Issue 140 – ISO 9001:2026 Element 4.0 Context of the Organization… What’s changed?
ISO 9001:2026…
Element 4.0 Context of the Organization… What’s changed?
I appreciate receiving emails with questions and/or comments from readers of this Newsletter… please continue to do so since it provides me with ideas on what these publications should cover. In my last Newsletter (ISO 9001:2026 Newsletter Issue 139) we discussed the topic of “The new ISO 9001:2026 is now published!… Good news or bad?”, and now in this Newsletter we will discuss “ISO 9001:2026 Element 4.0 Context of the Organization… What’s changed?”.
The ISO 9001:2026 Element numbering…
Element 4 – Context of the organization
Element 5 – Leadership
Element 6 – Planning
Element 7 – Support
Element 8 – Operation
Element 9 – Performance evaluation
Element 10 – Improvement
Element 4.0 Context of the Organization consists of four (4) Clauses as listed below:
4.1 Understanding the Organization and its Context
4.2 Understanding the Needs and Expectations of Interested Parties
4.3 Determining the Scope of the Quality Management System (QMS)
4.4 Quality Management System
What does “Context” mean in the title of Element 4?…
This revised edition once again begins by putting things into perspective (context) for you, hence the title of this Element. You may have heard someone in the past use the phrase “let me put this into context for you” while telling a story… because without some background information then the details lose some of their meaning and importance. Keep in mind that it is explicitly stated within the Standard that it is entirely up to you to decide what “context” means for your organization…. so remember that if External Auditors from the ISO Certification Bodies begin to make speeches about what THEY think “context” means for your company.
NOTE: Why am I beginning with Section/Element 4.0 (and not Sections 1.0, or 2.0, or 3.0)? Well that’s because the first time the word “shall” (i.e. requirement) occurs In the ISO 9001:2026 Standard is in Section/Element 4.0, so anything prior to that is just extra information. With that in mind I will however mention that within Section 3.0 (Terms and Definitions) numerous definitions have been added from the 2015 version, which mostly causes confusion/conflict when compared to what’s stated in the ISO 9000 Standard. Stay tuned because I am positive there will be some enthusiastic External Auditors who will want to debate the interpretation of these newly added definitions!
Let’s talk a little more about Element 4… As you might notice from the listing of Clauses (4.1 to 4.4) above, this first Element was placed there for management to decide how they want “Quality” to be handled in their organization. Each of these Clauses contain requirements that spell out what your Customers expect from you. Yes, that’s right, your Customers… because they are the ones who wrote the ISO 9001 Standard, and they did it with their needs in mind.
So that’s the first message, if you think Customers are important for your business then you should want to understand what it is they expect from you regarding the “Quality” of the products and services you sell to them. Even if you don’t think your Customers care about ISO 9001, they do care about the level of “Quality” you are selling to them.
Can you meet your Customers quality requirements without using the ISO 9001 template? Absolutely… To do so you’ll need to implement a number of processes (actually a system of interconnected processes) that you will use to manage “Quality” from the time the Customer tells you what they want until you give them what they asked for… The challenge will be to identify all of the processes you’ll need.
I’ve actually done this as a brainstorming session with a management team who were unsure what value ISO 9001 provided them… So after an hour of building a list of processes (that they would need to manage Quality), I then showed them that it covered 90% of what was already in ISO 9001… which caused some of them to realize that maybe ISO 9001 just might actually be useful.
The point is, if you want to take care of your Customers so they’ll keep buying from you year after year then why re-invent the wheel… If ISO 9001 has already done all the hard work, then why not use its framework for your business and for your Customers?
Clause 4.1 – Understanding the Organization and its Context… what’s changed?
The title of this Clause stays the same and the existing wording within Clause 4.1 remains identical to the 2015 version, including the inserted Amendment about Climate Change that was added in Feb/2024 (The organization shall determine whether climate change is a relevant issue). They did however do some word-smithing… or word-smoothing (a new term I just made up)… to the “NOTES” below this Clause but as with all “Notes”, they are NOT requirements since they do not contain the word “shall”!
Clause 4.2 – Understanding the Needs and Expectations of Interested Parties… what’s changed?
The title of this Clause remains the same and the existing wording within Clause 4.2 was word-smoothed (some deletions and some additions), with one (1) added new “shall” from the 2015 version that won’t pose much of an impact. As was the case with the previous Clause there is the added “NOTE” about climate change from the Feb/2024 Amendment. Again, it is NOT a requirement since it does not contain the word “shall”.
Clause 4.3 – Determining the Scope of the Quality Management System (QMS)… what’s changed?
The title of this Clause stays the same and the existing wording within Clause 4.3 was word-smoothed (again, with some deletions and some additions), and with NO new added “shall” requirements.
Clause 4.4 – Quality Management System (QMS)… what’s changed?
The title of this Clause has changed. They removed the words “…and its processes” at the end, and it is the first time a Clause title has been modified. This shouldn’t pose much of an impact from what it was in the 2015 version. Finally, the existing wording within Clause 4.4 was word-smoothed (yes, once again, with some deletions and some additions), and with NO new added “shall” requirements.
TRAINING OPTIONS FOR ISO 9001:2026?…
Most ISO Registrars and ISO Certification Bodies (CBs) will require that some type of training be conducted within organizations who want to be certified to the newly revised ISO 9001:2026 Standard. The type of training can range from auditor training, to understanding of the changes themselves, to QMS documentation development/revision training.
