ISO 9001:2026 does not use the words “artificial intelligence”, “software” or “digital transformation” in its requirements, and it adds no requirement to automate anything. What it does, for the first time, is acknowledge in its NOTEs and in Annex A that work is done remotely and hybrid, that knowledge lives in digital systems, that communication can happen between devices, and that technologies used to run the QMS or to support people create risks and opportunities that the system has to address. Vendors will claim the 2026 edition “requires” digital tools; it does not. What it requires is that where you use them, the information they produce is reliable, the responsibility for decisions is clear, and the controls on documented information still hold. This page lists every place the text speaks to technology, and what a digital QMS has to be able to show.
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Every reference, with its status
| Where | What it says | Status |
|---|---|---|
| 7.1.3 NOTE (infrastructure) | Infrastructure applies to all types of work, on site, remote or a combination, and includes buildings, equipment (hardware and software), transport and ICT | NOTE (informative): remote and hybrid work explicitly acknowledged |
| 7.1.6 NOTE (organisational knowledge) | Knowledge can take different forms, including knowledge represented in documented information, digital systems and other media | NOTE: digital systems named as a form of knowledge |
| 7.5.1 to 7.5.3 (documented information) | Documented information can be in any format and media; controls on distribution, access, storage, change control and retention; protection of evidence from unintended alteration; the NOTE that “access” can mean permission to view only or to view and change | Requirements: apply equally to a spreadsheet, a platform and paper |
| 8.2.1 NOTE (customer communication) | Communication can be direct (meetings, email, documents) or indirect through website content, publications, social media, FAQs and training | NOTE: digital channels are customer communication |
| Annex A.5.3 (roles) | Where technologies support the management of the QMS, confidence in its integrity depends on reliable information for decisions and clarity about who has responsibility and authority for those decisions | Informative: the accountability principle for automated systems |
| Annex A.7.1.2 (people) | Where technologies are used to support people in relevant roles, this can result in risks and opportunities relevant to the QMS | Informative: feeds 6.1.2 and 6.1.3 |
| Annex A.7.1.3 (infrastructure) | Hybrid and remote work and emerging technologies can introduce risks and opportunities for infrastructure management and control | Informative |
| Annex A.7.1.4 (environment) | The work environment can evolve with emerging technologies and working practices, and its management can become more complex when not under the organisation’s direct control | Informative: home and client-site working |
| Annex A.7.1.5 (monitoring and measuring) | Measurement can apply to less tangible aspects such as customer satisfaction or process performance using appropriate methods and resources, including IT systems for data collection and analysis | Informative |
| Annex A.7.4 (communication) | Communication can occur between people or through automated interactions between devices | Informative: machine-to-machine communication is still communication |
| Annex A.10.1 (improvement) | Improvement can result from the adoption of technologies; its nature and extent can be influenced by increased reliance on data and the integration of technologies within and between organisations | Informative |
Nothing in that table creates a new “shall”. The requirements that bite are the old ones, 7.5 on documented information, 7.1.5 on the validity of measurement, 6.1 on risks and opportunities, 5.3 on responsibilities, applied to a system that now runs on platforms rather than binders.
Why AI is not in ISO 9001:2026, and what governs it instead
ISO/TC 176 kept ISO 9001 technology-neutral, as it has since the 2000 edition. The text speaks of “technologies”, “emerging technologies”, “digital systems” and “automated interactions”, which covers AI without dating the standard. The management of AI itself is the subject of a separate standard, ISO/IEC 42001, which specifies an AI management system and can be integrated with a QMS under the same Harmonized Structure. For most Philippine organisations the relevant question in a 2026 quality audit is narrower than AI governance: if an automated tool decides something that affects product or service conformity (a scheduling algorithm, an automated inspection, a chatbot handling customer enquiries under 8.2.1, a system that generates the management review data), can you show that its outputs are reliable (A.5.3, 7.1.5), who is accountable for the decision (5.3, A.5.3), what risks and opportunities you identified in using it (6.1.2, 6.1.3, A.7.1.2), and that the people relying on it are competent to do so (7.2)?
