SIST EN ISO/IEC 17000:2020
(Main)Conformity assessment - Vocabulary and general principles (ISO/IEC 17000:2020, Corrected version 2020-12)
Conformity assessment - Vocabulary and general principles (ISO/IEC 17000:2020, Corrected version 2020-12)
This document specifies general terms and definitions relating to conformity assessment (including the
accreditation of conformity assessment bodies) and to the use of conformity assessment to facilitate trade.
The general principles of conformity assessment and a description of the functional approach to
conformity assessment are provided in Annex A.
Conformity assessment interacts with other fields such as management systems, metrology,
standardization and statistics. The boundaries of conformity assessment are not defined in this
document.
Konformitätsbewertung - Begriffe und allgemeine Grundlagen (ISO/IEC 17000:2020, korrigierte Fassung 2020-12)
Dieses Dokument legt allgemeine Begriffe der Konformitätsbewertung (einschließlich der Akkreditierung von Konformitätsbewertungsstellen) und für die Anwendung der Konformitätsbewertung zur Förderung des Handels fest.
Die allgemeinen Grundsätze der Konformitätsbewertung und eine Beschreibung des funktionalen Ansatzes der Konformitätsbewertung enthält Anhang A.
Konformitätsbewertung steht in Wechselwirkung mit anderen Gebieten wie Managementsysteme, Metrologie, Normung und Statistik. Die Grenzen der Konformitätsbewertung sind in diesem Dokument nicht festgelegt.
Évaluation de la conformité - Vocabulaire et principes généraux (ISO/IEC 17000:2020, Version corrigée 2020-12)
Ugotavljanje skladnosti - Slovar in splošna načela (ISO/IEC 17000:2020, popravljena verzija 2020-12)
General Information
Relations
Buy Standard
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO/IEC 17000:2020
01-september-2020
Nadomešča:
SIST EN ISO/IEC 17000:2005
Ugotavljanje skladnosti - Slovar in splošna načela (ISO/IEC 17000:2020,
popravljena verzija 2020-12)
Conformity assessment - Vocabulary and general principles (ISO/IEC 17000:2020,
Corrected version 2020-12)
Konformitätsbewertung - Begriffe und allgemeine Grundlagen (ISO/IEC 17000:2020,
korrigierte Fassung 2020-12)
Évaluation de la conformité - Vocabulaire et principes généraux (ISO/IEC 17000:2020,
Version corrigée 2020-12)
Ta slovenski standard je istoveten z: EN ISO/IEC 17000:2020
ICS:
01.040.03 Storitve. Organizacija Services. Company
podjetja, vodenje in kakovost. organization, management
Uprava. Transport. and quality. Administration.
Sociologija. (Slovarji) Transport. Sociology.
(Vocabularies)
03.120.20 Certificiranje proizvodov in Product and company
podjetij. Ugotavljanje certification. Conformity
skladnosti assessment
SIST EN ISO/IEC 17000:2020 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO/IEC 17000:2020
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SIST EN ISO/IEC 17000:2020
EUROPEAN STANDARD EN ISO/IEC 17000
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2020
ICS 01.040.03; 03.120.20
Supersedes EN ISO/IEC 17000:2004
English version
Conformity assessment - Vocabulary and general
principles (ISO/IEC 17000:2020, Corrected version 2020-
12)
Évaluation de la conformité - Vocabulaire et principes Konformitätsbewertung - Begriffe und allgemeine
généraux (ISO/IEC 17000:2020, Version corrigée Grundlagen (ISO/IEC 17000:2020, korrigierte Fassung
2020-12) 2020-12)
This European Standard was approved by CEN on 2 May 2020.
This European Standard was corrected and reissued by the CEN-CENELEC Management Centre on 09 December 2020.
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-CENELEC Management Centre or to
any CEN and 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 and CENELEC member into its own language and notified to the CEN-CENELEC
Management Centre has the same status as the official versions.
CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium,
Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia,
Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
CEN-CENELEC Management Centre:
Rue de la Science 23, B-1040 Brussels
© 2020 CEN/CENELEC All rights of exploitation in any form and by any means Ref. No. EN ISO/IEC 17000:2020 E
reserved worldwide for CEN national Members and for
CENELEC Members.
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SIST EN ISO/IEC 17000:2020
EN ISO/IEC 17000:2020 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO/IEC 17000:2020
EN ISO/IEC 17000:2020 (E)
European foreword
This document (EN ISO/IEC 17000:2020) has been prepared by Technical Committee ISO/CASCO
"Committee on conformity assessment" in collaboration with Technical Committee CEN/CLC/JTC 1
“Criteria for conformity assessment bodies” the secretariat of which is held by BSI.
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 December 2020, and conflicting national standards
shall be withdrawn at the latest by December 2020.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO/IEC 17000:2004.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO/IEC 17000:2020, Corrected version 2020-12 has been approved by CEN as
EN ISO/IEC 17000:2020 without any modification.
3
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SIST EN ISO/IEC 17000:2020
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SIST EN ISO/IEC 17000:2020
INTERNATIONAL ISO/IEC
STANDARD 17000
Second edition
2020-05
Corrected version
2020-12
Conformity assessment — Vocabulary
and general principles
Évaluation de la conformité — Vocabulaire et principes généraux
Reference number
ISO/IEC 17000:2020(E)
©
ISO/IEC 2020
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SIST EN ISO/IEC 17000:2020
ISO/IEC 17000:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO/IEC 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
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Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO/IEC 2020 – All rights reserved
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SIST EN ISO/IEC 17000:2020
ISO/IEC 17000:2020(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Terms related to conformity assessment in general . 1
5 Terms related to basic concepts . 4
6 Terms relating to selection and determination . 4
7 Terms relating to review, decision and attestation . 5
8 Terms relating to surveillance . 6
9 Terms relating to trade and regulation . 7
Annex A (informative) Principles of conformity assessment .10
Annex B (informative) Related terms defined in other standards .15
Bibliography .22
© ISO/IEC 2020 – All rights reserved iii
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SIST EN ISO/IEC 17000:2020
ISO/IEC 17000:2020(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.
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 www .iso .org/ directives).
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 www .iso .org/ patents) or the IEC
list of patent declarations received (see http:// patents .iec .ch).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www .iso .org/
iso/ foreword .html.
This document was prepared by the ISO Committee on Conformity Assessment (CASCO).
This second edition cancels and replaces the first edition (ISO/IEC 17000:2004), which has been
technically revised.
The main changes compared to the previous edition are as follows:
— addition of new terms: “object of conformity assessment” (see 4.2), “owner” (see 4.13), “impartiality”
(see 5.3), “independence” (see 5.4), “validation” (see 6.5), “verification” (see 6.6), “decision” (see 7.2),
“expiry” (see 8.4) and “restoration” (see 8.5);
— change of concept of conformity assessment system;
— deletion of the definition of the term “product” from the body of the document and addition to
Annex B;
— editorial revision of Annex A limited to changes in the terms and definitions in Clauses 4 to 9;
— extension of Annex B.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
This corrected version of ISO/IEC 17000:2020 corrects the price indication. The technical content
remains unchanged.
iv © ISO/IEC 2020 – All rights reserved
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SIST EN ISO/IEC 17000:2020
ISO/IEC 17000:2020(E)
Introduction
The ISO Committee on conformity assessment (CASCO) develops International Standards relating to
conformity assessment activities such as testing, inspection and various forms of certification. For
many years, ISO/IEC Guide 2 included a core vocabulary for conformity assessment, built up from a
small number of terms and definitions first compiled to facilitate communication and understanding
about product certification based on standards for traditional manufactured goods.
In 2000, CASCO decided to remove conformity assessment terminology from ISO/IEC Guide 2 and
provide instead a self-contained vocabulary more readily applicable within the planned international
standards on conformity assessment and in the drafting or revision of related documents. The first
edition of this document was published in 2004, as a consistent framework within which more specific
concepts could be defined appropriately and denoted by the most appropriate terms.
Additional concepts unique to particular activities such as accreditation, certification of persons
and use of marks of conformity are not included in this document but are provided in International
Standards related to those activities.
Terms and definitions related to trade and regulation are given in Clause 9. These are intended not
only to standardize usage within the conformity assessment community, but also to help policy makers
concerned with the facilitation of trade within regulatory and international treaty frameworks.
The terms and definitions specified in this document, particularly in Clauses 6 and 7, reflect the
adoption by CASCO in November 2001 of the functional approach.
To provide a better understanding of the defined concepts, their grouping and their relationships, a
description of the functional approach is included in Annex A for information.
The terms included in this document relate to concepts considered essential to define. General terms
used to denote conformity assessment concepts for which common language usage is sufficient are
not included in this document. Terms not common across all International Standards for conformity
assessment and with definitions specific to a particular application are not included in this document
but are included in the specific relevant standard.
Relevant terms defined in other documents are listed in Annex B:
— terms applicable to specific aspects of conformity assessment, as defined in other conformity
assessment standards;
— terms generally applicable in conformity assessment contexts for which definitions are published
outside conformity assessment standards.
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SIST EN ISO/IEC 17000:2020
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SIST EN ISO/IEC 17000:2020
INTERNATIONAL STANDARD ISO/IEC 17000:2020(E)
Conformity assessment — Vocabulary and general
principles
1 Scope
This document specifies general terms and definitions relating to conformity assessment (including the
accreditation of conformity assessment bodies) and to the use of conformity assessment to facilitate trade.
The general principles of conformity assessment and a description of the functional approach to
conformity assessment are provided in Annex A.
Conformity assessment interacts with other fields such as management systems, metrology,
standardization and statistics. The boundaries of conformity assessment are not defined in this
document.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
4 Terms related to conformity assessment in general
4.1
conformity assessment
demonstration that specified requirements (5.1) are fulfilled
Note 1 to entry: The process of conformity assessment as described in the functional approach in Annex A can
have a negative outcome, i.e. demonstrating that the specified requirements are not fulfilled.
Note 2 to entry: Conformity assessment includes activities defined elsewhere in this document, such as but not
limited to testing (6.2), inspection (6.3), validation (6.5), verification (6.6), certification (7.6), and accreditation (7.7).
Note 3 to entry: Conformity assessment is explained in Annex A as a series of functions. Activities contributing to
any of these functions can be described as conformity assessment activities.
Note 4 to entry: This document does not include a definition of “conformity”. “Conformity” does not feature in the
definition of “conformity assessment”. Nor does this document address the concept of compliance.
4.2
object of conformity assessment
object
entity to which specified requirements (5.1) apply
EXAMPLE Product, process, service, system, installation, project, data, design, material, claim, person, body
or organization, or any combination thereof.
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SIST EN ISO/IEC 17000:2020
ISO/IEC 17000:2020(E)
Note 1 to entry: The term “body” is used in this document to refer to conformity assessment bodies (4.6) and
accreditation bodies (4.7). The term “organization” is used in its general meaning and may include bodies
according to the context. The more specific ISO/IEC Guide 2 definition of an organization as a body based on
membership is not applicable to the field of conformity assessment (4.1).
