kSIST ISO/FDIS 10010:2022
(Main)Quality management - Guidance to understand, evaluate and improve organizational quality culture to drive sustained success
Quality management - Guidance to understand, evaluate and improve organizational quality culture to drive sustained success
This document gives guidance on the evaluation, development and improvement of organizational quality culture to help an organization to achieve sustained success. This document takes into account the fundamental concepts and quality management principles, with specific focus on people engagement and leadership.
The recommendations in this document are generic and are intended to be applicable to any organization, regardless of its size, industry, location, maturity or the products and services it provides.
NOTE This document provides example tools for the evaluation of organizational quality culture by self-assessment to determine quality culture maturity and potential for improvement
Titre manque
Vodenje kakovosti - Napotki za razumevanje, vrednotenje in izboljšanje kulture kakovosti organizacije za trajni uspeh
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INTERNATIONAL ISO
STANDARD 10010
First edition
2022-08
Quality management — Guidance to
understand, evaluate and improve
organizational quality culture
Management de la qualité — Recommandations pour comprendre,
évaluer et améliorer la culture de la qualité organisationnelle
Reference number
ISO 10010:2022(E)
© ISO 2022
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ISO 10010:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
© ISO 2022 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 10010:2022(E)
Contents Page
Foreword ........................................................................................................................................................................................................................................iv
Introduction .................................................................................................................................................................................................................................v
1 Scope ................................................................................................................................................................................................................................. 1
2 Normative references ..................................................................................................................................................................................... 1
3 Terms and definitions .................................................................................................................................................................................... 1
4 Context of the organization ......................................................................................................................................................................2
4.1 Relationship between quality culture and organizational culture ......................................................... 2
4.2 Understand the context of the organization ................................................................................................................ 3
4.2.1 External and internal issues .................................................................................................................................... 3
4.2.2 Understanding the needs and expectations of interested parties ........................................ 5
5 Determine desired quality culture .................................................................................................................................................. 6
5.1 General ........................................................................................................................................................................................................... 6
5.2 Leadership roles and responsibilities ................................................................................................................................ 6
6 Determine current quality culture .................................................................................................................................................. 7
6.1 General ........................................................................................................................................................................................................... 7
6.2 Decide what will be measured and how .......................................................................................................................... 7
6.3 Monitoring and measuring current quality culture.............................................................................................. 8
6.4 Analyse and evaluate the current quality culture .................................................................................................. 8
6.4.1 General ........................................................................................................................................................................................ 8
6.4.2 Analyse current quality culture ........................................................................................................................... 8
6.4.3 Evaluate current quality culture ......................................................................................................................... 9
7 Determine and implement actions to achieve desired quality culture .....................................................9
7.1 General ........................................................................................................................................................................................................... 9
7.2 Determine quality culture strategy .................................................................................................................................. 10
7.2.1 Aspects of quality culture ....................................................................................................................................... 10
7.2.2 Establish quality culture strategy ................................................................................................................... 10
7.2.3 Analyse need for quality culture in terms of quality strategy ............................................... 11
8 Embed desired quality culture ..........................................................................................................................................................11
8.1 General ........................................................................................................................................................................................................ 11
8.2 Enable continual improvement of quality culture ............................................................................................... 11
9 Sustain desired quality culture ........................................................................................................................................................12
9.1 General ........................................................................................................................................................................................................12
9.2 People engagement ..........................................................................................................................................................................12
9.2.1 Quality culture champions .....................................................................................................................................12
9.2.2 Awareness and training ............................................................................................................................................13
9.3 Communication ...................................................................................................................................................................................13
9.4 Management of change ................................................................................................................................................................. 13
9.5 Continual evaluation and benchmarking ..................................................................................................................... 14
Annex A (informative) Evaluation examples ...........................................................................................................................................15
Bibliography .............................................................................................................................................................................................................................17
iii© ISO 2022 – All rights reserved
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ISO 10010:2022(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, 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.© ISO 2022 – All rights reserved
---------------------- Page: 4 ----------------------
ISO 10010:2022(E)
Introduction
0.1 General
The purpose of this document is to assist an organization in understanding, evaluating, and improving
its quality culture to enhance organizational performance and to help achieve sustained success.
