ALPCO’s Quality Management System Receives ISO 13485:2016 Certification

A photo of the ALPCO quality team with the company's ISO 13485:2016 certificate from Intertek.

October 8, 2018

ALPCO recently announced that its quality management system received the distinguished ISO 13485:2016 certification from Intertek. ALPCO’s certification applies to the design, development, manufacture, and distribution of in vitro diagnostic reagents and kits.

The International Organization for Standardization (ISO) is the prominent and independently led worldwide organization that utilizes experts to develop specifications for products, services and systems for many different industries. ISO 13485:2016 is the gold standard for medical device companies to ensure the quality, safety and efficacy of products in the clinical diagnostics field.

“ALPCO has always been committed to producing in vitro diagnostic products that exceed our customers’ expectations. In order for our quality management system to receive the ISO 13485:2016 certification, we had to undergo a rigorous two-stage audit process conducted by Intertek,” explains ALPCO’s president, Sean Conley. “Our employees’ experience, expertise and commitment to quality were evident throughout this entire process and I am extremely proud of their accomplishments.”

Visit our Quality page to learn more about the ISO 13485:2016 certification of ALPCO’s quality management system.