ISO 9001:2026, the sixth edition of the standard was published in September 2026. While there have been no major changes to operational clauses it has left many in the industry or new to the standard wondering what has changed and what these changes mean for them. Major changes to the standard include a more explicit requirement for leadership to promote a quality culture, enhanced guidance in the Annex on the meaning of the requirements, and structural changes throughout the standard.
In this article, I outline what has changed, a first 90-days action plan and where training may help with assuring your organization is aligned and conforming.
What Is ISO 9001:2026, and What Is the Timeline?
Publication and status
ISO management system standard gets reviewed every 5 years and a determination is made at the time by the technical committee on whether to revise the standard or not. The decision to revise the standard is made based on inputs from stakeholders and to keep the standard relevant to changes in industry and technology.
The previous revision of the standard was in 2015 when including among other changes the ISO 9001 standard was assigned to the harmonized structure per Annex SL. With the revision of ISO 9001 other standards in the family have already been revised or are in the process of being revised. Examples includes ISO 9000:2026, the glossary of terms used in ISO 9001 and also other guidance standards in the ISO 10000 series.
Transition period explained
The ISO consulting industry at large is pushing the need to implement the changes in your organization quickly. However, as with previous revisions of the standard, certified organizations have up to three years to transition to ISO 9001:2026. The date set for transition is September 2029. In order to make the change cost-effective companies will want to align this with their next surveillance or certification audit. Certification to ISO 9001:2015 will remain valid throughout this transition period. However, companies that are looking to get certified for the first time after September 2027 will need to certify to ISO 9001:2026.
ISO 9001:2026 Changes: What’s Actually Different
What did not change
Before I speak about the changes, I would like to address what remains the same. The standard is still aligned to the harmonized structure and the process approach based on the PDCA cycle. The standard still has clauses numbered 1 through 10 with the emphasis for certification on clauses under 4 through 10. With the changes being primarily in concept your system will likely not need a major rewrite and in some cases based on your current documentation perhaps no re-write at all.
Changes to the standard include the inclusion of relevant terms and definitions within the standard itself, the removal of Annex B and the increase in guidance in Annex A among others. I will cover the detailed changes in the next section
Key changes to explain
- Planning and managing change: In the clauses under 6, to better align ISO 9001 with the structure of other standards (to make integration easier) clause 6.1.2 and 6.1.3 have been added for plans to address risks and opportunities. Clause 6.3 has been strengthened for planning, communicating, monitoring and reviewing QMS changes.
- Climate change: The 2024 amendment to ISO 9001 for climate-related considerations are now added to the standard. A great resource for those struggling with understanding how to apply and audit is the guidance document published by the TC172 Auditing Practices Group.
- Leadership, culture and ethics: As stated earlier there is a new requirement for leadership to promote a quality culture and ethical behavior. QMII’s ISO 9001 Lead Auditor course addresses how organizations can demonstrate conformity to this requirement as also how to audit this for effectiveness. This requirement is further supported by clause 7.3 for awareness.
- Continual Improvement: Clause 10.3 has been removed, and improvement is now covered solely in clause 10.1.
- Performance Evaluation: Additional clarity has been provided on measuring customer perception and the clause for internal audits has seen minor structural changes.
What to Do First: A Practical Starting Plan
Step 1. Get the standard and read the changes
Alright so the heading is stating the obvious. I am, however, often surprised by how many companies do not invest in a copy of the standard because of the high sticker price. The standard will probably not be revised for at least another 7-8 years based on previous revision history. So do not rely on summaries you read on the internet. Purchase a copy, read the standard, underline all the “shall” requirements for these you must implement and conform to.
Step 2. Run a gap analysis
Each time the standard updates is also a great time to review your system through a fresh perspective. With upgrade and certifications, an organization is likely to get enhanced cooperation from all departments. Use the opportunity to review existing documentation to ensure they reflect the “as-is” of how work is done before beginning a gap analysis.
With the as-is review complete, conduct a gap analysis. Having a matrix of which documents align to which clauses of the standard will make it easier to conduct the gap analysis. Keep in mind that because the standard clause structure has changed does not necessitate a change to the documents or numbering within them. A ‘manual’ written to the clauses is often indicative of a system documented for auditors.
Step 3. Brief leadership and secure resources
At any time in the process of transitioning, take time to brief the leadership on what are the new changes, what they mean for them and what they mean for the organization. Brief them on the timeline of the changes and what support you may require from them to implement the changes. Present them with your transition plan, identifying persons responsible for each phase and deadlines. Get their approval for the plan.