This document provides guidance on how to understand, determine, analyse, evaluate, implement,
embed and sustain the desired quality culture consistent with the context of the organization.
It also details:— the role of leadership and people engagement in achieving a desired quality culture;
— the role of quality culture in the performance of the organization in satisfying its customers and
other interested parties;— the ongoing determination of risks and opportunities for improvement relevant to quality culture;
— integration of the seven quality management principles (see 0.2) in the organization’s quality
culture.A representation of the framework for recommended actions is provided in Figure 1.
Figure 1 — Quality culture framework0.2 Quality management principles and fundamental concepts
The quality management principles and fundamental concepts described in ISO 9000:2015 are reflected
in this document as they can assist the organization in developing a quality culture that helps meet
challenges that arise in today’s environment of change and increasing expectations.
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ISO 10010:2022(E)
The seven quality management principles are:
— customer focus;
— leadership;
— engagement of people;
— process approach;
— improvement;
— evidence-based decision-making;
— relationship management.
NOTE Full descriptions of the quality management principles are provided in ISO 9000:2015, 2.3.
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INTERNATIONAL STANDARD ISO 10010:2022(E)
Quality management — Guidance to understand, evaluate
and improve organizational quality culture
1 Scope
This document gives guidance on the evaluation, development and improvement of organizational
quality culture to help an organization to achieve sustained success. This document takes into
account the fundamental concepts and quality management principles, with specific focus on people
engagement and leadership.The recommendations in this document are generic and are intended to be applicable to any
organization, regardless of its size, industry, location, maturity or the products and services it provides.
NOTE This document provides example tools for the evaluation of organizational quality culture by self-
assessment to determine quality culture maturity and potential for improvement.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 9000:2015, Quality management systems — Fundamentals and vocabulary3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 9000:2015 and the following
apply.ISO and IEC maintain terminology 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
culture
integrated shared values, beliefs, history, ethics, attitudes and observed behaviours
Note 1 to entry: In this document, “culture” refers to organizational culture.3.2
quality culture
culture (3.1) supporting the achievement of a quality policy and objectives, and the delivery of products
and services that meet the needs and expectations of customers and other relevant interested parties
3.3process owner
person (or team) responsible for defining and maintaining a process
Note 1 to entry: At the organizational level, the process owner is the person (or team) responsible for the
description of a standard process; at the project level, the process owner is the person (or team) responsible
for the description of the defined process. A process can therefore have multiple owners at different levels of
responsibility.© ISO 2022 – All rights reserved
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ISO 10010:2022(E)
[SOURCE: ISO/IEC/IEEE 24765:2017, 3.3068]
3.4
benchmarking
comparative evaluation and/or analysis of similar operational practices
[SOURCE: ISO 14644-16:2019, 3.3.1]
4 Context of the organization
4.1 Relationship between quality culture and organizational culture
To understand the relationship between quality culture and organizational culture, the organization
should consider the guidance provided in ISO 9000:2015, 2.2.1: “An organization focused on quality
promotes a culture that results in behaviour, attitudes, activities and processes that deliver value
through fulfilling the needs and expectations of customers and other relevant interested parties.”
The organization should consider quality culture as an integral part of the wider organizational culture,
whether or not a defined quality management system has been implemented, and take into account:
— behaviours that support the provision of product or service quality;— customer focus;
— risks and opportunities;
— performance evaluation;
— continual improvement.
To determine the maturity of its quality culture, the organization should determine the level to which
the integration of quality management principles and fundamental concepts has been embedded into
organizational culture and consider its impact on the establishment, operation and maintenance of
organizational systems, processes and procedures.To establish a quality culture, the organization should ensure that its vision, mission and values are
aligned to its objectives. The objectives should take into account the context of the organization and the
needs and expectations of relevant interested parties. Figure 2 demonstrates this.
