2 quality management principles, Quality management principles – Metrohm 843 Pump Station with membrane pump User Manual

Page 33

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9 Conformity and warranty

843 Pump Station with Membrane Pumps

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25

Metrohm Ltd. is holder of the SQS certificate ISO 9001:2000 Quality man-
agement system for development, production and sales of instruments
and accessories for ion analysis.

Herisau, 19 September 2007

D. Strohm

Vice President, Head of R&D

Ch. Buchmann

Vice President, Head of Production

Responsible for Quality Assurance

9.2

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 instruc-
tions on the following fields of activity:

Instrument development
The organization of the instrument design, its planning and the intermedi-
ate 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 environment.

Components
All components used in the Metrohm instruments have to satisfy the qual-
ity standards that are defined and implemented for our products. Suppli-
ers of components are audited by Metrohm as the need arises.

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