ReportCQI Standards Coordination
Committee member survey on
the case for revising ISO 9001
before the next strategic review

Contents
Executive summary2Introduction3
Background4
Purpose of this report

5

Survey of CQI and IRCA members

6

Survey results

7Comparing results with thecontent of ISO 9001:2015

14

Conclusion16

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Executive summary

Introduction

The Chartered Quality Institute (CQI) presents this executive summary
to highlight the need for a revision of ISO 9001:2015 Quality management
systems – Requirements. The CQI has conducted extensive consultations
with its members to gather their perspectives on the current state of ISO
9001 and the potential areas for improvement.

The Chartered Quality Institute (CQI) is the professional body for experts in improving product,
project, and service quality. For more than 100 years, it has been championing organisational excellenceby setting professional standards for quality management in the UK and globally.

The CQI conducted a survey in 2023 to examine the fitness for purpose of ISO 9001:2015, as wellas the priority areas for inclusion in any future revision, as identified by both the CQI Standards
Coordination Committee (SCC) and ISO/TC 176/SC 2/TG5, and thus the urgency for revision activity
to commence. It involved 820 responses from CQI and International Register of Certificated Auditors(IRCA) members, representing a wide range of expertise in quality management and management
systems audit.
While 50% of respondents expressed agreement that the standard is fit for purpose, the other
50% called for change or remained uncertain. However, several key themes emerged from thesurvey responses, indicating the need for revision. These themes include the importance of continual
improvement, the demand for clarity in certain clauses, the necessity to address emerging digitaltechnologies, changing work practices, and the need to reinforce leadership commitment.
When comparing the priority areas identified by the CQI SCC and the topics proposed by ISO/TC
176/SC 2/TG5 with the content of ISO 9001:2015, it became evident that the current standard falls
short in adequately addressing these areas. The CQI SCC concluded that of the nine priority areas
identified by the CQI SCC and the 15 proposed by TG5, a total of 13 are insufficiently addressed, or
not addressed at all, in ISO 9001:2015. The remaining 11 are only “somewhat” addressed.
Based on the survey results and analysis, the CQI strongly recommends a revision of ISO 9001 toensure its continued relevance, applicability, and value. The risks associated with not progressing areview at this time may result in the standard becoming less relevant to business and society. By revising
ISO 9001, organisations of all types and sizes can thrive by providing exceptional value to customers,
stakeholders, and society at large, embracing the necessary changes to meet the evolving needs ofquality management.

2 | CQI Standards Coordination Committee member survey on the case for revising ISO 9001 before the next strategic review

With 18,000 members in 100 countries, the CQI is the partner of choice for quality management
practitioners and, through its International Register of Certificated Auditors (IRCA) certification, formanagement systems audit professionals. Its mission is to champion quality management for the benefit
of society, and its vision is to bring about a world in which organisations of all types and sizes thrive by
providing outstanding value for customers, stakeholders, and society.
One of the means to support these ambitions has been a long association with the UK’s National
Standards Body, the British Standards Institute (BSI), and on a global basis, with the International
Organization for Standardization (ISO). As a fully committed and widely respected contributor tostandards development over the course of many years, the CQI has been granted category A liaison
status to a diverse range of BS and ISO technical committees and their associated working groups.
This report has been produced in response to the work of one such group, TC176/SC2/TG5 which,in March 2021, was tasked with producing a design specification for the next edition of ISO 9001. The
report describes the process through which the CQI has consulted its members on the both the needfor change, and those topics and themes which require consideration in any future revision of ISO 9001
and presents its conclusions on the need to revise ISO 9001:2015.

“With 18,000 members in 100 countries,
the CQI is the partner of choice for
quality management practitioners”

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BackgroundPurpose of this report

