1、BRITISH STANDARD BS EN ISO 10012:2003 Incorporating Corrigendum No. 1 Measurement management systems Requirements for measurement processes and measuring equipment The European Standard EN ISO 10012:2003 has the status of a British Standard ICS 03.120.10; 17.020 BS EN ISO 10012:2003 This British Sta
2、ndard was published under the authority of the Standards Policy and Strategy Committee on 16 April 2003 BSI 4 August 2003 ISBN 0 580 41654 2 National foreword This British Standard is the official English language version of EN ISO 10012:2003. It is identical with ISO 10012:2003. It supersedes BS EN
3、 30012-1:1994 and BS ISO 10012-2:1997 which are withdrawn. The UK participation in its preparation was entrusted by Technical Committee QS/1, Quality management and quality assurance, to Subcommittee QS/1/-/11, Measurement assurance, which has the responsibility to: A list of organizations represent
4、ed on this subcommittee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”,
5、 or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer
6、immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate
7、them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN ISO title page, the EN ISO foreword page, the ISO title page, pages ii to vi, pages 1 to 19, the Annex ZA page, an inside back cover and a back cover. The BSI copyright date displayed in this docume
8、nt indicates when the document was last issued. Amendments issued since publication Amd. No. Date Comments 14611 Corrigendum No. 1 4 August 2003 Replacing the EN ISO foreword page and incorporating the Annex ZA pageEUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM ENISO10012 April2003 ICS03.120.10;17.0
9、20 SupersedesEN300121:1993 Englishversion MeasurementmanagementsystemsRequirementsfor measurementprocessesandmeasuringequipment(ISO 10012:2003) SystmesdemanagementdelamesureExigencespour lesprocessusetlesquipementsdemesure(ISO 10012:2003) ThisEuropeanStandardwasapprovedbyCENon25March2003. CENmembers
10、areboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferencesconcernings uchnational standardsmaybeobtainedonapplicationtotheManagementCentreortoanyCENmember. T
11、hisEuropeanStandardexistsinthreeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheManagementCentrehasthesamestatusasthe official versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,C
12、zechRepublic,Denmark,Finland,France,Germany,Greece, Hungary,Iceland,Ireland,Italy,Luxembourg,Malta,Netherlands,Norway,Portugal,Slovakia,Spain,Sweden,SwitzerlandandUn ited Kingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassa
13、rt,36B1050Brussels 2003CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.ENISO10012:2003ECORRECTED20030716 Foreword Thisdocument(ENISO10012:2003)hasbeenpreparedbyTechnicalCommitteeISO/TC176 “Qualitymanagementandqualityassurance“incollaborationwithCMC. T
14、hisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherbypublicationof anidenticaltextorbyendorsement,atthelatestbyOctober2003,andconflictingnational standardsshallbewithdrawnatthelatestbyOctober2003. ThisdocumentsupersedesEN300121:1993. AccordingtotheCEN/CENELECInternalRegulations,thenat
15、ionalstandardsorganizationsof thefollowingcountriesareboundtoimplementthisEuropeanStandard:Austria,Belgium,Czech Republic,Denmark,Finland,France,Germany,Greece,Hungary,Iceland,Ireland,Italy, Luxembourg,Malta,Netherlands,Norway,Portugal,Slovakia,Spain,Sweden,Switzerlandand theUnitedKingdom. Endorseme
16、ntnotice ThetextofISO10012:2003hasbeenapprovedbyCENasENISO10012:2003withoutany modifications. NOTENormativereferencestoInternationalStandardsarelistedinAnnexZA(normative). ENISO10012:2003 Reference number ISO 10012:2003(E)INTERNATIONAL STANDARD ISO 10012 First edition 2003-04-15 Measurement manageme
17、nt systems Requirements for measurement processes and measuring equipment Systmes de management de la mesure Exigences pour les processus et les quipements de mesure ENISO10012:2003ENISO10012:2003iiIS:21001 O3002(E) I SO 3002 All irhgts seredevr iiiContents Page Foreword iv Introduction v 1 Scope 1
18、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
19、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 Auditi
20、ng 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 ENISO10012:2003iiiIS:21001 O3002(E) vi I SO 3002 All irhgts seredevrForeword ISO (the International Organization for Standardization)
21、 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 repre
22、sented 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
23、 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 Internationa
24、l 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 prep
25、ared 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. ENISO10012:2003ivIS:21001 O3002(E) I
26、 SO 3002 All irhgts seredevr vIntroduction 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 objecti
27、ve 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 organizations product. The methods used for the measurement management system range from basic equipment verification to the appl
28、ication 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 spe
29、cifying 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
30、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 ENISO10012:2003vIS:21001
31、 O3002(E) iv I SO 3002 All irhgts seredevrThis 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
32、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 me
33、asurement 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 Sta
34、ndard 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. ENISO10012:2003viINTENRATIONAL TSANDADR IS:21001 O3002(E)I SO 3002 All irhgts seredevr 1Me
35、asurement 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 de
36、monstrate 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 Interna
37、tional 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. T
38、his 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 interlaborat
39、ory 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:
40、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 IS
41、O 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 ENISO1001
42、2:20031IS:21001 O3002(E) 2 I SO 3002 All irhgts seredevr3.3 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
43、 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
44、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 seali
45、ng 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 erro
46、rs. 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 defini
47、ng 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 neede
48、d 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
