oSIST ISO/DIS 10009:2023

Quality management - Guidance for quality tools and their application

This document introduces quality tools which can be used with quality management systems to: a) maintain compliance; b) describe trends and process characteristics; c) focus on areas for improvement. 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.

Management de la qualité - Lignes directrices pour des instruments et techniques qualités pour l'ISO 9001

Vodenje kakovosti - Napotki za orodja za kakovost in njihovo uporabo

General Information

• Status: Not Published
• Public Enquiry End Date: 02-May-2023
• ICS: 03.100.70 - Management systems
• ICS: 03.120.10 - Quality management and quality assurance
• Technical Committee: VZK - Quality management and quality assurance
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 22-Feb-2023
• Due Date: 12-Jul-2023
• Completion Date: 03-May-2023
• Ref Project: ISO/DIS 10009 - Quality management — Guidance for quality tools and their application

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST ISO/DIS 10009:2023
01-april-2023
Vodenje kakovosti - Napotki za orodja za kakovost in njihovo uporabo
Quality management - Guidance for quality tools and their application
Management de la qualité - Lignes directrices pour des instruments et techniques
qualités pour l'ISO 9001
Ta slovenski standard je istoveten z: ISO/DIS 10009
ICS:
03.100.70 Sistemi vodenja Management systems
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
oSIST ISO/DIS 10009:2023 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST ISO/DIS 10009:2023

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oSIST ISO/DIS 10009:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 10009
ISO/TC 176/SC 3 Secretariat: SA
Voting begins on: Voting terminates on:
2023-02-13 2023-05-08
Quality management — Guidance for quality tools and
their application
Management de la qualité — Lignes directrices pour des instruments et techniques qualités pour l'ISO
9001
ICS: 03.120.10
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
This document is circulated as received from the committee secretariat.
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
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STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 10009:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

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oSIST ISO/DIS 10009:2023
ISO/DIS 10009:2023(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 10009
ISO/TC 176/SC 3 Secretariat: SA
Voting begins on: Voting terminates on:

Quality management — Guidance for quality tools and
their application
Management de la qualité — Lignes directrices pour des instruments et techniques qualités pour l'ISO
9001
ICS: 03.120.10
COPYRIGHT PROTECTED DOCUMENT
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2023
THEREFORE SUBJECT TO CHANGE AND MAY
This document is circulated as received from the committee secretariat.
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
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IN ADDITION TO THEIR EVALUATION AS
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ISO copyright office
USER PURPOSES, DRAFT INTERNATIONAL
CP 401 • Ch. de Blandonnet 8
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
CH-1214 Vernier, Geneva
POTENTIAL TO BECOME STANDARDS TO
Phone: [phone]
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: [e-mail]
NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 10009:2022(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
  © ISO 2023 – All rights reserved
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022

