ISO 9001:2026 · Clause-by-clause
Every change from 2015 to 2026
ISO 9001:2026 is the sixth edition, published 16 September 2026. The full clause-by-clause change table from clause 2 to clause 10, what is genuinely new, what is not new whatever you have been told, and what a certified South African site must actually do before the 30 September 2029 end of the Global ACI transition. Confirm the dates with your own certification body.
ISO 9001:2026 was published on 16 September 2026. It is the sixth edition of the standard, it cancels and replaces ISO 9001:2015, and it incorporates Amendment 1:2024, the climate change amendment. If your site holds an ISO 9001:2015 certificate, you have until 30 September 2029 to complete the transition, under the three year transition set out by Global Accreditation Cooperation, the body that took over the work of the IAF when the IAF ceased operations on 1 January 2026. From 31 March 2028 new and initial accredited certifications may only be issued to ISO 9001:2026. Confirm the exact dates with your own certification body. The work between now and then is smaller than the rumours suggest and more specific than the summaries admit. This page lists every change, clause by clause, from the foreword through to clause 10, and says what a certified site must actually do about each one.
The short answer. ISO 9001:2026 is the sixth edition, published 16 September 2026. It cancels and replaces ISO 9001:2015 and incorporates Amendment 1:2024. ISO 9001:2015 certificates are expected to remain valid until 30 September 2029, and certification bodies set their own earlier cut-off dates for initial certification to the 2015 edition, so confirm the exact dates with your own certification body.
The biggest new build for a certified site is the opportunity register under clause 6.1.3, which is a new dedicated sub-clause. Opportunities are now separated from risks and have to be determined, analysed, evaluated, planned, integrated, implemented and then evaluated for effectiveness in their own right. After that comes the rebuilt change record under 6.3, then dated evidence of quality culture and ethical behaviour under 5.1.1 i).
You do not have to author the 2026 system from a blank page. The ISO 9001:2026 Document Templates Toolkit turns this clause table into 202 editable documents, including a transition gap analysis checklist and a 123-row internal audit checklist.
Browse the ISO 9001:2026 toolkit See the three ISO 9001:2026 courses
What edition is ISO 9001 now, and when does the 2015 certificate expire?
ISO 9001:2026 is the sixth edition. It was published on 16 September 2026. It cancels and replaces ISO 9001:2015, which was the fifth edition, and it folds in Amendment 1:2024, the short climate change amendment that was already bolted onto the 2015 text in February 2024.
The transition period is three years from publication. It is set out by Global Accreditation Cooperation, known as Global ACI, which took over the work of the International Accreditation Forum when the IAF ceased operations on 1 January 2026, in document Global ACI-TECH-3-TR. Certified organisations have until 30 September 2029 to complete the transition, a date you should confirm with your own certification body. Two things follow from that, and both of them matter more than the headline date.
- Certification bodies set their own earlier cut-offs for initial certification to the 2015 edition. If you are certifying for the first time in 2027, you will almost certainly be certified to the 2026 edition, not the 2015 one.
- Your transition audit is not scheduled by you. It is scheduled by your certification body, usually alongside a surveillance or recertification visit, and the diary fills from the back. Sites that wait until 2029 will be competing for auditor days with everyone else who waited. Confirm your own transition audit date with your certification body.
Confirm the exact dates with your own certification body in writing. Ask them three questions: when is your last date for a 2015 edition initial certification, at which of our scheduled audits will the transition be assessed, and how many additional audit days do you allocate for the transition. Confirm the clause lettering against your own controlled copy of ISO 9001:2026.
What are the six changes the ISO 9001:2026 foreword lists?
The foreword names six changes. They are a fair summary of the revision, but each one hides a different amount of work.
