacije

dobavitelja, kontrolira predmete, ki jih proizvaja matična organizacija ali se zanjo proizvajajo za dobavo na trg ali dobavo kateri koli drugi stranki, izvaja kontrolni organ kontrolo kot prva stranka.

Kadar kontrolni organ tipa B, ki je del organizacije

uporabnika, kontrolira predmete, ki jih za uporabo matične organizacije dobavlja organizacija dobavitelj, ki ni matična organizacija kontrolnega organa iz z njim ni povezana, izvaja kontrolni organ kontrolo kot druga stranka.

4.2.3a Type C inspection bodies are involved, in the design,

manufacture, supply, installation, use or maintenance of items that they inspect. Inspections carried out by them may include first party inspections and second party inspections of the same type as carried out by Type B bodies. However, Type C inspection bodies are distinct from Type B inspection bodies for the following reasons:

A Type C inspection body need not be a separate part but

shall be identifiable within the organisation. A Type C body may itself be the designer, manufacturer, supplier, installer, user or maintainer of items that it inspects.

4.2.3a Kontrolni organi tipa C so vpleteni v načrtovanje, proizvodnjo, dobavo, montažo, uporabo ali vzdrževanje predmetov, ki jih kontrolirajo. Kontrole, ki jih izvajajo, lahko vključujejo kontrole prve stranke in kontrole druge stranke enake vrste kot kontrole, ki jih izvajajo organi tipa B. Vendar pa se kontrolni organi tipa C razlikujejo od kontrolnih organov tipa B zaradi naslednjega:

Kontrolnemu organu tipa C ni treba biti ločen del

organizacije, temveč mora biti prepoznaven znotraj nje. Organ tipa C je lahko sam načrtovalec, proizvajalec, dobavitelj, monter, uporabnik ali vzdrževalec predmetov, ki jih kontrolira.



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A Type C inspection body may offer its inspection service on the open market or to any other party and supply inspection service to external organisations. For example, it may inspect products supplied by it or by its parent organisation and used by another organisation. It may also supply other organisations with inspection of items that are similar to those designed, manufactured, supplied, installed, used or maintained by it or by its parent organisation, and which may therefore be regarded as competitive.

Inspections carried out by Type C inspection bodies

cannot be classified as third party inspections because they do not meet the requirements of independence of operations as stipulated for Type A inspection bodies in Annex A of ISO/IEC 17020. Type C inspection bodies may conform to some of the criteria concerning independence of other economic operators, non-involvement in ‘conflicting” activities and non-discriminatory operations that characterise Type A and Type B inspection bodies. Yet they remain Type C inspection bodies as long as they do not meet all of the requirements applicable to Type A or Type B inspection bodies.

The design/manufacture/supply/installation/servicing/

maintenance and the inspection of an entity carried out by a Type C inspection body should not be undertaken by the same person. An exception to this is where a regulatory or other authoritative requirement explicitly allows an individual person from a Type C inspection body to undertake both the design/ manufacture/supply installation/ servicing/ maintenance and the inspection of an entity.

Kontrolni organ tipa C lahko ponuja kontrolne storitve na odprtem trgu ali kateri koli stranki ter opravlja kontrolne storitve za zunanje organizacije. Tako lahko na primer kontrolira proizvode, ki jih dobavlja sam ali njegova matična organizacija in uporablja druga organizacija. Lahko tudi pri drugi organizaciji opravlja kontrolo predmetov, ki so podobni tistim, ki jih načrtuje, proizvaja, dobavlja, montira, uporablja ali vzdržuje sam ali njegova matična organizacija in ki se zato lahko štejejo za konkurenčne.

Kontrole, ki jih izvajajo kontrolni organi tipa C, ne

morejo biti razvrščene kot kontrole, ki jih izvaja tretja stranka, saj ne izpolnjujejo zahtev neodvisnosti delovanja, ki so za kontrolne organe tipa A določene v dodatku A k standardu ISO/IEC 17020. Kontrolni organi tipa C lahko izpolnjujejo nekatera merila v zvezi z neodvisnostjo drugih gospodarskih subjektov, nevključevanjem v "sporne" dejavnosti in nediskriminatornim delovanjem, ki so značilna za kontrolne organe tipa A in B. Vendar pa ostanejo kontrolni organi tipa C, vse dokler ne izpolnijo vseh zahtev za kontrolne organe tipa A ali B.

Načrtovanja/proizvodnje/dobave/montaže/servisiranja

/vzdrževanja in kontrole nekega subjekta, ki ga izvaja kontrolni organ tipa C, naj ne opravlja ista oseba. Izjemoma je lahko z zakonskimi predpisi ali drugo veljavno zahtevo pristojnega organa izrecno dovoljeno, da posameznik iz kontrolnega organa tipa C opravlja tako načrtovanje/proizvodnjo/dobavo/ montažo/servisiranje/vzdrževanje kot tudi kontrolo nekega subjekta.

5. Confidentiality 5. Zaupnost

5a The inspection body should have a policy, documented in its quality system, concerning the observance of the confidentiality requirements of the client by the inspection body (see clause 12.3 of ISO/IEC 17020) and by any sub-contractors engaged by it (see clause 14 of ISO/IEC 17020), taking into account any relevant legal requirements. For mandatory inspections the procedures should set out who, besides the client, is entitled to have access to the results.

5a Kontrolni organ naj ima politiko, dokumentirano v svojem sistemu kakovosti v zvezi z zahtevami naročnika o zaupnosti, ki velja tako za kontrolni organ (glej poglavje 12.3 standarda ISO/IEC 17020) kot za morebitne podpogodbenike kontrolnega organa (glej poglavje 14 standarda ISO/IEC 17020) in mora upoštevati ustrezne zakonske zahteve. Pri obveznih kontrolah naj bo navedeno, kdo ima poleg naročnika pravico dostopa do rezultatov.

6. Organization and management 6. Organizacija in vodenje

6.1a The size, structure and composition of an inspection body, taken together should be suitable for the

competent performance of the tasks with which the inspection body is concerned.

6.1a Kontrolni organ naj ima ustrezno velikost, zgradbo in sestavo, da bo lahko kompetentno izvajal svoje naloge.

6.2a The inspection body should maintain an up-to-date organisational chart clearly showing the functions and lines of authority for staff within the inspection body and the relationship, if any, between the inspection function and other activities of the organisation. The position of the technical manager and quality manager should be clearly shown in the chart.

