ISO 10012-2:1997
(Main)Quality assurance for measuring equipment — Part 2: Guidelines for control of measurement processes
Quality assurance for measuring equipment — Part 2: Guidelines for control of measurement processes
Assurance de la qualité des équipements de mesure — Partie 2: Lignes directrices pour la maîtrise des processus de mesure
1.1 La présente partie de l'ISO 10012 comporte des recommandations en matière d'assurance de la qualité applicables par un Fournisseur pour s'assurer de manière accrue que les mesurages sont effectués avec l'exactitude voulue. Elle contient également des lignes directrices concernant la mise en oeuvre de ces recommandations. 1.2 La présente partie de l'ISO 10012 a aussi pour but d'être utilisée comme un guide pour le management de la qualité ou comme un document d'exigences par accord entre le Fournisseur et l'Acheteur. 1.3 La présente partie de l'ISO 10012 est applicable aux processus de mesure. Elle traite des éléments pouvant influer sur les résultats des mesurages, tels que les modes opératoires de mesure, le personnel, etc., qui ne sont pas développés dans le détail dans l'ISO 10012-1. 1.4 La présente partie de l'ISO 10012 est applicable -- aux organismes qui utilisent le mesurage pour démontrer la conformité à des exigences spécifiées; -- aux Fournisseurs de produits qui mettent en oeuvre un système qualité dans lequel les résultats des mesurages sont utilisés pour démontrer la conformité à des exigences spécifiées; ceci inclut les systèmes qualité qui satisfont aux exigences de l'ISO 9001, l'ISO 9002 et l'ISO 9003. 19
Zahteve za zagotavljanje kakovosti merilne opreme - 2. del: Obvladovanje merilnih procesov
General Information
Relations
Buy Standard
Standards Content (Sample)
IS0
INTERNATIONAL
10012-2
STANDARD
First edition
1997-09- 15
Quality assurance for measuring
equipment -
Part 2:
Guidelines for control of measurement
processes
Assurance de la qua/it6 des kquipements de mesure -
Partie 2: Lignes directrices pour la maftrise des processus de mesure
Reference number
IS0 10012-2: 1997(E)
---------------------- Page: 1 ----------------------
IS0 10012-2: 1997(E)
Contents
1
1 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.
1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .~.~.
2 Normative references
1
3 Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.*
6
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .“.
4 Recommendations
6
4.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .~.
6
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.*.*.**.
4.2 Documentation
7
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.*.
4.3 Measurement processes
7
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .~.
4.4 Measurement process set-up and design
8
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.5 Metrological confirmation system
8
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .~.
4.6 System for the control of measurement processes
8
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.
4.7 Data analysis for the control of measurement processes
9
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.
4.8 Surveillance of the measurement process
9
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.9 Intervals of surveillance
9
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.*.
4.10 Indicated failure of a controlled measurement process
10
.,.
4.11 Verification of the measurement process
10
. . . . . . . . . . . . . . . . . . . .*.
4.12 Identification of verified measurement processes
10
. . . . . . . . . . . . . . . .L.
4.13 Records of the control of measurement processes
10
4.14 Personnel . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.
11
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.15 Periodic audit and review of the system of control of measurement processes
12
Annex A Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .‘.
12
A.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
14
A.2 Using check standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.
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 @I iso.ch
x.400 c=ch; a=400net; p=iso; o=isocs; s=central
Printed in Switzerland
ii
---------------------- Page: 2 ----------------------
IS0 10012=2:1997(E)
0 IS0
15
.................................................................................
A.3 Frequency of monitoring of measurement processes
15
..........................................................................................................................
A.4 Monitoring the control limits
16
Bibliography .
Annex B
. . .
III
---------------------- Page: 3 ----------------------
0 IS0
IS0 10012=2:1997(E)
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
Part 1 (now under revision) was published under the title Qualify assurance requirements for measuring equipment
- Par? 1: Metrological confirmation system for measuring equipment.
Annexes A and B of this part of IS0 10012 are for information only.
iv
---------------------- Page: 4 ----------------------
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
Customer and a Supplier for a product, all terms being interpreted in the broadest sense given in IS0 8402.
In order to distinguish 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”.
The text under “GUIDANCE” is for information only and contains no requirements. Statements given there are not to
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.
---------------------- Page: 5 ----------------------
0 IS0
IS0 10012=2:1997(E)
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
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
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 cannot be accepted.
The combination of metrological confirmation and control of measurement processes that is considered to be
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
---------------------- Page: 6 ----------------------
IS0 10012-2:1997(E)
INTERNATIONAL STANDARD 0 Is0
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 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 10012 is applicable to
- organizations where measurement is used to demonstrate compliance with specified requirements;
- 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
---------------------- Page: 7 ----------------------
0 IS0
IS0 10012-2:1997(E)
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
1 The result of a calibration permits either the assignment of values of measurands to the indications or the determination of
corrections with respect to indications.
2 A calibration may also determine other metrological properties such as the effect of influence quantities.
3 The result of a calibration may be recorded in 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
---------------------- Page: 8 ----------------------
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.
[VIM:1 993, 2.51
3.10
measurement process
set of interrelated resources, activities, and influences which produce a measurement
NOTES
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:
various operators using general purpose measuring equipment in a general plant environment, using informal
a)
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;
any variation or combination of or beyond the above two examples.