4.3
first-party conformity assessment activity
conformity assessment activity that is performed by the person or organization that provides or that is
the object of conformity assessment (4.2)
Note 1 to entry: The first-, second- and third-party descriptors used to characterize conformity assessment
activities in relation to a given object are not to be confused with the legal identification of the relevant parties
to a contract.
EXAMPLE Activities performed by providers, designers or owners of the object, investors in the object, and
advertisers or promoters of the object.
Note 2 to entry: If an activity is performed by an external body acting on behalf of and controlled by a person or
organization that provides or is the object, the activity is still called a first-party conformity assessment activity
(e.g. internal audits performed by a consultant who is not part of the organization).
4.4
second-party conformity assessment activity
conformity assessment activity that is performed by a person or organization that has a user interest in
the object of conformity assessment (4.2)
Note 1 to entry: The first-, second- and third-party descriptors used to characterize conformity assessment
activities in relation to a given object are not to be confused with the legal identification of the relevant parties
to a contract.
EXAMPLE Persons or organizations performing second-party conformity assessment activities include, for
example, purchasers or users of products, or potential customers seeking to rely on a supplier's management
system, or organizations representing those interests. Examples of organizations representing user interest
include consumer advocacy organizations, regulators implementing legislation governing products and services
for the protection of consumer and public interests, centralized government procurement organizations and
private sector purchasing agents.
Note 2 to entry: If an activity is performed by an external body acting on behalf of and controlled by a person or
organization with a user interest, the activity is still called a second-party conformity assessment activity (e.g.
supply chain audits conducted by an external body on behalf of the purchaser).
4.5
third-party conformity assessment activity
conformity assessment activity that is performed by a person or organization that is independent of the
provider of the object of conformity assessment (4.2) and has no user interest in the object
Note 1 to entry: The first-, second- and third-party descriptors used to characterize conformity assessment
activities in relation to a given object are not to be confused with the legal identification of the relevant parties
to a contract.
4.6
conformity assessment body
body that performs conformity assessment activities, excluding accreditation (7.7)
4.7
accreditation body
authoritative body that performs accreditation (7.7)
Note 1 to entry: The authority of an accreditation body can be derived from government, public authorities,
contracts, market acceptance or scheme owners.
2 © ISO/IEC 2020 – All rights reserved
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SIST EN ISO/IEC 17000:2020
ISO/IEC 17000:2020(E)
4.8
conformity assessment system
set of rules and procedures (5.2) for the management of similar or related conformity assessment
schemes (4.9)
Note 1 to entry: A conformity assessment system can be operated at an international, regional, national, sub-
national, or industry sector level.
4.9
conformity assessment scheme
conformity assessment programme
set of rules and procedures (5.2) that describes the objects of conformity assessment (4.2), identifies the
specified requirements (5.1) and provides the methodology for performing conformity assessment (4.1)
Note 1 to entry: A conformity assessment scheme can be managed within a conformity assessment system (4.8).
Note 2 to entry: A conformity assessment scheme can be operated at an international, regional, national sub-
national, or industry sector level.
Note 3 to entry: A scheme can cover all or part of the conformity assessment functions explained in Annex A.
4.10
access
access to a scheme
opportunity for an applicant to obtain a conformity assessment (4.1) service from a body under a
conformity assessment scheme (4.9)
4.11
participant
participant in a system
participant in a scheme
person or organization that implements or operates under the rules and procedures (5.2) of a conformity
assessment system (4.8) or scheme (4.9) without being involved in their development, revision or
approval
4.12
member
member of a system
member of a scheme
person or organization that is involved in the development, revision or approval of the rules and
procedures (5.2) of a conformity assessment system (4.8) or scheme (4.9)
4.13
owner
owner of a system
owner of a scheme
system owner
scheme owner
person or organization responsible for the development and maintenance of a conformity assessment
system (4.8) or conformity assessment scheme (4.9)
Note 1 to entry: A scheme owner does not necessarily operate the scheme (4.9).
Note 2 to entry: A system owner or a scheme owner can be a conformity assessment body (4.6) itself, a governmental
authority, a trade association, a group of conformity assessment bodies or others.
© ISO/IEC 2020 – All rights reserved 3
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SIST EN ISO/IEC 17000:2020
ISO/IEC 17000:2020(E)
5 Terms related to basic concepts
5.1
specified requirement
need or expectation that is stated
Note 1 to entry: Specified requirements can be stated in normative documents such as regulations, standards
and technical specifications.
Note 2 to entry: Specified requirements can be detailed or general.
5.2
procedure
specified way to carry out an activity or a process
Note 1 to entry: In this context, a process is defined as a set of interrelated or interacting activities that use
inputs to deliver an intended result.
[SOURCE: ISO 9000:2015, 3.4.5, modified — The original Note to entry has been replaced with a new
Note to entry.]
5.3
impartiality
objectivity with regard to the outcome of a conformity assessment activity
Note 1 to entry: Objectivity can be understood as freedom from bias or freedom from conflicts of interest.
5.4
independence
freedom of a person or organization from the control or authority of another person or organization
EXAMPLE A conformity assessment body (4.6) can be independent from the person who is the object of
conformity assessment (4.2) or from the organization providing the object of conformity assessment (4.2).
6 Terms relating to selection and determination
6.1
sampling
selection and/or collection of material or data regarding an object of conformity assessment (4.2)
Note 1 to entry: Selection can be on the basis of a procedure, an automated system, professional judgement etc.
Note 2 to entry: Selection and collection can be performed by the same or different persons or organizations.
6.2
testing
determination of one or more characteristics of an object of conformity assessment (4.2), according to a
procedure (5.2)
Note 1 to entry: The procedure can be intended to control variables within testing as a contribution to the
accuracy or reliability of the results.
Note 2 to entry: The results of testing can be expressed in terms of specified units or objective comparison with
agreed references.
Note 3 to entry: The output of testing can include comments (e.g. opinions and interpretations) about the test
results and fulfilment of specified requirements.
Note 4 to entry: Additional information on the concepts of testing (6.2) and inspection (6.3) is given in A.3.4.
4 © ISO/IEC 2020 – All rights reserved
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SIST EN ISO/IEC 17000:2020
ISO/IEC 17000:2020(E)
6.3
inspection
examination of an object of conformity assessment (4.2) and determination of its conformity with
detailed requirements or, on the basis of professional judgement, with general requirements
Note 1 to entry: Examination can include direct or indirect observations, which can include measurements or the
output of instruments.
Note 2 to entry: Conformity assessment schemes (4.9) or contracts can specify inspection as examination only.
Note 3 to entry: Additional information on the concepts of testing (6.2) and inspection (6.3) is given in A.3.4.
6.4
audit
process for obtaining relevant information about an object of conformity assessment (4.2) and evaluating
it objectively to determine the extent to which specified requirements (5.1) are fulfilled
Note 1 to entry: The specified requirements are defined prior to performing an audit so that the relevant
information can be obtained.
Note 2 to entry: Examples of objects for an audit are management systems, processes, products and services.
Note 3 to entry: For accreditation purposes, the audit process is called “assessment”.
6.5
validation
confirmation of plausibility for a specific intended use or application through the provision of objective
evidence that specified requirements (5.1) have been fulfilled
Note 1 to entry: Validation can be applied to claims to confirm the information declared with the claim regarding
an intended future use.
6.6
verification
confirmation of truthfulness through the provision of objective evidence that specified requirements
(5.1) have been fulfilled
Note 1 to entry: Verification can be applied to claims to confirm the information declared with the claim
regarding events that have already occurred or results that have already been obtained.
6.7
peer assessment
assessment of a body against specified requirements (5.1) by representatives of other bodies in, or
candidates for, an agreement group (9.10)
Note 1 to entry: “Candidates” are included for the situation where a new group is being formed, at which time
there would be no bodies in the group.
Note 2 to entry: The term “peer assessment” is sometimes referred to as “peer evaluation”.
7 Terms relating to review, decision and attestation
7.1
review
consideration of the suitability, adequacy and effectiveness of selection and determination activities,
and the results of these activities, with regard to fulfilment of specified requirements (5.1) by an object
of conformity assessment (4.2)
7.2
decision
conclusion, based on the results of review (7.1), that fulfilment of specified requirements (5.1) has or has
not been demonstrated
© ISO/IEC 2020 – All rights reserved 5
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SIST EN ISO/IEC 17000:2020
ISO/IEC 17000:2020(E)
7.3
attestation
issue of a statement, based on a decision (7.2), that fulfilment of specified requirements (5.1) has been
demonstrated
Note 1 to entry: The resulting statement, referred to in this document as a “statement of conformity”, is intended
to convey the assurance that the specified requirements have been fulfilled. Such an assurance does not, of itself,
provide contractual or other legal guarantees.
Note 2 to entry: First-party attestation and third-party attestation are distinguished by the terms declaration
(7.5), certification (7.6) and accreditation (7.7), but there is no corresponding term applicable to second-party
attestation.
7.4
scope of attestation
range or characteristics of objects of conformity assessment (4.2) covered by attestation (7.3)
7.5
declaration
first-party attestation (7.3)
7.6
certification
third-party attestation (7.3) related to an object of conformity assessment (4.2), with the exception of
accreditation (7.7)
7.7
accreditation
third-part
...
SLOVENSKI STANDARD
SIST EN ISO/IEC 17000:2020
01-september-2020
Nadomešča:
SIST EN ISO/IEC 17000:2005
Ugotavljanje skladnosti - Slovar in splošna načela (ISO/IEC 17000:2020)
Conformity assessment - Vocabulary and general principles (ISO/IEC 17000:2020)
Konformitätsbewertung - Begriffe und allgemeine Grundlagen (ISO/IEC 17000:2020)
Évaluation de la conformité - Vocabulaire et principes généraux (ISO/IEC 17000:2020)
Ta slovenski standard je istoveten z: EN ISO/IEC 17000:2020
ICS:
01.040.03 Storitve. Organizacija Services. Company
podjetja, vodenje in kakovost. organization, management
Uprava. Transport. and quality. Administration.
Sociologija. (Slovarji) Transport. Sociology.
(Vocabularies)
03.120.20 Certificiranje proizvodov in Product and company
podjetij. Ugotavljanje certification. Conformity
skladnosti assessment
SIST EN ISO/IEC 17000:2020 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO/IEC 17000:2020
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SIST EN ISO/IEC 17000:2020
EUROPEAN STANDARD
EN ISO/IEC 17000
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2020
ICS 01.040.03; 03.120.20
Supersedes EN ISO/IEC 17000:2004
English version
Conformity assessment - Vocabulary and general
principles (ISO/IEC 17000:2020)
Évaluation de la conformité - Vocabulaire et principes Konformitätsbewertung - Begriffe und allgemeine
généraux (ISO/IEC 17000:2020) Grundlagen (ISO/IEC 17000:2020)
This European Standard was approved by CEN on 2 May 2020.
