IS0

10012-2

First edition
1997-09- 15

Quality assurance for measuring

equipment -
Part 2:
Guidelines for control of measurement
processes
iTeh STANDARD PREVIEW
Assurance de la qua/it6 des kquipements de mesure -
(standards.iteh.ai)
Partie 2: Lignes directrices pour la maftrise des processus de mesure
ISO 10012-2:1997
https://standards.iteh.ai/catalog/standards/sist/27984b8c-6158-45a1-a761-
c4642ae04761/iso-10012-2-1997

INTERNATIONAL
STANDARD Reference number
IS0 10012-2: 1997(E)
IS0 10012-2: 1997(E)

Contents

1 Scope .. .. . .. .. ... ... ... .. .... ... .. .. .. .. .. . ... .. .. ...*....................................................................................................................... 1

2 Normative references .. .. .. .. .. .. .. .. .. .. .. .. .... .. .. .. .. ... .. .. .. ... ... .. .. .. ... .. . ..~...................................................................~........ 1

3 Definitions .. .. ... ... .... ... ... .. . .. .. ... .. .. .. .. .. .. ... .. .. .. ... .. .. ... .. ... .. ... .. .. ... . .. .. .. . .. . .. .. . .. . .. .. .. .. ... . ... .. .. .. .. ........................*..............* 1

4 Recommendations ... ... .. .. .. .. .. .. .. ... .. .. .. ... .. .. .. .. ... .. .. ... .. ... .. ... . ... .. .. . .. .. .. . .. . .. .. . .. .. .. .. .. .. ... .. .. .. .. .. .. .. .. .. .. .........................“.. 6

4.1 General . .. .... .. .... .... .. .. . .. ... . ... .. .. ... .. ... .. .. .. .. ... .. ... .. .. ... .. .. .. .. ... .. . ... . .. . .. .. . .. . .. .. .. . ... .. .. .. .. .. .. ... ......~............................... 6

4.2 Documentation ... .. .. .. .. ... .. .. .. .. ... .. .. ...*....................................................*.........................*.............**.................. 6

4.3 Measurement processes .. ... .. .. .. ... .. .. .. .. ... .. .. ... .. .. ... .. .. .. ... .. .. ...*....*..................................................................... 7

4.4 Measurement process set-up and design . ... . ... .. .. ... .. .. .. .. .. .. .. . .. .. . .. .. . .. .. .. . ... .. ..~............................................... 7

4.5 Metrological confirmation system . .. .. .. ... .. .. ... .. ... .. .. .. .. ... .. .. .. .. . .. . .. . .. .. .. . .. .. ... . ... .. .. . ... .. .. .. .. .. .. .. .. . .. ... . .. .. ... .. ... ... .. 8

4.6 System for the control of measurement processes . ... .. .. .. .. .. .. . .. . .. .. . .. .. .. .. .. .. ... .. . ... .. .. ...~................................ 8
iTeh STANDARD PREVIEW
4.7 Data analysis for the control of measurement processes . . .. .. . .. .. . .. . .. ... . ... .. .. .. .. .. ... . .. ... .. . .. .. .. .. . .. .. ..*............. 8
(standards.iteh.ai)
4.8 Surveillance of the measurement process ... .. .... .. .. . .. ... .. .. ... . . .. .. .. . .. . .. .. ... .. . .. ... .. ..*.......................................... 9
ISO 10012-2:1997
4.9 Intervals of surveillance ... ... .. .. ... .. .. .. .. .. .. .. ... ... .. .... . ... .. . .... .. . ... .. . .. .. . .. .. . .. .. .. ... . .. .. .. .. ... .. .. .. .. .. .. .. . .. .. .. .. .. .. .. ............ 9
https://standards.iteh.ai/catalog/standards/sist/27984b8c-6158-45a1-a761-
c4642ae04761/iso-10012-2-1997
4.10 Indicated failure of a controlled measurement process .. .. . .. . .. .. . .. .. .. .. .. .. .. ... . .. .. .. ... .. .. . ... . .. ..*...*................... 9