Cl
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
---------------------- Page: 9 ----------------------
0 IS0
IS0 10012-2:1997(E)
2 I 1001 the term “measuring equipment” is taken to encompass “measuring instruments”
n the context of this part of IS0 2,
and over, a “reference material” is considered to be a type of “measurement standard”.
“measurement standards”. More
[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
quality audit
systematic and independent 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
objectives
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”.
responsibility in the areas being audited but, preferably, working in
2 Quality audits are carried out by staff not having direct
cooperation with
the relevant personnel.
or corrective action. An audit should not be confused
3 One purpose of a quality audit is to evaluate the need for improvement
of process control or product acceptance.
with quality surveillance or inspection activities performed for the purpose
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
---------------------- Page: 10 ----------------------
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
3.18
uncertainty of measurement
parameter, associated with the result of a measurement, that characterizes the dispersion of the values that could
reasonably be attributed to the measurand
NOTES
given multiple of it), or the half-width of an interval having a
1 The parameter may be, for example, a standard deviation (or a
stated I evel 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 concerns the process of examining the result of a given activity to determine
design a .nd development, verification
confo rmity with activity.
the input requirement for that
2 The term “verified” is used to designate the corresponding status.
[ISO 8402:1994, 2.171
---------------------- Page: 11 ----------------------
0 IS0
IS0 10012=2:1997(E)
4 Recommendations
4.1 General
The Supplier should establish and document objective performance criteria and procedures for measurement
processes and the control of measurement processes. They should be specific in terms of which measurement
processes are subject to the provisions of this part of IS0 10012.
The Supplier should ensure that all procedures are adequate for their purpose. In particular, procedures should
contain sufficient information to ensure their proper implementation, to ensure consistency of application from one
application to another, and to ensure valid measurement results.
The procedures should provide for the prompt detection of deviations exceeding the stated limits of permissible
deviation, and for their timely correction.
The procedures should be available, as necessary, to staff involved in performing measurements and the control of
measurement processes.
GUIDANCE
Procedures may be, but are not necessarily, limited to the compilation of published standard measurement
process control practices. The amount of detail in procedures should be commensurate with the complexity of the
measurements and the control of the measurement processes.
It is not economical for the supplier and customer to control all measurement processes equally. The supplier and
customer should examine complex measurement processes, and agree which par?(s) of the process are critical
and suitable for the application of the requirements of this par? of IS0 100 12.
4.2 Documentation
The Supplier should document the methods used to implement each recommendation of this part of IS0 10012.
This documentation should be an integral part of the Supplier’s quality system. It should be specific in terms of
which items of equipment (including computer hardware and software) are included in each measurement process.
The documentation should state the allocation of responsibilities and the actions to be taken. The required
performance of the measurement process should be documented.
GUIDANCE
Examples of documentation may include:
- specification of measuring instruments;
- measurement procedures;
- instructions for the operator,.
- validation reports;
- verification repotis;
- measurement uncertainty budgets;
limits of permissible error;
-
- details of and/or listings of computer programs used.
NOTE
“Documentation” is used in the widest possible sense to cover all means of recording and presenting information.
6
---------------------- Page: 12 ----------------------
0 IS0 IS0 10012=2:1997(E)
4.3 Measurement processes
The performance characteristics required for the intended use of the measurement process should be
characterized.
GUIDANCE
Examples of the characteristics for instruments, equipment or methods include:
- uncertainty in use;
- stability;
- range;
- resolution;
- repeatability;
- reproducibility;
- skill level of operator.
Other characteristics may be important for some measurement processes.
Measurement processes and documentation should be maintained to take account of any corrections, conditions of
use (including environmental conditions), etc. that are necessary to achieve the required performance.
The Supplier should fully specify and document each measurement process that is
...
SLOVENSKI STANDARD
SIST ISO 10012-2:1998
01-avgust-1998
Zahteve za zagotavljanje kakovosti merilne opreme - 2. del: Obvladovanje merilnih
procesov
Quality assurance for measuring equipment -- Part 2: Guidelines for control of
measurement processes
Assurance de la qualité des équipements de mesure -- Partie 2: Lignes directrices pour
la maîtrise des processus de mesure
Ta slovenski standard je istoveten z: ISO 10012-2:1997
ICS:
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
17.020 Meroslovje in merjenje na Metrology and measurement
splošno in general
SIST ISO 10012-2:1998 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST ISO 10012-2:1998
---------------------- Page: 2 ----------------------
SIST ISO 10012-2:1998
IS0
INTERNATIONAL
10012-2
STANDARD
First edition
1997-09- 15
Quality assurance for measuring
equipment -
Part 2:
Guidelines for control of measurement
processes
Assurance de la qua/it6 des kquipements de mesure -
Partie 2: Lignes directrices pour la maftrise des processus de mesure
Reference number
IS0 10012-2: 1997(E)
---------------------- Page: 3 ----------------------
SIST ISO 10012-2:1998
IS0 10012-2: 1997(E)
Contents
1
1 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.
1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .~.~.
2 Normative references
1
3 Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.*
6
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .“.
4 Recommendations
6
4.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .~.
6
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.*.*.**.
4.2 Documentation
7
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.*.
4.3 Measurement processes
7
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .~.
4.4 Measurement process set-up and design
8
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.5 Metrological confirmation system
8
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .~.
4.6 System for the control of measurement processes
8
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.
4.7 Data analysis for the control of measurement processes
9
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.
4.8 Surveillance of the measurement process
9
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.9 Intervals of surveillance
9
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.*.
