Abingdon Health (“Abingdon”) has confirmed successful transition to the revised standards of ISO 9001:2015 (“ISO 9001”) & ISO 13485:2016 (“ISO 13485”).
The confirmation follows the completion of a successful transition audit conducted by Lloyd’s Register Ltd (LR). An ISO 9001 certification is based upon implementation of a Quality Management System across all areas of the business, including; Facilities, People, Training, Services and Equipment. All ISO standards are reviewed every five years and ISO 9001:2015 has more focus, inter alia, on risk management and continuous improvement procedures and processes.
ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. ISO 13485:2016 brings the Quality Management System (QMS) more in line with global regulatory requirements and specifically incorporates risk-based decision making throughout the process of manufacturing a medical device.
Marsha Leeman, Abingdon Health’s Quality and Regulatory Director, commented.
“The achievement of the revised ISO 9001: 2015 and ISO 13485: 2016 certifications underlines our commitment to our four building blocks: Quality, Customer, People and Collaboration. We strongly believe that achieving excellence in each of these areas will drive success and the achievement of our Company objectives to the benefit of all our stakeholders; investors, employees, customers and suppliers.
“It is testament to the continued hard work shown by everyone in the company, particularly the Quality and Regulatory team, that we have passed the audit and been recommended for the transition to the revised standards”.