Qualification documents

The balance within the quality management system

Documentation plays a very central role in all quality management systems, (ISO 9000ff,
DIN EN ISO/EC 17025, GMP, GLP).

These documents provide the qualification of equipment that its use as test equipment.

Monitoring of the test equipment must include initial commissioning and regular checks.

Qualification of equipment is categorized as follows:

 Design Qualification (DQ)

 Installation Qualification (IQ)
 Operation Qualification (OQ)
 Performance Qualification (PQ)
 Maintenance Qualification (MQ)

Design Qualification
Design Qualification establishes the requirements of the test equipment. This ensures
that you receive the most suitable equipment for your requirements.

Installation Qualification
The Installation Qualification ensures that the equipment has been supplied properly
and correctly commissioned.

Precisa Gravimetrics AG supplies a Test Report for this purpose.

Operation Qualification
Manufacturers’ specifications are based on optimum measuring conditions. The
Operation Qualification checks and records the performance of the equipment under the
prevailing conditions at the point of use. The Operation Qualification includes checks of
the calibration, standard deviation, corner load and linearity of the balance. Details of
training on the equipment can be recorded here.

The Standard Operating Procedure (SOP) and the Test Report are provided by Precisa
Gravimetrics AG.

Performance Qualification
The Performance Qualification ensures that the equipment conforms to the
requirements of its use under realistic conditions. The Performance Qualification is
customer specific and specially important for weighing of hygroscopic, electro-statically
charged or unstable test samples.

Maintenance Qualification
The Maintenance Qualification describes the required maintenance such as periodic
maintenance, cleaning and general repairs.