4.10 Indicated failure of a controlled measurement process
10
.,.
4.11 Verification of the measurement process
10
. . . . . . . . . . . . . . . . . . . .*.
4.12 Identification of verified measurement processes
10
. . . . . . . . . . . . . . . .L.
4.13 Records of the control of measurement processes
10
4.14 Personnel . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.
11
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.15 Periodic audit and review of the system of control of measurement processes
12
Annex A Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .‘.
12
A.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
14
A.2 Using check standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.
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 @I iso.ch
x.400 c=ch; a=400net; p=iso; o=isocs; s=central
Printed in Switzerland
ii
---------------------- Page: 4 ----------------------
SIST ISO 10012-2:1998
IS0 10012=2:1997(E)
0 IS0
15
.................................................................................
A.3 Frequency of monitoring of measurement processes
15
..........................................................................................................................
A.4 Monitoring the control limits
16
Bibliography .
Annex B
. . .
III
---------------------- Page: 5 ----------------------
SIST ISO 10012-2:1998
0 IS0
IS0 10012=2:1997(E)
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
Part 1 (now under revision) was published under the title Qualify assurance requirements for measuring equipment
- Par? 1: Metrological confirmation system for measuring equipment.
Annexes A and B of this part of IS0 10012 are for information only.
iv
---------------------- Page: 6 ----------------------
SIST ISO 10012-2:1998
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
Customer and a Supplier for a product, all terms being interpreted in the broadest sense given in IS0 8402.
In order to distinguish 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”.
The text under “GUIDANCE” is for information only and contains no requirements. Statements given there are not to
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.
---------------------- Page: 7 ----------------------
SIST ISO 10012-2:1998
0 IS0
IS0 10012=2:1997(E)
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
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
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 cannot be accepted.
The combination of metrological confirmation and control of measurement processes that is considered to be
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
---------------------- Page: 8 ----------------------
SIST ISO 10012-2:1998
IS0 10012-2:1997(E)
INTERNATIONAL STANDARD 0 Is0
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 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 10012 is applicable to
- organizations where measurement is used to demonstrate compliance with specified requirements;
- 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
---------------------- Page: 9 ----------------------
SIST ISO 10012-2:1998
0 IS0
IS0 10012-2:1997(E)
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
1 The result of a calibration permits either the assignment of values of measurands to the indications or the determination of
corrections with respect to indications.
2 A calibration may also determine other metrological properties such as the effect of influence quantities.
3 The result of a calibration may be recorded in 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
---------------------- Page: 10 ----------------------
SIST ISO 10012-2:1998
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.
[VIM:1 993, 2.51
3.10
measurement process
set of interrelated resources, activities, and influences which produce a measurement
NOTES
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:
various operators using general purpose measuring equipment in a general plant environment, using informal
a)
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;
any variation or combination of or beyond the above two examples.
Cl
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
---------------------- Page: 11 ----------------------
SIST ISO 10012-2:1998
0 IS0
IS0 10012-2:1997(E)
2 I 1001 the term “measuring equipment” is taken to encompass “measuring instruments”
n the context of this part of IS0 2,
and over, a “reference material” is considered to be a type of “measurement standard”.
“measurement standards”. More
[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
quality audit
systematic and independent 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
objectives
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”.
responsibility in the areas being audited but, preferably, working in
2 Quality audits are carried out by staff not having direct
cooperation with
the relevant personnel.
or corrective action. An audit should not be confused
3 One purpose of a quality audit is to evaluate the need for improvement
of process control or product acceptance.
with quality surveillance or inspection activities performed for the purpose
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
---------------------- Page: 12 ----------------------
SIST ISO 10012-2:1998
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
3.18
uncertainty of measurement
parameter, associated with the result of a measurement, that characterizes the dispersion of the values that could
reasonably be attributed to the measurand
NOTES
given multiple of it), or the half-width of an interval having a
1 The parameter may be, for example, a standard deviation (or a
stated I evel 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 concerns the process of examining the result of a given activity to determine
design a .nd development, verification
confo rmity with activity.
the input requirement for that
2 The term “verified” is used to designate the corresponding status.
[ISO 8402:1994, 2.171
---------------------- Page: 13 ----------------------
SIST ISO 10012-2:1998
0 IS0
IS0 10012=2:1997(E)
4 Recommendations
4.1 General
The Supplier should establish and document objective performance criteria and procedures for measurement
processes and the control of measurement processes. They should be specific in terms of which measurement
processes are subject to the provisions of this part of IS0 10012.
The Supplier should ensure that all procedures are adequate for their purpose. In particular, procedures should
contain sufficient information to ensure their proper implementation, to ensure consistency of application from one
application to another, and to ensure valid measurement results.
The procedures should provide for the prompt detection of deviations exceeding the stated limits of permissible
deviation, and for their timely correction.
The procedures should be available, as necessary, to staff involved in performing measurements and the control of
measurement processes.
GUIDANCE
Procedures may be, but are not necessarily, limited to the compilation of published standard measurement
process control practices. The amount of detail in procedures should be commensurate with the complexity of the
measurements and the control of the measurement processes.
It is not economical for the supplier and customer to control all measurement processes equally. The supplier and
customer should examine complex measurement processes, and agree which par?(s) of the process are critical
and suitable for the application of the requirements of this par? of IS0 100 12.
4.2 Documentation
The Supplier should document the methods used to implement each recommendation of this part of IS0 10012.
