EN ISO/IEC 17011:2004
(Main)Conformity assessment - General requirements for accreditation bodies accrediting conformity assessment bodies (ISO/IEC 17011:2004)
Conformity assessment - General requirements for accreditation bodies accrediting conformity assessment bodies (ISO/IEC 17011:2004)
ISO/IEC 17011:2004 specifies general requirements for accreditation bodies assessing and accrediting conformity assessment bodies (CABs). It is also appropriate as a requirements document for the peer evaluation process for mutual recognition arrangements between accreditation bodies.
Accreditation bodies operating in accordance with ISO/IEC 17011:2004 do not have to offer accreditation to all types of CABs.
For the purposes of ISO/IEC 17011:2004, CABs are organizations providing the following conformity assessment services: testing, inspection, management system certification, personnel certification, product certification and, in the context of this document, calibration.
Konformitätsbewertung - Allgemeine Anforderungen an Akkreditierungsstellen, die Konformitätsbewertungsstellen akkreditieren (ISO/IEC 17011:2004)
Diese Internationale Norm legt die allgemeinen Anforderungen an Akkreditierungsstellen fest, die Konformitätsbewertungsstellen begutachten und akkreditieren. Sie ist ebenfalls ein Dokument, das Anforderungen für den Evaluierungsprozess zur Erlangung gegenseitiger Anerkennungsvereinrungen zwischen Akkreditierungsstellen darlegt.
Akkreditierungsstellen, die nach dieser Internationalen Norm arbeiten, müssen die Akkreditierung nicht für alle Arten von Konformitätsbewertungsstellen anbieten.
Für die Anwendung dieser Internationalen Norm sind Konformitätsbewertungsstellen Organisationen, die folgende Dienstleistungen zur Konformitätsbewertung bereitstellen: Prüfung, Inspektion, Zertifizierung von Managementsystemen, Zertifizierung von Personen, Zertifizierung von Produkten und im Kontext mit dieser Internationalen Norm Kalibrierung.
ANMERKUNG Allgemeine Anforderungen an diese Stellen wurden beispielsweise in Internationalen Normen und Leitfäden aufgestellt (Beispiele dazu sind in den Literaturhinweisen gegeben).
Évaluation de la conformité - Exigences générales pour les organismes d'accréditation procédant à l'accréditation d'organismes d'évaluation de la conformité (ISO/IEC 17011:2004)
L'ISO/CEI 17011:2004 spécifie les exigences générales concernant les organismes d'accréditation procédant à l'évaluation et à l'accréditation des organismes d'évaluation de la conformité (OEC). Elle peut également être utilisée comme document servant de critère pour le processus d'évaluation par les pairs dans le cadre des accords de reconnaissance mutuelle entre organismes d'accréditation.
Il n'est pas nécessaire que les organismes d'accréditation fonctionnant conformément à l'ISO/CEI 17011:2004 proposent leurs services à tous les types d'OEC.
Pour les besoins de l'ISO/CEI 17011:2004, les OEC sont des organismes qui offrent les services suivants d'évaluation de la conformité: essais, inspection, certification des systèmes de management, certification de personnel, certification de produits, et, dans le contexte de ce document, étalonnages.
