ISO 10012
(Main)Quality management — Requirements for measurement management systems
Quality management — Requirements for measurement management systems
ISO 10012:2003 specifies generic requirements and provides guidance for the management of measurement processes and metrological confirmation of measuring equipment used to support and demonstrate compliance with metrological requirements. It specifies quality management requirements of a measurement management system that can be used by an organization performing measurements as part of the overall management system, and to ensure metrological requirements are met. ISO 10012:2003 is not intended to be used as a requisite for demonstrating conformance with ISO 9001, ISO 14001 or any other standard. Interested parties can agree to use ISO 10012:2003 as an input for satisfying measurement management system requirements in certification activities. Other standards and guides exist for particular elements affecting measurement results, for example, details of measurement methods, competence of personnel, interlaboratory comparisons. ISO 10012:2003 is not intended as a substitute for, or as an addition to, the requirements of ISO/IEC 17025.
Management de la qualité — Exigences pour les systèmes de management de la mesure
L'ISO 10012:2003 est destinée à fournir des exigences génériques et des guides d'application pour le management des processus de mesure et pour la confirmation des équipements de mesure utilisés pour démontrer la conformité aux exigences métrologiques. Elle spécifie les exigences qualité relatives au système de management de la mesure qu'un organisme effectuant des mesures peut utiliser et intégrer dans le cadre du système de management global et qui est destiné à garantir que les exigences métrologiques sont satisfaites. L'ISO 10012:2003 n'est pas destinée à être requise pour démontrer la conformité avec l'ISO 9001, avec l'ISO 14001 ou avec toute autre norme. Les parties intéressées peuvent convenir d'utiliser la présente Norme internationale comme point d'entrée à la satisfaction des exigences relatives au système de management de la mesure dans des activités de certification. L'ISO 10012:2003 n'est destinée ni à être substituée ni à être ajoutée aux exigences de l'ISO/IEC 17025.
Sistemi vodenja meritev – Zahteve za procese merjenja in merilno opremo
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Standards Content (Sample)
FINAL DRAFT
International
Standard
ISO/FDIS 10012
ISO/TC 176/SC 3
Quality management —
Secretariat: SA
Requirements for measurement
Voting begins on:
management systems
2025-10-15
Management de la qualité — Exigences pour les systèmes de
Voting terminates on:
management de la mesure
2025-12-10
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Reference number
ISO/FDIS 10012:2025(en) © ISO 2025
FINAL DRAFT
ISO/FDIS 10012:2025(en)
International
Standard
ISO/FDIS 10012
ISO/TC 176/SC 3
Quality management —
Secretariat: SA
Requirements for measurement
Voting begins on:
management systems
Management de la qualité — Exigences pour les systèmes de
Voting terminates on:
management de la mesure
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
© ISO 2025
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
ISO/CEN PARALLEL PROCESSING
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
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Published in Switzerland Reference number
ISO/FDIS 10012:2025(en) © ISO 2025
ii
ISO/FDIS 10012:2025(en)
Contents Page
Foreword .v
Introduction .vi
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 .6
4.3 Determining the scope of the measurement management system .6
4.4 Measurement management system .7
5 Leadership . 7
5.1 Leadership and commitment .7
5.2 Measurement management policy .8
5.3 Roles, responsibilities and authorities .8
5.4 Customer focus .8
6 Planning . 9
6.1 Actions to address risks and opportunities .9
6.2 Measurement management objectives and planning to achieve them .9
6.3 Planning of changes .10
7 Support .10
7.1 Resources .10
7.1.1 General .10
7.1.2 Personnel . .10
7.1.3 Facilities and environmental conditions .11
7.1.4 Equipment .11
7.1.5 Organizational knowledge .11
7.2 Competence .11
7.3 Awareness . 12
7.4 Communication . 12
7.5 Documented information . 12
7.5.1 General . 12
7.5.2 Creating and updating documented information . 13
7.5.3 Control of documented information . 13
8 Operation . 14
8.1 Operational planning and control .14
8.1.1 General .14
8.1.2 Operational risk management .14
8.2 Requirements for measurement processes . 15
8.2.1 General . 15
8.2.2 Customer communications . 15
8.2.3 Determination of requirements related to the measurement processes . 15
8.2.4 Review of customer requirements for measurement processes . 15
8.2.5 Changes to requirements for measurement processes.16
8.3 Design and development of measurement processes .16
8.3.1 General .16
8.3.2 Design and development planning .16
8.3.3 Design and development inputs .17
8.3.4 Design and development controls .18
8.3.5 Design and development outputs . 20
8.3.6 Design and development changes .21
8.4 Control of externally provided measurement processes, products and services . 22
8.4.1 General . 22
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ISO/FDIS 10012:2025(en)
8.4.2 Type and extent of control . 22
8.4.3 Information for external providers . 23
8.5 Measurement process implementation .24
8.5.1 Control of measurement processes .24
8.5.2 Identification and traceability . 26
8.5.3 Property belonging to customers or external providers . 26
8.5.4 Preservation .27
8.5.5 Measurement process post-delivery activities .27
8.5.6 Control of changes .27
8.6 Release of measurement process results .27
8.6.1 Planned arrangements for release of results .27
8.6.2 Documented information relating to release of results . 28
8.7 Control of nonconforming outputs . 28
8.7.1 Handling of nonconforming outputs . 28
8.7.2 Documented information . 29
9 Performance evaluation .29
9.1 Monitoring, measurement, analysis, and evaluation . 29
9.1.1 General . 29
9.1.2 Customer satisfaction . 30
9.1.3 Analysis and evaluation . 30
9.2 Internal audit . 30
9.2.1 General . 30
9.2.2 Internal audit programme . 30
9.3 Management review .31
9.3.1 General .31
9.3.2 Management review inputs .31
9.3.3 Management review results .31
10 Improvement .32
10.1 Continual improvement .32
10.1.1 Measurement management system improvement .32
10.1.2 Measurement process improvement .32
10.2 Nonconformity and corrective action .32
Annex A (informative) Calibration intervals optimization .34
Annex B (informative) Measurement uncertainty .39
Annex C (informative) Measurement decision risk and rules. 41
Bibliography .45
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ISO/FDIS 10012:2025(en)
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 technically
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.
v
ISO/FDIS 10012:2025(en)
Introduction
This document 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, 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 support 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 can 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 its products and services.
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FINAL DRAFT International Standard ISO/FDIS 10012:2025(en)
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 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 general concepts and associated terms (VIM)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 9000, ISO/IEC Guide 99 and the
following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
ISO/FDIS 10012:2025(en)
3.1
organization
person or group of people that has its own functions with responsibilities, authorities and relationships to
achieve its objectives (3.6)
Note 1 to entry: The concept of organization includes, but is not limited to, sole-trader, company, corporation, firm,
enterprise, authority, partnership, charity or institution, or part or combination thereof, whether incorporated or not,
public or private.
Note 2 to entry: If the organization is part of a larger entity, the term “organization” refers only to the part of the larger
entity that is within the scope of the measurement management system (3.19.4).
3.2
interested party (preferred term)
stakeholder (admitted term)
person or organization (3.1) that can affect, be affected by, or perceive itself to be affected by a decision or
activity
EXAMPLE Customers, owners, people in an organization, providers (3.21), metrology institutions, regulators,
unions, partners, society.
3.3
top management
person or group of people who directs and controls an organization (3.1) at the highest level
Note 1 to entry: Top management has the power to delegate authority and provide resources within the organization.
Note 2 to entry: If the scope of the management system (3.4) covers only part of an organization, then top management
refers to those who direct and control that part of the organization.
3.4
management system
set of interrelated or interacting elements of an organization (3.1) to establish policies (3.5) and objectives
(3.6), as well as processes (3.8) to achieve those objectives
Note 1 to entry: A management system can address a single discipline or several disciplines.
Note 2 to entry: The management system elements include the organization’s structure, roles and responsibilities,
planning and operation.
Note 3 to entry: The scope of a management system can include the whole of the organization, specific and identified
functions of the organization, specific and identified sections of the organization, or one or more functions across a
group of organizations.
3.5
policy
intentions and direction of an organization (3.1) as formally expressed by its top management (3.3)
3.6
objective
result to be achieved
Note 1 to entry: An objective can be strategic, tactical, or operational.
Note 2 to entry: Objectives can relate to different disciplines (such as finance, health and safety, and environment).
