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PHOENIX -- Ascent Healthcare Solutions, a leading independent third-party reprocessor of single-use medical devices, announces that its Phoenix reprocessing center has been officially recertified as an ISO 13485:2003 facility. This designation is an internationally recognized standard developed to ensure that companies provide medical devices that consistently meet customer and regulatory requirements.
In 2004, Ascent was the first medical device reprocessor to achieve ISO 13485:2003 Medical devicesQuality management systemsRequirements for regulatory purposes certification, and has since passed two mandatory surveillance audits. Recertification is a more extensive required process that occurs every three years.
This achievement shows that Ascent is investing in people, training and technology to enable us to continuously promote quality in everything we do, said John Grotting, chief executive officer. We develop and apply scientifically based state-of-the-art practices specifically designed for cleaning, testing and sterilizing reprocessed medical devices and related services.
During the rigorous five-day inspection, auditors conducted multiple employee interviews and looked at numerous measurable criteria, including customer satisfaction and communication. They also reviewed Ascents historical compliance with statutory, regulatory and contractual requirements. Among other things, the company had to produce documented procedures required by the international ISO accreditation organization, proof of procedures to ensure effective planning, operation and control of processes, written statements of a quality policy and quality objectives, and a quality manual.
According to Grotting, The facility and our employees essentially underwent a top-to-bottom review of all our operations. Everything is considered and weighed from employee training and education to the condition of our infrastructure to our safety measures and response to customer inquiries. Recertification shows we live up to our own high standards, which positively affect our customers and the public at large.
Source: Ascent Healthcare Solutions