INTERNATIONAL ISO

STANDARD 22514-7

Second edition
2021-08

Statistical methods in process

management — Capability and
performance —
Part 7:
Capability of measurement processes
Méthodes statistiques
iTeh STANDARD dans la gestion de processus — Aptitude et
PREVIEW
performance —
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Partie 7: Aptitude des processus de mesure

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Reference number
ISO 22514-7:2021(E)

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ISO 22514-7:2021(E)


iTeh STANDARD PREVIEW

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ISO 22514-7:2021
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Contents Page

Foreword...........................................................................................................................................................................................................................................v
Introduction................................................................................................................................................................................................................................. vi
1 Scope.................................................................................................................................................................................................................................. 1
2 Normative references....................................................................................................................................................................................... 1
3 Terms and definitions...................................................................................................................................................................................... 2
4 Symbols and abbreviated terms............................................................................................................................................................ 6
4.1 Symbols.......................................................................................................................................................................................................... 6
4.2 Abbreviated terms................................................................................................................................................................................ 9
5 Basic principles....................................................................................................................................................................................................... 9
5.1 General............................................................................................................................................................................................................ 9
5.2 Resolution................................................................................................................................................................................................. 12
5.3 Maximum permissible error known and used.......................................................................................................... 12
5.3.1 General................................................................................................................................................................................... 12
5.3.2 MPE, maximum permissible deviation of the measuring system — uMPE .................. 12
5.4 Capability and performance limits for a measuring system and measurement process...... 13
6 Implementation...................................................................................................................................................................................................13
6.1 General......................................................................................................................................................................................................... 13
6.2 Factors that influence the measurement process................................................................................................... 13
6.2.1
6.2.2
iTeh STANDARD PREVIEW
General................................................................................................................................................................................... 13
Uncertainty components that belong to the measuring system........................................... 14
6.2.3 (standards.iteh.ai)
Additional uncertainty components belonging to the measurement process......... 16
7 Studies for calculating the uncertainty components....................................................................................................19
7.1 Measuring system...............................................................................................................................................................................
ISO 22514-7:2021 19
7.1.1 General................................................................................................................................................................................... 19
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and bias based on one reference standard........................................................... 19
7.1.3 Standard uncertainty from the linearity deviation — uLIN ...................................................... 20
8 Calculation of combined uncertainty............................................................................................................................................23
8.1 General......................................................................................................................................................................................................... 23
8.2 Calculation of expanded uncertainty................................................................................................................................. 25
9 Capability................................................................................................................................................................................................................... 26
9.1 Performance ratios............................................................................................................................................................................ 26
9.1.1 General................................................................................................................................................................................... 26
9.1.2 Performance ratio of the measuring system.......................................................................................... 26
9.1.3 Performance ratio of the measurement process................................................................................ 26
9.2 Capability indices................................................................................................................................................................................ 26
9.3 Capability of a measurement process with one-sided specifications.................................................... 27
10 Capability of the measurement process compared to the capability of the
production process..........................................................................................................................................................................................31
10.1 Relation between observed process capability and measurement capability ratios............... 31
10.2 Relation between observed process capability and measurement capability............................... 32
11 Ongoing review of the measurement process stability..............................................................................................33
11.1 Ongoing review of the stability............................................................................................................................................... 33
12 Capability of attribute measurement processes...............................................................................................................34
12.1 General......................................................................................................................................................................................................... 34
12.2 Capability calculations without using reference values.................................................................................... 34
12.3 Capability calculations using reference values......................................................................................................... 35
12.3.1 Calculation of the uncertainty range............................................................................................................ 35
12.3.2 Symbols.................................................................................................................................................................................. 36
12.3.3 Working steps for determining the uncertainty range................................................................. 37

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12.4 Ongoing review..................................................................................................................................................................................... 38

Annex A (informative) Examples............................................................................................................................................................................40
Annex B (informative) Statistical methods used....................................................................................................................................46
Bibliography.............................................................................................................................................................................................................................. 51