They can be, for example, organization-wide or specific to a project, product, service or process (3.8).
Note 3 to entry: An objective can be expressed in other ways, e.g. as an intended result, as a purpose, as an operational
criterion, as a measurement management objective or by the use of other words with similar meaning (e.g. aim, goal,
or target).
Note 4 to entry: In the context of measurement management systems (3.19.4), measurement management objectives are
set by the organization (3.1), consistent with the measurement management policy (3.5), to achieve specific results.
ISO/FDIS 10012:2025(en)
3.7
risk
effect of uncertainty
Note 1 to entry: An effect is a deviation from the expected — positive or negative.
Note 2 to entry: Uncertainty is the state, even partial, of deficiency of information related to, understanding or
knowledge of, an event, its consequence, or likelihood.
Note 3 to entry: Risk is often characterized by reference to potential events and consequences, or a combination of these.
Note 4 to entry: Risk is often expressed in terms of a combination of the consequences of an event (including changes
in circumstances) and the associated likelihood of occurrence.
Note 5 to entry: In the context of measurement management systems (3.19.4), risk also refers to the impact of
uncertainty in a measurement quantity as determined by the metrological methods used.
Note 6 to entry: Refer to ISO 31000 and IEC 31010 for additional guidance.
3.8
process
set of interrelated or interacting activities that uses or transforms inputs to deliver a result
Note 1 to entry: Whether the result of a process is called an output, a product or a service depends on the context of
the reference.
3.9
competence
ability to apply knowledge and skills to achieve intended results
3.10
documented information
information required to be controlled and maintained by an organization (3.1) and the medium on which it
is contained
Note 1 to entry: Documented information can be in any format and media and from any source.
Note 2 to entry: Documented information can refer to:
— the management system (3.4), including related processes (3.8);
— information created in order for the organization to operate (documentation);
— evidence of results achieved (records).
3.11
performance
measurable result
Note 1 to entry: Performance can relate either to quantitative or qualitative findings.
Note 2 to entry: Performance can relate to managing activities, processes (3.8), products, services, systems or
organizations (3.1).
Note 3 to entry: In the metrological context, performance relates to the implementation of a process to obtain
appropriate or measurable results.
3.12
continual improvement
recurring activity to enhance performance (3.11)
3.13
effectiveness
extent to which planned activities are realized and planned results are achieved
ISO/FDIS 10012:2025(en)
3.14
requirement
need or expectation that is stated, generally implied or obligatory
Note 1 to entry: “Generally implied” means that it is custom or common practice for the organization (3.1) and
interested parties (3.2) that the need or expectation under consideration is implied.
Note 2 to entry: A specified requirement is one that is stated, e.g. in documented information (3.10).
3.15
conformity
fulfilment of a requirement (3.14)
3.16
nonconformity
non-fulfilment of a requirement (3.14)
3.17
corrective action
action to eliminate the cause(s) of a nonconformity (3.16) and to prevent recurrence
3.18
audit
systematic and independent process (3.8) for obtaining evidence and evaluating it objectively to determine
the extent to which the audit criteria are fulfilled
Note 1 to entry: An audit can be an internal audit (first party) or an external audit (second party or third party), and it
can be a combined audit (combining two or more disciplines).
Note 2 to entry: An internal audit is conducted by the organization (3.1) itself, or by an external party on its behalf.
Note 3 to entry: “Audit evidence” and “audit criteria” are defined in ISO 19011.
3.19
measurement
process (3.8) to determine a value
Note 1 to entry: According to ISO 3534-2, the value determined is generally the value of a quantity.
Note 2 to entry: In the context of measurement management systems (3.19.4), this refers to experimentally obtaining one
or more quantity values that can reasonably be attributed to a quantity. For further details, refer to ISO/IEC Guide 99.
3.19.1
measurement result
result of measurement
set of quantity values being attributed to a measurand together with any other available relevant information
Note 1 to entry: A measurement result generally contains “relevant information” about the set of quantity values,
such that some may be more representative of the measurand than others. This may be expressed in the form of a
probability density function (PDF).
Note 2 to entry: No measurement result is valid without an associated statement of measurement uncertainty (see
ISO/IEC Guide 98-1:2024).
[SOURCE: ISO/IEC Guide 99:2007, 2.9, modified — Notes 2 and 3 to entry deleted. New Note 2 to entry added.]
3.19.2
measurement process
set of operations to determine the value of a quantity
Note 1 to entry: See Figure C.3 for an illustration of the measurement process.
[SOURCE: ISO 9000:—, 3.12.8, modified — Note 1 to entry added.]
ISO/FDIS 10012:2025(en)
3.19.3
measuring equipment
measuring instrument, software, measurement standard, reference material or auxiliary apparatus, or a
combination thereof, necessary to realize a measurement process (3.19.2)
[SOURCE: ISO 9000:—, 3.12.9]
3.19.4
measurement management system
part of a management system (3.4) with regard to measurement (3.19)
3.20
monitoring
determining the status of a system, a process (3.8) or an activity
Note 1 to entry: To determine the status, there can be a need to check, supervise or critically observe.
3.21
provider
organization (3.1) that provides a product or a service
EXAMPLE Producer, distributor, retailer or vendor of a product or a service.
Note 1 to entry: A provider can be internal or external to the organization.
Note 2 to entry: In a contractual situation, a provider is sometimes called “contractor”.
3.22
metrological confirmation
set of operations required to ensure that measuring equipment (3.19.3) conforms to the requirements (3.14)
for its intended use
Note 1 to entry: Metrological confirmation generally includes calibration or verification, any necessary adjustment or
repair, and subsequent recalibration, comparison with the metrological requirements (3.24) for the intended use of the
equipment, as well as any required sealing and labelling.
Note 2 to entry: Metrological confirmation is not achieved until and unless the fitness of the measuring equipment for
the intended use has been demonstrated and documented.
Note 3 to entry: The requirements for intended use include such considerations as range, resolution and maximum
permissible errors.
Note 4 to entry: Metrological requirements are usually distinct from, and are not specified in, product requirements.
3.23
metrological function
function with administrative and technical responsibility for defining and implementing the measurement
management system (3.19.4)
3.24
metrological requirements
set of requirements (3.14) for measurement processes (3.19.2) that include criteria and practices necessary to
ensure that measurements (3.19) are reliable and comply with applicable requirements and regulations
Note 1 to entry: This may include, among other things, the accuracy and precision of the measurement process,
metrological traceability, calibration frequency, personnel training levels and necessary maintenance operations.
Note 2 to entry: Metrological requirements for measurement processes are generally separate from product
requirements and are not specified in the latter (usually given as an upper or lower specification limit, or both).
ISO/FDIS 10012:2025(en)
3.25
measurement service
task(s) and associated processes performed to implement a measurement or to document a measurement
EXAMPLE Repair of equipment where measurements are used in the repair process.
4 Context of the organization
4.1 Understanding the organization and its context
The organization shall determine, external and internal issues that are relevant to its purpose and that
affect its ability to achieve the intended result(s) of its measurement management system.
The organization shall determine whether climate change is a relevant issue.
It is important to understand and specify the structure of the organization and how it impacts on
measurements and their intended results.
The measurement management system enables the transfer of information within the entire organization,
so that each part of the organization is working with the same information.
The organization shall monitor and review information about all the determined external and internal issues.
NOTE 1 Issues can include positive and negative factors or conditions for consideration.
NOTE 2 Understanding the external context can be facilitated by considering issues arising from legal, technological,
competitive, market, cultural, social and economic environments, whether international, national, regional or local.
NOTE 3 Understanding the internal context can be facilitated by considering issues related to values, culture,
knowledge and performance of the organization.
4.2 Understanding the needs and expectations of interested parties
The organization shall determine:
a) the interested parties that are relevant to the measurement management system;
b) the relevant requirements of these interested parties;
c) which of these requirements will be addressed through the measurement management system.
The organization shall monitor and review information about these interested parties and their relevant
requirements.
NOTE Relevant interested parties can have requirements related to climate change.
4.3 Determining the scope of the measurement management system
The organization shall determine the boundaries and applicability of the measurement management system
to establish its scope.
When determining this scope, the organization shall consider:
a) the external and internal issues referred to in 4.1;
b) the requirements referred to in 4.2.
The scope shall be available as documented information.
The scope shall state the types of measurement activities related to product and services provided. It shall
provide justification for any requirement of this document that the organization determines is not applicable
to the scope of its measurement management system.
