What changes in ISO 9001:2026, and what it means for organisational knowledge
All the ISO 9001:2026 changes in one table, then clause 7.1.6: the knowledge you must keep, use and share, and the evidence an auditor will ask for.
ISO 9001:2026, published on 16 September 2026, replaces the 2015 edition with targeted changes: quality culture and ethical behaviour, risks separated from opportunities, stronger planning of changes, core terms in clause 3 and a rewritten Annex A. Certified organisations have until 30 September 2029 to move to the new edition.
Organisational knowledge (clause 7.1.6) is not one of the six main changes the standard lists, but a small change of wording has large consequences. Knowledge now serves the intended results of the whole quality management system, and it must be retained, applied and shared to the extent necessary, where the 2015 edition asked for it to be maintained and made available.
This page gives every change in one table, then the knowledge clause in detail, the knowledge cycle the new edition describes, and the evidence an auditor can reasonably ask for.
ISO 9001:2015 vs 2026: every change in one table
The standard's own foreword lists six main changes. The International Organization for Standardization (ISO) explains the edition with five headline changes and "smaller refinements", and names organisational knowledge among the refinements. Global Accreditation Cooperation (Global ACI), which sets the transition rules for accredited certification, gives its own list of key changes. The table compares the two editions of the standard clause by clause, in paraphrase. The last column says which of those three sources lists each change as a main one.
| Clause | 2015 edition | 2026 edition | Listed as a main change by |
|---|---|---|---|
| 3, terms and definitions | Terms sat in ISO 9000 only | 22 core terms defined in clause 3, including quality management system, quality policy and quality objective. ISO 9000 stays the normative reference | Foreword, Global ACI |
| 4.1, 4.2, climate change | Added by the 2024 amendment | Built into the main text | None: already in force |
| 4.2, interested parties | Determine their relevant requirements | Also decide which of those requirements the system will address | None |
| 5.1, leadership | Leaders promote improvement | New items: promote quality culture and ethical behaviour, and opportunity-based thinking beside risk-based thinking; "continual improvement" replaces "improvement" | Foreword, ISO, Global ACI |
| 5.2, quality policy | Policy appropriate to the purpose and context, supporting the strategic direction | Context and strategic direction get an item of their own | ISO, Global ACI |
| 6.1, risks and opportunities | One clause for both | Three subclauses: determining risks and opportunities, actions on risks, actions on opportunities. Risks must now be analysed and evaluated, not only determined | Foreword, ISO, Global ACI |
| 6.3, planning of changes | Four points to consider | Seven: adds whether information is available, how the change is communicated, how its effectiveness is monitored and evaluated, how its results are reviewed | Foreword, Global ACI |
| 7.1.6, organisational knowledge | Knowledge for processes and product conformity, maintained and made available; notes on internal and external sources | Wider purpose; retained, applied and shared to the extent necessary; a new note and a new A.7.1.6 (details below) | Not in the foreword's list; a "smaller refinement" for ISO |
| 7.3, awareness | Policy, objectives, contribution, consequences of not conforming | Adds quality culture and ethical behaviour | Foreword, ISO, Global ACI |
| 7.5 and elsewhere, documented information | "Maintain" documented information (documents) or "retain" it (records) | Information "available as documented information", or documented information "available as evidence". The duties stay the same | Global ACI |
| 8.5.1, production and service provision | Documented information available | Available and used | None |
| 9.3, management review | Inputs "taken into consideration"; 9.3.3 "outputs" | Inputs the review must include, with a new input on changes in interested parties' needs; 9.3.3 renamed "results" | Global ACI |
| 10, improvement | 10.1 general, 10.3 continual improvement | 10.1 general is deleted; continual improvement becomes 10.1, with named inputs (analysis results, management review results) and named actions | None |
| Annex A | Guidance on structure, terminology and concepts | Rewritten to explain structure, terms and the intent of each clause, with no added requirements | Foreword, ISO, Global ACI |
| Annex B | Other standards of ISO's quality committee | Removed | Foreword, Global ACI |
ISO says the new edition builds on 2015 and keeps the same clause structure, and Global ACI calls the overall changes "minimal". The UK accreditation body, the United Kingdom Accreditation Service (UKAS), names interested parties, quality culture and ethics, risks and opportunities, planning of changes and management review as the most significant.
