ISO 13485

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 13485.

2. P2

   Executes standard ISO 13485 activities accurately within established controls and escalates exceptions.

3. P3

   Owns complex ISO 13485 cases/processes, improves controls and coaches colleagues.

4. P4

   Sets cross-team standards and governance for ISO 13485, integrating risk, metrics and stakeholder needs.

5. P5

   Defines enterprise strategy or external practice for ISO 13485 and develops other experts.

Roles that ask for it

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