ISO Information

In 2021, Action Products, Inc. became certified to ISO 13485:2016 Medical Device and Quality Management Systems (QMS). This ISO standard an internationally recognized standard that ensures medical products are safe for their intended purpose through the process of consistent design, development, production, and sales. To be certified to this standard, an organization must demonstrate the ability to provide medical devices and related services that consistently meet customer and regulatory requirements.

For over 50 years, Action Products has had an unwavering mission to design and manufacture pressure injury prevention products made from its proprietary AKTON® viscoelastic polymer. Action’s achievement of certification for the ISO 13485:2016 Medical Device and Quality Management Systems is further evidence of its decades long commitment to manufacturing high quality medical products. Our QMS is the foundation of our Action® brand goods and the contract manufactured products we produce for other healthcare companies around the world.

Our wide range of pressure prevention products (wheelchair cushions, bed pads, patient positioners and O.R. support surfaces) has helped prevent pressure injuries in North America and in over 60 countries globally. Preventing pressure injuries is a primary goal of many hospitals and healthcare systems around the world. In the U.S. pressure injuries affect, on average, 2.5 million patients per year and can cause severe, often unnecessary pain and suffering. In addition, about 60,000 patients die as a direct result from a pressure injury each year. In the U.S. alone, pressure injuries cost $9.1-$11.6 billion per year and it is the second most common claim, after wrongful death, resulting in more than 17,000 lawsuits annually[i]

[i] https://www.hcup-us.ahrq.gov/reports/statbriefs/sb64.jsp

Click here to view the ISO Certificate

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