Metrohm 818 IC Pump - Handbuch (Seite 53)

6.5 Gewährleistung und Konformität
818 IC Pump / Gebrauchsanweisung 8.818.1021
47
6.5.3 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
audits 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
documented 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
activity:
Instrument development
The organisation of the instrument
design, its planning and the intermediate
controls are fully documented and
traceable. Laboratory testing
accompanies all phases of instrument
development.
Software development
Software development occurs in terms of
the software life cycle. Tests are
performed to detect programming errors
and to assess the program’s
functionality in a laboratory environment.
Components
All components used in the Metrohm
instruments have to satisfy the quality
standards that are defined and
implemented 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
equipment, user manuals, training, after-
sales service and processing of
customer complaints. The Metrohm
service organisation is equipped to
support customers in implementing
standards such as GLP, GMP, ISO 900X,
in performing Operational Qualification
and Performance Verification of the
system components or in carrying out
the System Validation for the quantitative
determination of a substance in a given
matrix.