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oSIST ISO/DIS 10009:2023
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 Control plans . 7
6.4 Flow Charts / Swim Lane Diagrams / Cross-functional Flow Chart . 7
6.5 Authority Matrix / RACI / Matrix Diagram . 8
6.6 Other relevant resources . 8
7 Risk and opportunity .9
7.1 Structured What If Technique (SWIFT) . 9
7.2 Risk Register / Risk Assessment . 9
7.3 Failure Mode 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
iii
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oSIST ISO/DIS 10009:2023
ISO/DIS 10009:2022(E)
11.2 JIT Just-In-Time (JIT) . 23
11.3 Other Relevant Resources . 23
12 Detection and Prevention.24
12.1 Error Proofing / Poka Yoke . 24
12.2 Visual Aids . 24
12.3 Cost of Poor Quality (COPQ) . 24
12.4 Other relevant resources . 25
13 Statistical Process Control .25
13.1 Box plots . 25
13.2 Pie diagram . 26
13.3 Radar Chart / Spider Web . 26
13.4 Pre-Control . 27
13.5 Critical to Quality (CTQ) Trees .28
13.6 Pareto Chart .28
13.7 Gage Repeatability & Reproducibility (GR&R) .29
13.8 Other relevant resources .30
14 Corrective Action / Problem Analysis.30
14.1 Root Cause Analysis (RCA) .30
14.2 Decision Tree . 30
14.3 Fault Tree Analysis (FTA) . 31
14.4 Five Why Analysis . 32
14.5 Ishikawa / Fishbone / Cause and Effect Diagrams . 32
14.6 Is / Is Not Analysis . 33
14.7 Other relevant resources .34
15 Improvement / Benchmarking .34
15.1 Benchmarking .34
15.2 Affinity Diagram . 35
15.3 Quality Circles . 35
15.4 Brainstorming . 36
15.5 Six Thinking Hats – Lateral Thinking . 36
15.6 Other relevant resources . 37
16 Families of Management Tools .37
16.1 Six Sigma Programme . 37
16.2 Toyota Production System (TPS) .38
16.3 Total Quality Management (TQM) . 39
16.4 Dynamic Working Design (non-manufacturing processes) .40
Annex A (informative) PDCA – Techniques overview .41
Annex B (informative) Review of the attributes of Quality Tools .43
Annex C (informative) Storyboard examples for Quality Tool Application .46
Bibliography .47
iv
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oSIST ISO/DIS 10009:2023
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
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
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 176 SC3.
This DIS edition cancels and replaces the CD2 which has been technically revised.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
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oSIST ISO/DIS 10009:2023
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
improving and stable metrics.
Most organisations are already using quality tools. Many areas of manufacturing already use statistical
quality tools for process control and early warnings of when these processes become less stable. This
standard is intended to be a companion standard to ISO 10017: Quality Systems: Use of Statistics.
However, ISO 10009 also covers some simple statistical techniques that are not covered in detail in
10017.
In this document, the term quality tool is defined and it is essentially synonymous with a quality
technique. The simplest quality tools are encountered at school so many are well known before
completing formal education. Other quality tools are used by certain industries, the public sector or in
specific cultural contexts. This standard aims to catalogue quality tools in general use somewhere in
the world.
No proprietary quality tools have been included and all tools are used by more than one organisation.
This standard is not promoting any novel quality tools which have not been accepted by the wider
quality community.
The standard aims to familiarise quality practitioners with what could be called “the tool-box” of
quality tools. It is intended as a reference on quality tools which may be used in a number of contexts.
Some quality tools are the subject of commercially available training and certification. The aim of this
standard is not to explain in detail how each quality tool works; this knowledge may be gained from
various publications and training courses (references at the end of the standard may assist). One of
the key concepts is the appropriate use of quality tools; this standard aims to enable users to better
select quality tools that are suited for the task that they have in mind. Some of these tools may also be
appropriate for use in other contexts and the reader is encouraged to consider their wider application.
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oSIST ISO/DIS 10009:2023
DRAFT INTERNATIONAL STANDARD ISO/DIS 10009:2022(E)
Quality management — Guidance for quality tools and
their application
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
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
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 9000, Quality management systems — Fundamentals and vocabulary
ISO 9001, Quality management systems — Requirements
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:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .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]
1
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oSIST ISO/DIS 10009:2023
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
anything perceivable or conceivable
[SOURCE: ISO 9000:2015, 3.6.1]
3.9
requirement
need or expectation that is stated, generally implied or obligatory
[SOURCE: ISO 9000:2015, 3.6.4]
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.
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oSIST ISO/DIS 10009:2023
ISO/DIS 10009:2022(E)
5 Strategy
5.1 Strengths, Weaknesses, Opportunities and Threats (SWOT) Analysis
SWOT analysis is a tool designed to help develop strong business strategy by consideration of key
strengths, weaknesses, opportunities and threats faced when implementing the intended strategy.
SWOT is used:
— To review the impact of external and internal f
...