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EN ISO 10012:2003

Current

Current

The latest, up-to-date edition.

Measurement management systems - Requirements for measurement processes and measuring equipment (ISO 10012:2003)

Published date

15-04-2003

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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Management responsibility
6 Resource management
7 Metrological confirmation and realization of measurement
  processes
8 Measurement management system analysis and improvement
Annex A (informative) - Overview of the metrological
        confirmation process
Bibliography
Annex ZA (normative) - Normative references to international
         publications with their relevant European publications

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.

Committee
CEN/BT
DevelopmentNote
Supersedes EN 30012-1 (05/2003)
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Current
Supersedes

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PD CEN/TR 15983:2010 Stationary source emissions. Guidance on the application of EN 14181:2004
BS EN 4650:2010 Aerospace series. Wire and cable marking process, UV Laser
I.S. EN 15424:2007 STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
BS EN 62047-25:2016 Semiconductor devices. Micro-electromechanical devices Silicon based MEMS fabrication technology. Measurement method of pull-press and shearing strength of micro bonding area
PREN 14180 : DRAFT 2012 STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
PREN 285 : DRAFT 2013 STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
PREN 4650 : 200P1 AEROSPACE SERIES - WIRE AND CABLE MARKING PROCESS, UV LASER
CEN/TR 16988:2016 Estimation of uncertainty in the single burning item test
I.S. EN 15358:2011 SOLID RECOVERED FUELS - QUALITY MANAGEMENT SYSTEMS - PARTICULAR REQUIREMENTS FOR THEIR APPLICATION TO THE PRODUCTION OF SOLID RECOVERED FUELS
BS EN 16910-1:2018 Railway applications. Rolling stock. Requirements for non-destructive testing on running gear in railway maintenance Wheelsets
BS EN 12697-38:2004 Bituminous mixtures. Test methods for hot mix asphalt Test equipment and calibration
BS EN 12668-1:2010 Non-destructive testing. Characterization and verification of ultrasonic examination equipment Instruments
BS EN 14343:2005 Rotary positive displacement pumps. Performance tests for acceptance
I.S. EN 14276-1:2006 PRESSURE EQUIPMENT FOR REFRIGERATING SYSTEMS AND HEAT PUMPS - PART 1: VESSELS - GENERAL REQUIREMENTS
BS EN 15424:2007 Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices
BS EN 14704-2:2007 Determination of the elasticity of fabrics Multiaxial tests
EN 12668-1:2010 Non-destructive testing - Characterization and verification of ultrasonic examination equipment - Part 1: Instruments
EN 15224:2016 Quality management systems - EN ISO 9001:2015 for healthcare
EN 12258-2:2004 Aluminium and aluminium alloys - Terms and definitions - Part 2: Chemical analysis
CEN/TR 15983:2010 Stationary source emissions - Guidance on the application of EN 14181:2004
DIN EN 14704-2:2007-05 DETERMINATION OF THE ELASTICITY OF FABRICS - PART 2: MULTIAXIAL TESTS
CEN/TR 16792:2014 Safety of children's clothing - Recommendations for the design and manufacture of children's clothing - Mechanical safety
DIN EN 15424:2007-08 STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
EN 15358:2011 Solid recovered fuels - Quality management systems - Particular requirements for their application to the production of solid recovered fuels
DIN EN 15224:2017-05 QUALITY MANAGEMENT SYSTEMS - EN ISO 9001:2015 FOR HEALTHCARE
PREN 1422 : DRAFT 2011 STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
