ISO 10012-1:1992
(Main)Quality assurance requirements for measuring equipment — Part 1: Metrological confirmation system for measuring equipment
Quality assurance requirements for measuring equipment — Part 1: Metrological confirmation system for measuring equipment
Applies to: testing laboratories, including those providing a calibration service; suppliers of products or services; other organizations where measurement is used to demonstrate compliance with specified requirements.
Exigences d'assurance de la qualité des équipements de mesure — Partie 1: Confirmation métrologique de l'équipement de mesure
1.1 La présente partie de l'ISO 10 012 comporte des exigences en matière d'assurance de la qualité applicables à un Fournisseur pour s'assurer que les mesures sont effectuées avec le degré d'exactitude voulu. Elle contient également des conseils concernant la mise en oeuvre des exigences. 1.2 La présente partie de l'ISO 10 012 définit les caractéristiques principales du système de confirmation à appliquer pour les équipements de mesure d'un Fournisseur. 1.3 La présente partie de l'ISO 10 012 s'applique aux équipements de mesure utilisés pour démontrer la conformité avec un cahier des charges; elle ne s'applique pas à d'autres équipements de mesure. La présente partie de l'ISO 10 012 ne traite pas en détail des autres éléments pouvant influer sur les résultats de mesurage, tels que les méthodes de mesurage, les compétences du personnel, etc.; ceux-ci sont traités plus en profondeur dans d'autres Normes internationales telles que celles citées en 1.4. 1.4 La présente partie de l'ISO 10 012 s'applique -- aux laboratoires d'essai, notamment ceux qui fournissent un service d'étalonnage; ceci inclut les laboratoires mettant en oeuvre un système qualité en harmonie avec l'ISO/CEI Guide 25; -- aux Fournisseurs de produits ou de services qui mettent en oeuvre un système qualité dans lequel les résultats de mesure sont utilisés pour démontrer la conf 564ormité avec des exigences spécifiées; ceci inclut les systèmes qualité qui satisfont aux exigences de l'ISO 9001, I'ISO 9002 et l'ISO 9003. Les conseils de l'ISO 9004 sont aussi applicables; -- à tous autres organismes où les résultats de mesure sont utilisés pour démontrer la conformité à des exigences spécifiées. 1.5 Le rôle de l'Acheteur dans la surveillance de la conformité d'un Fournisseur à la présente partie de l'ISO 10 012 peut être assuré par une tierce partie telle qu'un organisme de certification ou d'accréditation.
Zahteve zagotavljanja kakovosti za merilno opremo - 1. del: Sistem meroslovnega potrjevanja merilne opreme
General Information
Relations
Buy Standard
Standards Content (Sample)
INTERNATIONAL
ISO
STANDARD 100124
First edition
1992-01-15
Corrected and reprinted
1993-05-01
Quality assurance requirements for
measuring equipment -
Part 1:
Metrological confirmation System for
measuring equipment
Exigences d’assurance de Ia qua126 des gquipements de mesure -
Partie 1: Confirmation m&rologique de Mquipement de mesure
Reference number
ISO 10012-1:1992(E)
---------------------- Page: 1 ----------------------
ISO mW2=1:1992(E)
Contents
Fage
1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .~.~.~
1 Scope
1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.
2 Normative references
2
3 Def initions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4
. . . . . . . .~.~.~.,.
4 Requirements
4
4.1 General . . . . . . . . . . . . . . . . . . . . .~.,.,.~,.,.
4
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.
4.2 Measuring equipment
4
. .~.~~.~.~.~.~.~~.~.
4.3 Confirmation System
,. 5
4.4 Periodic audit and review of the confirmation System
5
4.5 Planning . . . . . . . . . . . . . . . .*.~.,,,.,,,.
. . . . . . . .~.~~.~.~~.~~.~.~.~ 6
4.6 Uncertainty of measurement
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
4.7 Documented confirmation procedures
6
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .~.
4.8 Records
. . . . . . . . . . . .*. 7
4.9 Nonconforming measuring equipment
7
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.10 Confirmation labelling
8
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .~.
4.11 lntervals of confirmation
8
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.12 Sealing for integrity
9
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .o
4.13 Use of outside products and Services
9
..~...,,....,,~,~...,,,,,,,,...,,,..,,,................~....
4.14 Storage and handling
9
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.
4.15 Traceability
10
..,....,.................,...........
4.16 Cumulative effect of uncertainties
10
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.17 Environmental conditions
10
4.18 Personne1 . . . . . . . . . . . . . .~.,,,.,,,,,,,,,.,,,.,,,.,,.,,.,,.
0 ISO 1992
All rights reserved. No part of this publication may be reproduced or utilized in any form or
by any means, electronie or mechanical, including photocopying and microfilm, without per-
mission in writing from the publisher.
International Organization for Standardization
Case Postale 56 l CH-l 211 Geneve 20 l Switzerland
Printed in Switzerland
ii
---------------------- Page: 2 ----------------------
ISO 1ooXM:i992(E)
Annexes
A Guidelines for the determination of confirmation intervals for
11
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
measuring equipment
11
. . . . . . . . . . . . .*.~.~.
A.1 Introduction
11
D.OOODO.D.D*.O~.*~~~.*.~
Initial choice of confirmation intervals
A.2
71
..,,......,...,...,..a
A.3 Methods of reviewing confirmation inten/als
14
~.,.,,.,,.,.,.,.,.,.,.
6 Bibliography
. . .
Ill
---------------------- Page: 3 ----------------------
ISO 10012=1:1992(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide
federation sf national Standards bodies (ISO member bodies). The work
of preparing International Standards is normally carried out through ISO
technical committees. Esch member body interested in a subject for
which a technical committee has been established has the right to be
represented on that committee. International organizations, governmental
and non-governmental, in liaison with ISO, also take part in the work. ISO
collaborates closely with the International Electrotechnical Commission
(IEC) on all matters of electrotechnical standardization.
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 ISO 10012-1 was prepared by Technical Committee
lSO/TC 176, Quality management and quality assurance, Sub-Committee
SC 3, Supporting technologies.
ISO 10012 consists of the following Parts, under the general title Quality
assurance requirements for measuring equipment:
- Part 1: Metrological confirmation System for measuring equipment
- Part 2: Measurement assurance
Annex A is based on Organisation Internationale de Metrologie Legale
(OIML) International Document No. 10, Guidelines for the determination
of recalibration intervals of measuring equipment used in testing labora-
tories.
Annexes A and B of this part of ISO 10012 are for information only.
iv
---------------------- Page: 4 ----------------------
ISO 1ooi2=1:1992(E)
Introduction
This part of ISO 10012 is written in the context of a Purchaser and a
Supplier, both terms being interpreted in the broadest sense. The “Sup-
plier” may be a manufacturer, an installer or a servicing organization re-
sponsible for providing a product or a Service. The “Purchaser” may be a
procurement authority or a customer using a product or Service. Suppliers
become Purchasers when procuring supplies and Services from vendors
or other outside sources. The subject of the negotiations relating to this
part of ISO 10012 may be a design, an artefact, a product or a Service. This
part of ISO 10012 may be applied, by agreement, to other situations.
Reference to this part of ISO 10012 may be made:
- by a Purchaser when specifying products or Services required;
- by a Supplier when specifying products or Services offered;
- by consumer or employee interests, or by legislative or regulatory
bodies;
- in assessment and audit of Iaboratories.
This patt of ISO 10012 includes both requirements and (in clause 4)
guidance on the implementation of the requirements.
In Order to distinguish clearly between requirements and guidance, in
clause 4 the latter appears in italic type-face, in a box, after each corre-
sponding Paragraph under the heading “GUIDANCE”.
The text under “GUIDANCE” is for Information only and contains no re-
quirements. Statements given there are not to be construed as adding to,
limiting or modifying any requirement.
NOTE 1 Use of the masculine gender in this part of ISO 10012 is not meant to
exclude the feminine gender where applied to persons. Similarly, use of the
Singular does not exclude the Plural (and vice versa) when the sense allows.
---------------------- Page: 5 ----------------------
This page intentionally left blank
---------------------- Page: 6 ----------------------
INTERNATIONAL STANDARD ISO 10012=1:1992(E)
Quality assurance requirements for measuring
equipment -
Part 1:
Metrological confirmation System for measuring
equipment
- to other organizations where measurement is
1 Scope
used to demonstrate compliance with specified
requirements.
1.1 This part of ISO 10012 contains quality assur-
ante requirements for a Supplier to ensure that
measurements are made with the intended accuracy.
1.5 The role of the Purchaser in monitoring a Sup-
lt also contains guidance on the implementation of the
plier’s compliance with the requirements of this part
requirements.
of ISO 10012 may be fulfilled by a third Party, such
as an accreditation or certification body.
1.2 This patt of ISO 10012 specifies the main fea-
tures of the confirmation System to be used for a
Supplier’s measuring equipment.
2 Normative references
1.3 This part of ISO 10012 is applicable to measur-
ing equipment used in the demonstration of com-
The following Standards contain provisions which,
pliance with a specification: it does not apply to other
through reference in this text, constitute provisions
items of measuring equipment. This part of
of this part of ISO 10012. At the time of publication,
ISO 10012 does not deal extensively with other el-
the editions indicated were valid. All Standards are
ements that may affect measurement results such as
subject to revision, and Parties to agreements based
methods of measurement, competence of Personne1
on this part of ISO 10012 are encouraged to investi-
etc.; these are dealt with more specifically in other
gate the possibility of applying the most recent edi-
International Standards, such as those referred to in
tions of the Standards indicated below. Members of
14 . .
IEC and ISO maintain registers of currently valid
International Standards.
1.4 This part of ISO 10012 is applicable:
ISO 8402:1986, Quality - Vocabulary.
- to testing laboratories, including those providing a
ISO 9001 :1987, Quality Systems - Model for quality
calibration Service; this includes laboratories oper-
assurance in design/development, production, instal-
ating a quality System in accordance with lSO/IEC
Ia tion and servicing.
