EN ISO/IEC 17040:2005
(Main)Conformity assessment - General requirements for peer assessment of conformity assessment bodies and accreditation bodies (ISO/IEC 17040:2005)
Conformity assessment - General requirements for peer assessment of conformity assessment bodies and accreditation bodies (ISO/IEC 17040:2005)
ISO/IEC 17040:2005 specifies the general requirements for the peer assessment process to be carried out by agreement groups of accreditation bodies or conformity assessment bodies. It addresses the structure and operation of the agreement group only insofar as they relate to the peer assessment process.
ISO/IEC 17040:2005 is not concerned with the wider issues of the arrangements for the formation, organization and management of the agreement group, and does not cover how the group will use peer assessment in deciding membership of the group. Such matters, which could for example include a procedure for applicants to appeal against decisions of the agreement group, are outside the scope of ISO/IEC 17040:2005.
ISO/IEC 17040:2005 is applicable to peer assessment of conformity assessment bodies performing activities such as testing, product certification, inspection, management system certification (sometimes also called registration), and personnel certification.
More than one type of activity can be included in a peer assessment process. This can be considered particularly appropriate when the body under assessment conducts combined assessments of multiple conformity assessment activities.
ISO/IEC 17040:2005 is also applicable to peer assessment amongst accreditation bodies, which is also known as peer evaluation.
Konformitätsbewertung - Allgemeine Anforderungen an die Begutachtung unter gleichrangigen Konformitätsbewertungsstellen und Akkreditierungsstellen (ISO/IEC 17040:2005)
1.1 Diese Internationale Norm legt die allgemeinen Anforderungen an den Begutachtungsprozess unter Gleichrangigen, die durch Übereinkommensgruppen von Akkreditierungs- oder Konformitätsbewertungs-stellen auszuführen sind, fest. Sie behandelt die Struktur und Arbeitsweise der Übereinkommensgruppe nur dann, wenn diese den Begutachtungsprozess unter Gleichrangigen betrifft.
1.2 Diese Internationale Norm behandelt nicht weitere Punkte der Abkommen wie die Gestaltung, die Organisation und das Management der Übereinkommensgruppe und beinhaltet nicht, wie die Gruppe die Begutachtung unter Gleichrangigen bei der Entscheidung über die Mitgliedschaft in der Gruppe nutzt. Derartige Angelegenheiten, die zum Beispiel ein Verfahren für Antragsteller beinhalten könnten, um gegen die Entscheidungen der Übereinkommensgruppe Einspruch zu erheben, sind nicht Gegenstand dieser Internationalen Norm.
ANMERKUNG 1 Weitere Informationen zu weiteren Punkten sind in ISO/IEC Guide 68 enthalten.
1.3 Diese Internationale Norm zur Begutachtung unter Gleichrangigen ist für Konformitäts-bewertungsstellen anwendbar, die Tätigkeiten anbieten, wie:
a) Prüfung;
b) Zertifizierung von Produkten;
c) Inspektion;
d) Zertifizierung von Managementsystemen ("certification" wird im Englischen manchmal auch "registration" genannt) und
e) Zertifizierung von Personen.
In einen Begutachtungsprozess unter Gleichrangigen kann mehr als eine Art von Tätigkeit einbezogen werden. Dies kann insbesondere als angebracht erscheinen, wenn eine in der Begutachtung befindliche Stelle kombinierte Begutachtungen mehrfacher Konformitätsbewertungstätigkeiten durchführt.
Diese Internationale Norm ist auch für die Begutachtung unter gleichrangigen Akkreditierungsstellen anwend-bar, die auch als Evaluierung unter Gleichrangigen bekannt ist.
ANMERKUNG 2 Stellen, die Mitglieder einer Übereinkommensgruppe sind, können sich auf die Zuverlässigkeit der Verfahren zur Begutachtung unter Gleichrangigen zur Bewertung der Kompetenz
Evaluation de la conformité - Exigences générales relatives à l'évaluation par des pairs des organismes d'évaluation de la conformité et des organismes d'accréditation (ISO/IEC 17040:2005)
L'ISO 17040:2005 spécifie les exigences générales relatives au processus d'évaluation par des pairs que doivent réaliser des groupes d'accord d'organismes d'accréditation ou d'évaluation de la conformité. Elle ne s'applique à la structure et au fonctionnement du groupe d'accord que dans la mesure où ces derniers concernent le processus d'évaluation par des pairs.
L'ISO 17040:2005 ne traite pas des questions plus larges concernant les accords relatifs à la constitution, à l'organisation et à la gestion du groupe d'accord, ni de la façon dont le groupe utilise l'évaluation par des pairs pour décider de l'adhésion du groupe. Ces sujets, qui pourraient par exemple inclure une procédure permettant aux candidats de faire appel des décisions du groupe d'accord, ne s'inscrivent pas dans le domaine d'application de L'ISO 17040:2005.
L'ISO 17040:2005 s'applique à l'évaluation par des pairs des organismes d'évaluation de la conformité exerçant des activités comme les essais, la certification de produits, l'inspection, la certification des systèmes de management (parfois également appelée enregistrement), et la certification de personnel.
Le processus d'évaluation par des pairs peut comprendre un ou plusieurs types d'activités. Il peut se révéler particulièrement approprié pour les organismes soumis à évaluation qui réalisent des évaluations combinées de plusieurs activités d'évaluation de la conformité.
L'ISO 17040:2005 s'applique également à l'évaluation par des pairs d'organismes d'accréditation, également désignée par le terme «appréciation par des pairs».
