ISO 14971 risk management
Ability to apply ISO 14971 risk management practices and professional judgment to deliver reliable outcomes in quality & regulatory contexts.
Qué significa cada nivel
La escala P1–P5 es común a todas las habilidades, pero lo que significa cada nivel cambia según la habilidad. Esto es lo que se espera observar.
P1
Describes the process, controls, stakeholders and basic decisions involved in ISO 14971 risk management.
P2
Executes standard ISO 14971 risk management activities accurately within established controls and escalates exceptions.
P3
Owns complex ISO 14971 risk management cases/processes, improves controls and coaches colleagues.
P4
Sets cross-team standards and governance for ISO 14971 risk management, integrating risk, metrics and stakeholder needs.
P5
Defines enterprise strategy or external practice for ISO 14971 risk management and develops other experts.
Fuente: PROCOMER FTZ employer benchmark