Metrohm 861 Advanced Compact IC - Handbuch (Seite 114)

5 Anhang
861 Advanced Compact IC / Gebrauchsanweisung 8.861.1031
104
5.4.3 Quality Management Principles
Metrohm Ltd., CH-9101 Herisau, Switzerland
CH-9101 Herisau/Switzerland
E-Mail
[email protected]
Internet www.metrohm.com
Metrohm Ltd. holds the ISO 9001 Certificate, registration number 10872-02, issued by
SQS (Swiss Association for Quality and Management Systems). Internal and external au-
dits are carried out periodically to assure that the standards defined by Metrohm’s QM
Manual are maintained.
The steps involved in the design, manufacture and servicing of instruments are fully docu-
mented and the resulting reports are archived for ten years. The development of software
for PCs and instruments is also duly documented and the documents and source codes
are archived. Both remain the possession of Metrohm. A non-disclosure agreement may
be asked to be provided by those requiring access to them.
The implementation of the ISO 9001
quality system is described in Metrohm’s
QM Manual, which comprises detailed
instructions on the following fields of ac-
tivity:
Instrument development
The organisation of the instrument de-
sign, its planning and the intermediate
controls are fully documented and trace-
able. Laboratory testing accompanies all
phases of instrument development.
Software development
Software development occurs in terms of
the software life cycle. Tests are perfor-
med to detect programming errors and
to assess the program’s functionality in a
laboratory environment.
Components
All components used in the Metrohm in-
struments have to satisfy the quality
standards that are defined and imple-
mented for our products. Suppliers of
components are audited by Metrohm as
the need arises.
Manufacture
The measures put into practice in the
production of our instruments guarantee
a constant quality standard. Production
planning and manufacturing procedures,
maintenance of production means and
testing of components, intermediate and
finished products are prescribed.
Customer support and service
Customer support involves all phases of
instrument acquisition and use by the
customer, i.e. consulting to define the
adequate equipment for the analytical
problem at hand, delivery of the equip-
ment, user manuals, training, after-sales
service and processing of customer
complaints. The Metrohm service organi-
sation is equipped to support customers
in implementing standards such as GLP,
GMP, ISO 900X, in performing Operatio-
nal Qualification and Performance Verifi-
cation of the system components or in
carrying out the System Validation for the
quantitative determination of a substan-
ce in a given matrix.