ISO 9001:2026 changes to Quality Management - what you need to know
The updated version of ISO 9001:2026 was published in September. We have worked closely with certification bodies to understand what those changes are and what evidence they are going to use to assess compliance.
What are the key changes to ISO 9001:2026?
Unlike the fundamental changes made to ISO 9001 in 2015, the ISO 9001 2026 changes are evolutionary. That’s not to say the changes are unimportant, your quality management system will need reviewing and updating.
What are the most important changes to ISO 9001 in 2026?
Potentially the biggest change, depending on what is already in place, is a new concept in clause 5.1.1 (i), leadership. It has an explicit need for you to establish and promote a quality culture and ethical behaviour. You might ask “how do I do that, & what is an auditor going to look for?" All concerned, not least the certification bodies, are working through how to audit this.
We have worked with certification bodies to agree the best approaches. These include
- Adding a values tab to the Business strategy workbook (if you we have used this tool with you)
- Working with you to create suitable statements such as mission, vision and values and as part of policy statements, Code of Conduct etc.
- Many of our clients have commissioned to carry out carbon management systems & reporting, which is a common environmental, social & governance (ESG) demand from their customers.
If you are an existing Episode client we will discuss this with you and agree how we want to meet the requirement.
Another important clarification is the need to focus as much on opportunity as on risk when carrying out strategic risk & opportunity planning. A new clause 6.1.3, “actions to address opportunities” is in place. It highlights the opportunities to address “opportunities that can have a desirable effect on its ability to continually and consistently provide conforming products and services and enhance customer satisfaction”. This has no impact for Episode Consultants clients as our approach has always ensured this anyway. For others, especially those who come from a compliance background, managing opportunities has not been as thoroughly done as it might be.
A good, in our opinion, additional requirement is in clause 8.2.1, customer communication. A new sub clause e) requires the communication of “information related to contingency actions, including where relevant to any disruptions in the products or services provided.” No doubt this came about because of the challenges COVID raised in 2019 & beyond.
The need to consider whether climate change is a relevant issue is now imbedded in the standard, but you will have already addressed the need because of the 2024 addendum (hopefully….?).
The rest of the ISO 9001 2026 changes
All the other changes (and there are changes on every page of the standard) are clarifying, not changing, the expectations. For example, there are now 23 definitions (albeit they are taken directly from ISO 9000, Quality management — Fundamentals and vocabulary). So, no change needed on that particular change. Most changes are in the notes (i.e. guidance, not requirements).
Some of the clarifications are significant, and do help clear ambiguities which has led to some interesting “discussions” with auditors about their interpretation of the standard. We had one auditor insist we needed a PESTLE analysis because note 2 to clause 4.1, organisational context, says context “can be facilitated by” such an approach. Anyone that knows ISO standards knows note are guidance, not requirements.
The main ISO 9001:2026 clarifications
Clause 6.1.2 has been amended to risk management, and it clarifies what risks need to be managed (“risks that can have an undesirable effect on its ability to "continually and consistently provide conforming products and services and enhance customer satisfaction”). Hopefully that is what you have been doing so far anyway.
New clause 6.1.3, opportunity management, as discussed above
Clause 6.3, change management has more, more explicit, considerations:
e. how the effectiveness of the changes will be monitored and evaluated;
f. communication of the changes;
g. how to review the results of the changes.
This s a perennial challenge with clients. Change can be well-managed, but covering all the bases such as amending the management system & providing evidence is often an issue. Often however, change is not well managed and, sadly, it shows.
Clause 7.1.6, organisational knowledge has minor wording changes and has (a useful) note discussing sources of such knowledge. Episode has always ensured this “hit by a bus” cause is dealt with; as our clients have grown & brought in more people, they find it hard to work on, not in, the business because they fail to pass on their knowledge.
Clause 8.4.3, information for external providers, now says where a supplier or contractor has direct interaction with your customers, you have to tell them what to do explicitly.
Clause 9.2.2 (a), internal audit planning, now requires objectives for the internal audits, as well as criteria & scope.
Clause 9.3.2, management review inputs, now states the review must include, not just consider, the list that existed in ISO 9001:2015. It also added the need to include “changes in needs and expectations of interested parties that are relevant to the quality management system.” This has no impact for Episode clients as we always ensure the inputs (plus others not called for but making it a more meaning full review) are documented agenda items.
