SIST EN 45004:1997
(Main)General criteria for the operation of various types of bodies performing inspection
General criteria for the operation of various types of bodies performing inspection
This European standard specifies general criteria for the competence of impartial bodies performing inspection irrespective of the sector involved. It also specifies independence criteria. This standard is intended for the use of inspection bodies and their accreditation bodies as well as other bodies concerned with recognising the competence of inspection bodies. This set of criteria may have to be interpreted when applied to particular sectors, or to in-service inspection.
Allgemeine Kriterien für den Betrieb verschiedener Typen von Stellen, die Inspektionen durchführen
In dieser Europäischen Norm werden allgemeine Kriterien der Kompetenz unparteiischer Stellen angegeben, die Inspektionen durchführen; diese Kriteriengelten ungeachtet der betroffenen fachlichen Bereiche. Es werden ferner Kriterien für Unabhängigkeit angegeben. Diese Norm ist bestimmt zur Anwendung durch Inspektionsstellen und durch Stellen, die sie akkreditieren, sowie durch andere Stellen, die sich mit der Anerkennung der Kompetenz von Inspektionsstellen befassen.
Criteres généraux pour le fonctionnement de différents types d'organismes procédant a l'inspection
La présente norme européenne spécifie les criteres généraux en matiere de compétence des organismes impartiaux procédant a l'inspection, quel que soit le secteur concerné. Elle spécifie aussi les criteres d'indépendance. Cette norme est prévue pour etre utilisée par des organismes d'inspection et par d'autres organismes concernés par la reconnaissance de la compétence des organismes d'inspection.
Splošna merila za delovanje različnih organov, ki izvajajo kontrolo
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.ORAllgemeine Kriterien für den Betrieb verschiedener Typen von Stellen, die Inspektionen durchführenCriteres généraux pour le fonctionnement de différents types d'organismes procédant a l'inspectionGeneral criteria for the operation of various types of bodies performing inspection03.120.20Certificiranje proizvodov in podjetij. Ugotavljanje skladnostiProduct and company certification. Conformity assessment03.120.10Vodenje in
...
SLOVENSKI SIST EN 45004
druga izdaja
STANDARD
september 1997
Splo{na merila za delovanje razli~nih organov, ki izvajajokontrolo
(istoveten EN 45004:1995)
General criteria for the operation of various types of bodies performing
inspection
Critères généraux pour le fonctionnement de différents types d’organismes
procédant à l’inspection
Allgemeine Kriterien für den Betrieb verschiedener Typen von Stellen, die
Inspektionen durchführen
Deskriptorji: certificiranje, akreditacija, kakovost, kontrolni organi, odobrene organizacije,
specifikacije
Referen~na {tevilka
ICS 03.120.20 SIST EN 45004:1997 (sl,en)
Nadaljevanje na straneh od II do III in od 2 do 22
© Standard je zalo`il in izdal Urad Republike Slovenije za standardizacijo in meroslovje pri Ministrstvu za znanost in tehnologijo.
Razmno`evanje ali kopiranje celote ali delov tega standarda ni dovoljeno.
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SIST EN 45004 : 1997
UVOD
Standard SIST EN 45004:1997 (sl, en), Splo{na merila za delovanje razli~nih organov, ki
izvajajokontrolo, druga izdaja, 1997, ima status slovenskega standarda in je istoveten
evropskemu standardu EN 45004, druga izdaja, 1995.
NACIONALNI PREDGOVOR
Evropski standard EN 45004:1995 je pripravil tehni~ni odbor Evropske organizacije za
standardizacijo CEN/CENELEC/TC 1 Merila za organe za ugotavljanje skladnosti, katerega
sekretariat sodi pod Centralni sekretariat CEN.
Slovenski standard SIST EN 45004:1997 je prevod evropskega standarda EN 45004:1995. V
primeru spora glede besedila slovenskega prevoda v tem standardu je odlo~ilen izvirni
evropski standard v angle{kem jeziku.