NOTE Different cultures can exist within the same organization depending on departments, geographic
locations, etc.© ISO 2022 – All rights reserved
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ISO 10010:2022(E)
NOTE Figure 2 is for illustration only. It includes examples of fundamental concepts, management principles
and internal and external issues that contribute to quality culture. For more information on the fundamental
concepts and quality management principles, see ISO 9000.Figure 2 — Example of a relationship between quality culture and organizational culture
4.2 Understand the context of the organization4.2.1 External and internal issues
4.2.1.1 General
The organization should consider the external and internal issues relevant to the organization’s quality
culture during the development of the organization’s vision, mission, values and objectives.
EXAMPLE 1 An organization that prides itself on independence and being entrepreneurial as a core basis of
its culture, can run different sites independently. However, the business requires coordination and standard
processes, which are identified as an internal issue.EXAMPLE 2 A start-up organization has no documented processes before entering a new, highly regulated
market which requires defined levels of documentation and records. This requirement to meet compliance
obligations is identified as an external issue that will impact the desired quality culture.
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ISO 10010:2022(E)
In both examples, the organizations should analyse their quality culture and identify whether there is
a need for change.Historic issues and expectations can also influence quality culture. This can be experienced at various
levels such as internationally, within industries or within a single site.EXAMPLE 3 An organization reconsidered its approach towards virtual workplaces and remote working due
to a series of events including a pandemic, a natural disaster and supply chain issues, which impacted its quality
culture.There is not a single quality culture that suits all organizations. Just as the impact of context on an
organization is very specific, the quality culture will reflect this, and this can be seen in differences
even within the same organizations, across different settings such as sites, departments, teams or job
roles.4.2.1.2 External issues
The organization should consider external issues with the potential to have a major impact on quality
culture. These include the following:a) industry and sector-specific (see below);
b) country and region;
c) political, economic, social and cultural factors and religious beliefs;
d) legal, statutory and regulatory requirements;
e) needs and expectations of customers, supply chain and other interested parties;
f) competitive and market forces;g) technological status;
h) environmental aspects and impacts;
i) history and traditions;
j) local demography.
The organization should ensure that it understands quality expectations and requirements in
its industry or sector [see a), above], as these vary and will have an impact on quality culture. The
organization should take into account such characteristics as specific quality requirements and
expectations, legal, regulatory and statutory requirements, standards and industry requirements,
and other industry-specific influences. A highly regulated industry is likely to have a different quality
culture to industries where price can be a more significant factor (e.g. an organization in the highly
regulated pharmaceutical industry differs from an organization in the fashion industry).
4.2.1.3 Internal issuesThe organization should consider internal issues with the potential to have a major impact on quality
culture. These include, but are not limited to:a) leadership and people (see 4.2.1.4);
b) product and service offering;
c) organizational maturity (see below);
d) approach to risks and opportunities;
e) resourcing;
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ISO 10010:2022(E)
f) training and education;
g) awareness of the need for quality culture;
h) available technologies;
i) earning expectations;
j) collective agreements and labour representatives;
k) diversity of workforce;
l) feedback and complaints.
The organization should consider its development stage and maturity [see c), above] when evaluating its
current quality culture and planning for improvement. Development stages can evolve from the initial
stage of entrepreneurship, through periods of rapid growth and on reaching established maturity.
Quality culture develops as a quality management system becomes more established and embedded,
so a start-up business is likely to have a different quality culture to that of an established organization.
The organization should consider where the focus of its quality culture should be according to its level
of maturity, taking into account its long-term plans to ensure that focus does not exclude or conflict
with other key aspects of quality culture.EXAMPLE An organization in the initial stages of development can have a quality culture that places greater
emphasis on rapidly meeting an emerging need than it does on the quality of its products and services. A more
established organization with a secure customer base can have a quality culture that is less agile in meeting
changes in the needs and expectations of its interested parties but a good understanding of the quality of its
products and services.4.2.1.4 Leadership and people
The organization should demonstrate top management commitment in the development and
improvement of quality culture, as this is potentially the most significant factor. Top management
should direct the organization’s vision, mission, values and culture, and ensure that desired behaviours
are demonstrated and communicated. The organization should also take into account the personalities
of key people of influence outside of top management, including (particularly for small organizations)
the personality of the owner, as such influence can also be a key factor.To ensure quality culture is effective, top management should be aware of the importance of people
throughout an organization: behaviours, competences, experience and diversity all play an important
role in cultural maturity and the achievement of plans for quality improvement.NOTE Guidance on competence and people development is provided in ISO 10015.