| Foreword change | What it actually means | How much work |
|---|---|---|
| Core management system terms and definitions added to Clause 3 | Clause 3 now carries terms 3.1 to 3.20. The 2015 edition had none of its own. ISO 9000 stays the normative reference for quality management terms and is now cited undated, so the latest edition applies | Low. Correct any in-house definition that contradicts one |
| Quality culture and ethical behaviour introduced within the requirements | Lands at 5.1.1 i), at a note under 7.1.4 and at 7.3 e) | Medium. Evidence, not documents |
| Risks and opportunities separated and separately addressed | 6.1.2 covers risks, and a new 6.1.3 covers opportunities. The split carries through to 5.3, 9.1.3 and 9.3 | High. This is the main build |
| Management of change strengthened | Clause 6.3 goes from four considerations to seven | Medium. Three new columns on the change record |
| Annex A expanded | Informative only. It adds no requirements | None |
| Annex B removed | Its references now sit in Annex A and on the ISO/TC 176 website | None |
ISO 9001:2026 vs ISO 9001:2015: the full clause-by-clause table
This is the table the rest of the internet summarises badly. Read the middle column to see what moved and the right column to see what you have to produce. Where a row says no action, it means no action. The revision is not a rewrite and treating it as one is how a transition becomes a six month project it never needed to be.
| Clause | What changed in the 2026 edition | What a certified site must actually do |
|---|---|---|
| 2 and 3 | ISO 9000 is cited undated. Clause 3 adds core terms 3.1 to 3.20, where the 2015 edition had none | Correct any in-house definition that contradicts one of the new terms. Nothing else |
| 4.1 | “The organization shall determine whether climate change is a relevant issue.” This came in with Amendment 1:2024, not with the 2026 revision itself | One dated context register entry: the issue, a yes or no determination, the reason, the owner and the date |
| 4.2 | Adds c), which requirements will be addressed through the QMS. A new note says interested parties can have climate-related requirements | Add a yes or no column and review dates to the interested parties register |
| 4.3 and 4.4 | Scope is substantively unchanged. The process requirements are now listed a) to i) | Renumber cross-references only |
| 5.1.1 | Ten leadership commitment items expanded to twelve, a) to l). New: i) promoting quality culture and ethical behaviour and k) promoting risk-based and opportunity-based thinking | Dated evidence of top management action on culture and on opportunity thinking, with measurable outcomes |
| 5.1.1 Note 2 | New note: “An organization’s quality culture and ethical behaviour are reflected in its shared values, attitudes, practices and actions” | Use it as your working definition. There is no requirement to adopt the note’s wording, but writing an in-house definition that pulls against it gives an auditor an easy question |
| 5.2.1 | “context of the organization and supports its strategic direction” now stands alone at e) | The policy must visibly reflect the 4.1 context analysis, not sit beside it |
| 5.2.2 | “implemented” replaces “appropriate to” | Show that the policy produced a change, not just that it was published and signed |
| 5.3 | Six items a) to f). b) and e) split reporting on QMS performance from reporting on opportunities. New f) keeping the integrity of the QMS when changes are planned and implemented | Split the two reporting duties in the responsibilities matrix. Integrity of the QMS becomes a standing named duty |
| 6.1.2 Risks | Separated from opportunities. Adds “analyse and evaluate”. Focused on undesired effects | Split the combined register. Add an analysis and evaluation step. Show that actions are proportionate to the risk |
| 6.1.3 Opportunities | A new dedicated sub-clause. Opportunities must be determined, analysed, evaluated, planned, integrated, implemented, and their effectiveness evaluated | Build a separate opportunities register. This is the single biggest new build for a certified site |
| 6.2 | Objectives are listed a) to h) at 6.2.1, with documented information at g). 6.2.2 a) to e) unchanged | No action if the objectives already cover what, resources, who, when and how results are evaluated |
| 6.3 | Four change considerations expanded to seven. New: e) communication of the changes, f) monitoring and evaluating the effectiveness of the changes, g) reviewing the results | Rebuild the change record with three new columns, and make sure closed changes actually get reviewed |
| 7.1.3 | New note: infrastructure applies to all types of work, on site, remote or a combination | Informative only. No action |
| 7.1.4 | Adds the note “Some factors can be influenced by the organizational quality culture and ethical behaviour” | No new build. Social and psychological factors were already in the 2015 note |
| 7.1.6 | “retained, applied and shared” replaces “maintained and made available” | Knowledge must be captured and accessible, not held in one person’s head or one locked folder |
| 7.2 | Unchanged | None |
| 7.3 | Four awareness items expanded to five. New: e) the organizational quality culture and ethical behaviour | Add it to induction and to how you prepare people for floor interviews |
| 7.4 | Unchanged | None |
| 7.5 | “available as documented information” and “documented information available as evidence of” replace the maintain and retain wording | Terminology only. No document rewrite |