6.2a Kontrolni organ naj ažurno vzdržuje organigram, v katerem so jasno prikazane funkcije in linije pooblastil osebja v kontrolnem organu ter odnosi med kontrolno funkcijo in drugimi dejavnostmi organizacije, če jih ima. V organigramu naj bo jasno prikazan položaj tehničnega vodje in vodje kakovosti.



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6.2b For each position in the organisation that could have an effect on the quality of inspections, or records of inspection, details of responsibility should be included in the quality system documentation.

6.2b V dokumentaciji sistema kakovosti naj bo podrobno navedena odgovornost za vsako delovno mesto v organizaciji, ki bi lahko vplivalo na kakovost kontrol ali zapise o kontroli.

6.2c The degree of complexity of documentation and the extent to which staff members can hold several functions will depend upon the size of the organisation.

6.2c Stopnja in kompleksnost dokumentacije in obseg do katerega lahko posamezno osebje ima več funkcij, je odvisna od velikosti organizacije.

6.3a Different persons may take up the role of technical manager for different activities. Where more than one person acts as the technical manager, the specific responsibilities of each person must be defined and documented.

6.3a Vlogo tehničnega vodje lahko za različne dejavnosti prevzamejo različne osebe. Če je tehničnih vodij več, morajo biti odgovornosti vsakega od njih določene in dokumentirane.

6.4a The inspection body should be able to demonstrate that it is organised in such a way that the work of the staff performing inspections is supervised by personnel who are familiar with the objectives of the inspections, the inspection methods and procedures being used and the assessments of the inspection results. The extent, nature and level of supervision exercised should take in to account the qualifications, experience, training and technical knowledge of the inspection staff and the inspections being undertaken.

6.4a Kontrolni organ naj bo sposoben dokazati, da je organiziran tako, da delo osebja, ki izvaja kontrolo, nadzira osebje, ki je seznanjeno s cilji kontrole, z metodami in postopki, ki se uporabljajo, ter z ocenjevanjem rezultatov kontrole. Pri obsegu, vrsti in ravni nadzora naj se upoštevajo kvalifikacije, izkušnje, strokovno izpopolnjevanje in strokovno znanje kontrolnega osebja ter vrsta kontrole, ki jo opravlja.

6.4b Effective supervision of inspections can be claimed only in situations where a supervisor is able to review, if required, actual observations and inspection decisions or otherwise personally verify that inspection decisions are reliable.

6.4b Lahko se trdi da je nadzor kontrole je učinkovit le, če je oseba, ki ga izvaja, sposobna po potrebi pregledati dejanska opažanja in ugotovitve kontrole ali kako drugače osebno preveriti da so ugotovitve kontrole zanesljive.

6.4c Supervision of inspection personnel may include, but not be limited to, the regular review of inspection reports to ensure that they are in accordance with relevant legislation, inspection body’s procedures and as necessary, contractual obligations agreed with the client. (See also Clause 10.5c & d).

6.4c Nadzor kontrolnega osebja lahko med drugim vključuje redni pregled poročil o kontroli, da se zagotovi njihova skladnost z veljavno zakonodajo, s postopki kontrolnega organa in po potrebi s pogodbenimi obveznostmi, dogovorjenimi z naročnikom. (Glej tudi poglavji 10.5c in d)

6.4d Monitoring of performance of inspections should include on-site witnessing of inspections. On-site witnessing of inspections should be carried out by technically competent personnel, who are sufficiently independent to carry out the witnessing of inspections objectively.

6.4d Opazovanje izvajanja kontrole naj vključuje spremljanje kontrol na lokaciji. Spremljanje kontrol na lokaciji naj izvaja strokovno usposobljeno osebje, ki je dovolj neodvisno, da lahko objektivno spremlja kontrole.

6.4e The inspection body’s programme for witnessing inspectors should be designed so that a representative sample of inspectors is witnessed. As a minimum, every inspector should be witnessed at least once during the normal accreditation cycle (typically 3 – 4 years) performing each field of inspection for which they are authorised by the inspection body. Records of observed inspections shall be kept.

6.4e Program kontrolnega organa za spremljanje dela kontrolorjev naj bo zasnovan tako, da bo opazovan reprezentativni vzorec kontrolorjev. Vsak kontrolor naj se spremlja vsaj enkrat med običajnim akreditacijskim ciklom (ponavadi na 3 do 4 leta) pri izvajanju vsakega področja kontrole, za katero ga je kontrolni organ pooblastil. Zapisi spremljanih kontrol se morajo shraniti.

6.5a The purpose of nominating a deputy is to satisfy the need for competent management in the absence of the manager. The deputy does not have to be permanently employed (see 8.1a) by the inspection body.

6.5a Namen imenovanja namestnika je, da se zadosti potrebi po kompetentnem vodstvu v odsotnosti vodje. Namestniku ni treba biti redno zaposlen (glej poglavje 8.1a) pri kontrolnem organu.



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6.5b In an organisation, where the absence of a key person causes the cessation of work, the requirement for deputies may be waived.

6.5b V organizacijah, kjer bi odsotnost ključne osebe povzročila prenehanje dela, se lahko zahtevi po namestniku odpovejo.

6.6a Positions, which could affect the quality of inspection services, may include managerial, clerical and other staff, as well as inspectors.

6.6a Delovna mesta, ki bi lahko vplivala na kakovost kontrolnih storitev, lahko vključujejo vodstveno, pisarniško in drugo osebje, pa tudi kontrolorje.

7. Quality system

7. Sistem kakovosti

7.3a For easy reference, it is recommended that the inspection body’s quality manual indicate where in the Quality System the requirements of ISO/IEC 17020 are addressed, e.g., a cross reference table may be included in the Quality Manual.

7.3a Za lažje sklicevanje se priporoča, da je npr. s tabelo, vključeno v poslovnik kakovosti kontrolnega organa, navedeno, kje v sistemu kakovosti so obravnavane zahteve standarda ISO/IEC 17020.

7.4a The position of the quality manager (however named) should be clearly shown in the organisational chart referred to in guidance to clause 6.2. The quality managershall be free from any influences or conflicts of interest that may affect the quality of his/her work.

7.4a Delovno mesto vodje kakovosti (ne glede na to, kako se imenuje) naj bo jasno prikazano v organigramu, omenjenem v napotku k poglavju 6.2. Vodja kakovosti ne sme biti obremenjen z nikakršnimi vplivi ali nasprotja interesov, ki bi lahko škodljivo vplivali na kakovost njegovega dela.