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-CENELEC Management Centre or to
any CEN and 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 and CENELEC member into its own language and notified to the CEN-CENELEC
Management Centre has the same status as the official versions.
CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium,
Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia,
Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
CEN-CENELEC Management Centre:
Rue de la Science 23, B-1040 Brussels
© 2020 CEN/CENELEC All rights of exploitation in any form and by any means Ref. No. EN ISO/IEC 17000:2020 E
reserved worldwide for CEN national Members and for
CENELEC Members.
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SIST EN ISO/IEC 17000:2020
EN ISO/IEC 17000:2020 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO/IEC 17000:2020
EN ISO/IEC 17000:2020 (E)
European foreword
This document (EN ISO/IEC 17000:2020) has been prepared by Technical Committee ISO/CASCO
"Committee on conformity assessment" in collaboration with Technical Committee CEN/CLC/JTC 1
“Criteria for conformity assessment bodies” the secretariat of which is held by BSI.
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 December 2020, and conflicting national standards
shall be withdrawn at the latest by December 2020.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO/IEC 17000:2004.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO/IEC 17000:2020 has been approved by CEN as EN ISO/IEC 17000:2020 without any
modification.
3
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SIST EN ISO/IEC 17000:2020
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SIST EN ISO/IEC 17000:2020
INTERNATIONAL ISO/IEC
STANDARD 17000
Second edition
2020-05
Conformity assessment — Vocabulary
and general principles
Évaluation de la conformité — Vocabulaire et principes généraux
Reference number
ISO/IEC 17000:2020(E)
©
ISO/IEC 2020
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SIST EN ISO/IEC 17000:2020
ISO/IEC 17000:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO/IEC 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO/IEC 2020 – All rights reserved
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SIST EN ISO/IEC 17000:2020
ISO/IEC 17000:2020(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Terms related to conformity assessment in general . 1
5 Terms related to basic concepts . 4
6 Terms relating to selection and determination . 4
7 Terms relating to review, decision and attestation . 5
8 Terms relating to surveillance . 6
9 Terms relating to trade and regulation . 7
Annex A (informative) Principles of conformity assessment .10
Annex B (informative) Related terms defined in other standards .15
Bibliography .22
© ISO/IEC 2020 – All rights reserved iii
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SIST EN ISO/IEC 17000:2020
ISO/IEC 17000:2020(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.
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 www .iso .org/ directives).
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 www .iso .org/ patents) or the IEC
list of patent declarations received (see http:// patents .iec .ch).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www .iso .org/
iso/ foreword .html.
This document was prepared by the ISO Committee on Conformity Assessment (CASCO).
This second edition cancels and replaces the first edition (ISO/IEC 17000:2004), which has been
technically revised.
The main changes compared to the previous edition are as follows:
— addition of new terms: “object of conformity assessment” (see 4.2), “owner” (see 4.13), “impartiality”
(see 5.3), “independence” (see 5.4), “validation” (see 6.5), “verification” (see 6.6), “decision” (see 7.2),
“expiry” (see 8.4) and “restoration” (see 8.5);
— change of concept of conformity assessment system;
— deletion of the definition of the term “product” from the body of the document and addition to
Annex B;
— editorial revision of Annex A limited to changes in the terms and definitions in Clauses 4 to 9;
— extension of Annex B.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO/IEC 2020 – All rights reserved
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SIST EN ISO/IEC 17000:2020
ISO/IEC 17000:2020(E)
Introduction
The ISO Committee on conformity assessment (CASCO) develops International Standards relating to
conformity assessment activities such as testing, inspection and various forms of certification. For
many years, ISO/IEC Guide 2 included a core vocabulary for conformity assessment, built up from a
small number of terms and definitions first compiled to facilitate communication and understanding
about product certification based on standards for traditional manufactured goods.
In 2000, CASCO decided to remove conformity assessment terminology from ISO/IEC Guide 2 and
provide instead a self-contained vocabulary more readily applicable within the planned international
standards on conformity assessment and in the drafting or revision of related documents. The first
edition of this document was published in 2004, as a consistent framework within which more specific
concepts could be defined appropriately and denoted by the most appropriate terms.
Additional concepts unique to particular activities such as accreditation, certification of persons
and use of marks of conformity are not included in this document but are provided in International
Standards related to those activities.
Terms and definitions related to trade and regulation are given in Clause 9. These are intended not
only to standardize usage within the conformity assessment community, but also to help policy makers
concerned with the facilitation of trade within regulatory and international treaty frameworks.
The terms and definitions specified in this document, particularly in Clauses 6 and 7, reflect the
adoption by CASCO in November 2001 of the functional approach.
To provide a better understanding of the defined concepts, their grouping and their relationships, a
description of the functional approach is included in Annex A for information.
The terms included in this document relate to concepts considered essential to define. General terms
used to denote conformity assessment concepts for which common language usage is sufficient are
not included in this document. Terms not common across all International Standards for conformity
assessment and with definitions specific to a particular application are not included in this document
but are included in the specific relevant standard.
Relevant terms defined in other documents are listed in Annex B:
— terms applicable to specific aspects of conformity assessment, as defined in other conformity
assessment standards;
— terms generally applicable in conformity assessment contexts for which definitions are published
outside conformity assessment standards.
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SIST EN ISO/IEC 17000:2020
INTERNATIONAL STANDARD ISO/IEC 17000:2020(E)
Conformity assessment — Vocabulary and general
principles
1 Scope
This document specifies general terms and definitions relating to conformity assessment (including the
accreditation of conformity assessment bodies) and to the use of conformity assessment to facilitate trade.
The general principles of conformity assessment and a description of the functional approach to
conformity assessment are provided in Annex A.
Conformity assessment interacts with other fields such as management systems, metrology,
standardization and statistics. The boundaries of conformity assessment are not defined in this
document.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
4 Terms related to conformity assessment in general
4.1
conformity assessment
demonstration that specified requirements (5.1) are fulfilled
Note 1 to entry: The process of conformity assessment as described in the functional approach in Annex A can
have a negative outcome, i.e. demonstrating that the specified requirements are not fulfilled.
Note 2 to entry: Conformity assessment includes activities defined elsewhere in this document, such as but not
limited to testing (6.2), inspection (6.3), validation (6.5), verification (6.6), certification (7.6), and accreditation (7.7).
Note 3 to entry: Conformity assessment is explained in Annex A as a series of functions. Activities contributing to
any of these functions can be described as conformity assessment activities.
Note 4 to entry: This document does not include a definition of “conformity”. “Conformity” does not feature in the
definition of “conformity assessment”. Nor does this document address the concept of compliance.
4.2
object of conformity assessment
object
entity to which specified requirements (5.1) apply
EXAMPLE Product, process, service, system, installation, project, data, design, material, claim, person, body
or organization, or any combination thereof.
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SIST EN ISO/IEC 17000:2020
ISO/IEC 17000:2020(E)
Note 1 to entry: The term “body” is used in this document to refer to conformity assessment bodies (4.6) and
accreditation bodies (4.7). The term “organization” is used in its general meaning and may include bodies
according to the context. The more specific ISO/IEC Guide 2 definition of an organization as a body based on
membership is not applicable to the field of conformity assessment (4.1).
4.3
first-party conformity assessment activity
conformity assessment activity that is performed by the person or organization that provides or that is
the object of conformity assessment (4.2)
Note 1 to entry: The first-, second- and third-party descriptors used to characterize conformity assessment
activities in relation to a given object are not to be confused with the legal identification of the relevant parties
to a contract.
EXAMPLE Activities performed by providers, designers or owners of the object, investors in the object, and
advertisers or promoters of the object.
Note 2 to entry: If an activity is performed by an external body acting on behalf of and controlled by a person or
organization that provides or is the object, the activity is still called a first-party conformity assessment activity
(e.g. internal audits performed by a consultant who is not part of the organization).
4.4
second-party conformity assessment activity
conformity assessment activity that is performed by a person or organization that has a user interest in
the object of conformity assessment (4.2)
Note 1 to entry: The first-, second- and third-party descriptors used to characterize conformity assessment
activities in relation to a given object are not to be confused with the legal identification of the relevant parties
to a contract.
EXAMPLE Persons or organizations performing second-party conformity assessment activities include, for
example, purchasers or users of products, or potential customers seeking to rely on a supplier's management
system, or organizations representing those interests. Examples of organizations representing user interest
include consumer advocacy organizations, regulators implementing legislation governing products and services
for the protection of consumer and public interests, centralized government procurement organizations and
private sector purchasing agents.
Note 2 to entry: If an activity is performed by an external body acting on behalf of and controlled by a person or
organization with a user interest, the activity is still called a second-party conformity assessment activity (e.g.
supply chain audits conducted by an external body on behalf of the purchaser).
4.5
third-party conformity assessment activity
conformity assessment activity that is performed by a person or organization that is independent of the
provider of the object of conformity assessment (4.2) and has no user interest in the object
Note 1 to entry: The first-, second- and third-party descriptors used to characterize conformity assessment
activities in relation to a given object are not to be confused with the legal identification of the relevant parties
to a contract.
4.6
conformity assessment body
body that performs conformity assessment activities, excluding accreditation (7.7)
4.7
accreditation body
authoritative body that performs accreditation (7.7)
Note 1 to entry: The authority of an accreditation body can be derived from government, public authorities,
contracts, market acceptance or scheme owners.
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SIST EN ISO/IEC 17000:2020
ISO/IEC 17000:2020(E)
4.8
conformity assessment system
set of rules and procedures (5.2) for the management of similar or related conformity assessment
schemes (4.9)
Note 1 to entry: A conformity assessment system can be operated at an international, regional, national, sub-
national, or industry sector level.
4.9
conformity assessment scheme
conformity assessment programme
set of rules and procedures (5.2) that describes the objects of conformity assessment (4.2), identifies the
specified requirements (5.1) and provides the methodology for performing conformity assessment (4.1)
Note 1 to entry: A conformity assessment scheme can be managed within a conformity assessment system (4.8).
Note 2 to entry: A conformity assessment scheme can be operated at an international, regional, national sub-
national, or industry sector level.
Note 3 to entry: A scheme can cover all or part of the conformity assessment functions explained in Annex A.
4.10
access
access to a scheme
opportunity for an applicant to obtain a conformity assessment (4.1) service from a body under a
conformity assessment scheme (4.9)
4.11
participant
participant in a system
participant in a scheme
person or organization that implements or operates under the rules and procedures (5.2) of a conformity
assessment system (4.8) or scheme (4.9) without being involved in their development, revision or
approval
4.12
member
member of a system
member of a scheme
person or organization that is involved in the development, revision or approval of the rules and
procedures (5.2) of a conformity assessment system (4.8) or scheme (4.9)
4.13
owner
owner of a system
owner of a scheme
system owner
scheme owner
person or organization responsible for the development and maintenance of a conformity assessment
system (4.8) or conformity assessment scheme (4.9)
Note 1 to entry: A scheme owner does not necessarily operate the scheme (4.9).
