SIST EN ISO/IEC 17050-1:2005
(Main)Conformity assessment - Supplier's declaration of conformity - Part 1: General requirements (ISO/IEC 17050-1:2004)
Conformity assessment - Supplier's declaration of conformity - Part 1: General requirements (ISO/IEC 17050-1:2004)
This Guide specifies general criteria for a supplier's declaration of conformity in cases where it is desirable, or necessary, that conformity of a product, process or service to normative documents be indicated, irrespective of the sector involved. The supplier may then declare under his/her responsibility the conformity to normative documents.
Konformitätsbewertung - Konformitätserklärung von Anbietern - Teil 1: Allgemeine Anforderungen (ISO/IEC 17050-1:2004)
Dieser Teil von ISO/IEC 17050 legt allgemeine Anforderungen für Konformitätserklärungen von Anbietern für die Fälle fest, wo es wünschenswert und notwendig ist, dass die Konformität eines Gegenstandes mit festgelegten Anforderungen bestätigt wird, unabhängig vom berührten Bereich. Für die Anwendung dieses Teils von ISO/IEC 17050 kann der Gegenstand der Konformitätserklärung ein Produkt, ein Prozess, ein Managementsystem, eine Person oder eine Stelle sein.
Dieser Teil von ISO/IEC 17050 enthält keine besonderen Festlegungen für den Gegenstand der Konformitätserklärung.
Anstelle von "Konformitätserklärung eines Anbieters" kann, wenn es angemessen erscheint, die Benennung "Konformitätserklärung" verwendet werden.
Evaluation de la conformité - Déclaration de conformité du fournisseur - Partie 1: Exigences générales (ISO/IEC 17050-1:2004)
Ugotavljanje skladnosti – Dobaviteljeva izjava o skladnosti – 1. del: Splošne zahteve (ISO/IEC 17050-1:2004)
Ta del ISO/IEC 17050 je bil razvit s ciljem zagotoviti splošne zahteve za dobaviteljevo izjavo o skladnosti. Ta del se nanaša na eno od treh vrst potrditve skladnosti, namreč na potrditev, ki jo izda prva stranka (npr. dobavitelj proizvoda). Drugi dve vrsti potrditve skladnosti sta potrditev druge stranke (npr. če potrditev izda uporabnik za proizvod, ki ga sam uporablja) ali potrditev tretje stranke. Vse tri vrste potrditve se uporabljajo na trgu zato, da bi se povečalo zaupanje v skladnost določenega predmeta. V tem delu ISO/IEC 17050 so opredeljene zahteve, ki veljajo takrat, kadar posameznik ali organizacija, ki je odgovorna za izpolnjevanje specificiranih zahtev (dobavitelj), izda izjavo, da je proizvod (vključno s storitvijo), proces, sistem vodenja, oseba ali organ v skladu s specificiranimi zahtevami, ki lahko vključujejo normativne dokumente, kot so na primer standardi, vodila, tehnične specifikacije, zakoni ali predpisi. Taka izjava o skladnosti se lahko sklicuje tudi na rezultate ocenjevanj, ki jih opravi ena ali več prvih, drugih ali tretjih strank. Teh sklicevanj ni dovoljeno tolmačiti kot kakršnokoli zmanjševanje odgovornosti dobavitelja. Te splošne zahteve se uporabljajo za vse sektorje. Za posebne namene, na primer za uporabo v zvezi s predpisi, pa bo mogoče treba te zahteve dopolniti. Dobaviteljeva izjava o skladnosti proizvoda (vključno s storitvijo), procesa, sistema vodenja, osebe ali organa s specificiranimi zahtevami je lahko podprta z dokumentacijo, za katero je odgovoren dobavitelj. Kadar je to zaželeno ali potrebno, se sklicuje tudi na ISO/IEC 17050-2.