This may be a good time to secure a budget for training of personnel to upgrade their auditor knowledge. An ISO 9001 lead auditor or transition course may be the requirement for you. With the auditing standard ISO 19011 updated in 2026 it may be a good idea to take the entire lead auditor course instead of just the transition, especially if your last training was more than three years ago.
Step 4. Update documented information and processes
As I earlier said this is a great time to review the system and upgrade as needed. As a part of this I highly encourage a review of the risk register, if the organization has documented one. Also review your change management procedure and if you have a quality manual make the needed changes. With respect to documentation the ISO 9001:2016 standard has moved away from the use of maintain and retain within the standard. Where documentation si required it now just states shall be available as documented information.
Pro Tip: Keep it proportionate and avoid creating paperwork the standard doesn’t require.
Step 5. Train people
With the upgrades in place, it is now time to conduct refresher training for all personnel within the company. While it is easy to just cover the key changes and what it means for personnel it may be a great time to renew the entire awareness training. In addition to what you expect from all personnel in contributing to quality it’s always great to have a video by leadership conveying their commitment to the system and to providing the resources needed.
Step 6. Test through an internal audit cycle
With the upgrades completed and the system in place, let it run for a month to a month and a half before initiating an internal audit of the system. Do not forget to include the leadership in the audit plan. Here is a link to a recent webinar on Auditing Upstream that addresses this aspect of the internal audit.
Make sure that before your certification body comes in you have completed a management review, following the internal audit and that all findings from the internal audit have been addressed.
Why ISO 9001 Lead Auditor Training Matters During the Transition
What a lead auditor actually does
Having been in the ISO consulting line of work for nearly two decades I see several organizations prefer internal auditor training for internal auditors. This for a variety of reasons. QMII’s recommendation is that at least two auditors on your internal audit team be trained as lead auditors. Choosing a course that is certified by a personnel certification body such as Exemplar Global is an even better choice.
Here is my reasoning for the above. A Lead Auditor course takes a deeper dive on the standard, auditing principles and applying those principles to your management system and your audit program. The participant gets more workshop practice in the additional day of training and in the long run will serve your audit program better. A subjective auditor can slowly kill the audit program and the system. Additionally, providing the employee with certified lead auditor training demonstrates that the company is invested in their personal and professional success.
With the changes the auditor must focus on auditing the top management and not the QMS manager as the leadership for the system. Auditors must be able to interpret the standard correctly and a good auditor makes a good auditee who can challenge certification body auditors when they are being subjective. A good auditing course will get auditors to move beyond focusing on completing a checklist and merely seeking conformity to seeking effectives.
Choosing the right ISO 9001 lead auditor course
Do not choose a course based on the title alone. Ask whether it covers the edition of ISO 9001 you will be working with and the auditing guidance in ISO 19011. If you are taking the training to support your transition, ask the provider how the changes are addressed in the course. You want to understand what the requirements mean for your system, not merely be given a list of what has changed.
As I stated earlier, look for a course recognized by a personnel certification body such as Exemplar Global, and confirm what that recognition covers. Also ask about the trainer’s auditing experience and how much time is spent in practical workshops and role-plays. In my view, being able to explain a clause is only part of the training. Participants need the opportunity to ask questions, review evidence and practice reaching an objective audit conclusion.
Whether you choose virtual or in-person training, consider how you learn best and whether you can set aside the time to participate fully. Do not let the convenience of attending from your desk result in work taking priority over the training. The right ISO 9001 lead auditor training should help you return to your organization ready to apply what you have learned.
Conclusion
The transition is an opportunity to take a fresh look at your system, not a reason to rewrite every document. Keep these three points in mind:
- Read the applicable edition of the standard rather than relying on summaries.
- Confirm your existing certificate’s validity and transition arrangements with your certification body.
- Begin preparing now, with changes proportionate to what your organization needs.
Start by getting the text and conducting a gap analysis against how work is actually done. Brief your leadership, agree on responsibilities and give your people the knowledge needed to make the changes work. If your auditors need a refresher or a deeper understanding of the requirements, explore QMII’s ISO 9001 lead auditor training. Choose training that supports your system and the effectiveness of your audit program. The goal is not simply to get through the next audit, but to have a system that works for your organization.
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About the Author
Julius DeSilva is CEO of QMII (Quality Management International, Inc.), with more than 25 years of experience in quality management systems, maritime safety and security, and information security. A former seagoing officer and Exemplar Global Certified Lead Auditor (ISO 9001, ISO 27001, ISO 50001, RC14001), he has trained over 1,500 professionals as lead auditors and led consulting and auditing engagements across manufacturing, government, maritime, and aerospace sectors. He holds an MBA from the Darden School of Business, University of Virginia, and is an Associate Fellow of the Nautical Institute.