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Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www​.iso​.org/​directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www​.iso​.org/​patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation 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
iTeh STANDARD PREVIEW
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www​.iso​.org/​
iso/​foreword​.html. (standards.iteh.ai)
This document was prepared by Technical Committee ISO/TC 69, Applications of statistical methods,
Subcommittee SC 4, Applications of statistical methods in product and process management.
ISO 22514-7:2021
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This second edition cancels and replaces the first edition (ISO 22514-7:2012), which has been technically
ed9ee735abbb/iso-22514-7-2021
revised.
The main changes compared to the previous edition are as follows:
— use of the MPE values in the calculations;
— revision of the calculation of the linearity, with amendments in the example in Clause A.1;
— addition of a method to calculate the capability when the specifications of the characteristic of
interest is defined as a one-sided specification (new 9.3).
A list of all parts in the ISO 22514 series can be found on the ISO website.
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 22514-7:2021(E)


Introduction
The purpose of a measurement process is to produce measurement results obtained from defined
characteristics on parts or processes. The capability of a measurement process is derived from the
statistical properties of measurements from a measurement process that is operating in a predictable
manner.
Calculations of capability and performance indices are based on measurement results. The uncertainty
of the measurement process used to generate capability and performance indices are estimated before
the indices can be meaningful. The actual measurement uncertainty should be adequately small.
If the measurement process is used to judge whether a characteristic of a product conforms to a
specification or not, the uncertainty of the measurement process is compared to the specification itself.
If the measurement process is used for process control of a characteristic, the uncertainty should be
compared with the process variation. Limits of acceptability are stated for both cases.
The quality of measurement results is given by the uncertainty of the measurement process. This is
defined by the statistical properties of multiple measurements, or estimates of properties, based on the
knowledge of the measurement process.
The methods specified in this document address the implementation uncertainty (for more information
on implementation uncertainty, see ISO 17450-2). Therefore, they are only useful if it is known that
the method uncertainty and the specification uncertainty are small compared to the implementation
uncertainty. This document specifies methods to define and calculate capability indices for
measurement processes based on estimated uncertainties. The approach given in ISO/IEC Guide 98-3
iTeh STANDARD PREVIEW
(GUM) is the basis of this approach.
(standards.iteh.ai)
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INTERNATIONAL STANDARD ISO 22514-7:2021(E)

Statistical methods in process management — Capability

and performance —
Part 7:
Capability of measurement processes

1 Scope
This document defines a procedure to validate measuring systems and a measurement process in order
to state whether a given measurement process can satisfy the requirements for a specific measurement
task with a recommendation of acceptance criteria. The acceptance criteria are defined as a capability
figure (CMS, CMP) or a capability ratio (QMS, QMP).
NOTE This document follows the approach taken in ISO/IEC Guide 98-3 (GUM), and establishes a basic,
simplified procedure for stating and combining uncertainty components used to estimate a capability index for
an actual measurement process.

This document is primarily developed to be used for simple one-dimensional measurement processes,
where it is known that the method uncertainty and the specification uncertainty are small compared
iTeh STANDARD PREVIEW
to the implementation uncertainty. It can also be used in similar cases, where measurements are
used to estimate process capability or process performance. It is not suitable for complex geometrical
(standards.iteh.ai)
measurement processes, such as surface texture and position measurements that rely on several
measurement points or simultaneous measurements in several directions.
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2 Normative references ed9ee735abbb/iso-22514-7-2021
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 3534-1, Statistics — Vocabulary and symbols — Part 1: General statistical terms and terms used in
probability
ISO 3534-2:2006, Statistics — Vocabulary and symbols — Part 2: Applied statistics
ISO 5725-1, Accuracy (trueness and precision) of measurement methods and results — Part 1: General
principles and definitions
ISO 5725-2, Accuracy (trueness and precision) of measurement methods and results — Part 2: Basic method
for the determination of repeatability and reproducibility of a standard measurement method
ISO 5725-3, Accuracy (trueness and precision) of measurement methods and results — Part 3: Intermediate
measures of the precision of a standard measurement method
ISO 5725-4, Accuracy (trueness and precision) of measurement methods and results — Part 4: Basic
methods for the determination of the trueness of a standard measurement method
ISO 5725-5, Accuracy (trueness and precision) of measurement methods and results — Part 5: Alternative
methods for the determination of the precision of a standard measurement method
ISO 5725-6, Accuracy (trueness and precision) of measurement methods and results — Part 6: Use in
practice of accuracy values

