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ISO/TR 10017:2003

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Guidance on statistical techniques for ISO 9001:2000
Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Superseded date

07-09-2021

Language(s)

English, Russian, Spanish, Castilian

Published date

05-08-2003

Preview

ISO/TR 10017:2003 provides guidance on the selection of appropriate statistical techniques that may be useful to an organization in developing, implementing, maintaining and improving a quality management system in compliance with ISO 9001. This is done by examining those requirements of ISO 9001 that involve the use of quantitative data, and then identifying and describing the statistical techniques that can be useful when applied to such data.

The list of statistical techniques cited in ISO/TR 10017:2003 is neither complete nor exhaustive, and does not preclude the use of any other techniques (statistical or otherwise) that are deemed to be beneficial to the organization. Furthermore, ISO/TR 10017:2003 does not attempt to prescribe which statistical technique(s) are to be used; nor does it attempt to advise on how the technique(s) are to be implemented.

ISO/TR 10017:2003 is not intended for contractual, regulatory or certification/registration purposes. It is not intended to be used as a mandatory checklist for compliance with ISO 9001:2000 requirements. The justification for using statistical techniques is that their application would help to improve the effectiveness of the quality management system.

DocumentType
Technical Report
Pages
26
PublisherName
International Organization for Standardization
Status
Superseded
SupersededBy
Supersedes