In March 2021, a task group, ISO/TC 176/SC 2/TG5, was given the mandate to collect data and perform
preliminary analysis to indicate whether there was any evidence that ISO 9001 should be revised earlier
than the next scheduled systematic review, due in 2026.
Thirteen (13) sources of evidence were examined, and 496 individual items were provided forevaluation. These items were analysed using an Impact-Benefit matrix. Whilst no single item, or
source of evidence, was found to be strong enough on its own for TG 5 to recommend a revisionof ISO 9001:2015, the collective impact of a number of factors (including responses to the Covid-19
pandemic, changes to Annex SL, new and emerging technologies, remote working, and global systems)
were considered sufficient to justify creating a design specification for the next edition. By producing
this document in advance, when a decision to proceed is made, the development team will have an
existing blueprint to work with and will not have to invest time its creation. This will shorten the overall
development process by several months. The CQI was represented on ISO/TC 176/SC 2/TG 5 andcontributed to the production of this specification.
The CQI Standards Coordination Committee (SCC), which is responsible for coordinating and direct
CQI standards activity, has undertaken a similar exercise identifying priorities for any future revisionof ISO 9001, and presents the following content for consideration by TG5, based on the CQI’s desire
for the world’s most prolific quality management system standard to remain relevant, applicable, andof value.
This work was undertaken with reference to the CQI’s globally recognised research on Quality
4.0, its Competency Framework and Professional Map, and to the views of its members andcorporate partners.
The purpose of this report is to communicate the views of CQI stakeholders in respect of:• The extent to which ISO 9001:2015 it fit for purpose and does not need revising before the next
strategic review.
• The extent to which members support the inclusion of potential content identified by the CQI SCC.
• The extent to which members support the inclusion of potential content identified by TC176/SC2/
TG5 in their design specification document.

4 | CQI Standards Coordination Committee member survey on the case for revising ISO 9001 before the next strategic review

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Survey of CQI and IRCA members

Survey results

To inform the answers to these questions, the CQI SCC undertook a survey of all CQI and IRCA
members. The survey was comprised of three parts:

Responses by gradePart A asked to what extent respondents agreed with the statement “ISO 9001:2015 is fit for purpose‘as is’ and does not require revision before its next review in 2026.”
Part B listed nine priority areas for inclusion and/or addition to any future revision of ISO 9001, which
had been identified, reviewed, and verified by the CQI SCC. Respondents were asked whether they
‘Strongly agreed’, ‘Agreed’, ‘Neither agreed nor disagreed’, ‘Disagreed’ or ‘Strongly disagreed’ with their
inclusion.

0% | Student
10% | Principal Auditor

Practitioner | 14%
22% | Lead Auditor

Part C listed potential topics for potential inclusion in the next edition of ISO 9001, as identified bymembers of ISO TC176/SC2/TG5 and embedded within their draft design specification. The topics
were identified followed extensive discussion by international subject matter experts, representatives
from the CQI SCC.

Respondents were asked whether they ‘Strongly agreed’, ‘Agreed’, ‘Neither agreed nor disagreed’,‘Disagreed’ or ‘Strongly disagreed’ with their inclusion.
The survey was published on 20 February 2023 and closed on 13 March 2023.
The survey received 820 responses. Based on this, we can be 95% confident that the results achieved
are representative of the membership as a whole, with a margin of error of just over 3%.

6 | CQI Standards Coordination Committee member survey on the case for revising ISO 9001 before the next strategic review

Affiliate | 3%

Chart 1
– Proportion of
responses
by grade.
Chartered
Member | 19%
6% | Auditor
4% | Internal Auditor

Chartered Fellow | 4%
Associate Auditor | 18%

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Table 1 compares the grade profile of respondents to the profile of CQI and IRCA membershipby grade.
Responseby Grade
Fellow CQI% share of membershipat this grade
2%
18%

Practitioner

18%
3%

22%

18%

2%

4%
25%

100%

Agree | 37%

6%5%

Associate auditor

ISO
9001:2015 is fit
for purpose ‘as is’and does not require
revision before its
next review in
2026

10%

5%

Auditor

Strongly Agree | 13%

26% | Disagree

0%

Lead auditor

Internal auditor

6% | Strongly Disagree

14%

1%

Principal auditor

Respondents were asked to add a comment explaining the rationale behind the answer provided.

19%

6%

Affiliate

Valid responses: ‘Strongly agree’, ‘Agree’, ‘Neither agree nor disagree’, ‘Disagree’ or ‘Strongly disagree’.

Chart 2 - Summary of results, Part A

4%

Chartered Member

Student% share of survey responses
by gradePart A – Is ISO 9001:2015 fit for purpose?

18%
100%

The profile of responses broadly corresponds to the profile of membership, indicating that input wasreceived from the full spectrum of grades across the CQI and IRCA. In general, response rates werehigher from more qualified members of the CQI and IRCA (charted quality professionals, lead auditors,
and principal auditors), those who may typically be expected to lead the implementation, management,
and audit of quality management systems based on ISO 9001:2015.

8 | CQI Standards Coordination Committee member survey on the case for revising ISO 9001 before the next strategic review

18% | Neither Agree nor Disagree

The results show no clear majority view, with 50% of those responding stating they strongly agreed
or agreed the 2015 is fit for purpose ’as is’, and 50% actively called for change or uncertain. While thisgives no clear mandate for change, neither does it demonstrate great confidence in the currency of ISO
9001:2015.