What a digital QMS has to be able to show
The controls do not change; the evidence does. Under 7.5.3.2 the system must control distribution, access, retrieval and use; storage and preservation, including legibility; change control, including version control; and retention and disposition. A platform that keeps version history, role-based access, an audit trail and defined retention meets those requirements by design, and an auditor will ask to see the audit trail rather than a document control procedure. Under 7.5.3.2 documented information kept as evidence must be protected from unintended alteration; that is the audit-trail question again. Under 7.1.5.1, where the platform’s data is used to verify conformity, the platform is a monitoring and measurement resource and its fitness for purpose has to be evidenced; a validation of the system or its configuration is the usual answer. Under 7.1.6 the platform is where knowledge is retained, applied and shared, so the 2026 wording is easier to meet with a searchable system than with a shared drive. Under 4.4.1 d) the criteria and methods, including monitoring, measurement and performance indicators, can live in the platform’s dashboards, provided someone owns them (5.3 b), A.5.3).
Remote and hybrid work adds two practical points. Under 7.1.3 the infrastructure for remote work (devices, connectivity, access to controlled documents) is within scope, and under 7.1.4 the environment for remote work is within scope even where it is not under the organisation’s direct control (A.7.1.4); competence and awareness (7.2, 7.3) still have to reach people who never enter the office, including the new awareness of quality culture and ethical behaviour (7.3 e)).
Where Effivity and Vegam AI fit, and where they do not
Organisations running their QMS on Effivity keep the document register, version history, access control, audit trail, risk and opportunity registers, audit programme and management review records in one system, which answers most of the 7.5 and 9.2 questions above by design and makes the 2026 additions (the split registers, the 6.3 change plan, the new 9.3.2 inputs) a configuration change rather than a rebuild. Vegam AI’s process automation sits a layer below, in the operational processes of Clause 8, where automated workflows generate the records 8.1, 8.5 and 8.6 require. Neither is required by the standard, and neither replaces the judgement the standard asks for: a platform can hold a risk register, but 6.1.2 requires a person to analyse and evaluate the risks; a workflow can route a customer complaint, but 10.2.1 requires a person to evaluate the need for corrective action. The evidence an auditor accepts from a platform is the same evidence they accept from paper, produced faster and harder to backdate.
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Frequently asked questions
Does ISO 9001:2026 require QMS software or digital tools? No. The standard is technology-neutral. It acknowledges digital systems, remote work and automated communication in NOTEs and Annex A, and applies its existing requirements on documented information, measurement, competence and responsibility to whatever technology is used.
Does ISO 9001:2026 mention artificial intelligence? No. It uses the terms technologies, emerging technologies, digital systems and automated interactions between devices. AI management systems are the subject of ISO/IEC 42001, which can be integrated with ISO 9001.
Is remote work covered by ISO 9001:2026? Yes. The 7.1.3 NOTE states that infrastructure applies to all types of work, on site, remote or a combination, and Annex A.7.1.3 and A.7.1.4 address the risks, opportunities and environment of hybrid and remote work.
What does Annex A.5.3 say about automated systems? That where technologies support the management of the QMS, confidence in its integrity depends on reliable information for decisions and clarity about who has responsibility and authority for those decisions.
Can an electronic audit trail replace a document control procedure? The standard requires the controls in 7.5.3.2, not a procedure. A platform that evidences distribution, access, versioning, retention and protection from alteration meets the requirement; describing how it does so is good practice.
Can our chatbot handle customer communication under 8.2.1? Yes, provided the communication meets 8.2.1 a) to e) and the outputs are reliable and owned (A.5.3). The 8.2.1 NOTE recognises website content and FAQs as customer communication.
Read next
The documented information list; risks and opportunities; the clause-by-clause register; Effivity for the QMS platform; and ISO 9001:2026 transition consulting from Sterling.
Sources
ISO 9001:2026, Quality management systems — Requirements, sixth edition (published 16 September 2026): 4.4.1 d), 5.3, 6.1.2, 6.1.3, 7.1.3 NOTE, 7.1.5.1, 7.1.6 and NOTE, 7.2, 7.3 e), 7.5.1 to 7.5.3, 8.2.1 NOTE, Annex A.5.3, A.7.1.2 to A.7.1.5, A.7.4, A.7.5, A.10.1. ISO/IEC 42001, Information technology — Artificial intelligence — Management system.
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