Iso-Dis-10009-2023 en
Iso-Dis-10009-2023 en
Iso-Dis-10009-2023 en
ICS:
03.100.70 Sistemi vodenja Management systems
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
oSIST ISO/DIS 10009:2023
ICS: 03.120.10
ISO/DIS 10009:2023(E)
ISO/DIS 10009:2022(E)
Contents Page
Foreword...........................................................................................................................................................................................................................................v
Introduction............................................................................................................................................................................................................................... vi
1 Scope.................................................................................................................................................................................................................................. 1
2 Normative references...................................................................................................................................................................................... 1
3 Terms and definitions..................................................................................................................................................................................... 1
4 Quality tools............................................................................................................................................................................................................... 2
4.1 General............................................................................................................................................................................................................ 2
4.2 Review............................................................................................................................................................................................................. 2
5 Strategy........................................................................................................................................................................................................................... 3
5.1 Strengths, Weaknesses, Opportunities and Threats (SWOT) Analysis................................................ 3
5.2 Political, Economic, Social, Technological, Legal and Environmental (PESTLE)
Analysis.......................................................................................................................................................................................................... 3
5.3 Porter’s Five or Six Forces............................................................................................................................................................. 4
5.4 Vision and Mission Statements................................................................................................................................................. 4
5.5 Other relevant resources................................................................................................................................................................ 5
6 Process Approach and Planning........................................................................................................................................................... 5
6.1 SIPOC / COPIS (useful for identifying processes)..................................................................................................... 5
6.2 Turtle diagrams...................................................................................................................................................................................... 6
6.3
6.4
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Control plans............................................................................................................................................................................................. 7
Flow Charts / Swim Lane Diagrams / Cross-functional Flow Chart...................................................... 7
6.5
6.6
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Authority Matrix / RACI / Matrix Diagram................................................................................................................... 8
Other relevant resources................................................................................................................................................................ 8
7 Risk and opportunity....................................................................................................................................................................................... 9
7.1 Structured What If oSIST
Technique ISO/DIS (SWIFT) 10009:2023
............................................................................................................................ 9
7.2 https://standards.iteh.ai/catalog/standards/sist/33956d49-b6c9-40e8-8509-
Risk Register / Risk Assessment............................................................................................................................................. 9
7.3 Failure Mode 6b0f45a31fd0/osist-iso-dis-10009-2023
and Effects Analysis (FMEA)................................................................................................................... 9
7.4 Traffic Light / Heat Maps............................................................................................................................................................. 10
7.5 Other relevant resources............................................................................................................................................................. 11
8 Objectives and Objective Management...................................................................................................................................... 11
8.1 Kaizen........................................................................................................................................................................................................... 11
8.2 Hoshin Kanri (also known as the X-Matrix)............................................................................................................... 11
8.3 Management by Objectives (MBO)...................................................................................................................................... 13
9 Customer Focus / Perception............................................................................................................................................................... 13
9.1 Quality Function Deployment (QFD)................................................................................................................................. 13
9.2 Net Promoter Score (NPS)......................................................................................................................................................... 14
9.3 Kano Model.............................................................................................................................................................................................. 15
9.4 Pugh Matrix............................................................................................................................................................................................. 16
9.5 Other relevant resources............................................................................................................................................................. 16
10 Process Performance.................................................................................................................................................................................... 17
10.1 Theory of Constraints (ToC).................................................................................................................................................... 17
10.2 Value Stream Mapping (VSM)................................................................................................................................................. 17
10.3 Deadly Wastes / MUDA................................................................................................................................................................. 19
10.4 Work Breakdown Structure..................................................................................................................................................... 19
10.5 Spaghetti Diagram............................................................................................................................................................................ 19
10.6 Five S.............................................................................................................................................................................................................. 20
10.7 Overall Equipment Effectiveness (OEE)......................................................................................................................... 21
10.8 HeiJunka / Production Levelling.......................................................................................................................................... 22
10.9 Other relevant resources............................................................................................................................................................. 22
11 Inventory Management / Preservation..................................................................................................................................... 22
11.1 Kanban......................................................................................................................................................................................................... 22
ISO/DIS 10009:2022(E)
ISO/DIS 10009:2022(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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
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expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
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www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 176 SC3.
oSIST
This DIS edition cancels and replaces theISO/DIS 10009:2023
CD2 which has been technically revised.