Guide 25;
ISO 9002:1987, Quality Systems - Model for quality
- to Suppliers of products or Services who operate
assurance in production and installation.
a quality System in which measurement results are
used to demonstrate compliance with specified
ISO 9003: 1987, Quality Systems - Model for quality
requirements; this includes operating Systems that
assurance in final inspection and test.
meet the requirements of ISO 9001, ISO 9002 and
ISO 9004: 1987, Quality management and quality sys-
ISO 9003. The guidance given in ISO 9004 is also
tem elements - Guidelines.
relevant;
---------------------- Page: 7 ----------------------
ISO 10012=1:1992(E)
ISO Guide 30:1981, Terms and definitions used in value of the measurand or the indication of the
connection with reference materials. measuring instrument.
ISO/IEC Guide 251990, Genera/ requirements for the EXAMPLES
calibra tion and campe tence o f tes ting labora tories.
ambient temperat ure; freq uency of an alternating
BIPM/IEC/ISO/OI ML, International vocabulary of basic
measured voltage.
and general terms in metrology: 1984.
[VIM, 2.101
3 Definitions
3.6 accuracy of measurement: The closeness of
For the purposes of this part of ISO 10012, the fol-
the agreement between the result of a measurement
lowing definitions apply. Most of them are based on
and the (conventional) true value of the measurand.
the International vocabulary of basic and general
terms in metrology (VIM): 1984, but they are not al-
NOTES
ways identical to the definitions given therein. Terms
in ISO 8402 are also relevant. Relevant reference
6 “Accuracy” is a qualitative concept.
numbers are given in brackets following the defi-
nitions. 7 of the term “precision,’ for “accuracy,’ should
The use
be avoided.
3.1 metrological confirmation: Set of operations
[VIM, 3.051
required to ensure that an item of measuring equip-
ment is in a state of compliance with requirements for
its intended use.
3.7 uncertainty of measurement: Result of the
NOTES
evaluation aimed at characterizing the range within
which the true value of a measurand is estimated to
2 Metrological confirmation normally includes, Unter alia,
lie, generally with a given Iikelihood.
calibration, any necessary adjustment or repair and sub-
sequent recalibration, as weil as any required sealing and
NOTE 8 Uncertainty of measurement comprises, in gen-
labelling.
eral, many components. Some of these components may
be estimated on the basis of the statistical distribution of
3 For brevity, in this part of ISO 10012, this term is re-
the results of series of measurements and tan be charac-
ferred to as “confirmation”.
terized by experimental Standard deviations. Estimates of
other components tan only be based on experience or other
3.2 measuring equipment: All of the measuring in-
information.
struments, measurement Standards, reference ma-
terials, auxiliary apparatus and instructions that are
[VIM, 3.091
necessary to carry out a measurement. This term in-
cludes measuring equipment used in the course of
testing and inspection, as well as that used in cali-
3.8 (absolute) error of measurement: The result
bration.
of a measurement minus the true value of the
measurand.
NOTE 4 In the context of this part of ISO 10012, the
term “measuring equipment” is taken to encompass
NOTES
“measuring instruments” and “measurement Standards”.
Moreover, a “reference material” is considered to be a type
9 See “true value (of a quantity)” and “conventional true
of “measurement Standard”.
value (of a quantity)” in VIM.
3.3 measurement: The set of operations having the
10 The term relates equally to
Object of determining the value of a quantity.
- the indication,
- the uncorrected result,
[VIM, 2.011
- the corrected result.
3.4 measurand: A quantity subjected to measure-
11 The known Parts of the error of measurement may be
ment.
compensated by applying appropriate corrections. The error
of the corrected result tan only be characterized by an un-
NOTE 5 As appropriate, this may be
the “measured
certainty.
quantity” or the “quantity to be measured”
12 “Absolute error”, which has a sign, should not be
[VIM, 2.091
confused with ‘,absolute value of an error” which is the
modulus of an error.
3.5 influence quantity: A quantity which is not the
subject of the measurement but which influences the [VIM, 3.101
2
---------------------- Page: 8 ----------------------
ISO loo12-i:1992(E)
3.9 NOTE 18 It is usual to consider stability with respect to
correction: The value which, added algebraically
time. Where stability with respect to another quantity is
to the uncorrected result of a measurement, com-
considered, this should be stated explicitly.
pensates for an assumed systematic error.
[VIM, 5.161
3.16 drift: The slow Variation with time of a
13 The correction is equal to the assumed systematic er-
rar, but of opposite sign. metrological characteristic of a measuring instrument.
[VIM, 5.181
14 Since the systematic error cannot be known exactly,
the correction is subject to uncertainty.
3.17 limits of permissible error (of a measuring
[VIM, 3.141
instrument): The extreme values of an error permit-
ted by specifications, regulations, etc. for a given
measuring instrument.
3.10 measuring instrument: A device intended to
make a measurement, alone or in conjunction with
VIM, 5.231
supplementary equipment.
3.18 (measurement) Standard: A material meas-
[VIM, 4.01)
ure, measuring instrument, reference material or sys-
tem intended to define, realize, conserve or reproduce
3.11 adjustment: The Operation intended to bring a
a unit or one or more values of a quantity in Order to
measuring instrument into a state of Performance and
transmit them to other measuring instruments by
freedom from bias suitable for its use.
comparison.
[VIM, 4.331 EXAMPLES
a) 1 kg mass Standard;
3.12 specified measuring range: The set of values
for a measurand for which the error of a measuring
b) Standard gauge block;
Instrument is intended to lie within specified Iimits.
c) 100 a Standard resistor;
NOTES
d) Weston Standard cell;
15 The upper and lower limits of the specified measuring
range are sometimes called the “maximum capacity” and
the “minimum capacity” respectively. e) caesium atomic frequency Standard;
16 In some other fields of knowledge, “range” is used to
f) Solution of cortisol in human Serum as a Standard
mean the differente between the greatest and the smallest
of concentration.
values.
[VIM, 6.011
[VIM, 5.041
3.19 reference material: A material or substance
3.13 reference conditions: Conditions of use for a one or more properties of which are sufficiently weil
measuring instrument prescribed for Performance established to be used for the calibration of an appar-
testing, or to ensure valid intercomparison of results atus, the assessment of a measurement method, or
of measurements. for assigning values to materials.
NOTE 17 The reference conditions generally specify NOTE 19 This definition is taken from ISO Guide 30,
“reference values” or “reference ranges” for the influence where it has several notes.
quantities affecting the measuring instrument.
[VIM, 6.151
[VIM, 5.071
3.20 international (measurement) Standard: A
Standard recognized by an international agreement to
3.14 resolution (of an indicating device): A quan-
setze internationally as the basis for fixing the value
titative expression of the ability of an indicating device
of all other Standards of the quantity concerned.
to permit distinguishing meaningfully between im-
mediately adjacent values of the quantity indicated.
D/IM, 6.061
[VIM, 5.131
3.21 national (measurement) Standard: A stan-
dard recognized by an official national decision to
serve, in a countty, as the basis for fixing the value
3.15 stability: The ability of a measuring instrument
of all other Standards of the quantity concerned.
to maintain constant its metrological characteristics.
---------------------- Page: 9 ----------------------
ISO 10012=1:i992(E)
NOTE 20
The national Standard in a country is often a quality System in relation to quality policy and new
“primary Standard”.
objectives resulting from changing circumstances.
[ISO 8402, 3.121
[VIM, 6.071
3.22 traceability: The property of the result of a
measurement whereby it tan be related to appropri-
4 Requirements
ate measurement Standards, generally international
or national Standards, through an unbroken chain of
comparisons.
4.1 General
NOTES
The Supplier shall document the methods used to
implement the provisions of this patt of ISO 10012.
21 The unbroken chain of comparisons is called a
This documentation shall be an integral part of the
“traceability chain”.
Supplier’s quality System. lt shall be specific in terms
of which items of equipment are subject to the pro-
22 (Applicable only to the French text.)
visions of this part of ISO 10012, in terms of the allo-
cation of responsibilities and in terms of the actions
[VIM, 6.121
to be taken. The Supplier shall make objective evi-
dence available to the Purchaser that the required ac-
3.23 calibration: The set of operations which es-
curacy is achieved.
tablish, under specified conditions, the relationship
between values indicated by a measuring instrument
or measuring System, or values represented by a
material measure or a reference material, and the
4.2 Measuring equipment
corresponding values of a quantity realized by a ref-
erence Standard.
Measuring equipment shall have metrological charac-
teristics as required for the intended use (for example
NOTES
accuracy, stability, range and resolution).
23 The result of a calibration permits the estimation of er-
Equipment and documentation shall be maintained so
rors of indication of the measuring instrument, measuring
as to take account of any corrections, conditions of
System or material measure, or the assignment of values to
use (including environmental conditions), etc. that are
marks on arbitrary scales.
necessary to achieve the required performante.
24 A calibration may also determine other metrological
The required Performance shall be documented.
properties.
25 The result of a calibration may be recorded in a docu-
GUIDANCE
ment, sometimes called a “calibration certificate” or a
“calibration report “.
The set of metrological characteristics (specific re-
quirements) is an essential component of the con-
26 The result of a calibration is sometimes expressed as
a correction or a “calibration factor”, or as a “calibration firma tion sys tem. The Supplier is expected to
curve”. include in his procedures a list of the specified re-
quirements. Usual sources for such requirements
[VIM, 6.131
include manufacturer’s litersture, regulations, etc.
Wherever the sources are inadequate, the Supplier
3.24 (quality) audit: A systematic and independent should himself determine the requirements.
examination to determine whether quality activities
and related results comply with planned arrange-
ments and whether these arrangements are im-
plemented effectively and are suitable to achieve
4.3 Confirmation System
objectives.