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SAE AS 9100D : 2016 QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR AVIATION, SPACE AND DEFENSE ORGANIZATIONS
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API Q1 PORTUGUESE : 2013 SPECIFICATION FOR QUALITY MANAGEMENT SYSTEM REQUIREMENTS FOR MANUFACTURING ORGANIZATIONS FOR THE PETROLEUM AND NATURAL GAS INDUSTRY
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ISO/IEC 19796-3:2009 Information technology — Learning, education and training — Quality management, assurance and metrics — Part 3: Reference methods and metrics
ISO/TR 16355-8:2017 Applications of statistical and related methods to new technology and product development process Part 8: Guidelines for commercialization and life cycle
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API Q1 : 2013 SPECIFICATION FOR QUALITY MANAGEMENT SYSTEM REQUIREMENTS FOR MANUFACTURING ORGANIZATIONS FOR THE PETROLEUM AND NATURAL GAS INDUSTRY
I.S. EN ISO 9001:2015 QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS (ISO 9001:2015)
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CEN/CLC ISO/IEC/TS 17021-3:2016 Conformity assessment - Requirements for bodies providing audit and certification of management systems - Part 3: Competence requirements for auditing and certification of quality management systems (ISO/IEC/TS 17021-3:2013)
CEN ISO/TR 14969:2005 Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003 (ISO/TR 14969:2004)
CEN/TR 15592:2007 Health services - Quality management systems - Guide for the use of EN ISO 9004:2000 in health services for performance improvement
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ISO/TR 14969:2004 Medical devices Quality management systems Guidance on the application of ISO 13485: 2003
UNE-EN ISO 9001:2015 Quality management systems - Requirements (ISO 9001:2015)
ISO 10019:2005 Guidelines for the selection of quality management system consultants and use of their services
UNE-ISO 10018:2015 Quality management. Guidelines on people involvement and competence
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03/314215 DC : DRAFT OCT 2003 ISO TR 14969 - MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
IEEE 15939-2008 IEEE Standard Adoption of ISO/IEC 15939:2007--Systems and Software Engineering--Measurement Process
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02/400378 DC : DRAFT APR 2002 ISO/DIS 10006 - QUALITY MANAGEMENT SYSTEMS - GUIDELINES FOR QUALITY MANAGEMENT IN PROJECTS
CSA ISO TR 14969 : 2005 : R2015 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
UNI CEN ISO/TS 29001 : 2011 PETROLEUM, PETROCHEMICAL AND NATURAL GAS INDUSTRIES - SECTOR-SPECIFIC QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR PRODUCT AND SERVICE SUPPLY ORGANIZATIONS
CSA ISO 9000 : 2016 QUALITY MANAGEMENT SYSTEMS - FUNDAMENTALS AND VOCABULARY
CSA ISO 10005 : 2005 QUALITY MANAGEMENT SYSTEMS - GUIDELINES FOR QUALITY PLANS
CSA ISO TR 14969 :2005 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
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ISO/TR 18532:2009 Guidance on the application of statistical methods to quality and to industrial standardization
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UNE-ISO 13053-2:2012 Quantitative methods in process improvement -- Six Sigma -- Part 2: Tools and techniques
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API Q2 PORTUGUESE : 2011 SPECIFICATION FOR QUALITY MANAGEMENT SYSTEM REQUIREMENTS FOR SERVICE SUPPLY ORGANIZATIONS FOR THE PETROLEUM AND NATURAL GAS INDUSTRIES
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API Q1 RUSSIAN : 2013 SPECIFICATION FOR QUALITY MANAGEMENT SYSTEM REQUIREMENTS FOR MANUFACTURING ORGANIZATIONS FOR THE PETROLEUM AND NATURAL GAS INDUSTRY.
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PD CEN ISO/TR 14969:2005 Medical devices. Quality management systems. Guidance on the application of ISO 13485:2003