| 8.1 | Restructured a) to e). Separates process criteria from acceptance criteria. Adds paragraphs on documented information, on planned and unintended changes, and on externally provided processes | Acceptance criteria must exist in writing, not only in the operator’s head |
| 8.2.1 e) | Adds “providing information related to contingency actions, when relevant, including any related to disruptions to the provision of products or services” | Write the trigger into the customer communication procedure. Decide now who calls the customer and at what point |
| 8.2 to 8.7 | Substantively unchanged. 8.5.1 g) actions to prevent human error was already in the 2015 edition | No new builds |
| 9.1.3 | Eight analysis and evaluation items a) to h). e) and f) split the effectiveness of actions on risks from actions on opportunities | Two analysis lines, matching the two registers |
| 9.2.2 a) | Now reads “define the audit objectives, criteria and scope for each audit” | Add one objective sentence to every internal audit plan |
| 9.3 | Six management review inputs expanded to eight. New c) changes in the needs and expectations of interested parties. g) and h) split risks from opportunities | Rebuild the management review agenda to eight headings, and make the minutes follow the agenda |
| 10 | Three sub-clauses reduced to two. 10.1 carries the improvement duty and the actions. 10.2 is as before, with a note that customer complaints can be a source of nonconformities | Renumber every reference to the old 10.3 |
What is NOT new, whatever you have been told
A revision year brings out consultants and LinkedIn posts selling requirements that already existed. Every item below was already in ISO 9001:2015. If somebody quotes one of these to you as a reason to buy a transition project, you are being sold your own system back.
- Actions to prevent human error, 8.5.1 g). Already in the 2015 edition, word for word.
- Considering changing organizational knowledge needs, 7.1.6. Already there. What changed is the verb: retained, applied and shared.
- Social and psychological factors in the working environment, the 7.1.4 note. Already there in 2015. The 2026 edition only adds a second sentence about culture influencing those factors.
- Updating risks and opportunities after corrective action, 10.2.1 e) and f). Already there.
- The climate change sentence at 4.1. It arrived with Amendment 1:2024, not with the 2026 revision. If you did the amendment in 2024, you have done it.
The quality manual, the six procedures and the management representative
Three things have never been required by ISO 9001, in either the 2015 edition or the 2026 edition:
- A quality manual. Not required. It was dropped in 2015 and it has not come back. Many sites keep one because a customer asks for it, which is a commercial reason, not a certification one.
- Six documented procedures. Not required. That was ISO 9001:2008 and it has been gone for over a decade.
- A management representative. Not required. Clause 5.3 requires that responsibilities and authorities are assigned and communicated. It does not require one named person holding a title.
We say this in every ISO 9001 conversation we have, and it saves sites more money than any other single point. If a template pack or a course tells you otherwise, it is built on the 2008 edition.
Separating the real work from the terminology tidying is most of the job. The toolkit includes a transition gap analysis checklist that does exactly that, so your team spends its time on 6.1.3 and 6.3 instead of rewriting documents that did not change.
Get the transition gap analysis checklist Talk to an ISO 9001 consultant
Which changes are actually big? A ranking by work required
Not every row in that table costs the same. Here is the honest ranking for a site that already holds an ISO 9001:2015 certificate and runs it properly.
First: the opportunity register at 6.1.3
This is the one. Nearly every certified site we see has a single register with a column headed “risks and opportunities”, and the opportunity entries in it are either blank, or they are risks written as positives. That will not survive a 2026 audit.
Clause 6.1.3 is a dedicated sub-clause with its own life cycle: determine the opportunity, analyse it, evaluate it, plan action, integrate that action into the QMS processes, implement it, then evaluate whether the action worked. That is seven verbs and it needs a register that carries all seven. Because 5.3 b) and e), 9.1.3 e) and f), and 9.3 g) and h) all split risk from opportunity too, a single combined register now breaks the responsibilities matrix, the analysis section and the management review agenda at the same time.
Budget the most time here. Half a day in the room with operations, sales, maintenance and planning. Getting that diary is harder than running the session. Then a second pass to take each one through the seven steps with an owner and a date, and remember that integrate means a process actually changes, not that a row is filled in. Allow two to three weeks end to end for a first register you would be happy to show.
Second: the change record at 6.3
The 2015 change record asked four things. The 2026 one asks seven. The three new ones are communication of the change, monitoring and evaluating its effectiveness, and reviewing the results. Most existing change forms stop the moment the change is approved and implemented.