7.7a The purpose of internal quality audits is to verify that the documented operational procedures of the inspection body are being implemented as required. Quality audits are normally planned and organised by the quality manager and carried out in accordance with a pre-determined schedule that encompasses all aspects of the quality system, including the performance of inspections. The scopes, dates and the detailed scheduling of audits should be planned and conducted in accordance with a documented procedure. Competent outside bodies may carry out internal audits. As a rule, internal audits should be arranged so that the quality system is examined at least once per year. Internal audits should ensure that the guidance given in 6.4e is met.

7.7a Namen notranje presoje kakovosti je preverjanje, ali so dokumentirani delovni postopki kontrolnega organa uvedeni v skladu z zahtevami. Presojo kakovosti ponavadi planira in organizira vodja kakovosti in se izvaja po v naprej določenem načrtu, ki zajema vse vidike sistema kakovosti, vključno z izvajanjem kontrole. Obseg, datum in podroben načrta presoje naj se planira in vodi v skladu z dokumentiranim postopkom. Notranjo presojo lahko izvajajo usposobljeni zunanji organi. Načeloma naj se notranja presoja uredi tako, da bo sistem kakovosti pregledan vsaj enkrat na leto. Z notranjo presojo naj se zagotovi, da bo izpolnjen napotek iz točke 6.4e.

7.7b Where an inspection body has more than one operational site all aspects of the quality system and all sites shall have a full internal audit during an accreditation cycle.

Note: In this context an “operational site” is an office (other than

the head office) which keeps records of inspection work and of the local implementation of the quality system independently of the head office.

7.7b Če kontrolni organ izvaja kontrolo na več delovnih lokacijah, mora biti med enim akreditacijskim ciklom izvedena popolna notranja presoja vseh vidikov sistema kakovosti in vseh lokacij.

Opomba: V tem kontekstu pomeni "delovna lokacija" pisarno

(ki pa ni uprava), v kateri so shranjeni zapisi o kontroli in o lokalnem izvajanju sistema kakovosti neodvisno od uprave.

7.9a Management reviews should take account of any relevant

information, such as reports from supervisory and managerial staff, the outcome of internal quality audits and external assessments, complaints from clients, changes needed in the quality system, the adequacy of current human and equipment resources, future plans, estimates for new work, and additional human resources, as well as the need for training of both new and existing staff. The frequency of management reviews should be determined by the inspection body, taking account of the results from internal audits and previous reviews and reports from an accreditation body. Once a year is normally considered acceptable.

7.9a Vodstveni pregledi naj upoštevajo vse pomembne informacije, kot so poročila nadzornega in vodstvenega osebja, izidi notranjih presoj kakovosti in zunanjih ocenjevanj, pritožbe naročnikov, potrebne spremembe v sistemu kakovosti, ustreznost trenutnih kadrovskih virov in opreme, plani za prihodnost, ocene novega dela in dodatni kadrovski viri, pa tudi potrebe po strokovnem izpopolnjevanju novega in obstoječega osebja. Pogostnost vodstvenih pregledov naj določi kontrolni organ glede na rezultate notranjih presoj in predhodnih pregledov ter poročila akreditacijskega organa. Ponavadi je sprejemljivo enkrat na leto.



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8. Personnel

8. Osebje

8.1a Permanent personnel are those who are employed by or under long term contract to the inspection body. They may be employed either on a full-time basis or on a part-time basis. Where it is necessary to use personnel for temporary situations, such personnel should be formally contracted for the period that the inspection body uses them. The inspection body should ensure that such personnel are effectively supervised (see 6.4b) and competent and that they work in accordance with the inspection body’s quality system.

8.1a Stalno osebje je tisto, ki ima s kontrolnim organom sklenjeno dolgoročno pogodbo o zaposlitvi. Lahko je zaposleno za polni ali nepolni delovni čas. Če je treba začasno zaposliti osebje, naj bo s takim osebjem sklenjena formalna pogodba za obdobje, dokler ga kontrolni organ potrebuje. Kontrolni organ naj zagotovi, da bo tako osebje učinkovito nadzorovano (glej poglavje 6.4b) in usposobljeno in da bo ravnalo v skladu s sistemom kakovosti kontrolnega organa.

8.1b The inspection body shall have a sufficient number of permanent competent personnel having the education, training, technical knowledge, skills and experience necessary for handling the category, range and volume of the work performed.

8.1b Kontrolni organ mora imeti na voljo zadostno število stalnega usposobljenega osebja s potrebno izobrazbo, strokovno izpopolnjenostjo, tehničnim znanjem, veščinami in izkušnjami za obvladovanje kategorije, obsega in količine dela, ki ga izvaja.

8.2a An accredited inspection body should define and document the qualifications, training, experience and the level of knowledge required for the inspections to be carried out (see also clause 6.6 of ISO/IEC 17020). Accreditation bodies should assess the appropriateness of such qualifications, training, experience and the level ofknowledge for the scope of inspections to be accredited.

Note: Achievement of qualifications and completion of training

and experience is not a guarantee of practical competence in inspection or the development of sound professional judgement.

8.2a Akreditiran kontrolni organ naj opredeli in dokumentira kvalifikacije, strokovno usposobljenost, izkušnje in raven znanja, ki so potrebne za izvajanje kontrol (glej tudi poglavje 6.6 standarda ISO/IEC 17020). Akreditacijski organi naj ocenijo ustreznost takih kvalifikacij, strokovne izpopolnjenosti, izkušenj in ravni znanja za tisti obseg kontrol, ki se akreditira.

Opomba: Dosežene kvalifikacije in zaključeno usposabljanje

ter izkušnje pa niso zagotovilo za praktično usposobljenost za izvajanje kontrole ali smisel za strokovno razsojanje.

8.3a Inspection bodies may use competent external

organisations for staff training.

8.3a Kontrolni organi lahko za strokovno usposabljanje osebja uporabijo usposobljene zunanje organizacije.

8.3b Identification of training needs for each person should normally take place at least once per year. This review should result in documented plans for further training or a statement that no further training is required for the individual at present. The purpose of these records is to demonstrate the competency of each member of the staff to perform specific inspection tasks and, where relevant, to use specific equipment.