General Information
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Standards Content (Sample)
SIST EN ISO/IEC 17050-1:2005SLOVENSKIjanuar 2005
STANDARD(istoveten EN ISO/IEC 17050-1:2004)Ugotavljanje skladnosti – Dobaviteljeva izjava o skladnosti – 1. del: Splošne zahteve (ISO/IEC 17050-1:2004)Conformity assessment - Supplier's declaration of conformity - Part 1: General requirements (ISO/IEC 17050-1:2004)©
Standard je založil in izdal Slovenski inštitut za standardizacijo. Razmnoževanje ali kopiranje celote ali delov tega dokumenta ni dovoljenoReferenčna številkaSIST EN ISO/IEC 17050-1:2005(en)ICS03.120.20
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO/IEC 17050-1
October 2004 ICS 03.120.20 Supersedes EN 45014:1998 English version
Conformity assessment - Supplier's declaration of conformity - Part 1: General requirements (ISO/IEC 17050-1:2004)
Evaluation de la conformité - Déclaration de conformité du fournisseur - Partie 1: Exigences générales (ISO/IEC 17050-1:2004)
Konformitätsbewertung - Konformitätserklärung von Anbietern - Teil 1: Allgemeine Anforderungen (ISO/IEC 17050-1:2004) This European Standard was approved by CEN and CENELEC on 30 September 2004.
CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN Management Centre or to any CEN or CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN or CENELEC member into its own language and notified to the CEN Management Centre has the same status as the official versions.
CEN and CENELEC members are the national standards bodies and national electrotechnical committees, respectively, of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
CEN Management Centre: CENELEC Central Secretariat:rue de Stassart, 36
B-1050 Brussels rue de Stassart, 35
B-1050 Brussels© 2004 CEN/CENELEC All rights of exploitation in any form and by any means reservedworldwide for CEN national Members and for CENELEC Members. Ref. No. EN ISO/IEC 17050-1:2004 E
EN ISO/IEC 17050-1:2004 (E)
2
Foreword
This document (EN ISO/IEC 17050-1:2004) has been prepared by Technical Committee ISO/CASCO "Committee on conformity assessment" in collaboration with Technical Committee CEN/CLC/TC 1 "Criteria for conformity assessment bodies", the secretariat of which is held by SN.
This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by April 2005, and conflicting national standards shall be withdrawn at the latest by April 2005.
This document supersedes EN 45014:1998.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Endorsement notice
The text of ISO/IEC 17050-1:2004 has been approved by CEN and CENELEC as EN ISO/IEC 17050-1:2004 without any modifications.
Reference numberISO/IEC 17050-1:2004(E)© ISO 2004
INTERNATIONAL STANDARD ISO/IEC17050-1First edition2004-10-01Conformity assessment — Supplier's declaration of conformity — Part 1: General requirements Évaluation de la conformité — Déclaration de conformité du fournisseur —
Partie 1: Exigences générales
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ii © ISO 2004 — All rights reserved
ISO/IEC 17050-1:2004(E) © ISO 2004 — All rights reserved iii Foreword ISO (the International Organization for Standardization) and IEC (the International Electrotechnical Commission) form the specialized system for worldwide standardization. National bodies that are members of ISO or IEC participate in the development of International Standards through technical committees established by the respective organization to deal with particular fields of technical activity. ISO and IEC technical committees collaborate in fields of mutual interest. Other international organizations, governmental and non-governmental, in liaison with ISO and IEC, also take part in the work. In the field of conformity assessment, the ISO Committee on conformity assessment (CASCO) is responsible for the development of International Standards and Guides. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. Draft International Standards are circulated to the national bodies for voting. Publication as an International Standard requires approval by at least 75 % of the national bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO/IEC 17050-1 was prepared by the ISO Committee on conformity assessment (CASCO). It was circulated for voting to the national bodies of both ISO and IEC, and was approved by both organizations. This first edition of ISO/IEC 17050-1, together with ISO/IEC 17050-2, cancels and replaces the second edition of ISO/IEC Guide 22:1996, General criteria for supplier's declaration of conformity. ISO/IEC 17050 consists of the following parts, under the general title Conformity assessment — Supplier's declaration of conformity: Part 1: General requirements Part 2: Supporting documentation
