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QUALITY MANUAL
DOCUMENT NUMBER: QA1-001-G
7 April 2008
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PURPOSE & SCOPE
This manual defines the operating practices for the
out in accerdance with this document.
iometrix Quality System. All quality act
is conied
RESPONSIBILITY
The Quality Assurance Director is responsible fer ensuring that this procedure is accurate, understood
and implemented effectively.
INTRODUCTION
The Quality System is defined as a series of procedures and supporting documentation established by
this QUALITY MANUAL with the purpose of meintaining the qualily of Biomelrix operations.
The Biometrix Quality System and QUALITY MANUAL are intended for use by Biometrix employees,
Biometrix Customers and various regulatory agencies. Customers may use this manual to evaluate the
suitablity of Biometrix as a qualified service vendor.
The QUALITY MANUAL and Quality System are written to comply with the ISO'9001:2000 standard and
FDA CGMPs,
The QUALITY MANUAL is organized by processes identified by Biometrix as being key to its operation.
PROPRIETARY NOTICE
This document and all referenced and associated Biomettix documents, herectter referred to as the
Quality System, are proprietary and confidential. On eccasion, the QUALITY MANUAL may be made
available for review by businesses associated with or doing business with Biometrix. At oll times, the
QUALITY MANUAL may not be Copied, cisclosed, or distributed to third parties without express written
permission from Biometix,
he services provided by Blomettix to a customer ore considered proprietary by both, Test reports,
certificates and any other informatian generated for or about @ customer ore confidential and ore
released to third parties only with the express written consent of the customer and Biometrix.
COMPANY DATA
Biometrix sin the business of providing high quality instrumentation services to the biotech ond
pharmaceutical industries. Servicesinclude validation, Calibration, maintenance, commissioning and
related services.
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QUALITY MANUAL
DOCUMENT NUMBER: QAI-001-G
EFFECTIVE DATE: 17 Apfil 2008
52 Biometrix's offices and laboratory space ore located at 127 Rivemeck Road. Chelmsford, MA 01824. The
office may be reached at 978-654-6631 or 800-890-8909. The general fax number is 978-654-6640. The
Biometrix webpage is www.biometti.com
60 QUALITY AUTHORITY STRUCTURE
£1 The Quality Assurance Director ensures that the Quality System is accurate, understood and effectively
Implemented, For more information on the Biemetrix organization, please reference ORGANIZATIONAL
HIERARCHY, document @A3-004,
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QUALITY MANUAL
DOCUMENT NUMBER: QA1-001-G-
EFFECTIVE DATE: 17 April 2008
7.0 BIOMETRIX KEY PROCESSES
Biometrix
Key Processes
60 ESTABLISHING QUALITY POLICY AND OBJECTIVES
61 Quality Policy
61.1 Blometrixis committed to achieving exceptional customer satisfaction. This is achieved by complying
with the Quality System requirements while continuously shriving for improvernent. Quality Objectives
are established and reviewed as described in the QUALITY MANUAL,
82 Quality Objectives
22.1 Biometrix maintains Quality Objectives used to measure compliance wi
's Quality Policy:
"Achieve exceptional customer satisfaction
* Achiave an exceptional level of training for customer service personnel
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