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INTERNATIONAL STANDARD
ISO/IEC CD 2 17011
Conformity assessment —Requirementsfor accreditation bodies accreditingconformity assessment bodies / Version: 29.01.2016
VUP-Stellungnahme (ENTWURF) / Stand:18.02.2016
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, ISO and IEC develop joint ISO/IEC documents under the management of the ISO Committee on Conformity assessment (ISO/CASCO).
The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of document should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO and IEC shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see
Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO's adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
ISO/IEC 17011 was prepared by the ISO Committee on Conformity Assessment (CASCO).
This International Standard specifies the general requirements for accreditation bodies accrediting conformity assessment 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. In the context of this International Standard, conformity assessment activities include but are not limited to testing, calibration, inspection, certification of management systems, persons, products, processes and services, provision of proficiency testing, production of reference materials and validation and verification.
It is important for interested parties to know that Conformity assessment bodies are competent to perform their tasks. For that reason there is an increasing demand for impartial attestation of their competence. Such attestation is done by accreditation bodies that are impartial and independent in relation to the conformity assessment bodies and the conformity assessment bodies' clients. Accreditation bodies conduct regular assessments of Conformity assessment bodies to ensure that conformity assessment bodies conform with relevant international standards, specifications and other normative documents.
A system to accredit Conformity assessment bodies should provide for a consistent application of conformity assessment to international consensus based standards and conformity assessment schemes in order to benefit public health, safety, environment and welfare and support regulators and end users.It should facilitate national and cross-border trade, as pursued by trade authorities and organizations.
In this International Standard, the following verbal forms are used:
- “shall” indicates a requirement;
- “should” indicates a recommendation;
- “may” indicates a permission;
- “can” indicates a possibility or a capability.
Further details can be found in the ISO/IEC Directives, Part 2.
Conformity assessment —Requirements for accreditation bodies accrediting conformity assessment bodies
1 / Scope
1
4-10 / This International Standard specifies requirements for the competence, consistent operation and impartiality of accreditation bodies assessing and accrediting conformity assessment bodies.
NOTE 1 Conformity assessment bodies' activities include but are not limited to testing, calibration, inspection, certification of management system, persons, products, processes, and services, provision of proficiency testing, production of reference materials and validation and verification.
NOTE 2 Accreditation bodies operating in accordance with this International Standard do not have to offer accreditation to all types of Conformity assessment bodies.
2 / Normative References
2
12-18 / 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, Quality management systems — Fundamentals and vocabulary
ISO/IEC 17000, Conformity assessment — Vocabulary and general principles
ISO/IEC Guide 99, International vocabulary of metrology -- Basic and general concepts and associated terms (VIM)
3 / Terms anddefinitions
3
20-21 / For the purposes of this document, the terms and definitions given in ISO/IEC 17000 and the 20 following apply.
3.1
22-26 / accreditation
third-party attestation related to a conformity assessment body conveying formal demonstration of its competence to carry out specific conformity assessment tasks
SOURCE: ISO/IEC 17000:2004, 5.3
3.2
27-30 / accreditation body
authoritative body that performs accreditation
SOURCE ISO/IEC 17000:2004, 2.6, modified note removed
3.3
31-33 / accreditation body logo
logo used by an accreditation body to identify itself
3.5
34-37 / accreditation symbol
symbol issued by an accreditation body to be used by accredited conformity assessment bodies to indicate their accredited status
3.6
38-43 / appeal
request by a conformity assessment body for reconsideration of any adverse accreditation decision related to its desired accreditation status
NOTE to entry: Requests from Conformity assessment bodies for reconsideration of other decisions such as those related to non –conformities or corrective action requests can be handled under complaints. / appeal
request by a conformity assessment body for reconsideration of any adverseaccreditation decision made by the accreditation body related to assessment activities or to its desired accreditation status
NOTE to entry: Requests from Conformity assessment bodies for reconsideration of other decisions such as those related to non –conformities or corrective action requests can be handled under complaints. / CABs should also have the possibility to contradict in terms of detected non-conformities and/or corrective actions request.
Then, the note, which offers the opportunity for complaints in case of “other decisions” is not needed.
3.7
44-52 / assessment
process undertaken by an accreditation body to determine the competence of a conformity assessment body, based on standard(s) and/or other normative documents and for a defined scope of accreditation
NOTE to entry: Assessing the competence of a conformity assessment body involves assessing the competence of the entire operations of the conformity assessment body, including the competence of the personnel, the validity of the conformity assessment methodology and the validity of the conformity assessment results.
