Management system guidance
6.0 Planning
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6.1 Actions to address risks and opportunities
6.1.3 Actions to address opportunities
Clause 6.1.3 is new in ISO 9001:2026. In the 2015 edition, opportunities were planned in the same clause as risks and were often treated as an afterthought, or simply as the positive side of a risk. The 2026 edition gives opportunities a requirement of their own, reflecting the idea of opportunity-based thinking.
Your organization needs to determine, analyse and evaluate the opportunities that could have a desired effect on its ability to provide conforming products and services consistently, and to enhance customer satisfaction. It must then plan:
- The actions it will take to address these opportunities;
- How those actions will be integrated into, and implemented through, its QMS processes;
- How it will evaluate whether the actions have been effective.
The actions your organization takes should suit its context (Clause 4.1 and Clause 4.2) and help it to achieve the results it wants. The standard gives examples of actions to address opportunities, such as:
- Adopting new practices or ways of working;
- Launching new products or services;
- Creating new partnerships, for example with suppliers, customers, trade bodies or universities;
- Making use of emerging technologies, such as automation, data analytics or artificial intelligence;
- Implementing initiatives and other actions that respond to the current and changing needs and expectations of customers and other relevant interested parties.
Opportunity-based thinking
Risk-based thinking is aimed at preventing undesired results. Opportunity-based thinking is its counterpart: it is aimed at pursuing desired results by recognizing where opportunities exist and taking advantage of them. ISO 9001:2026 expects top management to promote both (Clause 5.1.1), and the process approach is now described as having an overall focus on risk-based and opportunity-based thinking.
In practice, opportunity-based thinking means routinely asking “what could we do better, or differently, to deliver more value to our customers?” when reviewing performance, planning new work or responding to change – not only “what could go wrong?”.
Risks and opportunities are distinct
Annex A of ISO 9001:2026 explains that risks and opportunities are distinct and that they can be determined and addressed through separate processes. Risk is defined in Clause 3 as the “effect of uncertainty”, whereas an opportunity is a set of circumstances that makes it possible to achieve a beneficial effect on QMS performance. An opportunity is therefore not just a “positive risk” or the opposite of a risk.
A risk can sometimes lead to an opportunity – for example, a decision to take a risk in order to pursue an opportunity – but your organization should also look for opportunities in their own right. Many organizations keep a separate opportunity register, or a separate section of the risk and opportunity register, with its own evaluation criteria. As with risks, there is no requirement for a formal or documented process.
Where opportunities come from
Opportunities can be identified by looking at:
- External and internal issues (Clause 4.1), including changes in market conditions, regulations and technology;
- The needs and expectations of interested parties (Clause 4.2);
- Your organization’s own capability, capacity and competence;
- The results of monitoring and measurement, performance indicators, customer feedback and complaints;
- Internal audits, management reviews, benchmarking and suggestions from employees.
Typical opportunities include developing new products, services and processes; developing new markets or increasing market share; improving the work environment; improving productivity; and improving operational efficiency (reduction of resource use, reduction of waste, etc.).
Analysing and evaluating opportunities
Not every opportunity is worth pursuing. Assess each one against its potential benefit (for example to product and service conformity, customer satisfaction, efficiency or market position) and its feasibility (cost, resources, timescale, competence required and any new risks it introduces), and check that it fits the strategic direction of your organization. A simple benefit-versus-feasibility score is usually enough to rank opportunities and decide which to act on.
For example, analysis of customer feedback may show that customers value faster delivery. Introducing an online order-tracking service could be evaluated as an opportunity with a high benefit to customer satisfaction and moderate cost, and so be prioritized for action.
Planning and integrating actions
For each opportunity your organization decides to pursue, plan the action in the same disciplined way as any other piece of work:
- Agree what will be done, the resources required, who is responsible and the timescale;
- Decide how the action will be built into the relevant QMS processes, so that it becomes part of normal operations rather than a separate project;
- Where appropriate, turn the opportunity into a quality objective (Clause 6.2);
- Where the action changes the QMS, plan the change in accordance with Clause 6.3;
- Decide in advance how you will measure whether the expected benefit has been achieved.
Evaluating effectiveness
The effectiveness of actions taken to address opportunities is now evaluated separately from actions on risks (Clause 9.1.3 f)) and is a separate input to management review (Clause 9.3.2 h)). Check that any actions taken to address opportunities are recorded and that the expected benefits were realized. Objective evidence could be in the following various forms:
- Opportunity register or opportunity section of the risk and opportunity register;
- SWOT and/or PESTLE analysis;
- Strategic and business planning documents;
- Marketing and sales data;
- Reports on customer feedback and competitor analysis;
- Improvement project records and quality objectives;
- Design and development reviews for new products and services;
- Management review minutes.
More information on PDCA
Planning
Context
Planning
Support
Doing
Support
Operations
Checking
Monitoring, measurement, analysis and evaluation
Acting
Improvement
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