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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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Instant download. Editable files. One-organization licence. 30-day money-back guarantee.

One-organization licence · Free updates for this edition · Email support· Purchase terms

  • 30-day money-back guarantee. If it does not fit your QMS, email us within 30 days for a full refund. Conditions.
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This is one of the 11 tools in the ISO 9001:2026 Transition Toolkit. Get all 11 for $199, about $490 of tools bought separately.

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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

  1. Show me how you determined opportunities, and who was involved. Have ready: workshop notes or the opportunity sheet with owners.
  2. Pick one risk action and one opportunity action. How do you know each worked? Have ready: the effectiveness review columns, completed.
  3. 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

  1. Copy your existing entries into the two sheets.
  2. Rescore using the matrices and record treatment or pursuit actions.
  3. 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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Three ways to buy ISO 9001:2026 templates

Already certified to the 2015 edition? The Starter Bundle or the Transition Toolkit updates what you have. Building or rebuilding the whole system? The Complete Kit adds the manual, procedures and forms. Upgrade credits mean you never pay twice.

What is includedTransition Starter Bundle The three planning tools, for a quick first pass $99 bought separately $117View Transition Starter BundleTransition Toolkit Every tool for an in-house 2015 to 2026 transition $199 bought separately $490View Transition ToolkitBest sellerComplete QMS Kit A full QMS: manual, procedures, forms and all 11 tools $349 bought separately $569View Complete QMS Kit
ISO 9001:2015 to 2026 Change MatrixIncludedIncludedIncluded
Gap Analysis Workbook (178 lines)IncludedIncludedIncluded
Transition Plan Template with Gantt chartIncludedIncludedIncluded
Internal Audit Checklist (253 questions)Not includedIncludedIncluded
Risk and Opportunity Register, and Change Management Procedure and LogNot includedIncludedIncluded
Context, Interested Parties and Climate Change Pack, and Organizational Knowledge RegisterNot includedIncludedIncluded
Management Review Pack, and Quality Culture and Ethical Behavior PackNot includedIncludedIncluded
Awareness Training Kit (train unlimited staff)Not includedIncludedIncluded
Start-here guide sequencing a 20-week transitionNot includedIncludedIncluded
33-page Quality Manual and 20 procedures (QP-01 to QP-20)Not includedNot includedIncluded
43 forms and registers, with a pre-filled Master Document ListNot includedNot includedIncluded
24-week implementation roadmap for first-time certificationNot includedNot includedIncluded
Optional 60-minute onboarding call with the authorNot includedIncludedIncluded
30-day money-back guarantee, instant download, one-organization licence, free updates for this edition Included Included Included

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What every download includes

Instant downloadLink on the confirmation page and by email within minutes.
Fully editableExcel (.xlsx) and Word (.docx). No macros. Works in Microsoft 365 and Google Workspace.
30-day money-back guaranteeIf the files do not fit your QMS, ask for a full refund within 30 days. Conditions apply.
Free updatesRevised files for this edition of the standard are sent to you at no charge. We email you the new files. Version history.

Templates refer to clause numbers and describe requirements in our own words. They do not reproduce the text of any ISO standard, so you need your own licensed copy. Templates support your system; they do not guarantee certification. Licence, updates and refunds in one place: purchase terms. Sold by ISO Cloud Consulting LLC.

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.

Can I get a refund?

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.

Can I see the files before I buy?

Yes. The images above show real pages from the files, and most kits have free sample pages you can download with your email address. You can also see a fully worked example of a procedure and its linked records.

Will I get updates?

Yes, for the edition of the standard this product covers. Corrections, amendments and guidance changes for that edition are sent to you free, by email, for as long as we sell the product. If the standard is replaced by a new edition, the new kit is a separate product and existing buyers get an upgrade discount. See the version history.

Can I use the templates with more than one company?

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.

Ishan Maharaj, founder of ISO Cloud Consulting

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.