ISO/FDIS 10012:2025(en)
4.4 Measurement management system
The organization shall establish, implement, maintain, and continually improve a measurement management
system, including the processes needed and their interactions, in accordance with the requirements of this
document (see Figure 1). The intent of the measurement management system is to achieve the intended
results, including enhancing the measurement management performance.
NOTE 1 Customer requirements and customer satisfaction refer to both external and internal customers
NOTE 2 5M refers to material, man, machine, measure, method (see Figure C.3).
Figure 1 — Relationship between measurement management system and quality management
system with respect to the requirements of Clause 8 “Operation” in this document and ISO 9001
5 Leadership
5.1 Leadership and commitment
Top management shall demonstrate leadership and commitment with respect to the measurement
management system by:
a) ensuring that the measurement management policy and measurement management objectives are
established and are compatible with the strategic direction of the organization;
b) ensuring the integration of the measurement management system requirements into the organization’s
business processes;
c) ensuring that the resources needed for the measurement management system are available;
d) communicating the importance of effective measurement management and of conforming to the
measurement management system requirements;
e) ensuring that the measurement management system achieves its intended result(s);
f) directing and supporting persons to contribute to the effectiveness of the measurement management system;
g) promoting continual improvement;
ISO/FDIS 10012:2025(en)
h) supporting other relevant roles to demonstrate their leadership as it applies to their areas of
responsibility;
i) taking accountability for the effectiveness and relevance of the measurement management system;
j) promoting risk-based thinking.
NOTE Reference to “business” in this document can be interpreted broadly to mean those activities that are core
to the purposes of the organization’s existence.
5.2 Measurement management policy
Top management shall establish a measurement management policy that:
a) is appropriate to the purpose of the organization;
b) provides a framework for setting measurement management objectives;
c) includes a commitment to meet applicable requirements;
d) includes a commitment to continual improvement of the measurement management system.
The measurement management policy shall:
— be available as documented information;
— be communicated within the organization;
— be available to interested parties, as appropriate;
— be understood and applied.
5.3 Roles, responsibilities and authorities
Top management shall ensure that the responsibilities and authorities for relevant roles are assigned and
communicated within the organization.
Top management shall assign the responsibility and authority for:
a) ensuring that the measurement management system conforms to the requirements of this document;
b) reporting on the performance of the measurement management system to top management;
c) ensuring that the measurement management system is delivering it’s intended results;
d) ensuring that the integrity of the measurement management system is maintained when changes to the
measurement management system are planned and implemented.
Top management shall appoint a specific member of the organization’s management, who shall have
the responsibility and authority for oversight of the above requirements and shall have access to top
management to resolve measurement management issues.
5.4 Customer focus
Top management shall demonstrate leadership and commitment with respect to customer focus by
ensuring that:
a) customer and applicable statutory and regulatory requirements are determined, understood and
consistently met;
b) the risks and opportunities that can affect the validity and reliability of the processes measurement
results and the ability to enhance customer satisfaction are determined and addressed;
ISO/FDIS 10012:2025(en)
c) the focus on enhancing customer satisfaction is maintained as described in 9.1.
6 Planning
6.1 Actions to address risks and opportunities
When planning for the measurement management system, the organization shall consider the issues
referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and op
...
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
ISO/FDIS 10012:2025(en)
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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ISO/FDIS 10012:2025(en)
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
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ISO/FDIS 10012:2025(en)
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.
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ISO/FDIS 10012:2025(en)
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.
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ISO/FDIS 10012:2025(en)
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 general concepts and associated terms
(VIM)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 9000, ISO/IEC Guide 99 and the
following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp
— IEC Electropedia: available at https://www.electropedia.org/
ISO/FDIS 10012:2025(en)
3.1
organization
person or group of people that has its own functions with responsibilities, authorities and relationships to
achieve its objectives (3.6)
Note 1 to entry: The concept of organization includes, but is not limited to, sole-trader, company, corporation, firm,
enterprise, authority, partnership, charity or institution, or part or combination thereof, whether incorporated or not,
public or private.
Note 2 to entry: If the organization is part of a larger entity, the term “organization” refers only to the part of the larger
entity that is within the scope of the measurement management system (3.19.4(3.4).).
3.2
interested party (preferred term)
stakeholder (admitted term)
person or organization (3.1) that can affect, be affected by, or perceive itself to be affected by a decision or
activity
EXAMPLE Customers, owners, people in an organization, providers (3.21,), metrology institutions, regulators,
unions, partners, society.
3.3
top management
person or group of people who directs and controls an organization (3.1) at the highest level
Note 1 to entry: Top management has the power to delegate authority and provide resources within the organization.
Note 2 to entry: If the scope of the management system (3.4) covers only part of an organization, then top management
refers to those who direct and control that part of the organization.
3.4
management system
set of interrelated or interacting elements of an organization (3.1) to establish policies (3.5) and objectives
(3.6), as well as processes (3.8) to achieve those objectives
Note 1 to entry: A management system can address a single discipline or several disciplines.
Note 2 to entry: The management system elements include the organization’s structure, roles and responsibilities,
planning and operation.
Note 3 to entry: The scope of a management system can include the whole of the organization, specific and identified
functions of the organization, specific and identified sections of the organization, or one or more functions across a group
of organizations.
3.5
policy
intentions and direction of an organization (3.1) as formally expressed by its top management (3.3)
3.6
objective
result to be achieved
Note 1 to entry: An objective can be strategic, tactical, or operational.
Note 2 to entry: Objectives can relate to different disciplines (such as finance, health and safety, and environment). They
can be, for example, organization-wide or specific to a project, product, service or process (3.8).
ISO/FDIS 10012:2025(en)
Note 3 to entry: An objective can be expressed in other ways, e.g. as an intended result, as a purpose, as an operational
criterion, as a measurement management objective or by the use of other words with similar meaning (e.g. aim, goal, or
target).
Note 4 to entry: In the context of measurement management systems (3.19.4system (3.4),), measurement management
objectives are set by the organization (3.1), consistent with the measurement management policy (3.5), to achieve specific
results.
3.7
risk
effect of uncertainty
Note 1 to entry: An effect is a deviation from the expected — positive or negative.
Note 2 to entry: Uncertainty is the state, even partial, of deficiency of information related to, understanding or knowledge
of, an event, its consequence, or likelihood.
Note 3 to entry: Risk is often characterized by reference to potential events (as defined in ISO 31073:2022, 3.3.11) and
consequences (as defined in ISO 31073:2022, 3.3.18),, or a combination of these.
Note 4 to entry: Risk is often expressed in terms of a combination of the consequences of an event (including changes in
circumstances) and the associated likelihood (as defined in ISO 31073:2022, 3.3.16) of occurrence.
Note 5 to entry: In the context of measurement management systems (3.19.4,), risk also refers to the impact of uncertainty
in a measurement quantity as determined by the metrological methods used.
Note 6 to entry: Refer to ISO 31000: Risk management — Principles and guidelines and ISO IEC 31010: Risk management
— Risk assessment techniques for additional guidance.
3.8
process
set of interrelated or interacting activities that uses or transforms inputs to deliver a result
Note 1 to entry: Whether the result of a process is called an output, a product, or a service depends on the context of the
reference.
3.9
competence
ability to apply knowledge and skills to achieve intended results
3.10
documented information
information required to be controlled and maintained by an organization (3.1) and the medium on which it is
contained
Note 1 to entry: Documented information can be in any format and media and from any source.
Note 2 to entry: Documented information can refer to:
— the management system (3.4), including related processes (3.8);
— information created in order for the organization to operate (documentation);
— evidence of results achieved (records).
3.11
performance
measurable result
ISO/FDIS 10012:2025(en)
Note 1 to entry: Performance can relate either to quantitative or qualitative findings.
Note 2 to entry: Performance can relate to managing activities, processes (3.8), products, services, systems or
organizations (3.1).
Note 3 to entry: In the metrological context, performance relates to the implementation of a process to obtain
appropriate or measurable results.
3.12
continual improvement
recurring activity to enhance performance (3.11)
3.13
effectiveness
extent to which planned activities are realized and planned results are achieved
3.14
requirement
need or expectation that is stated, generally implied or obligatory
Note 1 to entry: “Generally implied” means that it is custom or common practice for the organization (3.1) and interested
parties (3.2) that the need or expectation under consideration is implied.