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ISO/IEC Guide 98-3:2008, Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in
measurement (GUM:​1995)

3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 3534-1, ISO 3534-2 and
ISO 5725 (all parts), 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://​w ww​.iso​.org/​obp
— IEC Electropedia: available at https://​w ww​.electropedia​.org/​
3.1
maximum permissible measurement error
maximum permissible error
limit of error
MPE
extreme value of measurement error, with respect to a known reference quantity value (3.15), permitted
by specifications or regulations for a given measurement, measuring instrument, or measuring system
Note 1 to entry: Usually, the term “maximum permissible errors” or “limits of error” is used where there are two
extreme values.

iTeh STANDARD PREVIEW

Note 2 to entry: The term “tolerance” cannot be used to designate “maximum permissible error”.

[SOURCE: ISO/IEC Guide 99:2007, 4.26, (standards.iteh.ai)

modified — The abbreviated term "MPE" has been added.]
3.2
measurand ISO 22514-7:2021
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quantity intended to be measured
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Note 1 to entry: The specification of a measurand requires knowledge of the kind of quantity, description of the
state of the phenomenon, body, or substance carrying the quantity, including any relevant component, and the
chemical entities involved.

Note 2 to entry: In the second edition of the VIM and in IEC 60050-300:2001, the measurand is defined as the
“quantity subject to measurement”.

Note 3 to entry: The measurement, including the measuring system and the conditions under which the
measurement is carried out, might change the phenomenon, body, or substance such that the quantity being
measured may differ from the measurand as defined. In this case, adequate correction is necessary.

EXAMPLE 1 The potential difference between the terminals of a battery may decrease when using a voltmeter
with a significant internal conductance to perform the measurement. The open-circuit potential difference can
be calculated from the internal resistances of the battery and the voltmeter.

EXAMPLE 2 The length of a steel rod in equilibrium with the ambient Celsius temperature of 23 °C is different
from the length at the specified temperature of 20 °C, which is the measurand. In this case, a correction is
necessary.

Note 4 to entry: In chemistry, “analyte”, or the name of a substance or compound, are terms sometimes used for
“measurand”. This usage is erroneous because these terms do not refer to quantities.

[SOURCE: ISO/IEC Guide 99:2007, 2.3]

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3.3
measurement uncertainty
uncertainty of measurement
uncertainty
non-negative parameter characterizing the dispersion of the quantity values being attributed to a
measurand (3.2), based on the information used
Note 1 to entry: Measurement uncertainty includes components arising from systematic effects, such as
components associated with corrections and the assigned quantity values of measurement standards, as well
as the definitional uncertainty. Sometimes estimated systematic effects are not corrected for but, instead,
associated measurement uncertainty components are incorporated.

Note 2 to entry: The parameter may be, for example, a standard deviation called standard measurement uncertainty
(3.6) (or a specified multiple of it), or the half-width of an interval, having a stated coverage probability.

Note 3 to entry: Measurement uncertainty comprises, in general, many components. Some of these may be
evaluated by Type A evaluation of measurement uncertainty (3.4) from the statistical distribution of the quantity
values from series of measurements and can be characterized by standard deviations. The other components,
which may be evaluated by Type B evaluation of measurement uncertainty (3.5), can also be characterized by
standard deviations, evaluated from probability density functions based on experience or other information.

Note 4 to entry: In general, for a given set of information, it is understood that the measurement uncertainty is
associated with a stated quantity value attributed to the measurand. A modification of this value results in a
modification of the associated uncertainty.

