Baxa Corporation Registered to New ISO Standard Under BSI
Baxa Corporation has met the requirements for management systems conformity under the British Standards Institution for ISO-13485:2003. The company recently named BSI as its new registrar and completed its first official assessment with them. 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.
“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™ ?Automated Syringe Fillers, Exacta-Med® Oral Dispensers, MicroFuse® Syringe Infusers, Repeater™ Pharmacy Pumps, and Exacta-Mix™ and MicroMacro™ 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 http://www.baxa.com.
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 http://www.bsi-global.com.
Marian Robinson, Vice President, Marketing
Baxa Corporation http://www.baxa.com: 800.567.2292 ext. 2157 or 303.617.2157
Maggie Chamberlin Holben, APR
Absolutely Public Relations http://www.absolutelypr.com: 303.984.9801 or 303.669.3558
Maggie Chamberlin Holben, APR
303.984.9801 or 303.669.3558