Note 2 to entry: A specified requirement is one that is stated, e.g. in documented information (3.10).
3.15
conformity
fulfilment of a requirement (3.14)
3.16
nonconformity
non-fulfilment of a requirement (3.14)
3.17
corrective action
action to eliminate the cause(s) of a nonconformity (3.16) and to prevent recurrence
3.18
audit
systematic, and independent process (3.8) for obtaining evidence and evaluating it objectively to determine
the extent to which the audit criteria are fulfilled
Note 1 to entry: An audit can be an internal audit (first party) or an external audit (second party or third party), and it
can be a combined audit (combining two or more disciplines).
Note 2 to entry: An internal audit is conducted by the organization (3.1) itself, or by an external party on its behalf.
Note 3 to entry: “Audit evidence” and “audit criteria” are defined in ISO 19011.
3.19
measurement
process (3.8) to determine a value
Note 1 to entry: According to ISO 3534-2, the value determined is generally the value of a quantity.
Note 2 to entry: In the context of measurement management systems (3.19.4, ), this refers to experimentally obtaining one
or more quantity values that can reasonably be attributed to a quantity. For further details, refer to ISO/IEC Guide 99.
ISO/FDIS 10012:2025(en)
3.19.1
measurement result
result of measurement
set of quantity values being attributed to a measurand together with any other available relevant information
Note 1 to entry: A measurement result generally contains “relevant information” about the set of quantity values, such
that some may be more representative of the measurand than others. This may be expressed in the form of a probability
density function (PDF).
[SOURCE: ISO/IEC Guide 99:2007, 2.9, modified — Notes 2 and 3 to entry deleted.]
Note 2: to entry: No measurement result is valid without an associated statement of measurement uncertainty. [SOURCE:
(see ISO GUIDE/IEC Guide 98]-1:2024).
[SOURCE: ISO/IEC Guide 99:2007, 2.9, modified — Notes 2 and 3 to entry deleted. New Note 2 to entry added.]
3.19.2
measurement process
set of operations to determine the value of a quantity
Note 1 to entry: See Figure C.3Annex C figure C3 for an illustration of the measurement process.
[SOURCE: ISO 9000:—, 3.1112.8], modified — Note 1 to entry added.]
3.19.3
measuring equipment
measuring equipmentinstrument, software, measurement standard, reference material or auxiliary
apparatus, or a combination thereof, necessary to realize a measurement process (3.19.2)
[SOURCE: ISO 9000:—, 3.1112.9]
3.19.4
measurement management system
part of a management system (3.4) with regard to measurement (3.19)
3.20
monitoring
determining the status of a system, a process (3.8) or an activity
Note 1 to entry: To determine the status, there can be a need to check, supervise or critically observe.
3.21
provider
organization (3.1) that provides a product or a service
EXAMPLE Producer, distributor, retailer or vendor of a product or a service.
Note 1 to entry: A provider can be internal or external to the organization.
Note 2 to entry: In a contractual situation, a provider is sometimes called “contractor”.
3.22
metrological confirmation
set of operations required to ensure that measuring equipment (3.19.3) conforms to the requirements (3.14)
for its intended use
ISO/FDIS 10012:2025(en)
Note 1 to entry: Metrological confirmation generally includes calibration or verification, any necessary adjustment or
repair, and subsequent recalibration, comparison with the metrological requirements (3.24) for the intended use of the
equipment, as well as any required sealing and labelling.
Note 2 to entry: Metrological confirmation is not achieved until and unless the fitness of the measuring equipment for
the intended use has been demonstrated and documented.
Note 3 to entry: The requirements for intended use include such considerations as range, resolution and maximum
permissible errors.
Note 4 to entry: Metrological requirements are usually distinct from, and are not specified in, product requirements.
3.23
metrological function
function with administrative and technical responsibility for defining and implementing the measurement
management system (3.19.4)
3.24
Metrologicalmetrological requirements
A set of requirements (3.14) for measurement processes (3.19.2) that include criteria and practices necessary
to ensure that measurements (3.19) are reliable and comply with applicable requirements and regulations.
Note 1: to entry: This may include, among other things, the accuracy and precision of the measurement process,
metrological traceability, calibration frequency, personnel training levels, and necessary maintenance operations.
Note 2: to entry: Metrological requirements for measurement processes are generally separate from product
requirements and are not specified in the latter (usually given as an upper or lower specification limit, or both).
3.25
3.25 Measurement
measurement service
In the context of this standard, service refers to task(s) and associated processes performed to implement a
measurement or to document a measurement. The term service includes tasks such as repair
EXAMPLE Repair of equipment where measurements are used in the repair process.
4 Context of the organization
4.1 Understanding the organization and its context
The organization shall determine, external and internal issues that are relevant to its purpose and that affect
its ability to achieve the intended result(s) of its measurement management system.
The organization shall determine whether climate change is a relevant issue.
It is important to understand and specify the structure of the organization and how it impacts on
measurements and their intended results.
The measurement management system enables the transfer of information within the entire organization, so
that each part of the organization is working with the same information.
The organization shall monitor and review information about all the determined external and internal issues.
NOTE 1 Issues can include positive and negative factors or conditions for consideration.
ISO/FDIS 10012:2025(en)
NOTE 2 Understanding the external context can be facilitated by considering issues arising from legal, technological,
competitive, market, cultural, social and economic environments, whether international, national, regional or local.
NOTE 3 Understanding the internal context can be facilitated by considering issues related to values, culture,
knowledge and performance of the organization.
4.2 Understanding the needs and expectations of interested parties
The organization shall determine:
a) the interested parties that are relevant to the measurement management system;
b) the relevant requirements of these interested parties;
c) which of these requirements will be addressed through the measurement management system;.
The organization shall monitor and review information about these interested parties and their relevant
requirements.
NOTE Relevant interested parties can have requirements related to climate change.
4.3 Determining the scope of the measurement management system
The organization shall determine the boundaries and applicability of the measurement management system
to establish its scope.
When determining this scope, the organization shall consider:
a) the external and internal issues referred to in 4.1;
b) the requirements referred to in 4.2.
The scope shall be available as documented information.
The scope shall state the types of measurement activities related to product and services provided. It shall
provide justification for any requirement of this document that the organization determines is not applicable
to the scope of its measurement management system.
4.4 Measurement management system
The organization shall establish, implement, maintain, and continually improve a measurement management
system, including the processes needed and their interactions, in accordance with the requirements of this
document (see Figure 1). The intent of the measurement management system is to achieve the intended
results, including enhancing itsthe measurement management performance.
ISO/FDIS 10012:2025(en)
Figure 1 : Relationship between Measurement Management System and Quality Management System with
respect to the requirements of clause 8 "operation" in ISO 10012 and ISO 9001
NOTE 1 Customer requirements and customer satisfaction refer to both external and internal customers
NOTE 2 5M refers to material, man, machine, measure, method (see Figure C.3: Material, Man, Machine, Measure,
Method (See figure C3)).
Figure 1 — Relationship between measurement management system and quality management
system with respect to the requirements of Clause 8 “Operation” in this document and ISO 9001
ISO/FDIS 10012:2025(en)
5 Leadership
5.1 Leadership and commitment
Top management shall demonstrate leadership and commitment with respect to the measurement
management system by:
a) ensuring that the measurement management policy and measurement management objectives are
established and are compatible with the strategic direction of the organization;
b) ensuring the integration of the measurement management system requirements into the organization’s
business processes;
c) ensuring that the resources needed for the measurement management system are available;
d) communicating the importance of effective measurement management and of conforming to the
measurement management system requirements;
e) ensuring that the measurement management system achieves its intended result(s);
f) directing and supporting persons to contribute to the effectiveness of the measurement management
system;
g) promoting continual improvement;
h) supporting other relevant roles to demonstrate their leadership as it applies to their areas of
responsibility;
i) taking accountability for the effectiveness and relevance of the measurement management system;
j) promoting risk-based thinking.
NOTE Reference to “business” in this document can be interpreted broadly to mean those activities that are core to
the purposes of the organization’s existence.
5.2 Measurement management policy
Top management shall establish a measurement management policy that:
a) is appropriate to the purpose of the organization;
b) provides a framework for setting measurement management objectives;
c) includes a commitment to meet applicable requirements;
d) includes a commitment to continual improvement of the measurement management system.
The measurement management policy shall:
— be available as documented information;
— be communicated within the organization;
— be available to interested parties, as appropriate;
— be understood and applied.
