SIST 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)
Setting out the "General requirements for bodies proving assessment and accreditation" as an European Standard.
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 a 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
SIST EN ISO/IEC 17011:2004
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
SIST EN ISO/IEC 17011:2004 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO/IEC 17011:2004
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SIST EN ISO/IEC 17011:2004
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.
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SIST EN ISO/IEC 17011:2004
EN ISO/IEC 17011:2004 (E)
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.
2
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SIST EN ISO/IEC 17011:2004
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
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SIST EN ISO/IEC 17011:2004
ISO/IEC 17011:2004(E)
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ii © ISO 2004 — All rights reserved
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SIST EN ISO/IEC 17011:2004
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 2004 – All rights reserved iii
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SIST EN ISO/IEC 17011:2004
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 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 17011 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 17011 cancels and replaces ISO/IEC Guide 58, ISO/IEC Guide 61, and
ISO/IEC/TR 17010. Many accreditation bodies requested this revision because, for quite similar activities, they
have had to comply with three sets of largely repetitious but slightly differing, requirements for the same
attributes.
This corrected version of ISO/IEC 17011:2004 incorporates the following corrections:
the French title has been amended;
the Foreword has been corrected to include reference to voting by IEC national bodies;
the copyright has been corrected to ISO only.
iv © ISO 2004 – All rights reserved
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SIST EN ISO/IEC 17011:2004
ISO/IEC 17011:2004(E)
Introduction
In the regulatory sector, government authorities implement laws covering the approval of products (including
services) for reasons of safety, health, environmental protection, fraud prevention or market fairness. In the
voluntary sector, many lines of industry have, both within an economy as well as globally, set up systems for
conformity assessment and approval, aiming at achieving a minimum technical level, enabling comparability,
and also ensuring competition on equal terms.
A prerequisite for trade on equal terms is that any product (including services), accepted formally in one
economy, must also be free to circulate in other economies without having to undergo extensive re-testing, re-
inspection, re-certification, etc. This should be the case regardless of whether the product (including services)
falls wholly or partly under the regulatory sector.
In today’s society it is often required to state objectively conformity of products (including services) to specified
requirements. Conformity assessment bodies (CABs) can objectively state such conformity. These CABs
perform conformity assessment activities that include certification, inspection, testing and, in the context of this
International Standard, calibration.
It is important for the purchaser, regulator and the public to know that these CABs are competent to perform
their tasks. For that reason there is an increasing demand for impartial verification of their competence. Such
verification is done by authoritative accreditation bodies that are impartial in relation to both the CABs and
their clients, and which normally operate in a non-profit distributing manner (see Figure 1).
A system to accredit CAB conformity assessment services should provide confidence to the purchaser and
regulator. Such a system should facilitate cross-border trade, as pursued by trade authorities and
organizations. The ultimate goal is to achieve one-stop accreditation and one-stop conformity assessment.
A “cross border” trade facilitating system can work well if accreditation bodies and CABs all operate to globally
accepted requirements in an equivalent manner and take into account the interests of all parties concerned.
This International Standard specifies the general requirements for accreditation bodies. Peer evaluation
mechanisms have been created at regional and international levels, through which assurance is provided that
accreditation bodies are operating in accordance with this International Standard. Those who have passed
such an evaluation can become members of mutual recognition arrangements. Through regular re-evaluations,
the continued adherence to this International Standard is assured.
These mutual recognition arrangement members facilitate the one-stop process, through recognition,
promotion and acceptance of each other’s accredited conformity assessments. This means that a CAB in an
economy should not need to be accredited more than once for the same scope by different accreditation
bodies.
© ISO 2004 – All rights reserved v
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SIST EN ISO/IEC 17011:2004
ISO/IEC 17011:2004(E)
NOTE The word supplier is used to mean provider of products (including services).
Figure 1 — Flowchart
vi © ISO 2004 – All rights reserved
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SIST EN ISO/IEC 17011:2004
INTERNATIONAL STANDARD ISO/IEC 17011:2004(E)
Conformity assessment — General requirements for
accreditation bodies accrediting conformity assessment bodies
1 Scope
This International Standard 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 this International Standard do not have to offer
accreditation to all types of CABs.
For the purposes of this International Standard, CABs are organizations providing the following conformity
assessment services: testing, inspection, management system certification, personnel certification, product
certification and, in the context of this International Standard, calibration.
NOTE General requirements for these bodies have been established, for example in International Standards and
Guides (examples of which are given in the Bibliography).
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 9000:2000, Quality management systems — Fundamentals and vocabulary
ISO/IEC 17000:2004, Conformity assessment — Vocabulary and general principles
VIM:1993, International vocabulary of basic and general terms in metrology, issued by BIPM, IEC, IFCC, ISO,
IUPAC, IUPAP and OIML
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO/IEC 17000 and the following apply.
Where the terms and definitions are neither included in this document nor in ISO/IEC 17000, the terms and
definitions of ISO 9000 or the International vocabulary of basic and general terms in metrology (VIM) apply. If
different definitions for specific metrological terms are given, the definitions of VIM have preference.
3.1
accreditation
third-party attestation related to a conformity assessment body conveying formal demonstration of its
competence to carry out specific conformity assessment tasks
3.2
accreditation body
authoritative body that performs accreditation
NOTE The authority of an accreditation body is generally derived from government.
© ISO 2004 – All rights reserved 1
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SIST EN ISO/IEC 17011:2004
ISO/IEC 17011:2004(E)
3.3
accreditation body logo
logo used by an accreditation body to identify itself
3.4
accreditation certificate
formal document or a set of documents, stating that accreditation has been granted for the defined scope
3.5
accreditation symbol
symbol issued by an accreditation body to be used by accredited CABs to indicate their accredited status
NOTE “Mark” is to be reserved to indicate direct conformity of an entity against a set of requirements.