8.3b Prepoznavanje potreb po strokovnem izpopolnjevanju za vsako osebo naj se opravi vsaj enkrat na leto. Rezultat takega pregleda naj bodo dokumentirani plani nadaljnjega strokovnega usposabljanja oziroma ugotovitev, da za posameznika nadaljnje strokovno izpopolnjevanje trenutno ni potrebno. Namen teh zapisov je dokazati usposobljenost vsakega člana osebja za izvajanje posebnih kontrolnih nalog in uporabo posebne opreme, če je treba.

8.5a This guidance may be in the form of a code of conduct. It

may include issues relating to work ethics, impartiality, personal safety, relationship with customers, company rules and any other issues needed to assure the proper conduct of inspection body staff.

8.5a Ti napotki so lahko v obliki kodeksa ravnanja. Vključujejo lahko vprašanja, povezana z delovno etiko, nepristranostjo, osebno varnostjo, odnosom do odjemalcev, pravilinikom in drugimi vprašanji zagotavljanja ustreznega vedenja osebja kontrolnega organa.

9. Facilities and equipment

9. Zmogljivosti in oprema

9.1a The inspection body need not be the owner of the facilities or equipment that it uses. Facilities and equipment may be borrowed, rented, hired, leased or provided by another party (e.g. the installer of the equipment). In all cases access to the equipment must bedefined and meet the requirements of ISO/IEC 17020. However, the responsibility for the suitability and the calibration status of the equipment used in inspection,

9.1a Kontrolnemu organu ni treba biti lastnik zmogljivosti in opreme, ki jih uporablja. Zmogljivosti in opremo si lahko izposodi, najame, vzame v zakup ali pa mu jih priskrbi druga stran (npr. monter opreme). V vsakem primeru mora biti določen dostop do opreme in mora ta izpolnjevati zahteve standarda ISO/IEC 17020. Kontrolni organ pa je izključno odgovoren za primernost in status kalibracije opreme, ki jo



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whether owned by the inspection body or not, lies solely with the inspection body.

uporablja pri kontroli, ne glede na to, ali je njen lastnik ali ne.

9.1b If controlled environmental conditions are needed and premises outside those of the inspection body are used, the inspection body should monitor the environmental conditions in these premises with calibrated equipment, record the results and note if conditions are outside the limits within which inspection can be performed.

9.1b Če so potrebni nadzorovani pogoji okolja in se kontrola izvaja v prostorih, ki so zunaj prostorov kontrolnega organa, naj kontrolni organ s kalibrirano opremo spremlja pogoje okolja v takih prostorih, zapiše rezultate in opozori, če so pogoji zunaj meja, v katerih se kontrola lahko izvaja.

9.2a Use of facilities and equipment by unauthorised persons should not be permitted. If any item is found to have left the inspection body’s direct control, measures must be taken to confirm its continuing suitability before its return to use. Typical measures would include visual inspection, functional checks and/or re-calibration.

9.2a Nepooblaščenim osebam naj uporaba prostorov in opreme ne bo dovoljena. Če se ugotovi, da je bil kakšen predmet izpuščen iz neposrednega nadzora kontrolnega organa, je treba sprejeti ukrepe za potrditev nadaljnje primernost tega predmeta, preden se vrne v uporabo. Običajni ukrepi so vizualni pregled, funkcionalni pregled in/ali ponovna kalibracija.

9.4a Unique identification of items of equipment is important

even when the organisation has only one example of a particular item. This enables tracking when items are replaced for whatever reason.

9.4a Pomembna je enotna identifikacija delov opreme, tudi če ima organizacija samo en primerek določenega dela. S tem je omogočeno sledenje, če se deli iz kakršnegakoli razloga zamenjajo.

9.6a All equipment used for measurements and tests, where the results of such measurements and tests have a significant influence on the results of the inspection, i.e. the conclusion about conformance with requirements, shall be traceably calibrated.

9.6a Vsa merilna in preskuševalna oprema, katere merilni rezultati pomembno vplivajo na rezultate kontrole, t.j. na ugotovitev skladnosti z zahtevami, mora biti sledljivo kalibrirana.

9.6b Where equipment not under the direct control of the inspection body is used, the inspection body shall verify that the equipment meets all relevant requirements of ISO/IEC 17020 before using it for inspection. The verification procedure shall be documented and verification records shall be kept. Where such verification is not practical, the report shall not be issued under accreditation or, where accreditation is mandatory, this fact shall be prominently stated in the inspection report and the client shall be informed of it.

9.6b Kadar se uporablja oprema, ki ni pod neposrednim nadzorom kontrolnega organa, mora kontrolni organ pred uporabo take opreme za kontrolo preveriti, ali izpolnjuje ustrezne zahteve standarda ISO/IEC 17020. Postopek preverjanja mora biti dokumentiran, zapisi o preverjanju pa shranjeni. Če tako preverjanje ni izvedljivo, poročilo o kontroli ne sme biti izdano v okviru akreditacije, če pa je akreditacija obvezna, mora biti to dejstvo navedeno na vidnem mestu v poročilu in mora biti naročnik o tem obveščen.

9.7a Equipment identified under the criteria in 9.6, as clarified

in 9.6a, should be traceably calibrated to national or international standards where possible.

9.7a Oprema, identificirana po merilih iz poglavja 9.6, kot je pojasnjeno v točki 9.6a, naj bo sledljivo kalibrirana na nacionalne oziroma mednarodne etalone, kjer je mogoče.

9.7b Where the calibrations are performed in-house,

traceability to national standards should be assured by using reference standards of measurement for which the inspection body holds a current calibration certificate or equivalent from a competent body. The certificate or equivalent should detail an uncertainty of measurement that is appropriate for the equipment that is to be calibrated from the reference standard. For further information on uncertainty of measurement see ILAC G8.

9.7b Če se izvajajo notranje kalibracije, naj se sledljivost na nacionalne etalone zagotovi z uporabo referenčnih merilnih etalonov, za katere ima kontrolni organ veljaven certifikat o kalibraciji ali enakovreden dokument od kompetentnega organa. V certifikatu oziroma enakovrednem dokumentu mora biti podrobno navedena merilna negotovost, ki je primerna za opremo, ki naj bi se kalibrirala z referenčnim etalonom. Za nadaljnje informacije v zvezi z merilno negotovostjo glej smernice ILAC G8.



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10. Inspection methods and procedures 10. Metode in postopki kontrole

10.1a The requirements against which the inspection is performed are normally specified in regulations, standards or specifications. Specifications may include customer or in-house requirements.