BS EN 60861:2008 Equipment for monitoring of radionuclides in liquid effluents and surface waters
UNE-EN 16421:2015 Influence of materials on water for human consumption - Enhancement of microbial growth (EMG)
12/30262894 DC : 0 BS EN 14180 - STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
UNI EN 4650 : 2011 AEROSPACE SERIES - WIRE AND CABLE MARKING PROCESS, UV LASER
11/30252448 DC : 0 BS EN 1422 - STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
13/30278676 DC : 0 BS EN 285 - STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
UNI EN 15358 : 2011 SOLID RECOVERED FUELS - QUALITY MANAGEMENT SYSTEMS - PARTICULAR REQUIREMENTS FOR THEIR APPLICATION TO THE PRODUCTION OF SOLID RECOVERED FUELS
I.S. EN 16421:2014 INFLUENCE OF MATERIALS ON WATER FOR HUMAN CONSUMPTION - ENHANCEMENT OF MICROBIAL GROWTH (EMG)
NF EN 4650 : 2010 AEROSPACE SERIES - WIRE AND CABLE MARKING PROCESS, UV LASER
I.S. EN ISO 25424:2011 STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
I.S. EN 62047-25:2016 SEMICONDUCTOR DEVICES - MICRO-ELECTROMECHANICAL DEVICES - PART 25: SILICON BASED MEMS FABRICATION TECHNOLOGY - MEASUREMENT METHOD OF PULL-PRESS AND SHEARING STRENGTH OF MICRO BONDING AREA
S.R. CEN/TR 16988:2016 ESTIMATION OF UNCERTAINTY IN THE SINGLE BURNING ITEM TEST
I.S. EN 14726:2005 ALUMINIUM AND ALUMINIUM ALLOYS - CHEMICAL ANALYSIS - GUIDELINE FOR SPARK OPTICAL EMISSION SPECTROMETRIC ANALYSIS
DIN EN 12697-38:2004-10 Bituminous mixtures - Test methods for hot mix asphalt - Part 38: Common equipment and calibration; German version EN 12697-38:2004
DIN EN 14343:2006-11 Rotary positive displacement pumps - Performance tests for acceptance
BS EN 295-2:2013 Vitrified clay pipe systems for drains and sewers Evaluation of conformity and sampling
ISO 25424:2009 Sterilization of medical devices Low temperature steam and formaldehyde Requirements for development, validation and routine control of a sterilization process for medical devices
I.S. EN 14704-3:2006 DETERMINATION OF THE ELASTICITY OF FABRICS - PART 3: NARROW FABRICS
I.S. EN 295-2:2013 VITRIFIED CLAY PIPE SYSTEMS FOR DRAINS AND SEWERS - PART 2: EVALUATION OF CONFORMITY AND SAMPLING
I.S. EN 14704-1:2005 DETERMINATION OF THE ELASTICITY OF FABRICS - PART 1: STRIP TESTS
UNI EN 12668-1 : 2010 NON-DESTRUCTIVE TESTING - CHARACTERIZATION AND VERIFICATION OF ULTRASONIC EXAMINATION EQUIPMENT - PART 1: INSTRUMENTS
I.S. EN 14704-2:2007 DETERMINATION OF THE ELASTICITY OF FABRICS - PART 2: MULTIAXIAL TESTS
I.S. EN 12668-1:2010 NON-DESTRUCTIVE TESTING - CHARACTERIZATION AND VERIFICATION OF ULTRASONIC EXAMINATION EQUIPMENT - PART 1: INSTRUMENTS
NF EN 14276-1 : 2006 + A1 2011 PRESSURE EQUIPMENT FOR REFRIGERATING SYSTEMS AND HEAT PUMPS - PART 1: VESSELS - GENERAL REQUIREMENTS
VDI/VDE 2631 Blatt 2:2014-06 Form measurement - Verification of the signal transmission chain
VDI/VDE 2631 Blatt 8:2013-09 Form measurement - Stability monitoring of form measuring systems
VDI/VDE/DGQ/DKD 2622 Blatt 15.1:2011-10 Calibration for measuring equipment for electrical quantities - Artificial mains networks
VDI/VDE 2600 Blatt 1:2013-10 Inspection process management - Identification, classification and proof of suitability for inspection processes
VDI/VDE/VDMA 2632 Blatt 2:2015-10 Machine vision - Guideline for the preparation of a requirement specification and a system specification
VDI 3431:2016-08 Bending of profiles - Testing notes for profile bending elements
VDI/VDE/DGQ/DKD 2622 Blatt 1:2014-06 Calibration of measuring equipment for electrical quantities - Fundamentals
BS EN 15358:2011 Solid recovered fuels. Quality management systems. Particular requirements for their application to the production of solid recovered fuels
PD CEN/TR 16988:2016 Estimation of uncertainty in the single burning item test
