Supplementary report

Analysis of CQI SCC
ISO 9001 Member Survey
against ISO 9001:2015

The following supplementary support sets out the CQIStandards Coordination Committee’s (SCC) analysis of theextent to which the priority areas for inclusion in any futurerevision of ISO 9001, and the topics set out in the TG5
design specification are addressed in ISO 9001:2015.
It 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, and therelevant clauses which could be revised to address each of these topics.
The tables are ordered in terms of the level of support for each topic, with the
topics gaining most support at the start of this section and those securing the least
support appearing at the end of the section. ‘Most support’ was determined byadding the percentage of those who ‘strongly agreed’ to the percentage of thosewho ‘agreed’ with the inclusion of each area or topic.
Additionally, the most popular response from the five possible responses iscoloured dark green, the next most popular light green, then yellow, orange andfinally red for the response receiving the least support.

quality.org | 1

Area for inclusion and/or addition

SA

A

NAD

D

SD

TOT

RANK

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

266

342

98

31

12

749

1
(82%)
(6%)

4%

2%

46%
36%
13%

Extent to which this is alreadyaddressed in ISO 9001:2015

Insufficiently

Basis for the response above

Annex L provides a framework which may enable theintegration of management systems based on Annex
L-based standards. However, ISO 9001 falls short ofproviding explicit requirements for organisations toembed the management of quality within the overallsystems of managing organisations.

How could this be addressed in
the next edition of ISO 9001?

“Include specific requirements for organisations tointegrate common elements of managements systems(e.g., OHSAS based on ISO 45001, RMS based on ISO
31000, etc.)
Include specific requirements for organisations tointegrate their system for managing quality into
appropriate systems for managing the business. “Potentially relevant clauses

4.4
5
8
10

Notes

Digital technologies facilitate greater integration of datafrom a many different sources. This is likely to accelerate
the drive to a more “integrated management systems”
approach. This is not a request for the development of an
integrated management system standard, however. Rather
it is an extension of the need for a holistic approach
when more than one management system is present
in an organisation. At present this is discussed in 0.4‘Relationship with other management system standards’
however given that this forms part of the Introduction
there is no requirement for this approach to be adopted.
At present different management systems can be as
distinct and separate as the organisation determines.

2 | Analysis of CQI SCC ISO 9001 Member Survey against ISO 9001:2015

Area for inclusion and/or addition

SA

A

NAD

D

SD

TOT

RANK

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

222

360

117

33

17

749

2
(78%)
(6%)

4%

2%

48%
30%
16%

Extent to which this is alreadyaddressed in ISO 9001:2015

Somewhat

Basis for the response above

The adoption of a process approach involves thesystematic definition and management of processes andtheir interactions so as to achieve intended results. In thisrespect, conformity with the requirements set out in thecurrent edition provides a high degree of ASSURANCE
that the customer will receive conforming products
and services. Similarly, the existing edition requiresorganisations to determine and select opportunities
for IMPROVING products and services, addressing any
undesired effects and for improving the QMS overall.
LEADERSHIP is addressed with respect to the quality
management system (QMS) and 5.1.1 b requires thequality objectives to be ‘compatible’ with the context
and strategic direction of the organisation, whilst 5.1.1 crequires the integration of QMS requirements into theorganisation’s business processes. Similarly, the current
edition requires leadership to address governanceof the QMS by means of setting policy, controls andmaking decisions. The issue here is not an absence of
requirements in these areas, but the lack of emphasis that
this is a top management function which should not bedelegated down the managerial hierarchy.

quality.org | 3

Area for inclusion and/or additionSA

How could this be addressed in
the next edition of ISO 9001?

Alignment and integration with and ability to drive/
deliver organisations strategy and operations. Where theorganisation as defined by the scope of certification is
the same as the organisation defined as a business unit,
governance, assurance, improvement, and leadershiparrangements will be common. Where the organisation
as defined by the scope of certification is different to
the organisation as defined by the business, this is notnecessarily the case. Whilst ISO 9001 identifies the needto link the QMS to the business, there is also a needto link the business to the QMS. In this respect ISO
9001 needs to do more to ensure that the governance,
assurance, improvement, and leadership requirements it
sets out are understood not only by leaders at the QMS
level, but by leaders at the business level too. They needto recognise that the ‘corporate’ controls, strategies, anddecisions they put in place must support the QMS, notdetract or encumber it.