All previous versions of the ISO 9001 Standard (including this new one) have never required that organizations receive outside, formal training, even though CBs like to push it (see my previous Newsletter ISO 9001:2015 Newsletter Issue 128). However, if you think you’d like assistance with training your employees then likely your Inbox will be inundated with all sorts of offers. Keep in mind that publicly offered training sessions will by definition be generic and vanilla flavored, so as to cover many industries, and not yours specifically… so don’t forget… “the devil is in the details”.
Over the past many years, when the ISO 9001 Standard has been revised, I have provided training for my Clients, which has always been customized to their specific QMS requirements. I plan to do this again with this newly revised ISO 9001:2026 Standard. This training will be offered both onsite at the company’s premises, and/or delivered remotely. I have had good success with “remote” training because it allows the training to be split into smaller segments which accommodates work loads and schedules.
ISG training modules will be as follows:
a) Overview of the changes to the ISO 9001:2026 Standard + a Gap Analysis;
b) QMS Documentation Revision Training;
c) Auditor Refresher Training.
This training will be available either as remote sessions, or as onsite sessions (…feel free to reach out if you have any questions). More details about these training sessions are described below.
Be sure to watch for our next Newsletter issue where I will be answering some of the questions that I get from readers of my Newsletters about how to implement the requirements of ISO 9001:2026 in a specific and practical way, that will also help improve business performance.
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Need Help?
ISO 9001:2026 Internal Audit Outsourcing (we can do it for you OR with you!)
For cost effectiveness, the Internal Audit function can be outsourced to an external experienced auditor on a periodic basis. This will provide an independent and objective assessment to management, of where process issues may exist, along with identifying opportunities for improvement. It will also provide the evidence needed to satisfy the Internal Audit requirements in the ISO Standards.
We have used two different approaches with this service: a) We conduct the entire audit ourselves, or b) We act as the lead auditor, and along with yourself, or your Team of internal auditors, we complete the entire audit together. This latter approach allows you and your people to receive guidance and direction from an experienced lead auditor while at the same time maintaining significant involvement in the internal audit process.
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Auditor Refresher Training for ISO 9001:2026
The one (1) day ISO 9001:2026 Internal Auditor Refresher Training Session is designed to provide employees with the knowledge and practical skills needed to effectively conduct internal audits of their Quality Management System (QMS). The course emphasizes a process-based approach to auditing, enabling participants to assess conformity with the ISO 9001:2026 requirements while also identifying opportunities for continual improvement within your organization. The training incorporates the auditing principles and guidance of ISO 19011, together with the process approach promoted by the ISO 9001:2026 Standard.
Participants will learn how to plan and conduct effective process audits, gather objective evidence, identify any nonconformances, and recognize opportunities for process improvement. Throughout the session, attendees will develop an audit checklist and participate in practical workshops designed to reinforce learning and build confidence in applying audit techniques.
If your organization is looking to satisfy the internal audit competency requirements of ISO 9001:2026, this refresher training provides an effective and practical solution. The course can be delivered either remotely or onsite at your facility. A Training Certificate is provided to each participant, and the training is available for groups ranging from two (2) to eight (8) attendees for the training session minimum charge.
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The one (1) day ISO 9001:2026 Overview of the Changes + Gap Analysis Training Session is focused on providing employees with a clear understanding of the revisions introduced in ISO 9001:2026 and how those changes may impact your organization’s Quality Management System (QMS). Each Clause of the new Standard is reviewed and compared with the previous version, highlighting the specific changes, new requirements, clarifications, and areas requiring attention. Throughout the session, participants will complete gap analysis workshops to evaluate the organization’s existing QMS against the revised requirements.
These workshops help identify two common types of gaps. The first occurs when an existing practice, activity, or process already meets the intent of the new requirement but is not adequately documented within the QMS. In these cases, the focus is on updating documentation to accurately reflect current practices. The second type of gap exists when a required practice or process is not currently in place. These gaps require the organization to develop and implement new processes, document them appropriately, provide the necessary training, and integrate them into the QMS before transitioning to ISO 9001:2026.
By the end of the training, participants will have a solid understanding of the ISO 9001:2026 requirements, a practical roadmap for addressing identified gaps, and the knowledge needed to plan a successful transition to the revised Standard. The course can be delivered either remotely or onsite at your facility. A Training Certificate is provided to each participant, and the training is available for groups ranging from two (2) to eight (8) attendees for the training session minimum charge.
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The one (1) day ISO 9001:2026 QMS Documentation Revision Training Session is designed to provide employees with the knowledge required to update their organization’s Quality Management System (QMS) documentation to meet the requirements of ISO 9001:2026. Building upon the results of a gap analysis, participants will learn how to effectively revise existing documentation and develop new documented information where required.
Throughout the session, participants will review each identified gap and determine the most appropriate method for addressing it. Where current practices already satisfy the intent of the revised Standard, the focus will be on updating procedures, work instructions, forms, and other documented information to accurately reflect existing processes and ensure conformance with ISO 9001:2026.
Where new or revised requirements require changes to the organization’s operations, participants will learn how to design, document, plan the implementation of any new processes, as well as identifying any training required to successfully integrate the revised processes into the QMS.
Practical workshops are conducted throughout the course, allowing participants to begin revising their own QMS documentation during the training session. By the end of the day, attendees will have a clear roadmap for completing the documentation updates required to support a successful transition to ISO 9001:2026.
This course is ideal for those individuals responsible for maintaining QMS documentation. Training can be delivered either remotely or onsite at your facility. A Training Certificate is provided to each participant, and the course is available for groups ranging from two (2) to eight (8) attendees for the training session minimum charge.
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Until next time…
Tim Renaud
Helping Business Professionals Reduce Risk and Remove Waste!