When the inspection methods and procedures are not

defined in regulations, standards or specifications the inspection body itself shall define and document the methods and procedures for inspection.

10.1a Zahteve, po katerih se izvaja kontrola, so ponavadi določene v predpisih, standardih ali specifikacijah. Specifikacije lahko vključujejo tudi zahteve odjemalca ali notranje zahteve.

Če metode in postopki kontrole niso določeni v predpisih, standardih ali specifikacijah, jih mora za kontrolo določiti in dokumentirati kontrolni organ sam.

10.1b In certain circumstances the inspection body’s customer may supply information for the inspection body to take into consideration when performing its inspection. If the inspection body uses such information supplied by any other party as part of the inspection body’s determination of conformity, then it should be able to demonstrate the measures taken to verify the integrity of such information.

10.1b V določenih okoliščinah lahko odjemalec kontrolnega organa posreduje informacije, ki jih sme kontrolni organ med izvajanjem kontrole upoštevati. Če kontrolni organ informacije, ki mu jih posreduje katerakoli druga stran, uporabi v okviru svojega ugotavljanja skladnosti, potem naj bo tudi sposoben dokazati, katere ukrepe izvaja za preverjanje celovitosti in neoporečnosti takih informacij.

10.3a A standard inspection method is one that has been

published, for example, in International, Regional or National standards or by reputable technical organisations or by co-operation of several inspection bodies or in relevant scientific text or journals. This means that methods developed by any other means, including bythe inspection body itself or by the customer, are considered to be non-standard methods.

10.3a Standardna metoda kontrole je tista, ki je objavljena na primer v mednarodnih, regionalnih ali nacionalnih standardih ali ki jo objavijo priznane strokovne organizacije oziroma združenja kontrolnih organov ali ki je objavljena v ustreznem znanstvenem besedilu ali reviji. To pomeni, da so metode, ki so kakorkoli drugače razvite, vključno s tistimi, ki jih razvije sam kontrolni organ ali odjemalec, nestandardne metode.

10.5a Where appropriate (see note) each contract or request

should be reviewed by the inspection body to ensure that:1. the client’s requirements are adequately defined,

documented and understood, and 2. the inspection body has the capability to meet the client’s

requirements, and 3. contract conditions are agreed, and 4. special equipment needs are identified, and 5. personnel training needs are identified, and 6. statutory requirements are identified, and 7. special safety requirements are identified, and 8. the extent of subcontracting arrangements required are

identified, and 9. documentation needs are identified, and 10. the final contract or request accepted by the inspection

body agrees with the original version that was reviewed as in (1), (2) and (3) above.

Records of contract review shall be retained. Note: For routine or repeat work requests, review may be limited

to considerations of time and human resources and an acceptable record in such cases would be a signed acceptance of the contract by an appropriately authorised person.

10.5a Kadar je to potrebno (glej opombo), naj kontrolni organ pregleda vsako pogodbo ali zahtevo, da se prepriča:

1. ali so zahteve naročnika ustrezno definirane, dokumentirane in razumljene,

2. ali je kontrolni organ sposoben izpolniti naročnikove zahteve,

3. ali so dogovorjeni pogodbeni pogoji, 4. ali so opredeljene posebne potrebe glede opreme, 5. ali so opredeljene potrebe glede usposobljenosti

osebja, 6. ali so opredeljene normativne zahteve, 7. ali so opredeljene posebne varnostne zahteve, 8. ali je opredeljen obseg zahtevanih podpogodbenih

dogovorov, 9. ali so opredeljene potrebe glede dokumentacije in 10. ali se končna pogodba oziroma zahteva, ki jo je

sprejel kontrolni organ, ujema s prvotno različico, ki jo je pregledal po točkah 1., 2. in 3. zgoraj.

Zapise o pregledu pogodbe je treba hraniti. Opomba: Pri rutinskem ali ponavljajočem se delu se lahko

pregled omeji na pregled potrebnega časa in kadrov; v takih primerih za sprejemljiv zapis o pregledu šteje od pooblaščene osebe podpisana pogodba.

10.5b In situations where verbal agreements are acceptable, the

inspection body should keep a record of all requests and instructions received verbally, dates and the identity of the client’s representative.

10.5b V primerih, ko so sprejemljivi tudi ustni dogovori, naj kontrolni organ vodi evidenco vseh ustnih zahtev in navodil, datumov ter identitete predstavnika naročnika, ki jih je izdal.



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10.6a Worksheets, notebooks etc used to record observations during inspections shall be retained for reference for a defined period.

10.6a Delovne liste, zvezke itd., ki se uporabljajo za zapisovanje opažanj med kontrolo, je treba določen čas hraniti kot dokazno gradivo.

10.8a Documented procedures should include procedures to

ensure the safety of personnel and, where appropriate, protection of the surrounding environment.

10.8a Dokumentirani postopki naj vključujejo postopke za zagotavljanje varnosti osebja in za zaščito okolice, če je to potrebno.

11. Handling inspection samples and items 11. Ravnanje z vzorci in primerki za kontrolo

12. Records

12. Zapisi

13. Inspection reports and inspection certificates 13. Poročila o kontroli in potrdila oziroma certifikati o kontroli

13.1a The terms “report” and “certificate” are used

synonymously in this clause. However, in this guidance document it is assumed that “reports” are detailed descriptions of the inspection and its results whereas “certificates” are generally short formal statements of conformity with requirements issued, for example, in connection with mandatory inspection.

13.1a Izraza "poročilo" in "potrdilo/certifikat" iz tega poglavja se uporabljata kot sinonima. Vendar pa se v teh napotkih "poročilo" razume kot podroben opis kontrole in njenih rezultatov, medtem kot je "potrdilo/certifikat" na splošno kratka, formalna izjava o skladnosti z zahtevami, ki se na primer izda v zvezi z obvezno kontrolo.

13.1b Where the inspection body issues an inspection

certificate, it may not be possible to cover all of the work carried out by the inspection body in the certificate itself. In those circumstances it would be acceptable to maintain separate documentation to demonstrate the work carried out by the inspection body, provided such documentation can be traceable to the correct inspection certificate.

13.1b Kadar kontrolni organ izda certifikat o kontroli, mogoče v njem ne bo mogel zajeti vsega dela, ki ga je opravil. V takih okoliščinah bi bilo sprejemljivo hraniti ločeno dokumentacijo kot dokaz za delo, ki ga je opravil kontrolni organ, pod pogojem, da je taka dokumentacija sledljiva na pravilni certifikat o kontroli.