This documentation should be an integral part of the Supplier’s quality system. It should be specific in terms of
which items of equipment (including computer hardware and software) are included in each measurement process.
The documentation should state the allocation of responsibilities and the actions to be taken. The required
performance of the measurement process should be documented.
GUIDANCE
Examples of documentation may include:
- specification of measuring instruments;
- measurem
...
NORME IS0
INTERNATIONALE
10012-2
Premikre bdition
1997-09- 15
Assurance de la qualit des equipements
de mesure -
Partie 2:
Lignes directrices pour la maTtrise des
processus de mesure
Quality assurance for measuring equipment -
Part 2: Guidelines for control of measurement processes
Numkro de rbfkence
IS0 10012-23 997(F)
---------------------- Page: 1 ----------------------
IS0 10012=2:1997(F)
Sommaire
1 Domaine d’application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .~. 1
2 Refhences normatives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*. 1
3 Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*. 1
4 Recommandations .*.,. 6
4.1 G&&alit& . . . . . . . . . . . . . . . . . . . .*.*. 6
4.2 Documentation .,.,.*.*. 6
4.3 Processus de mesure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .~. 7
4.4 lnitialisation et conception du processus de mesure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.*. a
4.5 Systkme de confirmation metrologique . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*. a
4.6 Systgme de la ma’itrise des processus de mesure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.
a
4.7 Analyse des donnees pour la maitrise des processus de mesure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . a
4.8 Surveillance du processus de mesure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
4.9 Intervalles de surveillance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .~. 9
4.10 Indication de defaillance d’un processus de mesure maitrise . . . . . . . . . . . . . . . . . . . . . . . . . . . .*. 9
4.11 Verification du processus de mesure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IO
4.12 Identification des processus de mesure vbrifiks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .~.~. IO
4.13 Conservation des rhultats de la maitrise des processus de mesure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IO
4.14 Personnel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.=.*. 11
4.15 Audit qualit et revue pkiodiques du systgme de maitrise des processus de mesure l . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Annexe A (informative) Prhentation g&&-ale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
A.1 Gh&alitks . . . . . .*. 12
A.2 Utilisation d’htalons de contrble . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .~. 14
0 IS0 1997
Droits de reproduction reserves. Sauf prescription differente, aucune partie de cette publi-
cation ne peut etre reproduite ni utilisee sous quelque forme que ce soit et par aucun pro-
cede, electronique ou mecanique, y compris la photocopie et les microfilms, sans I’accord
ecrit de I’editeur.
Organisation internationale de normalisation
Case postale 56 l CH-1211 Geneve 20 l Suisse
central @ iso.ch
Internet
x.400 c=ch; a=400net; p=iso; o=isocs; s=central
lmprime en Suisse
II
---------------------- Page: 2 ----------------------
0 IS0 IS0 10012=2:1997(F)
................................................................................. 15
A.3 Frbquence de surveillance des processus de mesure
.................................................................................................................... 15
A.4 Suivi des Iimites de surveillance
..................................................................................................................... 16
Annexe B (informative) Bibliographie
---------------------- Page: 3 ----------------------
IS0 10012=2:1997(F) 0 IS0
Avant-propos
L’ISO (Organisation internationale de normalisation) est une federation mondiale d’organismes nationaux de
normalisation (comites membres de I’ISO). L’elaboration des Normes internationales est en general confiee aux
comites techniques de I’ISO. Chaque comite membre interesse par une etude a le droit de faire pat-tie du comite
technique tree a cet effet. Les organisations internationales, gouvernementales et non gouvernementales, en
liaison avec I’ISO participent egalement aux travaux. L’ISO collabore etroitement avec la Commission
electrotechnique internationale (CEI) en ce qui concerne la normalisation electrotechnique.
Les projets de Normes internationales adopt& par les comites techniques sont soumis aux comites membres pour
vote. Leur publication comme Normes internationales requiert I’approbation de 75 % au moins des comites
membres votants.
La Norme internationale IS0 10112-2 a ete elaboree par le comite technique lSO/TC 176, Management et
assurance de la qualite, sous-comite SC 3, Techniques de soutien.
L’ISO 10012 comprend les parties suivantes, presentees sous le titre general Assurance de la qua/M des
equipements de mesure:
- Partie I: Exigences concernant la confirmation metrologique de I’equipement de mesure
- Pariie 2: Lignes directrices pour la maitrise des processus de mesure.
La partie 1 (en tours de revisio #n a l’heure actuelle) a ete publiee sous le titre Exigences d’assurance de la
quake
des equipements de mesure - Partie I: Confirmation metrologique de I’equipement de mesure.
Les annexes A et B de la presente partie de I’ISO 10012 sont donnees uniquement a titre d’information.
---------------------- Page: 4 ----------------------
0 IS0
IS0 10012=2:1997(F)
introduction
L’ISO 10012 fait pat-tie de la famille des normes IS0 9000.
La presente pat-tie de I’ISO 10012 est concue pour etre utilisee comme un document de conseil pour le
management de la qualite ou comme un document d’exigences par accord entre le Fournisseur et le Client. La
presente par-tie de I’ISO 10012 est redigee dans le contexte Client-Fournisseur, ces deux termes &ant interpret&
au sens le plus large. Par << Fournisseur >>, on peut entendre aussi bien le fabricant que I’installateur ou le
prestataire de services. Le << Client >> peut designer une agence administrative publique ou un client utilisateur d’un
produit. Les Fournisseurs deviennent Clients lorsqu’ils sont amen& a se procurer des produits aupres de vendeurs
ou d’autres sources exterieures.
