1 quality management principles – Metrohm 838 Advanced Sample Processor Installation Instructions User Manual
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6.5 Declaration of Conformity
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Metrohm 838 Advanced Sample Processor,
6.5.1 Quality Management Principles
Metrohm AG, CH-9101 Herisau, Switzerland
CH-9101 Herisau/Switzerland
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
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 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 per-
formed to detect programming errors
and to assess the program’s functional-
ity 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 or-
ganisation is equipped 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
Validation for the quantitative determina-
tion of a substance in a given matrix.