The Supplier shall establish and maintain an effective
NOTE 27 The quality audit typically applies, but is not
documented System for the managing, confirmation
limited, to a quality System or elements thereof, to pro-
cesses, to products, or to Services. Such audits are often and use of measuring equipment, including measure-
called “quality System audit”, “process quality audit”,
ment Standards, used to demonstrate compliance
“product quality audit”, “Service quality audit”.
with specified requirements. This System shall be
designed to ensure that all such measuring equip-
[ISO 8402, 3.101
ment performs as intended. The System shall provide
for the prevention 0% errors outside the specified lim-
its of permissible error, by prompt detection of defi-
3.25 (quality System) review: A formal evaluation
ciencies and by timely action for their correction.
by top management of the Status and adequacy of the
4
---------------------- Page: 10 ----------------------
ISO 10012=1:1992(E)
The confirmation System shall take full account of all
relevant data, including that available from any statis-
Some instruments, such as null detectors and co-
tical process control System operated by or for the
incidence detectors, need periodic calibra tion and
Supplier.
confirmation only in the restricted sense of func-
tional checking to assure that they are functioning
For each item of measuring equipment, the Supplier
correctly.
shall designate a competent member of his staff as
authorized officer to ensure that confirmations are A very useful check that a measuring instrument
continues to measure correctly is obtained by the
carried out in accordance with the System and that
use of a checking measurement Standard, applied
the equipment is in a satisfactory condition.
to the instrument by the User. This will demon-
strate if, at the value or values checked and under
In cases where any or all of a Supplier’s confirmation
(including calibration) are replaced or supplemented the conditions o f the check, the instrumen t is still
functioning correctly. The checking measurement
by Services from outside sources, the Supplier shall
Standard itself needs to be calibrated and con-
ensure that these outside sources also comply with
firmed and, in Order that the results obtained by its
the requirements of this patt of ISO 10012 to the ex-
use tan with confidence be attributed to the in-
tent necessary to ensure the Supplier’s compliance
strument and not to changes in the checking
with the requirements.
measurement Standard, it usually has to be simple
and robust. The use of a checking measurement
Standard is in no way a Substitute for regular cali-
GUIDANCE
bration and confirmation of the instrument, but its
The in tention of a confirmation s ystem is to ensure
use may prevent the use of an instrument which,
that the risk of measuring equipment producing
within the intetval between two formal confir-
results having unaccep table errors remains within
mations, ceases to con form to specifica tion.
acceptable bounds. The use of appropriate statis-
tical methods for analysing the results of preceding
calibrations, for assessing the results of cali-
brations of several similar items of measuring
equipmen t and for predicting cumula tive uncer-
tainties is recommended. (See ISO 9004: 1987,
4.4 Periodic audit and review of the
13.7.)
confirmation System
The error attributable to calibration should be as
small as possible. In most areas of measurement, The Supplier shall carry out, or shall arrange to be
it should be no more than one third and preferably carried out, periodic and systematic quality auditing
one tenth o f the permissible error of the con firmed of the confirmation System in Order to ensure its
equipment when in use. continuing effective implementation and compliance
with the requirements of this part of ISO 10012.
lt is usual to carry out the calibration associated
with an y con firma tion under re ference conditions,
Based on the results of the quality audits and of other
but where it is known tha t the Opera ting conditions
relevant factors, such as feedback from Purchasers,
are significantly different from the reference con-
the Supplier shall review and modify the System as
ditions, calibra tion under appropriate values o f the
necessafy.
influence quantities ma y be carried out. Where this
is impractical, due allowance should be made for Plans and procedures for the quality audit and review
the differente in the conditions. shall be documented. The conduct of the quality audit
and review and any subsequent corrective actions
For a commercial device, it is usual to take the
shall be recorded.
manufacturer’s claimed petiormance as the cri-
terion of satisfactory Performance and accuracy. lt
is sometimes necessary to modify the manufac-
turer’s Claims.
4.5 Planning
Where no manufacturer’s claimed Performance is
available, criteria for sa tis factory Performance ma y
The Supplier shal I review any relevant Purchaser’s and
have to be determined from experience.
other technical requirements before commencing
work on products or Services, and shall ensure that
the measuring equipment (including measurement
Standards) needed for the performante of the work
are available and are of the accuracy, stability, range
and resolution appropriate for the intended applica-
tion.
---------------------- Page: 11 ----------------------
ISO 10012~1:1992(E)
GUIDANCE GUIDANCE
This review should be carried out at as early a Procedures may be, but are not necessarily, limited
Stage as practical, so as to permit comprehensive to the compilation of published Standard measure-
and effective planning of the Supplier’s confir- ment practices and a Purchaser’s or an instrument
mation System. manufacturer’s written instructions. The amount
of detail in procedures should be commensurate
with the complexity of the confirmation process.
These methods ma y be elaborated using the tech-
4.6 Uncertainty of measurement
niques of sta tis tical process con trol, whereb y
measurement Standards and measuring instru-
In performing measurements and in stating and mak-
ments are intercompared in-house, drifts and faults
ing use of the results, the Supplier shall take into ac-
are determined, and any necessary corrective ac-
count all significant identified uncertainties in the
tion is taken. Sta tistical process con trol is comple-
measurement process including those that are attrib-
mentary to regular calibra tion and rein forces
utable to measuring equipment (including measure-
con fidence in measurement results during the in-
ment Standards) and those contributed by personnel
tervals between confirmations.
procedures and environment.
In estimating the uncertainties, the Supplier shall take
account of all relevant data including that available
from any statistical process control System operated 4.8 Records
by or for the Supplier.
The Supplier shall maintain records of the make, type
and serial number (or other identification) of all rele-
GUIDANCE vant measuring equipment (incuding measurement
Standards). These records shall demonstrate the
When it has been demonstra ted by a calibra tion
measurement capability of each item of measuring
tha t measuring equipmen t is performing correctly
equipment. Any calibration certificates and other rele-
(in accordance with its specification), it is usual to
vant information concerning its functioning shall be
assume that the errors produced while the equip-
available.
ment is in use do not exceed its specified limits
o f permissible error. This is assumed to hold until
the equipment is next calibra ted and con firmed.
GUIDANCE
This may not be true under the often more arduous
conditions o f use as compared with the controlled
The records may be in manuscript, typescript or
conditions of the calibration. It may therefore be
microfilm or may be in an electronie or a magnetic
expedient to compensate for this by tightening the
memory or on another data medium.
product acceptance limits. The amount of this
The minimum time for the retention of records is
tigh tening depends on the particular circums tances
dependent on many factors, such as the Pur-
and is a matter for judgement based on experi-
chaser ‘s requiremen ts, regula tory or legal require-
ence. (See 4.17.)
ments, manufacturer’s liability, etc.
The use of statistical methods is recommended to
ßecords concerned with the principal measure-
monitor and control measurement uncertainty on
...
SLOVENSKI STANDARD
SIST ISO 10012-1:1996
01-avgust-1996
Zahteve zagotavljanja kakovosti za merilno opremo - 1. del: Sistem meroslovnega
potrjevanja merilne opreme
Quality assurance requirements for measuring equipment -- Part 1: Metrological
confirmation system for measuring equipment
Exigences d'assurance de la qualité des équipements de mesure -- Partie 1:
Confirmation métrologique de l'équipement de mesure
Ta slovenski standard je istoveten z: ISO 10012-1:1992
ICS:
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
SIST ISO 10012-1:1996 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST ISO 10012-1:1996
---------------------- Page: 2 ----------------------
SIST ISO 10012-1:1996
INTERNATIONAL
ISO
STANDARD 100124
First edition
1992-01-15
Corrected and reprinted
1993-05-01
Quality assurance requirements for
measuring equipment -
Part 1:
Metrological confirmation System for
measuring equipment
Exigences d’assurance de Ia qua126 des gquipements de mesure -
Partie 1: Confirmation m&rologique de Mquipement de mesure
Reference number
ISO 10012-1:1992(E)
---------------------- Page: 3 ----------------------
SIST ISO 10012-1:1996
ISO mW2=1:1992(E)
Contents
Fage
1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .~.~.~
1 Scope
1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.
2 Normative references
2
3 Def initions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4
. . . . . . . .~.~.~.,.
4 Requirements
4
4.1 General . . . . . . . . . . . . . . . . . . . . .~.,.,.~,.,.
4
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.
4.2 Measuring equipment
4
. .~.~~.~.~.~.~.~~.~.
4.3 Confirmation System
,. 5
4.4 Periodic audit and review of the confirmation System
5
4.5 Planning . . . . . . . . . . . . . . . .*.~.,,,.,,,.
. . . . . . . .~.~~.~.~~.~~.~.~.~ 6
4.6 Uncertainty of measurement
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
4.7 Documented confirmation procedures
6
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .~.
4.8 Records
. . . . . . . . . . . .*. 7
4.9 Nonconforming measuring equipment
7
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.10 Confirmation labelling
8
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .~.
4.11 lntervals of confirmation
8
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.12 Sealing for integrity
9
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .o
4.13 Use of outside products and Services
9
..~...,,....,,~,~...,,,,,,,,...,,,..,,,................~....
4.14 Storage and handling
9
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.
4.15 Traceability
10
..,....,.................,...........
4.16 Cumulative effect of uncertainties
10
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.17 Environmental conditions
10
4.18 Personne1 . . . . . . . . . . . . . .~.,,,.,,,,,,,,,.,,,.,,,.,,.,,.,,.
0 ISO 1992
All rights reserved. No part of this publication may be reproduced or utilized in any form or
by any means, electronie or mechanical, including photocopying and microfilm, without per-
mission in writing from the publisher.
International Organization for Standardization
Case Postale 56 l CH-l 211 Geneve 20 l Switzerland
Printed in Switzerland
ii
---------------------- Page: 4 ----------------------
SIST ISO 10012-1:1996
ISO 1ooXM:i992(E)
Annexes
A Guidelines for the determination of confirmation intervals for
11
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
measuring equipment
11
. . . . . . . . . . . . .*.~.~.
A.1 Introduction
11
D.OOODO.D.D*.O~.*~~~.*.~
Initial choice of confirmation intervals
A.2
71
..,,......,...,...,..a
A.3 Methods of reviewing confirmation inten/als
14
~.,.,,.,,.,.,.,.,.,.,.
6 Bibliography
. . .
Ill
---------------------- Page: 5 ----------------------
SIST ISO 10012-1:1996
ISO 10012=1:1992(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide
federation sf national Standards bodies (ISO member bodies). The work
of preparing International Standards is normally carried out through ISO
technical committees. Esch member body interested in a subject for
which a technical committee has been established has the right to be
represented on that committee. International organizations, governmental
and non-governmental, in liaison with ISO, also take part in the work. ISO
collaborates closely with the International Electrotechnical Commission
(IEC) on all matters of electrotechnical standardization.