La reference a la presente partie de I’ISO 10012 peut etre faite
par un Client, lors de la specification des produits demand&;
par un Fournisseur, lors de la specification des produits offer-k;
- par des organismes representatifs des interets des consommateurs ou des travailleurs, ou par des organismes
legislatifs ou statutaires;
dans le cadre de I’evaluation et de I’audit de la maitrise des systemes de mesurage.
La presente partie de I’ISO 10012 contient (a I’article 4) a la fois des recommandations et des lignes directrices. Elle
est &rite dans le contexte d’un Client et d’un Fournisseur pour un produit, tous les termes etant compris dans
I’acception la plus large donnee dans I’ISO 8402.
Afin de bien faire la distinction entre recommandations et lignes directrices, dans I’article 4, les lignes directrices
sont encadrees et imprimees en italique sous le titre << GUIDE D’APPLICATION >>, apparaissant apres chaque
paragraphe correspondant.
Le texte dans <> est donne uniquement a titre d’information et ne comporte aucune
exigence. L’enonce qui y figure ne doit pas etre interprete comme ajout, restriction ou modification d’une exigence
quelconque.
La partie 1 de I’ISO 10012 contient des exigences g&kales d’assurance qualite pour la maTtrise des equipements
de mesure. La partie 2 fournit des lignes directrices supplementaires sur I’application de la maytrise statistique des
processus lorsque cela est justifie pour atteindre les objectifs de la pat-tie 1.
II convient de considerer le mesurage comme un processus global. Les methodes pour la maTtrise des processus
de mesure, fondees sur la surveillance et I’analyse regulieres des donnees de mesurage, sont applicables a tous
les niveaux du mesurage, depuis l’etalonnage des etalons de mesure du Fournisseur par un laboratoire de
metrologie exterieur jusqu’aux mesurages de routine propres au Fournisseur. Les procedures de ma7trise des
processus de mesure peuvent etre utilisees
- pour detecter des variations inhabituelles dans la mise en oeuvre du processus de mesure;
pour detecter des problemes de repetabilite;
pour identifier et quantifier les facteurs de compensation ou de correction pour toute derive;
pour aider a I’identification des variations periodiques previsibles, y compris les variations cycliques;
pour fournir une partie de la documentation demandee par les exigences de I’assurance qualite.
---------------------- Page: 5 ----------------------
0 IS0
IS0 10012=2:1997(F)
de mesure >) est aussi connu sous I’appellation << Assurance du
Ce concept de << Mait rise des processus
mesurage >>.
Dans la pratique, la maitrise des processus de mesure est applicable aux systkmes de mesurage critiques ou
complexes (par exemple B des fins konomiques ou de skuritk). Un Fournisseur peut considkrer que le systkme
de confirmation spkifi6 dans I’ISO 10012-I permet une ma’itrise adbquate pour des processus de routine tels que
I’essai de composants non critiques.
Le systhme de confirmation m&rologique dkcrit dans I’ISO 10012-I est destin6 & assurer que les mesures
(obtenues h I’aide d’un bquipement de mesure se trouvant dans son intervalle de confirmation) sont suffisamment
exactes pour I’objectif fix& Cependant, bien que I’intervalle de confirmation, fond6 sur I’expkience, garantisse avec
une forte probabilitk que I’kquipement de mesure continuera h fonctionner correctement au terme de cet intervalle, il
ne peut le mettre & I’abri d’une panne alkatoire ou d’un dommage imprhvisible et peu apparent. De plus, le systkme
de confirmation mktrologique ne permet pas d’assurer que I’kquipement de mesure est utilis6 correctement. M&me
I’kquipement de mesure le plus exact, s’il est mal utilis6, fournira des r6sultats de mesurage incorrects. Des modes
opkratoires de mesure correctement krits constituent gh&alement une skuritk; il n’est nkanmoins pas toujours
possible d’assurer que ces modes opkatoires sont appliquks convenablement. La maTtrise des mesurages, en tant
que processus conforme B la pksente partie I’ISO 10012, rkduit les possibilitks de probkmes provenant de pannes
alkatoires, de dommages ou de mauvaise utilisation. L’efficacitk ou degri! de telles rkductions est d6termin6 par la
fkquence h laquelle les contr6les (contreles du processus) sont entrepris. La fkquence est une question de
jugement kconomique et de management et, par consequent, des recommandations spkcifiques (quantifiees)
concernant la frkquence ne seront pas donnees dans la presente partie I’ISO 10012.
L’bquipement de mesure n’est que I’un des nombreux facteurs influant sur les mesurages. Le concept de
<< Processus de mesure >) considkre le mesurage comme un processus complet commenqant par I’analyse des
bases scientifiques du mesurage, la traGabilit6 des valeurs des 6talons de mesure, I’ktalonnage et, si nkcessaire,
I’ajustage, passant par une vhification et une confirmation m6trologique, et aboutissant aux ri!sultats produits par
I’kquipement de mesure sur le lieu de travail et dans les conditions normales d’utilisation.
