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Alcan Medical Flexibles receives ISO certification

Alcan Packaging, a division of Rio Tinto Alcan, announces that its Medical Flexibles Americas Commerce, California and Marshall, North Carolina facilities have received the ISO 13485:2003 certification, a quality management standard for medical devices.
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FILED IN:  Trends and Issues  > Regulatory
Three of the four Alcan Medical Flexibles Americas plants have now received this certification. “This certification demonstrates Alcan Global Pharmaceutical Packaging dedication to providing its customers with best-in-class operations,’’ said Michael Rubenstein, President, Alcan Global Pharmaceutical Packaging. “This is an important achievement made possible through the engagement and support of all employees of these plants,’’ he added.
The ISO 13485 certification outlines standards of systematic, management, resources, realization and remedial requirements for medical device manufacturing. This certification promotes an in-depth quality management system, focuses on risk management, specific requirements for product traceability and evaluates the effectiveness of corrective and preventive actions. “The certification of our Commerce and Marshall facilities testifies to our continued commitment to the ISO 13485 standard, and the alignment to our customer’s Quality Management Systems,” commented Jon Anderson, Director of Quality. “Three of the four Medical Flexible facilities completed certification in 2007, and we are working to achieve certification in the Milwaukee facility in 2008.”


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