Ugotavljanje skladnosti – Splošne zahteve za akreditacijske organe, ki akreditirajo organe za ugotavljanje skladnosti (ISO/IEC 17011:2004)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2004
1DGRPHãþD
SIST EN 45003:1999
SIST EN 45010:1998
Ugotavljanje skladnosti – Splošne zahteve za akreditacijske organe, ki akreditirajo
organe za ugotavljanje skladnosti (ISO/IEC 17011:2004)
Conformity assessment - General requirements for accreditation bodies accrediting
conformity assessment bodies (ISO/IEC 17011:2004)
Konformitätsbewertung - Allgemeine Anforderungen an Akkreditierungsstellen, die
Konformitätsbewertungsstellen akkreditieren (ISO/IEC 17011:2004)
Évaluation de la conformité - Exigences générales pour les organismes d'accréditation
procédant a l'accréditation d'organismes d'évaluation de la conformité (ISO/IEC
17011:2004)
Ta slovenski standard je istoveten z: EN ISO/IEC 17011:2004
ICS:
03.120.20 Certificiranje proizvodov in Product and company
podjetij. Ugotavljanje certification. Conformity
skladnosti assessment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO/IEC 17011
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2004
ICS 03.120.20
Supersedes EN 45003:1995, EN 45010:1998
English version
Conformity assessment - General requirements for accreditation
bodies accrediting conformity assessment bodies (ISO/IEC
17011:2004)
Évaluation de la conformité - Exigences générales pour les Konformitätsbewertung - Allgemeine Anforderungen an
organes d'accréditation procédant à l'accréditation des Akkreditierungsstellen, die Konformitätsbewertungsstellen
organes d'évaluation de la conformité (ISO/IEC akkreditieren (ISO/IEC 17011:2004)
17011:2004)
This European Standard was approved by CEN and CENELEC on 1 July 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 reserved Ref. No. EN ISO/IEC 17011:2004 E
worldwide for CEN national Members and for CENELEC
Members.
Foreword
This document (EN ISO/IEC 17011:2004) has been prepared by 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 March 2005, and conflicting national
standards shall be withdrawn at the latest by March 2005.
This document supersedes EN 45003:1995 and EN 45010:1998.
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 17011:2004 has been approved by CEN and CENELEC as EN ISO/IEC
17011:2004 without any modifications.
INTERNATIONAL ISO/IEC
STANDARD 17011
First edition
2004-09-01
Corrected version
2005-02-15
Conformity assessment — General
requirements for accreditation bodies
accrediting conformity assessment
bodies
Évaluation de la conformité — Exigences générales pour les organismes
d'accréditation procédant à l'accréditation des organismes d'évaluation
de la conformité
Reference number
ISO/IEC 17011:2004(E)
©
ISO 2004
ISO/IEC 17011:2004(E)
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ISO/IEC 17011:2004(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Normative references. 1
3 Terms and definitions. 1
4 Accreditation body. 4
4.1 Legal responsibility. 4
4.2 Structure. 4
4.3 Impartiality. 5
4.4 Confidentiality. 6
4.5 Liability and financing . 6
4.6 Accreditation activity. 6
5 Management. 6
5.1 General. 6
5.2 Management system. 7
5.3 Document control. 7
5.4 Records. 7
5.5 Nonconformities and corrective actions . 8
5.6 Preventive actions. 8
5.7 Internal audits. 8
5.8 Management reviews. 9
5.9 Complaints. 9
6 Human resources. 10
6.1 Personnel associated with the accreditation body . 10
6.2 Personnel involved in the accreditation process . 10
6.3 Monitoring. 10
6.4 Personnel records. 11
7 Accreditation process. 11
7.1 Accreditation criteria and information. 11
7.2 Application for accreditation . 12
7.3 Resource review. 12
7.4 Subcontracting the assessment. 12
7.5 Preparation for assessment. 13
7.6 Document and record review. 14
7.7 On-site assessment. 14
7.8 Analysis of findings and assessment report . 14
7.9 Decision-making and granting accreditation. 15
7.10 Appeals. 16
7.11 Reassessment and surveillance. 17
7.12 Extending accreditation. 17
7.13 Suspending, withdrawing or reducing accreditation . 17
7.14 Records on CABs. 18
7.15 Proficiency testing and other comparisons for laboratories . 18
8 Responsibilities of the accreditation body and the CAB. 18
8.1 Obligations of the CAB. 18
8.2 Obligations of the accreditation body . 19
8.3 Reference to accreditation and use of symbols . 19
Bibliography . 21
ISO/IEC 17011:2004(E)
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 or technical activity. ISO and IEC
technical committees collaborate in fields of mutual interest. Other International Organization, 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 draf
...
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