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.

Systemes 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

Status
Published
Publication Date
30-Jun-2003
Current Stage
6100 - Translation of adopted SIST standards (Adopted Project)
Start Date
01-Mar-2005
Due Date
01-Mar-2005
Completion Date
01-Mar-2005

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10012:2003
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
SIST EN ISO 10012:2003 sl,en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 10012:2003
---------------------- Page: 2 ----------------------
SIST EN ISO 10012:2003
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.
---------------------- Page: 3 ----------------------
SIST EN ISO 10012:2003
EN ISO 10012:2003 (E)
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).

---------------------- Page: 4 ----------------------
SIST EN ISO 10012:2003
EN ISO 10012:2003 (E)
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
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SIST EN ISO 10012:2003
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SIST EN ISO 10012:2003
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
---------------------- Page: 7 ----------------------
SIST EN ISO 10012:2003
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
---------------------- Page: 8 ----------------------
SIST EN ISO 10012:2003
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 2003 — All rights reserved iii
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SIST EN ISO 10012:2003
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
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SIST EN ISO 10012:2003
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 2003 — All rights reserved v
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SIST EN ISO 10012:2003
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 adding to, limiting, or

modifying any requirement.

Organizations have the responsibility to determine the level of controls needed and to specify the

measurement management system requirements to be applied as part of their overall management system.

Except by agreement, this International Standard is not intended to add to, subtract from, or replace any

requirements of other standards.

Following the requirements laid down in this International Standard will facilitate compliance with requirements

for measurements and measurement process control specified in other standards, for example,

ISO 9001:2000, Subclause 7.6, and ISO 14001:1996, Subclause 4.5.1.
vi © ISO 2003 — All rights reserved
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SIST EN ISO 10012:2003
INTERNATIONAL STANDARD ISO 10012:2003(E)
Measurement management systems — Requirements for
measurement processes and measuring equipment
1 Scope

This International Standard 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 the 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.

This International Standard 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 this International Standard as

an input for satisfying measurement management system requirements in certification activities.

This International Standard is not intended as a substitute for, or as an addition to, the requirements of

ISO/IEC 17025.

NOTE Other standards and guides exist for particular elements affecting measurement results, for example, details

of measurement methods, competence of personnel, and interlaboratory comparisons.

2 Normative references

The following referenced documents are indispensable for the application of this document. For dated

references, only the edition cited applies. For undated references, the latest edition of the referenced

document (including any amendments) applies.
ISO 9000:2000, Quality management systems — Fundamentals and vocabulary

VIM:1993, International vocabulary of basic and general terms used in metrology. Published jointly by BIPM,

IEC, IFCC, ISO, IUPAC, IUPAP, OIML
3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 9000 and VIM and the following

apply:
3.1
measurement management system

set of interrelated or interacting elements necessary to achieve metrological confirmation and continual control

of measurement processes
3.2
measurement process
set of operations to determine the value of a quantity
© ISO 2003 — All rights reserved 1
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SIST EN ISO 10012:2003
ISO 10012:2003(E)
3.3
measuring equipment

measuring instrument, software, measurement standard, reference material or auxiliary apparatus, or a

combination thereof, necessary to realize a measurement process
3.4
metrological characteristic
distinguishing feature which can influence the results of measurement
NOTE 1 Measuring equipment usually has several metrological characteristics.
NOTE 2 Metrological characteristics can be the subject of calibration.
3.5
metrological confirmation

set of operations required to ensure that measuring equipment conforms to the requirements for its intended

use

NOTE 1 Metrological confirmation generally includes calibration and verification, any necessary adjustment or repair,

and subsequent recalibration, comparison with the metrological requirements for the intended use of the equipment, as

well as any required sealing and labelling.

NOTE 2 Metrological confirmation is not achieved until and unless the fitness of the measuring equipment for the

intended use has been demonstrated and documented.

