EMD Aquastar AQV21, Информация по установке, Страница: 30 / 36

9 Declaration of system validation
AQCV21
We hereby give notice that this product / system and its software and accessories, were developed, test-
ed and successfully certified on the basis of the product life-cycle policies of Mettler-Toledo AG, Ana lyt i-
cal. These policies are based on ISO Standard 9001:1994. Life-cycle checkpoint details were reviewed
and approved by the Project Supervisory Group (PSG). The products / systems were tested in respect of
func tion al i ty and specification prior to shipment. In order to support GLP and validation requirements, we
will make the following documents available to authorized persons for inspection:
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Performance specifications
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Software specifications
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Quality plan
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Project management system
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Test Plan
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Customer requirements
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Review reports
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Source code
Mettler-Toledo AG, Analytical will retain possession of all documents and their reproductions and may
wish to conclude a nondisclosure agreement with those requesting access to these documents.
Schwerzenbach,
December 2008 Dr. Chris Radloff
General Manager
Business Unit Analytical Dr. Christof Bircher
Manager Business Area
Analytical Chemistry
ISO 9001 certification for METTLER TOLEDO
Mettler-Toledo AG, Greifensee, was reviewed and evaluated in 1991 by the Swiss Association for Qual-
i ty and Management Systems (SQS), and was awarded the ISO 9001 certificate. This certificate verifies
that Mettler-Toledo AG, Greifensee, has a quality management system in place which meets the require-
ments of the ISO 9000 series of international standards. Repeat audits are carried out by the SQS at
inter vals to verify that the quality management system is properly administered and continuously updat-
ed in relation to operational changes.
Volumetric Titrator 30
Declaration of system validation