ENGLEWOOD, Colo., May 3 /PRNewswire/ -- Baxa Corporation announces that it has unified its US and European operations under a single notified body, the British Standards Institution (BSI), and achieved registration to the ISO-13485:2003 standard. The company recently named BSI as its new registrar and completed its first official assessment with them. BSI assessed Baxa Corporation’s management system conformity to ISO-13485:2003, the upgrade to the ISO-13485:1996 standard to which it had been previously registered.
“BSI developed many of the original standards that have evolved into our ISO Standards,” noted Pat Hynes, Baxa VP of Global Quality. “The consolidation of Baxa worldwide Quality Systems with the British Standards Institution gives us the advantage of audits and services provided by a recognized world class standards organization.” Management system standards, such as the ISO 9000 series for quality management, provide manufacturers with a model for best practice in organization and operation. Previously, Baxa Corporation’s US and UK operations used different auditors for ISO and CE compliance. Under BSI, the company now has a single world-class auditor for both facilities.
ISO is the International Organization for Standardization. Its standards are developed by technical committees with representatives from many national standards organizations. Consequently, ISO standards tend to have worldwide support. ISO published the new ISO-13485:2003 standard on July 15, 2003. Companies have until July 15, 2006 to make the transition to the new standard as the old standards expire on that date. ISO-13485 is a process standard, requiring medical device companies to demonstrate their ability to supply medical devices and related services that meet customer expectations and comply with regulatory requirements.
BSI Management Systems operates worldwide to provide organizations with independent third-party certification of their management systems, including ISO. Baxa Corporation manufactures medical devices at its Englewood facility that are used worldwide for safe and effective IV admixture, TPN compounding and other pharmacy fluid handling applications.
About Baxa Corporation
Baxa, a customer-focused medical device company, provides innovative, solution-based technologies for fluid handling and delivery. Its systems and devices promote the safe and efficient preparation, handling, packaging, and administration of fluid medications. Key products include Rapid-Fill(TM) Automated Syringe Fillers, Exacta-Med(R) Oral Dispensers, MicroFuse(R) Syringe Infusers, Repeater(TM) Pharmacy Pumps, and Exacta-Mix(TM) and MicroMacro(TM) Multi-Source Compounders; used worldwide in hospitals and healthcare facilities. Privately held, Baxa Corporation has subsidiaries and sales offices in Canada and the United Kingdom; direct representation in Belgium, Denmark, Finland, France, Germany, Luxembourg and The Netherlands; and distribution partners worldwide. Further information is available at www.baxa.com.
About BSI
Founded in 1901, the BSI Group is a leading business services provider to organizations worldwide, with over 2,000 employees in 86 countries. The company provides independent certification of management systems and products; product testing services; the development of private, national and international standards; management systems training and information on standards and international trade. For more information, visit www.bsi-global.com.
Contact: Marian Robinson, Vice President, Marketing Baxa Corporation: 800.567.2292 ext. 2157 or 303.617.2157 Email: marian.robinson@baxa.com Maggie Chamberlin Holben, APR Absolutely Public Relations: 303.984.9801 or 303.669.3558 Email: maggie@absolutelypr.com
Baxa Corporation
CONTACT: Marian Robinson, Vice President, Marketing of Baxa Corporation,+1-800-567-2292, ext. 2157, or +1-303-617-2157, marian.robinson@baxa.com;or Maggie Chamberlin Holben, APR, of Absolutely Public Relations,+1-303-984-9801, or +1-303-669-3558, maggie@absolutelypr.com, for BaxaCorporation