4.2.2 Understanding the needs and expectations of interested parties
ISO 9004:2018, 4.1 states that “the quality of an organization is the degree to which the inherent
characteristics of the organization fulfil the needs and expectations of its customers and other
interested parties, in order to achieve sustained success”. The organization should therefore take into
account the needs and expectations of customers and other relevant interested parties and ensure
these are aligned with the organization’s vision, mission and values. The organization should ensure
objectives are achievable and form the basis for continual improvement (see Figure 1).
NOTE ISO 9004:2018, 4.1, NOTE 1, clarifies the origin of the term “quality of an organization”: ‘The term
“quality of an organization” is derived from the definition of “quality” given in ISO 9000:2015, 3.6.2 (“the
degree to which a set of inherent characteristics of an object fulfils requirements”), and from the definition
of “requirement” given in ISO 9000:2015, 3.6.4, (“needs or expectations that are stated, generally implied or
obligatory”). It is distinct from the purpose of ISO 9001, which focuses on the quality of products and services that
meet customer and applicable statutory and regulatory requirements and enhance its customers’ satisfaction.’
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ISO 10010:2022(E)
5 Determine desired quality culture
5.1 General
The organization should use its understanding of its context, including external and internal issues
(see Clause 4), to determine the desired quality culture. In determining the desired quality culture, the
organization should be aware of the interdependency of vision, mission, values and culture and their
dynamic relationships.The desired quality culture should be clearly articulated, accessible and retained as documented
information. This can include:— a quality culture commitment statement, which should be integrated with organizational policies;
— expected behaviours and values to support the desired quality culture.The organization should provide opportunities for people working at different levels to participate in
the determination and implementation of the desired quality culture.The organization should understand its own business model and where the quality of its product
or service fits in with that model to understand what its desired quality culture is or should be. The
organization should determine the needs and expectations of customers and other relevant interested
parties with respect to deliverables, through processes such as customer feedback.
The type of quality culture the organization desires can be influenced by characteristics of the
organization, such as:a) working directly with customers;
b) mass automated production;
c) custom and/or handmade product;
d) solely service or resource provision;
e) single source supplier or customer.
Once the desired quality culture is identified, the organization should use tools and techniques and
other sources of data, such as those described in 6.2, to measure performance and determine if it is
meeting the standards for desired quality culture.5.2 Leadership roles and responsibilities
The organization should recognize that quality culture is an important part of organizational culture
and significantly influenced by the attitude, thinking and understanding of top management.
Top management should formulate a quality policy consistent with its vision, mission and values. The
quality policy and culture should support the organization’s strategic direction and clarify the intention
and direction of the organization in terms of quality. The quality policy should be coordinated with the
desired quality culture development and integrated with the quality management system.
Top management should:— establish and communicate the desired quality culture;
— provide relevant policies and resources;
— engage, direct and support quality culture within the organization;
— define expectations and desired behaviours;
— lead by example.
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ISO 10010:2022(E)
Leadership at all levels should demonstrate the desired quality culture of the organization and
communicate that it is a shared responsibility throughout the organization, across all operational and
geographic boundaries.Top management responsibilities include:
a) determining the organization’s vision, mission, values and quality policy;
b) integrating requirements for quality culture with management systems through business
processes;c) determining planning, strategic direction, objectives and performance metrics to develop desired
quality culture;d) ensuring the desired quality culture takes into account the capabilities and potential for
improvement of the organizational culture;e) providing adequate resources for the development of quality culture;
f) identifying, appointing and developing quality culture champions;
g) ensuring ongoing commitment to quality culture to support sustained success.