4.11 Verification of the measurement process .,................................................................................................ 10

4.12 Identification of verified measurement processes . .. ... .. .. .. . .. .. . ...*.............................................................. 10

4.13 Records of the control of measurement processes .. .. ... . .. .. . .. ..L............................................................... 10

4.14 Personnel . ... ... .. ... .. .. .. .. ... .. .. ..*........................................................................................................................ 10

4.15 Periodic audit and review of the system of control of measurement processes . .. .. .. .. .. .. . .. .. .. .. .. .. ... ... .. 11

Annex A Overview . ... ... .. . ... . ... ... .. .. ... .. ... ... .. .. .. ... .. .. ... .. .... .. .. .. .. ... .. .. .. .. . .. .. . .. .. .. .. .. .. .. .. .. .. .. .. ... ...‘................................. 12

A.1 General ... .. ... .... ... ... ... . .. .. .. ... .. ... .. .. .... .. .. .. ... .. ... .. .. ... .. ... .. ... .. .. .. ... .. . .. .. .. . .. .. .. . ... . .. .. ... .. .. .. .. ...................................... 12

A.2 Using check standards . ... ... .. ... .. ... .. ... .. .. ... . ... ....*.............................................................................................. 14

0 IS0 1997
All rights reserved. Unless otherwise specified, no part of this publication may be
reproduced or utilized in any form or by any means, electronic or mechanical, including
photocopying and microfilm, without permission in writing from the publisher.
International Organization for Standardization
Case postale 56 l CH-1211 Geneve 20 l Switzerland
Internet central @Iiso.ch
x.400 c=ch; a=400net; p=iso; o=isocs; s=central
Printed in Switzerland

ii
0 IS0 IS0 10012=2:1997(E)

A.3 Frequency of monitoring of measurement processes ................................................................................. 15

A.4 Monitoring the control limits .......................................................................................................................... 15

Annex B Bibliography ............................................................................................................................................ 16

iTeh STANDARD PREVIEW

(standards.iteh.ai)
ISO 10012-2:1997
https://standards.iteh.ai/catalog/standards/sist/27984b8c-6158-45a1-a761-
c4642ae04761/iso-10012-2-1997

. ..
III
IS0 10012=2:1997(E) 0 IS0

Foreword

IS0 (the International Organization for Standardization) is a worldwide federation of national standards bodies (IS0
member bodies). The work of preparing International Standards is normally carried out through IS0 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. IS0 collaborates closely with the International Electrotechnical
Commission (IEC) on all matters of electrotechnical standardization.

Draft International Standards adopted by the technical committees are circulated to the member bodies for voting.
Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.

International Standard IS0 10112-2 was prepared by Technical Committee ISOTTC 176, Quality management and
quality assurance, Subcommittee SC 3, Supporting technologies.

IS0 10012 consists of the following parts, under the general title Quality assurance for measuring equipment:

- Par? 1: Metrological confirmation system requirements for measuring equipment

Part 2: Guidelines for control of measurement processes

iTeh STANDARD PREVIEW
Part 1 (now under revision) was published under the title Qualify assurance requirements for measuring equipment
- Par? 1: Metrological confirmation system for measuring equipment.
(standards.iteh.ai)
Annexes A and B of this part of IS0 10012 are for information only.
ISO 10012-2:1997
https://standards.iteh.ai/catalog/standards/sist/27984b8c-6158-45a1-a761-
c4642ae04761/iso-10012-2-1997

iv
0 IS0 IS0 10012-2:1997(E)

Introduction

IS0 10012 is part of the IS0 9000 family of standards.

This part of IS0 10012 is intended to be used as a guidance document for quality management or as a requirement
document by agreement between the Supplier and the Customer. It is written in the context of a Customer and a
Supplier, both terms being interpreted in the broadest sense. The “Supplier” may be a manufacturer, an installer or
a service organization. The “Customer” may be a procurement authority or a customer using a product. Suppliers
become customers when procuring products from vendors or other outside sources.