La mise en ceuvre d’un systkme de confirmation mktrologique entrahe souvent le dbplacement de I’6quipement de
mesure de son lieu d’utilisation vers un Iaboratoire central de m&rologie pour &re &alonn& ajust ou @par6 si
nkcessaire, vkifii! et reconfirm& On s’aperGoit frkquemment qu’un tel kquipement fonctionne en fait correctement
et que des rkparations ou des ajustages ne sont pas nkessaires. Si le cas contraire est constate pour une forte
proportion d’kquipements, la probabilitk pour que cet appareil ait fourni des rksultats incorrects est forte,
particulihrement vers la fin de I’intervalle de confirmation. Lorsqu’un kquipement de mesure, retourni! pour
confirmation simplement parce qu’il a atteint son intervalle de confirmation, s’avkre fonctionner correctement, il est
possible d’argumenter apt& coup qu’il aurait pu 6tre laiss6 en service, konomisant ainsi grandement les cotits et
inconvhients correspondants. Les risques qui rksultent de la fourniture de r&ultats error& imposent de ne pas
accepter ce type de raisonnement.
La combinaison de la confirmation m6trologique et de la ma’itrise des processus de mesure est fonction de
considkrations konomiques, d’aspects de s6curit6, de l’usage qui est fait de I’instrument, ainsi que d’autres
facteurs.
L’annexe A fournit une prksentation g&kale du concept consistant & considker la ma;itrise des instruments et
6quipement comme un processus continu.
Une Iiste de r6fkences informatives est donnke en annexe B.
---------------------- Page: 6 ----------------------
NORME INTERNATIONALE o IS0
IS0 10012=2:1997(F)
Assurance de la qualit des equipements de mesure -
Partie 2:
Lignes directrices pour la maTtrise des processus de mesure
1 Domaine d’application
1.1 La presente partie de I’ISO 10012 comporte des recommandations en matiere d’assurance de la qualite
applicables par un Fournisseur pour s’assurer de maniere accrue que les mesurages sont effect&s avec
I’exactitude voulue. Elle contient egalement des lignes directrices concernant la mise en oeuvre de ces
recommandations.
1.2 La presente partie de I’ISO 10012 a aussi pour but d’etre utilisee comme un guide pour le management de la
qualite ou comme un document d’exigences par accord entre le Fournisseur et I’Acheteur.
1.3 La presente partie de I’ISO 10012 est applicable aux processus de mesure. Elle traite des elements pouvant
influer sur les resultats des mesurages, tels que les modes operatoires de mesure, le personnel, etc., qui ne sont
pas developpes dans le detail dans I’ISO 10012-I.
1.4 La presente partie de I’ISO 10012 est applicable
- aux organismes qui utilisent le mesurage pour demontrer la conformite a des exigences specifiees;
- aux Fournisseurs de produits qui mettent en ceuvre un systeme qualite dans lequel les resultats des
mesurages sont utilises pour demontrer la conformite a des exigences specifiees; ceci inclut les systemes
qualite qui satisfont aux exigences de I’ISO 9001, I’ISO 9002 et I’ISO 9003.
2 Rbfbrences normatives
Les normes suivantes contiennent des dispositions qui, par suite de la reference qui en est faite, constituent des
dispositions valables pour la presente par-tie de I’ISO 10012. Au moment de la publication, les editions indiquees
etaient en vigueur. Toute norme est sujette a revision et les parties prenantes des accords fond& sur la presente
par-tie de I’ISO 10012 sont invitees a rechercher la possibilite d’appliquer les editions les plus recentes des normes
indiquees ci-apres. Les membres de la CEI et de I’ISO possedent le registre des Normes internationales en vigueur
a un moment don&.
IS0 8402:1994, Management de la qua/it6 et assurance de la qua/S - Vocabulaire.
IS0 10012-I :I 992, Exigences d/assurance de /a qua/it6 des kquipements de mesure - Partie I: Confirmation
mktrologique de Gquipemen t de mesure.
3 Dbfinitions
Pour les besoins de la presente pat-tie de I’ISO 10012, les definitions donnees dans I’ISO 8402 et les definitions
suivantes s’appliquent. La plupart des definitions sont issues du Vocabulaire international des termes fondamentaux
et generaux de metrologie (VIM). Certaines sont issues de I’ISO 10012-I. Les numeros de reference
1
---------------------- Page: 7 ----------------------
0 IS0
IS0 10012=2:1997(F)
correspondants figurent entre crochets apres chaque definition. Ces dbfinitions sont incluses pour aider & la
comprehension des concepts utilises dans la presente partie de I’ISO 10012 sans qu’il soit nkessaire de consulter
trop de documents.
3.1
exactitude de mesure
etroitesse de I’accord entre le rksultat d’un mesurage et une valeur vraie du mesurande
NOTES
Le concept d’<< exactitude >> est qualificatif.
2 Le terme << precision >> ne doit pas etre utilise pour << exactitude Y
[VIM:1 993, 3.51
32
aiustage (d’un instrument de mesure)
operation destinee a amener un instrument de mesure a un etat de fonctionnement convenant a son utilisation
NOTE L’ajustage peut etre automatique, semi-automatique ou manuel.
[VIM:1 993, 4.301
33
Galonnage
ensemble des opkrations btablissant, dans des conditions spkifibes, la relation entre les valeurs de la grandeur
indiqubes par un appareil de mesure ou un systeme de mesure, ou les valeurs reptkentbes par une mesure
materialisee ou un materiau de reference, et les valeurs correspondantes de la grandeur realisees par des etalons
NOTES
1 Le resultat d’un etalonnage permet soit d’attribue r aux i ns les valeurs correspondantes du mesurande, soit de
determiner les corrections a appliquer aux indications.
que les effets de grandeurs
2 Un etalonn age peut servir a determiner d’autres proprietes metrologiques
d’i nfluence.
d’etalonnage ou rapport
3 Le resultat d’un n nage peut etre consigne dans un document parfois appele certif icat
d’etalonnage.