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 ISO 10012-1 was prepared by Technical Committee
lSO/TC 176, Quality management and quality assurance, Sub-Committee
SC 3, Supporting technologies.
ISO 10012 consists of the following Parts, under the general title Quality
assurance requirements for measuring equipment:
- Part 1: Metrological confirmation System for measuring equipment
- Part 2: Measurement assurance
Annex A is based on Organisation Internationale de Metrologie Legale
(OIML) International Document No. 10, Guidelines for the determination
of recalibration intervals of measuring equipment used in testing labora-
tories.
Annexes A and B of this part of ISO 10012 are for information only.
iv
---------------------- Page: 6 ----------------------
SIST ISO 10012-1:1996
ISO 1ooi2=1:1992(E)
Introduction
This part of ISO 10012 is written in the context of a Purchaser and a
Supplier, both terms being interpreted in the broadest sense. The “Sup-
plier” may be a manufacturer, an installer or a servicing organization re-
sponsible for providing a product or a Service. The “Purchaser” may be a
procurement authority or a customer using a product or Service. Suppliers
become Purchasers when procuring supplies and Services from vendors
or other outside sources. The subject of the negotiations relating to this
part of ISO 10012 may be a design, an artefact, a product or a Service. This
part of ISO 10012 may be applied, by agreement, to other situations.
Reference to this part of ISO 10012 may be made:
- by a Purchaser when specifying products or Services required;
- by a Supplier when specifying products or Services offered;
- by consumer or employee interests, or by legislative or regulatory
bodies;
- in assessment and audit of Iaboratories.
This patt of ISO 10012 includes both requirements and (in clause 4)
guidance on the implementation of the requirements.
In Order to distinguish clearly between requirements and guidance, in
clause 4 the latter appears in italic type-face, in a box, after each corre-
sponding Paragraph under the heading “GUIDANCE”.
The text under “GUIDANCE” is for Information only and contains no re-
quirements. Statements given there are not to be construed as adding to,
limiting or modifying any requirement.
NOTE 1 Use of the masculine gender in this part of ISO 10012 is not meant to
exclude the feminine gender where applied to persons. Similarly, use of the
Singular does not exclude the Plural (and vice versa) when the sense allows.
---------------------- Page: 7 ----------------------
SIST ISO 10012-1:1996
This page intentionally left blank
---------------------- Page: 8 ----------------------
SIST ISO 10012-1:1996
INTERNATIONAL STANDARD ISO 10012=1:1992(E)
Quality assurance requirements for measuring
equipment -
Part 1:
Metrological confirmation System for measuring
equipment
- to other organizations where measurement is
1 Scope
used to demonstrate compliance with specified
requirements.
1.1 This part of ISO 10012 contains quality assur-
ante requirements for a Supplier to ensure that
measurements are made with the intended accuracy.
1.5 The role of the Purchaser in monitoring a Sup-
lt also contains guidance on the implementation of the
plier’s compliance with the requirements of this part
requirements.
of ISO 10012 may be fulfilled by a third Party, such
as an accreditation or certification body.
1.2 This patt of ISO 10012 specifies the main fea-
tures of the confirmation System to be used for a
Supplier’s measuring equipment.
2 Normative references
1.3 This part of ISO 10012 is applicable to measur-
ing equipment used in the demonstration of com-
The following Standards contain provisions which,
pliance with a specification: it does not apply to other
through reference in this text, constitute provisions
items of measuring equipment. This part of
of this part of ISO 10012. At the time of publication,
ISO 10012 does not deal extensively with other el-
the editions indicated were valid. All Standards are
ements that may affect measurement results such as
subject to revision, and Parties to agreements based
methods of measurement, competence of Personne1
on this part of ISO 10012 are encouraged to investi-
etc.; these are dealt with more specifically in other
gate the possibility of applying the most recent edi-
International Standards, such as those referred to in
tions of the Standards indicated below. Members of
14 . .
IEC and ISO maintain registers of currently valid
International Standards.
1.4 This part of ISO 10012 is applicable:
ISO 8402:1986, Quality - Vocabulary.
- to testing laboratories, including those providing a
ISO 9001 :1987, Quality Systems - Model for quality
calibration Service; this includes laboratories oper-
assurance in design/development, production, instal-
ating a quality System in accordance with lSO/IEC
Ia tion and servicing.
Guide 25;
ISO 9002:1987, Quality Systems - Model for quality
- to Suppliers of products or Services who operate
assurance in production and installation.
a quality System in which measurement results are
used to demonstrate compliance with specified
ISO 9003: 1987, Quality Systems - Model for quality
requirements; this includes operating Systems that
assurance in final inspection and test.
meet the requirements of ISO 9001, ISO 9002 and
ISO 9004: 1987, Quality management and quality sys-
ISO 9003. The guidance given in ISO 9004 is also
tem elements - Guidelines.
relevant;
---------------------- Page: 9 ----------------------
SIST ISO 10012-1:1996
ISO 10012=1:1992(E)
ISO Guide 30:1981, Terms and definitions used in value of the measurand or the indication of the
connection with reference materials. measuring instrument.
ISO/IEC Guide 251990, Genera/ requirements for the EXAMPLES
calibra tion and campe tence o f tes ting labora tories.
ambient temperat ure; freq uency of an alternating
BIPM/IEC/ISO/OI ML, International vocabulary of basic
measured voltage.
and general terms in metrology: 1984.
[VIM, 2.101
3 Definitions
3.6 accuracy of measurement: The closeness of
For the purposes of this part of ISO 10012, the fol-
the agreement between the result of a measurement
lowing definitions apply. Most of them are based on
and the (conventional) true value of the measurand.
the International vocabulary of basic and general
terms in metrology (VIM): 1984, but they are not al-
NOTES
ways identical to the definitions given therein. Terms
in ISO 8402 are also relevant. Relevant reference
6 “Accuracy” is a qualitative concept.
numbers are given in brackets following the defi-
nitions. 7 of the term “precision,’ for “accuracy,’ should
The use
be avoided.
3.1 metrological confirmation: Set of operations
[VIM, 3.051
required to ensure that an item of measuring equip-
ment is in a state of compliance with requirements for
its intended use.
3.7 uncertainty of measurement: Result of the
NOTES
evaluation aimed at characterizing the range within
which the true value of a measurand is estimated to
2 Metrological confirmation normally includes, Unter alia,
lie, generally with a given Iikelihood.
calibration, any necessary adjustment or repair and sub-
sequent recalibration, as weil as any required sealing and
NOTE 8 Uncertainty of measurement comprises, in gen-
labelling.
eral, many components. Some of these components may
be estimated on the basis of the statistical distribution of
3 For brevity, in this part of ISO 10012, this term is re-
the results of series of measurements and tan be charac-
ferred to as “confirmation”.
terized by experimental Standard deviations. Estimates of
other components tan only be based on experience or other
3.2 measuring equipment: All of the measuring in-
information.
struments, measurement Standards, reference ma-
terials, auxiliary apparatus and instructions that are
[VIM, 3.091
necessary to carry out a measurement. This term in-
cludes measuring equipment used in the course of
testing and inspection, as well as that used in cali-
3.8 (absolute) error of measurement: The result
bration.
of a measurement minus the true value of the
measurand.
NOTE 4 In the context of this part of ISO 10012, the
term “measuring equipment” is taken to encompass
NOTES
“measuring instruments” and “measurement Standards”.
Moreover, a “reference material” is considered to be a type
9 See “true value (of a quantity)” and “conventional true
of “measurement Standard”.
value (of a quantity)” in VIM.
3.3 measurement: The set of operations having the
10 The term relates equally to
Object of determining the value of a quantity.
- the indication,
- the uncorrected result,
[VIM, 2.011
- the corrected result.
3.4 measurand: A quantity subjected to measure-
11 The known Parts of the error of measurement may be
ment.
compensated by applying appropriate corrections. The error
of the corrected result tan only be characterized by an un-
NOTE 5 As appropriate, this may be
the “measured
certainty.
quantity” or the “quantity to be measured”
12 “Absolute error”, which has a sign, should not be
[VIM, 2.091
confused with ‘,absolute value of an error” which is the
modulus of an error.
3.5 influence quantity: A quantity which is not the
subject of the measurement but which influences the [VIM, 3.101
2
---------------------- Page: 10 ----------------------
SIST ISO 10012-1:1996
ISO loo12-i:1992(E)
3.9 NOTE 18 It is usual to consider stability with respect to
correction: The value which, added algebraically
time. Where stability with respect to another quantity is
to the uncorrected result of a measurement, com-
considered, this should be stated explicitly.
pensates for an assumed systematic error.
[VIM, 5.161
3.16 drift: The slow Variation with time of a
13 The correction is equal to the assumed systematic er-
rar, but of opposite sign. metrological characteristic of a measuring instrument.
[VIM, 5.181
14 Since the systematic error cannot be known exactly,
the correction is subject to uncertainty.
3.17 limits of permissible error (of a measuring
[VIM, 3.141
instrument): The extreme values of an error permit-
ted by specifications, regulations, etc. for a given
measuring instrument.
3.10 measuring instrument: A device intended to
make a measurement, alone or in conjunction with
VIM, 5.231
supplementary equipment.
3.18 (measurement) Standard: A material meas-
[VIM, 4.01)
ure, measuring instrument, reference material or sys-
tem intended to define, realize, conserve or reproduce
3.11 adjustment: The Operation intended to bring a
a unit or one or more values of a quantity in Order to
measuring instrument into a state of Performance and
transmit them to other measuring instruments by
freedom from bias suitable for its use.
comparison.
[VIM, 4.331 EXAMPLES
a) 1 kg mass Standard;
3.12 specified measuring range: The set of values
for a measurand for which the error of a measuring
b) Standard gauge block;
Instrument is intended to lie within specified Iimits.
c) 100 a Standard resistor;
NOTES
d) Weston Standard cell;
15 The upper and lower limits of the specified measuring
range are sometimes called the “maximum capacity” and
the “minimum capacity” respectively. e) caesium atomic frequency Standard;
16 In some other fields of knowledge, “range” is used to
f) Solution of cortisol in human Serum as a Standard
mean the differente between the greatest and the smallest
of concentration.
values.