Slovensko izdajo standarda je pripravila delovna skupina USM/TC UGS/WG 1 Ugotavljanje
skladnosti, pregledal pa tehni~ni odbor USM/TC UGS Ugotavljanje skladnosti in statisti~ne
metode.
Ta slovenski standard je dne 1997-08-25 odobril direktor USM.
ZVEZE S STANDARDI
S prevzemom tega evropskega standarda veljajo naslednje zveze:
SIST EN 45001:1996 (sl) Splo{ni kriteriji za delovanje preskusnih laboratorijev (istoveten
EN 45001:1989)
SIST EN 45002:1996 (sl) Splo{ni kriteriji za ocenjevanje preskusnih laboratorijev
(istoveten EN 45002:1989)
SIST EN 45003:1996 (en) Sistemi akreditiranja kalibracijskih in preskusnih laboratorijev -
Splo{ne zahteve za delovanje in priznanje (istoveten
EN 45003:1995)
PSIST prEN 45010:1996 (en) Splo{ne zahteve za ocenjevanje in akreditacijo
certifikacijskih/registracijskih organov (istoveten
prEN 45010:1995-01-00)
SIST EN 45011:1996 (sl) Splo{ni kriteriji za certifikacijske organe za podro~je
certificiranja proizvodov (istoveten EN 45011:1989)
SIST EN 45012:1996 (sl) Splo{ni kriteriji za certifikacijske organe za podro~je
certificiranja sistemov kakovosti (istoveten EN 45012:1989)
SIST EN 45013:1996 (sl) Splo{ni kriteriji za certifikacijske organe za podro~je
certificiranja osebja (istoveten EN 45013:1989)
SIST EN 45014:1996 (sl) Splo{ni kriteriji za dobaviteljevo izjavo o ustreznosti (istoveten
EN 45014:1989)
SIST EN 45020:1995 (en) Standardizacija in z njo povezane dejavnosti - Splo{ni slovar
(istoveten EN 45020:1993)
II
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SIST EN 45004 : 1997
OSNOVA ZA IZDAJO STANDARDA
- Prevzem standarda EN 45004:1995
OPOMBE
- Povsod, kjer se v besedilu standarda uporablja izraz “evropski standard”, v
SIST EN 45004:1997 to pomeni “slovenski standard”.
- Uvod in nacionalni predgovor nista sestavni del standarda.
- Slovenski standard SIST EN 45004:1997 je istoveten standardu EN 45004:1995 in je
izdan z dovoljenjem
CEN
Rue de Stassart, 36
1050 Bruselj
Belgija
This national document is identical with EN 45004:1995 and it is published with the
permission of
CEN
Rue de Stassart, 36
1050 Bruxelles
Belgium
3
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EVROPSKI STANDARD EN 45004
EUROPEAN STANDARD
EUROPÄISCHE NORM Marec 1995
NORME EUROPÉENNE
ICS: 03.120.20
Deskriptorji: certificiranje, akreditacija, kakovost, kontrolni organi, odobrene organizacije, specifikacije
Slovenska izdaja
Splo{na merila
za delovanje razli~nih organov,
ki izvajajokontrolo
General criteria for the Critères généraux pour le Allgemeine Kriterien für den
operation of various types of fonctionnement de différents Betrieb verschiedener Typen
bodies performing inspection types d’organismes procédant von Stellen, die Inspektionen
à l’inspection durchführen
Ta evropski standard je dne 1995-03-06 sprejel CEN/CENELEC. ^lanice CEN/CENELEC
morajo izpolnjevati dolo~ila poslovnika CEN/CENELEC, s katerim je predpisano, da mora biti
ta standard brez kakr{nihkoli sprememb sprejet kot nacionalni standard.
Seznam najnovej{ih izdaj teh nacionalnih standardov in njihovi bibliografski podatki so na
voljo pri Centralnem sekretariatu ali ~lanicah CEN/CENELEC.