6 Determine current quality culture
6.1 General
Every organization has a quality culture, whether or not they know or measure it. The organization
should establish measurable performance criteria, indicators and target values that are used to evaluate
the effectiveness of quality culture. The indicators should cover all aspects of the organization. The
performance criteria should clearly express the level and status of quality culture that the organization
wants to achieve and clarify the quantitative and/or qualitative target of each indicator, clearly
describing the status and level required.6.2 Decide what will be measured and how
The organization should determine the scope of the quality culture evaluation (e.g. total organization,
division, site, plant or country). Once this has been determined, the organization should decide
the criteria for measuring quality culture (e.g. understanding of the quality policy and objectives,
how people working on behalf of the organization comply with management system arrangements,
behaviours, mind-sets and attitudes towards quality).The organization should determine appropriate tools, techniques and sources of data that enable
understanding of the organization’s quali...
SLOVENSKI STANDARD
oSIST ISO/DIS 10010:2021
01-november-2021
Vodenje kakovosti - Napotki za razumevanje, vrednotenje in izboljšanje kulture
kakovosti organizacije za trajni uspeh
Quality management - Guidance to understand, evaluate and improve organizational
quality culture to drive sustained success
Titre manque
Ta slovenski standard je istoveten z: ISO/DIS 10010
ICS:
03.100.70 Sistemi vodenja Management systems
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
oSIST ISO/DIS 10010:2021 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST ISO/DIS 10010:2021
DRAFT INTERNATIONAL STANDARD
ISO/DIS 10010
ISO/TC 176/SC 3 Secretariat: NEN
Voting begins on: Voting terminates on:
2021-09-23 2021-12-16
Quality management — Guidance to understand, evaluate
and improve organizational quality culture to drive
sustained success
ICS: 03.120.10
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
This document is circulated as received from the committee secretariat.
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
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 10010:2021(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 2021
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oSIST ISO/DIS 10010:2021
ISO/DIS 10010:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
---------------------- Page: 4 ----------------------
oSIST ISO/DIS 10010:2021
ISO/DIS 10010:2021(E)
Contents Page
Foreword ........................................................................................................................................................................................................................................iv
Introduction ..................................................................................................................................................................................................................................v
1 Scope ................................................................................................................................................................................................................................. 1
2 Normative references ...................................................................................................................................................................................... 1
3 Terms and definitions ..................................................................................................................................................................................... 1
4 Understand organizational context .................................................................................................................................................. 1
4.1 Relationship between quality culture and organizational culture ............................................................. 1
4.2 Understand the context of the organization .................................................................................................................. 3
4.2.1 External and internal issues................................................................................................................................... 3
4.2.2 Understanding the needs and expectations of interested parties ........................................ 5
5 Determine desired quality culture .................................................................................................................................................... 5
5.1 General ........................................................................................................................................................................................................... 5
5.2 Leadership roles and responsibilities ................................................................................................................................. 5
5.3 Quality culture and objectives ................................................................................................................................................... 6
6 Analyse and evaluate current quality culture ........................................................................................................................ 6
6.1 General ........................................................................................................................................................................................................... 6
6.2 Decide what will be measured and how ........................................................................................................................... 6
6.3 Identify the desired quality culture ...................................................................................................................................... 7
6.4 Assess current quality culture ................................................................................................................................................... 7
6.5 Evaluate the quality culture ......................................................................................................................................................... 8
6.6 Continual improvement of quality culture...................................................................................................................... 9
7 Identify and implement actions to achieve desired quality culture ............................................................10
7.1 General ........................................................................................................................................................................................................10
7.2 Determine quality culture strategy ....................................................................................................................................10
7.2.1 Aspects of quality culture ......................................................................................................................................10
7.2.2 Establish a reasonable and achievable quality strategy .............................................................10
7.2.3 Analyse needs for quality culture in terms of quality strategy .............................................11
8 Embed desired quality culture ...........................................................................................................................................................11
9 Sustain desired quality culture ..........................................................................................................................................................12
9.1 General ........................................................................................................................................................................................................12
9.2 People engagement ..........................................................................................................................................................................12
9.2.1 Quality culture champions ...................................................................................................................................12
9.2.2 Awareness and training ..........................................................................................................................................12
9.3 Communication ...................................................................................................................................................................................13
9.4 Management of change .................................................................................................................................................................13
9.5 Ongoing assessment planning and revisiting benchmarks ...........................................................................14
Annex A (informative) Evaluation examples .............................................................................................................................................15
Bibliography .............................................................................................................................................................................................................................17
© ISO 2021 – All rights reserved iii---------------------- Page: 5 ----------------------
oSIST ISO/DIS 10010:2021
ISO/DIS 10010:2021(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 Quality management and quality
assurance, Subcommittee SC 3 Supporting technologies.This is the first edition of this standard.