NOTE 3 The requirements for intended use include such considerations as range, resolution and maximum permissible

errors.

NOTE 4 Metrological requirements are usually distinct from, and are not specified in, product requirements.

NOTE 5 A diagram of the processes involved in metrological confirmation is given in Figure 2.

3.6
metrological function

function with administrative and technical responsibility for defining and implementing the measurement

management system
4 General requirements

The measurement management system shall ensure that specified metrological requirements are satisfied.

Guidance

Specified metrological requirements are derived from requirements for the product. These requirements are

needed for both measuring equipment and measurement processes. Requirements may be expressed as

maximum permissible error, permissible uncertainty, range, stability, resolution, environmental conditions or

operator skills.

The organization shall specify the measurement processes and the measuring equipment that are subject to

the provisions of this International Standard. When deciding the scope and extent of the measurement

management system, the risks and consequences of failure to comply with metrological requirements shall be

taken into account.

The measurement management system consists of the control of designated measurement processes and

metrological confirmation of measuring equipment (see Figure 2), and the necessary supporting processes.

The measurement processes within the measurement management system shall be controlled (see 7.2). All

measuring equipment within the measurement management system shall be confirmed (see 7.1).

Changes to the measurement management system shall be in accordance with the procedures of the

organization.
2 © ISO 2003 — All rights reserved
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SIST EN ISO 10012:2003
ISO 10012:2003(E)
5 Management responsibility
5.1 Metrological function

The metrological function shall be defined by the organization. Top management of the organization shall

ensure the availability of necessary resources to establish and maintain the metrological function.

Guidance

The metrological function may be a single department or distributed throughout the organization.

The management of the metrological function shall establish, document and maintain the measurement

management system and continually improve its effectiveness.
5.2 Customer focus
The management of the metrological function shall ensure that

a) customer measurement requirements are determined and converted into metrological requirements,

b) the measurement management system meets the customers’ metrological requirements, and

c) compliance to customer-specified requirements can be demonstrated.
5.3 Quality objectives

The management of the metrological function shall define and establish measurable quality objectives for the

measurement management system. Objective performance criteria and procedures for the measurement

processes, and their control, shall be defined.
Guidance

Examples of such quality objectives at different organizational levels are as follows:

 no nonconforming product is to be accepted nor conforming product rejected due to incorrect

measurements;

 no measurement process is to be out of control for more than one day without detection;

 all metrological confirmations are to be completed by the agreed times;
 there are to be no illegible metrological confirmation records;

 all of the technical training programmes are to be completed per the established schedule;

 the amount of time measuring equipment is out of operation is to be reduced by a stated percentage.

5.4 Management review

Top management of the organization shall ensure the systematic review of the measurement management

system at planned intervals to ensure its continual adequacy, effectiveness and suitability. The top

management shall ensure that the necessary resources are available to review the measurement

management system.

The results of the management review shall be used by the management of the metrological function to

modify the system as necessary, including improving measurement processes (see Clause 8) and reviewing

quality objectives. The results of all reviews and all actions taken shall be recorded.

© ISO 2003 — All rights reserved 3
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SIST EN ISO 10012:2003
ISO 10012:2003(E)
6 Resource management
6.1 Human resources
6.1.1 Responsibilities of personnel

The management of the metrological function shall define and document the responsibilities of all personnel

assigned to the measurement management system.
Guidance

These responsibilities may be defined in organization charts, job descriptions, and work instructions or

procedures.

This International Standard does not exclude the use of specialist personnel external to the metrological

function.
6.1.2 Competence and training

The management of the metrological function shall ensure that personnel involved in the measurement

management system have demonstrated their ability to perform their assigned tasks. Any specialized skills

required shall be specified. The management of the metrological function shall ensure that training is provided

to address identified needs, records of training activities are maintained, and that the effectiveness of the

training is evaluated and recorded. Personnel shall be made aware of the extent of their responsibilities and

accountabilities, and the impact of their activities on the effectiveness of the measurement management

system and product quality.
Guidance

Competence may be achieved through education, training and experience, and demonstrated by testing or

observed performance.