Ta evropski standard obstaja v treh uradnih izdajah (angle{ki, francoski in nem{ki). Izdaje v
drugih jezikih, ki jih ~lanice CEN/CENELEC na lastno odgovornost prevedejo in izdajo ter
prijavijo pri Centralnem sekretariatu CEN, veljajo kot uradne izdaje.
^lanice CEN/CENELEC so nacionalne organizacije za standardizacijo in nacionalni
elektrotehni{ki odbori Avstrije, Belgije, Danske, Finske, Francije, Gr~ije, Irske, Islandije, Italije,
Luksemburga, Nem~ije, Nizozemske, Norve{ke, Portugalske, [panije, [vedske, [vice in
Zdru`enega kraljestva.
CEN/CENELEC
Centralni sekretariat: Rue de Stassart 36, B-1050 Bruselj
© 1995 Lastnice avtorskih pravic so vse dr`ave ~lanice CEN/CENELEC.
Referen~na {tevilka EN 45004:1995 E
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SIST EN 45004 : 1997
VSEBINA Stran CONTENTS Page
Predgovor.3 Foreword.4
Uvod.3 Introduction.4
1 Predmet standarda.6 1 Scope.7
2 Definicije.6 2 Definitions.7
3 Upravne zahteve.7 3 Administrative requirements.8
4 Neodvisnost, nepristranost in po{tenost.8 4 Independence, impartiality and integrity.8
5 Zaupnost.8 5 Confidentiality.9
6 Organizacija in vodenje.8 6 Organisation and management.9
7 Sistem kakovosti.9 7 Quality system.10
8 Osebje.11 8 Personnel.12
9 Zmogljivosti in oprema.12 9 Facilities and equipment.13
10 Metode in postopki kontrole.14 10 Inspection methods and procedures.15
11 Ravnanje z vzorci in primerki za 11 Handling inspection samples and
kontrolo.16 items.16
12 Zapisi.16 12 Records.17
13 Poro~ila in potrdila oziroma certifikati o 13 Inspection reports and inspection
kontroli.17 certificates.17
14 Sklepanje podpogodb.17 14 Sub-contracting.18
15 Prito`be in prizivi.18 15 Complaints and appeals.18
16 Sodelovanje.18 16 Co-operation.19
Dodatek A (normativni): Merila neodvisnosti Annex A (normative): Independence criteria
za kontrolni organ tipa A.19 for Type A inspection body.19
Dodatek B (normativni): Merila neodvisnosti Annex B (normative): Independence criteria
za kontrolni organ tipa B.20 for Type B inspection body.20
Dodatek C (normativni): Merila neodvisnosti Annex C (normative): Independence criteria
za kontrolni organ tipa C.21 for Type C inspection body.21
Dodatek D (informativni): Informacije, ki jih Annex D (informative): Information to be
mora poslovnik kakovosti vsebovati ali se included or referenced in the Quality
nanje sklicevati.22 manual.22
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SIST EN 45004 : 1997
Predgovor Foreword
Ta evropski standard je pripravil tehni~ni This European Standard has been drawn up
odbor CEN/CLC/TC 1 Merila za organe za by CEN/CENELEC/TC 1 “Criteria for
ugotavljanje skladnosti, katerega sekretariat conformity assessment bodies”, whose
spada pod Centralni sekretariat CEN. secretariat is held by the CEN Central
Secretariat.
Ta evropski standard mora dobiti status This European Standard shall be given the
nacionalnega standarda z objavo istovetnega status of a national standard, either by
besedila ali z razglasitvijo, in sicer publication of an identical text or by
najpozneje do septembra 1995. Nacionalne endorsement, at the latest by September
standarde, ki so v nasprotju s tem 1995, and conflicting national standards
standardom, je treba umakniti najpozneje do shall be withdrawn at the latest by
septembra 1995. September 1995.
