ISO/FDIS 10012

ISO/DIS FDIS 10012:2024(en)
ISO/TC 176/SC 3/WG 27
Secretariat: SA
Date: 2024-12-172025-10-01
Quality management — Requirements for measurement
management systems
Management de la qualité — Exigences pour les systèmes de management de la mesure
FDIS stage
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Published in Switzerland
ii
Contents
Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Context of the organization . 6
4.1 Understanding the organization and its context . 6
4.2 Understanding the needs and expectations of interested parties . 7
4.3 Determining the scope of the measurement management system . 7
4.4 Measurement management system . 7
5 Leadership . 9
5.1 Leadership and commitment . 9
5.2 Measurement management policy . 9
5.3 Roles, responsibilities and authorities . 10
5.4 Customer focus . 10
6 Planning . 10
6.1 Actions to address risks and opportunities . 10
6.2 Measurement management objectives and planning to achieve them . 11
6.3 Planning of changes . 12
7 Support . 12
7.1 Resources . 12
7.2 Competence . 13
7.3 Awareness . 13
7.4 Communication . 14
7.5 Documented information . 14
8 Operation . 16
8.1 Operational planning and control . 16
8.2 Requirements for measurement processes . 17
8.3 Design and development of measurement processes . 18
8.4 Control of externally provided measurement processes, products and services . 25
8.5 Measurement process implementation . 27
8.6 Release of measurement process results . 31
8.7 Control of nonconforming outputs . 32
9 Performance evaluation . 33
9.1 Monitoring, measurement, analysis, and evaluation . 33
9.2 Internal audit . 34
9.3 Management review . 35
10 Improvement . 36
10.1 Continual improvement . 36
10.2 Nonconformity and corrective action . 36
Annex A (informative) Calibration intervals optimization . 38
Annex B (informative) Measurement uncertainty . 44
Annex C (informative) Measurement decision risk and rules . 46
Bibliography . 51

iii
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
ISO 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights
in respect thereof. As of the date of publication of this document, ISO had not received notice of (a) patent(s)
which may be required to implement this document. However, implementers are cautioned that this may not
represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
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 Technical Committee ISO/TC 176, Quality management and quality assurance,
Subcommittee SC 3, Supporting technologies, in collaboration with the European Committee for
Standardization (CEN) Technical Committee CEN/SS F20, Quality assurance, in accordance with the
Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (ISO 10012:2003), which has been restructured to
follow the Harmonized Structure for Management System Standards and clauses have been extensively
revised in response to stakeholder needstechnically revised.
The main changes are as follows:
— the document has been restructured to follow the harmonized structure for management system
standards;
— the clauses have been extensively revised in response to the needs of interested parties.
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
Introduction
This International standarddocument assists organizations who have or would like to implement
a measurement management system, by providing the necessary framework for an organization in designing,
maintaining and continually improving a measurement management system.
This is a major revision of ISO 10012:2003 international standard, whose purpose is to establish the basis for
an organization to implement and improve a measurement management system for end-to-end application of
measurement processes in the organization (see Figure 1).
The main objective of a measurement management system is to provide confidence in the validity and
reliability of the measurement results and ensure capability to supportingsupport the measurement of the
organization’s delivered products and/or services at the required quality level. This includes managing the
risk associated with measurement processes that couldcan produce incorrect measurement results affecting
the quality of an organization’s products and/or services.
A measurement management system can be implemented in the design and development, test, monitoring
and delivering of valid measurement results. It also provides an organization with the basis to demonstrate
conformity to measurement management system requirements.
This document can be used by any industrial sectors requiring a measurement management system, and is
complementary to the requirements of ISO 9001, ISO 14001 or other management system standards.
The implementation of a management system for confirmation of validity of measurements is an important
decision for an organization to establish a robust measurement management system that will provide a
consistent level of measurement quality for an organization’sits products and services.
v
Quality management — Requirements for measurement management
systems
1 Scope
This document specifies the requirements for a measurement management system when an organization:
a) needs to demonstrate its ability to consistently ensure confidence in validity and reliability of
measurement results and thereby to provide a consistent level of measurement quality for an
organization’s products and services;
b) aims to rely on reliable and valid measurement results useful to enhance customer satisfaction and
effectively apply its measurement management system processes;
c) implements processes for a measurement management system that enhance conformity with customer,
statutory and regulatory requirements.
All the requirements of this document are generic. This document is applicable to any organization, regardless
of its type or size, or the products and services it provides. This includes those organizations manufacturing
products, and providing engineering services (except for calibration and test services included within the
scope of ISO/IEC 17025).
This document is not intended to substitute requirements for, or to add requirements to, the general
requirements for the competence of testing and calibration laboratories specified in ISO/IEC 17025.
NOTE For organizations that operate internal testing and calibration laboratories, the competence of those functions
can be evaluated in accordance with ISO/IEC 17025.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 9000, Quality management systems — Fundamentals and vocabulary
ISO 17034, General requirements for the competence of reference material producers
ISO/IEC Guide 99, International vocabulary of metrology — Basic and
...

