Lifa Air Plc has been awarded ISO 13485 certificate for medical device quality management
Lifa Air Plc's quality management system is certified in accordance with the requirements of the medical device standard ISO 13485: 2016. Certification demonstrates that an organization is able to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
The company's management system was first certified more than 20 years ago to ISO 14001-compliant environmental management system standard. Three years later the quality management system was updated and certified to meet the requirements of the ISO 9001 standard. The now certified ISO 13485 quality management system is built to complement the ISO 9001 quality management system to ensure compliance with healthcare requirements for the manufacturing and sales of medical face masks.
ISO 13485 certification is part of the company's long-term strategy: "Our company has started international operations to increase Lifa Air's sales of medical face masks outside Finland. Our company and our products are registered in the European medical device database EUDAMED as required. In addition to registering in this database, professional customers require an ISO 13485 quality certificate. We see this as strengthening the company's opportunities to grow our business internationally in the medical device industry, "commented Vesa Mäkpää, Managing Director of Lifa Air Plc.
Mirella Lehtiö, Lifa Air Plc's Quality and Environmental Manager, adds: "Quality management in accordance with ISO 13485 ensures that the industry's strict requirements are met and provides effective tools for developing operations. ISO 13485 certification is a demonstration of Lifa Air's commitment to high quality and continuous improvement."
The ISO 13485: 2016 certificate was awarded to Lifa Air by LRQA on June 20, 2022. The scope of the certification is the manufacturing and sales of medical face masks.