The fix is three new columns and a discipline: who was told and how, what measure tells us it worked, and a dated review entry. The discipline is harder than the columns. An auditor will pull a change from six months ago and ask for the review.
Third: quality culture evidence at 5.1.1 i)
This one is not a document, which is why it catches people. Clause 5.1.1 i) requires top management to promote quality culture and ethical behaviour, and 7.3 e) requires people to be aware of it.
What satisfies it: dated top management actions with measurable outcomes. A managing director who changed a release rule after a complaint, and the record showing the complaint rate afterwards. What does not satisfy it: posters, a values statement on the wall, a culture survey with no recorded action, or a management review slide that says culture is important. We have seen all four offered and all four written up.
Clause 7.3 e) is tested by interview, not by document. It is satisfied when operators answer in their own words, consistently across shifts, with multilingual induction where the workforce needs it. A signed attendance register on its own does not satisfy it.
How long does the ISO 9001:2026 transition take, and who does it?
For a site that already holds a 2015 certificate and runs it properly, allow four to six months of elapsed time, of which the build itself is two to three months part-time. The extra is running the new registers for a quarter so there is a history to sample, and waiting for the audit slot your certification body gives you. The three big items above are most of the build. The rest is renumbering, terminology and a management review agenda.
The work splits cleanly by role, which is how we structure the training. The usual pattern on a South African manufacturing site is one or two people on Implementation and everyone else on the Introduction.
| Who they are | What they do in the transition | Course | Price and length |
|---|---|---|---|
| The person who already holds the 2015 certificate and has to move it | Runs the gap analysis, builds 6.1.3, rebuilds 6.3 and the 9.3 agenda, books the transition audit | Transition to ISO 9001:2026 | R1 950. About 8 hours, 22 lessons, with an interactive Transition Planner |
| Supervisors, line leaders, QA staff, anyone an auditor will interview | Work inside the system. Must be able to answer on culture, on their process criteria and on nonconformity in their own words | Introduction to ISO 9001:2026 | R1 495. About 6 hours, 21 lessons |
| The people who build, upgrade or run the system | Own the QMS end to end, including a first-time build or a deep upgrade | ISO 9001:2026 Understanding and Implementation | R4 800. About 24 hours, 75 lessons, 7 interactive tools, 68 case packs, marked workbook, proctored final |
All three are self paced with lifetime access, a 70 percent pass mark and three attempts. If you are sending five or more people, ask us about a group arrangement.
Turning the table into documents you already own
Everything above tells you what to produce. The ISO 9001:2026 Document Templates Toolkit for Food Contact Packaging Manufacturing is the version of it you can edit tonight.
It is 202 documents, 190 Word and 12 Excel, plus the proof-read and remediation report, roughly 553 000 words. Part 1 covers ISO 9001:2026 clauses 4 to 10 as policies, procedures, work instructions and control forms. Part 2 adds ten packaging quality control modules, from artwork, print and colour through converting, laboratory and test methods, statistical process control and capability, measurement system analysis, customer specific requirements, identification, labelling and packing, warehousing and dispatch, equipment, tooling and maintenance, to cost of poor quality. Part 3 adds six QMS enabler modules, including quality culture and ethical behaviour, climate change and sustainability, organizational knowledge, resilience and business continuity, risk and opportunity methodology, and transition from 2015 to 2026.
Two items in it map directly onto this article:
- The transition gap analysis checklist. It separates the genuinely new requirements from the terminology tidying, so a certified site does the work that is real. It is the article you have just read, in a form your team can sign off row by row.
- The 123-row internal audit checklist. It walks every sub-clause from 4.1 to 10.2, with the 2026-specific rows flagged. Run it as your pre-transition mock audit and you will find the 6.1.3 and 6.3 gaps before your certification body does.