Note 2 to entry: A system owner or a scheme owner can be a conformity assessment body (4.6) itself, a governmental
authority, a trade association, a group of conformity assessment bodies or others.
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SIST EN ISO/IEC 17000:2020
ISO/IEC 17000:2020(E)
5 Terms related to basic concepts
5.1
specified requirement
need or expectation that is stated
Note 1 to entry: Specified requirements can be stated in normative documents such as regulations, standards
and technical specifications.
Note 2 to entry: Specified requirements can be detailed or general.
5.2
procedure
specified way to carry out an activity or a process
Note 1 to entry: In this context, a process is defined as a set of interrelated or interacting activities that use
inputs to deliver an intended result.
[SOURCE: ISO 9000:2015, 3.4.5, modified — The original Note to entry has been replaced with a new
Note to entry.]
5.3
impartiality
objectivity with regard to the outcome of a conformity assessment activity
Note 1 to entry: Objectivity can be understood as freedom from bias or freedom from conflicts of interest.
5.4
independence
freedom of a person or organization from the control or authority of another person or organization
EXAMPLE A conformity assessment body (4.6) can be independent from the person who is the object of
conformity assessment (4.2) or from the organization providing the object of conformity assessment (4.2).
6 Terms relating to selection and determination
6.1
sampling
selection and/or collection of material or data regarding an object of conformity assessment (4.2)
Note 1 to entry: Selection can be on the basis of a procedure, an automated system, professional judgement etc.
Note 2 to entry: Selection and collection can be performed by the same or different persons or organizations.
6.2
testing
determination of one or more characteristics of an object of conformity assessment (4.2), according to a
procedure (5.2)
Note 1 to entry: The procedure can be intended to control variables within testing as a contribution to the
accuracy or reliability of the results.
Note 2 to entry: The results of testing can be expressed in terms of specified units or objective comparison with
agreed references.
Note 3 to entry: The output of testing can include comments (e.g. opinions and interpretations) about the test
results and fulfilment of specified requirements.
Note 4 to entry: Additional information on the concepts of testing (6.2) and inspection (6.3) is given in A.3.4.
4 © ISO/IEC 2020 – All rights reserved
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SIST EN ISO/IEC 17000:2020
ISO/IEC 17000:2020(E)
6.3
inspection
examination of an object of conformity assessment (4.2) and determination of its conformity with
detailed requirements or, on the basis of professional judgement, with general requirements
Note 1 to entry: Examination can include direct or indirect observations, which can include measurements or the
output of instruments.
Note 2 to entry: Conformity assessment schemes (4.9) or contracts can specify inspection as examination only.
Note 3 to entry: Additional information on the concepts of testing (6.2) and inspection (6.3) is given in A.3.4.
6.4
audit
process for obtaining relevant information about an object of conformity assessment (4.2) and evaluating
it objectively to determine the extent to which specified requirements (5.1) are fulfilled
Note 1 to entry: The specified requirements are defined prior to performing an audit so that the relevant
information can be obtained.
Note 2 to entry: Examples of objects for an audit are management systems, processes, products and services.
Note 3 to entry: For accreditation purposes, the audit process is called “assessment”.
6.5
validation
confirmation of plausibility for a specific intended use or application through the provision of objective
evidence that specified requirements (5.1) have been fulfilled
Note 1 to entry: Validation can be applied to claims to confirm the information declared with the claim regarding
an intended future use.
6.6
verification
confirmation of truthfulness through the provision of objective evidence that specified requirements
(5.1) have been fulfilled
Note 1 to entry: Verification can be applied to claims to confirm the information declared with the claim
regarding events that have already occurred or results that have already been obtained.
6.7
peer assessment
assessment of a body against specified requirements (5.1) by representatives of other bodies in, or
candidates for, an agreement group (9.10)
Note 1 to entry: “Candidates” are included for the situation where a new group is being formed, at which time
there would be no bodies in the group.
Note 2 to entry: The term “peer assessment” is sometimes referred to as “peer evaluation”.
7 Terms relating to review, decision and attestation
7.1
review
consideration of the suitability, adequacy and effectiveness of selection and determination activities,
and the results of these activities, with regard to fulfilment of specified requirements (5.1) by an object
of conformity assessment (4.2)
7.2
decision
conclusion, based on the results of review (7.1), that fulfilment of specified requirements (5.1) has or has
not been demonstrated
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SIST EN ISO/IEC 17000:2020
ISO/IEC 17000:2020(E)
7.3
attestation
issue of a statement, based on a decision (7.2), that fulfilment of specified requirements (5.1) has been
demonstrated
Note 1 to entry: The resulting statement, referred to in this document as a “statement of conformity”, is intended
to convey the assurance that the specified requirements have been fulfilled. Such an assurance does not, of itself,
provide contractual or other legal guarantees.
Note 2 to entry: First-party attestation and third-party attestation are distinguished by the terms declaration
(7.5), certification (7.6) and accreditation (7.7), but there is no corresponding term applicable to second-party
attestation.
7.4
scope of attestation
range or characteristics of objects of conformity assessment (4.2) covered by attestation (7.3)
7.5
declaration
first-party attestation (7.3)
7.6
certification
third-party attestation (7.3) related to an object of conformity assessment (4.2), with the exception of
accreditation (7.7)
7.7
accreditation
third-party attestation (7.3) related to a conformity assessment body (4.6), conveying formal
demonstration of its competence, impartiality (5.3) and consistent operation in performing specific
conformity assessment activities
8 Terms relating to surveillance
8.1
surveillance
systematic iteration of conformity assessment activities as a basis for maintaining the validity of the
statement of conformity
8.2
suspension
temporary restriction of the sta
...
SLOVENSKI SIST EN ISO/IEC 17000
STANDARD
september 2020
Ugotavljanje skladnosti – Slovar in splošna načela
(ISO/IEC 17000:2020, popravljena verzija 2020-12)
Conformity assessment – Vocabulary and general principles
(ISO/IEC 17000:2020, Corrected version 2020-12)
Konformitätsbewertung – Begriffe und allgemeine Grundlagen
(ISO/IEC 17000:2020, korrigierte Fassung 2020-12)
Évaluation de la conformité – Vocabulaire et principes généraux
(ISO/IEC 17000:2020, Version corrigée 2020-12)
Referenčna oznaka
ICS 01.040.03; 03.120.20 SIST EN ISO/IEC 17000:2020 (sl,en,fr,de)
Nadaljevanje na straneh II do III in od 1 do 87
© 2021-12: Slovenski inštitut za standardizacijo. Razmnoževanje ali kopiranje celote ali delov tega dokumenta ni dovoljeno.
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SIST EN ISO/IEC 17000 : 2020
NACIONALNI UVOD
Standard SIST EN ISO/IEC 17000 (sl, en, ne, fr), Ugotavljanje skladnosti – Slovar in splošna načela
(ISO/IEC 17000:2020, popravljena verzija 2020-12), 2020, ima status slovenskega standarda in je
enakovreden evropskemu standardu EN ISO/IEC 17000 (en), Conformity assessment – Vocabulary and
general principles (ISO/IEC 17000:2020, Corrected version 2020-12), 2020.
Ta standard nadomešča SIST EN ISO/IEC 17000:2005.
NACIONALNI PREDGOVOR
Evropski standard EN ISO/IEC 17000:2020 je pripravil Odbor za ugotavljanje skladnosti CASCO v
sodelovanju s tehničnim odborom Evropskega komiteja za standardizacijo CEN/CLC TC 1 "Merila za
ugotavljanje skladnosti", katerega sekretariat vodi BSI.
Slovenski standard SIST EN ISO/IEC 17000:2020 je prevod evropskega standarda EN ISO/IEC
17000:2020. V primeru spora glede besedila slovenskega prevoda v tem standardu je odločilen izvirni
evropski standard v angleškem jeziku. Slovensko izdajo standarda je pripravil SIST/TC UGA
Ugotavljanje skladnosti.
Odločitev za izdajo tega standarda je 15. 7. 2020 sprejel SIST/TC UGA Ugotavljanje skladnosti.
ZVEZA S STANDARDI
S prevzemom tega evropskega standarda veljajo za omejeni namen referenčnih standardov vsi
standardi, navedeni v izvirniku, razen tistih, ki so že sprejeti v nacionalno standardizacijo:
SIST-V ISO/IEC Vodilo 99:2012 (sl,en,fr) Mednarodni slovar za meroslovje – Osnovni in splošni
koncepti ter z njimi povezani izrazi (VIM)
SIST ISO 19600:2016 (sl,en) Sistemi za upravljanje skladnosti – Smernice
SIST EN ISO 9000:2015 (sl,en) Sistemi vodenja kakovosti – Osnove in slovar
(ISO 9000:2015)
SIST EN ISO/IEC 17025:2017 (sl,en) Splošne zahteve za usposobljenost preskuševalnih in
kalibracijskih laboratorijev (ISO/IEC 17025:2017)
SIST EN ISO 19011:2018 (sl,en) Smernice za presojanje sistemov vodenja
(ISO 19011:2018)
OSNOVA ZA IZDAJO STANDARDA
– privzem standarda SIST EN ISO/IEC 17000:2020
PREDHODNA IZDAJA
– SIST EN ISO/IEC 17000:2005 (sl,en), Ugotavljanje skladnosti – Slovar in splošna načela
(enakovreden ISO/IEC 17000:2004)
OPOMBE
– Povsod, kjer se v besedilu standarda uporablja izraz »evropski standard« oziroma »mednarodni
standard«, v SIST EN ISO/IEC 17000:2020 to pomeni »slovenski standard«.
– Nacionalni uvod in nacionalni predgovor nista sestavni del standarda.
II
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SIST EN ISO/IEC 17000 : 2020
– Ta nacionalni dokument je enakovreden EN ISO/IEC 17000:2020 in je objavljen z dovoljenjem
Upravni center CEN-CENELEC
Rue de la Science 23
1040 Bruselj
Belgija
This national document is identical with EN ISO/IEC 17000:2020 and is published with the
permission of
CEN-CENELEC Management Centre
Rue de la Science 23
1040 Brussels
Belgium
III
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SIST EN ISO/IEC 17000 : 2020
IV
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EVROPSKI STANDARD EN ISO/IEC 17000
EUROPEAN STANDARD
NORME EUROPÉENNE
junij 2020
EUROPÄISCHE NORM
ICS 01.040.03; 03.120.20 Nadomešča EN ISO/IEC 17000:2004
Slovenska izdaja
Ugotavljanje skladnosti – Slovar in splošna načela
(ISO/IEC 17000:2020, popravljena verzija 2020-12)
Conformity assessment – Évaluation de la conformité – Konformitätsbewertung – Begriffe
Vocabulary and general principles Vocabulaire et principes généraux und allgemeine Grundlagen
(ISO/IEC 17000:2020, Corrected (ISO/IEC 17000:2020, Version (ISO/IEC 17000:2020, korrigierte
version 2020-12) corrigée 2020-12) Fassung 2020-12)
Ta evropski standard je CEN odobril 2. maja 2020.
