ISO Certifications / Registration - For quality systems standards, ISO recognition is
paramount to competing in a global economy. In order to achieve ISO certification, a
Company needs to implement a quality assurance system, educate its personnel, and
demonstrate to an authorized registrar that the quality system functions in accordance
with the Standard. The Company's earned ISO 13485:2003 certification (specifically
earmarked for medical devices) in 2007. This followed the ISO 9001:2000 general-
industry registration that the Company achieved in 2004.
ISO 9001:2000 Certificate
ISO 9001 is by far the world’s most established
quality framework, currently being used by around
897,000 organizations in 170 countries worldwide,
and sets the standard not only for quality
management systems, but management systems
in general. It helps all kinds of organizations to
succeed through improved customer satisfaction,
staff motivation and continual improvement.
ISO 13485:2003 Certificate
Effective quality management systems are
recognised as a key regulatory consideration for
allowing medical device manufacturers to market
their products around the world. ISO 13485
provides a focus for the quality management
system requirements for medical device
manufacturers.

An ISO 13485:2003, 9001:2000 Registered Company
An ISO 13485:2003, 9001:2000 Registered Company
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155 Gibraltar Road, PO Box 347, Horsham, PA 19044-0347 USA
(215) 441-4000 Worldwide / (800) 257-3282 USA / (215) 443-8820 Fax Worldwide
Website: www.biodatacorp.com / Email: customer.service@biodatacorp.com
© BIO/DATA CORPORATION 2008. All Rights Reserved.
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