Alongside those, 12 Excel risk assessment workbooks carry live formulas, 5×5 scoring, inherent and residual scores, conditional formatting, drop-down lists and an action tracker on every one. An integration matrix carries thirty-eight clause-level rows from 4.1 to 10.2 mapping ISO 9001:2026 against ISO 22000:2018 and FSSC 22000 V7, each marked SHARE, EXTEND or SEPARATE, with the decision recorded and signed. 20 of its 38 clause rows are marked SHARE and 13 EXTEND, which means one context register, one interested parties register, one competence matrix, one calibration register, one document control system, one internal audit programme and one management review across both certificates. One column of that matrix references ASC’s companion FSSC 22000 toolkit, TK02. A master product and process specification holds every parameter once, so no two documents can state a different limit. The whole pack is built on ISO 19011:2026, the fourth edition of the auditing guidelines, including its new remote auditing and virtual location guidance, and was independently proof-read before release by an ISO 9001 lead auditor, a packaging technical manager and a document control specialist. The proof-read and remediation report ships with it.
It is R6 850, at a launch price of R5 480 until 30 November 2026. All ASC prices on this page, for the toolkit and for the courses, are excluding VAT, and no VAT is added at checkout. For comparison, Advisera sells a 61-document ISO 9001 toolkit from US$897, roughly R16 000. Editable Word and Excel, once-off price, no subscription, delivered by email after payment.
We will say the obvious thing: the toolkit does not implement itself. It removes the authoring, which is most of the calendar time, but somebody at your site still has to make the decisions, populate the registers and run the reviews. That is what the courses are for, and it is why we sell both.
Two files, one clause table, a certificate that moves on time. Get the 202-document toolkit with the transition gap analysis checklist and the 123-row audit checklist, and put the right person on the right course.
Get the ISO 9001:2026 toolkit at R5 480 Book the transition course
Where to go next
- New to the standard, or the customer asked and you are starting from nothing: read what ISO 9001 is and what a South African manufacturer needs to know.
- Budgeting the certificate: see what ISO 9001 certification costs in South Africa.
- Already certified to FSSC 22000 and wondering whether you need both: read ISO 9001 vs FSSC 22000, do we need both.
- Want somebody in the room: see our ISO 9001 implementation consulting in Gqeberha, Johannesburg, Cape Town and Durban.
Questions people ask
When was ISO 9001:2026 published and which edition is it?
ISO 9001:2026 was published on 16 September 2026 and is the sixth edition of the standard. It cancels and replaces ISO 9001:2015 and incorporates Amendment 1:2024, the climate change amendment.
When do ISO 9001:2015 certificates expire?
The transition period set by Global Accreditation Cooperation, known as Global ACI, which took over the work of the IAF when the IAF ceased operations on 1 January 2026, is three years, so certified organisations have until 30 September 2029 to complete the transition. From 31 March 2028 new and initial accredited certifications may only be issued to ISO 9001:2026. Confirm the exact dates with your own certification body, and ask at which scheduled audit your transition will be assessed.
What is the biggest change in ISO 9001:2026?
The new dedicated sub-clause 6.1.3 on opportunities. Risks and opportunities are now separated, and opportunities must be determined, analysed, evaluated, planned, integrated, implemented and evaluated for effectiveness in their own right. Most certified sites run a single combined register, so a separate opportunity register is the single biggest new build. The split also flows through to 5.3, 9.1.3 and 9.3.
Does ISO 9001:2026 require a quality manual or a management representative?
No. Neither a quality manual, nor six documented procedures, nor a management representative has been required by ISO 9001 in either the 2015 or the 2026 edition. Clause 5.3 requires responsibilities and authorities to be assigned and communicated, which is not the same as one named title. Anything telling you otherwise is built on the 2008 edition.
Is the climate change requirement new in ISO 9001:2026?
No. The sentence at 4.1, “The organization shall determine whether climate change is a relevant issue”, came from Amendment 1:2024 and was already applicable to the 2015 edition. It is carried into the 2026 text. If you made the dated context register entry in 2024, that requirement is already met.
How long does the ISO 9001:2026 transition take?
For a site already certified to 2015 and running the system properly, allow four to six months of elapsed time, of which the build itself is two to three months part-time. The extra is running the new registers for a quarter so there is a history to sample, and waiting for the audit slot your certification body gives you. Most of the build is the 6.1.3 opportunity register, the three new columns on the 6.3 change record and the rebuilt eight-heading management review agenda. The rest is renumbering and terminology.
ISO 9001:2026 is published by the International Organization for Standardization. ASC Food Safety Consultants is an independent consultancy, training provider and auditing firm. Our toolkits and courses are our own products and are not approved, endorsed or accredited by ISO or by any certification body.