V skladu s poslovnikom CEN/CENELEC According to the CEN/CENELEC Internal
morajo uporabo tega evropskega standarda Regulations, the following countries are
obvezno uvesti naslednje dr`ave: Avstrija, bound to implement this European Standard:
Belgija, Danska, Finska, Francija, Nem~ija, Austria, Belgium, Denmark, Finland, France,
Gr~ija, Islandija, Irska, Italija, Luksemburg, Germany, Greece, Iceland, Ireland, Italy,
Nizozemska, Norve{ka, Portugalska, [panija, Luxembourg, Netherlands, Norway, Portugal,
[vedska, [vica in Zdru`eno kraljestvo. Spain, Sweden, Switzerland, United
Kingdom.
Uvod Introduction
Ta evropski standard je bil pripravljen z This European Standard has been drawn up
namenom, da se pove~a zaupanje v tiste with the objective of promoting confidence
organe, ki izvajajo kontrolo v skladu z njim. in those bodies performing inspection which
conform to it.
Pri pripravi so bile upo{tevane izku{nje It has been drawn up in the light of
evropskih organov, ki izvajajo kontrolo, ter experience of European bodies performing
zahteve in priporo~ila evropskih in inspections taking into account requirements
mednarodnih dokumentov, kot sta skupina and recommendations of European and
standardov ISO 9000 (EN ISO 9000) ter international documents such as ISO 9000
Vodilo ISO/IEC 39. (EN/ISO 9000) series of standards and
ISO/IEC Guide 39.
Kontrolni organi so izvedli ocenitve v imenu Inspection bodies have carried out
zasebnih odjemalcev, svojih mati~nih assessments on behalf of private clients,
organizacij in/ali uradnih organov, da bi tako their parent organizations, and/or official
tem strankam priskrbeli informacije v zvezi s authorities with the objective of providing
skladnostjo s predpisi, standardi ali information to those parties relative to
specifikacijami. Parametri kontrole lahko conformity with regulations, standards or
vklju~ujejo vpra{anja koli~ine, kakovosti, specifications. Inspection parameters may
varnosti, primernosti za uporabo in stalnega include matters of quantity, quality, safety,
izpolnjevanja zahtev varnega delovanja obrata fitness for use, and continued safety
ali sistema. Splo{na merila, ki jih morajo ti compliance of plant or systems in operation.
organi izpolnjevati, ~e `elijo, da bodo tako The general criteria, with which these bodies
naro~niki kot kontrolni organi oblasti sprejeli are required to comply in order that their
njihove storitve, morajo biti usklajena v services be accepted by clients and by
2
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SIST EN 45004 : 1997
evropskem standardu. supervisory authorities, need to be
harmonized in a European standard.
Zato ta standard obsega funkcije organov, ki This standard, therefore, covers the functions
se ukvarjajo s preiskovanjem materialov, of bodies whose work may include the
proizvodov, in{talacij, obratov, procesov, examination of materials, products,
delovnih postopkov ali storitev in z installations, plant, processes, work
ugotavljanjem njihove skladnosti z zahtevami, procedures, or services, and the
ter s poro~anjem o rezultatih teh dejavnosti determination of their conformity with
odjemalcem in, ~e se zahteva, nadzornim requirements, and the subsequent reporting
organom oblasti. Kontrola proizvoda, of results of these activities to clients and,
in{talacije ali obrata lahko zadeva vse when required, to supervisory authorities.
stopnje v `ivljenjski dobi teh objektov, Inspection of a product an installation or
vklju~no s stopnjo na~rtovanja. Tako delo plant may concern all stages during the
ponavadi zahteva strokovno razsojanje, zlasti lifetime of these items, including the design
{e, ~e se ugotavlja skladnost. stage. Such work normally requires the
exercise of professional judgment in
providing the service, in particular when
assessing conformity.
Zahteve po neodvisnosti kontrolnih organov The requirement for the independence of
se razlikujejo glede na zakonodajo in inspection bodies varies according to
potrebe trga. Zato so v ta standard legislation and market needs. This standard
vklju~ena merila za neodvisnost, in sicer v therefore includes, in annexes A, B and C.,
dodatkih A, B in C. criteria for independence.