ISO/IEC 17050-1:2004(E) iv © ISO 2004 — All rights reserved Introduction This part of ISO/IEC 17050 has been developed with the objective of providing general requirements for a supplier’s declaration of conformity. It addresses one of the three types of attestation of conformity, namely attestation undertaken by the first party (e.g. the supplier of a product). Other types are second-party attestation (e.g. where a user issues an attestation for the product the user is using) or third-party attestation. Each of these three types is used in the market in order to increase confidence in the conformity of an object. This part of ISO/IEC 17050 specifies requirements applicable when the individual or organization responsible for fulfilment of specified requirements (supplier) provides a declaration that a product (including service), process, management system, person or body is in conformity with specified requirements, which can include normative documents such as standards, guides, technical specifications, laws and regulations. Such a declaration of conformity can also make reference to the results of assessments by one or more first, second or third parties. Such references are not to be interpreted as reducing the responsibility of the supplier in any way. These general requirements are applicable to all sectors. However, these requirements might need to be supplemented for specific purposes, for example for use in connection with regulations. A supplier's declaration of conformity of a product (including service), process, management system, person or body to specified requirements can be substantiated by supporting documentation under the responsibility of the supplier. In cases where this is desirable, or necessary, reference is made to ISO/IEC 17050-2.
INTERNATIONAL STANDARD ISO/IEC 17050-1:2004(E) © ISO 2004 — All rights reserved 1 Conformity assessment — Supplier's declaration of conformity — Part 1: General requirements 1 Scope This part of ISO/IEC 17050 specifies general requirements for a supplier’s declaration of conformity in cases where it is desirable, or necessary, that conformity of an object to the specified requirements be attested, irrespective of the sector involved. For the purposes of this part of ISO/IEC 17050, the object of a declaration of conformity can be a product, process, management system, person or body. This part of ISO/IEC 17050 does not define any particular object for the declaration of conformity. Instead of “supplier's declaration of conformity”, the term “declaration of conformity” can be used when appropriate. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO/IEC 17000:2004, Conformity assessment — Vocabulary and general principles 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO/IEC 17000 apply. NOTE 1 “Supplier's declaration of conformity” is a “declaration” as defined in ISO/IEC 17000, i.e. first-party attestation. NOTE 2 To avoid any confusion with attestation by certification bodies, the term “self-certification” is deprecated and should not be used. 4 Purpose of the declaration of conformity The purpose of the declaration is to give assurance of confo
...
SLOVENSKI SIST EN ISO/IEC 17050-1
STANDARD
januar 2005
Ugotavljanje skladnosti – Dobaviteljeva izjava o skladnosti – 1. del: Splošne
zahteve (ISO/IEC 17050-1:2004)
Conformity assessment – Supplier's declaration of conformity – Part 1: General
requirements (ISO/IEC 17050-1:2004)
Evaluation de la conformité – Déclaration de conformité du fournisseur – Partie 1:
Exigences générales (ISO/IEC 17050-1:2004)
Konformitätsbewertung – Konformitätserklärung von Anbietern – Teil 1:
Allgemeine Anforderungen (ISO/IEC 17050-1:2004)
Referenčna oznaka
ICS 03.120.20 SIST EN ISO/IEC 17050-1:2005 (sl, en)
Nadaljevanje na strani II in III in od 1 do 14
© 2008-04. Standard je založil in izdal Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO/IEC 17050-1 : 2005
NACIONALNI UVOD
Standard SIST EN ISO/IEC 17050-1 (sl, en), Ugotavljanje skladnosti – Dobaviteljeva izjava o skladnosti
– 1. del: Splošne zahteve (ISO/IEC 17050-1:2004), 2005, ima status slovenskega standarda in je
istoveten evropskemu standardu EN ISO/IEC 17050-1 (en), Conformity assessment – Supplier's
declaration of conformity – Part 1: General requirements (ISO/IEC 17050-1:2004), 2004-10-01.