ISO/FDIS 10012:2025(en)
5.3 Roles, responsibilities and authorities
Top management shall ensure that the responsibilities and authorities for relevant roles are assigned, and
communicated within the organization.
Top management shall assign the responsibility and authority for:
a) ensuring that the measurement management system conforms to the requirements of this document;
b) reporting on the performance of the measurement management system to top management;
c) ensuring that the measurement management system is delivering it’s intended results;
d) ensuring that the integrity of the measurement management system is maintained when changes to the
measurement management system are planned and implemented.
Top management shall appoint a specific member of the organization’s management, who shall have the
responsibility and authority for oversight of the above requirements and shall have access to top management
to resolve measurement management issues.
5.4 Customer focus
Top management shall demonstrate leadership and commitment with respect to customer focus by ensuring
that:
a) customer and applicable statutory and regulatory requirements are determined, understood and
consistently met;
b) the risks and opportunities that can affect the validity and reliability of the processes measurement results
and the ability to enhance customer satisfaction are determined and addressed;
c) the focus on enhancing customer satisfaction is maintained as described in 9.1clause 9.1;.
6 Planning
6.1 Actions to address risks and opportunities
When planning for the measurement management system, the organization shall consider the issues referred
to in 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that need to be
addressed to:
— give assurance that the measurement management system can achieve its intended result(s);
— prevent, or reduce, undesired effects;
— achieve continual improvement;
— enhance desirable effects.
The organization shall plan:
a) actions to address these risks and opportunities;
b) how to:
1) — integrate and implement the actions into its measurement management system processes;
ISO/FDIS 10012:2025(en)
2) — evaluate the effectiveness of these actions;
3) — document the processes used in the risks and opportunities analyses;
4) — ensure new objectives do not compromise the existing measurement management system and
validity and reliability of results.
Actions taken to address risks and opportunities shall be proportionate to the potential impact on the
measurement management system.
NOTE 1 The strategy for dealing with a risk includes these decision options: escalating, avoiding, transferring,
mitigating, accepting.
NOTE 2 The strategy for dealing with an opportunity includes these decision options: escalating, exploiting, sharing,
enhancing, and accepting.
NOTE 3 The effectiveness of risk and opportunity responses shows whether the identified measures were appropriate
and is an interface to the continuous improvement in the company. organization.
6.2 Measurement management objectives and planning to achieve them
The organization shall establish measurement management objectives at relevant functions and levels.
The measurement management objectives shall:
a) be consistent with the measurement management policy (see 5.2);
b) be measurable (if practicable);
c) take into account applicable requirements;
d) be monitored;
e) be communicated;
f) be updated as appropriate;
g) be available as documented information;
h) be relevant to the impact on the conformity of products and services and to enhancement of customer
satisfaction;.
When planning how to achieve its measurement management objectives, the organization shall determine:
— what will be done;
— what resources will be required;
— who will be responsible;
— when it will be completed;
— how the results will be evaluated.;
— Howhow the results will be documented.
ISO/FDIS 10012:2025(en)
NOTE : applicable Applicable requirements maycan include regulatory, legal, contractual requirements,
interested parties or customers, etc.
6.3 Planning of changes
When the organization determines the need for changes to the measurement management system, the
changes shall be carried out in a planned manner.
The organization shall consider:
a) the purpose of the changes and their potential consequences;
b) the integrity of the measurement management system;
c) the availability of resources;
d) the allocation or reallocation of responsibilities and authorities;
e) notification of the changes to interested parties where applicable.
7 Support
7.1 Resources
7.1.1 General
The organization shall determine and provide the resources needed for the establishment, implementation,
maintenance, and continual improvement of the measurement management system.
The organization shall consider:
a) the capabilities of and constraints of existing internal resources;
b) what needs to be obtained from external providers.
7.1.2 Personnel
The organization shall determine and provide the persons necessary for the effective implementation of its
Measurementmeasurement management system and for the operation and control of its processes.
7.1.3 Environment and facilities
7.1.3 Facilities and environmental conditions
The requirements for facilities and environmental conditions necessary for the performance of the
measurement activities shall be specified, and monitored, and shall be available as documented information.
The facilities and environmental conditions shall be suitable for the measurement activities and shall not
adversely affect the validity of measurement results.
When on-site work (i.e. outside of a controlled environment) is performed, the design of the measurement
process shall consider conditions out of the control of the user. The measurement process shall be documented
and monitored with due consideration regarding compensating environmental corrections, if required.
NOTE 1 Environmental conditions affecting measurement systems can include temperature, temperature gradient,
humidity, hygiene, airflow, lighting, vibration, dust control, cleanliness, electromagnetic interference and other factors.
ISO/FDIS 10012:2025(en)
NOTE 2 Facilities can include buildings and associated utilities, transportation resources and communication systems.
This mayThe documented information can include information regarding the facility’s historical environmental
performance and stability.
NOTE 3 A suitable environment can be a combination of human and physical factors.
7.1.4 Equipment
All equipment including hardware and software necessary to satisfy the specified metrological requirements
shall be available and identified in the measurement management system, (see 8.3.3.3clause 8.3.3.3 e).
7.1.5 Organizational knowledge
The organization shall determine the knowledge necessary for the operation of its measurement processes
and to achieve continuity of measurement operations and services.
This knowledge shall be maintained and shall be made available to the extent necessary for the organization.
When addressing changing needs and trends, the organization shall consider its current knowledge and
determine how to acquire or access any necessary additional knowledge and required technical and
regulatory updates.
NOTE 1 Organizational knowledge includes best practice knowledge specific to the organization; it is generally gained
by experience. It is information that is used and shared to achieve the organization’s objectives.
NOTE 2 Organizational knowledge can be based on:
— internal sources (e.g. intellectual property, knowledge gained from experience, lessons learned from failures and
successful projects, capturing and sharing undocumented knowledge and experience, the results of improvements
in processes, products and services);
— external sources (e.g. standards, academia, conferences, gathering knowledge from customers or external providers).
7.2 Competence
The organization shall:
a) determine the necessary competence of person(s) doing work under its control that affects its
measurement management performance;
b) ensure that these persons are competent on the basis of appropriate education, training or experience;
c) where applicable, take actions to acquire the necessary competence, and evaluate the effectiveness of the
actions taken.
Appropriate documented information shall be available as evidence of competence.
NOTE Applicable actions can include, for example: the provision of training to, the mentoring of, or the re-
assignment of currently employed persons; or the hiring or contracting of competent persons.
7.3 Awareness
Persons doing work under the organization’s control shall be aware of:
a) the measurement management policy;
ISO/FDIS 10012:2025(en)
b) their contribution to the effectiveness of the measurement management system, including the benefits of
improved measurement management performance;
c) the implications of not conforming with the measurement management system requirements;
d) any relevant measurement management system requirements;
e) their contribution that impacts on the validity of results;
f) the importance of ethical behaviour;
g) their contribution to product conformity.
7.4 Communication
The organization shall determine the internal and external communications relevant to the measurement
management system including:
a) on what it will communicate;
b) when to communicate;
c) with whom to communicate;
d) how to communicate;
e) who communicates;
f) the importance of ethical behaviour.
In relation to communication, the originator of the communication shall ensure that the information is only
provided to persons authorized to receive it. The confidentiality requirements of 7.5.3 Documented
information of shall be conformed to for both internal and external communications shall be consistent with
the confidentiality requirements of the organization and its customers.
In cases where it is necessary to notify a customer of a nonconforming process or documented information
(see 10.2Clause 10.2)), the organization shall notify the customer in a timely manner so that the customer can
properly analyzeanalyse the effect of the nonconformity on the products and services provided by the
organization.
The data shall be presented and communicated in a clear and concise manner which can be understood by all
parties.
The organization shall implement ethical policies to protect data integrity and the overall responsibility of the
organization.
7.5 Documented information
7.5.1 General
The organization’s measurement management system shall include:
a) documented information required by this document;
b) documented information determined by the organization as being necessary for the effectiveness of the
measurement management system.
ISO/FDIS 10012:2025(en)
NOTE 1 The extent of documented information for a measurement management system can differ from one
organization to another due to:
— the size of organization and its type of activities, processes, products and services;
— the complexity of processes and their interactions;
— the competence of persons.
NOTE 2 An example of documented information to be maintained would beis a record of analyses performed
regarding the observed end of pe
...
