#260 What is ISO 9004? Guidance For Quality Management Systems

Putting work into Quality Management doesn’t stop once you achieve ISO 9001. Continual Improvement is at the heart of every ISO Standard, but sometimes it’s hard to know what good looks like beyond certification.

This is where Guidance Standards can lend a hand. ISO 9004 provides guidance for Quality Management Systems, and though its current iteration was published in 2018, its advice is more aligned with the 2026 version of ISO 9001 than the previous 2015 edition.

In this episode, Ian Battersby dives into the purpose of ISO 9004, its applicability to the new 2026 version of ISO 9001 and explores the clauses and differences between ISO 9001 and ISO 9004.

You’ll learn

• What is ISO 9004?
• What’s the main difference between ISO 9001 and ISO 9004?
• Is ISO 9004 due an update?
• Where do ISO 9001 and ISO 9004 connect?
• What are the other differences between ISO 9001 and ISO 9004
• Breaking down ISO 9004 by clause

Resources

• ISO 9004
• Isologyhub

In this episode, we talk about:

[02:30] Episode Summary – Ian Battersby dives into the guidance Standard for Quality Management, ISO 9004, looking at the key connections and differences between it and ISO 9001.  

[02:45] What is ISO 9004? ISO 9004 is a Guidance Standard designed to support ISO 9001. Its latest iteration was published in 2018, which was 3 years on from ISO 9001’s previous iteration, meaning much of its guidance aligns with the newer 2026 version of ISO 9001.  

[03:35] What’s the main difference between ISO 9001 and ISO 9004? There is a core distinction between the two:

ISO 9001 is a management system standard — it specifies requirements. An organisation can be audited and certified against it. Its job is to give confidence that an organisation can consistently deliver products and services that meet customer and applicable statutory/regulatory requirements.

ISO 9004 is guidance, not requirements — you can’t be certified to it. It addresses the “quality of an organization” itself: the degree to which its inherent characteristics fulfil the needs and expectations of all relevant interested parties (not just customers), with the aim of sustained success over the long term, in a changing environment.

ISO 9001 gives confidence in what you produce or deliver and ISO 9004 gives confidence in what you are as an organisation. In short, the two complement each other.

Something worth noting: The 2018 edition of ISO 9004 deliberately repositioned itself as independent of ISO 9001 rather than an “add-on”; a change from earlier editions, which were more explicitly paired as a “consistent pair” with 9001.

[06:00] Is ISO 9004 due an update? ISO 9001 has been updated as of 2026, so should we expect ISO 9004 to follow suit?

The answer is no, there is no planned revision date currently, so the most current edition is still 2018.

[08:45] Where do ISO 9001 and ISO 9004 connect? There are a number of features of each Standard that connect.

Both sit under the same quality management principles from ISO 9000, so they share a common vocabulary and philosophical base, so there’s no contradiction, just different altitude.

ISO 9001:2026 has an Annex which is very helpful in explaining requirements, but ISO 9004 can be read as picking up where 9001 stops. ISO 9001’s clauses (context, leadership, planning, support, operation, evaluation, improvement, all clarified in the new ISO 9001 Annex) reappear in 9004 but are expanded and extended into strategic territory, eg, 9001’s “leadership” clause vs 9004’s full treatment of policy, strategy, and organisational identity.

An organisation that’s already certified to 9001 has the infrastructure that 9004 assumes and builds on, so 9004 may be used as a maturity roadmap after certification, not before it.

Remember: ISO 9001 is the ground, 9004 is the sky you’re reaching toward.

[10:50] What are the other differences between ISO 9001 and ISO 9004 – Other key differences include:

• Certifiable vs non-certifiable (single biggest practical difference for clients: no third-party audit, no certificate, so no external pressure to adopt it).
• Compliance / conformity mindset (ISO 9001) vs performance / excellence mindset (ISO 9004).
• Narrower interested-party scope (customer focus, mainly) vs broader (all relevant interested parties).
• Operational / tactical (ISO 9001) vs strategic / cultural (ISO 9004) — identity, values, culture literally appear as a clause heading in 9004 and have no equivalent requirement in 9001.

[12:20] Why this matters for organisations right now, with 9001:2026 just out – ISO 9001:2026 has actually pulled a bit closer to ISO 9004’s territory.

The new 2026 version of ISO 9001 adds “quality culture and ethical behaviour” language and stronger strategic framing, which was already present in the 2018 version of ISO 9004.

This narrows the conceptual gap slightly, even without ISO 9004 itself being revised.

[13:05] Breaking down ISO 9004’s Clauses 1-4 – 1–3: Scope, normative references, terms and definitions: standard preliminaries.

Clause 4 – Quality of an organization and sustained success: defines the core concept: quality of an organization is the degree to which its inherent characteristics fulfil the needs and expectations of customers and other relevant interested parties, and sets out what “managing for sustained success” means.

