Metrohm 863 Compact Autosampler - Manual (Página 168)

12.3 Quality Management Principles ￭￭￭￭￭￭￭￭￭￭￭￭￭￭￭￭￭￭￭￭￭￭
158 ￭￭￭￭￭￭￭￭ 862 Compact Titrosampler
12.3 Quality Management Principles
Metrohm Ltd. holds the ISO 9001:2000 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 docu-
mented 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 9001:2000 quality management system is
described in Metrohm’s QM Manual, which comprises detailed instructions
on the following fields of activity:
Instrument development
The organization of the instrument design, its planning and the intermediate
controls are fully documented and traceable. Laboratory testing accompa-
nies 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 func-
tionality 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 guar-
antee 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 ana-
lytical problem at hand, delivery of the equipment, user manuals, training,
after-sales service and processing of customer complaints. The Metrohm
service organization is equipped to support customers in implementing
standards such as GLP, GMP, ISO 900X, in performing Operational Qualifi-