[VIM, 6.011
[VIM, 5.041
3.19 reference material: A material or substance
3.13 reference conditions: Conditions of use for a one or more properties of which are sufficiently weil
measuring instrument prescribed for Performance established to be used for the calibration of an appar-
testing, or to ensure valid intercomparison of results atus, the assessment of a measurement method, or
of measurements. for assigning values to materials.
NOTE 17 The reference conditions generally specify NOTE 19 This definition is taken from ISO Guide 30,
“reference values” or “reference ranges” for the influence where it has several notes.
quantities affecting the measuring instrument.
[VIM, 6.151
[VIM, 5.071
3.20 international (measurement) Standard: A
Standard recognized by an international agreement to
3.14 resolution (of an indicating device): A quan-
setze internationally as the basis for fixing the value
titative expression of the ability of an indicating device
of all other Standards of the quantity concerned.
to permit distinguishing meaningfully between im-
mediately adjacent values of the quantity indicated.
D/IM, 6.061
[VIM, 5.131
3.21 national (measurement) Standard: A stan-
dard recognized by an official national decision to
serve, in a countty, as the basis for fixing the value
3.15 stability: The ability of a measuring instrument
of all other Standards of the quantity concerned.
to maintain constant its metrological characteristics.
---------------------- Page: 11 ----------------------
SIST ISO 10012-1:1996
ISO 10012=1:i992(E)
NOTE 20
The national Standard in a country is often a quality System in relation to quality policy and new
“primary Standard”.
objectives resulting from changing circumstances.
[ISO 8402, 3.121
[VIM, 6.071
3.22 traceability: The property of the result of a
measurement whereby it tan be related to appropri-
4 Requirements
ate measurement Standards, generally international
or national Standards, through an unbroken chain of
comparisons.
4.1 General
NOTES
The Supplier shall document the methods used to
implement the provisions of this patt of ISO 10012.
21 The unbroken chain of comparisons is called a
This documentation shall be an integral part of the
“traceability chain”.
Supplier’s quality System. lt shall be specific in terms
of which items of equipment are subject to the pro-
22 (Applicable only to the French text.)
visions of this part of ISO 10012, in terms of the allo-
cation of responsibilities and in terms of the actions
[VIM, 6.121
to be taken. The Supplier shall make objective evi-
dence available to the Purchaser that the required ac-
3.23 calibration: The set of operations which es-
curacy is achieved.
tablish, under specified conditions, the relationship
between values indicated by a measuring instrument
or measuring System, or values represented by a
material measure or a reference material, and the
4.2 Measuring equipment
corresponding values of a quantity realized by a ref-
erence Standard.
Measuring equipment shall have metrological charac-
teristics as required for the intended use (for example
NOTES
accuracy, stability, range and resolution).
23 The result of a calibration permits the estimation of er-
Equipment and documentation shall be maintained so
rors of indication of the measuring instrument, measuring
as to take account of any corrections, conditions of
System or material measure, or the assignment of values to
use (including environmental conditions), etc. that are
marks on arbitrary scales.
necessary to achieve the required performante.
24 A calibration may also determine other metrological
The required Performance shall be documented.
properties.
25 The result of a calibration may be recorded in a docu-
GUIDANCE
ment, sometimes called a “calibration certificate” or a
“calibration report “.
The set of metrological characteristics (specific re-
quirements) is an essential component of the con-
26 The result of a calibration is sometimes expressed as
a correction or a “calibration factor”, or as a “calibration firma tion sys tem. The Supplier is expected to
curve”. include in his procedures a list of the specified re-
quirements. Usual sources for such requirements
[VIM, 6.131
include manufacturer’s litersture, regulations, etc.
Wherever the sources are inadequate, the Supplier
3.24 (quality) audit: A systematic and independent should himself determine the requirements.
examination to determine whether quality activities
and related results comply with planned arrange-
ments and whether these arrangements are im-
plemented effectively and are suitable to achieve
4.3 Confirmation System
objectives.
The Supplier shall establish and maintain an effective
NOTE 27 The quality audit typically applies, but is not
documented System for the managing, confirmation
limited, to a quality System or elements thereof, to pro-
cesses, to products, or to Services. Such audits are often and use of measuring equipment, including measure-
called “quality System audit”, “process quality audit”,
ment Standards, used to demonstrate compliance
“product quality audit”, “Service quality audit”.
with specified requirements. This System shall be
designed to ensure that all such measuring equip-
[ISO 8402, 3.101
ment performs as intended. The System shall provide
for the prevention 0% errors outside the specified lim-
its of permissible error, by prompt detection of defi-
3.25 (quality System) review: A formal evaluation
ciencies and by timely action for their correction.
by top management of the Status and adequacy of the
4
---------------------- Page: 12 ----------------------
SIST ISO 10012-1:1996
ISO 10012=1:1992(E)
The confirmation System shall take full account of all
relevant data, including that available from any statis-
Some instruments, such as null detectors and co-
tical process control System operated by or for the
incidence detectors, need periodic calibra tion and
Supplier.
confirmation only in the restricted sense of func-
tional checking to assure that they are functioning
For each item of measuring equipment, the Supplier
correctly.
shall designate a competent member of his staff as
authorized officer to ensure that confirmations are A very useful check that a measuring instrument
continues to measure correctly is obtained by the
carried out in accordance with the System and that
use of a checking measurement Standard, applied
the equipment is in a satisfactory condition.
to the instrument by the User. This will demon-
strate if, at the value or values checked and under
In cases where any or all of a Supplier’s confirmation
(including calibration) are replaced or supplemented the conditions o f the check, the instrumen t is still
functioning correctly. The checking measurement
by Services from outside sources, the Supplier shall
Standard itself needs to be calibrated and con-
ensure that these outside sources also comply with
firmed and, in Order that the results obtained by its
the requirements of this patt of ISO 10012 to the ex-
use tan with confidence be attributed to the in-
tent necessary to ensure the Supplier’s compliance
strument and not to changes in the checking
with the requirements.
measurement Standard, it usually has to be simple
and robust. The use of a checking measurement
Standard is in no way a Substitute for regular cali-
GUIDANCE
bration and confirmation of the instrument, but its
The in tention of a confirmation s ystem is to ensure
use may prevent the use of an instrument which,
that the risk of measuring equipment producing
within the intetval between two formal confir-
results having unaccep table errors remains within
mations, ceases to con form to specifica tion.
acceptable bounds. The use of appropriate statis-
tical methods for analysing the results of preceding
calibrations, for assessing the results of cali-
brations of several similar items of measuring
equipmen t and for predicting cumula tive uncer-
tainties is recommended. (See ISO 9004: 1987,
4.4 Periodic audit and review of the
13.7.)
confirmation System
The error attributable to calibration should be as
small as possible. In most areas of measurement, The Supplier shall carry out, or shall arrange to be
it should be no more than one third and preferably carried out, periodic and systematic quality auditing
one tenth o f the permissible error of the con firmed of the confirmation System in Order to ensure its
equipment when in use. continuing effective implementation and compliance
with the requirements of this part of ISO 10012.
lt is usual to carry out the calibration associated
with an y con firma tion under re ference conditions,
Based on the results of the quality audits and of other
but where it is known tha t the Opera ting conditions
relevant factors, such as feedback from Purchasers,
are significantly different from the reference con-
the Supplier shall review and modify the System as
ditions, calibra tion under appropriate values o f the
necessafy.
influence quantities ma y be carried out. Where this
is impractical, due allowance should be made for Plans and procedures for the quality audit and review
the differente in the conditions. shall be documented. The conduct of the quality audit
and review and any subsequent corrective actions
For a commercial device, it is usual to take the
shall be recorded.
manufacturer’s claimed petiormance as the cri-
terion of satisfactory Performance and accuracy. lt
is sometimes necessary to modify the manufac-
turer’s Claims.
4.5 Planning
Where no manufacturer’s claimed Performance is
available, criteria for sa tis factory Performance ma y
The Supplier shal I review any relevant Purchaser’s and
have to be determined from experience.
other technical requirements before commencing
work on products or Services, and shall ensure that
the measuring equipment (including measurement
Standards) needed for the performante of the work
are available and are of the accuracy, stability, range
and resolution appropriate for the intended applica-
tion.
---------------------- Page: 13 ----------------------
SIST ISO 10012-1:1996
ISO 10012~1:1992(E)
GUIDANCE GUIDANCE
This review should be carried out at as early a Procedures may be, but are not necessarily, limited
Stage as practical, so as to permit comprehensive to the compilation of published Standard measure-
and effective planning of the Supplier’s confir- ment practices and a Purchaser’s or an instrument
mation System. manufacturer’s written instructions. The amount
of detail in procedures should be commensurate
with the complexity of the confirmation process.
These methods ma y be elaborated using the tech-
4.6 Uncertainty of measurement
niques of sta tis tical process con trol, whereb y
measurement Standards and measuring instru-
In performing measurements and in stating and mak-
ments are intercompared in-house, drifts and faults
ing use of the results, the Supplier shall take into ac-
are determined, and any necessary corrective ac-
count all significant identified uncertainties in the
tion is taken. Sta tistical process con trol is comple-
measurement process including those that are attrib-
mentary to regular calibra tion and rein forces
utable to measuring equipment (including measure-
con fidence in measurement results during the in-
ment Standards) and those contributed by personnel
tervals between confirmations.
procedures and environment.
In estimating the uncertainties, the Supplier shall take
account of all relevant data including that available
from any statistical process control System operated 4.8 Records
by or for the Supplier.
The Supplier shall maintain records of the make, type
and serial number (or other identification) of all rele-
GUIDANCE vant measuring equipment (incuding measurement
Standards). These records shall demonstrate the
When it has been demonstra ted by a calibra tion
measurement capability of each item of measuring
tha t measuring equipmen t is performing correctly
equipment. Any calibration certificates and other rele-
(in accordance with its specification), it is usual to
...