Reference to this International Standard is recommended to be made:

- by a Customer when specifying products required;

by a Supplier when specifying products offered;

by consumer or employee interests, or by legislative or regulatory bodies;

in assessment and audit of the control of measurement systems.

This part of IS0 10012 includes (in clause 4) both recommendations and guidance. It is written in the context of a
iTeh STANDARD PREVIEW
Customer and a Supplier for a product, all terms being interpreted in the broadest sense given in IS0 8402.

In order to distinguish
(standards.iteh.ai)
clearly between recommendations and guidance, in clause 4 the latter appears in italic type-
face, in a box, after each corresponding paragraph under the heading “GUIDANCE”.
ISO 10012-2:1997
https://standards.iteh.ai/catalog/standards/sist/27984b8c-6158-45a1-a761-
The text under “GUIDANCE” is for information only and contains no requirements. Statements given there are not to
c4642ae04761/iso-10012-2-1997
be construed as adding to, limiting, or modifying any requirement.

Part 1 of IS0 10012 contains general quality assurance requirements for the control of measuring equipment. Part 2
provides supplementary guidance on the application statistical process control when this is appropriate for achieving
the objectives of part 1.

Measurement should be considered as an overall process. The methods for the control of measurement processes,
based on the regular monitoring and analysis of measurement data, are applicable at all levels of measurement,
ranging from the calibration of the Supplier’s measurement standards by an outside metrology laboratory to the
Supplier’s own routine measurements. Procedures for the control of measurement processes can be used

to detect unusual variations in the operation of the measurement process;

- to detect problems with repeatability;

to identify and quantify the compensations or correction factors for any drift;

to help in the identification of predictable periodic variations, including cyclic variations;

to provide some of the documentation required by quality assurance requirements.

This concept of “Measurement Process Control” has also been known as ‘LMeasurement Assurance”.

In practice, the control of measurement processes is specifically applicable to critical or complex measurement
systems (for example for safety or economic purposes). A Supplier may consider that the confirmation system
specified in IS0 10012-I provides adequate control for routine processes, such as the testing of non-critical
components.
IS0 10012=2:1997(E) 0 IS0

The Metrological Confirmation System described in IS0 10012~1 is intended to ensure that the measurements
(performed using measuring equipment that is within its confirmation interval) are sufficiently accurate for the
purpose. However, while the confirmation interval, based on experience, provides a high probability that measuring
equipment is still functioning correctly at the expiry of its confirmation interval, it cannot guard against random failure
or unsuspected and not easily visible damage. Additionally, the metrological confirmation system does not provide
any assurance that the measuring equipment is being used correctly. Even the most accurate measuring equipment
will provide incorrect measurement results when used incorrectly. Correctly written measurement procedures
should be a safeguard, but it is not always possible to ensure that the procedures are being correctly followed.
Controlling measurements as processes, in accordance with part 2 of IS0 10012, reduces the possibilities of
problems arising from random failure, damage or misuse. The effectiveness or degree of such reductions is
determined by how frequently the checks (process controls) are undertaken. The frequency is a matter of
managerial and commercial judgement and, therefore, specific (quantified) recommendations concerning the
frequency will not be made in this part of IS0 10012.

Measuring equipment is only one of many factors affecting measurements. The concept of a “Measurement
process” views measurement as a complete process starting from analysis of the implications of the scientific basis
of the measurement, traceability of the values of measurement standards, calibration and, if necessary, adjustment
through verification and metrological confirmation, to the results produced by the measuring equipment at the place
of work and under the conditions of use.