Namen tega standarda je tudi podpreti This standard has also been produced to
uvajanje postopkov ugotavljanja skladnosti, support the introduction of the conformity
specificiranih v sklepu Sveta ES o modulih assessment procedures specified in the EC
za razne faze ugotavljanja skladnosti, ki Council decision concerning the modules for
bodo predvidoma uporabljeni v tehni~no the various phases of the conformity
harmoniziranih direktivah. assessment procedures which are intended
to be used in the technical harmonization
directives.
V ta standard so vklju~ene tiste zahteve iz The relevant requirements of the EN/ISO
serije standardovEN ISO 9000, ki se 9000 series of standards applying to the
nana{ajo na sisteme kakovosti za quality systems for inspection bodies are
kontrolneorgane. incorporated in this standard.
Ta standard spada v naslednjo skupino This standard forms part of the following
standardov, ki obravnavajo presku{anje, series of standards covering testing,
kontrolo, certificiranje in akreditacijo: inspections, certification and accreditation:
EN 45001 Splo{na merila za delovanje EN 45001 General criteria for the operation
preskusnih laboratorijev of testing laboratories
EN 45002 Splo{na merila za ocenjevanje EN 45002General criteria for the
preskusnih laboratorijev assessment of testing
laboratories
EN 45003 Splo{na merila za organe za EN 45003 General criteria for the laboratory
akreditiranje laboratorijev accreditation bodies
4
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SIST EN 45004 : 1997
EN 45004 Splo{na merila za delovanje EN 45004 General criteria for the operation
organov, ki izvajajo kontrolo of bodies performing inspection
* *
EN xxxx Splo{na merila za akreditacijo EN xxxx General criteria for the
razli~nih vrst organov, ki izvajajo accreditation of various types of
kontrolo bodies performing inspection
EN 45011 Splo{na merila za certifikacijske EN 45011 General criteria for certification
organe za podro~je certificiranja bodies operating product
proizvodov certification
EN 45012 Splo{na merila za certifikacijske EN 45012 General criteria for certification
organe za podro~je certificiranja bodies operating quality system
sistemov kakovosti certification
EN 45013 Splo{na merila za certifikacijske EN 45013 General criteria for certification
organe za podro~je certificiranja bodies operating certification for
osebja personnel
EN 45014 Splo{na merila za dobaviteljevo EN 45014 General criteria for suppliers
izjavo o skladnosti declaration of conformity
EN 45020 Standardizacija in z njo povezane EN 45020General terms and their
dejavnosti - Splo{ni slovar definitions concerning
standardization and related
activities
*
V pripravi.
2
1
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SIST EN 45004 : 1997
1 Predmet standarda 1 Scope
1.1 Ta evropski standard dolo~a splo{na 1.1 This European Standard specifies general
merila za usposobljenost nepristranskih criteria for the competence of impartial
organov, ki izvajajo kontrolo, ne glede na bodies performing inspection irrespective of
sektor, v katerem delujejo. Dolo~a tudi merila the sector involved. It also specifies
za neodvisnost. independence criteria.
1.2 Ta standard je namenjen kontrolnim 1.2 This standard is intended for the use of
organom in njihovim akreditacijskim organom inspection bodies and their accreditation
kakor tudi drugim organom, ki se ukvarjajo s bodies as well as other bodies concerned
priznavanjem usposobljenosti kontrolnih with recognizing the competence of
organov. inspection bodies.
1.3 Za uporabo v dolo~enih sektorjih ali za 1.3 This set of criteria may have to be
notranjo kontrolo bo morda temu sklopu interpreted when applied to particular
meril treba dodati posebno razlago. sectors, or to in-service inspection.