3.6
appeal
request by a CAB for reconsideration of any adverse decision made by the accreditation body related to its
desired accreditation status
NOTE Adverse decisions include
refusal to accept an application,
refusal to proceed with an assessment,
corrective action requests,
changes in accreditation scope,
decisions to deny, suspend or withdraw accreditation, and
any other action that impedes the attainment of accreditation .
3.7
assessment
process undertaken by an accreditation body to assess the competence of a CAB, based on particular
standard(s) and/or other normative documents and for a defined scope of accreditation
NOTE Assessing the competence of a CAB involves assessing the competence of the entire operations of the CAB,
including the competence of the personnel, the validity of the conformity assessment methodology and the validity of the
conformity assessment results.
3.8
assessor
person assigned by an accreditation body to perform, alone or as part of an assessment team, an assessment
of a CAB
3.9
complaint
expression of dissatisfaction, other than appeal, by any person or organization, to an accreditation body,
relating to the activities of that accreditation body or of an accredited CAB, where a response is expected
3.10
conformity assessment body
CAB
body that performs conformity assessment services and that can be the object of accreditation
NOTE Whenever the word “CAB” is used in the text, it applies to both the “applicant and accredited CABs” unless
otherwise specified.
2 © ISO 2004 – All rights reserved
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SIST EN ISO/IEC 17011:2004
ISO/IEC 17011:2004(E)
3.11
consultancy
participation in any of the activities of a CAB subject to accreditation
EXAMPLES:
preparing or producing manuals or procedures for a CAB;
participating in the operation or management of the system of a CAB;
giving specific advice or specific training towards the development and implementation of the management system
and/or competence of a CAB;
giving specific advice or specific training for the development and implementation of the operational procedures of a
CAB.
3.12
expert
person assigned by an accreditation body to provide specific knowledge or expertise with respect to the scope
of accreditation to be assessed
3.13
extending accreditation
process of enlarging the scope of accreditation
3.14
interested parties
parties with a direct or indirect interest in accreditation
NOTE Direct interest refers to the interest of those who undergo accreditation; indirect interest refers to the interests
of those who use or rely on accredited conformity assessment services.
3.15
lead assessor
assessor who is given the overall responsibility for specified assessment activities
3.16
reducing accreditation
process of cancelling accreditation for part of the scope of accreditation
3.17
scope of accreditation
specific conformity assessment services for which accreditation is sought or has been granted
3.18
surveillance
set of activities, except reassessment, to monitor the continued fulfilment by accredited CABs of requirements
for accreditation
NOTE Surveillance includes both surveillance on-site assessments and other surveillance activities, such as the
following:
a) enquiries from the accreditation body to the CAB on aspects concerning the accreditation;
b) reviewing the declarations of the CAB with respect to what is covered by the accreditation;
c) requests to the CAB to provide documents and records (e.g. audit reports, results of internal quality control for
verifying the validity of CAB services, complaints records, management review records);
d) monitoring the performance of the CAB (such as results of participating in proficiency testing).
© ISO 2004 – All rights reserved 3
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SIST EN ISO/IEC 17011:2004
ISO/IEC 17011:2004(E)
3.19
suspending accreditation
process of temporarily making accreditation invalid, in full or for part of the scope of accreditation
3.20
withdrawing accreditation
process of cancelling accreditation in full
3.21
witnessing
observation of the CAB carrying out conformity assessment services within its scope of accreditation
4 Accreditation body
4.1 Legal responsibility
The accreditation body shall be a registered legal entity.
NOTE Governmental accreditation bodies are deemed to be legal entities on the basis of their governmental status.
Where the governmental accreditation body is part of a larger governmental entity, the government is responsible for
identifying the accreditation body in a way that no conflict of interest with governmental CABs occur. This accreditation
body is deemed to be the "registered legal entity" in the context of this International Standard.
4.2 Structure
4.2.1 The structure and operation of an accreditation body shall be such as to give confidence in its
accreditations.
4.2.2 The accreditation body shall have authority and shall be responsible for its decisions relating to
accreditation, including the granting, maintaining, extending, reducing, suspending and withdrawing of
accreditation.
4.2.3 The accreditation body shall have a description of its legal status, including the names of its owners if
applicable, and, if different, the names of the persons who control it.
4.2.4 The accreditation body shall document the duties, responsibilities and authorities of top management
and other personnel associated with the accreditation body who could affect the quality of the accreditation.
4.2.5 The accreditation body shall identify the top management having overall authority and responsibility
for each of the following:
a) development of policies relating to the operation of the accreditation body;
b) supervision of the implementation of the policies and procedures;
c) supervision of the finances of the accreditation body;
d) decisions on accreditation;
e) contractual arrangements;
f) delegation of authority to committees or individuals, as required, to undertake defined activities on behalf
of top management.
4.2.6 The accreditation body shall have access to necessary expertise for advising the accreditation body
on matters directly relating to accreditation.
NOTE Access to the necessary expertise may be obtained through one or more advisory committees (either ad-hoc
or permanent), each responsible within its scope.
4 © ISO 2004 – All rights reserved
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SIST EN ISO/IEC 17011:2004
ISO/IEC 17011:2004(E)
4.2.7 The accreditation body shall have formal rules for the appointment, terms of reference and operation
of committees that are involved in the accreditation process, and shall identify the parties participating.
4.2.8 The accreditation body shall document its entire structure, showing lines of authority and responsibility.
4.3 Impartiality
4.3.1 The accreditation body shall be organized and operated so as to safeguard the objectivity and
im
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