National foreword

This British Standard is the UK implementation of ISO 10009:2024.

The UK participation in its preparation was entrusted to Technical Committee QS/1/3, Quality Management - Supporting Standards.

A list of organizations represented on this committee can be obtained on request to its committee manager.

Contractual and legal considerations

This publication has been prepared in good faith, however no representation, warranty, assurance or undertaking (express or implied) is or will be made, and no responsibility or liability is or will be accepted by BSI in relation to the adequacy, accuracy, completeness or reasonableness of this publication. All and any such responsibility and liability is expressly disclaimed to the full extent permitted by the law.

This publication is provided as is, and is to be used at the recipient’s own risk.

The recipient is advised to consider seeking professional guidance with respect to its use of this publication.

This publication is not intended to constitute a contract. Users are responsible for its correct application.

Compliance with a British Standard cannot confer immunity from legal obligations.

This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 June 2024.

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 document 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).

ISO draws attention to the possibility that the implementation of this document may involve the use of (a) patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a) patent(s) which may be required to implement this document. However, implementers are cautioned that this may not represent the latest information, which may be obtained from the patent database available at www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.

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, Quality management and quality assurance, Subcommittee SC 3, Supporting technologies.

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.

Introduction

The quality of products and services delivered by an organization is achieved through the processes and procedures that constitute a quality management system (QMS). The function of a QMS is, in broad terms, to enable and ensure that the resulting products and services meet the desired objectives.

Quality tools are an integral element of a QMS. This document seeks to familiarize users with a range of quality tools that potentially have useful applications in a QMS as described by ISO 9001, and to assist in the selection of quality tools appropriate to the task at hand.

In this document, the term “quality tool” is synonymous with “quality techniques”. The range of tools that could be cited is vast. Therefore, the focus of this document is on tools that have seen successful application in a wide range of activities in diverse sectors, and to draw attention to some that can be relatively less known to some users. Statistical techniques are addressed in a separate standard, ISO 10017.

This document provides a brief description of each of the selected tools to assist the user in determining whether the tool has beneficial application in a particular context. The document also provides instruction on how the tool can be used.

1 Scope

This document gives guidance on the selection and application of tools that can be used in a quality management system to:

characterize a process or a variable;
facilitate problem solving;
highlight areas for improvement;
improve effectiveness.

2 Normative references

3 Terms and definitions

4 Quality tools

4.1 General

4.2 Review

5 Strategy

5.1 SWOT analysis

5.2 PESTLE analysis

5.3 Porter’s five or six forces

5.4 Vision and mission statements

5.5 Other relevant tools

6 Process approach and planning

6.1 SIPOC/COPIS (useful for identifying processes)

6.2 Turtle diagram

6.3 Control plan

6.4 Flow diagram/swim lane diagram/cross-functional flow chart

6.5 Authority matrix/RACI/RASCI

6.6 Other relevant tools

7 Risk and opportunity

7.1 SWIFT

7.2 Risk register/risk assessment

7.3 Failure mode and effects analysis (FMEA)

7.4 Traffic light/heat map

7.5 Other relevant tools

8 Objectives and objective management

8.1 Kaizen

8.2 Hoshin Kanri (also known as the “X-matrix”)

8.3 Management by objectives (MBO)

8.4 Other relevant tools

9 Customer focus/perception

9.1 Quality function deployment (QFD)

9.2 Net promoter score (NPS)

9.3 Kano model

9.4 Pugh matrix / Decision matrix

9.5 Other relevant tools

10 Process performance

10.1 Theory of constraints (ToC)

10.2 Value stream management (VSM)

10.3 Process wastes/muda

10.4 Work breakdown structure (WBS)

10.5 Spaghetti diagram

10.6 5S

10.7 Overall equipment effectiveness (OEE)

10.8 Production levelling (Heijunka)

10.9 Other relevant tools

11 Inventory management/preservation

11.1 Kanban

11.2 Just-in-time (JIT)

11.3 Other relevant tools

12 Detection and prevention

12.1 Error proofing/poka-yoke

12.2 Visual aid

12.3 Cost of quality (COQ)

12.4 Other relevant tools

13 Process control tools

13.1 General

13.2 Box plot

13.3 Pie chart

13.4 Radar chart/spider diagram

13.5 Pre-control

13.6 Critical to quality (CTQ) trees

13.7 Pareto chart

13.8 Gage repeatability and reproducibility (GR&R)

13.9 Other relevant tools

14 Corrective action/problem analysis

14.1 Root cause analysis (RCA)

14.2 Decision tree

14.3 Fault tree analysis (FTA)

14.4 Five whys analysis

14.5 Fishbone/Ishikawa diagrams

14.6 Is/is not analysis

14.7 Other relevant tools

15 Improvement

15.1 Benchmarking

15.2 Affinity diagram

15.3 Quality circles / QC circles

15.4 Brainstorming

15.5 Six Thinking Hats

15.6 Other relevant tools

16 Families of management tools

16.1 Six Sigma programme

16.2 Total quality management (TQM)

16.3 Other relevant tools

Bibliography

BS ISO 10009:2024

Quality management. Guidance for quality tools and their application

Current

Published:

30 Jun 2024