UNE-CEN/CLC ISO/IEC/TS 17021-3:2016 Conformity assessment - Requirements for bodies providing audit and certification of management systems - Part 3: Competence requirements for auditing and certification of quality management systems (ISO/IEC/TS 17021-3:2013)
BS PD ISO/IEC TS 17021-3 : 2013 CONFORMITY ASSESSMENT - REQUIREMENTS FOR BODIES PROVIDING AUDIT AND CERTIFICATION OF MANAGEMENT SYSTEMS - PART 3: COMPETENCE REQUIREMENTS FOR AUDITING AND CERTIFICATION OF QUALITY MANAGEMENT SYSTEMS
04/30092984 DC : DRAFT JAN 2004 ISO 10005 - QUALITY MANAGEMENT SYSTEMS - GUIDELINES FOR QUALITY PLANS
BS ISO/IEC 27004:2016 Information technology. Security techniques. Information security management. Monitoring, measurement, analysis and evaluation
I.S. CEN TS 15224:2006 HEALTH SERVICES - QUALITY MANAGEMENT SYSTEMS - GUIDE FOR THE USE OF EN ISO 9001:2000
CSA ISO 10012 : 2003 : R2013 MEASUREMENT MANAGEMENT SYSTEMS - REQUIREMENTS FOR MEASUREMENT PROCESSES AND MEASURING EQUIPMENT
CSA ISO TR 14969 : 2005 : R2010 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
CSA ISO 10005 : 2005 : R2010 QUALITY MANAGEMENT SYSTEMS - GUIDELINES FOR QUALITY PLANS
CSA ISO 10005 : 2005 : R2015 QUALITY MANAGEMENT SYSTEMS - GUIDELINES FOR QUALITY PLANS
PD ISO/TS 16949:2009 Quality management systems. Particular requirements for the application of ISO 9001:2008 for automotive production and relevant service part organizations
CSA ISO 9004 : 2009 MANAGING FOR THE SUSTAINED SUCCESS OF AN ORGANIZATION - A QUALITY MANAGEMENT APPROACH
UNE-EN 15224:2017 Quality management systems - EN ISO 9001:2015 for healthcare
CSA ISO 9004 : 2009 : R2015 MANAGING FOR THE SUSTAINED SUCCESS OF AN ORGANIZATION - A QUALITY MANAGEMENT APPROACH
CSA ISO 10005 : 2005 : R2010 : FR QUALITY MANAGEMENT SYSTEMS - GUIDELINES FOR QUALITY PLANS
DIN EN ISO 9004:2009-12 MANAGING FOR THE SUSTAINED SUCCESS OF AN ORGANIZATION - A QUALITY MANAGEMENT APPROACH
ISO 10018:2012 Quality management Guidelines on people involvement and competence
SAE AS 9110 : 2016 QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR AVIATION MAINTENANCE ORGANIZATIONS
EN ISO 15378:2017 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017)
UNE 179002:2018 Health services. Quality management system for health care transport organization.
I.S. ISO 10019:2005 GUIDELINES FOR THE SELECTION OF QUALITY MANAGEMENT SYSTEM CONSULTANTS AND USE OF THEIR SERVICES
S.R. CEN/CLC/ISO/IEC/TS 17021-3:2016 CONFORMITY ASSESSMENT - REQUIREMENTS FOR BODIES PROVIDING AUDIT AND CERTIFICATION OF MANAGEMENT SYSTEMS - PART 3: COMPETENCE REQUIREMENTS FOR AUDITING AND CERTIFICATION OF QUALITY MANAGEMENT SYSTEMS (ISO/IEC/TS 17021-3:2013)
S.R. ISO/TS 9002:2016 QUALITY MANAGEMENT SYSTEMS - GUIDELINES FOR THE APPLICATION OF ISO 9001:2015
UNI ISO 10004 : 2013 QUALITY MANAGEMENT - CUSTOMER SATISFACTION - GUIDELINES FOR MONITORING AND MEASURING
IWA 2:2007 Quality management systems Guidelines for the application of ISO 9001:2000 in education
I.S. EN ISO 15378:2017 PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2015, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP) (ISO 15378:2017)
API SPEC Q2 : 2011+ADD 1 : 2016 SPECIFICATION FOR QUALITY MANAGEMENT SYSTEM REQUIREMENTS FOR SERVICE SUPPLY ORGANIZATIONS FOR THE PETROLEUM AND NATURAL GAS INDUSTRIES
DIN EN ISO 9001:2015-11 QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS (ISO 9001:2015)
BS EN ISO 9000:2015 Quality management systems. Fundamentals and vocabulary
BS EN ISO 9001:2015 Quality management systems. Requirements
ISO 10012:2003 Measurement management systems — Requirements for measurement processes and measuring equipment
BS EN ISO 10012:2003 Measurement management systems. Requirements for measurement processes and measuring equipment
DIN EN 15224:2017-05 QUALITY MANAGEMENT SYSTEMS - EN ISO 9001:2015 FOR HEALTHCARE
CEN ISO/TS 29001:2011 Petroleum, petrochemical and natural gas industries - Sector-specific quality management systems - Requirements for product and service supply organizations (ISO/TS 29001:2010)
EN 60300-2:2004 Dependability management - Part 2: Guidelines for dependability management