The operation of a metrological confirmation system often involves measuring equipment having to be taken from its
place of use to a central metrological laboratory for calibration, adjustment or repair and, if necessary, verification
and re-confirmation. It is frequently found that such returned equipment is, in fact, operating correctly, no repairs or
adjustments being necessary. Indeed, if this were not so for a high proportion of the equipment, there would be a
iTeh STANDARD PREVIEW
significant chance that incorrect results had been obtained while it was in use, especially towards the end of its
confirmation interval. If measuring equipment, returned for confirmation merely because it has reached the end of its
(standards.iteh.ai)
confirmation interval, is found to be functioning correctly, it is possible to argue that, with hindsight, it could have
been left in use, at a great saving in cost and inconvenience. The risks of producing erroneous measurement
results will usually dictate that this argument cannotISO
be 10012-2:1997
accepted.
https://standards.iteh.ai/catalog/standards/sist/27984b8c-6158-45a1-a761-
The combination of metrological confirmation and control of measurement processes that is considered to be
c4642ae04761/iso-10012-2-1997
adequate depends on economic aspects, safety, fitness for use and other factors.

An overview of the concept of viewing the control of instruments and equipment as continuous process es is given in
annex A.

A list of informative references is given in annex B.

vi
INTERNATIONAL STANDARD 0 Is0 IS0 10012-2:1997(E)

Quality assurance for measuring equipment -

Part 2:
Guidelines for control of measurement processes

1 Scope

1.1 This part of IS0 10012 contains quality assurance recommendations that may be used by a Supplier to
provide enhanced assurance that measurements are made with the intended accuracy. It also contains guidance on
the implementation of the recommendations.

1.2 It is also intended to be used as a guide for quality management or as a requirement document on agreement
between the Supplier and the Customer.

1.3 iTeh STANDARD PREVIEW

This part of IS0 10012 is applicable to measurement processes. It deals with elements that may affect
measurement results, such as measurement procedures, personnel, etc., not extensively covered in IS0 10012-I.

1.4 This part of IS0

(standards.iteh.ai)
10012 is applicable to
ISO 10012-2:1997
- organizations where measurement is used to demonstrate compliance with specified requirements;
https://standards.iteh.ai/catalog/standards/sist/27984b8c-6158-45a1-a761-
-
c4642ae04761/iso-10012-2-1997
suppliers of products who operate a quality system in which measurement results are used to demonstrate
compliance with specified requirements; this includes operating systems that meet the requirements of
IS0 9001, IS0 9002 and IS0 9003.

2 Normative references

The following standards contain provisions which, through reference in this text, constitute provisions of this part of
IS0 10012. At the time of publication, the editions indicated were valid. All standards are subject to revision, and
parties to agreements based on this part of IS0 10012 are encouraged to investigate the possibility of applying the
most recent editions of the standards indicated below. Members of IEC and IS0 maintain registers of currently valid
International Standards.

IS0 8402: 1994, Quality management and quality assurance - Vocabulary.

IS0 10012-l :I 992, Quality assurance requirements for measuring equipment - Part I: Metrological confirmation
system for measuring equipment,

3 Definitions

For the purposes of this part of IS0 10012, the definitions given in IS0 8402 and the following apply. Most of the
definitions are taken from the International vocabulary of basic and general terms in metrology (VIM). Some are
taken from IS0 10012-I. Relevant reference numbers are given in square brackets following the definitions. These
definitions are included to assist the understanding of the concepts used in this part of IS0 10012 without the need
to consult too many other documents.

1
IS0 10012-2:1997(E) 0 IS0

31
accuracy of measurement
closeness of the agreement between the result of a measurement and a true value of the measurand

NOTES

“Accuracy” is a qualitative concept.

2 The term precision should not be used for “accuracy”.

[VIM: 1993, 3.51

32
abjustment (of a measuring instrument)
operation of bringing a measuring instrument into a state of performance suitable for its use

NOTE Adjustment may be automatic, semiautomatic or manual.

