EN ISO 10012:2003
(Main)Measurement management systems - Requirements for measurement processes and measuring equipment (ISO 10012:2003)
Measurement management systems - Requirements for measurement processes and measuring equipment (ISO 10012:2003)
ISO 10012:2003 specifies generic requirements and provides guidance for the management of measurement processes and metrological confirmation of measuring equipment used to support and demonstrate compliance with metrological requirements. It specifies quality management requirements of a measurement management system that can be used by an organization performing measurements as part of the overall management system, and to ensure metrological requirements are met.
ISO 10012:2003 is not intended to be used as a requisite for demonstrating conformance with ISO 9001, ISO 14001 or any other standard. Interested parties can agree to use ISO 10012:2003 as an input for satisfying measurement management system requirements in certification activities. Other standards and guides exist for particular elements affecting measurement results, for example, details of measurement methods, competence of personnel, interlaboratory comparisons.
ISO 10012:2003 is not intended as a substitute for, or as an addition to, the requirements of ISO/IEC 17025.
Messlenkungssysteme - Anforderungen an Messprozesse und Messmittel (ISO 10012:2003)
Diese Internationale Norm legt allgemeine Anforderungen fest und bietet Anleitungen für die Lenkung von Messprozessen und die metrologische Bestätigung von Messmitteln, die für die Unterstützung und den Nachweis der Übereinstimmung mit den Anforderungen eingesetzt werden. Es werden Anforderungen an das Qualitätsmanagement von Messlenkungssystemen festgelegt, damit diese von einer Organisation eingesetzt werden können, die als Teil ihres übergeordneten Managementsystems Messungen durchführt und damit die Einhaltung der metrologischen Anforderungen sichergestellt ist.
Diese Internationale Norm ist nicht als Nachweis für die Übereinstimmung mit ISO 9001, ISO 14001 oder mit weiteren Normen vorgesehen. Interessierte Kreise können jedoch im Zusammenhang mit Zertifizierungs-vorgängen die Anwendung der vorliegenden Internationalen Norm als Vorgabe für die Einhaltung von Anforderungen an Messlenkungssysteme vereinbaren.
Diese Internationale Norm ist nicht als Ersatz oder Ergänzung für die Anforderungen von ISO/IEC 17025 vorgesehen.
ANMERKUNG Es bestehen weitere Normen und Anleitungen für bestimmte Einzelelemente mit Einfluss auf die Messergebnisse, wie z. B. Einzelheiten der Messverfahren, Qualifikation des Personals und Vergleichsuntersuchungen zwischen Laboratorien.
Systèmes de management de la mesure - Exigences pour les processus et les équipements de mesure (ISO 10012:2003)
L'ISO 10012:2003 est destinée à fournir des exigences génériques et des guides d'application pour le management des processus de mesure et pour la confirmation des équipements de mesure utilisés pour démontrer la conformité aux exigences métrologiques. Elle spécifie les exigences qualité relatives au système de management de la mesure qu'un organisme effectuant des mesures peut utiliser et intégrer dans le cadre du système de management global et qui est destiné à garantir que les exigences métrologiques sont satisfaites.
L'ISO 10012:2003 n'est pas destinée à être requise pour démontrer la conformité avec l'ISO 9001, avec l'ISO 14001 ou avec toute autre norme. Les parties intéressées peuvent convenir d'utiliser la présente Norme internationale comme point d'entrée à la satisfaction des exigences relatives au système de management de la mesure dans des activités de certification.
L'ISO 10012:2003 n'est destinée ni à être substituée ni à être ajoutée aux exigences de l'ISO/IEC 17025.
Sistemi vodenja meritev – Zahteve za procese merjenja in merilno opremo (ISO 10012:2003)
Slovenski standard je enakovreden evropskemu standardu EN ISO 10012:2003, z njim pa sta bila nadomeščena standarda SIST EN 30012-1:1997, Zahteve za zagotavljanje kakovosti merilne opreme - 1. del: Sistem meroslovnega potrjevanja merilne opreme (ISO 10012-1:1992), in SIST ISO 10012-2:1998, Zahteve za zagotavljanje kakovosti merilne opreme - 2. del: Obvladovanje merilnih procesov. Namenjen je odjemalcem pri specificiranju zahtevanih proizvodov in dobaviteljem pri specificiranju ponujenih proizvodov, nanj pa se lahko sklicujejo tudi zakonodajni in regulativni organi ter udeleženi pri ocenjevanju in presojanju sistemov vodenja meritev.Uspešen sistem vodenja meritev zagotavlja, da merilna oprema in merilni procesi ustrezajo nameravani uporabi, pri čemer se v standardu izraz "merilni proces" uporablja za aktivnosti fizičnih merjenj (npr. v razvoju, preskušanju, proizvodnji, kontroli). Z njim je mogoče obvladovati tveganja zaradi nepravilnih merilnih rezultatov, ki jih lahko povzročijo merilna oprema in merilni procesi, s tem pa se potrjuje njegov pomen pri doseganju ciljev kakovosti proizvodov. Sistem vodenja meritev zato vključuje metode od osnovnega overjanja opreme do uporabe statističnih metod v obvladovanju merilnega procesa. Čeprav ta standard ni namenjen dokazovanju skladnosti z ISO 9001, ISO 14001 ali drugimi standardi, pa upoštevanje zahtev, navedenih v njem, pripomore k usklajenosti z zahtevami za merjenja in obvladovanje merilnih procesov, specificiranih v drugih standardih, npr. ISO 9001:2000. V njem so tako določene izvorne zahteve in dani napotki za vodenje merilnih procesov in meroslovnega potrjevanja merilne opreme, uporabljene za podporo in prikaz skladnosti z meroslovnimi zahtevami.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2003
1DGRPHãþD
SIST EN 30012-1:1997
SIST ISO 10012-1:1996
SIST ISO 10012-2:1998
Sistemi vodenja meritev – Zahteve za procese merjenja in merilno opremo (ISO
10012:2003)
Measurement management systems - Requirements for measurement processes and
measuring equipment (ISO 10012:2003)
Messlenkungssysteme - Anforderungen an Messprozesse und Messmittel (ISO
10012:2003)
Systemes de management de la mesure - Exigences pour les processus et les
équipements de mesure (ISO 10012:2003)
Ta slovenski standard je istoveten z: EN ISO 10012:2003
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 10012
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2003
ICS 03.120.10; 17.020 Supersedes EN 30012-1:1993
English version
Measurement management systems - Requirements for
measurement processes and measuring equipment (ISO
10012:2003)
Systèmes de management de la mesure - Exigences pour Messlenkungssysteme - Anforderungen an Messprozesse
les processus et les équipements de mesure (ISO und Messmittel (ISO 10012:2003)
10012:2003)
This European Standard was approved by CEN on 25 March 2003.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2003 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10012:2003 E
worldwide for CEN national Members.