NACIONALNI PREDGOVOR
Evropski standard EN ISO/IEC 17050-1:2004 je pripravil Odbor ISO za ugotavljanje skladnosti
(CASCO) v sodelovanju s tehničnim odborom Evropskega komiteja za standardizacijo CEN/CLC TC 1
Merila za organe za ugotavljanje skladnosti.
Slovenski standard SIST EN ISO/IEC 17050-1:2005 je prevod evropskega standarda EN ISO/IEC
17050-1:2004. Ob sporu zaradi besedila slovenskega prevoda v tem standardu je odločilen izvirni
evropski standard v angleškem jeziku. Slovensko izdajo standarda je pripravil tehnični odbor SIST/TC
UGA Ugotavljanje skladnosti in ga potrdil 1. januarja 2005.
ZVEZE S STANDARDI
S prevzemom tega evropskega standarda veljajo za omejeni namen referenčnih standardov vsi
standardi, navedeni v izvirniku, razen tistega, ki je že sprejet v nacionalno standardizacijo:
SIST EN ISO 9000:2005 (sl,en) Sistemi vodenja kakovosti – Osnove in slovar
(ISO 9000: 2005)
SIST EN ISO/IEC 17000:2005 (sl,en,fr,de) Ugotavljanje skladnosti – Slovar in splošna načela
(ISO/IEC 17000:2004)
SIST EN ISO/IEC 17020:2004 (en) Splošna merila za delovanje različnih organov, ki
izvajajo kontrolo (ISO/IEC 17020:1998)
SIST EN ISO/IEC 17021:2006 (en) Ugotavljanje skladnosti – Zahteve za organe, ki
presojajo in certificirajo sisteme vodenja (ISO/IEC
17021:2006)
SIST EN ISO/IEC 17024:2004 (en) Ugotavljanje skladnosti - Splošne zahteve za organe
na področju certificiranja osebja (ISO/IEC 17024:2003)
SIST EN ISO/IEC 17025:2005 (sl,en) Splošne zahteve za usposobljenost preskuševalnih in
kalibracijskih laboratorijev (ISO/IEC 17025:2005)
SIST EN ISO/IEC 17025:2005/AC:2007 (en) Splošne zahteve za usposobljenost preskuševalnih in
kalibracijskih laboratorijev (ISO/IEC 17025:2005/
Cor.1:2006)
SIST EN ISO/IEC 17040:2005 (en) Ugotavljanje skladnosti – Splošne zahteve za
medsebojno ocenjevanje organov za ugotavljanje
skladnosti in akreditacijskih organov (ISO/IEC
17040:2005)
SIST EN ISO/IEC 17050-2:2005 (en) Ugotavljanje skladnosti – Dobaviteljeva izjava o
skladnosti – 2. del: Podporna dokumentacija (ISO/IEC
17050-2:2004)
SIST EN ISO 19011:2003 (sl,en) Smernice za presojanje sistemov vodenja kakovosti
in/ali sistemov ravnanja z okoljem (ISO 19011:2002)
PREDHODNA IZDAJA
– SIST EN 45014:1998 (en) Splošna merila za dobaviteljevo izjavo o skladnosti (ISO/IEC Vodilo
22:1996)
II
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SIST EN ISO/IEC 17050-1 : 2005
OPOMBI
– Nacionalni uvod in nacionalni predgovor nista sestavni del standarda.