It’s distinct from 9001, which focuses on quality of products / services.

It introduces broader concepts than ISO 9001 in relation to IPs, relationship management, and the varied expressions of needs and expectations.

[14:50] Breaking down ISO 9004’s Clauses 5 & 6 –

Clause 5 – Context of an organization: identifying relevant interested parties and the external/internal issues affecting the organisation (it corresponds to but receives broader treatment than ISO 9001’s equivalent clause).

It builds upon ISO 9001 clause regarding internal and external issues and proposes external factors such as globalisation, innovation & natural environment. It expands on internal factors to bring in strategy, complexity and maturity.

It invites top management to consider these issues and to determine which could result in risks to sustained success or opportunities to enhance sustained success

Clause 6 – Identity of an organization: This is the clause with no real ISO 9001 equivalent: it’s where 9004 moves into genuinely strategic / organisational territory.

An organization is defined by its identity and context. The identity of an organization is determined by its characteristics, based on its mission, vision, values and culture.

These are all too vague in many organisations, but here it lays out what they should really mean:

• Mission: the organization’s purpose for existing;
• Vision: aspiration of what an organization would like to become;
• Values: principles and/or thinking patterns intended to play a role in shaping the organization’s culture and to determine what is important to the organization, in support of the mission and vision;
• Culture: beliefs, history, ethics, observed behaviour and attitudes that are interrelated with the identity of the organization

Note the word ‘ethics’, ISO 9004 is way ahead of ISO 9001 in addressing ethical behaviour.

[18:15] Breaking down ISO 9004’s Clause 7 Leadership – Policy, strategy, objectives, and communication, all framed around driving sustained success rather than just QMS conformity.

It refers back to leaders promoting the mission, vision etc. It talks about them creating the environment in which people are engaged and committed to objectives. It also describes unity of purpose and direction (established by top management).

In 7.2 we have policy AND strategy.

ISO 9001 does require alignment to strategic direction, but here it guides us to develop strategy, either by a recognised model or one bespoke to the organisation. It even proposes that top management should make strategic decisions regarding competitive factors and provides a model for doing that, it then goes on to discuss the alignment of objectives.

It takes objectives way beyond ISO 9001 and considers framing them in terms of the organisation’s positive impact on society and the environment, and it’s people’s engagement in society beyond merely business-related activities.  Again, we see the ethical slant in ISO 9004 well before its inclusion in ISO 9001.

[18:15] Breaking down ISO 9004’s Clauses 8 & 9 –

Clause 8 – Process management: Determining processes, assigning responsibility and authority, and managing processes. This clause contains fuller treatment than ISO 9001’s process-approach requirements, but also one which discusses processes as means to fulfilling objectives.

Clause 9 – Resource management: Beginning with people (engagement, empowerment, competence), organizational knowledge.

Competent, engaged, empowered and motivated people are a key resource. Engagement of people enhances the organization’s ability to create and deliver value for interested parties. Empowerment enhances the motivation of people to take responsibility for their work and its results.

9.3 covers organisational knowledge, which receives very scant treatment in ISO 9001, but is expanded upon greatly here.

Here it’s described as:

‘An intellectual asset which top management should manage as an essential element of the organization’s sustained success.’

The rest of clause 9 gives very broad guidance on technology, infrastructure and work environment, externally provided resources.  All much more detailed than the ISO 9001 equivalents.

In one part it discusses:

‘Creative work methods and opportunities for greater involvement, to realize the potential of people in the organization.’

And notably it mentions natural resources, which doesn’t appear in ISO 9001 at all.

[23:35] Breaking down ISO 9004’s Clauses 10 &11 –

Clause 10 – Analysis and evaluation of an organization’s performance: performance indicators, performance analysis and evaluation. ISO 9004 ties these back to policy commitments, needs and expectations of IPs, efficiency of processes, efficiency of resource use, finance, compliance, risks & opportunities.

It frames internal audit, not just in terms of conformity, but also in terms of opportunities, promotion of good practice, increasing understanding.

Clause 10.6 also introduces self-assessment

Clause 11 – Improvement, learning and innovation: Improvement here is defined as an activity to enhance performance, small-scale or organisation-wide.

It goes beyond ISO 9001 to encourage improvement and innovation through learning (learning doesn’t appear in ISO 9001). It also has a whole sub-clause on innovation (11.4).

A note about Annex A of ISO 9004: It can be utilised as a self-assessment tool. It includes a maturity model plus detailed element-by-element assessment criteria, which organisations can use to score themselves against the concepts in the document.

If you’d like help with ISO 9001 or assistance with making best use of ISO 9004, feel free to reach out to us, we’d be happy to help.

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