What's going on with ISO 9001?

What’s going on with ISO 9001?  And how does it affect my organization?

As a representative on TAG176 (the group representing the US in all things ISO), and also working at the international level on TC176 (the international group representing countries across the globe and doing the work of revising the standards), I encourage you to use the information available at www.iso.org to stay informed of changes when they occur.

ISO 9001:2015 is the current version of the Quality Management Systems Standard.

However, there was also a recent change in requirements through the issuing of an “amendment” which takes effect immediately and may require action by your organization to maintain compliance.  And this applies to all organizations which are currently certified and those seeking certification.

There is also a revision underway, with an expected publishing date sometime in 2026.  But, this is different than the “amendment”.

How did this change take place?

The International ISO community has been a strong proponent of global stewardship and has decided to leverage its International Standards in support of the United Nations’ Sustainable Development Goals.  This is available to the public on the ISO website.

The London Declaration on Climate Action was a significant step in deploying ISO’s support of these global initiatives.  And this declaration resulted in the issuance of “amendments” affecting all MSS Management Systems Standards maintained by ISO. These amendments took effect immediately when they were published in February 2024 and are subject to audit for the purposes of ISO certification.

In clause 4.1 the following was added:

• “The organization shall determine whether climate change is a relevant issue.”

In clause 4.2 there’s an added note:

• “NOTE: Relevant interested parties can have requirements related to climate change.”

Many organizations have already addressed climate change in their consideration of their “internal and external issues”.  These subtle changes put forth by the amendment, simply make them more into requirements than suggestions.  So, if your organization has not already considered and addressed climate change, it’s time to do so now.

*It should be noted that it is unlikely these requirements will get any less “toothy” in the next revision of ISO 9001.

Who is affected by the amendment(s)?

All organizations involved in the certification process:

• Organizations seeking certification,

• Certified organizations,

• Certification bodies (conducting the audits and issuing certificates), and

• Accreditation bodies (organizations providing oversight of certification bodies).

What does my organization have to do to maintain compliance?

Expect to be asked in your next third-party assessment.

First, I encourage you to keep your documentation tidy by getting a copy of the amendment(s).  If your organization maintains an authorized, licensed copy of ISO 9001, ISO 14001, ISO 45001 or others affected by the amendments, the amendments are available at no charge.  Contact your provider or wherever you purchased your licensed copy.

Next, your organization should fulfill the requirement by “determining whether climate change is a relevant issue”.  And this should be documented.  Sure, the new requirements don't explicitly call for documentation (yet), but what easier way to demonstrate that it was considered and determined than by documenting it?  And NO, I don’t mean make a new document.  Here are some simple suggestions:

• Add it has having been a discussion/decision point in a management review or other type of decision-making session by management
• If you maintain a strategic plan, SWOT analysis or other risk assessment activity, note your discussion/decision there
• Treat it as a potential change to the QMS and proceed accordingly – who should be aware of this? What actions need to be taken?  By whom?  By when?

And because of the “NOTE” added in 4.2, the decision should include not only your internal organization’s views of climate change, but a clear consideration of your relevant interested parties’ views on it as well.  And, then your organization will determine what actions, if any, are necessary.

Next, if you are certified to any other MSS, such as ISO 14001 or ISO 45001, consider the above requirements in those contexts as well.

And, finally, if your organization is certified to any industry specific standards which are based on any ISO MSS, the new requirements also apply as part of the ISO requirements embedded within your standard.

Please share your experience with us. 

If your organization is scheduled to participate in a third-party assessment, whether it’s for a new certification or an existing surveillance audit, please tell us what happened.  We love to hear stories that can help keep our community informed on how other organizations are managing their quality systems.

Ready to refresh or improve your QMS?

If you need help bringing your QMS up to date with the new standards, contact us and let’s get started.

We can help by informing your team about the goings on with ISO 9001 and how it impacts your organization.  Or you may just want to take a moment to target a particular area of your QMS – perhaps its taking a look at:

• Your KPIs – a kaizen event to validate your KPIs and data analysis is a great way to ensure you’re measuring the right things and collecting the right data to optimize the value of your QMS and get the improvement you’re looking for!
• Your internal audit process – a workshop to ensure that the risks associated with your context and internal and external issues with your relevant interested parties (including climate change) is important to remain compliant with ISO 9001 and other MSS.
• Your corrective action and problem-solving processes – this is the NUMBER ONE concern of top management! When asked, executives and top level managers want staff who can effectively solve problems through critical thinking.  We customize our problem-solving training workshop to use YOUR process and YOUR tools.  And we even use YOUR REAL LIFE problems in the workshop to identify best practices and develop better problem-solving, with a tight focus on doing a better job when “failure to follow procedure” is the culprit.
• Your training processes – this is one of the most difficult processes in a QMS, because it requires some of the most intense and well-coordinated collaboration across organizations. We can help you map your process, measure it and take action whenever training is provided, but the desired competencies are still lacking.

These are just some of the types of projects that can boost your QMS from not only compliance with standards, but with real results of outstanding quality and an excellent customer experience.