– Ta nacionalni dokument je istoveten EN ISO/IEC 17050-1:2004 in je objavljen z dovoljenjem
CEN
Rue de Stassart, 36
1050 Bruxelles
Belgija
This national document is identical with EN ISO/IEC 17050-1:2004 and is published with the
permission of
CEN
Rue de Stassart, 36
1050 Bruxelles
Belgium
III
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SIST EN ISO/IEC 17050-1 : 2005
(Prazna stran)
IV
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EVROPSKI STANDARD EN ISO/IEC 17050-1
EUROPEAN STANDARD
EUROPÄISCHE NORM
NORME EUROPÉENNE oktober 2004
ICS: 03.120.20 Nadomešča EN 45014:1998
Slovenska izdaja
Ugotavljanje skladnosti – Dobaviteljeva izjava o skladnosti – 1. del:
Splošne zahteve (ISO/IEC 17050-1:2004)
Conformity assessment – Evaluation de la conformité – Konformitätsbewertung –
Supplier's declaration of Déclaration de conformité du Konformitätserklärung von
conformity – Part 1: General fournisseur – Partie 1: Exigences Anbietern – Teil 1: Allgemeine
requirements (ISO/IEC 17050- générales (ISO/IEC 17050-1: Anforderungen (ISO/IEC 17050-1:
1: 2004) 2004) 2004)
Ta evropski standard sta CEN in CENELEC sprejela 12. septembra 2005.
Člani CEN in CENELEC morajo izpolnjevati določila notranjih predpisov CEN/CENELEC, s katerimi je
predpisano, da mora biti ta standard brez kakršnihkoli sprememb sprejet kot nacionalni standard.
Seznami najnovejših izdaj teh nacionalnih standardov in njihovi bibliografski podatki so na voljo pri
Upravnem centru CEN ali članih CEN ali CENELEC.
Ta evropski standard obstaja v treh uradnih izdajah (angleški, francoski in nemški). Izdaje v drugih
jezikih, ki jih člani CEN ali CENELEC na lastno odgovornost prevedejo in izdajo ter prijavijo pri
Upravnem centru CEN, veljajo kot uradne izdaje.
Člani CEN in CENELEC so nacionalni organi za standarde in nacionalni elektrotehniški komiteji
Avstrije, Belgije, Cipra, Češke republike, Danske, Estonije, Finske, Francije, Grčije, Irske, Islandije,
Italije, Latvije, Litve, Luksemburga, Madžarske, Malte, Nemčije, Nizozemske, Norveške, Poljske,
Portugalske, Slovaške, Slovenije, Španije, Švedske, Švice in Združenega kraljestva.
CEN CENELEC
Evropski komite za standardizacijo Evropski komite za standardizacijo v elektrotehniki
European Committee for Standardization European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Normung Europäisches Komitee für Elektrotechnische Normung
Centralni sekretariat CEN: Centralni sekretariat CENELEC:
Rue de Stassart 36, B-1050 Bruselj Rue de Stassart 35, B-1050 Bruselj
© 2004. Lastnice avtorskih pravic so vse države članice CEN in CENELEC Ref. št. EN ISO/IEC 17050-1:2004 E
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SIST EN ISO/IEC 17050-1 : 2005
Uvod
Ta dokument (EN ISO/IEC 17050-1:2004) je pripravil tehnični odbor ISO/CASCO za ugotavljanje
skladnosti v sodelovanju s tehničnim odborom Evropskega komiteja za standardizacijo CEN/CLC TC 1
Merila za organe za ugotavljanje skladnosti, katerega sekretariat vodi SN.
Ta evropski standard mora dobiti status nacionalnega standarda bodisi z objavo istovetnega besedila
ali z razglasitvijo najpozneje aprila 2005, nasprotujoče nacionalne standarde pa je treba razveljaviti
najpozneje aprila 2005.
Ta dokument nadomešča EN 45014:1998.
Po notranjih predpisih CEN/CENELEC so dolžne ta evropski standard privzeti nacionalne organizacije
za standarde naslednjih držav: Avstrije, Belgije, Cipra, Češke republike, Danske, Estonije, Finske,
Francije, Grčije, Irske, Islandije, Italije, Latvije, Litve, Luksemburga, Madžarske, Malte, Nemčije,
Nizozemske, Norveške, Poljske, Portugalske, Slovaške, Slovenije, Španije, Švedske, Švice in
Združenega kraljestva.
Razglasitvena objava
Besedilo standarda ISO/IEC 17050-1:2004 sta CEN in CENELEC odobrila kot evropski standard
EN ISO/IEC 17050-1:2004 brez sprememb.