What clause 7.1.6 asked in 2015, and what it asks now
The 2015 edition was the first to treat knowledge as a requirement. The 2026 edition keeps the clause, its title and its four parts, and changes three of them. In paraphrase:
| Part of 7.1.6 | 2015 | 2026 |
|---|---|---|
| Purpose | The knowledge needed to run processes and to achieve conforming products and services | The knowledge needed to run processes and to achieve the intended results of the quality management system |
| What happens to it | Maintained and made available, to the extent necessary | Retained, applied and shared, to the extent necessary |
| When needs change | Consider current knowledge, then acquire or access what is missing | Unchanged |
| Notes | Where knowledge comes from: internal sources (experience, lessons from failures and successes) and external ones (standards, conferences, customers, suppliers) | What form knowledge takes: held by people through experience; gained through education, training and learning from others; embedded in methods, processes and products; represented in documented information, digital systems and other media |
Three shifts follow. The scope is wider: knowledge now serves every result of the system, such as customer satisfaction, objectives and improvement, not only product conformity. "Applied" is new: knowledge that is kept but never used does not meet the clause on its own. And "shared" replaces "made available": knowledge has to move, not only sit where people could find it. AFNOR, the French standards body, describes the same change of verbs in its own summary.
The new Annex A adds an informative subclause, A.7.1.6. It describes organisational knowledge as dynamic: it changes with the organisation's context and is updated through use and experience. Managing it means acquiring or creating knowledge, applying it, keeping it valid and relevant, and retaining it to reduce the risk of losing it. A note points to ISO 30401, the standard for knowledge management systems. The 2015 annex gave the clause two purposes: protecting against the loss of knowledge, for example when people leave, and encouraging the organisation to acquire it.
Most summaries of the new edition say nothing about the knowledge clause. On 9 October 2026, we read 20 summaries published by ISO, accreditation bodies, standards bodies and certification bodies: 14 do not mention organisational knowledge, and none of those from the accreditation side mentions it. Our audit of the published guides counts how many cover the clause, and what they get wrong.
The knowledge cycle in ISO 9001:2026
Read together, the 2026 clauses describe a complete knowledge cycle, without using that name. The 2015 edition covered the first steps well and the later ones only by implication.
| Step | Where the 2026 standard says it | What is new since 2015 |
|---|---|---|
| Determine the knowledge needed | 7.1.6; competence in 7.2; information for changes in 6.3 | Knowledge serves the results of the whole system; changes must check that information is available |
| Acquire or create it | 7.1.6; A.7.1.6 | Creating knowledge is named, not only acquiring it |
| Retain it | 7.1.6; documented information in 7.5 | Digital systems are named as a place where knowledge is held |
| Keep it valid | A.7.1.6; control of obsolete information in A.7.5 | The validity of knowledge, not only of documents, is in scope |
| Share it | 7.1.6; communication in 7.4; quality culture in 5.1 and 7.3 | Sharing is an active duty, and culture becomes a requirement |
| Apply it | 7.1.6; documented information used in 8.5.1; competence defined in clause 3 | ISO 9001 now defines competence itself, as the ability to apply knowledge and skills |
| Update it through use | A.7.1.6; continual improvement in 10.1 and A.10.1 | Annex A says improving can mean adapting processes, knowledge and resources |
The rest of this page follows the three verbs of 7.1.6.
Retained: knowledge that stays when people leave
Retained means the organisation keeps the knowledge it depends on when people, sites, suppliers or products change. A.7.1.6 says that retaining knowledge reduces the risk of losing it. The guidance written for auditors on this clause is a three-page paper from the ISO 9001 Auditing Practices Group (APG), a group set up by ISO's quality committee (ISO/TC 176) and the International Accreditation Forum (IAF), written in 2016 for the 2015 verbs and not revised since. It names mentoring and succession planning as ways to capture knowledge that sits in people's heads.
