Metrohm 820 IC Separation Center - Manual (Page 118)

6 Appendix
819 IC Detector / 820 IC Separation Center
110
6.5.4 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 ex-
ternal 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 com-
prises detailed instructions on the
following fields of activity:
Instrument development
The organisation of the instrument
design, its planning and the interme-
diate 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 environ-
ment.
Components
All components used in the Metrohm
instruments have to satisfy the quality
standards that are defined and im-
plemented 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 guaran-
tee a constant quality standard. Pro-
duction planning and manufacturing
procedures, maintenance of produc-
tion means and testing of compo-
nents, intermediate and finished pro-
ducts are prescribed.
Customer support and ser-
vice
Customer support involves all phases
of instrument acquisition and use by
the customer, i.e. consulting to define
the adequate equipment for the ana-
lytical problem at hand, delivery of the
equipment, user manuals, training, af-
ter-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 Verifi-
cation of the system components or
in carrying out the System Validation
for the quantitative determination of a
substance in a given matrix.