[SOURCE: ISO/IEC Guide 99:2007, 2.26]

3.4 iTeh STANDARD PREVIEW
Type A evaluation of measurement uncertainty
Type A evaluation
(standards.iteh.ai)
evaluation of a component of measurement uncertainty (3.3) by statistical analysis of measurement
quantity values obtained under defined measurementISO 22514-7:2021conditions
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Note 1 to entry: For various types of measurement conditions, see repeatability condition of measurement,
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intermediate precision condition of measurement, and reproducibility condition of measurement.

Note 2 to entry: For information about statistical analysis, see e.g. ISO/IEC Guide 98-3.

Note 3 to entry: See also ISO/IEC Guide 98-3:2008, 2.3.2, ISO 5725 (all Parts), ISO 13528, ISO 21748, ISO/TS 21749.

[SOURCE: ISO/IEC Guide 99:2007, 2.28]

3.5
Type B evaluation of measurement uncertainty
Type B evaluation
evaluation of a component of measurement uncertainty (3.3) determined by means other than a Type A
evaluation of measurement uncertainty (3.4)
EXAMPLE Evaluation based on information

— associated with authoritative published quantity values,

— associated with the quantity value of a certified reference material,

— obtained from a calibration certificate,

— about drift,

— obtained from the accuracy class of a verified measuring instrument,

— obtained from limits deduced through personal experience.

Note 1 to entry: See also ISO/IEC Guide 98-3:2008, 2.3.3.

[SOURCE: ISO/IEC Guide 99:2007, 2.29]

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3.6
standard measurement uncertainty
standard uncertainty of measurement
standard uncertainty
measurement uncertainty (3.3) expressed as a standard deviation
[SOURCE: ISO/IEC Guide 99:2007, 2.30]
3.7
combined standard measurement uncertainty
combined standard uncertainty
standard measurement uncertainty (3.6) that is obtained using the individual standard measurement
uncertainties associated with the input quantities in a measurement model (3.11)
Note 1 to entry: In case of correlations of input quantities in a measurement model, covariances must
also be taken into account when calculating the combined standard measurement uncertainty; see also
ISO/IEC Guide 98-3:2008, 2.3.4.

[SOURCE: ISO/IEC Guide 99:2007, 2.31]

3.8
expanded measurement uncertainty
expanded uncertainty
product of a combined standard measurement uncertainty (3.7) and a factor larger than the number one
Note 1 to entry: The factor depends upon the type of probability distribution of the output quantity in a
iTeh STANDARD PREVIEW
measurement model (3.11) and on the selected coverage probability.

(standards.iteh.ai)
Note 2 to entry: The term “factor” in this definition refers to a coverage factor.

Note 3 to entry: Expanded measurement uncertainty is termed “overall uncertainty” in paragraph 5 of

ISO 22514-7:2021
Recommendation INC-1 (1980) (see the GUM) and simply “uncertainty” in IEC documents.
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3.9
measurement bias
bias
estimate of a systematic measurement error
[SOURCE: ISO/IEC Guide 99:2007, 2.18]
3.10
measurement result
set of quantity values being attributed to a measurand (3.2), 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 can be more representative of the measurand than others. This can be expressed in the form of a
probability density function (PDF).

Note 2 to entry: A measurement result is generally expressed as a single measured quantity value and a
measurement uncertainty (3.3). If the measurement uncertainty is considered to be negligible for some purpose,
the measurement result may be expressed as a single measured quantity value. In many fields, this is the common
way of expressing a measurement result.

Note 3 to entry: In the traditional literature and in the previous edition of the ISO/IEC Guide 99 (VIM),
measurement result was defined as a value attributed to a measurand and explained to mean an indication, or an
uncorrected result, or a corrected result, according to the context.