Ugotavljanje skladnosti – Splošne zahteve za medsebojno ocenjevanje organov za ugotavljanje skladnosti in akreditacijskih organov (ISO/IEC 17040:2005)
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-april-2005
Ugotavljanje skladnosti – Splošne zahteve za medsebojno ocenjevanje organov za
ugotavljanje skladnosti in akreditacijskih organov (ISO/IEC 17040:2005)
Conformity assessment - General requirements for peer assessment of conformity
assessment bodies and accreditation bodies (ISO/IEC 17040:2005)
Konformitätsbewertung - Allgemeine Anforderungen an die Begutachtung unter
gleichrangigen Konformitätsbewertungsstellen und Akkreditierungsstellen (ISO/IEC
17040:2005)
Evaluation de la conformité - Exigences générales relatives a l'évaluation par des pairs
des organismes d'évaluation de la conformité et des organismes d'accréditation
(ISO/IEC 17040:2005)
Ta slovenski standard je istoveten z: EN ISO/IEC 17040:2005
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 17040
NORME EUROPÉENNE
EUROPÄISCHE NORM
January 2005
ICS 03.120.20
English version
Conformity assessment - General requirements for peer
assessment of conformity assessment bodies and accreditation
bodies (ISO/IEC 17040:2005)
Evaluation de la conformité - Exigences générales relatives Konformitätsbewertung - Allgemeine Anforderungen an die
à l'évaluation par des pairs des organismes d'évaluation de Begutachtung unter gleichrangigen
la conformité et des organismes d'accréditation (ISO/IEC Konformitätsbewertungsstellen und Akkreditierungsstellen
17040:2005) (ISO/IEC 17040:2005)
This European Standard was approved by CEN/CENELEC on 10 December 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
© 2005 CEN/CENELEC All rights of exploitation in any form and by any means reserved Ref. No. EN ISO/IEC 17040:2005 E
worldwide for CEN national Members and for CENELEC
Members.
Foreword
This document (EN ISO/IEC 17040:2005) 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 July 2005, and conflicting national standards
shall be withdrawn at the latest by July 2005.
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 17040:2005 has been approved by CEN and CENELEC as EN ISO/IEC
17040:2005 without any modifications.
INTERNATIONAL ISO/IEC
STANDARD 17040
First edition
2005-01-15
Conformity assessment — General
requirements for peer assessment of
conformity assessment bodies and
accreditation bodies
Évaluation de la conformité — Exigences générales relatives à
l'évaluation par des pairs des organismes d'évaluation de la conformité
et des organismes d'accréditation
Reference number
ISO/IEC 17040:2005(E)
©
ISO 2005
ISO/IEC 17040:2005(E)
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ii © ISO 2005 — All rights reserved
ISO/IEC 17040:2005(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Normative references. 1
3 Terms and definitions. 2
4 Structural requirements. 2
5 Human resource requirements. 3
5.1 Qualifications and selection. 3
5.2 Languages — translation . 3
6 Information and documentation . 3
7 Peer assessment process requirements . 4
7.1 General. 4
7.2 Application for peer assessment or an extension of scope. 5
7.3 Review and acceptance of the application. 5
7.4 Preparation for the peer assessment process. 5
7.5 Appointment of peer assessment team. 6
7.6 Documentation review. 7
7.7 On-site assessment. 7
7.8 Analysis of findings . 7
7.9 Peer assessment report. 7
7.10 Review of the peer assessment report . 8
7.11 Peer assessment in support of continuing membership of agreement group. 8
7.12 Notification of changes . 9
8 Confidentiality. 9
9 Complaints. 9
Annex A (informative) Financial aspects . 10
Annex B (informative) Assessment techniques for use by peer assessment teams. 11
Annex C (normative) Information to be included in the peer assessment report . 12
Bibliography . 13
ISO/IEC 17040:2005(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 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 17040 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.
iv © ISO 2005 – All rights reserved
ISO/IEC 17040:2005(E)
Introduction
Peer assessment has been used for many years as a means of deciding upon whom to admit to a particular
group of equals or peers. Membership of a professional institution, for example, can be decided by using a
process that the existing members have established, involving the setting of requirements for membership and
the assessment of candidates for conformity with those requirements. In the field of conformity assessment,
groups of bodies conducting the same type of work, for example testing or accreditation, have used peer
assessment in order that the work of each body can be assessed and found acceptable to all the other bodies.
The global economy has accelerated the need for mutual recognition amongst accreditation and conformity
assessment bodies. Each group has developed a form of peer assessment appropriate to its activities. It
became apparent when reviewing the methods used by the different groups that there were many aspects in
common. It was felt that there would be benefits in creating an International Standard that gave generic
requirements for an effective peer assessment process, while leaving it open to individual groups to adopt
specific measures appropriate to their individual fields of activities.
This International Standard is intended to be used by groups of peers performing any conformity assessment
activity (e.g. conformity assessment bodies, accreditation bodies). Such groups of peers have been described
in various ways, and are called agreement groups in ISO/IEC Guide 68. That is not to say that other groups in
different fields of work cannot use the peer assessment process. However, such groups would need to adopt
suitable organizational and managerial arrangements to provide the right conditions for the peer assessment
process to be carried out to the best effect. As a result, each group can achieve its desired outcomes with the
expenditure of less resources.
This International Standard is also intended to enhance the confidence of those who use or depend upon the
results of conformity assessment that the work is being conducted in a competent and proper manner.
In this Internation
...
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