13.2a The fact that the client does not require a detailed report does not remove the requirement for detailed inspection recordsto be kept.

13.2a Samo dejstvo, da naročnik ne zahteva podrobnega poročila, še ne pomeni, da ni treba hraniti podrobnejših zapisov o kontroli.

13.2b The content of an inspection report or inspection

certificate may vary depending on the type of inspection and legal requirements. Appendix 3 contains a list of elements to be included in inspection reports and inspection certificates. Some of these elements are considered to be mandatory for compliance with ISO/IEC 17020. The mandatory elements of Appendix 3 are marked with an asterisk (*). The list should be considered when drafting inspection reports and inspection certificates.

13.2b Vsebina poročila o kontroli oziroma certifikata o kontroli je lahko različna, odvisno od vrste kontrole in zakonskih zahtev. V dodatku 3 je seznam elementov, ki jih je treba vključiti v poročila in certifikate o kontroli. Nekateri od teh elementov so za skladnost s standardom ISO/IEC 17020 obvezni. Obvezni elementi so v dodatku 3 označeni z zvezdico (*). Ta seznam naj se upošteva pri pripravi poročil o kontroli in certifikatov o kontroli.

13.2c Where inspection is for legal purposes national authorities may place special requirements on the reporting of inspection results.

13.2c Če se kontrola izvaja v zakonske namene, lahko nacionalni organi oblasti postavijo posebne zahteve glede poročanja o rezultatih kontrole.

13.2d Under its accreditation the inspection body may issue inspection reports or certificates, indicating accreditation status, for inspection activities described in generic terms in the accreditation, provided that such reports or certificates are issued for a defined type of inspection using a defined technical procedure and that they are referring to a defined field of inspection.

13.2d Kontrolni organ lahko v okviru svoje akreditacije izdaja poročila ali certifikate o kontroli, v katerih navede status akreditacije, za dejavnosti kontrole, na splošno opisane v akreditaciji, če so taka poročila ali certifikati izdani za določeno vrsto kontrole, pri kateri se uporablja določen tehnični postopek, in če se sklicujejo na določeno področje kontrole.

13.3a In all cases it must be possible to identify the person

accepting responsibility for the verification and release of the inspection report or certificate.

13.3a V vseh primerih mora biti mogoče identificirati osebo, ki sprejme odgovornost za overovitev in izdajo poročila oziroma certifikata o kontroli.



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13.3b An example of an “otherwise approved” inspection report or inspection certificate is one approved by secure electronic authorisation or by seal. In such cases the inspection body must be able to demonstrate that authorisation is secure and access to the electronic storage medium is strictly controlled.

13.3b Primer "drugače odobrenega" poročila o kontroli oziroma certifikata o kontroli je, če je odobreno z varnim elektronskim pooblastilom ali z zaščitno oznako. V takih primerih mora biti kontrolni organ sposoben dokazati, da je pooblastilo varno in da je dostop do elektronskega pomnilniškega medija strogo nadzorovan.

13.4a It must not be possible for ambiguity to exist between a

report or certificate with an error and the corresponding corrected report. This is most commonly avoided by issuing a replacement report or certificate with words such as “this report/certificate replaces report/certificate No. XYZ”.

13.4a Med poročilom ali certifikatom z napako in ustrezno popravljenim poročilom ne sme biti dvoumnosti. Temu se ponavadi izognemo tako, da izdamo nadomestno poročilo ali certifikat, ki mu dodamo besedilo npr. "to poročilo/certifikat nadomešča poročilo/certifikat št. XYZ".

14. Sub-contracting

14. Sklepanje podpogodb

4.1a Sub-contracting of inspections which are within the inspection body’s scope of accreditation may take place only when any of the following conditions apply:

1. It is necessary because there has been a unforeseen or

abnormal overload, key inspection staff members are incapacitated or key facilities or items of equipment are temporarily unfit for use.

2. A small part of the contract from the client involves

inspection not covered by the inspection body’s accreditation or is beyond the capability or resources of the Inspection Body. This does not prevent the inspection body subcontracting testing.

14.1a Za kontrole, ki so v obsegu akreditacije kontrolnega organa, se lahko sklene podpogodba le, če je izpolnjen kateri od spodnjih pogojev:

1. da je podpogodbo treba skleniti zaradi

nepredvidenega ali nenormalnega povečanja obsega dela, da je onesposobljeno ključno kontrolno osebje ali da so ključne zmogljivosti ali deli opreme začasno neprimerni za uporabo;

2. da gre pri manjšem delu pogodbe z naročnikom za

kontrolo, ki je akreditacija kontrolnega organa ne zajema ali da ta presega sposobnosti ali vire kontrolnega organa; da ta ne preprečuje kontrolnemu organu sklepanja podpogodbe za preskušanje.

14.1b Whenever work, which forms part of an inspection, is carried out by sub-contractors, the responsibility for determination of conformity of the inspected item with the requirements always remains with the inspection body.

14.1b Kadarkoli del kontrole izvajajo podpogodbeniki, kontrolni organ vedno obdrži odgovornost za ugotovitev skladnosti kontroliranega predmeta z zahtevami.

14.2a Where the inspection body engages individuals or

employees of the organisations to provide additional resources or expertise, these individuals are not considered to be sub-contractors provided they are formally contracted to operate under the inspection body’s quality system and have equivalent training and records to permanent employees. (See also guidance to clause 8.1)

14.2a Če kontrolni organ, da bi pridobil dodatne vire ali izvedensko znanje, vključi posameznike ali zaposlene iz drugih organizacij, se ti posamezniki ne štejejo za podpogodbenike, če imajo sklenjeno formalno pogodbo za delo v okviru sistema kakovosti kontrolnega organa in če imajo enakovredno izobrazbo ter so v evidenci kot stalno osebje. (Glej tudi napotek k poglavju 8.1).

14.2b Competence of a sub-contractor may be demonstrated either:

o by the sub-contractor having accreditation to ISO/IEC 17020 or ISO/IEC 17025 for the relevant inspections/tests and providing endorsed reports or certificates

or

o by the inspection body itself assessing the competence

of the sub-contractor to the requirements of ISO/IEC 17020 or ISO/IEC 17025, as applicable.