The same paper warns that document control alone does not make tacit or experience-based knowledge available. The new note to 7.1.6 agrees: documents and digital systems are one form of knowledge out of four.
Applied: knowledge used where the work happens
Applied means the knowledge reaches the person at the moment of the task, in a form they can use. Clause 3 now defines competence as the ability to apply knowledge and skills to achieve intended results, so this verb links 7.1.6 to competence (7.2). Clause 8.5.1 points the same way: documented information for production and service provision must be available and used.
The APG paper on competence (2022) gives four questions that work well for this verb: what knowledge an activity needs, how people reach it, how it is kept current, and how knowledge gained by experience is captured. If a technician on a night shift cannot reach the current procedure from where they work, the knowledge exists but is not applied.
Shared: from one person or one site to the rest
Shared means knowledge moves beyond the person or team that holds it. The 2016 APG paper lists sources auditors can check, among them learning from failures, near misses and successes, knowledge from customers and suppliers, and updating knowledge after improvements. A lessons learned process and planned knowledge transfer between experts and newcomers are two common practices. The 2026 edition also strengthens what makes sharing possible: top management must now promote a quality culture (5.1), and people must be aware of it (7.3).
The evidence an auditor can reasonably ask for
The standard does not list the evidence for 7.1.6, and the clause asks for no documented information, in 2015 or in 2026. The APG's guidance on evidence (2016) adds that objective evidence does not have to be documented information unless the standard asks for it. This is the evidence we would prepare: our reading of the standard and the APG papers, not a list from the standard.
| Verb | What it means in practice | Evidence an auditor can reasonably ask for |
|---|---|---|
| Retained | Critical knowledge has an owner and does not depend on one person | An owner per knowledge area; a review record (who checked it, when, the next date); a retention plan for each critical role, ready before the person in that role leaves |
| Applied | People reach the current knowledge at the moment of the task | A record of where knowledge is applied: which procedure or instruction each process step uses, and which version people saw |
| Shared | Lessons and experience reach the other teams and sites | Lessons-learned records that led to an updated procedure; a list of who receives a change, and when |
To build that map, start with a knowledge audit: list the knowledge each process depends on, who holds it, where it is written, in which of the four forms, and when it was last checked.
The clauses around 7.1.6
Knowledge is one clause, but four other clauses decide whether it stays current.
- 6.3, planning of changes. When planning a change, the organisation must now consider whether information is available, as well as resources, and how the change is communicated, monitored and reviewed. A change to a process often changes the knowledge it needs.
- 7.5, documented information. This is the home of document control, and of the electronic quality management system (eQMS), where an organisation runs one. Annex A adds that obsolete information must be controlled. Documents are one form of knowledge. Experience, learning and know-how held by people are the others, and 7.5 does not cover them.
- 9.3, management review. The inputs the review must include are now fixed, with a new one on changes in interested parties' needs. Knowledge is not a named input. Knowledge gaps found in audits or after incidents can still reach the review through the inputs that exist, such as audit results and opportunities for improvement.
- 10, improvement. Continual improvement is now 10.1, with named inputs and actions, and Annex A adds that improving can mean adapting processes, knowledge and resources. An improvement that does not reach the procedure people use is lost at the next shift.
The 2026 text never says "artificial intelligence" (AI), and it adds no information security or cybersecurity requirement. Technology appears in neutral terms: knowledge represented in digital systems (the note to 7.1.6), emerging technologies as a source of opportunities (6.1.3), and, in Annex A, technologies that support people and the management of the system. In the second case, the organisation still needs reliable information and clear responsibility for decisions. A 2026 paper for ISO 9001 auditors on AI says auditors need new knowledge but no new audit methods.
ISO 9000:2026 and ISO 30401: knowledge management gets a definition
Two related standards are changing too, and both bring knowledge management closer to quality.