A list of all parts in the ISO 9000 and ISO 10000 series can be found on the ISO website.
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.iv © ISO 2021 – All rights reserved
---------------------- Page: 6 ----------------------
oSIST ISO/DIS 10010:2021
ISO/DIS 10010:2021(E)
Introduction
0.1 General
The purpose of this document is to assist organizations in understanding, evaluating, and improving
their quality culture to improve performance and to achieve sustained success.ISO 10010 provides guidance on:
— how to determine, define and promote the desired quality culture consistent with the context of the
organization;— the role of leadership and people engagement in achieving a desired quality culture;
— the role of quality culture in the performance of the organization in satisfying its customers and
other interested parties;— using risk-based thinking to support the ongoing identification of risk and opportunities for
improvement relevant to quality culture;— integration of the seven quality management principles (QMPs) in the organization’s quality culture.
A representation of the framework for recommended actions is provided in Figure 1.
Figure 1 — Framework for actions to understand, evaluate and improve organizational quality
culture to drive sustained success0.2 Quality management principles and fundamental concepts
The quality management principles and fundamental concepts described in ISO 9000:2015 are
reflected in this document and can assist the organization in developing a quality culture that helps
meet challenges that arise in today’s environment of constant change and increasing demands.
© ISO 2021 – All rights reserved v---------------------- Page: 7 ----------------------
oSIST ISO/DIS 10010:2021
ISO/DIS 10010:2021(E)
The seven quality management principles listed in ISO 9001:2015 (0.2), to be considered and addressed
when developing the desired organization quality culture are:— customer focus;
— leadership;
— engagement of people;
— process approach;
— improvement;
— evidence-based decision making;
— relationship management.
Note Full descriptions of the quality management principles are provided in ISO 9000:2015 (2.3).
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DRAFT INTERNATIONAL STANDARD ISO/DIS 10010:2021(E)
Quality management — Guidance to understand, evaluate
and improve organizational quality culture to drive
sustained success
1 Scope
This document provides recommendations for the evaluation, development and improvement of
organizational quality culture, including fundamental concepts, quality management principles, people
engagement and leadership.The recommendations in this document are generic and are intended to be applicable to any
organization, regardless of its size, industry, location, maturity, or the products and services it provides.
Note This document provides example tools for the evaluation of organizational quality culture by self-
assessment to determine quality culture maturity and potential for improvement.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 9000:2015, Quality management systems — Fundamentals and vocabularyISO 9001:2015, Quality management systems — Requirements
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 9000:2015 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
culture
integrated shared values, attitudes, standards, behaviours, and practices in the organization
3.2quality culture
culture (3.1) supporting delivery of the quality policy and objectives, and the delivery of products and
services that meet the needs and expectations of customers and other relevant interested parties
4 Understand organizational context4.1 Relationship between quality culture and organizational culture
To understand the relationship between quality culture and organizational culture the organization
should consider the guidance provided in ISO 9001:2015 (2.2.1): “An organization focused on quality
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promotes a culture that results in behaviour, attitudes, activities and processes that deliver value
through fulfilling the needs and expectations of customers and other relevant interested parties.”
The organization should consider quality culture as an integral part of the wider organizational culture,
whether or not a defined quality management system has not been implemented, and take into account:
— behaviours relevant to product or service quality;— customer focus;
— risk and opportunity;
— performance evaluation;
— continual improvement.