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Summary of qualitative responses
Respondents were invited to provide additional comments to support their responses. From these,
several key themes emerged both in support and in opposition of revising ISO 9001:2015. These
included:

Chart 3 – Agreement with CQI SCC priority areas for inclusion in ISO 9001
(Part B)

In support of revision

Encourage the exploitation of novel and emerging
technologies and practices• Respondents citing the continual improvement of ISO 9001 as being good practice.
• There is demand for clarification over clauses which are considered difficult to understand,apply, or audit.
• Key topics and themes which are of increasing importance to organisations in general and the
management of quality in particular (eg risk) are considered to be insufficiently covered.
• That leadership and top management commitment is lacking and requirements around this need
to be reinforced.
• The standard which ISO 9001:2015 sets is insufficient for a quality management system which is truly
effective and adds value.
• Since 2015, much has changed. Technology and ways of working in particular have transformed
business and society, and ISO 9001:2015 does not reflect the world today.

In opposition to revision• Sector-specific variants plug the gaps in ISO 9001:2015.
• The need for change is not urgent.
• Users need more help implementing the requirements.
• Some respondents considered “new” requirements (eg climate change, digital transformation) toalready be accommodated in ISO 9001:2015.
• Revising ISO 9001:2015 will have “knock-on” effect on related standards.
• Some responders cited needing more time to understand and adopt the standard.

To what extent do you agree that any future revision to ISO 9001 shall…
22

28

8

4

Enable and encourage innovation in business andquality practices

29

44

20

4 3

Be current, allowing for the application andexploitation of modern technologies

30

44

18

6 2

Provide effective requirements for the managementof risks and opportunities associated with hybrid,
multisite, and decentralised workspaces

31

43

19

5 2

Reflect, support, and encourage best practice
regardless of size, sector, or location

29

43

19

6 2

Be compatible with ethical and societal needs andexpectations of all relevant interested parties

28

Promote a systemic management of quality whichis integrated in an organisation’s overall system ofmanagement

39

Require organisations to set clarity of mission,
purpose, and understand the impact of its system
for managing quality on interested parties

28

Set effective requirements for systemic
governance, assurance, and improvement, and theleadership of quality

30

Total Strongly
Agree

Total Agree

20

36

0%

10 | CQI Standards Coordination Committee member survey on the case for revising ISO 9001 before the next strategic review

38

10%

Total Neither Agree
Nor Disagree

9

46

13

46

17

48

20%

30%

40%

50%

Total Disagree

4

42

6 2

16

60%

70%

80%

42

90% 100%

Total Strongly
Disagreequality.org | 11

Chart 4 - Agreement with TC 176/SC 2/TG 5 topics to feature in ISO 9001
(Part C)
Improving ISO 9001’s ability to be audited
remotely

27

Improving ISO 9001’s auditability

30

The effectiveness of the organisation’s internal andexternal communication

35

39

24

Improved use of user survey information

41

16

6

Clarification of the requirements for the control
of documented information in line with Annex SL

23

5 3

Clarification of the need for root cause wheninvestigating nonconformities

37

40

15

6 2

27

5 3

Clarification of the existing risk and opportunities
requirements

33

45

16

42

5

Effective management of change

24

33

8

36

10

23

39

39

The effective use of the organisation’s data

27

44

22

5 2

Organisational agility

20

Clarification of the requirements for the supply
and the control of external providers

27

47

18

6 2

Collaborative supply chains

24

Clarification of the requirements for the control
of documented information in line with changes intechnology

27

43

22

5 3

Sustainability

28

80%

90% 100%

0%

10%

20%

30%

40%

50%

60%

70%

Organisational resilience

12 | CQI Standards Coordination Committee member survey on the case for revising ISO 9001 before the next strategic review

Total Agree

13

43

10%

43

44

Total Neither Agree
Nor Disagree

43

20%

6 3

45

23

0%

Total Strongly
Agree

29

30%

40%

50%

Total Disagree

60%

70%

22

28

6 3

23

8

3

16

7

5

24

7 3

80%

90% 100%

Total Strongly
DisagreeComparing results with thecontent of ISO 9001:2015

Of the 15 topics contained with the TC 176/SC2/TG5 design specification for ISO 9001, the CQI SCC
determined that:• Five are somewhat addressed in ISO 9001:2015• Seven are insufficiently addressed in ISO 9001:2015• Three are not addressed at all.