NORME
IS0
INTERNATIONALE
100124
Premihre bdition
1992-61-15
Corrigbe et rbimprimbe
1993-05-o 1
Exigences d’assurance de la qualit des
bquipements de mesure -
Partie 1:
Confirmation mittrologique de kquipement
de mesure
Quality assurance requirements for measuring equipment -
Part 1: Metrological confirmation system for measuring equipment
Wumkro de rbfbrence
IS0 10012-l :I 992(F)
---------------------- Page: 1 ----------------------
IS0 10012=1:1992(F)
Sommaire
Page
1 Domaine d’application ,,.~.,,,,.,,,.,,,,.,.~.~.,. 1
,.,.,.~.~~.~.~. %
2 References normatives
2
3 Definitions ,.,,.,.~.,.,.~.,.~
I*~.~.~*.~.,.,=“,, 4
4 Exigences .“,.l.C.~.,.~.~.~.
4.1 G&WaIit& . . .~.,,,.,,,,,.,~,.~,,.,,,,~.‘.~.~.~.~~.~.~~.~~.~~”.~~.,.~~. 4
. . . . . . . . . . . . . . . . . . . . . . . . . .~.~.~.~. 4
4.2 tquipement de mesure
. . . . . . . .I. 5
4.3 Systeme de confirmation
.-. 6
4.4 Audits et revues phiodiques du systhme de confirmation
4.5 Planification . . . . . . . . . . . . . .~~.~~~.~~~.~“.~.~~~~.~.~.~~~.~.~~.~.~. 6
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .~.“.~~~.‘~.~ 6
4.6 Incertitude de mesure
. .“01.“.,.,,.~.,D 6
4.7 Procedures de confirmation document&es
7
4.8 Enregistrements . . . . . . . .~.I.~.~.~.
. . . . . . . . . . . . . . . . . . . . . .*.*. 8
4.9 Equipement de mesure non conforme
4.10 Etiquette de confirmation . . . . . . . . . . . . . . . . . . . . . .‘.~.*.~.~.“.“. 8
. . . . . . . . . .I~.~~. 9
4.11 lntervalles de confirmation
4.12 Protection des dispositifs d’ajustage . . . . . . . . . . . . . . . . . . .m.“. 9
4.13 Utilisation de produits et services ext&ieurs . . . . . . . . . . . . . . . . . . . . . 10
4.14 Stockage et manutention . . . . . . . . . . . . . . . . . . . . .“.‘. 10
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
4.15 Tracabilitb
4.16 Effet cumulatif des incertitudes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .“. 11
. . .‘I.,.,.~,.,.,,,.,., 11
4.17 Conditions d’environnement
4.18 Personnel . . . . . . . . . . .~.*. 11
(P IS0 1992
Droits de reproduction r6serhs. Aucune par-tie de cette publication ne peut &re reproduite
ni utilisbe SOUS quelque forme que ce soit et par aucun pro&&, bctronique ou mhanique,
y compris la photocopie et les microfilms, sans I’accord hcrit de l’bditeur.
Organisation internationale de normalisation
Case Postale 56 l CH-1211 Geneve 20 l Suisse
Imprime en Suisse
ii
---------------------- Page: 2 ----------------------
IS0 10012-1:1992(F)
A Conseils pour la d6termination des intervalles de confirmation des
,.,,,,,.,.,.,.,.,.~. 12
6quipements de mesure
. . . . . . . . . . . . . . . . . . . . . .~. 12
A.1 Introduction
. . . . . . . . . . . . . . . . . . . . . . . . 12
A.2 Choix initial des intervalles de confirmation
.-. 13
A.3 Methodes de revision des intervalles de confirmation
15
B Bibliographie .~.,.,.,.
. . .
III
---------------------- Page: 3 ----------------------
IS0 10012=1:1992(F)
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 confide 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 gouvernemen-
tales, en liaison avec I’ISO participent egalement aux travaux. L’ISO colla-
bore 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 co-
mites membres votants.
La Norme internationale IS0 10012-l a ete elaboree par le comite techni-
que ISO/TC 176, Management et assurance de la qua/it& sous-comite SC
3, Techniques de soutien.
L’ISO 10012 comprend les parties suivantes, presentees sous le titre ge-
neral Exigences d’assurance de la qualite des equipements de mesure:
- Partie 1: Confirmation metrologique de I’equipement de mesure
- Partie 2: Assurance de mesure
L’annexe A est basee sur le Document international no 10 de I’Organi-
sation internationale de metrologie legale (OIML), Conseils pour /a deter-
mina tion des in ten/al/es de reetalonnage des equipements de mesure
u tilises dans les labora toires d ‘essai.
Les annexes A et B de la presente partie de I’ISO 10012 sont donnees
uniquement a titre d’information.
---------------------- Page: 4 ----------------------
IS0 10012=1:1992(F)
Introducti
La presente partie de I’ISO 10012 est redigee dans le contexte Acheteur-
Fournisseur, ces deux termes &ant interpret& au sens le plus large. Par
{(Fournisseuw, on peut entendre aussi bien le fabricant que I’installateur
ou le prestataire de sewice, a qui il incombe de fournir un produit ou un
service. L’((Acheteuw peut designer une agence administrative publique,
un client utilisateur du produit ou du service consider-e. Les Fournisseurs
deviennent Acheteurs lorsqu’ils sont amen& 8 se procurer des fournitures
et services aupres de vendeurs ou d’autres sources exterieures. Le sujet
des negotiations faisant reference a la presente pat-tie de I’ISO 10012
peut porter sur une conception, un objet fabrique, un produit ou un ser-
vice. II peut etre fait reference a la presente partie de I’ISO 10012 en
d’autres situations dans le cadre d’un accord particulier.
La reference a la presente par-tie de I’ISO 10012 peut etre faite
- par un Acheteur, lors de la specification des produits ou services de-
mand&;
- par un Fournisseur, lors de la specification des produits ou services
offerts;
- par des organismes representatifs des inter&s des consommateurs
ou des travailleurs, ou par des organismes legislatifs ou statutaires;
- dans le cadre de l’evaluation ou de l’audit de laboratoires.
La presente par-tie de I’ISO 10012 contient a la fois des exigences et (a
I’article 4) des conseils pour la mise en ceuvre de ces exigences.
Afin de bien faire la distinction entre exigences et conseils, dans
I’article 4, les conseils sont encadres et imprimes en italique sous le titre
((GUIDE D’APPLICATION)), apparaissant apres chaque paragraphe corres-
pondant.
Le texte dans le ((GUIDE D’APPLICATION)) 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.
NOTE 1 L’emploi du genre masculin dans la prbsente partie de I'ISO 10012
n’exclut pas le genre fkminin Iorsqu’il s’applique aux personnes. De meme, l’utili-
sation du singulier n’exclut pas le pluriel (et vice versa) lorsque le sens le permet.
V
---------------------- Page: 5 ----------------------
This page intentionally left blank
---------------------- Page: 6 ----------------------
NORME INTERNATIONALE IS0 10012~1:1992(F)
ualit6 des bquipements
Exigences
de mesure -
Partie 1:
Confirmation mhtrologique de Mquipement de mesure
exigences de I’ISO 9001, I’ISO 9002 et I’ISO 9003.
1 Domaine d’application
Les conseils de I’ISO 9004 sont aussi applicables;
1.1 La presente pat-tie de I’ISO 10012 comporte des
- a tous autres organismes ou les resultats de me-
exigences en mat&e d’assurance de la qualite appli-
sure sont utilises pour demontrer la conformite a
cables a un Fournisseur pour s’assurer que les me-
des exigences specifiees.
sures sont effect&es avec le degre d’exactitude
voulu. Elle contient egalement des conseils concer-
nant la mise en ceuvre des exigences.
“‘I.5 Le role de I’Acheteur dans la surveillance de la
conformite d’un Fournisseur a la presente partie de
I’ISO 10012 peut etre assure par une tierce partie telle
1.2 La presente partie de I’ISO 10012 definit les ca-
qu’un organisme de certification ou d’accreditation.
racteristiques principales du systeme de confirmation
8 appliquer pour les equipements de mesure d’un
Fournisseur.
1.3 La presente par-tie de I’ISO 10012 s’applique aux
2 Mfbrences normatives
equipements de mesure utilises pour demontrer la
conformite avec un cahier des charges; elle ne s’ap-
Les normes suivantes contiennent des dispositions
plique pas a d’autres equipements de mesure.
qui, par suite de la reference qui en est faite, consti-
La presente pat-tie de I’ISO 10012 ne traite pas en
tuent des dispositions valables pour la presente
detail des autres elements pouvant influer sur les re-
Norme internationale. Au moment de la publication,
sultats de mesurage, tels que les methodes de me-
les editions indiquees etaient en vigueur. Toute
surage, les competences du personnel, etc.; ceux-ci
norme est sujette a revision et les parties prenantes
sont trait& plus en profondeur dans d’autres Normes
des accords fond& sur la presente Norme internatio-
internationales telles que celles citees en 1.4.
nale sont invitees a rechercher la possibilite d’appli-
quer les editions les plus recentes des normes
indiquees ci-apres. Les membres de la CEI et de I’ISO
1.4
La presente partie de I’ISO 10012 s’applique
possedent le registre des Normes ,internationaIes en
vigueur a un moment donne.
- aux laboratoires d’essai, notamment ceux qui
fournissent un service d’etalonnage; ceci inclut les
IS0 8402: 1986, &alit& - Vocabulaire.
Iaboratoires mettant en oauvre un systeme qualite
en harmonie avec l’lSO/CEl Guide 25;
IS0 9001 :1987, Systdmes qua/it6 - Mod&/e pour
I’assurance de la qua/it6 en conception/d&elop-
- aux Fournisseurs de produits ou de services qui
pement, production, installation et soutien apr&s la
mettent en ceuvre un systeme qualite dans lequel
ven te.
les resultats de mesure sont utilises pour demon-
IS0 9002:1987, Systhmes qua/it6 - Mod&/e pour
trer la conformite avec des exigences specifiees;
/‘assurance de la qualith en production et installation.
ceci inclut les systemes qualite qui satisfont aux
---------------------- Page: 7 ----------------------
IS0 10012-1:1992(F)
3.4 mesurande: Grandeur soumise a mesurage.