[VIM:1 993, 6.1 I]
34
halon de contkle
equipement de mesure, produit ou autres objets servant a collecter des donnees visant a la maytrise d’un processus
de mesure, en le soumettant a des mesurages realises par ce processus
NOTES
1 Voir egalement VIM:1 993, 6.7, note 2.
2 II convient d’utiliser un etalon de controle uniquement pour cet usage.
3 Une presentation generale de I’utilisation des etalons de controle est donnee en annexe A.
35
iaitrise des processus de mesure
surveillance et analyse des donnees issues d’un processus de mesure, associees a des actions correctives et
destinees a maintenir continuellement le processus de mesure a l’interieur d’une specification
NOTE Ceci peut inclure I’utilisation d’etalons de controle et de cartes de controle, ou leurs equivalents.
2
---------------------- Page: 8 ----------------------
0 IS0
IS0 10012=2:1997(F)
3.6
erreurs maximales tolbrees (d’un instrument de mesure)
limites d’erreur tolhrkes (d’un instrument de mesure)
valeurs extremes d’une erreur tolerees par les specifications, reglements, etc., pour un instrument de mesure donne
[VIM:1 993, 5.211
37
iesurande
grandeur particuliere soumise a mesurage
EXEMPLE pression de vapeur d’un echantillon donne d’eau a 20 “C.
NOTE La definition du mesurande peut necessiter des indications relatives a des grandeurs telles que le temps, la
temperature et la pression.
[VIM:1 993, 2.61
3.8
mesurage
ensemble d’operations ayant pour but de determiner une valeur d’une grandeur
NOTE Le deroulement des operations peut etre automatique.
[VIM:1 993, 2.11
3.9
mode ophratoire (de mesure)
ensemble des operations, d&rites d’une maniere specifique, mises en ceuvre lors de I’execution de mesurages
particuliers selon une methode donnee
NOTE he mode operatoire est habituellement decrit dans un document qui est quelquefois appele lui-meme
operatoire >> et qui donne assez de details pour qu’un operateur puisse effectuer un mesurage sans avoir besoin d’autres
informations.
[VIM:1 993, 2.51
3.10
processus de mesure
ensemble de ressources, d’activites et d’influences correlees produisant un mesurage
NOTES
Les ressources concernees component I’equipement de mesure, les modes operatoires de mesure et I’operateur.
2 Les << influences >> so nt tous les facteurs tels ceux causes par I’environ nement qui peuvent etre ou ne pas etre
we
malt rises ou maitrisables et qui s’ajoutent a la varia .bilite ou au biais du processus.
3 Voir egalement la definition de << processus >> en 1.2 de I’ISO 8402:1994.
4 Un processus de mesure peut consister en des mesurages effect&s par exemple:
par dive rs operateurs utilisant des equipements de mesure a u sage general, dans un environnement general d’une
4
usine et appliquant des methodes ou des procedures informelles
b) par des techniciens de laboratoire d’etalonnage form&, utilisant un systeme de mesurage avec bain d’huile
thermostat& des resistances etalon, des comparateurs et d’autre equipements annexes, suivant une procedure
detaillee pour etalonner d’autres resistances etalons;
par toute variante ou toute combinaison des deux exemples precites, ou independamment de ces deux exemples.
C)
5 Un processus de mesure peut consister en l’utilisation d’un seul instrument de mesure.
3
---------------------- Page: 9 ----------------------
0 IS0
IS0 10012-2: 1997(F)
3.11
bquipement de mesure
tous les instruments de mesure, etalons, materiaux de reference, appareils auxiliaires et ogiciels necessaires a
I’execution d’une mesure
NOTES
1 Ce terme comprend I%quipement de mesure utilisi! pour les essais et les contr6les ainsi que pour I ktalonnage.
2 Dans la prksente partie de I’ IS0 10012, le terme << kquipement de mesure >> comprend les instrum ents de mesure et les
6talons. On considkre, en outre, qu’u n mat6 riau de r6fkence correspond B un type dUalon particulier.
[Adapte de I’ISO 10012-I :I 992, 3.21
3.12
instrument de mesure
appareil de mesure
dispositif destine a etre utilise pour faire des mesurages, seul ou associe a un ou plusieurs dispositifs annexes
[VIM:1 993, 4.11
3.13
confirmation m6trologique
ensemble des operations requises pour s’assurer de la conformite d’un equipement de mesure avec les exigences
prescrites pour I’utilisation projetee
NOTES
1 La confirmatio In metrologique comporte normalem ent, entre autres, I’&alonnage, tout ajustage ou Gparation nkcessaire et
le r&talonnage u It&ieur, ainsi que toute protection et tout ktiquetage 6ventuellement requis.