To determine the maturity of its quality culture the organization should determine the level to which
the integration of quality management principles and concepts have been embedded into organizational
culture and consider its impact on the establishment, operation and maintenance of organizational
processes and procedures.Figure 2 demonstrates the importance to quality culture of aligning the core mission, vision, and
values of the organization to objectives that take into account organizational context and the needs and
expectations of relevant interested parties.Note Sub-cultures can exist in the same organization at different levels, locations, departments etc. and
cultural differences across organizations can vary extensively.Figure 2 — Relationship between quality culture and organizational culture
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4.2 Understand the context of the organization
4.2.1 External and internal issues
The organization should take into account external and internal issues relevant to the organization’s
purpose and strategic direction that can impact its quality culture.The organization should consider the external and internal issues relevant to the organization’s quality
culture during the development of the organization’s mission, vision, values, and quality objectives.
EXAMPLE 1 An organization that prides itself on independence and being entrepreneurial as a core basis
of its culture can run different sites independently. However, the business requires coordination and standard
processes, which are identified as an internal issue.EXAMPLE 2 A start-up organization that has no documented processes before entering a new, highly regulated
market, which requires defined levels of documentation and records. This requirement to meet compliance
obligations would be identified as an external issue that would impact the desired quality culture.
In both examples, the organizations should analyse their quality culture and identify whether there is a
requirement for change.Historic issues and expectations can also influence quality culture. This can be experienced at various
levels such as internationally, within industries or within a single site.The quality culture should be re-evaluated when there is a major change that impacts the organization.
For example, this was experienced in 2020/21 at a global level where many organizations have
considered their approach to virtual workplaces and/or workforce, with the associated changes to
quality expectations and culture.There is not a single quality culture that suits all organizations. Just as the impact of context on an
organization is very specific, the quality culture will reflect this, and this can be seen in differences
even within the same organizations, across different settings such as sites, departments, teams, or job
roles.4.2.1.1 External factors
The organization should consider external factors with the potential to have a major impact on quality
culture. These include:a) industry and sector (see below). The organization should ensure that it understands quality
expectations and requirements in its industry or sector, as these vary and will have an impact on
quality culture. The organization should take into account such characteristics as specific quality
requirements and expectations; legal, regulatory and statutory requirements; standards and
industry requirements; and other industry specific influences. A highly regulated industry is likely
to have a different quality culture to industries where price may be more significant factor (e.g. an
organization in the highly regulated pharmaceutical industry differs from an organization in the
fashion industry);b) country and region;
c) political, economic, social and religious;
d) legal, statutory and regulatory requirements;
e) needs and expectations of customers, supply chain and other interested parties;
f) competitive and market forces;g) technological status;
h) environmental aspects and impacts;
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i) history and traditions.
4.2.1.2 Internal factors
The organization should consider internal factors with the potential to have a major impact on quality
culture. These include:a) leadership and people (see 4.2.1.2.1);
b) product and service offering;
c) organizational maturity (see text below);
d) approach to risk;
e) resourcing;
f) training and education;
g) awareness;
h) available technologies;
i) earning expectations;
j) unionization;
k) local demography.
Regarding organizational maturity, the organization should consider its development stage and
maturity when evaluating its current quality culture and planning for improvement. Development
stages can evolve from the initial stage of entrepreneurship, through periods of rapid growth and on
reaching established maturity. Quality culture develops as a quality management system becomes
more established and embedded, so a start-up business is likely to have a different quality culture to
that of an established organization.The organization should consider where the focus of its quality culture should be according to its level
of maturity, taking into account its long-term plans to ensure that focus does not exclude or conflict
with other key aspects of quality culture.EXAMPLE An organization in the initial stages of development can have a quality culture that places greater
emphasis on rapidly meeting an emerging need than it does on the quality of its products and services. A more
established organization with a secure customer base can have a quality culture that is less agile in meeting
changes in the needs and expectations of its interested parties but a sound understanding of the quality of its
products and services.4.2.1.3 Leadership and people
The organization should demonstrate top management commitment in the development and
improvement of quality culture, as this is potentially the most significant factor. Top management
should direct the organization’s mission, vision and values and ensure that desired behaviours are
demonstrated. The organization should also take into account the personalities of key people of
influence outside of top management, including (particularly for small organizations) the personality of
the owner as such influence can also be a key factor.To ensure quality culture is effective top management should be aware of the importance of people
throughout an organization: behaviours, competences, experience, and composition all play an
important role in cultural maturity and the achievement of plans for quality improvement.