Potentially relevant clauses

4
9.2
9.3

Notes

Many organisations fail to understand who top
management are in respect to the operation of the
QMS. They view top management as the most senior
managers in the business, not those who control
and direct the operations covered by the scope ofthe certificate. In these cases, there is a need for thegovernance demonstrated by the QMS top management
to align with the governance of the organisation as awhole, and vice versa. Evidence from audit suggests
the QMS is often viewed by leaders managing groupstructures as a matter for the certificated business
unit themselves. This has the potential to cause issues
where the aims and requirements of corporate policies,
strategies and objectives are set without reference to therequirements for such arising from need to demonstrate
9001 compliance.

4 | Analysis of CQI SCC ISO 9001 Member Survey against ISO 9001:2015

A

NAD

D

SD

TOT

RANK

Area for inclusion and/or addition

SA

A

NAD

D

SD

TOT

RANK

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

206

348

131

48

16

749

3
(74%)
(8%)

46%
28%
17%
6%

2%

Extent to which this is alreadyaddressed in ISO 9001:2015

Insufficiently

Basis for the response above

At present the requirements of ISO 9001 areoverwhelmingly focussed on the ‘here and now’ but if anorganisation is to be successful in the medium to longterm it has to establish and communicate its mission,
vision and values (MVV) to its stakeholders and it mustalso create a culture of quality capable of supporting
its MVV. Part of establishing this culture of quality is the
production of strategies and policies to support theattainment of MVV. The current edition of ISO 9001
makes reference to the need to align the Quality Policy
and Quality Objectives with ‘the strategic direction of thebusiness’ but fails to fully define the ‘golden thread’ whichlinks high level mission to the performance of operationaltasks.

How could this be addressed in
the next edition of ISO 9001?

There is well established guidance in ISO 9004 relating
to importance of establishing MVV, the linking of these to
strategy and policy and the creation of a quality culture.
Much of this guidance could be readily translated into
requirements and inserted in the same position within
the next edition of ISO 9001, namely within clauses
4 Context of the Organisation and 5, Leadership andcommitment.

Potentially relevant clauses

4
5

Notes

An organisation cannot serve the interests of its
customers if it ceases to trade.
ISO 9004 is an excellent standard and arguably of greater
benefit to an organisation than 9001. The fact it cannot
be certificated against should not prevent us taking andadapting key concepts from it to use in other standards,
including 9001. 9004 addresses mission, vision, values, andculture well and these are all critical success factors inensuring an effective QMS.

quality.org | 5

Area for inclusion and/or addition

SA

A

NAD

D

SD

TOT

RANK

Provide effective
requirements for the
management of risks andopportunities associatedwith hybrid, multisite, anddecentralised workspaces.

229

321

142

41

16

749

4=
(74%)
(7%)

43%
31%
19%
5%

2%

Extent to which this is alreadyaddressed in ISO 9001:2015

Insufficiently

Basis for the response above

ISO 9001:2015 requires that organisations determine,
provide, and maintain the infrastructure necessary forthe operation of its processes, including its locations,buildings, etc. It is increasingly the case that theselocations may include those outside the direct control of
the organisations, e.g., home-based, shared, and/or public
workspaces.

How could this be addressed in
the next edition of ISO 9001?

ISO 9001 must reflect these significant changes inworkforce, workflow, and workplace to reflect current
practice and accommodate future trends in ways ofworking. Additional guidance could be provided within
Annex A to remind organisations what they need toconsider when addressing the requirements of clauses
7.1.3 Infrastructure and 7.1.4 environment for theoperation of processes.

Potentially relevant clauses

7.1.3
7.1.4

Notes

Changes in workflow, workforce, and workplace
practices, which have been in some circumstances
been exacerbated by actions taken in response to the
Covid-19 pandemic, have led to significant changes inwhere and how work can take place.
TC283 have already identified this as an area for possible
additional requirement inclusion in the next edition of
ISO 45001.
Organisations must also be encouraged to recognise
the risks associated with a failure to manage their ethical,
societal and governance responsibilities appropriately, as
well as the potential rewards arising from managing these
aspects well.

