Risk & Opportunity Register (ISO 9001:2026 Clauses 6.1.2 & 6.1.3)
Risk & Opportunity Register (ISO 9001:2026 Clauses 6.1.2 & 6.1.3)
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ISO 9001:2026 sets out actions to address risks (6.1.2) and actions to address opportunities (6.1.3) in separate sub-clauses, after a general clause on determining them (6.1.1). This Excel register gives each its own sheet, scoring method and effectiveness review, so your records follow that structure.
What you get
- Risk register with likelihood and consequence scoring on a 5 by 5 matrix, inherent and residual ratings, treatment actions, owners, dates and effectiveness review.
- Opportunity register scored on benefit and feasibility, with pursuit decisions, actions and results.
- Automatic heat maps for both registers and a one-page summary for management review.
- 48 example entries (28 risks and 20 opportunities) for manufacturing and service businesses, including supply disruption and continuity risks.
- Word procedure (8 pages) for determining, analyzing, evaluating and acting on risks and opportunities and integrating actions into QMS processes.
Who it is for
Companies whose current register mixes risks and opportunities in one list, or treats opportunities as an afterthought.
3 questions your auditor will ask about risks and opportunities
- Show me how you determined opportunities, and who was involved. Have ready: workshop notes or the opportunity sheet with owners.
- Pick one risk action and one opportunity action. How do you know each worked? Have ready: the effectiveness review columns, completed.
- How do the actions in this register reach your processes, objectives or plans? Have ready: objectives, procedures or plans that cite register items.
These are examples. Questions vary by auditor and organisation. The two-sheet register and effectiveness review columns in this product give you the records to answer them.
Good to know
The standard does not require a risk register, two separate registers or a particular scoring method. The two-sheet layout and the scoring scales are design choices of this template, and you can edit them. The scoring scales are examples. Template version 1.1 (October 2026), checked line by line against ISO 9001:2026 as published on 16 September 2026.
How to use it
- Copy your existing entries into the two sheets.
- Rescore using the matrices and record treatment or pursuit actions.
- Review effectiveness at each management review using the summary sheet.
Watch: how this works in practice
Watch: Risks and opportunities done properly: the register that auditors like and managers actually use.
Watch: This is week five of twelve weeks to ISO 9001:2026. Twelve weeks to ISO 9001:2026, week five: risks and opportunities, handled separately.

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|---|---|---|---|
| ISO 9001:2015 to 2026 Change Matrix | Included | Included | Included |
| Gap Analysis Workbook (178 lines) | Included | Included | Included |
| Transition Plan Template with Gantt chart | Included | Included | Included |
| Internal Audit Checklist (253 questions) | Not included | Included | Included |
| Risk and Opportunity Register, and Change Management Procedure and Log | Not included | Included | Included |
| Context, Interested Parties and Climate Change Pack, and Organizational Knowledge Register | Not included | Included | Included |
| Management Review Pack, and Quality Culture and Ethical Behavior Pack | Not included | Included | Included |
| Awareness Training Kit (train unlimited staff) | Not included | Included | Included |
| Start-here guide sequencing a 20-week transition | Not included | Included | Included |
| 33-page Quality Manual and 20 procedures (QP-01 to QP-20) | Not included | Not included | Included |
| 43 forms and registers, with a pre-filled Master Document List | Not included | Not included | Included |
| 24-week implementation roadmap for first-time certification | Not included | Not included | Included |
| Optional 60-minute onboarding call with the author | Not included | Included | Included |
| 30-day money-back guarantee, instant download, one-organization licence, free updates for this edition | Included | Included | Included |
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Questions about Risk & Opportunity Register (ISO 9001:2026 Clauses 6.1.2 & 6.1.3)
Does ISO 9001:2026 require a risk register?
No specific document is named. The standard requires you to determine, analyze and evaluate risks and opportunities, plan actions, integrate them into your processes and evaluate their effectiveness. A register is a simple way to show that.
How are risks and opportunities organized in the 2026 edition?
Clause 6.1 has three sub-clauses: 6.1.1 on determining risks and opportunities, 6.1.2 on actions to address risks and 6.1.3 on actions to address opportunities. Annex A notes that they can be handled through separate processes, but separate registers are not required.
Can I keep my existing risk matrix?
Yes. The scoring scales are editable, and the heat maps update to match.
How will I receive the files?
A download button appears on the order confirmation page and the same link is emailed to you within a few minutes. Bundles arrive as one ZIP file.
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Yes. With our 30-day money-back guarantee, if the files do not fit your quality management system you can ask for a full refund within 30 days of your order. It applies once per customer and organization, covers the whole product, and requires you to confirm you have deleted the files. We also refund non-delivery, defective files, wrong items and duplicate purchases within 30 days. Read the full refund policy.
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Each purchase is licensed to one organization (one legal entity). Consultants can use one product with up to 10 client organizations with the Consultant Multi-Client Licence, including applying their own or the client's branding. See consultant rights and the licence agreement.
Who wrote these templates
Ishan Maharaj
Founder and Principal Consultant
BSc Engineering (Industrial) Honours and MSc Engineering Management
An industrial engineer who has worked in regulated medical device manufacturing throughout his career, in senior operations and quality leadership roles since 2019. Every template on this site was written and checked by him against the published standard, and the same person answers your questions.
Working in medical devices too?
If your organization is also ISO 13485 certified, these templates apply the same requirement to a medical device quality system.

