Actions to address risks & opportunities
Changed in ISO 9001:2026
ISO 9001:2026 splits the clause into 6.1.1 (determining risks and opportunities), 6.1.2 (actions to address risks) and 6.1.3 (actions to address opportunities) — each half analysed, evaluated, actioned and checked for effect in its own right. The empty opportunities column is no longer an option.
Plain-language summary
Before things go wrong, work out what could — and what could go right — and plan actions proportionate to the impact on your product and customers.
What the clause is really asking
Take the issues from 4.1 and the parties from 4.2 and turn them into planned action: which risks threaten the QMS achieving its results, which opportunities are worth chasing, what you will do about both, and how you will build that into your processes and judge whether it worked. No formal risk method is prescribed — proportionality is the principle.
What auditors look for
Auditors trace the thread: context issues -> risk register -> actions -> evidence the action happened -> evaluation of effectiveness. They probe whether risks live in the processes (FMEA-style thinking at operations level) or only in a register nobody opens, and whether any opportunity was ever actually pursued.
Typical evidence
Risk and opportunity register; action plans with owners and dates; management review evaluation; process-level risk evidence (e.g. FMEAs as input).
How to comply — recommendations
A one-page register scored simply (impact x likelihood) is enough for an SME. Review it quarterly, retire dead risks, and force at least one opportunity action per cycle — auditors rarely see the opportunity half done, and it is where the business value sits.
Common nonconformities
A risk register created for certification and never updated; risks with no linked action; opportunities section empty; no evaluation of whether actions worked.
Related clauses
IATF 16949: extended by 6.1.2.1-6.1.2.3; ISO 14001 6.1; ISO 45001 6.1
In the book
Chapter 6 — Planning — Risk, Opportunity and the Discipline of Change treats this clause family in full: what it is really asking, what auditors look for, the evidence that satisfies, how to make it work on a real floor, and where companies stumble.
Resources for this clause
- ArticleRisk and opportunity, pulled apart: the restructured clause 6.1
- Toolkit · $29ISO 9001:2026 Transition ToolkitTurn the 2026 changes into a working plan: gap checklist, clause-by-clause guidance and an action plan you can put in front of management.
- Toolkit · $99ISO 9001 Documentation ToolkitStop writing your QMS from a blank page: a fully-written quality manual, ten complete procedures and the working forms, logs and registers behind them — one numbering scheme, already cross-referenced, ready to adapt.
- Free masterclass · ~21 minISO 9001:2026 MasterclassEvery ISO 9001:2026 change from the published text — the six changes ISO names, the renumbering, Annex A as it is, the Global ACI dates and a six-step plan.
- Free course moduleInternal Auditor course — Auditing the New Ground: ISO 9001:2026 Audit Trails
- Course modulePractitioner course — Planning: Risks, Opportunities, Objectives & ChangeClauses 6.1–6.3
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