UNI EN ISO 25424 : 2011 STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
BS EN 16421:2014 Influence of materials on water for human consumption. Enhancement of microbial growth (EMG)
BS EN 16653:2015 Rubber or plastics-coated fabrics. Determination of stitch tear resistance (using a needle). Test method
UNE-EN 15358:2011 Solid recovered fuels - Quality management systems - Particular requirements for their application to the production of solid recovered fuels
14/30292494 DC : 0 BS EN ISO 22476-15 - GEOTECHNICAL INVESTIGATION AND TESTING - FIELD TESTING - PART 15: MEASURING WHILE DRILLING
16/30208484 DC : 0 BS EN 15654-2 - RAILWAY APPLICATIONS - MEASUREMENT OF VERTICAL FORCES ON WHEELS AND WHEELSETS - PART 2: TEST IN WORKSHOP FOR NEW, MODIFIED AND MAINTAINED VEHICLES
S.R. CEN/TR 16792:2014 SAFETY OF CHILDREN'S CLOTHING - RECOMMENDATIONS FOR THE DESIGN AND MANUFACTURE OF CHILDREN'S CLOTHING - MECHANICAL SAFETY
EN 14726:2005 Aluminium and aluminium alloys - Chemical analysis - Guideline for spark optical emission spectrometric analysis
I.S. EN 15224:2016 QUALITY MANAGEMENT SYSTEMS - EN ISO 9001:2015 FOR HEALTHCARE
DIN EN 295-2:2013-05 VITRIFIED CLAY PIPE SYSTEMS FOR DRAINS AND SEWERS - PART 2: EVALUATION OF CONFORMITY AND SAMPLING
DIN EN 14276-1:2011-05 PRESSURE EQUIPMENT FOR REFRIGERATING SYSTEMS AND HEAT PUMPS - PART 1: VESSELS - GENERAL REQUIREMENTS
BS EN 14726:2005 Aluminium and aluminium alloys. Chemical analysis. Guideline for spark optical emission spectrometric analysis
EN 14276-1:2020 Pressure equipment for refrigerating systems and heat pumps - Part 1: Vessels - General requirements
UNI EN 14276-1 : 2011 PRESSURE EQUIPMENT FOR REFRIGERATING SYSTEMS AND HEAT PUMPS - PART 1: VESSELS - GENERAL REQUIREMENTS
UNI EN 14343 : 2006 ROTARY POSITIVE DISPLACEMENT PUMPS - PERFORMANCE TESTS FOR ACCEPTANCE
DIN EN ISO 25424:2011-09 STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
DIN EN 12668-1:2010-05 Non-destructive testing - Characterization and verification of ultrasonic examination equipment - Part 1: Instruments
BS EN ISO 25424:2011 Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices
17/30351224 DC : 0 BS EN 14276-1 - PRESSURE EQUIPMENT FOR REFRIGERATING SYSTEMS AND HEAT PUMPS - PART 1: VESSELS - GENERAL REQUIREMENTS
UNE-CEN/TR 15983:2011 IN Stationary source emissions - Guidance on the application of EN 14181:2004
I.S. EN 16910-1:2018 RAILWAY APPLICATIONS - ROLLING STOCK - REQUIREMENTS FOR NON-DESTRUCTIVE TESTING ON RUNNING GEAR IN RAILWAY MAINTENANCE - PART 1: WHEELSETS
PD CEN/TR 16792:2014 Safety of children\'s clothing. Recommendations for the design and manufacture of children\'s clothing. Mechanical safety
DD CEN/TS 15358:2006 Solid recovered fuels. Quality management systems. Particular requirements for their application to the production of solid recovered fuels
S.R. CEN TR 15983:2010 STATIONARY SOURCE EMISSIONS - GUIDANCE ON THE APPLICATION OF EN 14181:2004
UNE-EN 16653:2015 Rubber or plastics-coated fabrics - Determination of stitch tear resistance (using a needle) - Test method
PREN 9100 : 200P4 QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR AVIATION, SPACE AND DEFENCE ORGANIZATIONS
16/30334735 DC : 0 BS EN 15224 - HEALTH CARE SERVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS BASED ON EN ISO 9001:2015
PREN 15224 : DRAFT 2016 HEALTH CARE SERVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS BASED ON EN ISO 9001:2015
EN 16910-1:2018 Railway applications - Rolling stock - Requirements for non-destructive testing on running gear in railway maintenance - Part 1: Wheelsets
BS EN 12258-2:2004 Aluminium and aluminium alloys. Terms and definitions Chemical analysis
BS EN 14704-1:2005 Determination of the elasticity of fabrics Strip tests
