ISO 14971 risk management

What each level means

The P1–P5 scale is shared across every skill, but what each level means changes with the skill. This is what it looks like in practice.

1. P1

   Describes the process, controls, stakeholders and basic decisions involved in ISO 14971 risk management.

2. P2

   Executes standard ISO 14971 risk management activities accurately within established controls and escalates exceptions.

3. P3

   Owns complex ISO 14971 risk management cases/processes, improves controls and coaches colleagues.

4. P4

   Sets cross-team standards and governance for ISO 14971 risk management, integrating risk, metrics and stakeholder needs.

5. P5

   Defines enterprise strategy or external practice for ISO 14971 risk management and develops other experts.