Drive Medical has successfully obtained ISO 13485:2003 certification, according to a news announcement from Harvey Diamond, board chairman and CEO of Drive Medical.
ISO 13485 is an International Organization for Standardization (ISO) standard, published in 2003, that represents the requirements for a comprehensive quality management system for medical devices.
The ISO Certification was obtained in December 2014 and is valid for three years. ISOQAR was the accredited certification body for this certification and is accredited to audit organizations against a variety of management standards. On a day-to-day basis, this work is regulated by the ANSI-ASQ National Accreditation Board (ANAB).
“We are thrilled that Drive has obtained the ISO 13485:2003 certification; the certification confirms that the necessary quality assurance protocols at Drive are being implemented to deliver superior products for our customers,” said Diamond.
ISOQAR will perform yearly surveillance audits on Drive Medical and its distribution centers in accordance with the ISO 13485:2003 standard.
ISO (International Organization for Standard) is a global, independent non-governmental organization made up of 165 member countries. ISO provides world-class specifications for products, services and systems to ensure quality, safety and efficiency. ISO is an instrumental organization that facilitates international trade and has published over 19,500 International Standards covering almost every industry from food safety to agriculture, to healthcare and technology.