When using staff who are undergoing training, adequate supervision shall be provided.

6.2 Information resources
6.2.1 Procedures

Measurement management system procedures shall be documented to the extent necessary and validated to

ensure the proper implementation, their consistency of application, and the validity of measurement results.

New procedures or changes to documented procedures shall be authorized and controlled. Procedures shall

be current, available and provided when required.
Guidance

Technical procedures may be based on published standard measurement practices, or on customers’ or

equipment manufacturers’ written instructions.
6.2.2 Software

Software used in the measurement processes and calculations of results shall be documented, identified and

controlled to ensure suitability for continued use. Software, and any revisions to it, shall be tested and/or

validated prior to initial use, approved for use, and archived. Testing shall be to the extent necessary to

ensure valid measurement results.
4 © ISO 2003 — All rights reserved
---------------------- Page: 16 ----------------------
SIST EN ISO 10012:2003
ISO 10012:2003(E)
Guidance

Software may be in several forms, such as embedded, programmable, or off-the-shelf packages.

Off-the-shelf software might not require testing.

Testing may include virus checking, checking of user-programmed algorithms, or a combination thereof as

necessary to achieve the required measurement result.

Software configuration control can help maintain the integrity and validity of measurement processes using

software. Archiving may be accomplished by creating back-up copies, off-site storage, or any other means to

safeguard programming, ensure accessibility, and to provide the level of traceability necessary.

6.2.3 Records

Records containing information required for the operation of the measurement management system shall be

maintained. Documented procedures shall ensure the identification, storage, protection, retrieval, retention

time and disposition of records.
Guidance

Examples of records are confirmation results, results of measurement, purchasing, operational data,

nonconformance data, customer complaints, training, qualification, or any other historical data supporting the

measurement processes.
6.2.4 Identification

Measuring equipment and technical procedures used in the measurement management system shall be

clearly identified, individually or collectively. There shall be an identification of the status of the metrological

confirmation of equipment. Equipment confirmed for use only in a particular measurement process or

processes shall be clearly identified or otherwise controlled to prevent unauthorized use. Equipment used in

the measurement management system shall be distinguishable from other equipment.
6.3 Material resources
6.3.1 Measuring equipment

All measuring equipment necessary to satisfy the specified metrological requirements shall be available and

identified in the measurement management system. Measuring equipment shall have a valid calibration status

prior to being confirmed. Measuring equipment shall be used in an environment that is controlled or known to

the extent necessary to ensure valid measurement results. Measuring equipment used to monitor and record

the influencing quantities shall be included in the measurement management system.

Guidance

Measuring equipment can be confirmed for use for particular measurement processes, and not confirmed for

use for other measurement processes because of differing metrological requirements. Metrological

requirements for the measuring equipment are derived from specified requirements for the product or the

equipment to be calibrated, verified and confirmed.

The maximum permissible error may be designated by reference to the published specification of the

measuring equipment manufacturer, or by the metrological function.

Measuring equipment may be calibrated by an organization other than the metrological function performing

the metrological confirmation.

The characterization of reference materials might meet the requirement for calibration.

© ISO 2003 — All rights reserved 5
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SIST EN ISO 10012:2003
ISO 10012:2003(E)

The management of the metrological function shall establish, maintain and use documented procedures for

receiving, handling, transporting, storing and dispatching measuring equipment, in order to prevent abuse,

misuse, damage and changes to its metrological characteristics. There shall be procedures for processing

measuring equipment introduced into or removed from the measurement management system.

6.3.2 Environment

The environmental conditions required for the effective operation of the measurement processes covered by

the measurement management system shall be documented.

Environmental conditions affecting measurements shall be monitored and recorded. Corrections based on the

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