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3.11
measurement model
model of measurement
model
mathematical relation among all quantities known to be involved in a measurement
Note 1 to entry: A general form of a measurement model is the equation h(Y, X1, …, Xn) = 0, where Y, the output
quantity in the measurement model, is the measurand (3.2), the quantity value of which is to be inferred from
information about input quantities in the measurement model X1, …, Xn.

Note 2 to entry: In more complex cases, where there are two or more output quantities in a measurement model,
the measurement model consists of more than one equation.

[SOURCE: ISO/IEC Guide 99:2007, 2.48]

3.12
measurement task
quantification of a measurand (3.2) according to its definition
Note 1 to entry: The measurement task is synonymous with the purpose of applying the measurement procedure.

Note 2 to entry: The measurement task can be used, e.g.:

— to compare the measurement results (3.10) with one or two specification limits in order to state whether the
value of the measurand is an admissible value;

— to state whether the measurand characterizing a manufacturing process is within the specifications given;
iTeh STANDARD PREVIEW
— to obtain a confidence interval of given average length for the difference between two values of the same
measurand. (standards.iteh.ai)
3.13 ISO 22514-7:2021
measurement process https://standards.iteh.ai/catalog/standards/sist/5b712493-b5da-48e8-a1d3-
set of operations to determine the ed9ee735abbb/iso-22514-7-2021
value of a quantity
[SOURCE: ISO 9000:2015, 3.11.5]
3.14
resolution
smallest change in a quantity being measured that causes a perceptible change in the corresponding
indication provided by a measuring equipment
Note 1 to entry: Resolution can depend on, for example, noise (internal or external) or friction. It may also depend
on the value of a quantity being measured.

Note 2 to entry: For a digital displaying device, the resolution is equal to the digital step.

Note 3 to entry: Resolution not necessarily linear.

[SOURCE: ISO/IEC Guide 99:2007, 4.14 modified - "provided by a measuring equipment" has been added
in the definition, Notes 2 and 3 to entry have been added.]
3.15
reference quantity value
reference value
quantity value used as a basis for comparison with values of quantities of the same kind
Note 1 to entry: A reference quantity value can be a true quantity value of a measurand (3.2), in which case it is
unknown, or a conventional quantity value, in which case it is known.

Note 2 to entry: A reference quantity value with associated measurement uncertainty (3.3) is usually provided
with reference to:

a) a material, e.g. a certified reference material,

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b) a device, e.g. a stabilized laser,

c) a reference measurement procedure,

d) a comparison of measurement standards.

[SOURCE: ISO/IEC Guide 99:2007, 5.18]

3.16
measurement repeatability
repeatability
measurement precision under repeatability conditions of measurement
[SOURCE: ISO/IEC Guide 99:2007, 2.21]
3.17
measurement reproducibility
reproducibility
measurement precision under reproducibility conditions of measurement
[SOURCE: ISO/IEC Guide 99:2007, 2.25, modified — The Note has been deleted.]
3.18
stability of a measurement process
property of a measurement process (3.13), whereby its properties remain constant in time
3.19
item iTeh STANDARD PREVIEW
entity (standards.iteh.ai)
object
anything that can be described and considered separately
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4.1 Symbols

a half width of a distribution of possible values of input quantity

aOBJ maximal form deviation

α significance level

Bi bias

Bi max maximal found bias

Bi arithmetic mean of biases

CMP measurement process capability index

CMP min minimum measurement process capability index

CMS measuring system capability index

CMS min minimum measuring system capability index

Cp process capability index

Cpk minimum process capability index

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Cp obs observed process capability index

