As this article is being written, the (final draft) FDIS ISO 9001:2026 global vote has concluded, and we should soon see the new published requirements.

If published as drafted, which is widely expected, one of the most significant changes is an increased emphasis on demonstrating the effectiveness of the quality management system. This will be particularly true for solving issues or problems in your system. And at least in the management review, this effectiveness will need to be documented.

Here’s what to pay attention to in each section of the FDIS.

Introduction

The Terms and Definitions Clause 3.0 will now actually have some definitions. Clause 3.13—“Effectiveness” will be defined as “extent to which planned activities are realized and planned results are achieved.” The word effectiveness appears in the FDIS 32 times.

Based on the FDIS, process effectiveness appears to focus on an organization’s ability to demonstrate that its processes consistently:
• Achieve intended outputs
• Control variation
• Meet customer requirements
• Show continual improvement

So, a critical step that all organizations must take now is to start reviewing how effectiveness is evaluated in their organization and recorded in their management system. If you want to prevent findings from your registrar, you should start now. To do a formal effectiveness review, time is needed to evaluate the changes that are intended to improve the system. This could easily take six months to a year to fully understand whether the change worked (look up the Kirkpatrick Training Evaluation Model, levels three and four).

So functionally, if we get the three-year transition to the new standard, your organization has only two audit cycles to prove that it’s meeting this new focus on effectiveness.

Clause 6—‘Planning’

A new addition in Clause 6 will be the separation of risk and opportunities into their own separate subclauses. This means that you may be required to show two different categories of records, one for dealing with risks and one for opportunities (similar to the preventive action approach used before the 2015 revision). Both subclauses will state that your management system shall evaluate the effectiveness of these actions.

6.1.2—“Actions to address risks” will state, “Actions taken shall be proportionate to the potential impact of the risks on the intended results of the quality management system.”

6.1.3—“Actions to address opportunities” will state, “Actions taken to address opportunities shall be appropriate to the organization’s context and support the achievement of desired results.”

Clause 7—‘Support’

In Clause 7, the word effectiveness is already in subclauses 7.2—“Competence” and 7.3—“Awareness.” With the new focus, these will be examined with greater rigor to see whether your management system is really evaluating the training and learning processes in your organization. The Rice & Munro Training Evaluation Model uses the Kirkpatrick levels 3 and 4 to include the QMS internal audit process to gather data on the effectiveness of the training. 

Clause 9—‘Performance Evaluation’

The real driver that’s pushing this effort will be found in the subclause 9.3.2—“Management review inputs”: 
g) the effectiveness of actions taken to address risks (see 6.1.2)
h) the effectiveness of actions taken to address opportunities (see 6.1.3)

Note that, again, risks and opportunities have been divided into their own separate subclauses, and your third-party auditor will probably expect that your management system will have documented information for each category within your system. Many organizations already have something in the management review documentation dealing with some form of overview of the risks to the organization. What I find missing in many companies—having completed more than 1,030 third-party audits since 2013—is that even when they have a risk matrix or list, opportunities are often absent from it entirely, and neither risks nor opportunities have a column addressing the effectiveness question that auditors will now expect to see.

Clause 10—‘Improvement’

The last note here isn’t new, but with the new focus, it will have a bearing on third-party audits for subclause 10.2—“Nonconformity and corrective action” 10.2.1: When a nonconformity occurs, the organization shall (d) review the effectiveness of any corrective action taken.

Recommendations

From the registrar’s view, this is most commonly seen during the audit finding reviews after a formal site evaluation, where companies will list the plan for correction, the actual correction, and a weak root cause analysis. What is most often missing is whether the correction to the problem actually worked. In future audits, I will be looking for a lot more evidence (documented) that the organization has done some form of evaluation to verify the effectiveness of corrective actions as well as the other areas mentioned to this point.

So what are some practical suggestions to manage the effectiveness requirements by not creating new documents but looking at ways to demonstrate that your quality management system consistently achieves its intended results? The aim should be to build effectiveness into every level of the QMS.

Other areas that could be considered include:

1. Define what ‘effective’ means for each process

Each process should have:
• A defined purpose
• Expected outputs
• Measurable objectives
• Process owner
• Success indicators

For example: Purchasing

Objective: Ensure suppliers consistently provide conforming products.

Effectiveness measures:
• Supplier defect rate
• On-time delivery
• Supplier corrective action closure
• Number of emergency purchases

If these indicators improve or remain within target, the process is demonstrably effective.

2. Move beyond activity metrics

Many organizations measure activity instead of results.

Poor metric
• Number of audits completed

Better metric:
• Percentage of audit findings permanently eliminated 
• Time to implement improvements
• Repeat finding rate

The question becomes “Did the audit improve performance?” rather than “Did we perform the audit?”

3. Use KPIs that connect to business outcomes

Every core process should have leading and lagging indicators.

For example: Production

Leading indicators:
• First-pass yield
• Machine availability
• Operator competency
• Preventive maintenance completion

Lagging indicators:
• Customer complaints
• Scrap cost
• Rework
• Warranty claims

This demonstrates that monitoring drives improvement rather than simply collects data.

4. Make management review evidence-based

Management review should answer questions such as:
• Which processes are performing well?
• Which objectives were achieved?
• Which objectives were missed?
• Why?
• What decisions were made?
• Were previous decisions effective?

Avoid presentations that simply list KPIs. Show trends, analysis, and decisions that result in improvement. The draft standard continues to emphasize effective use of performance information rather than additional documentation.

5. Verify that corrective actions actually work

Instead of closing a corrective action after implementation:
1. Implement the action.
2. Monitor performance.
3. Verify the issue has not recurred.
4. Record the verification.

For example: Complaint—Wrong labels shipped

Action: Barcode verification added

Effectiveness verification (after 3–6 months):
• Zero labeling complaints
• Shipping accuracy increased from 98.4% to 99.9%

This is much stronger evidence than simply stating “procedure updated.”

6. Link objectives to strategic direction

Quality objectives should support business goals.

For example: Business objective—Increase market share

Quality objectives:
• Reduce complaints by 30%
• Improve on-time delivery to 98%
• Reduce engineering changes after release
• Improve first-pass yield

This demonstrates that the QMS contributes to organizational performance rather than operating independently.

7. Demonstrate leadership effectiveness

The draft revision places greater emphasis on leadership, quality culture, and ethical behavior. Auditors are likely to look for evidence that leaders actively use quality information to make decisions and support continual improvement, rather than simply approving documents.

Evidence may include:
• Management review decisions implemented
• Resources provided to address issues
• Improvement projects sponsored by leadership
• Employee suggestions acted upon
• Quality objectives reviewed regularly

8. Measure continual improvement

Maintain an improvement register showing:

This demonstrates that improvement activities produce measurable results.

A practical ‘effectiveness dashboard’

In many cases, time is needed to evaluate the changes before effectiveness can be confirmed. Organizations can satisfy the intent of the revised requirements with a concise dashboard covering each key process:
• Process objective
• KPI target
• Current performance
• Trend (improving, stable, declining)
• Risks affecting performance
• Actions taken for corrective actions, risks, and also opportunities
• Evidence that actions were effective
• Date effectiveness was verified

The proposed revisions to ISO 9001:2026 don’t necessarily require more documentation. Instead, they encourage organizations to demonstrate that their quality management system consistently achieves its intended results. Organizations that embed effectiveness into their processes, objectives, management reviews, and corrective actions will be well positioned for the transition while also strengthening overall business performance.