Metrohm 871 Advanced Bioscan - Handbuch (Seite 53)

5.4 Gewährleistung und Konformität
871 Advanced Bioscan / Gebrauchsanweisung 8.871.1001
45
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-
ual are maintained.
nufacture and servicing of instruments are fully docu-
lopment of software
documented and the documents and source codes
t may
dits are carried out periodically to assure that the standards defined by Metrohm’s QM
Man
The steps involved in the design, ma
mented and the resulting reports are archived for ten years. The deve
for PCs and instruments is also duly
are archived. Both remain the possession of Metrohm. A non-disclosure agreemen
be asked to be provided by those requiring access to them.
The implementation of the ISO 9001
, which comprises detailed
instructions on the following fields of
activity:
Instrument development
g
sign, its the intermediate
controls are fully documented and trace-
phases of instrument development.
the software life cycle. Tests are perfor-
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
Manufacture
production of our instruments guarantee
a constant quality standard. Production
testing of components, intermediate and
e
Customer support involves all phases of
instrument acquisition and use by the
t for the analytical
problem at hand, delivery of the equip-
er
trohm service or-
ed to support cus-
tomers in implementing standards such
as GLP, GMP, ISO 900X, in performing
Operational Qualification and Perform-
ance Verification of the system compo-
nents or in carrying out the System Vali-
antitative determination
in a given matrix.
quality system is described in Metrohm’s
QM Manual
The measures put into practice in the
The or anisation of the instrument de-
planning and
finished products are prescribed.
able. Laboratory testing accompanies all
Customer support and servic
Software development
Software development occurs in terms of
customer, i.e. consulting to define the
adequate equipmen
med to detect programming errors and
to assess the program’s functionality in a
ment, user manuals, training, after-sales
service and processing of custom
laboratory environment.
complaints. The Me
ganisation is equipp
Components
arises. of a substance
planning and manufacturing procedures,
maintenance of production means and
dation for the qu