Ta evropski standard je bil popravljen in ponovno izdan 9. decembra 2020 pri Upravnem centru
CEN/CENELEC.
Člani CEN in CENELEC morajo izpolnjevati določila notranjih predpisov CEN/CENELEC, s katerimi
je predpisano, da mora biti ta evropski standard brez kakršnih koli sprememb sprejet kot nacionalni
standard. Seznami najnovejših izdaj teh nacionalnih standardov in njihovi bibliografski podatki so
na voljo pri Upravnem centru CEN-CENELEC ali članih CEN in CENELEC.
Ta evropski standard obstaja v treh uradnih izdajah (angleški, francoski in nemški). Izdaje v drugih
jezikih, ki jih člani CEN in CENELEC na lastno odgovornost prevedejo in izdajo ter prijavijo pri
Upravnem centru CEN-CENELEC, veljajo kot uradne izdaje.
Člani CEN in CENELEC so nacionalni organi za standarde in nacionalni elektrotehniški odbori
Avstrije, Belgije, Bolgarije, Cipra, Češke republike, Danske, Estonije, Finske, Francije, Grčije,
Hrvaške, Irske, Islandije, Italije, Latvije, Litve, Luksemburga, Madžarske, Malte, Nemčije,
Nizozemske, Norveške, Poljske, Portugalske, Republike Severna Makedonija, Romunije,
Slovaške, Slovenije, Srbije, Španije, Švedske, Švice, Turčije in Združenega kraljestva.
CEN
Evropski komite za standardizacijo
European Committee for Standardization
Comité Européen de Normalisation
Europäisches Komitee für Normung
CENELEC
Evropski komite za standardizacijo v elektrotehniki
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Electrotechnische Normung
Upravni center CEN-CENELEC:
Rue de la Science 23, B-1040 Bruselj
© 2020 CEN/CENELEC Lastnice avtorskih pravic so vse države članice CEN Ref. št. EN ISO/IEC 17000:2020 E
in CENELEC
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SIST EN ISO/IEC 17000 : 2020
Evropski predgovor European foreword
Ta dokument (EN ISO/IEC 17000:2020) je This document (EN ISO/IEC 17000:2020) has
pripravil tehnični odbor ISO/CASCO "Odbor za been prepared by Technical Committee
ugotavljanje skladnosti" skupaj s tehničnim ISO/CASCO "Committee on confformity
odborom CEN/CLC/JTC 1 "Merila za organe za assessment" in collaboration with Technical
ugotavljanje skladnosti", katerega tajništvo vodi Committee CEN/CLC/JTC 1 "Criteria for
BSI. conformity assessment bodies" the secretariat of
which is held by BSI.
Ta evropski standard mora dobiti status This European Standard shall be given the
nacionalnega standarda bodisi z objavo status of a national standard, either by
istovetnega besedila ali z razglasitvijo publication of an identical text or by
najpozneje do decembra 2020, nasprotujoče endorsement, at the latest by December 2020,
nacionalne standarde pa je treba razveljaviti and conflicting national standards shall be
najpozneje decembra 2020. withdrawn at the latest by December 2020.
Opozoriti je treba na možnost, da so nekateri Attention is drawn to the possibility that some of
elementi tega dokumenta lahko predmet the elements of this document may be the
patentnih pravic. CEN ne prevzema subject of patent rights. CEN shall not be held
odgovornosti za identifikacijo nekaterih ali vseh responsible for identifying any or all such patent
takih patentnih pravic. rights.
Ta dokument nadomešča EN ISO/IEC This document supersedes EN ISO/IEC
17000:2004. 17000:2004.
V skladu z notranjimi predpisi CEN-CENELEC According to the CEN-CENELEC Internal
morajo ta evropski standard obvezno uvesti Regulations, the national standards
nacionalne organizacije za standardizacijo organizations of the following countries are
naslednjih držav: Avstrije, Belgije, Bolgarije, bound to implement this European Standard:
Cipra, Češke republike, Danske, Estonije, Austria, Belgium, Bulgaria, Croatia, Cyprus,
Finske, Francije, Grčije, Hrvaške, Irske, Czech Republic, Denmark, Estonia, Finland,
Islandije, Italije, Latvije, Litve, Luksemburga, Republic of North Macedonia, France,
Madžarske, Malte, Republike Severna Germany, Greece, Hungary, Iceland, Ireland,
Makedonija, Nemčije, Nizozemske, Norveške, Italy, Latvia, Lithuania, Luxembourg, Malta,
Poljske, Portugalske, Romunije, Srbije, Netherlands, Norway, Poland, Portugal,
Slovaške, Slovenije, Španije, Švedske, Švice, Romania, Serbia, Slovakia, Slovenia, Spain,
Turčije in Združenega kraljestva. Sweden, Switzerland, Turkey and the United
Kingdom.
Razglasitvena objava Endorsement notice
Besedilo ISO/IEC 17000:2020, popravljena The text of ISO/IEC 17000:2020, Corrected
verzija 2020-12, je CEN odobril kot EN ISO/IEC version 2020-12 has been approved by CEN as
17000:2020 brez kakršnihkoli sprememb. EN ISO/IEC 17000:2020 without any
modification.
2
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SIST EN ISO/IEC 17000 : 2020
Avant-propos européen Europäisches Vorwort
Le présent document (EN ISO/IEC 17000:2020) Dieses Dokument (EN ISO/IEC 17000:2020)
a été élaboré par le Comité Technique wurde vom Technischen Komitee ISO/CASCO
ISO/CASCO « Comité pour l'évaluation de la „Committee on conformity assessment“ in
conformité » en collaboration avec le Comité Zusammenarbeit mit dem Technischen Komitee
Technique CEN/CLC/JTC 1 « Critères CEN/CLC/JTC 1 „Kriterien für
applicables aux organismes d'évaluation de la Konformitätsbewertungsstellen“ erarbeitet,
conformité » dont le secrétariat est tenu par BSI. dessen Sekretariat von BSI gehalten wird.
La présente Norme européenne devra recevoir Diese Europäische Norm muss den Status einer
le statut de norme nationale, soit par publication nationalen Norm erhalten, entweder durch
d’un texte identique, soit par entérinement, au Veröffentlichung eines identischen Textes oder
plus tard en décembre 2020 et les normes durch Anerkennung bis Dezember 2020, und
nationales en contradiction devront être retirées etwaige entgegenstehende nationale Normen
au plus tard en décembre 2020. müssen bis Dezember 2020 zurückgezogen
werden.
L'attention est appelée sur le fait que certains Es wird auf die Möglichkeit hingewiesen, dass
des éléments du présent document peuvent faire einige Elemente dieses Dokuments
l'objet de droits de propriété intellectuelle ou de Patentrechte berühren können. CEN ist nicht
droits analogues. Le CEN ne saurait être tenu dafür verantwortlich, einige oder alle
responsable de l’identification de tels ou tels diesbezüglichen Patentrechte zu identifizieren.
brevets.
Ce document remplace l’EN ISO/IEC Dieses Dokument ersetzt EN ISO/IEC
17000:2004. 17000:2004.
Selon le règlement intérieur du CEN/CENELEC, Entsprechend der CEN-CENELEC-
les instituts de normalisation nationaux des pays Geschäftsordnung sind die nationalen
suivants sont tenus de mettre cette Norme Normungsinstitute der folgenden Länder
européenne en application: Allemagne, gehalten, diese Europäische Norm zu
Autriche, Belgique, Bulgarie, Chypre, Croatie, übernehmen: Belgien, Bulgarien, Dänemark,
Danemark, Espagne, Estonie, Finlande, France, Deutschland, die Republik Nordmazedonien,
Grèce, Hongrie, Irlande, Islande, Italie, Lettonie, Estland, Finnland, Frankreich, Griechenland,
Lituanie, Luxembourg, Malte, Norvège, Pays- Irland, Island, Italien, Kroatien, Lettland, Litauen,
Bas, Pologne, Portugal, République de Luxemburg, Malta, Niederlande, Norwegen,
Macédoine du Nord, République tchèque, Österreich, Polen, Portugal, Rumänien,
Roumanie, Royaume-Uni, Serbie, Slovaquie, Schweden, Schweiz, Serbien, Slowakei,
Slovénie, Suède, Suisse et Turquie. Slowenien, Spanien, Tschechische Republik,
Türkei, Ungarn, Vereinigtes Königreich und
Zypern.
Notice d’entérinement Anerkennungsnotiz
Le texte de l’ISO/IEC 17000:2020, Version Der Text von ISO/IEC 17000:2020 wurde von
corrigée 2020-12 a été approuvé par le CEN CEN als EN ISO/IEC 17000:2020 ohne
comme EN ISO/IEC 17000:2020 sans aucune irgendeine Abänderung genehmigt.
modification.
3
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SIST EN ISO/IEC 17000 : 2020
VSEBINA Stran CONTENTS Page
Predgovor . 6 Foreword . 6
0 Uvod . 10 0 Introduction .10
1 Področje uporabe . 14 1 Scope .14
2 Zveze s standardi . 14 2 Normative references . 14
3 Izrazi in definicije . 14 3 Terms and definitions . 14
4 Izrazi, povezani z ugotavljanjem skladnosti 4 Terms related to conformity assessment
na splošno . 14 in general . 14
5 Izrazi, povezani z osnovnimi pojmi . 24 5 Terms related to basic concepts . 24
6 Izrazi, povezani z izbiranjem 6 Terms relating to selection and
in ugotavljanjem . 26 determination .26
7 Izrazi, povezani s pregledom, odločitvijo 7 Terms relating to review, decision
in potrditvijo . 30 and attestation . 30
8 Izrazi, povezani z nadzorovanjem . 32 8 Terms relating to surveillance . 32
9 Izrazi, povezani s trgovino in predpisi . 36 9 Terms relating to trade and regulation . 36
Dodatek A (informativni): Načela ugotavljanja Annex A (informative) Principles of conformity
skladnosti . 44 assessment . 44
Dodatek B (informativni): Sorodni izrazi, Annex B (informative) Related terms defined
opredeljeni v drugih standardih . 66 in other standards . 66
Literatura . 84 Bibliography . 84
4
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SIST EN ISO/IEC 17000 : 2020
Sommaire Page Inhalt Seite
Avant-propos . 7 Vorwort . 7
0 Introduction . 11 0 Einleitung . 11
1 Domaine d’application . 15 1 Anwendungsbereich . 15
2 Références normatives . 15 2 Normative Verweisungen . 15
3 Termes et définitions . 15 3 Begriffe . 15
4 Termes relatifs à l’évaluation de la 4 Begriffe zu Konformitätsbewertung
conformité en général . 15 im Allgemeinen . 15
5 Termes relatifs aux concepts 5 Begriffe zu grundlegenden Konzepten . 25
fondamentaux . 25
6 Termes relatifs à la sélection et à 6 Begriffe zu Auswahl und Ermittlung . 27
la détermination . 27
7 Termes relatifs à la revue, à la décision et 7 Begriffe zu Bewertung, Entscheidung
à l’attestation . 31 und Bestätigung . 31
8 Termes relatifs à la surveillance . 33 8 Begriffe zu Überwachung . 33
9 Termes relatifs au commerce et à 9 Begriffe zu Handel und Gesetzgebung . 37
la réglementation . 37
Annexe A (informative) Principes d’évaluation Anhang A (informativ) Grundlagen
de la conformité . 45 der Konformitätsbewertung . 45
Annexe B (informative) Termes connexes Anhang B (informativ) Verwandte Begriffe,
définis dans d’autres normes . 67 die in anderen Normen definiert werden 67
Bibliographie. . 85 Literaturhinweise . 85
5
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SIST EN ISO/IEC 17000 : 2020
Predgovor Foreword
Mednarodna organizacija za standardizacijo ISO (the International Organization for
(ISO) in Mednarodna elektrotehniška komisija Standardization) and IEC (the International
(IEC) tvorita specializiran sistem svetovne Electrotechnical Commission) form the
standardizacije. Nacionalni organi, ki so člani specialized system for worldwide standardization.