[VIM:1 993, 4.301

33
cilibration
set of operations that establish, under specified conditions, the relationship between values of quantities indicated
by a measuring instrument or measuring system, or values represented by a material measure or a reference
material, and the corresponding values realized by standards

NOTES iTeh STANDARD PREVIEW

1 The result of a calibration permits either the(standards.iteh.ai)
assignment of values of measurands to the indications or the determination of
corrections with respect to indications.
ISO 10012-2:1997
2 A calibration may also determine other metrological properties such as the effect of influence quantities.
https://standards.iteh.ai/catalog/standards/sist/27984b8c-6158-45a1-a761-
3 The result of a calibration may be recorded in c4642ae04761/iso-10012-2-1997
a document, sometimes called a calibration certificate or a calibration report.

[VIM:1 993, 6.1 I]

34
check standard
measuring equipment, product, or other objects serving to collect a data base for the control of a measurement
process, by being measured by that process

NOTES

1 See also VIM:1 993, 6.7, note 2.

2 A check standard should only be used as a check standard.

3 An overview of the use of check standards is given in annex A.

35
cbntrol of measurement processes
monitoring and analysis of data from a measurement process, together with corrective actions, intended to maintain
the process of measurement continuously within a specification

NOTE This may include the use of check standards, control charts, or their equivalents.

36
limits of permissible error (of a measuring instrument)
maximum permissible errors (of a measuring instrument)
extreme values of error permitted by specifications, regulations, etc. for a given measuring instrument

[VIM:1 993, 5.211

2
0 IS0 IS0 10012=2:1997(E)

3.7
measurand
particular quantity subject to measurement

EXAMPLE Vapour pressure of a given sample of water at 20 “C.

NOTE The specification of a measurand may require statements about quantities such as time, temperature and pressure.

[VIM:1 993, 2.61

3.8
measurement
set of operations having the object of determining the value of a quantity

NOTE The operations may be performed automatically.

[VIM:1 993, 2.11

39
measurement procedure
set of operations, described specifically, used in the performance of particular measurements according to a given
method

NOTE A measurement procedure is usually recorded in a document that is sometimes itself called a “measurement
procedure” (or a measurement method) and is usually in sufficient detail to enable an operator to carry out a measurement
without additional information.
iTeh STANDARD PREVIEW
[VIM:1 993, 2.51
(standards.iteh.ai)
3.10
measurement process ISO 10012-2:1997
set of interrelated resources, activities, and influences which produce a measurement
https://standards.iteh.ai/catalog/standards/sist/27984b8c-6158-45a1-a761-
NOTES
c4642ae04761/iso-10012-2-1997
1 The resources concerned include measuring equipment, measurement procedures, operator.
2 “Influences” are all factors such as those caused by the environment which may or may not be cant rolled or controllable and
which add to the variability or the bias of the process.
3 See also definition 1.2 (process) of IS0 84027 994.
4 A measurement process may consist of measurements made, for example, by:

a) various operators using general purpose measuring equipment in a general plant environment, using informal
methods or proced ures;

b) trained calibration laboratory technicians using a measurement system with a temperature controlled oil bath,
reference standard resistors, comparators, and other auxiliary equipment, following a detailed procedure for the
purpose of calibrating other standard resistors;

Cl any variation or combination of or beyond the above two examples.

5 A measurement process may consist of the use of a single measuring instrument.

3.11
measuring equipment
all of the measuring instruments, measurement standards, reference materials, auxiliary apparatus and instructions
that are necessary to carry out a measurement

NOTES

This term includes measuring equipment used in the course of testing and inspection, as well as that used in calibration.

3
IS0 10012-2:1997(E) 0 IS0

2 I n the context of this part of IS0 1001 2, the term “measuring equipment” is taken to encompass “measuring instruments”
and “measurement standards”. More over, a “reference material” is considered to be a type of “measurement standard”.

[Adapted from IS0 10012-I :I 992, 3.21

3.12
measuring instrument
device intended to be used to make measurements, alone or in conjunction with supplementary device(s)

[VIM:1 993, 4.11

3.13
metrological confirmation
set of operations required to ensure that an item of measuring equipment is in a state of compliance with
requirements for its intended use

NOTES

1 Metrological confirmation normally includes, inter alia, calibration, any necessary adjustment or repair and subsequent
recalibration, as well as any required sealing and labelling.