2
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SIST EN ISO/IEC 17050-1 : 2005
CONTENTS Page
VSEBINA Stran
Predgovor . 4 Foreword .4
Uvod . 5 Introduction.5
1 Področje uporabe . 6 1 Scope .6
2 Zveza z drugimi standardi . 6 2 Normative references.6
3 Izrazi in definicije . 6 3 Terms and definitions.6
4 Namen izjave o skladnosti. 6 4 Purpose of the declaration of conformity . 6
5 Splošne zahteve. 7 5 General requirements .7
6 Vsebina izjave o skladnosti . 7 6 Contents of the declaration of conformity .7
7 Oblika izjave o skladnosti . 8 7 Form of declaration of conformity.8
8 Dostopnost . 9 8 Accessibility.9
9 Označevanje proizvodov . 9 9 Product marking .9
10 Stalna veljavnost izjave o 10 Continuing validity of the declaration
skladnosti . 9 of conformity.9
Dodatek A (informativni): Dobaviteljeva Annex A (informative): Supplier's declaration
izjava o skladnosti . 10 of conformity.10
3
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SIST EN ISO/IEC 17050-1 : 2005
Predgovor Foreword
ISO (Mednarodna organizacija za standardizacijo) ISO (the International Organization for
in IEC (Mednarodna elektrotehniška komisija) Standardization) and IEC (the International
tvorita specializiran sistem za svetovno Electrotechnical Commission) form the
standardizacijo. Nacionalni organi, člani ISO ali specialized system for worldwide
IEC, sodelujejo pri pripravi mednarodnih standardization. National bodies that are
standardov prek tehničnih odborov, ki jih prva members of ISO or IEC participate in the
ali druga organizacija ustanovi za obravnavanje development of International Standards through
določenega tehničnega področja. Na področjih, technical committees established by the
ki so v skupnem interesu, tehnični odbori ISO in respective organization to deal with particular
IEC medsebojno sodelujejo. Pri delu sodelujejo fields of technical activity. ISO and IEC
tudi druge vladne in nevladne mednarodne technical committees collaborate in fields of
organizacije, ki se povezujejo z ISO in IEC. Za mutual interest. Other international
razvoj mednarodnih standardov in vodil s organizations, governmental and non-
področja ugotavljanja skladnosti je odgovoren governmental, in liaison with ISO and IEC, also
Odbor ISO za ugotavljanje skladnosti CASCO take part in the work. In the field of conformity
(Committee on conformity assessment). assessment, the ISO Committee on conformity
assessment (CASCO) is responsible for the
development of International Standards and
Guides.
Mednarodni standardi so pripravljeni v skladu s International Standards are drafted in
pravili, podanimi v 2. delu Direktiv ISO/IEC. accordance with the rules given in the ISO/IEC
Directives, Part 2.
Osnutki mednarodnih standardov se pošljejo Draft International Standards are circulated to
vsem članom v glasovanje. Za objavo the national bodies for voting. Publication as an
mednarodnega standarda je treba pridobiti International Standard requires approval by at
soglasje najmanj 75 odstotkov članov, ki se least 75 % of the national bodies casting a vote.
udeležijo glasovanja.
Opozoriti je treba na možnost, da je lahko nekaj Attention is drawn to the possibility that some of
elementov tega mednarodnega standarda the elements of this document may be the
predmet patentnih pravic. ISO ne prevzema subject of patent rights. ISO shall not be held
odgovornosti za identifikacijo katerihkoli ali vseh responsible for identifying any or all such patent
takih patentnih pravic. rights.
Standard ISO/IEC 17050-1 je pripravil Odbor ISO/IEC 17050-1 was prepared by the ISO
ISO za ugotavljanje skladnosti (CASCO). Committee on conformity assessment
(CASCO).
V glasovanje je bil razposlan nacionalnim It was circulated for voting to the national
organom ISO in IEC in sta ga obe organizaciji bodies of both ISO and IEC, and was approved
odobrili. by both organizations.