6 | Analysis of CQI SCC ISO 9001 Member Survey against ISO 9001:2015

Area for inclusion and/or addition

SA

A

NAD

D

SD

TOT

RANK

Be current, allowing
for the applicationand exploitation ofmodern technologies

225

326

137

43

17

748

4=
(74%)
(8%)

44%
30%
18%
6%

2%

Extent to which this is alreadyaddressed in ISO 9001:2015

Somewhat

Basis for the response above

There is limited reference to ‘hardware and software’ inclause 7.1.3 – Infrastructure, however the focus of thiscause is on ‘providing and maintaining’ rather than the
exploitation of new technologies.

How could this be addressed in
the next edition of ISO 9001?

The focus of 7.1.3 could be extended to include not
only how the organisation must ensure its current
infrastructure can support the achievement ofconforming products and services but how changes
to the infrastructure could be made to improve
effectiveness of product and service delivery further.

Potentially relevant clauses

7.1.3
10

Notes

When previous editions of ISO 9001 were being
considered, proposals were made for the inclusion of an
innovation clause, however these were not progressed.
Improvement on its own is not sufficient, that focuses onmaking existing things better. Innovation is aimed at newideas, concepts and practices and therefore should beconsidered in association with Improvement.
Additionally, where organisations are exploiting new
or disruptive technologies in novel ways, it will benecessary to provide assurance of those technologies.
This is especially the case with regards autonomous orsemi-autonomous systems, the assurance of Artificial
Intelligence, etc.

quality.org | 7

Area for inclusion and/or addition

Enable and encourage
innovation in business andquality practices

SA

A

NAD

D

SD

TOT

RANK

215

333

149

33

19

749

6
(73%)
(8%)

4%

3%

44%
29%

20%

Extent to which this is alreadyaddressed in ISO 9001:2015

Insufficiently

Basis for the response above

ISO 9001:2015 requires organisations to seek
opportunities for improvement but falls short ofrequiring organisations to actively seek out opportunities
to innovate, e.g., introducing new or significantly
improved products, services, and/or processes whichmeet the needs and expectations of interested parties.

How could this be addressed in
the next edition of ISO 9001?

Include requirements for organisations to identify specificneeds for innovation, establish processes necessary for
effective innovation, and provide the resources required.

Potentially relevant clauses

10

Notes

When previous editions of ISO 9001 were being
considered, proposals were made for the inclusion of an
innovation clause, however these were not progressed.
Improvement on its own is not sufficient, that focuses onmaking existing things better. Innovation is aimed at newideas, concepts and practices and therefore should beconsidered in association with Improvement.

8 | Analysis of CQI SCC ISO 9001 Member Survey against ISO 9001:2015

Area for inclusion and/or addition

SA

A

NAD

D

SD

TOT

RANK

Reflect, support, andencourage best practice
regardless of size, sector,
or location.

219

325

144

48

13

749

7
(72%)
(8%)

43%
29%
19%
6%

2%

Extent to which this is alreadyaddressed in ISO 9001:2015

Somewhat

Basis for the response above

ISO 9001 sets out minimum requirements for an
organisation wishing to supply conforming products andservices to its customers. It does not set out to establish
best practice, nor do those who implement the standard
necessarily wish to aspire to best practice.

How could this be addressed in
the next edition of ISO 9001?

Whilst the standard contains requirements for
improvement in products and services and the QMS
overall, it does not link such improvement to thesustained success of the organisation. This is an importantcausal relationship which should be made more explicit.
There needs to be a greater ‘aspirational’ focus to thestandard, just doing sufficient to satisfy the requirements
will not elevate quality to the next level. The introduction
could be amended to state conformance with therequirements is the starting point, not the end point
and that an understanding of best practice within the
sector should be an input into the determination of theContext of the Organisation.

Potentially relevant clauses

Introduction
4

Notes

The requirements of ISO 9001 must be universally
applicable to organisations, regardless of size, sector, or
location. Organisations must demonstrate how thesefactors have been considered in determining the scopeand context of their systems for managing quality.

quality.org | 9

Area for inclusion and/or addition

SA

A

NAD

D

SD

TOT

RANK

Be compatible with ethicaland societal needs andexpectations of all relevantinterested parties

210

295

151

66

27

749

8
(67%)
(13%)

39%
28%

20%
9%

4%

Extent to which this is alreadyaddressed in ISO 9001:2015

Insufficiently

Basis for the response above

ISO 9001 does not set out any requirements in respectof ethical behaviour, provided the desired results
are achieved the role of top management has been
fulfilled. Societal needs should be considered as partfor the understanding of the needs and expectations ofinterested parties but often organisations fail to include
society when determining their stakeholders.