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Any feedback or questions on this document should be directed to the user’s national standards body. A
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complete listing of these bodies can be found at www.iso.org/members.html.
ISO/DIS 10009:2022(E)
Introduction
Organisations that maintain a quality management system want it to deliver value and implementing a
quality management system should be a strategic decision for an organization.
Depending on the organisation’s area of activity, value can be measured in metrics such as:
— Reduction in complaints
— Reduction in waste
— Improved turn-around times
— Improved delivery times
— Improved responsiveness
— Better staff retention
— Greater confidence in regulatory compliance
— Increase in sales and profitability
It is therefore important to any organisation not only to have an effective quality management system
but one that may be seen through internal and external metrics to be a system with associated
1 Scope
This document identifies tools that may be used in a quality management system to:
a) Characterize a process or a variable
b) Facilitate problem solving
c) Highlight areas for improvement
d) Improve effectiveness
Guidance on their selection and application is provided with the aim of providing a resource to
practitioners and promoting the appropriate use of quality tools.
2 Normative references
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The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
(standards.iteh.ai)
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 9000, Quality management systems — Fundamentals and vocabulary
oSIST—ISO/DIS
ISO 9001, Quality management systems 10009:2023
Requirements
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3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 9000, Quality Management
Systems – Fundamentals and vocabulary and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://w ww.iso.org/obp
— IEC Electropedia: available at https://w ww.electropedia.org/
3.1
quality tool
method or procedure (3.2) to perform an operation to achieve a quality objective (3.3)
3.2
procedure
specified way to carry out an activity or a process (3.4)
[SOURCE: ISO 9000:2015, 3.4.5]
3.3
quality objective
objective (3.5) related to quality (3.6)
[SOURCE: ISO 9000:2015, 3.7.2]
ISO/DIS 10009:2022(E)
3.4
process
set of interrelated or interacting activities that use inputs to deliver an intended result
[SOURCE: ISO 9000:2015, 3.4.1]
3.5
objective
result to be achieved
[SOURCE: ISO 9000:2015, 3.7.1]
3.6
quality
degree to which a set of inherent characteristics (3.7) of an object (3.8) fulfils requirements (3.9)
[SOURCE: ISO 9000:2015, 3.6.2]
3.7
characteristic
distinguishing feature
[SOURCE: ISO 9000:2015, 3.10.1]
3.8
object
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anything perceivable or conceivable
[SOURCE: ISO 9000:2015, 3.6.1]
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3.9
requirement
oSIST ISO/DIS 10009:2023
need or expectation that is stated, generally implied or obligatory
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4 Quality tools
4.1 General
The quality tools given in this standard have been arranged in approximate alignment with the
sequence of the quality system requirements of ISO 9001. This structure is intended to assist user
access and does not imply priority. A listing of the tools in relation to the PDCA (Plan-Do-Check-Act)
approach is provided in Annex A.
Annex B provides a quick reference tool for guiding appropriate application
Annex C gives examples of how quality tools are used in combination as storyboards
4.2 Review
Each quality tool is reviewed as follows:
— Short explanation of the tool and its context in its use within a quality system.
— How the quality tools are normally used.
— Reasons to use the quality tool and guidance on effective use..
ISO/DIS 10009:2022(E)
5 Strategy
ISO/DIS 10009:2022(E)
ISO/DIS 10009:2022(E)
ISO/DIS 10009:2022(E)
ISO/DIS 10009:2022(E)
BENEFITS
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POINTS TO NOTE
Provides a clear and structured approach to Product and process characteristics must be
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product and process control
Assists in effective auditing.
unambiguously defined.
Process flows, FMEA and control plans should
be reviewed and updated when non-conform-
oSIST ISO/DIS ities occur
10009:2023
Helps drive conformity in “special processes” The control plan does not replace work in-
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structions which provide greater detail of the
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manufacturing process