Cp real real process capability index

∆ process dispersion/variation

∆U 50 % process dispersion/variation to upper limit

∆L 50 % process dispersion/variation to lower limit

dLR interval from the last reference value, for which all operators have assessed the result as
unsatisfied to the first reference value, for which all operators have the result as approved

dUR interval from the last reference value, for which all operators have assessed the result as
approved to the first reference value, for which all operators have the result as unsatisfied

k coverage factor

K total number of replicate measurements on one reference. The reference can be a reference
standard or a reference workpiece

kCAL coverage factor from the calibration certificate

l measured length

L lower specification limit

iTeh STANDARD PREVIEW
MPE1 maximum permissible error (of the first characteristic)
(standards.iteh.ai)
MPE2 maximum permissible error (of the second characteristic)
ISO 22514-7:2021
MPE maximum permissible error (of the measuring system) (MPE-value)
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N number of standards

n number of measurements

nij ijth frequencies of measurement results

nji jith frequencies of measurement results

P probability

Pp process performance index

Pp obs observed process performance index

Pp real real process performance index

Qattr attributive measurement process capability ratio

QMS min minimum measuring system capability ratio

QMS measuring system capability ratio

QMP min minimum measurement process capability ratio

QMP measurement process capability ratio

RE resolution of measuring system

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s sample standard deviation (on the mean bias)

sA sample standard deviation (on the measuring system repeatability, ANOVA)

sEV sample standard deviation (on the measuring system repeatability)

sLIN sample standard deviation (from the linearity system repeatability)

sobs sample standard deviation (the observed standard deviation)

sRES sample standard deviation (on the mean bias)

T temperature

ΔT temperature difference

t1-(α/2) the two-sided critical value of Student's t distribution

U upper specification limit

u standard uncertainty

uα standard uncertainty on the coefficient of expansion

uAV standard uncertainty from the operator's reproducibility

uBI iTeh STANDARD PREVIEW

standard uncertainty from the measurement bias

uCAL (standards.iteh.ai)
calibration standard uncertainty on a standard

uEV standard uncertainty from maximum ISOvalue of repeatability or resolution

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uEVR standard uncertainty from repeatability on standards
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uEVO standard uncertainty from repeatability on test parts

uGV standard uncertainty from reproducibility of the measuring system

uIAi standard uncertainty from interactions

uLIN standard uncertainty from linearity of the measuring system

uMP combined standard uncertainty on measurement process

uMPE standard uncertainty calculated based on maximum permissible error

uMS combined standard uncertainty on measuring system

uMS-REST standard uncertainty from other influence components not included in the analysis of the
measuring system

uOBJ standard uncertainty from test part inhomogeneity

uRE standard uncertainty from resolution of measuring system

uREST standard uncertainty from other influence components not included in the analysis of the
measurement process

uSTAB standard uncertainty from the stability of measuring system

uT standard uncertainty from temperature

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uTA standard uncertainty from expansion coefficients

uTD standard uncertainty from temperature difference between workpiece and measuring system

Uattr expanded uncertainty on an attributive measurement

UCAL expanded uncertainty on the calibration of a standard

UMS expanded uncertainty of the measuring system

UMP expanded uncertainty of the measurement process

U LIN expanded uncertainty from linearity of the measuring system

X 0 ,135% 0,135 % quantile of process dispersion

X 50% 50 % quantile of process dispersion

X 99 ,865% 99,865 % quantile of process dispersion

xi ith measurement input quantity

xm reference quantity value

X mid process midpoint

Xnom iTeh STANDARD PREVIEW

nominal value/operating point

xg (standards.iteh.ai)
arithmetic mean of all the sample values

yn nth measurement value ISO 22514-7:2021

https://standards.iteh.ai/catalog/standards/sist/5b712493-b5da-48e8-a1d3-
ynj njth measurement value ed9ee735abbb/iso-22514-7-2021
y average of all measurements

4.2 Abbreviated terms

ANOVA analysis of variance

GPS geometrical product specifications

GUM guide to the expression of the uncertainty of measurement (ISO/IEC Guide 98-3)

MPE maximum permissible error

MPL maximum permissible error limit

SPC statistical process control

VIM international vocabulary of metrology (ISO/IEC Guide 99)

5 Basic principles

5.1 General
The method described in this document covers a large part of the estimation of measurement
uncertainty that occurs in practice. In some cases, where the preconditions set out for this method (no
correlation between influence components, no sensitivity factors, simple linear model present) are not

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