IS0 9003:1987, Syst&mes qua/it6 - Mod&/e pour
/‘assurance de la qua/it6 en contr6le et essais finals.
NOTE 5 Ce peut &re, selon le cas, la grandeur 3 mesurer
(grandeur qui sera soumise au mesurage) ou la grandeur
IS0 9004: 1987, Gestion de la qua/it6 et 6kments de
mesuree (grandeur qui a 6th soumise au mesurage).
- Lignes directrices.
systhme qua/it6
ISO/CEI Guide 25:1990, Prescriptions gh?ra/es
[VIM, 2.091
concernan t la comphence des labora toires d ‘8 talon-
nage et d ‘essais.
3.5 grandeur d’inffuence: Grandeur qui ne fait pas
IS0 Guide 30:1981, Termes et ddfinitions utilis6s en
I’objet du mesurage mais qui influe sur la valeur du
rapport avec /es mathiaux de rgfkence.
mesurande ou star les indications de I’instrument de
mesure.
BIPM/CEl/lS0/0IML, Vocabulaire international des
termes fondamentaux et g$n&aux de mhrologie
EXEtvlPLES
(VIM): 1984.
temperature ambiante; frequence d’une tension elec-
trique alternative mesuree.
[VIM, 2.101
3 Dbfinitions
Pour les besoins de la presente partie de I’ISO 10012,
3.6 exactitude de mesure: kroitesse de liaccord
les definitions suivantes s’appliquent. La plupart
entre le resultat d’un mesurage et la valeur (conven-
d’entre elles sont issues du Vocabulaire international
tionnellement) vraie du mesurande.
des termes fondamentaux et generaux de metrologie
(VIM), mais ne sont pas toujours identiques aux defi-
NOTES
nitions de ce dernier. Les definitions de I’ISO 8402
sont aussi pertinentes. Les references correspon-
6 Le concept d’ ((exactitude)) est qualitatif.
dantes figurent entre crochets apres les definitions.
7 L’emploi du terme qhcision)) au lieu dkexactitude))
doit &re kvitk.
3.1 confirmation mbtrologique: Ensemble des
[VIM, 3.051
operations requises pour s’assurer de la conformite
d’un equipement de mesure avec les exigences
prescrites pour I’utilisation projetee.
3=7 incertitude de mesure: Wesultat de I’evaluation
visant 8 caracteriser l’etendue du domaine a l’interieur
NOTES
duquel la valeur vraie d’un mesurande es% estimee
2 La confirmation mhrologique comporte normalement,
devoir se trouver, generalement avec une vraisem-
entre autres, I’&alonnage, tout ajustage ou reparation n&- blance donnee.
cessaire et le r&talonnage ulthieur, ainsi que toute pro-
tection et tout btiquetage kventuellement requis.
NOTE 8 L’incertitude de mesure comprend, en g&Wai,
plusieurs composantes. Certaines peuvent &re estimbes
3 Pour plus de bri&vet& dans la prksente partie de
en se fondant sur la distribution statistique des rksultats de
I’ISO 10012, ce terme est design6 sous le nom de ((confir-
shies de mesurages et peuvent &re caractkiskes par un
mation)).
&cart-type exphimental. L’estimation des autres compo-
santes ne peut &re fondbe que sur I’expkience ou sur
d’autres informations.
3.2 kquipement de mesure: Tous les instruments
[VIM, 3.091
de mesure, etalons, materiaux de reference, appareils
auxiliaires et logiciels necessaires a l’execution d’une
mesure. Ce terme comprend l’equipement de mesure
utilise pour les essais et les controles ainsi que pour 3.8 errewr (absolue) de mesure: Resultat d’un me-
I’etalonnage. surage moins la valeur vraie du mesurande.
NOTE 4 Dans la pksente partie de I’ISO 10012, le terme NOTES
&quipement de mesure)) comprend les instruments de
mesure et les 6talons. On consid&e, en outre, qu’un ma- 9 Voir waleur vraie waleur conven-
(d’une grandeu r))) et
t&iau de rbfkrence correspond h un type d’ktalon particulier. tionnellement vraie (d
‘une grandeur))) dans le VIM.
10 Le terme s’applique kgalement
3.3 mesurage: Ensemble d’operations ayant pour
but de determiner la valeur d’une grandeur. - h I’indication,
- au r6sultat brut,
[VIM, 2.011 - au resultat corrigk
2
---------------------- Page: 8 ----------------------
IS0 100124:1992(F)
NOTE 17
11 Les parties connues de I’erreur de mesure peuvent Les conditions de reference sphcifient gene-
ralement des waleurs de reference)) ou des &endues de
etre compensees par I’application de corrections appro-
rbf&ence)) pour les grandeurs d’influence affectant un ins-
prices. L’erreur du resultat corrige ne peut etre caracterisee
trument de mesure.
que par une incertitude.
12 Ne pas confondre I’erreur absolue, qui peut etre posi-
[VIM, 5.071
tive ou negative, et la valeur absolue d’une erreur qui est le
module d’une erreur.
3.14 rhsolution (d’un dispositif indicateur): Ex-
pression quantitative de l’aptitude d’un dispositif indi-
[VIM, 3.10]
cateur $I permettre de faire la distinction de man&e
significative entre des valeurs voisines de la grandeur
indiqube.
3.9 correction: Valeur qui, ajoutbe algbbriquement
au rksultat brut d’un mesurage, compense une erreur
[VIM, 5.131
systbmatique pksumbe.
NOTES
3.15 constance: Aptitude d’un instrument de me-
sure h conserver ses caracthristiques mhrologiques
13 La correction est egale a l’erreur systematique presu-
constantes.
mee changee de signe.
NOTE 18 La Constance est habituellement consideree
erreur systematique ne peut etre connue
14 Puisque
comme rapporthe au temps. Lorsqu’elle est rapportbe h une
la correction est entach 6e d’une incertitude.
exactement,
autre grandeur, il est necessaire de le mentionner explici-
tement.
[VIM, 3.141
@/IM, 5.161
3.10 appareil de mesure; appareif mesureur; ins-
3.16 derive: Lente variation au tours du temps
trument de mesure: Dispositif destine! 3 faire un
d’une caracteristique mhtrologique d’un instrument
mesurage, seul ou associb a des bquipements an-
de mesure.
nexes.
[VIM, 5.181
[VIM, 4.011
3.17 limites d’erreur tokrbes (d’un instrument de
3.11 ajustage: Op&ation destinbe h amener un ap- mesure): Valeurs extremes d’une erreur tol&hes par
pareil de mesure ZI un &at de fonctionnement et de les sp&ifications, reglements, etc. pour un instru-
justesse convenant a son utilisation. ment de mesure donnh.
@/IM, 5.231
[VIM, 4.331
3.18 Qtalon: Mesure mathialisbe, appareil de me-
3.12 &endue de mesure spkifihe: Ensemble des
sure, mat&iau de reference ou systhme de mesure
valeurs d’un mesurande pour lesquelles l’erreur d’un
destine 8 dbfinir, rbaliser, conserver ou reproduire une
instrument de mesure est supposbe comprise entre
unite ou une ou plusieurs valeurs d’une grandeur pour
des limites sp&ifiees.
les transmettre par comparaison 8 d’autres instru-
ments de mesure.
NOTES
EXEMPLES
15 Les limites superieure et inferieure de I’etendue de
mesure specifiee sont parfois appelees respectivement
a) 6talon de masse de 1 kg;
((portee maximale)) et ((portee minimale)).
b) tale 6talon;
16 Dans certains autres domaines de connaissances, le
terme &endue)) est utilise pour exprimer la difference en-
c) resistance halon de 100 Q;
tre la plus grande et la plus petite des valeurs.
d) pile &alon de Weston;
[VIM, 5.041
e) halon atomique de frbquence a cesium;
3.13 conditions de rhfbrence: Conditions d’utili-
f) solution de cortisol dans le s&urn humain utilishe
sation d’un instrument de mesure prescrites pour des
comme &talon de concentration.
essais de fonctionnement ou pour assurer vala-
blement la comparaison des rhultats de mesure en-
[VIM, 6.011
tre eux.
---------------------- Page: 9 ----------------------
IS0 10012=1:1992(F)
24 Un etalonnage peut aussi determ iner d’autres proprie-
3.19 matekiau de reference: Mathriau ou substance
tes metrologiques.
dont une ou plusieurs proprietes sont suffisamment
bien definies pour permettre de I’utiliser pour l’eta-
25 Le resultat d’un etalonnage peut Btre consigne dans
lonnage d’un appareil, l’evaluation d’une methode de
un document parfois appele ((certificat d’etalonnage)) ou
mesure ou I’attribution de valeurs aux materiaux.
wapport d’etalonnage)).
NOTE 19 Cette definition provient de I’ISO Guide 30, 00
26 l-e resultat d’un etalonnage est parfois exprime sous la
elle est accompagnee de plusieurs notes.
forme d’une correction, d’un (tfacteur d’etalonnage)), ou
d’une wourbe d’etalonnage~~.
[VIM, 6.151
[VIM’ 6.131
3.20 6talon international: kalon reconnu par un
3.24 audit (qualitk): Examen mbthodique et ind&-
accord international pour servir de base internationale
pendant en vue de determiner si les activites et re-
a la fixation des valeurs de tous les autres etalons de
sultats relatifs 8 la qualit satisfont aux dispositions
la grandeur concernee.
pr&tablies, et si ces dispositions sont mises en
ceuvre de faGon efficace et sont aptes a atteindre les
[VIM, 6.061
objectifs.
3.21 etaIon national: etaIon reconnu par une deci-
NOTE 27 L’audit qualite s’applique essentieilement, mais
sion nationale officielle comme base de depart, dans
nest pas restreint a un systeme qualite ou A des elements
un pays, pour fixer la valeur de tous les autres etalons
de celui-ci, a des procedes, a des produits ou a des servi-
de la grandeur consideree.
ces. De tels audits sont couramment appeles: ((audit qualite
de systeme)), ((audit qualite de pro&d&, ((audit qualite de
NOTE 20 L’etalon national dans un pays est souvent un
produit jr, ((audit qualite de service)).
etalon primaire.
