According to the standard, organizations should monitor and review issues that may impact their operations or long-term viability. The significance is determined by the context or the needs of those affected. If relevant changes occur, they must be incorporated into the system so that future processes can benefit from them.

The standard requires that the interactions between quality-relevant processes are documented. This must also be guaranteed for all functions:

• Clear formulation of the tasks to be fulfilled

• Definition of responsibility, competence and interfaces

• Provision of the resources required for fulfillment

• Monitoring the implementation of processes and evaluating their success

• Systematic identification of risks and opportunities

Customer focus and the resulting increase in customer satisfaction are key components of continuous improvement.

The step-by-step procedure follows the PDCA cycle so that all operational processes can be constantly analyzed and improved.

Risks and opportunities are important in connection with the objectives and processes of an organization. Risks and opportunities must be assessed each time the QM system or its processes are introduced, maintained or improved. By anticipating events and planning accordingly, companies are better able to prevent problems from occurring.