PROJET FINAL
Norme
internationale
ISO/FDIS 10012
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
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ISO/FDIS 10012:2025(fr) © ISO 2025
PROJET FINAL
ISO/FDIS 10012:2025(fr)
Norme
internationale
ISO/FDIS 10012
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
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ii
ISO/FDIS 10012:2025(fr)
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
ISO/FDIS 10012:2025(fr)
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 . 30
9 Évaluation des performances .31
9.1 Surveillance, mesure, analyse et évaluation .31
9.1.1 Généralités .31
9.1.2 Satisfaction du client . . .31
9.1.3 Analyse et évaluation .31
9.2 Audit interne . .32
9.2.1 Généralités .32
9.2.2 Programme d’audit interne .32
9.3 Revue de direction .32
9.3.1 Généralités .32
9.3.2 Éléments d’entrée de la revue de direction . 33
9.3.3 Résultats de la revue de direction . 33
10 Amélioration .33
10.1 Amélioration continue . 33
10.1.1 Amélioration du système de management de la mesure . 33
10.1.2 Amélioration du processus de mesure . 34
10.2 Non-conformité et action corrective . 34
Annexe A (informative) Optimisation des intervalles d’étalonnage .35
Annexe B (informative) Incertitude de mesure .40
Annexe C (informative) Risque et règles de la décision de mesure .42
Bibliographie .46
iv
ISO/FDIS 10012:2025(fr)
Avant-propos
L’ISO (Organisation internationale de normalisation) est une fédération mondiale d’organismes nationaux
de normalisation (comités membres de l’ISO). L’élaboration des Normes internationales est en général
confiée aux comités techniques de l’ISO. Chaque comité membre intéressé par une étude a le droit de faire
partie du comité technique créé à cet effet. Les organisations internationales, gouvernementales et non
gouvernementales, en liaison avec l’ISO participent également aux travaux. L’ISO collabore étroitement avec
la Commission électrotechnique internationale (IEC) en ce qui concerne la normalisation électrotechnique.
Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont
décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier, de prendre note des différents
critères d’approbation requis pour les différents types de documents ISO. Le présent document
a été rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2
(voir www.iso.org/directives).
L’ISO attire l’attention sur le fait que la mise en application du présent document peut entraîner l’utilisation
d’un ou de plusieurs brevets. L’ISO ne prend pas position quant à la preuve, à la validité et à l’applicabilité
de tout droit de brevet revendiqué à cet égard. À la date de publication du présent document, l’ISO n’avait
pas reçu notification qu’un ou plusieurs brevets pouvaient être nécessaires à sa mise en application.
Toutefois, il y a lieu d’avertir les responsables de la mise en application du présent document que des
informations plus récentes sont susceptibles de figurer dans la base de données de brevets, disponible à
l’adresse www.iso.org/brevets. L’ISO ne saurait être tenue pour responsable de ne pas avoir identifié de tels
droits de brevet et averti de leur existence.
Les appellations commerciales éventuellement mentionnées dans le présent document sont données pour
information, par souci de commodité, à l’intention des utilisateurs et ne sauraient constituer un engagement.
Pour une explication de la nature volontaire des normes, la signification des termes et expressions
spécifiques de l’ISO liés à l’évaluation de la conformité, ou pour toute information au sujet de l’adhésion de
l’ISO aux principes de l’Organisation mondiale du commerce (OMC) concernant les obstacles techniques au
commerce (OTC), voir www.iso.org/avant-propos.
Le présent document a été élaboré par le comité ISO/TC 176, Management et assurance de la qualité, sous-
comité SC 3, Techniques de soutien, en collaboration avec le comité technique CEN/SS F20, Assurance de la
qualité, du Comité européen de normalisation (CEN), conformément à l’Accord de coopération technique
entre l’ISO et le CEN (Accord de Vienne).
Cette deuxième édition annule et remplace la première édition (ISO 10012:2003), qui a fait l’objet d’une
révision technique.
Les principales modifications sont les suivantes:
— le document a été restructuré pour suivre la structure harmonisée des normes de systèmes de
management;
— les paragraphes ont été largement révisés pour répondre aux besoins des parties intéressées.
Il convient que l’utilisateur adresse tout retour d’information ou toute question concernant le présent
document à l’organisme national de normalisation de son pays. Une liste exhaustive desdits organismes se
trouve à l’adresse www.iso.org/fr/members.html.
v
ISO/FDIS 10012:2025(fr)
Introduction
Le présent document est destiné à aider les organismes qui ont mis en place un système de management
de la mesure ou qui souhaitent le faire, en fournissant le cadre nécessaire aux organismes pour concevoir,
tenir à jour et améliorer en permanence un système de management de la mesure.
Il s’agit d’une révision majeure de l’ISO 10012:2003, dont l’objectif est d’établir les bases pour permettre à
un organisme de mettre en œuvre et d’améliorer un système de management de la mesure pour l’application
complète des processus de mesure au sein de l’organisme (voir la Figure 1).
Le principal objectif d’un système de management de la mesure est de renforcer la confiance dans la validité
et la fiabilité des résultats de mesure et de garantir l’aptitude à assurer la mesure des produits fournis et/ou
services assurés par l’organisme au niveau de qualité requis. Cela implique notamment de gérer les risques
associés aux processus de mesure qui peuvent produire des résultats de mesure incorrects susceptibles de
compromettre la qualité des produits et/ou des services d’un organisme.
Un système de management de la mesure peut être mis en œuvre dans la conception et le développement, les
essais, la surveillance et la production de résultats de mesure valides. Il apporte également aux organismes
la base nécessaire pour démontrer la conformité aux exigences du système de management de la mesure.
Le présent document peut être utilisé dans tous les secteurs industriels nécessitant un système de
management de la mesure et vient compléter les exigences de l’ISO 9001, de l’ISO 14001 ou des autres normes
relatives aux systèmes de management.
La mise en œuvre d’un système de management pour la confirmation de la validité des mesures est une
décision importante pour un organisme qui souhaite mettre en place un système de management de la
mesure robuste, capable d’assurer un niveau constant de qualité de mesure pour ses produits et services.
vi
PROJET FINAL Norme internationale ISO/FDIS 10012:2025(fr)
Management de la qualité — Exigences pour les systèmes de
management de la mesure
1 Domaine d’application
Le présent document spécifie les exigences relatives aux systèmes de management de la mesure lorsqu’un
organisme:
a) est tenu de démontrer sa capacité à garantir en permanence la confiance dans la validité et la fiabilité de
ses résultats de mesure et donc à fournir un niveau constant de qualité de mesure pour ses produits et
services;
b) cherche à s’appuyer sur des résultats de mesure fiables et valides, utiles pour améliorer la satisfaction
des clients et mettre en œuvre efficacement les processus de son système de management de la mesure;
c) met en œuvre des processus dans le cadre d’un système de management de la mesure qui permettent de
mieux se conformer aux exigences des clients ainsi qu’aux exigences légales et réglementaires.
Toutes les exigences du présent document sont génériques. Le présent document s’applique à tout organisme,
quel que soit son type ou sa taille, ou aux produits et services qu’il fournit. Cela inclut les organismes qui
fabriquent des produits et assurent des services d’ingénierie (à l’exception des services d’étalonnage et
d’essai inclus dans le domaine d’application de l’ISO/IEC 17025).
Le présent document n’a pas pour intention de se substituer aux exigences générales concernant la
compétence des laboratoires d’étalonnages et d’essais spécifiées dans l’ISO/IEC 17025 ni d’ajouter des
exigences à ces dernières.
NOTE Pour les organismes qui exploitent des laboratoires d’essai et d’étalonnage internes, la compétence de ces
fonctions peut être évaluée conformément à l’ISO/IEC 17025.
2 Références normatives
Les documents suivants sont cités dans le texte de sorte qu’ils constituent, pour tout ou partie de leur
contenu, des exigences du présent document. Pour les références datées, seule l’édition citée s’applique. Pour
les références non datées, la dernière édition du document de référence s’applique (y compris les éventuels
amendements).
ISO 9000, Systèmes de management de la qualité — Principes essentiels et vocabulaire
ISO 17034, Exigences générales pour la compétence des producteurs de matériaux de référence
Guide ISO/IEC 99, Vocabulaire international de métrologie — Concepts fondamentaux et généraux et termes
associés (VIM)
3 Termes et définitions
Pour les besoins du présent document, les termes et les définitions de l’ISO 9000 et le Guide ISO/IEC 99 ainsi
que les suivants s’appliquent.