ISO ali IEC, sodelujejo pri pripravi mednarodnih National bodies that are members of ISO or IEC
standardov prek tehničnih odborov, ki jih za participate in the development of International
obravnavanje določenih strokovnih področij Standards through technical committees
ustanovi ustrezna organizacija. Tehnični odbori established by the respective organization to deal
ISO in IEC sodelujejo med seboj na področjih, ki with particular fields of technical activity. ISO and
so v njihovem skupnem interesu Pri delu IEC technical committees collaborate in fields of
sodelujejo tudi druge mednarodne, vladne in mutual interest. Other international organizations,
nevladne organizacije, povezane z ISO in IEC. governmental and non-governmental, in liaison
with ISO and IEC, also take part in the work.
Postopki, uporabljeni pri razvoju tega The procedures used to develop this document
dokumenta, in postopki, predvideni za njegovo and those intended for its further maintenance
nadaljnje vzdrževanje, so opisani v Direktivah are described in the ISO/IEC Directives, Part 1.
ISO/IEC, 1. del. Posebna pozornost naj se In particular, the different approval criteria
nameni različnim kriterijem odobritve, potrebnim needed for the different types of document
za različne vrste dokumentov. Ta dokument je bil should be noted. This document was drafted in
pripravljen v skladu z uredniškimi pravili Direktiv accordance with the editorial rules of the
ISO/IEC, 2. del (glej www.iso.org/directives). ISO/IEC Directives, Part 2 (see
www.iso.org/directives).
Opozoriti je treba na možnost, da je lahko nekaj Attention is drawn to the possibility that some of
elementov tega dokumenta predmet patentnih the elements of this document may be the
pravic. ISO in IEC ne prevzemata odgovornosti subject of patent rights. ISO and IEC shall not be
za prepoznavanje katerihkoli ali vseh takih held responsible for identifying any or all such
patentnih pravic. Podrobnosti o morebitnih patent rights. Details of any patent rights
patentnih pravicah, identificiranih med pripravo identified during the development of the
tega dokumenta, bodo navedene v uvodu in/ali document will be in the Introduction and/or on
na seznamu patentnih izjav, ki jih je prejela the ISO list of patent declarations received (see
organizacija ISO (glej www.iso.org/patents), ali www.iso.org/patents) or the IEC list of patent
na seznamu patentnih izjav, ki jih je prejela declarations received (see http://patents.iec.ch).
organizacija IEC (glej http://patents.iec.ch).
Morebitna trgovska imena, uporabljena v tem Any trade name used in this document is
dokumentu, so informacije za uporabnike in ne information given for the convenience of users
pomenijo podpore blagovni znamki. and does not constitute an endorsement.
6
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SIST EN ISO/IEC 17000 : 2020
Avant-propos Vorwort
L'ISO (Organisation internationale de ISO (die Internationale Organisation für
normalisation) et l’IEC (Commission Normung) und IEC (die Internationale
électrotechnique internationale) forment le Elektortechnische Kommission) bilden das auf
système spécialisé de la normalisation die weltweite Normung spezialisierte System.
mondiale. Les organismes nationaux membres Nationale Normungsorganisationen, die
de l'ISO ou de l’IEC participent au Mitglieder von ISO oder IEC sind, beteiligen sich
développement de Normes internationales par an der Entwicklung von Internationlen Normen in
l'intermédiaire des comités techniques créés par Technischen Komitees, die von der jeweiligen
l'organisation concernée afin de s'occuper des Organisation eingerichtet wurden, um
domaines particuliers de l'activité technique. Les spezifische Gebiete technischer Aktivitäten zu
comités techniques de l'ISO et de l’IEC behandeln. Auf Gebieten von beiderseitigem
collaborent dans des domaines d'intérêt Intersse arbeiten die Technischen Komitees von
commun. D'autres organisations internationales, ISO und IEC zusammen. Weitere internationale
gouvernementales et non gouvernementales, en staatliche und nichtstaatliche Organisationen,
liaison avec l'ISO et l’IEC, participent également die in engem Kontakt mit ISO und IEC stehen,
aux travaux. nehmen ebenfalls an der Arbeit teil.
Les procédures utilisées pour élaborer le présent Die Verfahren, die bei der Entwicklung dieses
document et celles destinées à sa mise à jour Dokuments angewendet wurden und die für die
sont décrites dans les Directives ISO/IEC, Partie weitere Pflege vorgesehen sind, werden in den
1. Il convient, en particulier de prendre note des ISO/IEC-Direktiven, Teil 1 beschrieben. Im
différents critères d'approbation requis pour les Besonderen sollten die für die verschiedenen
différents types de documents ISO. Le présentISO-Dokumentarten notwendigen
document a été rédigé conformément aux règles Annahmekriterien beachtet werden. Dieses
de rédaction données dans les Directives Dokument wurde in Übereinstimmung mit den
ISO/IEC, Partie 2 (voir www.iso.org/directives). Gestaltungsregeln der ISO/IEC-Direktiven, Teil
2 erarbeitet (siehe www.iso.org/directives).
L'attention est attirée sur le fait que certains des Es wird auf die Möglichkeit hingewiesen, dass
éléments du présent document peuvent faire einige Elemente dieses Dokuments
l'objet de droits de propriété intellectuelle ou de Patentrechte berühren können. ISO und IEC
droits analogues. L'ISO et l’IEC ne sauraient être sind nicht dafür verantwortlich, einige oder alle
tenues pour responsables de ne pas avoir diesbezüglichen Patentrechte zu identifizieren.
identifié de tels droits de propriété et averti de Details zu allen während der Entwicklung des
leur existence. Les détails concernant les Dokuments identifizierten Patentrechten finden
références aux droits de propriété intellectuelle sich in der Einleitung und/oder in der ISO-Liste
ou autres droits analogues identifiés lors de der erhaltenen Patenterklärungen (siehe
l'élaboration du document sont indiqués dans www.iso.org/patents) oder in der IEC-Liste der
l'Introduction et/ou dans la liste des déclarations erhaltenen Patenterklärungen (siehe
de brevets reçues par l'ISO (voir http://patents.iec.ch).
www.iso.org/brevets) ou dans la liste des
déclarations de brevets reçues par l'IEC (voir
http://patents.iec.ch).
Les appellations commerciales éventuellement Jeder in diesem Dokument verwendete
mentionnées dans le présent document sont Handelsname dient nur zur Unterrichtung der
données pour information, par souci de Anwender und bedeutet keine Anerkennung.
commodité, à l’intention des utilisateurs et ne
sauraient constituer un engagement.
7
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SIST EN ISO/IEC 17000 : 2020
Za razlago prostovoljne narave standardov, For an explanation of the voluntary nature of
pomena specifičnih pojmov in izrazov ISO, standards, the meaning of ISO specific terms
povezanih z ugotavljanjem skladnosti, ter and expressions related to conformity
informacij o tem, kako ISO spoštuje načela assessment, as well as information about ISO's
Svetovne trgovinske organizacije (WTO) v adherence to the World Trade Organization
tehničnih ovirah pri trgovanju (TBT), glej spletno (WTO) principles in the Technical Barriers to
mesto www.iso.org/iso/foreword.html. Trade (TBT) see www.iso.org/iso/foreword.html.
Ta dokument je pripravil odbor ISO za This document was prepared by the ISO
ugotavljanje skladnosti (CASCO). Committee on Conformity Assessment
(CASCO).
Ta druga izdaja razveljavlja in nadomešča prvo This second edition cancels and replaces the
izdajo (ISO/IEC 17000:2004), ki je tehnično first edition (ISO/IEC 17000:2004), which has
revidirana. been technically revised.
Glavne spremembe glede na predhodno The main changes compared to the previous
različico so naslednje: edition are as follows:
‒ dodani so novi izrazi: "predmet ugotavljanja ‒ addition of new terms: "object of conformity
skladnosti" (glej 4.2), "lastnik" (glej 4.13), assessment" (see 4.2), "owner" (see 4.13),
"nepristranskost" (glej 5.3), "neodvisnost" "impartiality" (see 5.3), "independence"
(glej 5.4), "validacija" (glej 6.5), "overitev" (see 5.4), "validation" (see 6.5),
(glej 6.6), "odločitev" (glej 7.2 ), "potek" (glej "verification" (see 6.6), "decision" (see 7.2),
8.4) in "obnova" (glej 8.5); "expiry" (see 8.4) and "restoration" (see
8.5);
‒ sprememba pojmov sistema ugotavljanja ‒ change of concept of conformity
skladnosti; assessment system;
‒ definicija izraza "izdelek" je bila izbrisana iz ‒ deletion of the definition of the term
glavnega dela dokumenta in dodana v "product" from the body of the document
dodatek B; and addition to Annex B;
‒ uredniška revizija dodatka A je omejena na ‒ editorial revision of Annex A limited to
spremembe izrazov in definicij v točkah od changes in the terms and definitions in
4 do 9; Clauses 4 to 9;
‒ razširitev dodatka B. ‒ extension of Annex B.
Uporabnik naj vse povratne informacije ali Any feedback or questions on this document
vprašanja o tem dokumentu posreduje should be directed to the user’s national
nacionalnemu organu za standarde v svoji standards body. A complete listing of these
državi. Celoten seznam teh organov je na voljo bodies can be found at
na spletnem mestu www.iso.org/members.html. www.iso.org/members.html.
Ta popravljena verzija standarda ISO/IEC This corrected version of ISO/IEC 17000:2020
17000:2020 vsebuje spremenjeno navedbo corrects the price indication. The technical
cene. Tehnična vsebina ostaja nespremenjena. content remains unchanged.
