ISO/DIS 10010

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

Vodenje kakovosti - Napotki za razumevanje, vrednotenje in izboljšanje kulture kakovosti organizacije za trajni uspeh

General Information

• Status: Published
• ICS: 03.120.10 - Quality management and quality assurance
• Technical Committee: ISO/TC 176/SC 3 - Supporting technologies
• Drafting Committee: ISO/TC 176/SC 3/WG 25 - Guidance to understand and improve quality culture
• Current Stage: 6000 - International Standard under publication
• Completion Date: 29-Jun-2022
• Ref Project: kSIST ISO/FDIS 10010:2022 - Quality management - Guidance to understand, evaluate and improve organizational quality culture to drive sustained success

Standards Content (sample)

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
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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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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

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Published in Switzerland
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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

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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.
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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 success
0.2 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.

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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 vocabulary
ISO 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

3.2
quality 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 context
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 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 culture
5.1 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

across all operational and geographic boundaries.
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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 culture
6.1 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
...