ISO 9000:2026, the fundamentals and vocabulary that ISO 9001 cites as its normative reference, was published in May 2026 (fifth edition). Its table of contents adds a group of "additional concepts" with an entry 4.4.9, "Knowledge management", next to change management, information management, innovation and business continuity. The text of that entry is not in ISO's free preview.
ISO 30401, the standard for knowledge management systems, dates from 2018 and is now cited by ISO 9001:2026, in A.7.1.6 and in its bibliography. Its own annex on related disciplines already presented a knowledge management system as one way to meet the knowledge clause of ISO 9001. ISO 9001 does not ask for an ISO 30401 system. ISO 30401 is being revised, and ISO's preview of the draft second edition says that a knowledge management system is part of the organisation's overall management system. The draft can still change. Our guide to knowledge management explains the standard in more detail.
Where to read the official text of ISO 9001:2026
There is no free legal copy of the full text. ISO sells it, and national standards bodies sell EN ISO 9001:2026. The European Committee for Standardization (CEN) approved EN ISO 9001:2026 on 10 August 2026, and every national body must adopt it by March 2027. AFNOR publishes the French edition, NF EN ISO 9001:2026. ISO's Online Browsing Platform shows the foreword, introduction and table of contents for free. Copies that circulate as free PDFs are not licensed, and a draft is not the published text, whether a Draft International Standard (DIS) or a Final Draft International Standard (FDIS).
Transition dates for certified organisations
The transition rules come from Global ACI, which replaced the International Accreditation Forum (IAF) and the International Laboratory Accreditation Cooperation (ILAC) on 1 January 2026. Every deadline runs from 30 September 2026, the last day of the month of publication.
| Milestone | Date |
|---|---|
| Accreditation bodies ready to assess certification bodies | 31 March 2027 |
| New and initial certifications only to ISO 9001:2026 | 31 March 2028 |
| End of transition: 2015 certificates no longer valid | 30 September 2029 |
A transition audit can take place during a surveillance or recertification audit, or as a special audit, and can be remote. The certification body decides whether it needs extra time. The transition concerns many organisations: France counted 21,880 valid ISO 9001 certificates at the end of 2022, according to AFNOR's reading of the ISO Survey. Our 90-day plan for operations teams turns the three verbs into a schedule before the first audit on the new edition.
Where Elium fits: a system of record for knowledge, beside the eQMS
The sources stop at what the clause asks. How an organisation keeps knowledge retained, applied and shared day after day is a question of tools and habits, and this is where we work.
Elium is not an eQMS and does not replace document control. The eQMS keeps the controlled documents that 7.5 governs. Elium holds the knowledge around them: how a procedure is really applied on each site, the fixes that work, the lessons from incidents, the answers experts give every week. It is a European knowledge management platform where every space has owners and every article can carry a verification date that puts it in its owner's task list when the date is near. Changes can go through approval before they are published, Elium keeps every version with its author and date, and, in spaces where requests are turned on, people who can publish there can file a content request when something is missing.
Two customers show what this looks like with procedures. The IT team of the Département de l'Orne gave every procedure an expiry date, with an annual review, so nothing stays active without being checked. At L'Oréal Opérations, 113 spaces sit in about fifteen families, with access rights, versioning and a named owner for every change, and the corpus was cleaned before it was migrated.
Documents get filed, archived, re-synthesised; documents that existed in French and in English get merged into one. Simplifying the corpus reassures the person who has to manage it.
Common questions
The standard's foreword lists six main changes: core terms in clause 3, quality culture and ethical behaviour, risks and opportunities separated, stronger requirements on planning changes, a rewritten Annex A, and the removal of Annex B. Outside that list, management review inputs are now mandatory, with a new input on interested parties, and the knowledge clause (7.1.6) is reworded.
The 2026 edition keeps the structure and the principles of 2015 and adds targeted changes. The main ones concern leadership and quality culture (5.1, 7.3), risks and opportunities (6.1), planning of changes (6.3), management review (9.3) and the annexes. Global ACI calls the overall changes minimal.