How could this be addressed in
the next edition of ISO 9001?

Include specific requirements for organisations todemonstrate they have considered the ethical andsocietal needs and expectations of all interested parties
in defining the scope and context of their system for
managing quality, including in post-delivery activities.
Also include specific requirements regarding externallyprovided processes, products and services conformingwith ethical and societal requirements of the organisation.

Potentially relevant clauses

4
8.4.1

Notes

Whilst this was not seen by the CQI membership as anarea for particular focus, it is clear from developmentsin the wider world that ethical and societal needs andexpectations are playing an ever-increasing role in theshaping of organisational behaviour.
Driven on the one hand by legislation, and on the otherby social conscience, organisations are increasingly awareof their political, environmental, social, technological, legal,
and economic imprint on those who are directly andindirectly impacted by their operations. A failure to act
responsibly now brings with it significant risk as a resultof social and other media’s immediacy of communication.
It is time for ISO 9001 to recognise the need fororganisation’s to not just act effectively, but also to act
appropriately.

10 | Analysis of CQI SCC ISO 9001 Member Survey against ISO 9001:2015

Area for inclusion and/or addition

Encourage the exploitationof novel and emerging
technologies and practices

SA

A

NAD

D

SD

TOT

RANK

165

286

209

61

28

749

9
(60%)
(12%)

38%
22%

28%
8%

4%

Extent to which this is alreadyaddressed in ISO 9001:2015

Insufficiently

Basis for the response above

Digital transformations have the potential to significantly
affect the practice of quality management. While not
all organisations may wish to digitally transform, there
should be a requirement to consider whether by doing
so the outcomes for interested parties can be improved.

How could this be addressed in
the next edition of ISO 9001?

Include requirements for organisations to identify
opportunities to adopt novel and emerging technologies,
to constructively transform processes, especially withregards to performance evaluation, management review,leadership.

Potentially relevant clauses

10

Notes

When previous editions of ISO 9001 were being
considered, proposals were made for the inclusion of an
innovation clause, however these were not progressed.
Improvement on its own is not sufficient, that focuses onmaking existing things better. Innovation is aimed at newideas, concepts and practices and therefore should beconsidered in association with Improvement.

quality.org | 11

Section C – Potential areas for inclusion in the next edition ISO 9001 as identified
in the TC 176/SC2/TG5 design specification.
The following topics for potential inclusion in the next edition of ISO 9001 were identified by membersof ISO TC176/SC2/TG5 and embedded within their draft design specification, due to be presented to
SPOTG on 17 May 2023.
The topics were identified followed extensive discussion by international subject matter experts,
including a representative from the CQI, which is a Category A liaison to this ISO technical group.
During Part C of the survey, Members of the CQI were invited to comment on the fifteen topics
contained within the draft design specification. The results appear in the tables which follow.
Members were asked to categorise their response as follows:
SA = strongly agree with the topic’s inclusion.
A = agree with the topic’s inclusion.
NAD = neither agree nor disagree with the topic’s inclusion.
D = disagree with the topic’s inclusion.
SD = strongly disagree with the topic’s inclusion.

The tables are ordered in terms of the level of support for each topic, with the topics gaining most
support at the start of this section and those securing the least support appearing at the end of thesection. ‘Most support’ was determined by adding the percentage of those who ‘strongly agreed’ to thepercentage of those who ‘agreed’ with the topic’s inclusion.
Additionally, the most popular response from the five possible responses is coloured dark green, thenext most popular light green, then yellow, orange and finally red for the response receiving the least
support.

12 | Analysis of CQI SCC ISO 9001 Member Survey against ISO 9001:2015

Topic for potential inclusion

Effective managementof change

SA

A

NAD

D

SD

TOT

RANK

277

322

93

11

13

716

1
(84%)
(4%)

2%

2%

39%

45%

13%

Extent to which this is alreadyaddressed in ISO 9001:2015

Somewhat

Basis for the response above

The 2015 edition of ISO 9001 does include provision
for the review and control of changes for production
or service provision to the extent necessary to ensure
continuing conformity with requirements and for related
documentation to be retained.

How could this be addressed in
the next edition of ISO 9001?

6.3 addresses planning of changes to the QMS itself. This
subclause should be revisited to determine whether
there is a need for additional wording or the clarificationof existing wording.

