Metrohm 864 Robotic Balance Sample Processor Manuel d'utilisateur télécharger pdf (Page 87)

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8 Konformität und Gewährleistung

864 Robotic Balance Sample Processor

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EN 61010-2-081 Particular requirements for automatic and semi-

automatic laboratory equipment for analysis and

other purposes

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, 10 January, 2008

D. Strohm

Vice President, Head of R＆D

A. Dellenbach

Head of Quality Management

8.2 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.

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Metrohm 864 Robotic Balance Sample Processor Manuel d'utilisateur Page 87