Metrohm 797 VA Computrace - Manual (Page 123)

4.6 Index
797 VA Computrace / Hardware-Manual 8.797.8001EN
115
4.5.3 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 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
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 per-
formed 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 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 Opera-
tional 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.
4.6 Index
731 Relay Box
Ordering designation......110, 111
Tubing connections ..................49
813 Compact Autosampler
als Lieferoption ...................... 110
Electrical connection................ 47
Operation.................................53
Ordering designation .............110
Tubing connections............48, 49