L’ISO et l’IEC tiennent à jour des bases de données terminologiques destinées à être utilisées en normalisation,
consultables aux adresses suivantes:
— ISO Online browsing platform: disponible à l’adresse https:// www .iso .org/ obp
ISO/FDIS 10012:2025(fr)
— IEC Electropedia: disponible à l’adresse https:// www .electropedia .org/
3.1
organisme
personne ou groupe de personnes ayant ses propres fonctions, avec des responsabilités, des autorités et des
relations lui permettant d’atteindre ses objectifs (3.6)
Note 1 à l'article: Le concept d’organisme englobe sans s’y limiter, les travailleurs indépendants, les compagnies,
les sociétés, les firmes, les entreprises, les administrations, les partenariats, les organisations caritatives ou les
institutions, ou bien une partie ou une combinaison des entités précédentes, à responsabilité limitée ou ayant un autre
statut, de droit public ou privé.
Note 2 à l'article: Si l’organisme fait partie d’une plus grande entité, le terme «organisme» fait uniquement référence à
la partie de cette entité qui est comprise dans le domaine d’application du système de management de la mesure (3.19.4).
3.2
partie intéressée (terme privilégié)
partie prenante (terme admis)
personne ou organisme (3.1) qui peut soit influer sur une décision ou une activité, soit être influencé(e) ou se
sentir influencé(e) par une décision ou une activité
EXEMPLE Clients, propriétaires, personnel d’un organisme, prestataires (3.21), institutions de métrologie,
autorités réglementaires, syndicats, partenaires, sociétés.
3.3
direction
personne ou groupe de personnes qui oriente et dirige un organisme (3.1) au plus haut niveau
Note 1 à l'article: La direction a le pouvoir de déléguer son autorité et de fournir des ressources au sein de l’organisme.
Note 2 à l'article: Si le domaine d’application du système de management (3.4) ne couvre qu’une partie de l’organisme,
alors «direction» fait référence à ceux qui orientent et dirigent cette partie de l’organisme.
3.4
système de management
ensemble d’éléments corrélés ou en interaction d’un organisme (3.1) utilisés pour établir des politiques (3.5)
et des objectifs (3.6), ainsi que des processus (3.8) de façon à atteindre ces objectifs
Note 1 à l'article: Un système de management peut couvrir un seul ou plusieurs domaines.
Note 2 à l'article: Les éléments du système de management comprennent la structure, les rôles et responsabilités,
la planification et le fonctionnement de l’organisme.
Note 3 à l'article: Le domaine d’application d’un système de management peut comprendre l’ensemble de l’organisme,
des fonctions ou des sections spécifiques et identifiées de l’organisme, ou une ou plusieurs fonctions dans un groupe
d’organismes.
3.5
politique
intentions et orientations d’un organisme (3.1), telles qu’elles sont officiellement formulées par sa direction (3.3)
3.6
objectif
résultat à atteindre
Note 1 à l'article: Un objectif peut être stratégique, tactique ou opérationnel.
Note 2 à l'article: Les objectifs peuvent se rapporter à plusieurs domaines (tels que la finance, la santé et la sécurité,
et environnement). Ils peuvent, par exemple, concerner tout l’organisme ou bien un projet, un produit, un service ou un
processus (3.8).
Note 3 à l'article: Il est possible qu’un objectif soit exprimé de différentes manières, par exemple par un résultat
escompté, une finalité, un critère opérationnel, un objectif de management de la mesure, ou par l’utilisation d’autres
termes ayant la même signification (par exemple ambition, but ou cible).
ISO/FDIS 10012:2025(fr)
Note 4 à l'article: Dans le contexte des systèmes de management de la mesure (3.19.4), les objectifs de management de
la mesure sont fixés par l’organisme (3.1), en cohérence avec sa politique (3.5) de management de la mesure, en vue
d’obtenir des résultats précis.
3.7
risque
effet de l’incertitude
Note 1 à l'article: Un effet est un écart, positif ou négatif, par rapport à une attente.
Note 2 à l'article: L’incertitude est l’état, même partiel, de manque d’information, de compréhension ou de connaissance
relative à un événement, à ses conséquences ou à sa vraisemblance.
Note 3 à l'article: Un risque est souvent caractérisé par référence à des événements potentiels et à des conséquences
potentielles, ou par référence à une combinaison des deux.
Note 4 à l'article: Un risque est souvent exprimé sous forme de combinaison des conséquences d’un événement
(y compris une variation des circonstances) et de la vraisemblance de son occurrence.
Note 5 à l'article: Dans le domaine des systèmes de management de la mesure (3.19.4), le risque désigne l’impact de
l’incertitude d’une grandeur de mesure, telle que déterminée par les méthodes de métrologie utilisées.
Note 6 à l'article: Voir l’ISO 31000 et l’IEC 31010 pour des recommandations supplémentaires.
3.8
processus
ensemble d’activités corrélées ou en interaction qui utilise ou transforme des éléments d’entrée pour fournir
un résultat
Note 1 à l'article: La qualification du «résultat d’un processus» comme «élément de sortie», «produit» ou «service»
dépend du contexte de référence.
3.9
compétence
aptitude à mettre en pratique des connaissances et des savoir-faire pour obtenir les résultats escomptés
3.10
information documentée
information devant être maîtrisée et tenue à jour par un organisme (3.1) ainsi que le support sur lequel elle
est disponible
Note 1 à l'article: Les informations documentées peuvent se présenter sous n’importe quel format et support et peuvent
provenir de n’importe quelle source.
Note 2 à l'article: «Information documentée» peut renvoyer:
— au système de management (3.4), y compris les processus (3.8) connexes;
— aux informations créées en vue du fonctionnement de l’organisme (documentation);
— aux preuves des résultats atteints (enregistrements).
3.11
performance
résultat mesurable
Note 1 à l'article: Les performances peuvent se rapporter à des résultats quantitatifs ou qualitatifs.
Note 2 à l'article: Les performances peuvent concerner le management d’activités, de processus (3.8), de produits, de
services, de systèmes ou d’organismes (3.1).
Note 3 à l'article: Dans le domaine de la métrologie, les performances se rapportent à la mise en œuvre d’un processus
en vue d’obtenir des résultats appropriés ou mesurables.
ISO/FDIS 10012:2025(fr)
3.12
amélioration continue
activité récurrente menée pour améliorer les performances (3.11)
3.13
efficacité
niveau de réalisation des activités planifiées et des résultats attendus
3.14
exigence
besoin ou attente, formulé(e), généralement implicite ou obligatoire
Note 1 à l'article: «Généralement implicite» signifie qu’il est habituel ou courant, pour l’organisme (3.1) et les
parties intéressées (3.2), que le besoin ou l’attente en question soit implicite.
Note 2 à l'article: Une exigence spécifiée est une exigence qui est formulée, par exemple dans des
informations documentées (3.10).
3.15
conformité
satisfaction d’une exigence (3.14)
3.16
non-conformité
non-satisfaction d’une exigence (3.14)
3.17
action corrective
action visant à éliminer la ou les causes d’une non-conformité (3.16) et à prévenir sa récurrence
3.18
audit
processus (3.8) systématique et indépendant visant à obtenir des preuves et à les évaluer de manière
objective pour déterminer dans quelle mesure les critères d’audit sont satisfaits
Note 1 à l'article: Un audit peut être interne (de première partie) ou externe (de seconde ou tierce partie), et il peut être
un audit combiné (s’il combine au moins deux domaines).
Note 2 à l'article: Un audit interne est conduit par l’organisme (3.1) lui-même ou par une partie externe pour le compte
de celui-ci.
Note 3 à l'article: Les termes «preuves d’audit» et «critères d’audit» sont définis dans l’ISO 19011.
3.19
mesure
mesurage
processus (3.8) visant à déterminer une valeur
Note 1 à l'article: Conformément à l’ISO 3534-2, la valeur déterminée est généralement la valeur d’une grandeur.
Note 2 à l'article: Dans le cadre des systèmes de management de la mesure (3.19.4), ce terme fait référence à l’obtention
par voie expérimentale d’une ou plusieurs valeurs qui peuvent être raisonnablement attribuées à une grandeur.
Pour plus de détails, se reporter au Guide ISO/IEC 99.
