Capture risks and opportunities
Under ISO 9001 both belong together. You capture risks and opportunities in the same module.
Risk management under ISO 9001, risks and opportunities in the matrix
You capture risks and opportunities, rate them in the risk matrix and add actions with deadlines. The effectiveness check shows whether an action worked, and that is the decisive evidence in the audit.
30 minutes, free, on your own workflows
In short
What does ISO 9001 require on risks and opportunities?
Clause 6.1 of ISO 9001:2015 requires a company to determine the risks and opportunities that affect the success of its QMS, plan actions to address them and evaluate their effectiveness. No specific method and no documented risk management process is required. In practice a risk matrix of likelihood and impact has proven itself. QuKI keeps risks and opportunities in a risk matrix, with actions, deadlines and effectiveness checks.
| Product | QuKI, QM software with AI |
|---|---|
| Vendor | Digital Airways GmbH, Basel |
| Standards | any standard, such as ISO 9001, IFS, BRCGS, FSSC 22000, IATF 16949, VDA 6.3, ISO 13485 or your own rules |
| Modules | ten, booked individually |
| Delivery | web app in the browser, no installation |
| Hosting | in Switzerland |
| AI | proposes, approval always with the customer, no model training on customer data |
| Sign-in | Microsoft Entra ID (SSO) or email and password |
| Price | from CHF 110 per month by number of employees, all users included |
| Trial | 30 days free |
| Offline | no |
Reviewed by Dario Tomas, CEO of Digital Airways, former quality manager for ISO 9001 and 14001. Digital Airways is ISO 9001:2015 certified. Updated .
Why risks are often rated only on paper
- The risk list was made for certification and has not been looked at since
- Opportunities do not appear in the list at all
- Actions are agreed, nobody checks whether they worked
- For the management review the status has to be gathered from scratch every time
QuKI
How you manage risks and opportunities in QuKI
Rate in the risk matrix
Every risk is placed in the risk matrix. You see at a glance where action is needed.
Actions with deadlines
For every risk you add actions with an owner and a deadline.
Effectiveness check
After implementation you check whether the action worked. That is exactly what the auditor wants to see.
From risk to effective action
- 1
Determine
Capture risks and opportunities from your company’s context.
- 2
Rate
Place them in the risk matrix and prioritise.
- 3
Act
Set actions with an owner and a deadline.
- 4
Check
Evaluate effectiveness after implementation.
What changes for you
- The risk register lives instead of gathering dust after certification
- Opportunities are managed just like risks
- You evidence effectiveness, not just intent
- The management review gets the risk status with no extra effort
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Frequently asked questions
Must risk management under ISO 9001 be documented?
ISO 9001:2015 requires no documented risk analysis and no specific method. In the audit you must be able to show that you determined risks and opportunities, planned actions and evaluated their effectiveness. A maintained list or matrix is the simplest way to do that.
What does ISO 9001:2026 change on risks and opportunities?
The new version was published on 16 September 2026. According to the certification body DQS it separates risks and opportunities more clearly. According to certification bodies the transition period runs 36 months, until September 2029. Which adjustments your system needs is best clarified with your certification body.
Does risk management have its own AI function?
No, the module works without its own AI. Your risk data can still be reached through the AI analysis in the management review, where you ask questions in your own words.
Risks and opportunities that convince in the audit.
In 30 minutes we show you how to rate risks and opportunities in QuKI and track actions through to effectiveness. On your own workflows, with no sales pressure.
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