[2]NOTE Guidance on competence and people development is provided in ISO 10015 .
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4.2.1.4 Future development goals
The organization should ensure that its vision and plans to meet future goals align with the desired
quality culture. This may be demonstrated through the organization’s attitude to innovation, risk and
agility and its ability to meet changing needs and expectations through achievement of policies and
objectives.4.2.2 Understanding the needs and expectations of interested parties
ISO 9004:2018 (4.1) states that “the quality of an organization is the degree to which the inherent
characteristics of the organization fulfil the needs and expectations of its customers and other
interested parties, in order to achieve sustained success”. The organization should therefore take into
account the needs and expectations of customers and other relevant interested parties and ensure
these are aligned with the organization’s mission, vision, values and objectives. The organization should
ensure objectives are actionable and form the basis for continual improvement.[1]
NOTE ISO 9004:2018 clarifies the origin of the term ‘quality of an organization’ (4.1. Note 1): The term
“quality of an organization” is derived from the definition of “quality” given in ISO 9000:2015, 3.6.2 (“the
degree to which a set of inherent characteristics of an object fulfils requirements”), and from the definition
of “requirement” given in ISO 9000:2015, 3.6.4, (“needs or expectations that are stated, generally implied or
obligatory”). It is distinct from the purpose of ISO 9001, which focuses on the quality of products and services that
meet customer and applicable statutory and regulatory requirements and enhance its customers’ satisfaction.
5 Determine desired quality culture5.1 General
The organization should use its understanding of context and the factors described in Clause 4 to
determine the desired quality culture. In determining the desired quality culture through development
of suitable mission, vision and values top management should ensure integration of quality management
principles and concepts into business processes.The desired quality culture should be clearly articulated and accessible and retained as documented
information. This may include:— quality culture commitment statement, which should be integrated with organizational policies;
— expected behaviours and values to support the desired quality culture.5.2 Leadership roles and responsibilities
The organization should recognize that quality culture is an important part of organizational
culture and significantly influenced by the attitude, thinking, and understanding of its leaders (top
management).Top management should:
— establish and communicate the quality strategy;
— provide relevant policies and resources;
— engage, direct and support quality within the organization;
— lead by example.
Leadership at all levels should model the desired quality culture of the organization and communicate
that it is a shared responsibility throughout the organization to demonstrate desired quality culture
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Top management responsibilities include:
a) determining the organization's quality values and quality policies;
b) integrating requirements for quality culture with management systems;
c) determining planning, strategic direction, objectives and performance metrics to cultivate desired
quality culture;d) ensuring the desired quality culture takes into account the capabilities and potential for
improvement of the organizational culture;e) providing adequate resources for the cultivation of quality culture;
f) guiding cultivation and identifying and appointing quality culture promoters;
g) ensuring ongoing commitment to quality culture to ensure sustained success.
5.3 Quality culture and objectives
Top management should ensure that the context of the organization is considered when adapting its
mission, vision, and values. This should include an understanding of its existing culture and assessing
the need to change that culture. The strategic direction of the organization and its policy should be
aligned with these identity elements. Top management should review the mission, vision, values, and
culture at planned intervals and whenever the context of the organization changes. This review should
consider external and internal issues that can influence the organization’s ability to achieve sustained
success. When changes are made to any of the identity elements, they should be communicated within
the organization and to interested parties, as appropriate.Based on adapting to its mission and environment, the organization should formulate a quality policy
consistent with its quality values and able to support its strategic direction, and which clarifies the
intention and direction of the organization in terms of quality. The quality policy should be coordinated
with the desired quality culture development and integrated with the quality management system.
6 Analyse and evaluate current quality culture6.1 General
Every organization has a quality culture, whether or not they know or measure it. The organization
should establish measurable performance standards, indicators and target values that are used to
evaluate the effectiveness of quality culture. The indicators should cover all aspects of the organization.
The performance standard should clearly express the level and s...
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