8
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SIST EN ISO/IEC 17000 : 2020
Pour une explication de la nature volontaire des Für eine Erläuterung des freiwilligen Charakters
normes, la signification des termes et von Normen, der Bedeutung ISO-spezifischer
expressions spécifiques de l'ISO liés à Begriffe und Ausdrücke in Bezug auf
l'évaluation de la conformité, ou pour toute Konformitätsbewertungen sowie Informationen
information au sujet de l'adhésion de l'ISO aux darüber, wie ISO die Grundsätze der
principes de l’Organisation mondiale du Welthandelsorganisation (WTO, en: World
commerce (OMC) concernant les obstacles Trade Organization) hinsichtlich technischer
techniques au commerce (OTC), voir: Handelshemmnisse (TBT, en: Technical
www.iso.org/iso/avant-propos. Barriers to Trade) berücksichtigt, siehe
www.iso.org/iso/foreword.html.
Le présent document a été élaboré par le comité Dieses Dokument wurde vom ISO Committee on
ISO pour l’évaluation de la conformité (CASCO). Conformity Assessment (CASCO) erarbeitet.
Cette deuxième édition annule et remplace la Diese zweite Ausgabe ersetzt die erste Ausgabe
première édition (ISO/IEC 17000:2004), qui a fait (ISO/IEC 17000:2004), die technisch überarbeitet
l’objet d’une révision technique. wurde.
Les principales modifications par rapport à Diese zweite Ausgabe ersetzt die erste Ausgabe
l’édition précédente sont les suivantes: (ISO/IEC 17000:2004), die technisch überarbeitet
wurde.
‒ ajout de nouveaux termes: "objet de ‒ Ergänzung um neue Begriffe: "Gegenstand
l’évaluation de la conformité" (voir 4.2), der Konformitätsbewertung" (siehe 4.2),
"propriétaire" (voir 4.13), "impartialité" (voir "Eigentümer" (siehe 4.13),
5.3), "indépendance" (voir 5.4), "validation" "Unparteilichkeit" (siehe 5.3),
(voir 6.5), "vérification" (voir 6.6), "décision" "Unabhängigkeit" (siehe 5.4), "Validierung"
(voir 7.2), "expiration" (voir 8.4) et (siehe 6.5), "Verifizierung" (siehe 6.6),
"restauration" (voir 8.5); "Entscheidung" (siehe 7.2), "Ablauf" (siehe
8.4) und "Wiederherstellung" (siehe 8.5);
‒ modification du concept de système ‒ Änderung des Konzepts eines
d’évaluation de la conformité; Konformitätsbewertungssystems;
‒ suppression de la définition du terme ‒ Streichung der Definition des Begriffs
"produit" du corps du document et ajout à "Produkt" aus dem Dokumententext und
l’Annexe B; dessen Hinzufügung in Anhang B;
‒ révision rédactionnelle de l’Annexe A ‒ redaktionelle Überarbeitung von Anhang A
limitée aux modifications apportées aux und Beschränkung auf Änderungen der
termes et définitions des Articles 4 à 9; Begriffe in Abschnitt 4 bis Abschnitt 9;
‒ extension de l’Annexe B. ‒ Erweiterung von Anhang B.
Il convient que l’utilisateur adresse tout retour Rückmeldungen oder Fragen zu diesem
d’information ou toute question concernant le Dokument sollten an das jeweilige nationale
présent document à l’organisme national de Normungsinstitut des Anwenders gerichtet
normalisation de son pays. Une list
...
SLOVENSKI STANDARD
oSIST prEN ISO/IEC 17000:2019
01-junij-2019
8JRWDYOMDQMHVNODGQRVWL±6ORYDULQVSORãQDQDþHOD ,62,(&',6
Conformity assessment - Vocabulary and general principles (ISO/IEC DIS 17000)
Évaluation de la conformité - Vocabulaire et principes généraux (ISO/IEC DIS 17000)
Ta slovenski standard je istoveten z: prEN ISO/IEC 17000
ICS:
01.040.03 Storitve. Organizacija Services. Company
podjetja, vodenje in kakovost. organization, management
Uprava. Transport. and quality. Administration.
Sociologija. (Slovarji) Transport. Sociology.
(Vocabularies)
03.120.20 Certificiranje proizvodov in Product and company
podjetij. Ugotavljanje certification. Conformity
skladnosti assessment
oSIST prEN ISO/IEC 17000:2019 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
oSIST prEN ISO/IEC 17000:2019
---------------------- Page: 2 ----------------------
oSIST prEN ISO/IEC 17000:2019
DRAFT INTERNATIONAL STANDARD
ISO/IEC DIS 17000
ISO/CASCO Secretariat: ISO
Voting begins on: Voting terminates on:
2019-04-05 2019-06-28
Conformity assessment — Vocabulary and general
principles
Évaluation de la conformité — Vocabulaire et principes généraux
ICS: 01.040.03; 03.120.20
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
This draft is submitted to a parallel vote in ISO and in IEC.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
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Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Terms and definitions . 1
2.1 Terms relating to conformity assessment in general . 1
2.2 Basic terms . 3
2.3 Conformity assessment terms relating to selection and determination . 4
2.4 Conformity assessment terms relating to review, decision and attestation . 5
2.5 Conformity assessment terms relating to surveillance. 6
2.6 Terms relating to trade and regulation . 7
Annex A (informative) Principles of conformity assessment . 9
Annex B (informative) Related terms defined in other documents .14
Annex C (informative) Concept diagrams .21
Bibliography .28
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Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
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 www .iso .org/directives).
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. 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 www .iso .org/patents).
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.
This document was prepared by the ISO Committee on Conformity Assessment (CASCO).
This second edition cancels and replaces ISO/IEC 17000:2004.
The main changes compared to the previous edition are as follows:
— addition of new terms: object of conformity assessment (2.2.1), validation (2.3.5), and verification
(2.3.6),
— deletion of the term product from the body of the document and addition to the Annex B (Related
terms defined in other documents),
— extension of the Annex B,
— editorial revision of Annex A (Functional Approach) limited to changes that reflect the changes to
the normative content of ISO/IEC 17000.
— addition of an informative Annex C, showing the relationship between the concepts of ISO/IEC 17000.
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Introduction
0.1 Terms and definitions applicable to conformity assessment
International Standards and other publications relating to conformity assessment activities such
as testing, inspection and various forms of certification are prepared by working groups of the ISO
Committee on conformity assessment (CASCO). For many years, ISO/IEC Guide 2 included a core
vocabulary for conformity assessment, built up from a small number of terms and definitions first
compiled to facilitate communication and understanding about product certification based on
standards for traditional manufactured goods.
In 2000, CASCO decided to take conformity assessment terminology out of ISO/IEC Guide 2 and provide
instead a self-contained vocabulary more readily applicable within the planned ISO/IEC 17000 series
of standards and in the drafting or revision of related guides. CASCO Working Group 5, Definitions,
produced the first edition of this document in 2004 in consultation with other active CASCO working
groups, as a consistent framework within which more specific concepts may be defined appropriately
and denoted by the most appropriate terms. Extra concepts unique to particular activities such as
accreditation, certification of persons and use of marks of conformity, are found in the International
Standards or other documents related to those activities and are not included in this document.
In 2017, CASCO WG49 was convened to revise ISO/IEC 17000:2004, retaining the framework of the
functional approach described in Annex A.
Conformity assessment interacts with other fields such as management systems, metrology,
standardization and statistics. This document does not define the boundaries of conformity assessment.
These remain elastic.
0.2 Terms and definitions applicable to trade policy
Clause 7 includes some terms and definitions for several broader concepts. These are intended not only
to standardize usage within the conformity assessment community, but also to help policy makers
concerned with the facilitation of trade within regulatory and international treaty frameworks.
0.3 A functional approach to conformity assessment
The terms and definitions specified in this document, particularly under Clauses 4 and 5, reflect the
adoption by CASCO in November 2001 of the functional approach.
To provide a better understanding of the defined concepts, their grouping and their relationships, a
description of the functional approach is included in Annex A for information.
0.4 Selection of terms and definitions
Some of the terms included in this document relate to concepts that are considered essential to define.
Others it was thought helpful to explain. Many of the general terms used to distinguish conformity
assessment concepts are used in common language in a broader sense or with a wider range of
meanings. Some also appear in other standard vocabularies with definitions specific to the relevant
field of application.
An alphabetical index lists the terms defined in this document. Standards defining other relevant terms
are given in Annex B with separate alphabetical lists. First are terms applicable to specific aspects of
conformity assessment, as defined in other standards in the ISO/IEC 17000 series. Second are terms
for which definitions published outside the ISO/IEC 17000 series are generally applicable in conformity
assessment contexts.
0.5 Conformity and compliance
This document does not include a definition of “conformity” on the grounds that it is not necessary
to do so. “Conformity” does not feature in the definition of “conformity assessment”. The concept of
“conformity assessment” is concerned with “fulfilment of specified requirements”, not with the wider
concept of “conformity”. A definition of the term “specified requirement” (2.2.1) is included. In English,
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the term “compliance” is used to distinguish the action of doing what is required (e.g. an organization
“complies” by making something conform or by fulfilling a regulatory requirement).
For the purposes of research, users are encouraged to share their views on this document and their
priorities for changes to future editions. Click on the link below to take part in the online survey:
17000_ed2_usersurvey
(Add the link to the survey after DIS)
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Conformity assessment — Vocabulary and general
principles
1 Scope
This document specifies general terms and definitions relating to conformity assessment, including the
accreditation of conformity assessment bodies, and to the use of conformity assessment to facilitate
trade. A description of the functional approach to conformity assessment is included in Annex A, as a
further aid to understanding among users of conformity assessment, conformity assessment bodies
and accreditation bodies, in both voluntary and regulatory environments.
This document does not set out to provide a vocabulary for all of the concepts that may need to be used
in describing particular conformity assessment activities. Terms and definitions are given only where
the concept defined would not be understandable from the general language use of the term, or where
an existing standard definition is not applicable.
NOTE 1 The notes appended to certain definitions offer clarification or examples to facilitate understanding
of the concepts described. In certain cases, the notes may differ in different languages for linguistic reasons, or
additional notes may be given.
NOTE 2 The terms and definitions are laid out in a systematic order, with an alphabetical index. A term in
a definition or note that is defined in another entry is indicated by bold-face followed by its entry number in
parentheses. Such terms may be replaced by their complete definition.
2 Terms and definitions
2.1 Terms relating to conformity assessment in general
2.1.1
conformity assessment
demonstration that specified requirements (2.2.1) are fulfilled
Note 1 to entry: The process of conformity assessment as described in the functional approach in the Annex A
can have a negative outcome.
Note 2 to entry: The field of conformity assessment includes activities defined elsewhere in this document, such
as but not limited to testing (2.3.2), inspection (2.3.3), validation (2.3.5), verification (2.3.6) and certification
(2.4.6), as well as the accreditation (2.4.7) of conformity assessment bodies (2.1.6)
Note 3 to entry: Conformity assessment is explained in Annex A as a series of functions. Tasks contributing to any
of these functions may be described as conformity assessment activities.
2.1.2
object of conformity assessment
object
entity to which specified requirements (2.2.1) apply
Note 1 to entry: Examples are product, process, service, system, installation, project, data, design, material,
claim, person, body or organization or any combination thereof.
