3 quality management principles, Quality management principles – Metrohm 871 Advanced Bioscan User Manual
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5 Appendix
871 Advanced Bioscan / Instructions for Use 8.871.1003
46
5.4.3 Quality
Management
Principles
Metrohm Ltd., CH-9101
Herisau, Switzerland
CH-9101 Herisau/Switzerland
E-Mail
Internet www.metrohm.com
Metrohm Ltd. hold
SQS (Swiss Asso
dits are carried ou
Manual are maint
The steps involved in the design, manufacture and servicing of instruments are fully docu-
mented and the re
for PCs and instru
nts and source codes
are archived. Both remain the possession of Metrohm. A non-disclosure agreement may
be asked to be pr
s the ISO 9001 Certificate, registration number 10872-02, issued by
ciation for Quality and Management Systems). Internal and external au-
t periodically to assure that the standards defined by Metrohm’s QM
ained.
sulting reports are archived for ten years. The development of software
ments is also duly documented and the docume
ovided by those requiring access to them.
The implementat
quality system is
QM Manual, whic
instructions on th
activity:
Instrument de
The organization
sign, its planning
controls are fully
able. Laboratory
phases of instrum
Software dev
Software develop
the software life cycle. Tests are perfor-
med to detect pr
to assess the pro
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.
a constant quality standard. Production
e equip-
complaints. The Metrohm service or-
ganization 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 Vali-
dation for the quantitative determination
of a substance in a given matrix.
ion of the ISO 9001
described in Metrohm’s
h comprises detailed
e following fields of
Manufacture
The measures put into practice in the
production of our instruments guarantee
velopment
of the instrument de-
and the intermediate
documented and trace-
testing accompanies all
ent development.
elopment
ment occurs in terms of
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 th
ogramming errors and
gram’s functionality in a
ment, user manuals, training, after-sales
service and processing of customer