3.8
53-56 / assessor
person assigned by an accreditation body to perform, alone or as part of an assessment team, an assessment of a conformity assessment body
3.9
57-62 / 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 conformity assessment body, where a response is expected
SOURCE: ISO/IEC 17000:2004, 6.5
3.10
63-68 / conformity assessment body
body that performs conformity assessment activities and that can be the object of accreditation
NOTE to entry: Whenever the word “conformity assessment body” is used in the text, it applies to both the “applicant and accredited Conformity assessment bodies” unless otherwise specified.
SOURCE: ISO/IEC 17000:2004, 2.5, modified - Note of 2.5 replaced by the Note to
3.11
69-77 / consultancy
participation in any of the activities of a conformity assessment body subject to accreditation
EXAMPLES:
- preparing or producing manuals or procedures for a conformity assessment body;
- Participating in the operation or management of the system of a conformity assessment body;
- Giving specific advice or specific training towards the development and implementation of the management system, operational procedures and/or competence of a conformity assessment body.
3.12
78-82 / technical expert
person assigned by an accreditation body, working under the responsibility of an assessor, who provides specific knowledge or expertise with respect to the scope of accreditation to be assessed
NOTE to entry: A technical expert is not expected to have assessor qualifications and training / technical expert
person assigned by an accreditation body, working under the responsibility of an assessor, who provides specific knowledge or expertise with respect to the scope of accreditation to be assessed
NOTE to entry: A technical expert is not expected to have assessor qualifications and training / The note confuses. Does “technical expert” stand for the german “Fachbegutachter”? If this is the case, why this person should have no assessor qualification and training?
3.13
83-85 / extending accreditation
process of adding conformity assessment activities to the scope of accreditation
3.14
86-90 / interested parties
parties with a direct or indirect interest in accreditation
NOTE to entry: 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 activities.
3.15
91-93 / team leader
assessor who is given the overall responsibility for the management of an assessment
3.16
94-96 / reducing accreditation
process of cancelling part of the scope of accreditation
3.17
97-99 / scope of accreditation
specific conformity assessment activities for which accreditation is sought or has been granted
3.18
100-102 / suspending accreditation
process of temporarily making accreditation invalid, in full or for part of the scope of accreditation
3.19
103-105 / withdrawing accreditation
process of cancelling accreditation
3.20
106-109 / witnessing
observation by the accreditation body of a conformity assessment body carrying out conformity assessment activities within its scope of accreditation / Clear definition / The wording does not make clear, that “witnessing” is an observation of conformity assessment activities, which does not take place in fixed or mobile facilities of CABs.
.
3.21
110-115 / remote assessment
an assessment of a conformity assessment body physical or virtual site, using electronic mean
NOTE to entry: A virtual site is an on-line environment allowing persons to execute processes, for example in a cloud environment
3.22
116-129 / assessment techniques
methods used by an accreditation body to perform the assessment
NOTE to entry: Assessment techniques, can include but are not limited to:
- on-site assessment,
- remote assessment,
- witnessing,
- document review,
- file review,
- measurement audits,
- review of performance in proficiency testing and other intercomparisons,
- validation audits,
- unannounced assessments.
3.23
130-135 / conformity assessment activity
an activity conducted by a conformity assessment body which includes but is not limited to testing, calibration, inspection, certification of management systems, persons, products, processes, and services, provision of proficiency testing, production of reference materials and validation and verification
3.24
136-140 / assessmentprogramme
set of assessments consistent with a specific accreditation scheme that the accreditation body performs on a specific conformity assessment body during an accreditation cycle.
3.25
141-143 / Accreditation decision
decisions on granting, maintaining, extending, reducing, suspending and withdrawing of accreditation
3.26
144-146 / granting accreditation
process of awarding accreditation for a defined scope of accreditation
3.27
147-152 / accreditation scheme
Rules and procedures for carrying out and management of accreditation of conformity assessment bodies to which the same requirements, rules and procedures apply
NOTE to entry: Accreditation scheme requirements include ISO/IEC 17020, ISO/IEC 17021, ISO/IEC 17025, ISO/IEC 17024, ISO 17034, ISO/IEC 17043 , ISO/IEC 17065, ISO 15189 and ISO 14065.
3.28
153-158 / assessment plan
description of the activities and arrangements for an assessment
NOTE to entry: Adapted from ISO 19011:2011 definition 3.15
3.29
159-164 / personnel
individuals, internal or external, of the accreditation body carrying out activities for the accreditation body
NOTE to entry: These include committee members and volunteers.
3.30
165-167 / maintaining accreditation
process which confirms the continuance of accreditation for a defined scope
4 / General requirements
4.1
169-176 / Legal entity
The accreditation body shall be a legal entity, or a defined part of a legal entity such that it can be held legally responsible for its accreditation activities.
NOTE 1 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 withgovernmental Conformity assessment bodies occur.
NOTE 2 An accreditation body that is part of a larger body may operate under a different name.