IEC 61025:2006 Fault tree analysis (FTA)
ISO 5725-1:1994 Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions
ISO 11843-2:2000 Capability of detection — Part 2: Methodology in the linear calibration case
IEC 61123:1991 Reliability testing - Compliance test plans for success ratio
ISO 2859-4:2002 Sampling procedures for inspection by attributes Part 4: Procedures for assessment of declared quality levels
ISO 10725:2000 Acceptance sampling plans and procedures for the inspection of bulk materials
IEC 60863:1986 Presentation of reliability, maintainability and availability predictions
ISO 2859-3:2005 Sampling procedures for inspection by attributes — Part 3: Skip-lot sampling procedures
ISO/TS 14253-2:1999 Geometrical Product Specifications (GPS) Inspection by measurement of workpieces and measuring equipment Part 2: Guide to the estimation of uncertainty in GPS measurement, in calibration of measuring equipment and in product verification
ISO 11843-1:1997 Capability of detection Part 1: Terms and definitions
ISO 7873:1993 Control charts for arithmetic average with warning limits
ISO 2854:1976 Statistical interpretation of data — Techniques of estimation and tests relating to means and variances
ISO 16269-7:2001 Statistical interpretation of data — Part 7: Median — Estimation and confidence intervals
IEC 60812:2006 Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA)
ISO 3951:1989 Sampling procedures and charts for inspection by variables for percent nonconforming
IEC 61649:2008 Weibull analysis
IEC 61014:2003 Programmes for reliability growth
ISO/IEC Guide 43-1:1997 Proficiency testing by interlaboratory comparisons Part 1: Development and operation of proficiency testing schemes
IEC 61070:1991 Compliance test procedures for steady-state availability
ISO 14253-1:2017 Geometrical product specifications (GPS) — Inspection by measurement of workpieces and measuring equipment — Part 1: Decision rules for verifying conformity or nonconformity with specifications
IEC 61078:2016 Reliability block diagrams
IEC 61165:2006 Application of Markov techniques
ISO 7870:1993 Control charts General guide and introduction
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 Guide 33:2015 Reference materials Good practice in using reference materials
ISO 11648-2:2001 Statistical aspects of sampling from bulk materials — Part 2: Sampling of particulate materials
ISO 2859-2:1985 Sampling procedures for inspection by attributes — Part 2: Sampling plans indexed by limiting quality (LQ) for isolated lot inspection
ISO 5725-6:1994 Accuracy (trueness and precision) of measurement methods and results — Part 6: Use in practice of accuracy values
ISO Guide 35:2017 Reference materials Guidance for characterization and assessment of homogeneity and stability
ISO 2859-0:1995 Sampling procedures for inspection by attributes — Part 0: Introduction to the ISO 2859 attribute sampling system
IEC 61163-1:2006 Reliability stress screening - Part 1: Repairable assemblies manufactured in lots
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 11095:1996 Linear calibration using reference materials
ISO 2602:1980 Statistical interpretation of test results Estimation of the mean Confidence interval
ISO 8422:2006 Sequential sampling plans for inspection by attributes
IEC 61163-2:1998 Reliability stress screening - Part 2: Electronic components
ISO 3301:1975 Statistical interpretation of data — Comparison of two means in the case of paired observations
ISO 3534-2:2006 Statistics Vocabulary and symbols Part 2: Applied statistics
IEC 61124:2012 Reliability testing - Compliance tests for constant failure rate and constant failure intensity
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/TR 8550:1994 Guide for the selection of an acceptance sampling system, scheme or plan for inspection of discrete items in lots
IEC 61164:2004 Reliability growth - Statistical test and estimation methods
ISO 7966:1993 Acceptance control charts
ISO 8423:2008 Sequential sampling plans for inspection by variables for percent nonconforming (known standard deviation)
IEC 60300-1:2014 Dependability management - Part 1: Guidance for management and application
ISO 3494:1976 Statistical interpretation of data — Power of tests relating to means and variances
ISO 10012:2003 Measurement management systems — Requirements for measurement processes and measuring equipment
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
IEC 60300-2:2004 Dependability management - Part 2: Guidelines for dependability management
ISO 3534-3:2013 Statistics — Vocabulary and symbols — Part 3: Design of experiments
IEC 60300-3-9:1995 Dependability management - Part 3: Application guide - Section 9: Risk analysis of technological systems
ISO 5479:1997 Statistical interpretation of data — Tests for departure from the normal distribution
ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
ISO 11462-1:2001 Guidelines for implementation of statistical process control (SPC) Part 1: Elements of SPC
ISO 8595:1989 Interpretation of statistical data Estimation of a median
SA HB 13485:2020 AS ISO 13485:2017 - Medical devices - A practical guide
IEC 61650:1997 Reliability data analysis techniques - Procedures for comparison of two constant failure rates and two constant failure (event) intensities
ISO/IEC Guide 43-2:1997 Proficiency testing by interlaboratory comparisons Part 2: Selection and use of proficiency testing schemes by laboratory accreditation bodies
ISO/TR 7871:1997 Cumulative sum charts Guidance on quality control and data analysis using CUSUM techniques
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
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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