[ISO 8402, 3.101
[VIM, 6.07)
3.25 revue [du systkme qualMI: Evaltiation en r&
3.22 tra~abilitk Propriete du resultat d’un mesu-
gle, effect&e par la direction g&Wale, de l’etar et de
rage tel qu’il puisse etre relic a des etalons appro-
I’adequation du systeme qualite par rapport a la poli-
pries, generalement internationaux ou nationaux, par
tique qualite et aux nouveaux objectifs resultant de
I’intermediaire d’une cha’ine ininterrompue de compa-
l’evolution de ia conjoncture.
raisons.
[ISO 8402, 3.121
NOTES
4 Exigenees
21 La chaine ininterrompue de comparaisons est appelee
((chaine de raccordement aux etaIons) ou whaine d’eta-
lonnage)). 4.1 GhSralit6s
liaison aux etalon
22 La man&e dont s’effectue la s est
Le Fournisseur doit materialiser par des documents
((raccordement aux etalons )) .
appelee
les methodes utilisees pour satisfaire aux dispositions
de la presente partie de I’ISO 10012. La documen-
[VIM, 6.121
tation correspondante doit faire par-tie integrante du
systeme qualite du Fournisseur. Elle doit specifier
3.23 btalonnage: Ensemble des operations etablis-
quels equipements doivent etre soumis aux dispo-
sant, dans des conditions specifiees, la relation entre
sitions de la pr&ente par-tie de I’ISO 10012, les res-
les valeurs indiquees par un appareil de mesure ou
ponsabilites de chacun et les actions a entreprendre.
un systeme de mesure, ou les valeurs representees
Le Fournisseur doit mettre a la disposition de I’Ache-
par une mesure materialisee ou un materiau de refe-
teur les preuves tangibles que les mesures ont
rence, et les valeurs correspondantes d’une grandeur
I’exactitude requise.
realisees par un etalon de reference.
4.2 tquipement de mesure
NOTES
L’equipement de mesure doit presenter des caracte-
23 Le resultat d’un etalonnage permet d’estimer les er-
ristiques metrologiques exigees en fonction de
reurs d’indication de I’appareil de mesure, du systeme de
l’usage envisage (notamment, I’exactitude, la stabilite,
mesure ou de la mesure materialisee, ou d’attribuer des
valeurs % des rep&es sur des 6chelles arbitraires. II&endue de mesure et la resolution).
---------------------- Page: 10 ----------------------
IS0 100124:1992(F)
L’equipement et la documentation doivent etre main-
Dans les cas ou tout ou pat-tie de la confirmation (y
tenus 8 jour et comporter toutes les corrections, les
compris I’etalonnage) du Fournisseur est remplacb
indications sur les conditions d’utilisation (y compris
ou completee par des prestations de services extk-
les conditions d’environnement), etc., necessaires a
rieures, le Fournisseur doit veiller a ce que ces sour-
I’obtention de l’exactitude requise.
ces exterieures se conferment, elles aussi, aux
exigences de la presente pat-tie de I’ISO 10012 dans
Les caracteristiques exigees doivent etre specifiees
toute la mesure necessaire a assurer la conformite du
dans un document.
Fournisseur a ces exigences.
GUIDE D’APPLICATlON
GUIDE D’APPLICATION
L ‘ensemble des caracteristiques metrologiques L’objectif d’un systeme de confirmation est de
(exigences specifiques) cons titue un element es- faire en sorte que le risque qu ‘un equipement de
sentiel du systeme de confirmation. Le Fournis- mesure produise des resulta ts ayant des erreurs
sew est tense inclure dans ses procedures une inacceptables soit inferieur a une valeur accep-
lis te des exigences specifiees. Ca documentation
table. II est recommande d’employer des metho-
du fabricant, /es reglements, etc., figurent parmi des s ta tis tiques appropriees pour analyser les
les sources types pour de telles exigences. Lors-
resulta ts des precedents etalonnages, pour evaluer
que les sources s ‘a&rent insuffisantes, il incombe
les resulta ts des etalonnages de plusieurs equi-
au Fournisseur de determiner lui-meme lesdites
pements de mesure semblables et pour calculer 9
exigences.
I’avance les incertitudes cumula tives (voir
IS0 9004: 1987, 13.1).
II convient que I’erreur attribuable 8 I’etalonnage
soit aussi faible que possible et qu ‘elle ne d6passe
pas, dans la plupart des domaines de mesure, un
tiers et de preference, un dixieme de I’erreur tole-
ree de I’equipement confirm8 lors de son utili-
sa tion.
4.3 Systkme de confirmation
II est courant de kaliser un Gtalonnage prdalable a
toute confirmation dans des conditions de r6f&-
rence. Cependant, lorsqu’on est inform6 que les
conditions de fonctionnemen t different des condi-
tions de reference de man&e significative, l’eta-
Le Fournisseur doit etablir et maintenir e n bon &at
lonnage peut etre realise avec les valeurs
un systeme pour la gestion, la confirmation e t I’emploi
appropriees pour les grandeurs d ‘influence. Lors-
des equipements de mesure, y compris les etalons,
que ceci s’avere irrealisable, il convient de tenir
utilises pour demontrer la conformite a des exigences
camp te des differences des conditions.
specifiees. Ce systeme doit etre materialise par des
documents et fonctionner effectivement. Ce systeme
Pour un appareil du commerce, il est courant de
doit etre concu de man&e que tous les equipements
prendre comme critere de bon fonctionnement et
de mesure se corn portent comme prevu . Le systeme
d’exactitude les caracteristiques specifiees par le
doit comprendre des dispositions preventives pour
fabrican t. II est parfois necessaire de prendre un
eviter, grace a la detection rapide de defauts et par
autre critere que /es valeurs assignees par le fabri-
des actions correctives prises en temps utile, que les
cant.
erreurs depassent les erreurs maximales specifiees.
Si on ne dispose pas de valeurs sp&ifiGes par le
Le systeme de confirmation doit prendre en compte,
fabricant, il est recommande de determiner les
dans leur integralite, toutes les donnees utiles, y
criteres de bon fonctionnemen t par I’experience.
compris celles provenant d’un systeme de suivi sta-
Pour certains instruments, tels que les detecteurs
tistique exploite par le Fournisseur ou pour son
de zero et les detecteurs de coincidence, les eta-
compte.
lonnages et les confirmations periodiques se limi-
tent a des verifications perme ttan t d’assurer qu ‘ils
Pour chacun des equipements de mesure, le Four-
fonctionnen t correctemen t.
nisseur designe un membre competent de son per-
sonnel, comme responsable des operations de
confirmation, de leur deroulement conformement au
systeme et du bon &at des equipements.
5
---------------------- Page: 11 ----------------------
IS0 10012=1:1992(F)
4.6 Incertitude de mesure
Pour v&ifier qu ‘un instrument de mesure continue
de mesurer correctement, il est commode pour
Pour proceder aux mesures, pour en exprimer les re-
I’utilisateur d’employer un etalon de controle.
sultats et pour les utiliser, le Fournisseur doit tenir
Celui-ci met en hvidence si, pour la valeur ou /es
compte de toutes les sources d’incertitudes identi-
valeurs v&ifi6es et dans /es conditions de la v&i-
frees et significatives dans le processus de mesure.
fication, /‘instrument fonctionne encore correc-
Ces sources comprennent les contributions des equi-
tement. L ‘etalon de controle devrait etre lui-meme
pements de mesure (y compris les etalons), du per-
etalonne et confirm& a fin que les resultats obte-
sonnel, des procedures et de I’environnement.
nus puissent t%re consid&& comme traduisant le
comportement de I’instrument, et non des d&rives
Dans kvaluation des sources d’incertitudes, le Four-
de l’etalon de controle. Ce dernier devrait etre
nisseur doit tenir compte de toutes les donnees uti-
simple et robuste. L’emploi d’un &talon de contrdle
les, y compris celles provenant de tout systeme de
ne se substitue en aucune man&e aux etalon-
suivi statistique exploite par le Fournisseur ou pour
nages et confirmations reguliers de I’ins trumen t,
son compte.
mais peut empecher I’utilisation d’un instrument
qui cesserait d’&re conforme 8 ses spkifications
en tre deux confirmations regulieres.
WIDE D’APPLICATION
Quant un etalonnage a demontre qu ‘un equi-
pement de mesure fonctionne correctement
(c’est-&dire con formemen t B ses specifications),
4.4 Audits et revues phriodiques du systeme
on presume ordinairement que les erreurs pro-
de confirmation duites lors de son utilisation ne depassen t pas les
limites specifiees pour I’erreur toleree. Ceci est
presume valable jusqu’au moment du prochain
Le Fournisseur doit proceder ou faire proceder 8 des
etalonnage lors de la prochaine confirmation de
audits qualite periodiques et systematiques pour as-
I’equipement. Cette supposition peut ne pas etre
surer que le systeme de confirmation continue d’etre
justifiee du fait des conditions d ‘utilisa tion souvent
mis en ceuvre effectivement et reste conforme aux
plus s&&es 9ue les conditions de I’etalonnage. II
exigences de la presente partie de I’ISO 10012.
peut done etre opportun de compenser cela en
Le Fournisseur doit passer en revue le systeme et le resserran t les limites d’accepta tion du produit.
modifier si necessaire, en s’appuyant sur les resultats L ‘importance de ce resserrement depend des cir-
des audits qualite et d’autres facteurs significatifs, tels constances particulieres et se determine par
que le retour d’informations provenant des Acheteurs. I’exercice du jugement fonde sur I’experience (voir
4.17}.
Les plans et procedures applicables aux revues et aux
L ‘utilisa tion des me thodes s ta tis tiques es t recom-
audits qualite doivent etre materialises par des docu-
mandee pour surveiller et ma2riser en continu I’in-
ments. La trace &rite de la conduite des audits qua-
.
certitude de mesure (voir IS0 9004:1987, 13.1).
des revues et des a
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.