EN 14276-1:2006+A1:2011 Pressure equipment for refrigerating systems and heat pumps - Part 1: Vessels - General requirements
BS EN 14276-1 : 2006 PRESSURE EQUIPMENT FOR REFRIGERATING SYSTEMS AND HEAT PUMPS - PART 1: VESSELS - GENERAL REQUIREMENTS
UNE-EN 295-2:2013 Vitrified clay pipe systems for drains and sewers - Part 2: Evaluation of conformity and sampling
BS EN 14704-3:2006 Determination of the elasticity of fabrics Narrow fabrics
EN 14704-3:2006 Determination of the elasticity of fabrics - Part 3: Narrow fabrics
EN 16421:2014 Influence of materials on water for human consumption - Enhancement of microbial growth (EMG)
EN 15424:2007 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
EN 14704-2:2007 Determination of the elasticity of fabrics - Part 2: Multiaxial tests
EN ISO 25424:2011 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009)
EN 14704-1:2005 Determination of the elasticity of fabrics - Part 1: Strip tests
EN 295-2:2013 Vitrified clay pipe systems for drains and sewers - Part 2: Evaluation of conformity and sampling
EN 16653:2015 Rubber or plastics-coated fabrics - Determination of stitch tear resistance (using a needle) - Test method
ONORM EN 14704-1 : 2005 DETERMINATION OF THE ELASTICITY OF FABRICS - PART 1: STRIP TESTS
EN 4650:2010 Aerospace series - Wire and cable marking process, UV Laser
DIN EN 16653:2015-05 RUBBER OR PLASTICS-COATED FABRICS - DETERMINATION OF STITCH TEAR RESISTANCE (USING A NEEDLE) - TEST METHOD
I.S. CEN TS 15358:2006 SOLID RECOVERED FUELS - QUALITY MANAGEMENT SYSTEMS - PARTICULAR REQUIREMENTS FOR THEIR APPLICATION TO THE PRODUCTION OF SOLID RECOVERED FUELS
DIN EN 15224:2016-04 (Draft) QUALITY MANAGEMENT SYSTEMS - EN ISO 9001:2015 FOR HEALTHCARE
09/30202002 DC : 0 BS EN 15358 - SOLID RECOVERED FUELS - QUALITY MANAGEMENT SYSTEMS - PARTICULAR REQUIREMENTS FOR THEIR APPLICATION TO THE PRODUCTION OF SOLID RECOVERED FUELS
CEI EN 62047-25 : 1ED 2017 SEMICONDUCTOR DEVICES - MICRO-ELECTROMECHANICAL DEVICES - PART 25: SILICON BASED MEMS FABRICATION TECHNOLOGY - MEASUREMENT METHOD OF PULL-PRESS AND SHEARING STRENGTH OF MICRO BONDING AREA
I.S. EN 60861:2008 EQUIPMENT FOR MONITORING OF RADIONUCLIDES IN LIQUID EFFLUENTS AND SURFACE WATERS
UNE-EN 15224:2017 Quality management systems - EN ISO 9001:2015 for healthcare
DIN EN 16421:2015-05 INFLUENCE OF MATERIALS ON WATER FOR HUMAN CONSUMPTION - ENHANCEMENT OF MICROBIAL GROWTH (EMG)
UNI EN 16421 : 2015 INFLUENCE OF MATERIALS ON WATER FOR HUMAN CONSUMPTION - ENHANCEMENT OF MICROBIAL GROWTH (EMG)
PREN 14276-1 : DRAFT 2017 PRESSURE EQUIPMENT FOR REFRIGERATING SYSTEMS AND HEAT PUMPS - PART 1: VESSELS - GENERAL REQUIREMENTS
I.S. EN 16653:2015 RUBBER OR PLASTICS-COATED FABRICS - DETERMINATION OF STITCH TEAR RESISTANCE (USING A NEEDLE) - TEST METHOD
I.S. EN 4650:2010 AEROSPACE SERIES - WIRE AND CABLE MARKING PROCESS, UV LASER
UNE-EN ISO 25424:2011 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009)
CEN/TS 15358:2006 Solid recovered fuels - Quality management systems - Particular requirements for their application to the production of solid recovered fuels
DIN EN 14704-3:2007-03 DETERMINATION OF THE ELASTICITY OF FABRICS - PART 3: NARROW FABRICS
DIN EN 14726:2005-12 ALUMINIUM AND ALUMINIUM ALLOYS - CHEMICAL ANALYSIS - GUIDELINE FOR SPARK OPTICAL EMISSION SPECTROMETRIC ANALYSIS
DIN EN 14704-1:2005-07 DETERMINATION OF THE ELASTICITY OF FABRICS - PART 1: STRIP TESTS
EN 12697-38:2004 Bituminous mixtures - Test methods for hot mix asphalt - Part 38: Common equipment and calibration
EN 60861:2008 Equipment for monitoring of radionuclides in liquid effluents and surface waters
UNE-EN 14276-1:2007 Pressure equipment for refrigerating systems and heat pumps - Part 1: Vessels - General requirements

ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
ISO 5725-1:1994 Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions
ISO 19011:2011 Guidelines for auditing management systems
ISO/TR 10017:2003 Guidance on statistical techniques for ISO 9001:2000
ISO 5725-3:1994 Accuracy (trueness and precision) of measurement methods and results — Part 3: Intermediate measures of the precision of a standard measurement method
ISO 5725-6:1994 Accuracy (trueness and precision) of measurement methods and results — Part 6: Use in practice of accuracy values
ISO 5725-4:1994 Accuracy (trueness and precision) of measurement methods and results Part 4: Basic methods for the determination of the trueness of a standard measurement method
ISO/IEC Guide 99:2007 International vocabulary of metrology Basic and general concepts and associated terms (VIM)
ISO 3534-2:2006 Statistics — Vocabulary and symbols — Part 2: Applied statistics
ISO/TR 13425:2006 Guidelines for the selection of statistical methods in standardization and specification
ISO 9004:2009 Managing for the sustained success of an organization A quality management approach
ISO 14001:2015 Environmental management systems — Requirements with guidance for use
ISO 5725-2:1994 Accuracy (trueness and precision) of measurement methods and results Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method
ISO 9001:2015 Quality management systems — Requirements
ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
ISO 5725-5:1998 Accuracy (trueness and precision) of measurement methods and results — Part 5: Alternative methods for the determination of the precision of a standard measurement method
EN ISO 9000:2015 Quality management systems - Fundamentals and vocabulary (ISO 9000:2015)
OIML D 10 : 2007 GUIDELINES FOR THE DETERMINATION OF CALIBRATION INTERVALS OF MEASURING INSTRUMENTS
ISO/IEC Guide 98-3:2008 Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)
ISO 3534-1:2006 Statistics — Vocabulary and symbols — Part 1: General statistical terms and terms used in probability

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