Ta, prva izdaja standarda ISO/IEC 17050-1 This first edition of ISO/IEC 17050-1, together
skupaj z ISO/IEC 17050-2 preklicuje in with ISO/IEC 17050-2, cancels and replaces
nadomešča drugo izdajo Vodila ISO/IEC the second edition of ISO/IEC Guide 22:1996,
22:1996, Splošna merila za dobaviteljevo izjavo General criteria for supplier's declaration of
o skladnosti. conformity.
Standard ISO/IEC 17050 pod skupnim naslovom ISO/IEC 17050 consists of the following parts,
Ugotavljanje skladnosti – Dobaviteljeva izjava o under the general title Conformity assessment
skladnosti sestavljata naslednja dva dela: — Supplier's declaration of conformity:
– 1. del: Splošne zahteve Part 1: General requirements
– 2. del: Podporna dokumentacija Part 2: Supporting documentation
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SIST EN ISO/IEC 17050-1 : 2005
Uvod Introduction
Ta del ISO/IEC 17050 je bil razvit s ciljem This part of ISO/IEC 17050 has been
zagotoviti splošne zahteve za dobaviteljevo developed with the objective of providing
izjavo o skladnosti. general requirements for a supplier’s
declaration of conformity.
Ta del se nanaša na eno od treh vrst potrditve It addresses one of the three types of
skladnosti, namreč na potrditev, ki jo izda prva attestation of conformity, namely attestation
stranka (npr. dobavitelj proizvoda). Drugi dve undertaken by the first party (e.g. the supplier of
vrsti potrditve skladnosti sta potrditev druge a product). Other types are second-party
stranke (npr. če potrditev izda uporabnik za attestation (e.g. where a user issues an
proizvod, ki ga sam uporablja) ali potrditev tretje attestation for the product the user is using) or
stranke. Vse tri vrste potrditve se uporabljajo na third-party attestation. Each of these three
trgu zato, da bi se povečalo zaupanje v types is used in the market in order to increase
skladnost določenega predmeta. confidence in the conformity of an object.
V tem delu ISO/IEC 17050 so opredeljene This part of ISO/IEC 17050 specifies
zahteve, ki veljajo takrat, kadar posameznik ali requirements applicable when the individual or
organizacija, ki je odgovorna za izpolnjevanje organization responsible for fulfilment of
specificiranih zahtev (dobavitelj), izda izjavo, da specified requirements (supplier) provides a
je proizvod (vključno s storitvijo), proces, sistem declaration that a product (including service),
vodenja, oseba ali organ v skladu s process, management system, person or body
specificiranimi zahtevami, ki lahko vključujejo is in conformity with specified requirements,
normativne dokumente, kot so na primer which can include normative documents such
standardi, vodila, tehnične specifikacije, zakoni as standards, guides, technical specifications,
ali predpisi. Taka izjava o skladnosti se lahko laws and regulations. Such a declaration of
sklicuje tudi na rezultate ocenjevanj, ki jih conformity can also make reference to the
opravi ena ali več prvih, drugih ali tretjih strank. results of assessments by one or more first,
Teh sklicevanj ni dovoljeno tolmačiti kot second or third parties. Such references are not
kakršnokoli zmanjševanje odgovornosti to be interpreted as reducing the responsibility
dobavitelja. of the supplier in any way.
Te splošne zahteve se uporabljajo za vse These general requirements are applicable to all
sektorje. Za posebne namene, na primer za sectors. However, these requirements might need
uporabo v zvezi s predpisi, pa bo mogoče treba to be supplemented for specific purposes, for
te zahteve dopolniti. example for use in connection with regulations.
Dobaviteljeva izjava o skladnosti proizvoda A supplier's declaration of conformity of a product
(vključno s storitvijo), procesa, sistema vodenja, (including service), process, management system,
osebe ali organa s specificiranimi zahtevami je person or body to specified requirements can be
lahko podprta z dokumentacijo, za katero je substantiated by supporting documentation
odgovoren dobavitelj. Kadar je to zaželeno ali under the responsibility of the supplier. In cases
potrebno, se sklicuje tudi na ISO/IEC 17050-2. where this is desirable, or necessary, reference
is made to ISO/IEC 17050-2.
