Metrohm 827 pH lab Manuale Utente Scaricare il pdf (Pagina 79)

9 Annexe

826/827 pH mètre, Mode d‘emploi 71

9.5.4 Quality Management Principles

Metrohm Ltd., CH-9101 Herisau, Switzerland

CH-9101 Herisau/Switzerland

E-Mail info@metrohm.com

Internet www.metrohm.com

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 do-

cumented and the resulting reports are archived for ten years. The development of soft-

ware for PCs and instruments is also duly documented and the documents and source

codes are archived. Both remain the possession of Metrohm. A non-disclosure agree-

ment 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 de-

sign, its planning and the intermediate

controls are fully documented and trace-

able. Laboratory testing accompanies all

phases of instrument development.

Software development

Software development occurs in terms of

the software life cycle. Tests are per-

formed to detect programming errors

and to assess the program’s functionali-

ty in a laboratory environment.

Components

All components used in the Metrohm

instruments have to satisfy the quality

standards that are defined and imple-

mented 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 guarantee

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

equate equipment for the analytical

problem at hand, delivery of the equip-

ment, user manuals, training, after-sales

service and processing of customer

complaints. The Metrohm service organ-

ization is equipped to support customers

in implementing standards such as GLP,

GMP, ISO 900X, in performing Opera-

tional Qualification and Performance Ve-

rification of the system components or in

carrying out the System Validation for the

quantitative determination of a sub-

stance in a given matrix.

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Metrohm 827 pH lab Manuale Utente Pagina 79

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