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: marian.robinson@baxa.com
Maggie Holben, Absolutely Public Relations
303.984.9801 or 303.669.3558
Email: maggie@absolutelypr.com
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