2 Pour plus de brievet& dans la prksente partie de I’ISO 10012, ce terme est design6 sous le nom de << confirmation >>.
[ISO 10012-1:1992, 3.1)
3.14
audit qualit
examen methodique et independant en vue de determiner si les activites et resultats relatifs a la qualite satisfont
aux dispositions preetablies et si ces dispositions sont mises en oeuvre de facon effective et sont aptes a atteindre
les objectifs
NOTES
1 L’audit qualit s’applique essentiellement, mais n’est pas restreint, & un systgme qualit ou A des 6lkments de celui-ci, h des
processus, A des produits ou & des services. De tels audits sont couramment appelks << audit de systkme qualit >>,
qualit de processus >>, << audit qualiti! de produit >>, CC audit qualit de service >>.
2 Les audits qualiti! sont conduits par une 6quipe n’ayant pas de responsabiliti! directe dans les secteurs & auditer et de
t+f&ence en coopkation avec le personnel de ces secteurs.
P
3 L’un des buts d’un audit qualit est d’haluer le besoin d’am6Iioration ou d’action corrective. II convient de ne pas confondre
I’audit avec des activith de surveillance de la qualiti! ou de contr6le conduites dans le but de maitrise d’un processus ou
d’acceptation d’un produit.
4 Les audits qualit peuvent &re conduits pour des besoins internes ou externes.
[ISO 8402:1994, 4.91
3.15
rbolution (d’un dispositif afficheur)
la plus petite difference d’indication d’un dispositif afficheur qui peut etre percue de maniere significative
---------------------- Page: 10 ----------------------
0 IS0
IS0 10012-2: 1997(F)
NOTES
1 Pour un dispositif afficheur numerique, difference d’indication qui correspond au changement d’une unite du chiffre le moins
significatif.
2 Ce concept s’applique aussi a un dispositif enregistreur.
[VIM:1 993’ 5.121
3.16
Constance
aptitude d’un instrument de mesure a consewer ses caracteristiques metrologiques constantes au tours du temps.
NOTES
necessaire de le mentionner
1 Lorsque I’on considere la Constance en fonction d’une grandeur autre que le temps, il est
explicitement.
2 La Constance peut etre exprimee quantitativement de plusieurs facons, par exemple:
- par la duke au tours de laquelle une caracteristique metrologique evolue d’une quantite donnee, ou;
- par la variation d’une caracteristique au tours d’une duree donnee.
[VIM:1 993, 5.141
3.17
traCabilit6
propriete du resultat d’un mesurage ou d’un etalon tel qu’il puisse etre relic a des references determinees,
generalement des etalons nationaux ou internationaux, par I’intermediaire d’une chaTne ininterrompue de
comparaisons ayant toutes des incertitudes determinees.
NOTES
Ce concept est souvent designe par I’adjectif << tracable >>.
2 La chalne ininterrompue de comparaisons es% appelee << chaline de raccordement aux etalons >> ou << cha?ne d’etalonnage >>.
3 La maniere dont s’effectue la liaison aux etalons est appelee << raccordement aux etalons >>.
[VIM:1 993, 6.101
3.18
incertitude de mesure
parametre, associe au resultat d’un mesurage, qui caracterise la dispersion des valeurs qui pourraient
raisonnablement etre attribuees au mesurande
NOTES
1 Le parametre peut etre, par exemple, un &art-type (ou un multiple de celui-ci), ou la demi-largeur d’un intervalle de niveau
de confiance determine.
2 L’incertitude de mesure comprend, en general, plusieurs composantes. Certaines peuvent etre evaluees a partir de la
distribution statistique des resultats de series de mesurages et peuvent etre caracterisees par des &arts-types experimentaux.
Les autres composantes, qui peuvent aussi etre caracterisees par des &arts-types, sont &al&es en admettant des
distributions de probabilite, d’apres I’experience acquise ou d’apres d’autres informations.
3 II est entendu que le resultat du mesurage est la meilleure estimation de la valeur du mesurande et que toutes les
composantes de I’incertitude, y compris celles qui proviennent d’effets systematiques telles que les composantes associees
aux corrections et aux etalons de reference, contribuent a la dispersion.
[VIM:1 993, 3.91
4 Cette definition est celle du “Guide pour I’expression de I’incertitude de mesure” ou ses bases sont exposees en detail (voir
en particulier 2.2.4 et I’annexe D).
---------------------- Page: 11 ----------------------
0 IS0
IS0 10012=2:1997(F)
3.19
v&if ication
confirmation par examen et apport de preuves tangibles que les exigences specifiees ont ete satisfaites
NOTES
1 En conception et dbveloppement, la vhification concerne le processus d’examen du rhultat d’une activitb en vue de
dkterminer la conformitti! aux exigences fixbes pour ladite activitk.
2 Le terme << v6rifi6 >’ dbsigne II&at correspondant.
[ISO 8402:1994, 2.171
4 Recommandations
4.1 Gh&alitds
Le Fournisseur etablit et specific des criteres de fonctionnement objectifs et des procedures pour les processus de
mesure ainsi que pour la maitrise de ces processus. Elles specifient quels processus de mesure sont soumis aux
dispositions de la presente partie de I’ISO 10012.
Le Fournisseur donne I’assurance que toutes les procedures sont adaptees a leur objet. En particulier, ces
procedures contiennent des informations suffisantes pour en assurer une mise en ceuvre convenable, une
utilisation coherente d’une application a I’autre et garantir des resultats de mesurage valables.
Les procedures permettent une detection rapide des derives excedant les limites prescrites de derive tolerees et
leur correction opportune.
Les procedures sont disponibles selon la necessite pour les personnes impliquees dans la realisation de
mesurages et la ma’itrise des proces
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.