Baxa Corporation Recertified to ISO 13485 and EN46001
Baxa Corporation announces its recertification to the standards for ISO 13485 and EN46001. In meeting the demands of these harmonized standards, the company demonstrated that it has the appropriate quality systems in place and that these systems are consistently executed in daily operations. Baxa achieved its original certification to ISO 9001 in 1997, followed by EN46001 in 1998. Today, ISO 13485 is the ISO 9001 quality standard for medical device manufacturers.
Englewood, CO (PRWEB) April 30, 2004 -- Baxa Corporation announces its
recertification to the standards for ISO 13485 and EN46001. In meeting the
demands of these harmonized standards, the company demonstrated that it has the
appropriate quality systems in place and that these systems are consistently
executed in daily operations.
"Maintaining a world-class quality
management system is a key goal for Baxa," affirms Pat Hynes, VP of Global
Quality System. "Our employees are fully trained in the quality requirements for
their positions and understand the important role each plays in providing safe
and effective medical devices." That quality focus is evident in the company's
mission statement and the principles that drive its daily activities.
The
quality assurance standards under ISO 13485 cover Baxa Corporation's drug
handling and administration systems, including oral liquid dispensers, fluid
transfer needles, syringe infusion systems, filters, nutrition compounding
systems, peristaltic pumps, sterile administration bags and oral liquid
vials.
Baxa achieved its original certification to ISO 9001 in 1997,
followed by EN46001 in 1998. Today, ISO 13485 is the ISO 9001 quality standard
for medical device manufacturers. This standard aims to facilitate harmonized
medical device regulatory requirements for quality management systems. Baxa is
certified for both ISO and EN through Orion (ORI), accredited by the Dutch
RvA.
Baxa has designed and manufactured systems to ensure the safe and
efficient handling and delivery of medications for nearly 30 years. As a
manufacturer of devices used in hospital and alternate site healthcare
facilities worldwide, the company feels it is critical to maintain certification
to international quality standards. Customers can feel confident that the
company's products meet rigorous quality standards as well as offering features
that satisfy their needs for safe and effective medication
delivery.
About Baxa Corporation:
A leading provider of devices and
systems for the preparation, handling, packaging, and administration of liquid
medications, Baxa manufactures and markets a wide range of healthcare products
for use in hospitals, critical care units and alternate-site pharmacies.
Headquartered in Englewood, Colorado, Baxa has subsidiaries and sales offices in
Canada, the United Kingdom; Denmark, and Germany; and distribution partners
worldwide. Further information is available at http://www.baxa.com.
About Orion Registrar:
Orion
Registrar is a quality and environmental systems registrar, headquartered in the
Denver area, with partners and associates located throughout the United States
and the world. Orion Registrar is a small, woman-owned business founded in 1994
by Auditors who recognized the need for a professional and fair registration
service in North America. Further information is available at www.orion-iso.com.
Contacts:
Marian Robinson, Vice
President, Marketing
Baxa Corporation: 800.567.2292 ext. 2157 or
303.617.2157
Email: e-mail protected from spam bots
Maggie Holben,
Absolutely Public Relations
303.984.9801 or 303.669.3558
Email: e-mail
protected from spam bots
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Source : http://www.prweb.com/releases/2004/4/prweb122445.htm