1.4 Ta standard ne vklju~uje preskusnih 1.4 This standard does not cover testing
laboratorijev, certifikacijskih organov ali laboratories, certification bodies or the
dobaviteljeve izjave o skladnosti; merila zanje suppliers’ declaration of conformity, the
vsebujejo drugi evropski standardi iz serije criteria for which are contained in other
EN 45000. European Standards of the EN 45000 series.
2 Definicije 2 Definitions
V tem standardu so uporabljene naslednje For the purpose of this standard the
definicije: following definitions apply
2.1 Kontrola 2.1 Inspection
Preiskovanje na~rtovanja proizvoda, Examination of a product design, product,
proizvoda, storitve, procesa ali obrata in service, process or plant, and determination
ugotavljanje njihove skladnosti s specifi~nimi of their conformity with specific requirements
zahtevami ali, na podlagi strokovne razsodbe, or, on the basis of professional judgment,
s splo{nimi zahtevami. general requirements.
OPOMBI 1.Kontrola procesov vklju~uje osebje, Note 1: Inspection of processes includes personnel,
prostore, tehnologijo in metodologijo. facilities, technology and methodology.
2. Rezultati kontrole se lahko uporabijo v Note 2: The results of inspection may be used to
podporo certificiranju. support certification.
2.2 Kontrolni organ 2.2 Inspection body
Organ, ki izvaja kontrolo. Body that performs inspection.
OPOMBA: Organ je lahko organizacija ali del Note: A body can be an organization, or part of an
organizacije. organization.
Za druge izraze veljajo definicije, ki so For other definitions those given in EN
podane v EN 45020:1993. 45020:1993 are applicable.
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SIST EN 45004 : 1997
3 Upravne zahteve 3 Administrative requirements
3.1 Kontrolni organ ali organizacija, katere 3.1 The inspection body, or the organization
del je, mora biti pravno prepoznaven. of which it forms a part, shall be legally
identifiable.
3.2 ^e je kontrolni organ del organizacije, ki 3.2 An inspection body that is part of an
se poleg kontrole ukvarja {e z drugimi organization involved in functions other than
funkcijami, mora biti prepoznaven znotraj te inspection shall be identifiable within the
organizacije. organization.
3.3 Kontrolni organ mora imeti 3.3 The inspection body shall have
dokumentacijo, ki opisuje njegove funkcije in documentation which describes its functions
tehni~ni obseg dejavnosti, za katero je and the technical scope of activity for which
usposobljen. it is competent.
Natan~en obseg kontrole se dolo~i s The precise scope of an inspection will be
posamezno pogodbo ali delovnim nalogom. determined by the terms of the individual
contract or work order.
3.4 Kontrolni organ mora imeti primerno 3.4 The inspection body shall have adequate
zavarovanje odgovornosti, razen ~e njegovo liability insurance unless its liability is
odgovornost prevzame dr`ava v skladu z assumed by the State in accordance with
nacionalnimi zakoni ali organizacija, katere national laws or by the organization of which
del je. it forms a part.
3.5 Kontrolni organ mora imeti 3.5 The inspection body shall have
dokumentacijo, v kateri so opisani pogoji, documentation describing the conditions on
pod katerimi posluje, razen ~e je del which it does business unless it is part of
organizacije in zagotavlja kontrolne storitve an organization and provides inspection
samo tej organizaciji. services only to that organization.
3.6 Kontrolni organ ali organizacija, katere 3.6 The inspection body, or the organization
del je, mora imeti neodvisno pregledane of which it forms a part, shall have
ra~unovodske izkaze. independently audited accounts.
4 Neodvisnost, nepristranost in 4 Independence, impartiality and
po{tenost integrity
4.1 Splo{no 4.1 General
Osebje kontrolnega organa ne sme biti pod The personnel of the inspection body shall
nikakr{nimi komercialnimi, finan~nimi ali be free from any commercial, financial, and
druga~nimi pritiski, ki bi lahko vplivali na other pressures which might affect their
njegovo razsojanje. Vpeljati je treba judgment. Procedures shall be implemented
postopke, ki zagotavljajo, da osebe ali to ensure that persons or organizations
organizacije zunaj kontrolnega organa ne external to the inspection body, cannot
morejo vplivati na rezultate kontrol. influence the results of inspections carried
out.