Note 2 to entry: The term “body” is used in this document to refer to conformity assessment bodies (2.1.6) and
accreditation bodies (2.1.7). The term “organization” is used in its general meaning and may include bodies
according to the context. The more specific ISO/IEC Guide 2 definition of an organization as a body based on
membership is not applicable to the field of conformity assessment (2.1.1).
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2.1.3
first-party conformity assessment activity
conformity assessment activity that is performed by the person or organization that provides or that is
the object of conformity assessment (2.1.2)
Note 1 to entry: The first-, second- and third-party descriptors used to characterize conformity assessment
activities in relation to a given object are not to be confused with the legal identification of the relevant parties
to a contract.
Note 2 to entry: Examples include activities performed by providers, designers or owners of the object, investors
in the object, and advertisers or promoters of the object.
Note 3 to entry: If a first party activity is performed not by the person or organization itself but by an external
body, this is still called first party provided that the external body is acting on behalf of or under the control
of that person or organization (e.g. internal audits performed by a consultant who is not part of the staff of the
organization.
2.1.4
second-party conformity assessment activity
conformity assessment activity that is performed by a person or organization that has a user interest in
the object of conformity assessment (2.1.2)
Note 1 to entry: Persons or organizations performing second-party conformity assessment activities include,
for example, purchasers or users of products, or potential customers seeking to rely on a supplier's management
system, or organizations representing those interests. Examples of organizations representing user interest
include consumer advocacy organizations, regulators implementing legislation governing products and services
for the protection of consumer and public interests, centralized government procurement organizations and
private sector purchasing agents.
Note 2 to entry: If a second party activity is performed not by the person or organization itself but by an external
body, this is still called second party provided that the external body is acting on behalf of or under the control of
that person or organization (e.g. supply chain audits conducted by an external body on behalf of the purchaser).
2.1.5
third-party conformity assessment activity
conformity assessment activity that is performed by a person or organization that is not the provider of
the object (2.1.2) and has no user interest in the object
2.1.6
conformity assessment body
body that performs conformity assessment activities, excluding accreditation (2.4.7)
2.1.7
accreditation body
body that performs accreditation (2.4.7)
2.1.8
conformity assessment system
set of common rules and procedures for the management of similar or related conformity assessment
schemes (2.1.9)
Note 1 to entry: A conformity assessment system may be operated at an international, regional, national, sub-
national, or industry sector level.
2.1.9
conformity assessment scheme
conformity assessment programme
set of rules and procedures (2.2.2) that describes the objects of conformity assessment (2.1.2), identifies the
specified requirements (2.2.1) and provides the methodology for performing conformity assessment (2.1.1)
Note 1 to entry: A conformity assessment scheme may operate within a conformity assessment system (2.1.8).
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Note 2 to entry: A conformity assessment scheme may be operated at an international, regional, national sub-
national, or industry sector level.
Note 3 to entry: to entry:A scheme can cover part or all of the conformity assessment functions explained in
Annex A.
2.1.10
access
access to a system or scheme
opportunity for an applicant to obtain conformity assessment (2.1.1) under the rules of a system (2.1.8)
or scheme (2.1.9)
2.1.11
participant
participant in a system or scheme
person or organization that operates under the applicable rules without having the opportunity to take
part in the management of the system (2.1.8) or scheme (2.1.9)
2.1.12
member
member of a system or scheme
person or organization that operates under the applicable rules and has the opportunity to take part in
the management of the system (2.1.8) or scheme (2.1.9)
2.1.13
owner
owner of a system or scheme
system owner, scheme owner
person or organization responsible for the development and maintenance of a system (2.1.8) or
scheme (2.1.9)
Note 1 to entry: A scheme owner does not necessarily operate the scheme (2.1.9) .
Note 2 to entry: A system or scheme owner can be a conformity assessment body (2.1.6) itself, a governmental
authority, a trade association, a group of conformity assessment bodies or others.
2.2 Basic terms
2.2.1
specified requirement
need or expectation that is stated
Note 1 to entry: Specified requirements may be stated in normative documents such as regulations, standards
and technical specifications.
Note 2 to entry: Specified requirements can be detailed or general.
2.2.2
procedure
specified way to carry out an activity or a process
Note 1 to entry: ISO 9000:2015 defines a process as a set of interrelated or interacting activities that use inputs
to deliver an intended result.
[SOURCE: ISO 9000:2015, 3.2.3.5 modified — Note 1 to entry added.]
2.2.3
impartiality
objectivity with regard to the outcome of a conformity assessment activity
Note 1 to entry: Objectivity can be understood as freedom from bias or freedom from conflicts of interest.
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2.2.4
independence
freedom of a person or organization from the control or authority of another person or organization
Note 1 to entry: For example a conformity assessment body (2.1.6) can be independent from the person who is the
object of conformity assessment (2.1.2) or from the organization providing the object of conformity assessment.
2.3 Conformity assessment terms relating to selection and determination
(see Figure A.1)
2.3.1
sampling
selection of a sample of the object of conformity assessment (2.1.2), according to a procedure (2.2.2)
2.3.2
testing
determination of one or more characteristics of an object of conformity assessment (2.1.2), according to
a procedure (2.2.2)
Note 1 to entry: For additional information on the concepts of testing (2.3.2) and inspection (2.3.3) see A.2.2.4.
Note 2 to entry: The procedure can be intended to control variables within testing as a contribution to the
accuracy or reliability of the results.
Note 3 to entry: The output of testing can include comments (e.g. opinions and interpretations) about the test
results and fulfilment of specified requirements.
2.3.3
inspection
examination of an object of conformity assessment (2.1.2) and determination of its conformity with
detailed requirements or, on the basis of professional judgement, with general requirements
Note 1 to entry: For additional information on the concepts of testing (2.3.2) and inspection (2.3.3) see A.2.2.4.
Note 2 to entry: Procedures or schemes can restrict inspection to examination only.
2.3.4
audit
process for obtaining relevant information about an object of conformity assessment (2.1.2) and
evaluating it objectively to determine the extent to which specified requirements (2.2.1) are fulfilled
Note 1 to entry: The specified requirements are defined prior to performing an audit so that the relevant
information can be obtained.
Note 2 to entry: Examples of objects of conformity assessment for an audit are management systems, processes
or products.
Note 3 to entry: For accreditation purposes, the audit process is called assessment (ISO/IEC 17011:2017,
clause 3.22).
2.3.5
validation
confirmation of plausibility for a specific intended use or application, through the provision of objective
evidence that specified requirements (2.2.1) have been fulfilled
Note 1 to entry: Validation can be applied to claims to confirm the information declared with the claim regarding
an intended future use.
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2.3.6
verification
confirmation of truthfulness, through the provision of objective evidence that specified requirements
(2.2.1) have been fulfilled
Note 1 to entry: Verification can be applied to claims to confirm the information declared with the claim
regarding events that have already occurred or results that have already been obtained.
2.3.7
peer assessment
assessment of a body against specified requirements (2.2.1) by representatives of other bodies in, or
candidates for, an agreement group (2.6.10)
Note 1 to entry: “Candidates” are included for the situation where a new group is being formed, at which time
there would be no bodies in the group.
Note 2 to entry: The term "peer assessment" is sometimes referred to as "peer evaluation".
2.4 Conformity assessment terms relating to review, decision and attestation
(see Figure A.1)
2.4.1
review
consideration of the suitability, adequacy and effectiveness of selection and determination activities,
and the results of these activities, with regard to fulfilment of specified requirements (2.2.1) by an object
of conformity assessment (2.1.2).
2.4.2
decision
conclusion based on the results of review (2.4.1), that fulfilment of specified requirements (2.2.1) has or
has not been demonstrated
2.4.3
attestation
issue of a statement, based on a decision (2.4.2) that fulfilment of specified requirements (2.2.1) has been
demonstrated
Note 1 to entry: The resulting statement, referred to in this document as a “statement of conformity”, is intended
to convey the assurance that the specified requirements have been fulfilled. Such an assurance does not, of itself,
afford contractual or other legal guarantees.
Note 2 to entry: First-party and third-party attestations are distinguished by the terms 2.4.2 to 2.4.7. For second-
party attestation, no such term is available.
2.4.4
scope of attestation
range or characteristics of objects of conformity assessment (2.1.2) covered by attestation (2.4.3)
2.4.5
declaration
first-party attestation (2.4.3)
2.4.6
certification
third-party attestation (2.4.3) related to objects of conformity assessment (2.1.2), with the exception of
conformity assessment bodies (2.1.6)
Note 1 to entry: Certification is applicable to all objects of conformity assessment except for conformity
assessment bodies themselves, to which accreditation (2.1.7) is applicable.
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2.4.7
accreditation
third-party attestation (2.4.3) related to a conformity assessment body (2.1.6) conveying formal
demonstration of its competence, consistent operation and impartiality (2.2.3) in performing specific
conformity assessment activities
2.5 Conformity assessment terms relating to surveillance
(see Figure A.1)
2.5.1
surveillance
systematic iteration of conformity assessment activities as a basis for maintaining the validity of the
statement of conformity
2.5.2
suspension
temporary restriction of the statement of conformity by the body that issued the statement, for all or
part of the specified scope of attestation (2.4.4)
EXAMPLES:
— The issuing body may suspend the statement of conformity because the specified requirements are
no longer fulfilled.
— The client of the issuing body may voluntarily request suspension of the statement of conformity.
— The issuing body may need to suspend the statement of conformity because it temporarily ceases to
perform that type of conformity assessment activity.
2.5.3
withdrawal
cancellation
revocation of the statement of conformity by the body that issued the statement
EXAMPLES:
— The issuing body may withdraw the statement of conformity because the specified requirements
are no longer fulfilled.
— The client of the issuing body may voluntarily request withdrawal of the statement of conformity.
— The issuing body may need to withdraw or transfer the statement of conformity because it ceases
to perform that type of conformity assessment activity.
2.5.4
expiry
ending of the validity of the statement of conformity after a specified period
2.5.5
restoration
reinstatement of the full or partial statement of conformity following a suspension
2.5.6
appeal
request by the provider of the object of conformity assessment (2.1.2) to the conformity assessment body
(2.1.6) or accreditation body (2.1.7) for reconsideration by that body of a decision (2.4.2) it has made
relating to that object
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2.5.7
complaint
expression of dissatisfaction, other than appeal (2.5.6), by any person or organization to a conformity
assessment body (2.1.6) or accreditation body (2.1.7), relating to the activities of that body, where a
response is expected
2.6 Terms relating to trade and regulation
2.6.1
approval
permission for a product, service or process to be marketed or used for stated purposes or under stated
conditions
Note 1 to entry: Approval can be based on fulfilment of specified requirements or completion of specified
procedures
Note 2 to entry: Approval can be given in the context of a conformity assessment scheme.
2.6.2
designation
governmental authorization of a conformity assessment body (2.1.6) to perform specified conformity
assessment activities
Note 1 t
...
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