Potentially relevant clauses

8.5.6
6.3

Notes

Of the suggested topics contained within the draft design
specification for the next edition of ISO 9001, it was
the effective management of change which received themost support from CQI members. The current content
of 6.3 focusses on planning rather than managementof change and does not require lessons learned to belearned.

quality.org | 13

Topic for potential inclusion

Clarification ofexisting risk andopportunity requirements

SA

A

NAD

D

SD

TOT

RANK

238

322

111

30

15

716

2
(78%)
(6%)

4%

2%

45%
33%
16%

Extent to which this is alreadyaddressed in ISO 9001:2015

Insufficiently

Basis for the response above

There is still considerable confusion as to what
constitutes a risk or an opportunity, and which risks
and opportunities need to be considered by a 9001
certificated organisation. Some organisations appear tolist every risk imaginable whilst others only list one or
two. Many do not plan actions to address opportunities.
Clarification is needed within 9001 itself in respectof the above. Understanding of risk and opportunity
requirements, and risk-based thinking were frequently
cited in the CQI survey results as an “issue” with ISO
9001:2015.

How could this be addressed in
the next edition of ISO 9001?

Update A.4 risk-based thinking, possibly with a diagram,to illustrate which risk and opportunities are ‘in scope’and how clauses 4, 6 and 8 link together from a risk
perspective.

Potentially relevant clauses

6.1
Annex A

Notes

Business leaders are likely to challenge their functional
leads to “join the dots” of risk and assurance across allareas of quality, environmental, safety, finance, supply
chain, etc.
The driver of this will be overall business risk, collated atenterprise level and driven by a top-down approach thatbalances risk appetite, costs of assurance and potential
business impact. This will significantly affect the design ofthe organisation’s assurance framework. ISO 9001 needs
to support this approach.

Topic for potential inclusion

SA

A

NAD

D

SD

TOT

RANK

Clarification of the needfor root cause analysis
when investigating
nonconformity

264

285

108

45

13

715

37%

40%

3
(77%)
(8%)

15%

6%

2%

Extent to which this is alreadyaddressed in ISO 9001:2015

Insufficiently

Basis for the response above

The 2015 edition of the standard calls for organisations
to determine the ‘cause’ of the nonconformity and to
determine the need to eliminate the ‘cause’.

How could this be addressed in
the next edition of ISO 9001?

This wording should be amended to ‘root cause’.

Potentially relevant clauses

10.2

Notes

Root cause analysis is essential in order to determine thetrue cause of a nonconformity from a potential cause. Ifroot cause is not determined, then there is a risk that thecorrective action taken will be ineffective and that the
problem will manifest itself again at a future date.
There are many quality tools and techniques focused on
identifying root cause. The existence of these needs to behighlighted, perhaps in Annex A.4

quality.org | 15

Topic for potential inclusion

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

SA

A

NAD

D

SD

TOT

RANK

195

336

128

42

14

715

4
(74%)
(8%)

47%
27%

18%
6%

2%

Extent to which this is alreadyaddressed in ISO 9001:2015

Somewhat

Basis for the response above

Clause 8.4 of ISO 9001:2015 sets out requirements
relating to the control of externally provided processes,
products, and services.

How could this be addressed in
the next edition of ISO 9001?

Revisit and update the existing guidance provided
in Annex A. Provide more detail in respect of the
expectations around monitoring and assessing of external
providers. Also update clause 8.4.1 if the revised guidancesuggests additional requirements / revised requirements
are necessary.

Potentially relevant clauses

Annex A.8

Notes

Confusion still exists as to how to monitor and evaluate
external providers. Some organisations still believe thisshould be a one-off exercise. Others are unclear ‘external
providers can include parts of the same business
who are not covered by the scope of the certificate.
Clarification is needed on these points.
Digital transformations will create opportunities for more
complex networks This will extend the scope of external
providers. The interrelationships will also have a digitaland possibility prescriptive (e.g., automated) element. ISO
9001 must be able to address this.

16 | Analysis of CQI SCC ISO 9001 Member Survey against ISO 9001:2015

Topic for potential inclusion

Sustainability

SA

A

NAD

D

SD

TOT

RANK

203

313

117

50

34

717

5
(72%)
(12%)

7%

5%

44%
28%
16%

Extent to which this is alreadyaddressed in ISO 9001:2015

Insufficiently

Basis for the response above

ISO 9001 lacks any significant sustainability content which
is illogical for a document with such potential to mandate
sustainability improvements.

