Quality Management Principles - Metrohm 850 Professional IC Manual

7.2 Quality Management Principles

Manufacturer
7.2 Quality Management Principles
￭￭￭￭￭￭￭￭
106
Metrohm Ltd., CH-9101 Herisau/Switzerland
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, 31 March, 2008
D. Strohm
Vice President, Head of R&D
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.
￭￭￭￭￭￭￭￭￭￭￭￭￭￭￭￭￭￭￭￭￭￭
Ch. Buchmann
Vice President, Head of Production
Responsible for Quality Assurance
850 Professional IC– AnCat