DirectMed Parts & Service LLC, a medical imaging parts and service company, has received the ISO 13485:2016 certification for its magnetic resonance imaging (MRI) and computed tomography (CT) parts and service. This achievement is in addition to the company’s ISO 9001:2015 certification.
The International Organization for Standardization (ISO) is the world’s largest developer and publisher of international standards for the implementation of quality management systems. The ISO 13485:2016 Quality Management Standard for Medical Devices represents the requirements for a comprehensive management system for the design and manufacture of medical devices. ISO 9001 specifies requirements for a quality management system where an organization needs to demonstrate its ability to consistently provide products that meet customer and applicable statutory and regulatory requirements.
“Achieving ISO certification demonstrates that DirectMed has successfully implemented a quality management system that conforms to the world-wide standard for medical device and medical imaging parts and service,” said Tim Kearney, Director of Inventory Management at DirectMed. “The ISO 13485:2016 certification represents an important milestone for our company and reflects our commitment to providing high quality products that meet or exceed customer expectations and comply with regulations.”
“This ISO certification is a testament to the high level of performance, quality control and continuous improvement we expect at our company. With an expanding global customer base, this level of rigor is important to ensure our 16,000 imaging products continue to provide reliable and measurable results,” CEO of DirectMed Parts & Service LLC Brad de Koning said.