How could this be addressed in
the next edition of ISO 9001?

By adding in additional requirements in respect of thedesign and development of products and services andProduction and Service Provision. Consider also bringing
in as requirements content from ISO 9004 clause 4.2 Managing for the sustained success of the organisation.

Potentially relevant clauses

8.3
8.5
4

Notes

The United Nations Sustainable Development goals
developed in 2015 are viewed as central to ensuring thepeace and prosperity of our planet.
Corporate social responsibility, ethical operation andsound governance are all essential ingredients for
ensuring the sustained success of an organisation. Whenconsidering sustainability, these key contributors mustalso be explicitly considered.

quality.org | 17

Topic for potential inclusion

The effective use of theorganisation’s data

SA

A

NAD

D

SD

TOT

RANK

190

314

157

39

15

715

6
(71%)
(7%)

5%

2%

44%
27%

22%

Extent to which this is alreadyaddressed in ISO 9001:2015

Insufficiently

Basis for the response above

This suggested area for development is wider in scopethan the one which follows (user survey data) andattracted more support from the CQI membership.
Making effective use of data facilitates better decision
making and hence improved QMS outcomes. Thereis nothing in the standard which emphasises thisrelationship. This should be addressed, perhaps by meansof a new clause in Annex A.

How could this be addressed in
the next edition of ISO 9001?

There are existing requirements in the standard relating
to the analysis and evaluation of customer satisfaction
and other data. With the proliferation, immediacy, andcomplexity of data from both within and without anorganisation’s business model, there may be increasingneed to use and control data of strategic value, of diverse
origin. Additional requirements could usefully be addedat this time to ensure the results of data evaluation areacted upon.

Potentially relevant clauses

9.1.3
Annex A

Notes

Digital is transforming quality and ISO 9001 needs to beable cope with this and be applicable to all organisations
even those at the cutting edge of digitally enabled quality.
Businesses will benefit from the use of “extragenic” data(outside of the organisation) in achieving assurance.
ISO/IEC 27001 provides requirements relating to theprotection and preservation of the confidentiality,
integrity, and accessibility of an organisation’s information,with ISO/IEC 27002 setting out associated controls.
ISO/IEC 27000 provides a useful information security
management system overview.

Topic for potential inclusion

SA

A

NAD

D

SD

TOT

RANK

Clarification of therequirements for thecontrol of documented
information in line withchanges in technology

196

308

156

35

20

715

7
(70%)
(8%)

5%

3%

43%
27%

22%

Extent to which this is alreadyaddressed in ISO 9001:2015

Insufficiently

Basis for the response above

CQI members supported TG5’s suggestion that
additional consideration is given as to whether clause
7.5.3 needs to be amended to reflect the increased
use of technology in evidencing the conformity ofan organisation’s QMS. Whilst the existing high-level
requirements do address the availability and protectionof documented information additional guidance aroundachieving this could be added into Annex A.

How could this be addressed in
the next edition of ISO 9001?

Changes to Annex SL Appendix 2 need to be echoedto ISO 9001 including those relating to documented
information being ‘available’. For digital documented
information, technical controls will need to be employed
in order to meet the requirements of 7.5.3. The existing
requirements should be reviewed to establish theirsufficiency.

Potentially relevant clauses

7.5.3

Notes

ISO/IEC 27001 - information security management
systems could be used to inform the development of
new ISO 9001 requirements relating to protecting andpreserving the confidentiality, integrity, and availability of
documented information.

quality.org | 19

Topic for potential inclusion

Improving ISO 9001’s
auditability

SA

A

NAD

D

SD

TOT

RANK

215

277

162

38

22

714

8
(69%)
(8%)

5%

3%

30%

39%
23%

Extent to which this is alreadyaddressed in ISO 9001:2015

Somewhat

Basis for the response above

Whilst a general competence requirement for
persons doing work that affects the performance andeffectiveness of the QMS is contained in ISO 9001, it
is ISO 19011 and IOS 17021-3 that provides the detailbehind this. 19011 however is only guidance and audit
experience indicate not all internal auditors are aware ofits contents.

How could this be addressed in
the next edition of ISO 9001?

