3.8 Staff qualification
WARNING!
Danger of damage and injury due to commis-
sioning by unqualified staff!
If commissioning is performed incorrectly by
unqualified staff, serious damage to the chilled
goods can result, which in turn can seriously harm
patients.
– Have all tasks performed only by staff qualified
for those tasks.
– Keep unauthorised persons away from the
working area.
Medical products may in principle be set up, operated, used and
maintained only by persons who have the necessary training or
skills and experience.
This manual specifies the staff qualifications for various fields of
activity as listed below:
Inspector
The inspector is responsible for the safety inspection according to
the Medical Devices Operator Ordinance.
They must only perform these tasks if they have the necessary
qualifications and independence:
n They must have the training, skills and practical experience to
ensure that the safety inspections are performed correctly.
n They must not be subject to any direction as regards the
inspection activity.
n They must have suitable measuring and testing equipment.
Trained medical technicians are suitable, for example.
The inspector must provide proof of their qualification upon request
by the responsible authority.
System/network administrator (recommended)
The system/network administrator has the training, IT skills and
experience required to set up the system requirements and
working environment, including all technical equipment, to enable
the software to be used.
The system/network administrator performs the following duties:
n Installing KIRSCH-DATANET
n Integrating the unit in the network
The system/network administrator has been authorised by the
owner to manage the users of the software and to make settings to
the software.
Inadequate staff qualification
Staff qualifications
Safety
Staff qualification
18.12.2018 Refrigerator/freezer BL series 33
To Next Page
Loading...