Having established that a significant majority of respondents agree or strongly agree that all the priority
areas for inclusion as identified by the CQI SCC and the topics set out in the TG5 should be included in
ISO 9001, the CQI SCC determined the extent to which the standard in its current form addresses eachpriority area and topic. It also described:• The basis on which this conclusion had been drawn.
• How each topic could be addressed by TC 176/SC2 in any future revision to ISO 9001.
• The relevant clauses which could be revised toaddress each of these topics.
The detailed analysis for each topic is contained in the supplementary report, “Analysis
of CQI SCC ISO 9001 member survey against ISO 9001:2015”.
On this basis, the CQI SCC concluded that, of the nine topics it identified:• three were somewhat addressed in ISO 9001:2015• six were addressed insufficiently.

Table 2. Extent to which priority areas for inclusion and/or addition to any futurerevision of ISO 9001, as identified by the CQI SCC, are addressed in ISO 9001:2015

Table 3. Extent to which topics for inclusion and/or addition to any future revision of
ISO 9001 contained in the TC 176/SC2/TG5 design are addressed in ISO 9001:2015
Topics for inclusion and/or addition to any future revision of ISO
9001, as identified by the CQI SCC

Addressed in
ISO 9001:2015

Organisational resilience

Not at all

Sustainability

Insufficiently

Collaborative supply chainsNot at all

Organisational agility

Not at all

Effective management of change

Somewhat

Clarification of existing risk and opportunity requirements

Insufficiently

Clarification of the need for root cause analysis when investigating
nonconformity

Insufficiently

Topics for inclusion and/or addition to any future revision of
ISO 9001, as identified by the CQI SCC

Addressed in
ISO 9001:2015

Clarification of the requirements for the control of documented information inline with Annex SL

Insufficiently

Set effective requirements for systemic governance, assurance, andimprovement, and the leadership of quality

Somewhat

Clarification of the requirements for the control of documented information inline with changes in technology

Insufficiently

Require organisations to set clarity of mission, purpose, and understand theimpact of its system for managing quality on interested parties

Insufficiently

Clarification of the requirements for the supply and the control ofexternal providers

Somewhat

Promote a systemic management of quality which is integrated in an
organisation's overall system of management

Insufficiently

The effective use of the organisation's data

Insufficiently

Be compatible with ethical and societal needs and expectations of all relevantinterested parties

Insufficiently

Improved use of user survey information

Somewhat

Reflect, support, and encourage best practice regardless of size, sector, or
location

Insufficiently

Somewhat

The effectiveness of the organisations internal and external communication

Provide effective requirements for the management of risks and opportunities
associated with hybrid, multisite, and decentralised workspaces

Improving ISO 9001's auditability

Somewhat

Insufficiently

Improving ISO 9001's ability to be audited remotely

Somewhat

Be current, allowing for the application and exploitation of modern
technologies

Somewhat

Enable and encourage innovation in business and quality practices

Insufficiently

Encourage the exploitation of novel and emerging technologies and practices

Insufficiently

14 | CQI Standards Coordination Committee member survey on the case for revising ISO 9001 before the next strategic review

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Conclusion
The findings presented in the report indicate a pressing need to revise ISO 9001. While there is a
divided opinion among CQI and IRCA members regarding the overall need for revision, the survey
results and subsequent analysis clearly identify that ISO 9001:2015 does not adequately reflect thecurrent world, which has witnessed transformative changes in technology, ways of working, and advancesin the management of quality and organisations. This implies that ISO 9001 must adapt to remain
relevant and effective.
The CQI SCC, along with the TC176/SC2/TG5, has recognised the importance of addressing digitaltechnologies in any future revision of ISO 9001. The identified topics within the design specification,such as the control of documented information in line with technological changes, the effective use oforganisational data, and the ability to be audited remotely, all underscore the need for ISO 9001 toincorporate provisions that align with emerging digital trends.
Furthermore, respondents to the survey have clearly expressed their support for the inclusion ofpotential content related to digital technologies in ISO 9001. This indicates a recognition within thequality management community that ISO 9001 must evolve to embrace and enable the effective use
and exploitation of novel and emerging technologies.
Considering the weight of agreement on the need to address those areas and topics described inthis report, it is imperative for the CQI, ISO, and other relevant stakeholders to collaboratively work
towards revising the standard. By incorporating provisions that encompass the effective use of digitaltechnologies, ISO 9001 can provide organisations with the necessary framework to navigate thechallenges and harness the opportunities presented by the digital era.
In conclusion, the revision of ISO 9001 is crucial for ensuring the continued relevance and applicabilityof the standard in a rapidly changing landscape. By embracing these advancements, ISO 9001 can equiporganisations with the necessary tools and guidelines to thrive in an increasingly digital-driven world.

16 | CQI Standards Coordination Committee member survey on the case for revising ISO 9001 before the next strategic review

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