PROJET FINAL
Norme
internationale
ISO/TC 176/SC 3
Management de la qualité —
Secrétariat: SA
Exigences pour les systèmes de
Début de vote:
management de la mesure
2025-10-15
Quality management — Requirements for measurement
Vote clos le:
management systems
2025-12-10
LES DESTINATAIRES DU PRÉSENT PROJET SONT
INVITÉS À PRÉSENTER, AVEC LEURS OBSERVATIONS,
NOTIFICATION DES DROITS DE PROPRIÉTÉ DONT ILS
AURAIENT ÉVENTUELLEMENT CONNAISSANCE ET À
FOURNIR UNE DOCUMENTATION EXPLICATIVE.
OUTRE LE FAIT D’ÊTRE EXAMINÉS POUR
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INDUSTRIELLES, TECHNOLOGIQUES ET COM-MERCIALES,
AINSI QUE DU POINT DE VUE DES UTILISATEURS, LES
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NORMES POUVANT
SERVIR DE RÉFÉRENCE DANS LA RÉGLEMENTATION
NATIONALE.
Numéro de référence
PROJET FINAL
Norme
internationale
ISO/TC 176/SC 3
Management de la qualité —
Secrétariat: SA
Exigences pour les systèmes de
Début de vote:
management de la mesure
2025-10-15
Quality management — Requirements for measurement
Vote clos le:
management systems
2025-12-10
LES DESTINATAIRES DU PRÉSENT PROJET SONT
INVITÉS À PRÉSENTER, AVEC LEURS OBSERVATIONS,
NOTIFICATION DES DROITS DE PROPRIÉTÉ DONT ILS
AURAIENT ÉVENTUELLEMENT CONNAISSANCE ET À
FOURNIR UNE DOCUMENTATION EXPLICATIVE.
DOCUMENT PROTÉGÉ PAR COPYRIGHT
OUTRE LE FAIT D’ÊTRE EXAMINÉS POUR
ÉTABLIR S’ILS SONT ACCEPTABLES À DES FINS
© ISO 2025 INDUSTRIELLES, TECHNOLOGIQUES ET COM-MERCIALES,
AINSI QUE DU POINT DE VUE DES UTILISATEURS, LES
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SERVIR DE RÉFÉRENCE DANS LA RÉGLEMENTATION
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Publié en Suisse Numéro de référence
ii
Sommaire Page
Avant-propos .v
Introduction .vi
1 Domaine d’application . 1
2 Références normatives . 1
3 Termes et définitions . 1
4 Contexte de l’organisme . 6
4.1 Comprendre l’organisme et son contexte .6
4.2 Comprendre les besoins et attentes des parties intéressées .6
4.3 Déterminer le domaine d’application du système de management de la mesure .7
4.4 Système de management de la mesure .7
5 Leadership . 8
5.1 Leadership et engagement .8
5.2 Politique de management de la mesure .8
5.3 Rôles, responsabilités et autorités au sein de l’organisme .8
5.4 Orientation client .9
6 Planification. 9
6.1 Actions pour traiter les risques et opportunités .9
6.2 Objectifs du management de la mesure et planification pour les atteindre .10
6.3 Planification des modifications .10
7 Support .11
7.1 Ressources .11
7.1.1 Généralités .11
7.1.2 Personnel . .11
7.1.3 Installations et conditions ambiantes .11
7.1.4 Moyen de mesure .11
7.1.5 Connaissances organisationnelles .11
7.2 Compétence . 12
7.3 Sensibilisation . 12
7.4 Communication . 13
7.5 Informations documentées . 13
7.5.1 Généralités . 13
7.5.2 Création et mise à jour des informations documentées .14
7.5.3 Maîtrise des informations documentées .14
8 Réalisation . 14
8.1 Planification et maîtrise . .14
8.1.1 Généralités .14
8.1.2 Management du risque opérationnel . 15
8.2 Exigences relatives aux processus de mesure . 15
8.2.1 Généralités . 15
8.2.2 Communication avec les clients .16
8.2.3 Détermination des exigences relatives aux processus de mesure .16
8.2.4 Revue des exigences des clients en matière de processus de mesure .16
8.2.5 Modifications des exigences relatives aux processus de mesure .17
8.3 Conception et développement de processus de mesure .17
8.3.1 Généralités .17
8.3.2 Planification de la conception et du développement .17
8.3.3 Éléments d’entrée de la conception et du développement .18
8.3.4 Maîtrise de la conception et du développement .19
8.3.5 Éléments de sortie de la conception et du développement .21
8.3.6 Modifications de la conception et du développement . 23
8.4 Maîtrise des processus de mesure réalisés, des produits fournis et des services assurés
par des prestataires externes . 23

iii
8.4.1 Généralités . 23
8.4.2 Type et étendue de la maîtrise .24
8.4.3 Informations à l’attention des prestataires externes .24
8.5 Mise en œuvre des processus de mesure . 25
8.5.1 Maîtrise des processus de mesure . 25
8.5.2 Identification et traçabilité .27
8.5.3 Propriété des clients ou des prestataires externes . 28
8.5.4 Préservation . 28
8.5.5 Activités après livraison relatives au processus de mesure . 28
8.5.6 Maîtrise des modifications . 29
8.6 Communication des résultats du processus de mesure . 29
8.6.1 Dispositions prévues pour la communication des résultats . 29
8.6.2 Informations documentées relatives à la communication des résultats . 29
8.7 Maîtrise des éléments de sortie non conformes . 30
8.7.1 Traitement des éléments de sortie non conformes . 30
8.7.2 Informations documentées .
...