Improving ISO 9001’s auditability will require any
requirements which are not well understood to be
identified and clarified. Internal auditors need to becompetent to undertake their duties.

Potentially relevant clauses

7.2
Annex A

Notes

This was not seen as a priority area for addressing
amongst CQI members. The requirements set out in
ISO 9001:2015 are generally well defined, it is theirinterpretation that leads to the majority of issues.
For this reason, it is the guidance contained within ISO
9001 and its’ partner standards that need to be focussed
on as opposed to the core requirements themselves.

20 | Analysis of CQI SCC ISO 9001 Member Survey against ISO 9001:2015

Topic for potential inclusion

Collaborative supply chains

SA

A

NAD

D

SD

TOT

RANK

170

308

163

54

22

717

9
(67%)
(11%)

43%
24%

23%
8%

3%

Extent to which this is alreadyaddressed in ISO 9001:2015

Not at all

Basis for the response above

This topic is not included in ISO 9001:2015

How could this be addressed in
the next edition of ISO 9001?

Inclusion of additional quality and control requirements
in clause 8.4 - Control of externally provided processes,
products and services relating to supply chains, not justthe immediate (once removed) external provider.

Potentially relevant clauses

8.4

Notes

At present most organisations limit the scope of theirinteraction with external providers to the company thatthey buy their raw materials, products, or services from.
There is little consideration of the wider supply chain. By
encouraging organisations to manage supply chains as
opposed to simply direct suppliers, there is the potential
to drive quality improvement more widely.
If an organisation fails to take reasonable action to makesure that its supply of labour is legitimate it can lead tosignificant legal, financial, and reputational damage.
The Supply Chain Due Diligence Act which cameinto effect in Germany on Jan 1st this year for larger
organisations will require those businesses to adapt andupdate their compliance, purchasing and contract drafting
processes. In the UK, the Modern Slavery Act 2015 (the‘MSA’) contains provisions relating to transparency insupply chains. Requirements relating to collaborative
supply chains should be extended to also recognise thegrowing acceptance of the need for due diligence within
supply chains.

quality.org | 21

Topic for potential inclusion

Organisational resilience

SA

A

NAD

D

SD

TOT

RANK

167

309

170

47

24

717

10
(66%)
(10%)

7%

3%

43%
23%

24%

Extent to which this is alreadyaddressed in ISO 9001:2015

Not at all

Basis for the response above

This topic is not included in ISO 9001:2015

How could this be addressed in
the next edition of ISO 9001?

Through the inclusion of additional requirements
necessitating the introduction of arrangements to protect
infrastructure and the environment for operation ofprocesses

Potentially relevant clauses

7.1.3
7.1.4

Notes

It would be straightforward to add high level
requirements requiring organisations to put in place
contingency arrangements designed to ensure the QMS
can continue to function to the best extent possible ina crisis situation. The extent of the arrangements should
be determined via risk analysis and consideration of the
impact of a crisis on the organisation’s ability to deliver
the intended outcomes of its QMS.			

22 | Analysis of CQI SCC ISO 9001 Member Survey against ISO 9001:2015

Topic for potential inclusion

The effectiveness of theorganisations internal andexternal communication

SA

A

NAD

D

SD

TOT

RANK

169

295

191

39

20

714

11
(65%)
(8%)

5%

3%

41%
24%

27%

Extent to which this is alreadyaddressed in ISO 9001:2015

Insufficiently

Basis for the response above

There remains confusion as to what is actuallyrequired by clause 7.4. Some organisations haveproduced extensive matrices setting out who they willcommunicate with, how often, about what etc. Somehave based this on their determination of interested
parties. Others claim to have made the determination
however the absence of the need for retained
documented information makes this difficult to verify.

How could this be addressed in
the next edition of ISO 9001?

Consider adding additional guidance to bolster thecontent of clause 7.4

Potentially relevant clauses

Annex A

Notes

The wording in the current edition has led to someorganisations producing very detailed matrices covering
every communication type and method both within
and external to their business. Furthermore, the only
requirement at present is for organisations ‘to determine’such information. Once this determination is completed
there is no explicit requirement to use the results of thedetermination or to monitor the effectiveness of thecommunication process.

quality.org | 23

Topic for potential inclusion

SA

A

NAD

D

SD

TOT

RANK

144

308

198

42

23

715

12
(63%)
(9%)

6%

3%

43%

Organisational agility
20%

28%

Extent to which this is alreadyaddressed in ISO 9001:2015

Not at all

Basis for the response above

This topic is not included in ISO 9001:2015

How could this be addressed in
the next edition of ISO 9001?