CORRECTED 2003-07-16
Foreword
This document (EN ISO 10012:2003) has been prepared by Technical Committee ISO/TC 176
"Quality management and quality assurance" in collaboration with CMC.
This European Standard shall be given the status of a national standard, either by publication of
an identical text or by endorsement, at the latest by October 2003, and conflicting national
standards shall be withdrawn at the latest by October 2003.
This document supersedes EN 30012-1:1993.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium, Czech
Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and
the United Kingdom.
Endorsement notice
The text of ISO 10012:2003 has been approved by CEN as EN ISO 10012:2003 without any
modifications.
NOTE Normative references to International Standards are listed in Annex ZA (normative).
Annex ZA
(normative)
Normative references to international publications
with their relevant European publications
This European Standard incorporates by dated or undated reference, provisions from other
publications. These normative references are cited at the appropriate places in the text and the
publications are listed hereafter. For dated references, subsequent amendments to or revisions of
any of these publications apply to this European Standard only when incorporated in it by
amendment or revision. For undated references the latest edition of the publication referred to
applies (including amendments).
NOTE Where an International Publication has been modified by common modifications, indicated
by (mod.), the relevant EN/HD applies.
Publication Year Title EN Year
ISO 9000 2000 Quality management systems - EN ISO 9000 2000
Fundamentals and vocabulary
INTERNATIONAL ISO
STANDARD 10012
First edition
2003-04-15
Measurement management systems —
Requirements for measurement
processes and measuring equipment
Systèmes de management de la mesure — Exigences pour les
processus et les équipements de mesure
Reference number
ISO 10012:2003(E)
©
ISO 2003
ISO 10012:2003(E)
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© ISO 2003
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 either ISO at the address below or
ISO's member body in the country of the requester.
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Published in Switzerland
ii © ISO 2003 — All rights reserved
ISO 10012:2003(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Normative references . 1
3 Terms and definitions. 1
4 General requirements . 2
5 Management responsibility. 3
5.1 Metrological function. 3
5.2 Customer focus. 3
5.3 Quality objectives . 3
5.4 Management review. 3
6 Resource management. 4
6.1 Human resources. 4
6.2 Information resources . 4
6.3 Material resources . 5
6.4 Outside suppliers. 6
7 Metrological confirmation and realization of measurement processes. 6
7.1 Metrological confirmation . 6
7.2 Measurement process . 9
7.3 Measurement uncertainty and traceability. 11
8 Measurement management system analysis and improvement. 12
8.1 General. 12
8.2 Auditing and monitoring . 12
8.3 Control of nonconformities. 13
8.4 Improvement. 15
Annex A (informative) Overview of the metrological confirmation process . 17
Bibliography . 19
ISO 10012:2003(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. 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.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 10012 was prepared by Technical Committee ISO/TC 176, Quality management and quality assurance,
Subcommittee SC 3, Supporting technologies.
This first edition of ISO 10012 cancels and replaces ISO 10012-1:1992 and ISO 10012-2:1997, of which it
constitutes a technical revision.
iv © ISO 2003 — All rights reserved
ISO 10012:2003(E)
Introduction
An effective measurement management system ensures that measuring equipment and measurement
processes are fit for their intended use and is important in achieving product quality objectives and managing
the risk of incorrect measurement results. The objective of a measurement management system is to manage
the risk that measuring equipment and measurement processes could produce incorrect results affecting the
quality of an organization’s product. The methods used for the measurement management system range from
basic equipment verification to the application of statistical techniques in the measurement process control.
In this International Standard, the term “measurement process” applies to physical measurement activities
(e.g. in design, test, production, inspection).
References to this International Standard can be made
by a customer when specifying products required,
by a supplier when specifying products offered,
by legislative or regulatory bodies, and
in assessment and audit of measurement management systems.
One of the stated management principles in ISO 9000 addresses the process-oriented approach.
Measurement processes should be considered as specific processes aiming to support the quality of the
products produced by the organization. Application of the measurement management system model
applicable to this International Standard is shown in Figure 1.
Figure 1 — Model of measurement management system
ISO 10012:2003(E)
This International Standard includes both requirements and guidance for implementation of measurement
management systems, and can be useful in improving measurement activities and the quality of products. The
requirements appear in normal typeface. Guidance appears in italic typeface within a box after the appropriate
requirement paragraph. Guidance is for information only and is not to be construed as
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