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SIST EN ISO/IEC 17050-1 : 2005
Ugotavljanje skladnosti – Conformity assessment – Supplier's
Dobaviteljeva izjava o skladnosti – declaration of conformity – Part 1:
1. del: Splošne zahteve General requirements
1 Področje uporabe 1 Scope
Ta del ISO/IEC 17050 navaja splošne zahteve This part of ISO/IEC 17050 specifies general
za dobaviteljevo izjavo o skladnosti v primerih, requirements for a supplier’s declaration of
ko je zaželeno ali potrebno potrditi skladnost conformity in cases where it is desirable, or
določenega predmeta s specificiranimi necessary, that conformity of an object to the
zahtevami, ne glede na to, za kateri sektor gre. specified requirements be attested, irrespective
V tem delu ISO/IEC 17050 je predmet izjave o of the sector involved. For the purposes of this
skladnosti lahko proizvod, proces, sistem part of ISO/IEC 17050, the object of a
vodenja, oseba ali organ. declaration of conformity can be a product,
process, management system, person or body.
Ta del ISO/IEC 17050 ne določa nobenega This part of ISO/IEC 17050 does not define any
posebnega predmeta za izjavo o skladnosti. particular object for the declaration of conformity.
Kadar je primerno, se lahko namesto izraza Instead of “supplier's declaration of conformity”,
"dobaviteljeva izjava o skladnosti" uporablja the term “declaration of conformity” can be used
izraz "izjava o skladnosti". when appropriate.
2 Zveza z drugimi standardi 2 Normative references
Za uporabo tega standarda so nujno potrebni The following referenced documents are
spodaj navedeni dokumenti. Pri datiranem indispensable for the application of this
sklicevanju velja samo navedena izdaja; pri document. For dated references, only the
nedatiranem sklicevanju pa velja najnovejša edition cited applies. For undated references,
izdaja dokumenta (vključno z morebitnimi the latest edition of the referenced document
spremembami). (including any amendments) applies.
ISO/IEC 17000:2004 Ugotavljanje skladnosti ISO/IEC 17000:2004, Conformity assessment
– Slovar in splošna načela — Vocabulary and general principles
3 Izrazi in definicije 3 Terms and definitions
V tem dokumentu se uporabljajo izrazi in For the purposes of this document, the terms
definicije, navedeni v ISO/IEC 17000. and definitions given in ISO/IEC 17000 apply.
OPOMBA 1: "Dobaviteljeva izjava o skladnosti" je "izjava", NOTE 1 “Supplier's declaration of conformity” is a
kot je določeno v standardu ISO/IEC 17000, tj. “declaration” as defined in ISO/IEC 17000,
potrditev, ki jo izda prva stranka. i.e. first-party attestation.
OPOMBA 2: Da bi se izognili zamenjavi s potrdili NOTE 2 To avoid any confusion with attestation by
certifikacijskih organov, je odsvetovana certification bodies, the term “self-
uporaba izraza "samocertificiranje" in naj se certification” is deprecated and should not
ne uporablja. be used.
4 Namen izjave o skladnosti 4 Purpose of the declaration of conformity
Namen izjave je dati zagotovilo o skladnosti The purpose of the declaration is to give
določenega predmeta s specificiranimi assurance of conformity of the identified object to
zahtevami, na katere se izjava sklicuje, in jasno specified requirements to which the declaration
opredeliti, kdo je odgovoren za to skladnost in refers, and to make clear who is responsible for
izjavo. Dobaviteljeva izjava o skladnosti se that conformity and declaration. A supplier’s
lahko uporablja samostojno ali v povezavi z declaration of conformity may be used alone or in
drugim postopkom ugotavljanja skladnosti v conjunction with another conformity assessment
regulativne ali neregulativne namene. procedure for reg
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