This section should describe what the risk management covers.
This plan covers risk management activities from project start to project completion. (1)
From a product lifecycle perspective, the scope covers design, manufacturing, assembly, transport, storage, operation and disposal. (2)
It covers risk of harm to people (patients, users and other) and property with a main focus on people. (3)
In the risk management process, also risks that do not relate to safety may be addressed for customer satisfaction purposes. (4)
Comments and instructions
(1) The plan covers both the development project and the risk management that continues after the design has been released.
(2) The lifecycle phases defined are mandated by the standard.
(3) Please note that the ISO 14971 covers harm to people, property and the environment, but hardly anyone will look for hazards or risks relating to property or the environment.
(4) Can be removed.