14.2b Podpogodbenik lahko izkaže svojo usposobljenost:

o bodisi s tem, da ima akreditacijo po ISO/IEC 17020 ali ISO/IEC 17025 za ustrezne kontrole/preskuse in izdaja poročila ali certifikate s sklicevanjem na akreditacijo

o bodisi da kontrolni organ sam, če je primerno, oceni

njegovo usposobljenost po zahtevah standarda ISO/IEC 17020 oziroma ISO/IEC 17025.



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14.2c Where the assessment of the sub-contractor is carried out by the inspection body, it should be able to demonstrate that the assessment team is technically competent and knowledgeable in the application of ISO/IEC 17020 or ISO/IEC 17025.

14.2c Če ocenjevanje podpogodbenika izvede kontrolni organ, mora biti slednji sposoben dokazati, da je ocenjevalna komisija strokovno usposobljena in seznanjena z uporabo standarda ISO/IEC 17020 oziroma ISO/IEC 17025.

14.3a If the competence of the subcontractor is based partly or in full on its accreditation, the scope of its accreditation shall cover the activities to be subcontracted and the inspection body shall have records available to show that it has checked the status of the subcontractor.

If the subcontracted bodies are not accredited according

to the relevant standard for the specific activities to be subcontracted, the inspection body shall provide appropriate evidence of the subcontracted body’s competence, such as records of evaluation performed by qualified personnel according to appropriate procedures.

14.3a Če usposobljenost podpogodbenika temelji delno ali v celoti na akreditaciji, mora obseg njegove akreditacije zajemati dejavnosti, za katere se sklene podpogodba, kontrolni organ pa mora imeti na voljo zapise o tem, da je preveril status podpogodbenika.

Če podpogodbeni organi niso akreditirani v skladu z

ustreznim standardom za določene dejavnosti, za katere se sklepa podpogodba, mora kontrolni organ priskrbeti ustrezne dokaze o usposobljenosti podpogodbenega organa, kot so na primer zapisi o ovrednotenju, ki jo je izvedlo usposobljeno osebje v skladu z ustreznimi postopki.

15. Complaints and appeals

15. Pritožbe in prizivi

15.1a Causes of complaints should be analysed as part of management review so that common causes can be identified and appropriate action taken to minimise such complaints in future.

15.1a Vzroki za pritožbe naj se analizirajo v okviru vodstvenega pregleda, tako da se lahko prepoznajo skupni vzroki in se ustrezno ukrepa, da bi bilo takih pritožb v prihodnje čim manj.

15.2a It should be noted that Appeals procedures are required only if the inspection body is appointed to undertake work by a national authority.

15.2a Omeniti je treba, da so postopki priziva potrebni samo, če je kontrolni organ za opravljanje dela imenoval nacionalni organ oblasti.

16. Cooperation

16. Sodelovanje

16a The purpose of this clause is to encourage inspection bodies to exchange knowledge, subject to commercial sensitivities and confidentiality, and learn from each other to improve the general standard and consistency of accredited inspection results.

16a Namen tega poglavja je spodbujati kontrolne organe k izmenjavi znanja, ob spoštovanju poslovne etike in zaupnosti, in k učenju drug od drugega, da bi izboljšali splošni standard in usklajenost rezultatov akreditiranih kontrolnih organov.



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Some differences between Inspection (ISO/IEC 17020) and Product Certification (ISO/IEC Guide 65)

Activity

Inspection

Product Certification

Nature of operation

Inspection of individual products, and not necessarily by third party (direct determination of conformance

Certification of series of products and always by third party (indirect determination of conformance)

Conformity

Examined against standards or other normative documents and/or general requirements

Assessed against standards or other normative documents

Assurance

Report provides condition at the time of inspection

Certification normally provides continuing assurance of compliance

Decisions

No need for separation of those taking inspection decisions from those performing inspection

Certification decisions taken by a different person(s) from those who have carried out evaluation

Issuing of licences No licences issued Grants licence to suppliers to issue certificate

Marking of products Marks put only on products covered

Marks may be put on a certified product

Surveillance Only where required in order to support inspection

Normally necessary to provide continuing assurance of compliance

In-service inspection of products Always by inspection Not by product certification Nekaj razlik med kontrolo (ISO/IEC 17020) in certificiranjem proizvodov (ISO/IEC Vodilo 65)

Dejavnost Kontrola Certificiranje proizvodov Vrsta procesa Kontrola posameznih proizvodov, ki je

nujno ne izvaja tretja stranka (neposredno ugotavljanje skladnosti)

Certificiranje serije proizvodov, ki ga vedno izvaja tretja stranka (posredno ugotavljanje skladnosti)

Skladnost Preiskava skladnosti glede na standarde ali druge normativne dokumente in/ali splošne zahteve

Ocena skladnosti glede na standarde ali normativne dokumente

Zagotavljanje V poročilu je podano stanje v času kontrole

Certifikacija ponavadi daje stalno zagotavljanje skladnosti

Odločitve Ni treba razlikovati med tistimi, ki sprejemajo odločitve glede kontrole, in tistimi, ki izvajajo kontrolo

Odločitve glede certifikacije sprejema(-jo) druga(-e) oseba(-e), kot izvaja(-jo) vrednotenje.

Izdaja dovoljenj Ne izdajo se nikakršna dovoljenja Dobaviteljem se podeli dovoljenje za izdajo certifikata

Označevanje proizvodov Označijo se samo proizvodi, ki so zajeti v kontroli

Certificiran proizvod se lahko označi na podlagi dovoljenja

Nadzor Samo po potrebi kot podpora kontroli Običajno potreben za stalno zagotavljanje skladnosti

kontrola proizvodov v uporabi Vedno s kontrolo Ne s certificiranjem proizvodov



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Appendix 1: Example of layout of an Accreditation Certificate

[Name of Accreditation Body]

Controlled Inspection Ltd Unit K

Impartial Business Centre Sometown

Somecountry

Accreditation No. 1234

is accredited to undertake inspections as a Type A body as detailed in the Schedule bearing the above accreditation number and [name of accreditation body] logo.

From time to time this Schedule may be revised and reissued by [name of accreditation body].

This Accreditation shall remain in force until further notice subject to continuing compliance with the [name of accreditation body] requirements

and regulations specified by [name of accreditation body].

Accredited inspection bodies meet the requirements of ISO 17020.