3.19.1
résultat de mesure
résultat d’un mesurage
ensemble de valeurs attribuées à un mesurande, complété par toute autre information pertinente disponible
Note 1 à l'article: Un résultat de mesure contient généralement des informations pertinentes sur l’ensemble de valeurs,
certaines pouvant être plus représentatives du mesurande que d’autres. Cela peut s’exprimer sous la forme d’une
fonction de densité de probabilité.
ISO/FDIS 10012:2025(fr)
Note 2 à l'article: Aucun résultat de mesure n’est valide sans une déclaration d’incertitude de mesure associée (voir le
Guide ISO/IEC 98-1:2024).
[SOURCE: Guide ISO/IEC 99:2007, 2.9, modifié — Les Notes 2 et 3 à l’article ont été supprimées. Une nouvelle
Note 2 à l’article a été ajoutée.]
3.19.2
processus de mesure
ensemble d’opérations permettant de déterminer la valeur d’une grandeur
Note 1 à l'article: Voir la Figure C.3 pour une illustration du processus de mesure.
[SOURCE: ISO 9000:—, 3.12.8, modifié — La Note 1 à l’article a été ajoutée.]
3.19.3
équipement de mesure
instrument de mesure, logiciel, étalon de mesure, matériau de référence ou appareil auxiliaire ou
combinaison de ceux-ci, nécessaires pour réaliser un processus de mesure (3.19.2)
[SOURCE: ISO 9000:—, 3.12.9]
3.19.4
système de management de la mesure
partie d’un système de management (3.4) relatif à la mesure (3.19)
3.20
surveillance
détermination de l’état d’un système, d’un processus (3.8) ou d’une activité
Note 1 à l'article: Pour déterminer cet état, il peut être nécessaire de vérifier, de superviser ou d’observer d’un point de
vue critique.
3.21
prestataire
organisme (3.1) qui procure un produit ou un service
EXEMPLE Producteur, distributeur, détaillant ou marchand d’un produit ou d’un service.
Note 1 à l'article: Un prestataire peut être interne ou externe à l’organisme.
Note 2 à l'article: Dans une situation contractuelle, le prestataire peut être appelé «contractant».
3.22
confirmation métrologique
ensemble d’opérations requises pour assurer qu’un équipement de mesure (3.19.3) est conforme aux exigences
(3.14) pour son utilisation prévue
Note 1 à l'article: La confirmation métrologique comprend généralement l’étalonnage et la vérification, tout réglage
nécessaire ou la réparation et le réétalonnage, la comparaison avec les exigences métrologiques (3.24) pour l’utilisation
prévue de l’équipement de mesure ainsi que tout verrouillage et étiquetage requis.
Note 2 à l'article: La confirmation métrologique n’est considérée comme achevée que lorsque, et si, l’aptitude de
l’équipement de mesure pour l’utilisation prévue est démontrée et documentée.
Note 3 à l'article: Les exigences pour l’utilisation prévue comprennent des considérations telles que l’étendue,
la résolution et les erreurs maximales tolérées.
Note 4 à l'article: Les exigences relatives à la confirmation métrologique sont distinctes, et ne sont pas spécifiées dans
les exigences pour le produit.
3.23
fonction métrologique
fonction qui a la responsabilité administrative et technique de définir et de mettre en œuvre le système de
management de la mesure (3.19.4)
ISO/FDIS 10012:2025(fr)
3.24
exigences métrologiques
ensemble d’exigences (3.14) pour les processus de mesure (3.19.2) qui comprennent les critères et pratiques
nécessaires pour garantir que les mesures (3.19) sont fiables et conformes aux exigences et réglementations
applicables
Note 1 à l'article: Il peut s’agir, entre autres, de l’exactitude et de la précision du processus de mesure, de la traçabilité
métrologique, de la fréquence d’étalonnage, des niveaux de formation du personnel et des opérations de maintenance
nécessaires.
Note 2 à l'article: Les exigences métrologiques pour les processus de mesure sont généralement séparées des exigences
relatives au produit et ne sont pas spécifiées dans ces dernières (généralement indiquées sous la forme d’une limite de
spécification supérieure, inférieure ou des deux).
3.25
service de mesure
une ou plusieurs tâches et processus associés effectués pour mettre en œuvre une mesure ou pour
documenter une mesure
EXEMPLE La réparation d’équipements où des mesures sont utilisées dans le processus de réparation.
4 Contexte de l’organisme
4.1 Comprendre l’organisme et son contexte
L’organisme doit déterminer les enjeux externes et internes pertinents par rapport à sa finalité et qui ont une
incidence sur sa capacité à atteindre le ou les résultats escomptés de son système de management de la mesure.
L’organisme doit déterminer si le changement climatique est un enjeu pertinent.
Il est important de bien comprendre et de spécifier la structure de l’organisme ainsi que son impact sur les
mesures et les résultats escomptés.
Le système de management de la mesure permet le transfert d’informations au sein de l’ensemble de
l’organisme, de sorte que chaque partie de l’organisme travaille avec les mêmes informations.
L’organisme doit surveiller et revoir les informations relatives à tous les enjeux externes et internes
déterminés.
NOTE 1 Les enjeux peuvent comprendre des facteurs positifs et négatifs ou des conditions, à prendre en
considération.
NOTE 2 La compréhension du contexte externe peut être facilitée par la prise en compte des enjeux découlant
de l’environnement juridique, technologique, concurrentiel, commercial, culturel, social et économique, qu’il soit
international, national, régional ou local.
NOTE 3 La compréhension du contexte interne peut être facilitée par la prise en compte des enjeux liés aux valeurs,
à la culture, aux connaissances et à la performance de l’organisme.
4.2 Comprendre les besoins et attentes des parties intéressées
L’organisme doit déterminer:
a) les parties intéressées qui sont concernées dans le cadre du système de management de la mesure;
b) les exigences pertinentes de ces parties intéressées;
c) lesquelles de ces exigences seront traitées par le système de management de la mesure.
ISO/FDIS 10012:2025(fr)
L’organisme doit surveiller et revoir les informations relatives à ces parties intéressées et à leurs exigences
pertinentes.
NOTE Les parties intéressées pertinentes peuvent avoir des exigences relatives aux changements climatiques.
4.3 Déterminer le domaine d’application du système de management de la mesure
L’organisme doit déterminer le ou les périmètres et l’applicabilité du système de management de la mesure
afin d’établir son domaine d’application
Lorsque l’organisme établit ce domaine d’application, il doit prendre en compte:
a) les questions externes et internes auxquels il est fait référence en 4.1;
b) les exigences auxquelles il est fait référence en 4.2.
Le domaine d’application doit être disponible sous la forme d’informations documentées.
Le domaine d’application doit indiquer les types d’activités de mesure associées aux produits et services
couverts. Il doit fournir une justification pour toute exigence du présent document que l’organisme juge non
applicable dans le cadre du domaine d’application de son système de management de la mesure.
4.4 Système de management de la mesure
L’organisme doit établir, mettre en œuvre, tenir à jour et améliorer en continu un système de management de
la mesure, incluant les processus nécessaires et leurs interactions, conformément aux exigences du présent
document (voir la Figure 1). L’objectif du systèmes de management de la mesure est d’atteindre les résultats
escomptés, y compris l’amélioration des performances de management de la mesure.
NOTE 1 Les exigences des clients et la satisfaction des clients concernent les clients externes et internes.
NOTE 2 5M désigne les matériaux, les hommes, les machines, les mesures et les méthodes (voir la Figure C.3).
Figure 1 — Relations entre le système de management de la mesure et le système de management
de la qualité par rapport aux exigences de l’Article 8 «fonctionnement» du présent document et de
l’ISO 9001
ISO/FDIS 10012:2025(fr)
5 Leadership
5.1 Leadership et engagement
La direction générale doit démontrer son leadership et son engagement vis-à-vis du système de management
de la mesure en:
a) s’assurant que la politique et les objectifs de management de la mesure sont établis et qu’ils sont
compatibles avec l’orientation stratégique de l’organisme;
b) s’assurant que les exigences liées au système de management de la mesure sont intégrées aux processus
métiers de l’organisme;
c) s’assurant que les ressources nécessaires pour le système de management de la mesure sont disponibles;
d) communiquant sur l’importance de l’efficacité du management de la mesure et de la conformité aux
exigences du système de management de la mesure;
e) s’assurant que le système de manag
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