ISO 9001:2026 Clause 6: Planning
Published October 23, 2026
Clause 6 of ISO 9001:2026 turns your understanding of the business into action. It covers risks and opportunities, measurable quality objectives and planned changes to the QMS. The 2026 edition gives risks and opportunities separate action requirements and expands what organizations must consider when planning changes.
6.1.1 Connect planning to your context
Consider the context issues and interested-party requirements identified under Clause 4. Determine which risks and opportunities need attention so that the QMS can achieve its intended results, reduce unwanted effects, improve and strengthen desired results.
Keep this connected to actual processes. A list of generic business risks is less useful than understanding how a shortage of trained staff could affect service delivery, or how better scheduling could reduce delays.
6.1.2 Analyze risks and plan proportionate action
Determine, analyze and evaluate risks that could adversely affect the consistent provision of conforming products and services and the enhancement of customer satisfaction. Plan the actions, integrate them into QMS processes and decide how to evaluate their effectiveness.
Actions must be proportionate to the potential effect on the QMS’s intended results. For example, dependence on a sole supplier might justify an alternative source, a suitable stock arrangement or another control appropriate to the product and delivery commitment. Check whether the chosen action actually improves reliability.
The requirement is not satisfied merely by naming a risk. Equally, the standard does not prescribe a particular numerical scoring model or a single risk-register format. Choose a method that supports a reasoned evaluation and effective action.
6.1.3 Evaluate opportunities in their own right
Opportunities also need to be determined, analyzed and evaluated. Plan appropriate action, build it into your processes and evaluate the results. Actions should fit your context and support the desired outcomes.
An opportunity is not simply the reverse of a risk. For example, a simpler customer approval process might shorten delivery time and reduce clarification calls. Define the intended benefit, trial the change where appropriate and compare the results with the starting point.
6.2 Set measurable quality objectives
Establish objectives at the relevant functions, levels and processes. They must align with the quality policy, take applicable requirements into account, and matter to conformity and customer satisfaction. Keep them documented, communicate and monitor them, and update them as appropriate.
For each objective, determine the actions, resources, responsible person, completion timing and evaluation method. For example: reduce incomplete customer orders from 8% to 3% within six months by revising order intake and coaching the team. These figures are an illustration, not an ISO target.
6.3 Plan, communicate and evaluate changes
Make QMS changes in a planned way. Consider the purpose and potential consequences, the effect on system integrity, resources and information, and the allocation of responsibilities and authority. The 2026 requirements also explicitly address communication, monitoring and evaluating effectiveness, and reviewing results.
When introducing new software, this could mean defining the intended benefit, checking interfaces and data needs, assigning ownership, training users and communicating the rollout. After implementation, check whether the new process produces accurate results and whether further action is needed.
For the bigger picture, return to the ISO 9001:2026 requirements overview. For structured learning, explore our ISO 9001 online training. Check the standard edition shown on each course page before enrolling.
Based on ISO 9001:2026, Quality management systems — Requirements. Clause 6 explained in practical terms. Use the standard itself for the complete requirements. Examples illustrate possible approaches, not additional ISO requirements.