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SIST EN 45004 : 1997
4.2 Neodvisnost 4.2 Independence
Kontrolni organ mora biti neodvisen do take The inspection body shall be independent to
mere, kot se zahteva glede na okoli{~ine, v the extent that is required with regard to the
katerih opravlja storitve. conditions under which it performs its
services.
Odvisno od teh okoli{~in mora izpolnjevati Depending on these conditions it shall meet
minimalna merila, navedena v enem od the minimum criteria stipulated in one of the
normativnih dodatkov A, B ali C. normative Annexes A, B, C.
4.2.1 Kontrolni organ tipa A 4.2.1 Type A inspection body
Kontrolni organ, ki opravlja storitve kot "tretja The inspection body providing “third party”
stranka", mora izpolnjevati merila iz dodatka services shall meet the criteria of Annex A
A (normativni). (normative).
4.2.2 Kontrolni organ tipa B 4.2.2 Type B inspection body
^e je kontrolni organ lo~en in prepoznaven The inspection body which forms a separate
del organizacije, katere dejavnosti so and identifiable part of an organization
na~rtovanje, proizvodnja, dobava, monta`a, involved in the design, manufacture, supply,
uporaba ali vzdr`evanje predmetov, ki jih ta installation, use or maintenance of the items
kontrolni organ kontrolira, in ~e je bil ta it inspects and has been established to
kontrolni organ ustanovljen zato, da opravlja supply inspection services to its parent
kontrolne storitve mati~ni organizaciji, mora organization shall meet the criteria of Annex
izpolnjevati merila iz dodatka B (normativni). B (normative).
4.2.3 Kontrolni organ tipa C 4.2.3 Type C inspection body
^e se kontrolni organ ukvarja z The inspection body which is involved in the
na~rtovanjem, proizvodnjo, dobavo, monta`o, design, manufacture, supply, installation, use
uporabo ali vzdr`evanjem predmetov, ki jih or maintenance of the items it inspects or of
kontrolira, ali podobnih konkuren~nih similar competitive items and may supply
predmetov in morebiti opravlja kontrolne inspection services to other parties not being
storitve drugim strankam, ki niso njegova its parent organization shall meet the criteria
mati~na organizacija, mora izpolnjevati merila of Annex C (normative).
iz dodatka C (normativni).
5 Zaupnost 5 Confidentiality
Kontrolni organ mora v ~asu, ko izvaja The inspection body shall ensure
kontrolne aktivnosti, zagotoviti zaupnost confidentiality of information obtained in the
informacij. Lastni{ke pravice morajo biti course of its inspection activities. Proprietary
za{~itene. rights shall be protected.
6 Organizacija in vodenje 6 Organization and management
6.1 Kontrolni organ mora biti organiziran 6.1 The inspection body shall have an
tako, da lahko vzdr`uje sposobnost organization that enables it to maintain the
opravljanja svoje tehni~ne funkcije. capability to perform its technical functions
satisfactorily.
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6.2 Kontrolni organ mora dolo~iti in 6.2 The inspection body shall define and
dokumentirati odgovornosti in strukturo document the responsibilities and reporting
poro~anja v organizaciji. ^e kontrolni organ structure of the organization. Where the
opravlja tudi storitve certificiranja in/ali inspection body also supplies certification
presku{anja, morajo biti odnosi med and/or testing services, the relationship
njegovimi funkcijami jasno dolo~eni. between its functions must be clearly
defined.
6.3 Kontrolni organ mora imeti tehni~nega 6.3 The inspection body shall have a
vodjo s poljubnim nazivom, ki je kvalificiran technical manager however named, who is
in ima izku{nje v delovanju kontrolnega qualified and experienced in the operation of
organa in ki nosi celotno odgovornost za to, the inspection body and who has overall
da se dejavnosti kontrole izvajajo v skladu s responsibility that the inspection activities are
tem standardom. Biti mora redno zaposlen. carried out in accordance with this standard.
