SIST EN ISO 10012:2026

SLOVENSKI STANDARD
01-april-2026
Nadomešča:
SIST EN ISO 10012:2003
Vodenje kakovosti - Zahteve za sisteme vodenja meritev (ISO 10012:2026)
Quality management - Requirements for measurement management systems (ISO
10012:2026)
Qualitätsmanagement - Anforderungen an Messmanagementsysteme (ISO 10012:2026)
Management de la qualité - Exigences pour les systèmes de management de la mesure
(ISO 10012:2026)
Ta slovenski standard je istoveten z: EN ISO 10012:2026
ICS:
03.100.70 Sistemi vodenja Management systems
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
17.020 Meroslovje in merjenje na Metrology and measurement
splošno in general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 10012
EUROPEAN STANDARD
NORME EUROPÉENNE
February 2026
EUROPÄISCHE NORM
ICS 03.100.70; 17.020 Supersedes EN ISO 10012:2003
English Version
Quality management - Requirements for measurement
management systems (ISO 10012:2026)
Management de la qualité - Exigences pour les Qualitätsmanagement - Anforderungen an
systèmes de management de la mesure (ISO Messmanagementsysteme (ISO 10012:2026)
10012:2026)
This European Standard was approved by CEN on 11 January 2026.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2026 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10012:2026 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 10012:2026) has been prepared by Technical Committee ISO/TC 176 "Quality
management and quality assurance" in collaboration with CCMC.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by August 2026, and conflicting national standards shall
be withdrawn at the latest by August 2026.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 10012:2003.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 10012:2026 has been approved by CEN as EN ISO 10012:2026 without any modification.

International
Standard
ISO 10012
Second edition
Quality management —
2026-02
Requirements for measurement
management systems
Management de la qualité — Exigences pour les systèmes de
management de la mesure
Reference number
ISO 10012:2026(en) © ISO 2026
ISO 10012:2026(en)
© ISO 2026
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
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or ISO’s member body in the country of the requester.
ISO copyright office
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Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 10012:2026(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 .9
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 People .11
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 . 13
7.5.1 General . 13
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 .16
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 .17
8.3.3 Design and development inputs .17
8.3.4 Design and development controls .19
8.3.5 Design and development outputs . 20
8.3.6 Design and development changes . 22
8.4 Control of externally provided measurement processes, products and services . 22
8.4.1 General . 22

iii
ISO 10012:2026(en)
8.4.2 Type and extent of control . 23
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

iv
ISO 10012:2026(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 10012:2026(en)
Introduction
This document assists organizations who have or intend 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.

vi
International Standard ISO 10012:2026(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 10012:2026(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 10012:2026(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 10012:2026(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.

ISO 10012:2026(en)
1)
[SOURCE: ISO 9000:—, 3.11.8, modified — Note 1 to entry added.]
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:—, 3.11.9]
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).
1) Under preparation. Stage at the time of publication: ISO/FDIS 9000:2025.

ISO 10012:2026(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.

ISO 10012:2026(en)
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 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 (i.e. people), 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
...