Blog
What is risk-based thinking in ISO 9001?
Risk-based thinking requires organizations to consider risks and opportunities that can affect the intended results of the QMS.
Examples of quality-related risks include:
- Supplier delays
- Equipment breakdown
- Incorrect specifications
- Lack of competent personnel
- Software failures
- Inadequate inspection
- Incorrect customer information
- Material shortages
Organizations should determine appropriate actions to address significant risks and opportunities.
The standard does not require every organization to use a particular risk assessment methodology. The approach should be appropriate to the organization's circumstances.