He shall be a permanent employee.
OPOMBA: ^e ima kontrolni organ ve~ oddelkov z Note: Where an inspection body consists of
razli~nimi podro~ji dejavnosti, ima lahko vsak several divisions with different scopes of
oddelek svojega tehni~nega vodjo. activity, there may be one technical
manager per division.
6.4 Kontrolni organ mora zagotavljati 6.4 The inspection body shall provide
u~inkovit nadzor, ki ga opravljajo osebe, effective supervision by persons familiar with
seznanjene z metodami in postopki kontrole, the inspection methods and procedures, the
cilji kontrole in ocenjevanjem rezultatov objectives of the inspection and the
preiskave. assessment of the examination results.
6.5 Kontrolni organ mora imenovati osebe, ki 6.5 The inspection body shall have named
v primeru odsotnosti nadome{~ajo persons who will deputize in the absence of
kateregakoli vodjo, ki je odgovoren za any manager, however named, responsible
kontrolne storitve. for inspection services.
6.6 Vsaka kategorija delovnega mesta, ki 6.6 Each position category affecting the
vpliva na kakovost kontrolnih storitev, mora quality of the inspection services shall be
biti opisana. Ti opisi del morajo vsebovati described. These job descriptions shall
zahteve glede izobrazbe, strokovnega include the requirements for education,
izpopolnjevanja, tehni~nega znanja in training, technical knowledge and experience.
izku{enj.
7 Quality system
7 Sistem kakovosti
7.1 Vodstvo kontrolnega organa mora 7.1 The inspection body’s management shall
opredeliti in dokumentirati politiko kakovosti, define and document its policy and
cilje kakovosti ter zavezanost h kakovosti ter objectives for, and commitment to, quality,
mora poskrbeti, da to politiko v organizaciji and shall ensure that this policy is
razumejo, uvajajo in vzdr`ujejo na vseh understood, implemented and maintained at
ravneh. all levels in the organization.
7.2. Kontrolni organ mora imeti u~inkovit 7.2 The inspection body shall operate an
sistem kakovosti, primeren vrsti, obsegu in effective quality system appropriate to the
koli~ini dela, ki ga izvaja. type, range and volume of work performed.
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SIST EN 45004 : 1997
7.3 Sistem kakovosti mora biti popolnoma 7.3 The quality system shall be fully
dokumentiran. Obstajati mora poslovnik documented. There shall be a Quality
kakovosti, v katerem morajo biti informacije, Manual, which shall contain the information
ki jih zahteva ta standard in ki so na{tete v required by this standard and as listed in
dodatku D (informativni). Annex D (informative).
7.4 Vodstvo kontrolnega organa mora 7.4 The management of the inspection body
imenovati osebo, ki mora imeti ne glede na shall designate a person who, irrespective of
druge obveznosti dolo~ena pooblastila in other duties, shall have defined authority and
odgovornost za zagotavljanje kakovosti responsibility for quality assurance within the
znotraj kontrolnega organa. Ta oseba mora inspection body. This person shall have
imeti neposreden dostop do najvi{jega direct access to top management.
vodstva.
7.5 Ista oseba mora biti odgovorna za 7.5 The quality system shall be maintained
primerno in teko~e vzdr`evanje sistema relevant and current under the responsibility
kakovosti. of the same person.
7.6 Kontrolni organ mora vzdr`evati sistem 7.6 The inspection body shall maintain a
obvladovanja vse dokumentacije, povezane z system for control of all documentation
njegovimi dejavnostmi. Zagotoviti mora: relating to its activities. It shall ensure that:
a) da so veljavne izdaje ustreznih a) the current issues of the appropriate
dokumentov na voljo na vseh mestih, documentation are available at all
kjer je potrebno, in vsemu osebju, ki relevant locations and to a
...
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