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2 quality management principles, Quality management principles – Metrohm 850 Professional IC Anion MCS Prep 3 User Manual

Page 134

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7.2 Quality Management Principles

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850 Professional IC –Anion – MCS – Prep 3

EN 61010-1

Safety requirements for electrical equipment for
measurement, control and laboratory use

This instrument meets the requirements of the ETL Listed Mark for the
North American market. It conforms to the electrical safety standards UL
61010-1 and CSA-C22.2 No. 61010-1. This product is listed in Intertek’s
Directory of Listed Products.

Manufacturer

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, 27 October, 2008

D. Strohm

Vice President, Head of R&D

Ch. Buchmann

Vice President, Head of Production

Responsible for Quality Assurance

7.2

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.