Risk-based thinking

considering risks and opportunities in planning

Risk-based thinking means that the organisation considers what could go wrong, and what could be gained, when it plans its processes. ISO 9001:2015 replaced the separate preventive action requirement with it.

The standard does not require a formal risk management method. An FMEA, a risk register or a simple table can be enough if the actions are proportionate to the impact on conformity.

Calculate it

FMEA Worksheet: Severity, occurrence and detection ratings with RPN, priority ranking and CSV export.

Related terms

• PFMEA: process failure mode and effects analysis
• QMS: quality management system
• Context of the organisation: external and internal issues (clause 4.1)