Signed by Chief Executive [name of accreditation body]

Issued on [date] Initial Accreditation [date]



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Dodatek 1: Primer akreditacijske listine

[Ime akreditacijskega organa]

"Nadzorovana kontrola d.o.o Enota K

Nepristranski poslovni center Mesto

Država"

Akreditacija št. 1234

se podeli kontrolnemu organu tipa A za izvajanje kontrol, kot je podrobneje opisano v prilogi k akreditacijski listini pod zgornjo številko akreditacije in logotipom [ime akreditacijskaga organa]

[Ime akreditacijskega organa] lahko prilogo od časa do časa revidira in ponovno izda.

Ta akreditacija ostane v veljavi do nadaljnjega, pod pogojem, da so stalno izpolnjene zahteve [ime akreditacijskega organa] in predpisi, ki jih določi [ime akreditacijskega organa].

Akreditirani kontrolni organi izpolnjujejo zahteve standarda ISO 17020.

Podpis glavnega izvršnega direktorja [ime akreditacijskega organa]

Izdano dne [datum] Prva akreditacija [datum]



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Appendix 2: Example of layout of an Accreditation Schedule

[Name and logo of Accreditation Body]

Name of Inspection Body Accreditation No 1234

Type A

Address of Inspection Body:

Inspection Body Contact

Telephone: Facsimile:

Issue No: Date:

Field of Inspection, such as: Product Design, Products (specified as Materials or Equipment), Installations, Plant, Premises, Processes,Services

and Surveys

Type and Range of Inspection (e.g, In-Service Inspection or Inspection of New Products)

Methods and Procedures, such as Regulations, Standards,Specifications, Internal Procedures



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Dodatek 2: Primer priloge k akreditacijski listini

[Ime in logotip akreditacijskega organa]

Ime kontrolnega organa Akreditacija št. 1234

Tip A

Naslov kontrolnega organa Kontaktna oseba kontrolnega organa Telefon: Faks:

Izvod št.: Datum:

Področje kontrole, npr.: načrtovanje proizvodov, proizvodi (specificirani kot material ali oprema), objekti in naprave, obrat, prostori, procesi, storitve in nadzori

Vrsta in obseg kontrole (npr. notranja kontrola ali kontrola novih proizvodov)

Metode in postopki, kot so: predpisi, standardi, specifikacije, organizacijski predpisi



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Appendix 3: Elements of inspection reports and inspection certificates Dodatek 3: Elementi poročil o kontroli in certifikatov o kontroli 1* Designation of the document, i.e. as an inspection

report or an inspection certificate, as appropriate 1* Določitev dokumenta kot poročilo o kontroli

oziroma certifikat o kontroli, kakor je primerno 2* Identification of the document, i.e. date of issue and

unique identification 2* Označitev dokumenta z datumom izdaje in enotno

oznako 3* Identification of the issuing body 3* Označitev organa, ki ga je izdal

4* Identification of the client 4* Označitev naročnika

5* Description of the inspection work ordered 5* Opis naročenega kontrolnega dela

6* Date(s) of inspection 6* Datum(-i) kontrole

7* Identification of the object(s) inspected and, where applicable, identification of the specific components that have been inspected and identification of locations where e.g. NDT methods have been applied

7* Označitev predmeta(-ov) kontrole in po potrebi označitev posebnih sestavnih delov, ki so bili kontrolirani, ter označitev lokacij, na katerih so bile uporabljene metode npr. neporušitvenega preskušanja (NDT)

8* Information on what has been omitted from the original scope of work

8* Informacija o tem, kaj je bilo izpuščeno iz prvotnega obsega dela

9* Identification or brief description of the inspection method(s) and procedure(s) used, mentioning the deviations from, additions to or exclusions from the agreed methods and procedures

9* Označitev ali kratek opis uporabljene kontrolne metode (oziroma metod) in postopka (oziroma postopkov), z omembo odstopanj od, dodatkov k ali izvzetij iz dogovorjenih metod in postopkov

10 Identification of equipment used for measuring/testing 10 Označitev opreme, uporabljene za merjenje/preskušanje

11 Where applicable, and if not specified in theinspection method or procedure, reference to or description of the sampling method and information on where, when, how and by whom the samples were taken

11 Po potrebi, in če ni določeno v metodi oziroma postopku kontrole, sklicevanje na ali opis metode vzorčenja in informacija o tem, kje, kdaj, kako in kdo je vzel vzorce

12* If any part of the inspection work has been subcontracted, the results of this work shall be clearly identified

12* Če je bil kateri del kontrole oddan podpogodbeniku, naj bodo rezultati tega dela jasno označeni

13 Information on where the inspection was carried out 13 Informacija o tem, kje se je kontrola izvajala

14 Information on environmental conditions during the inspection, if relevant

14 Informacija o okoljskih razmerah med kontrolo, če je pomembna

15* The results of the inspection including a declaration of conformity and any defects or other non-compliances found (results can be supported by tables, graphs, sketches and photographs)

15* Rezultati kontrole vključno z izjavo o skladnosti in morebitnimi ugotovljenimi hibami ali drugimi neskladnostmi (rezultati so lahko podprti s tabelami, grafi, risbami in fotografijami)

16 A statement that the inspection results relate exclusively to the work ordered or the object(s) or the lot inspected

16 Izjava, da se rezultati kontrole nanašajo izključno na naročeno delo oziroma na kontrolirani(-e) predmet(-e) ali serijo

17 A statement that the inspection report shall not be reproduced except in full without the approval of the inspection body and the client

17 Izjava, da se poročilo o kontroli brez dovoljenja kontrolnega organa in naročnika lahko razmnožuje samo v celoti

18 The inspector’s mark or seal 18 Znak kontrolorja 19* Names (or unique identification) of the staff members

who have performed the inspection and in cases when secure electronic authentication is not undertaken, their signature, (see also clause 13.3 ofISO/IEC 17020)

19* Imena (ali enotna oznaka) članov osebja, ki so izvedli kontrolo, in v primeru, da ni uporabljeno varno elektronsko potrdilo, njihovi podpisi (glej tudi poglavje 13.3 v standardu ISO/IEC 17020)

Note: The elements of inspection reports/certificates that are considered to be mandatory for compliance with ISO/IEC 17020 are marked with an asterisk (*)

Opomba: Elementi poročil/certifikatov o kontroli, ki so za skladnost s standardom ISO/IEC 17020 obvezni, so označeni z zvezdico (*)

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