Reston, Va.-based Aptiv Solutions has achieved the Quality Management System Requirements ISO 9001:2008 certification. This certification is granted when a company demonstrates good management of quality, making sure customers are protected from bad products. Aptiv was granted the certificate after an audit of its medical device operations—created, in large part, due to the recent acquisition of Massachusetts-based MDCI.
Aptiv conducts adaptive clinical trials for the biopharmaceutical and medical device industry, as well as other ancillary services. Specifically for its medical device clients, Aptiv develops a range of regulatory documents; designs all aspects of a clinical trial; manages quality systems and ensures they adhere to regulations; and provides general consulting services.
“Our decision to achieve and maintain ISO 9001:2008 certification is a proactive one that demonstrates our commitment to providing the highest quality medical device operational and consulting services to our clients, now and into the future,” said Vicki Anastasi, senior vice president of the company’s Medical Devices division.
In order for Aptiv to keep the ISO current, the company will be subject to semi-annual audits. Every three years, Aptiv also will have to complete a verification audit and set goals for continued improvement.