Inclusion of additional requirements requiringorganisations to consider how best to structure
themselves in order to be able to react swiftly to changes
in context. Increased emphasis on revisiting context
regularly.

Potentially relevant clauses

4

Notes

The need for organisational agility is linked toboth sustainability and the management of change.
Organisations need to be able to react quickly tochanges in their context whilst ensuring that during
this time of evolution normal service continues to beprovided.

24 | Analysis of CQI SCC ISO 9001 Member Survey against ISO 9001:2015

Topic for potential inclusion

SA

A

NAD

D

SD

TOT

RANK

Clarification of therequirements for thecontrol of documented
information in linewith Annex SL

166

282

205

43

18

714

13
(62%)
(9%)

6%

3%

39%
23%

29%

Extent to which this is alreadyaddressed in ISO 9001:2015

Insufficiently

Basis for the response above

CQI members acknowledge that the next edition of ISO
9001 will need to incorporate the changes made to the
HLS during the 2021 revision of annex SL.

How could this be addressed in
the next edition of ISO 9001?

Changes to Annex SL Appendix 2 need to be echoedto ISO 9001 including those relating to documented
information being ‘available’.

Potentially relevant clauses

7.5.3

Notes

Whilst this topic failed to ignite the enthusiasm of CQI
members, there is nevertheless an ISO imperative toincorporate amendment made to annex SL appendix
2 in all future editions of type A management systemstandards. Accordingly, the development team forthe next edition of ISO 9001 will need to ensurethat the latest version of the ISO/IEC Directives (andConsolidated ISO Supplement) forms an input into theirrevision work.

quality.org | 25

Topic for potential inclusion

SA

A

NAD

D

SD

TOT

RANK

196

250

173

56

40

715

13
(62%)
(14%)

8%

6%

Improving
ISO 9001’s ability to
be audited remotely

27%

Extent to which this is alreadyaddressed in ISO 9001:2015

Somewhat

Basis for the response above

Specific guidance on auditing virtually is provided in ISO
19011 A.16 and the solution here may be to ensure that
this is explicitly referenced in ISO 9001.

How could this be addressed in
the next edition of ISO 9001?

Simply amending the requirements of ISO 9001 is
unlikely to materially improve its remote auditability. As
for the above suggested revision above, the greatest gains
are likely to arise from improving the auditor’s ability toremote audit which is a matter for ISO 19011 and ISO
17021-3.

Potentially relevant clauses

7.2
Annex A

Notes

There is no reason ISO 9001 cannot be audited
effectively remotely as it currently stands. Covid-19
forced both certification bodies and organisations
themselves to carry out conformity assessments inthis manner and many have continued to perform a
proportion of their audits remotely despite an improving
Covid situation. The ability to carry out audits effectively
has always and will always be predominantly dependent
on the auditors’ skill set, and organisations such as
the CQI need to ensure that their training partners
are suitably equipping auditors to operate in remoteenvironments.

35%
24%

Whilst there was some support for this topics’ potential
inclusion in the next edition this was not seen as apriority.
A greater concern and priority should be to establish
how ISO 9001 may be audited automatically or semiautomatically, as organisations increasingly exploit digitaltechnologies to provide assurance in real-time.

26 | Analysis of CQI SCC ISO 9001 Member Survey against ISO 9001:2015

Topic for potential inclusion

Improved use of user
survey information

SA

A

NAD

D

SD

TOT

RANK

113

237

260

70

35

715

33%

36%

15
(49%)
(15%)

16%

10%

5%

Extent to which this is alreadyaddressed in ISO 9001:2015

Somewhat

Basis for the response above

There are existing requirements in the standard relating
to the analysis and evaluation of customer satisfaction
and other data.

How could this be addressed in
the next edition of ISO 9001?

It is unclear as to what additional requirements could
usefully be added at this time. The scope of user surveys
could be expanded upon using surveys to solicit awider range of views on a wider range of topics andthen utilising the results as an input into Context of theOrganisation.

Potentially relevant clauses

4
9.1.3

Notes

Whilst this was suggested by TG5 members for inclusionin the draft design specification, this was not seen as apriority area for future consideration by CQI members.

quality.org | 27

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