Yes, although it is not one of the six main changes. Knowledge now serves the intended results of the quality management system, not only product conformity, and must be retained, applied and shared, to the extent necessary, instead of maintained and made available. A new note lists the forms knowledge takes, and a new Annex A section points to ISO 30401.
Three years: certified organisations must move to the 2026 edition by 30 September 2029, after which 2015 certificates are no longer valid. From 31 March 2028, new certifications are only to the 2026 edition. These dates come from Global ACI's mandatory transition document.
Yes, ISO published the sixth edition of ISO 9001 on 16 September 2026. It replaces ISO 9001:2015, and AFNOR publishes the French edition as NF EN ISO 9001:2026.
No legal free copy exists. ISO and the national standards bodies sell the text, and ISO's Online Browsing Platform shows its first pages for free. Free PDFs found online are unlicensed copies or drafts.
No, the standard never says "artificial intelligence" and adds no information security requirement. It mentions technology in neutral terms, such as knowledge represented in digital systems and emerging technologies as opportunities, and the 2026 auditor paper on AI says no new audit methods are needed.
The standard does not list it, and 7.1.6 asks for no documented information. Our reading of the auditor guidance: prepare an owner per knowledge area, a review record, a retention plan for critical roles before their holders leave, and a record of where knowledge is applied in your processes.
Where to go next
- Compare: see how operations teams keep one current version of every procedure on our global operations page.
- Use a template: map your knowledge with the knowledge audit checklist, draw a process and the knowledge each step needs with the process flowchart, and check outputs with the quality control checklist.
- Read more: what makes a standard operating procedure usable, and how pharmaceutical quality systems handle knowledge under ICH Q10.
- Do it in Elium: set verification dates and approval on your procedures, or book a demo.
Sources
- ISO, ISO 9001:2026, Quality management systems: Requirements, sixth edition, September 2026, clauses 3, 4 to 10 and Annex A, read in the redline edition EVS-EN ISO 9001:2026 on 10 October 2026, and its foreword in ISO's free preview (checked 9 October 2026).
- ISO, ISO 9001:2026: What businesses need to know and ISO launches update to quality management standard, 16 September 2026 (checked October 2026).
- Global Accreditation Cooperation, Global ACI-TECH-3-TR 2029-09-30 (M), Transition requirements for ISO 9001:2026, version 1.0, 4 September 2026, and its announcement (checked October 2026).
- UKAS, Technical bulletin: QMS ISO 9001:2026 transition, revision 1, 7 October 2026 (checked 9 October 2026).
- AFNOR, ISO 9001 et ISO 14001 : le point sur la dernière version, updated 22 September 2026 (checked October 2026), and ISO Survey: why France's falling behind in quality is worrying, updated 15 September 2026 (checked 9 October 2026).
- ISO 9001 Auditing Practices Group (ISO/TC 176 and IAF), Guidance on organisational knowledge, edition 1, 2016 (checked October 2026); Guidance on auditing competence, edition 2, 2022; Guidance on evidence collection, edition 1, 2016; and Auditing a QMS that uses AI systems, edition 1, May 2026 (checked 9 October 2026).
- ISO, ISO 9000:2026, Quality management: Fundamentals and vocabulary, fifth edition, May 2026 (checked October 2026).
- ISO, ISO 30401:2018, Knowledge management systems: Requirements, Annex B, and ISO/DIS 30401, draft second edition (checked October 2026).
Data and sources
The comparison of the two editions comes from our reading, on 10 October 2026, of the redline edition of EN ISO 9001:2026, which marks every change against 2015, checked against the foreword in ISO's free preview, ISO's explainer and Global ACI's transition document. The standard is paraphrased throughout: no clause text is reproduced on this page. The count of summaries comes from our reading, on 9 October 2026, of 20 summaries of the new edition (six by ISO, Global ACI, UKAS and AFNOR, the others by certification bodies), recorded with the date and the clauses each one mentions. Software vendors and consultancies were read for structure only and are not cited. Last reviewed on 20 October 2026.