4.2
177-207 / Accreditation agreement
The accreditation body shall have a legally enforceable agreement with the CAB that requires the conformity assessment body to conform to at least the following:
a) to commit to fulfil continually the requirements for accreditation for the scope for which accreditation is sought or granted and to commit to provide evidence of fulfilment. This includes agreement to adapt to changes in the requirements for accreditation, as set out in 8.2.5;
b) to cooperate as is necessary to enable the accreditation body to verify fulfilment of requirements for accreditation;
c) to provide access to locations, personnel, information, documents and records as necessary to verify fulfilment of requirements for accreditation ;
d) to provide evidence about the impartiality and the level of independence of the conformity assessment body;
e) to arrange the witnessing of conformity assessment services when requested by the accreditation body;
f) to have, where applicable, legally enforceable arrangements with their clients that commit the clients to provide, on request, access to accreditation body assessment teams to assess the conformity assessment bodies performance carrying out conformity assessment activities at the client’s site;
g) to claim accreditation only with respect to the scope for which it has been granted accreditation;
h) to commit to follow the accreditation body's policy for the use of the accreditation symbol;
i) not to use its accreditation in such a manner as to bring the accreditation body into disrepute;
j) to inform the accreditation body without delay of significant changes relevant to its accreditation, in any aspect of its status or operation relating to:
- its legal, commercial, ownership or organizational status,
- the organization, top management and key personnel,
- resources and location(s)
- scope of accreditation, and
- other such matters that may affect the ability of the conformity assessment body to fulfil requirements for accreditation;
k) to pay fees as determined by the accreditation body;
l) to assist in the investigation and resolution of any accreditation related complaints about the conformity assessment body referred to it by the accreditation body.
4.3 / Use of accreditation symbols and other claims of accreditation
4.3.1
209-218 / The accreditation body shall take measures to ensure that the accredited conformity assessment body:
a) fully conforms with the requirements of the accreditation body for claiming accreditation status, when making reference to its accreditation in communication media;
b) does not make any misleading or unauthorized statement regarding its accreditation;
c) upon withdrawal of its accreditation, discontinues its use of any reference to an accredited status,
d) does not allow the fact of its accreditation to be used to imply that a product, process, service, management system or person is approved by the accreditation body;
e) inform its affected clients of the suspension, reduction or withdrawal of its accreditation and the associated consequences. / The accreditation body shall take measures to ensure that the accredited conformity assessment body:
a) fully conforms with the requirements of the accreditation body for claiming accreditation status, when making reference to its accreditation in communication media;
b) does not make any misleading or unauthorized statement regarding its accreditation;
c) upon withdrawal of its accreditation, immediatelydiscontinues its use of any reference to an accredited status,
d) does not allow the fact of its accreditation to be used to imply that a product, process, service, management system or person is approved by the accreditation body;
e) inform its affected clients of the suspension, reduction or withdrawal of its accreditation and the associated consequenceswithout undue delay. / For reasons of fair competition and consumer protection timings have to be specified
4.3.2
219-231 / When an accreditation body has an accreditation symbol, the accreditation body shall have the legal right to use it and the accreditation symbol shall be legally protected. The accreditation body shall have a policy governing the use of the accreditation symbol .This policy shall specify as a minimum:
a) that the accreditation symbol or claim of accreditation status is not affixed to an item or product (or any part of it) or used to imply that an item or product has been certified;
b) requirements for reproduction of the accreditation symbol;
c) requirements for the use and monitoring of the accreditation symbol in combination with any mark;
d) requirements for any reference to accreditation;
e) requirements for the use of the symbol in media;
f) that the conformity assessment body only uses the accreditation symbol for the specific services covered by the scope of accreditation.
4.3.3
232-233 / The accreditation symbol shall have, or be accompanied with, a clear indication as to which conformity assessment activity the accreditation is related.
4.3.4
234-238 / The accreditation body shall take suitable action to deal with incorrect or unauthorised claims of accreditation status, or misleading, or unauthorised use of accreditation symbols and accreditation body's logo.
NOTE Suitable actions may include request for corrective action, withdrawal of accreditation, publication of the transgression and, if necessary, legal action.
4.4 / Impartialityrequirements
4.4.1
240-241 / The accreditation body shall be organized and operated so as to safeguard the objectivity and impartiality of its activities. Accreditation shall be undertaken impartially.
4.4.2
242-243 / The accreditation body shall be accreditation activities and shall not allow commercial, financial or other pressures to compromise impartiality.
4.4.3
244-247 / The accreditation body shall have top management commitment to impartiality. It shall have and make public an impartiality policy which includes the importance of impartiality in carrying out its accreditation activities, managing conflict of interest and ensuring objectivity of its accreditation activities.