A side note here – the standard does not say a meeting (i.e. it does not have to be a a single session, and not a meeting. We encourage clients to incorporate the review items into their current management mechanisms. Typically clients have annual strategic planning sessions, quarterly board meetings and frequent operational management sessions, & they deal with the relevant requirements in the right environment.
Get in touch today
For a no-obligation, free half-day session where we will talk you through the ISO9001:2026 changes, review your current management system & make recommendations for changes. We are happy to meet onsite or have an online meeting, whatever suits you best.
Call us on 0113 801 9001, email us on info@episodeltd.com or fill in the form below
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What is quality management and ISO 9001
ISO 9001:2015, quality management systems requirements, is the international standard that specifies requirements for a quality management system (QMS). Organisations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements. It is the most popular standard in the world and can be used as a business management and improvement tool.
The standard will help you become a more consistent competitor in the marketplace. It will provide better quality management that helps you to meet present and identify future customer needs.
It increases efficiency that will save you time, money and resources. It improves operational performance that will cut errors and improves profits. It will motivate, engage and involve staff with more efficient internal processes. It will help you win more high value customers, and achieve improved customer retention with better customer service. It will broaden business opportunities by demonstrating compliance
When done correctly, gaining and maintaining ISO certification is not as complicated as most think. Trust Episode to make ISO work for you, not the other way around.
Contact us today on 0113 801 9001 or click here to email us
It was only by utilising the expert guidance and experience of Episode that Thurston Group was able to attain certification within an exceptionally challenging time frame. We therefore offer our thanks to Episode Ltd. For the diligent and professional services provided. We also look forward to working with them again soon and would not hesitate to recommend their services."
Peter Speight, Senior Divisional Director, Thurston Group, Wakefield
Roger's support was invaluable in terms of gap analysis, recommendations for improvement, and facilitation of the certification process. I would strongly recommend Roger to any organisation wishing to develop or improve its management systems, in a way which minimizes bureaucracy, and focuses on best serving the needs of the organization.
Gary Evans, Flour Corporation, Abu Dhabi
Roger and Sandy at Episode were great in helping us achieve not only one but two ISO standards 9001:2015 and 14001:2015. Episode were extremely helpful from the onset, they were able to break down the ISO standard so they were easily comprehensible and well applied to our business in a sustainable manner. They are a company that offers a guaranteed certification at the end of the process and they delivered it. I believe that the work completed during this process was key to us having won the Leeds Bid contract.
Harvey Mills, Managing Director, Forge Recycling, Leeds.
If Sandy hasn’t already updated you we are delighted to say we passed the transition audit for ISO 9001 and ISO 14001. Sandy did an absolutely fab job and all credit to her, we have loved having both of you here it’s been a pleasure.
I have had a brief chat with Morgan[the CEO] about the next steps and how we manage things going forwards. Morgan will be in touch with you soon about this and getting Episode/Sandy back in on a regular basis. Once again many thanks for everything and especially to Sandy!!
Morag Tearne, HR and Health & Safety Manager, H. Slingsby plc, Shipley
Episode is always prepared to go the extra mile. When in a tight spot the lead consultant carried out an audit for us at very short notice (on a Sunday afternoon) to keep us on track. What is important to us is the advice they give us is practical and tailored to us. The quality of output Episode produces is very high.
This has resulted in us having a multi-year managed service from Episode so as a company we know our ISO 9001, ISO 14001 and ISO 45001 integrated system is up to date and working for us.
Gareth Walters, Financial Controller, Sports Turf Research Institute, Bingley.
When asked by Episode what three things they do well, and what three things they could improve upon, my answers were:
Done well
1. Client Communication, responded to queries very quickly
2. Requirements of the standard were communicated in a simple manner.
3. Assistance from initial implementation to date of assessment was very good.
I can honestly there is nothing I feel they should improve upon.
Paul Hunneybell, Operations Manager, Fenland Fire Contracts Limited, Luton
The consultant worked with the team in Scott Bader Middle East Ltd. to completely re-engineer our Integrated Management System incorporating ISO 9001, ISO 14001 and OHSAS 18001. Until then we were slaves to the ISO audits, with the systems not adding much value beyond certification. Now we have a business management system that really works for us and is truly integrated into our operations. We were also successfully re-certified along the way.
John Kemp, CEO Scott Bader Middle East, Africa and Asia
The consultant really focused on making our systems and processes work better for us, not just help us comply with ISO 9001. He was able to work with Department Heads and Senior Management to shape their strategic thinking about quality and business objectives without telling them what they had to do because the standard says so.
Karim D'Alessandro, HSE Director, Shelf Drilling Inc.