2 For brevity, in this part of IS0 10012, this term is referred to as “confirmation”.

[ISO 10012-1 :I 992, 3.11

3.14
iTeh STANDARD PREVIEW
quality audit
systematic and independent
(standards.iteh.ai)
examination to determine whether quality activities and related results comply with
planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve
ISO 10012-2:1997
objectives https://standards.iteh.ai/catalog/standards/sist/27984b8c-6158-45a1-a761-
c4642ae04761/iso-10012-2-1997
NOTES

1 The quality audit typically applies to, but is not limited to, a quality system or elements thereof, to processes, to products or
to services. Such audits are often called “quality system audit”, “process quality audit”, “product quality audit” or “service quality
audit”.

2 Quality audits are carried out by staff not having direct responsibility in the areas being audited but, preferably, working in
cooperation with the relevant personnel.

3 One purpose of a quality audit is to evaluate the need for improvement or corrective action. An audit should not be confused
with quality surveillance or inspection activities performed for the purpose of process control or product acceptance.

4 Quality audits can be conducted for internal or external purposes.

[ISO 8402:1994, 4.91

3.15
resolution (of a displaying device)
smallest difference between indications of a displaying device that can be meaningfully distinguished

NOTES

For a digital displaying device, this is the change in the indication when the least significant digit changes by one step.

2 This concept also applies to a recording device.

[VIM:1 993, 5.121

4
0 IS0 IS0 10012-2: 1997(E)

3.16
stability
ability of a measuring instrument to maintain constant its metrological characteristics with time

NOTES

Where stability with respect to a quantity other than time is considered, this should be stated explicitly.

2 Stability may be quantified in several ways, for example:

- in terms of the time over which a metrological characteristic changes by a stated amount, or
- in terms of the change in a characteristic over a stated time.

[VIM:1 993, 5.141

3.17
traceability
property of the result of a measurement or the value of a standard whereby it can be related to stated references,
usually national or international standards, through an unbroken chain of comparisons all having stated
uncertainties

NOTES

The concept is often expressed by the adjective “traceable”.

2 The unbroken chain of comparisons is called a “traceability chain”.

[VIM:1 993, 6.101

iTeh STANDARD PREVIEW
3.18
uncertainty of measurement
(standards.iteh.ai)
parameter, associated with the result of a measurement, that characterizes the dispersion of the values that could
reasonably be attributed to the measurand ISO 10012-2:1997
https://standards.iteh.ai/catalog/standards/sist/27984b8c-6158-45a1-a761-
NOTES c4642ae04761/iso-10012-2-1997

1 The parameter may be, for example, a standard deviation (or a given multiple of it), or the half-width of an interval having a
stated Ievel of con fidence.

2 Uncertainty of measurement comprises, in general, many components. Some of these components may be evaluated from
the statistical distribution of the results of series of measurements and can be characterized by experimental standard
deviations. The other components, which can also be characterized by standard deviations, are evaluated from assumed
probability distributions based on experience or other information.

3 It is understood that the result of the measurement is the best estimate of the value of the measurand, and that all
components of uncertainty, including those arising from systematic effects, such as components associated with corrections
and reference standards, contribute to the dispersion.

[VIM:1 993, 3.91

4 This definition is identical with that in the Guide to the expression of uncerfainty in measurement, in which its rationale is
detailed (see, in particular, 2.2.4 and annex D).

3.19
verification
confirmation by examination and provision of objective evidence that specified requirements have been fulfilled

NOTES

1 In design a.nd development, verification concerns the process of examining the result of a given activity to determine
confo rmity with the input requirement for that activity.

2 The term “verified” is used to designate the corresponding status.

[ISO 8402:1994, 2.171