Quality is a mindset that influences our tasks, leadership, and interactions, shaping the excellence of the products and services we provide.
Quality is an integral part of all our processes, forming a sum of its parts. It encompasses state-of-the-art standards, product specifications, work instructions, statistics reporting, third-party inspections, and customer satisfaction, forming a basis for all our operations. In the context of medical device quality, safety, performance, and a risk-based approach are paramount, guiding all our decisions and actions.
Our commitment to quality means that all our projects meet, and exceed, your expectations and the deliverables fulfil the requirements of end users as well as relevant standards and regulations.
The flow-chart demonstrates some main components of the overall quality at Innokas from the idea through transformation into a final device and market release. All components are equal and provide important input for the continuous improvement of Innokas’ certified Quality Management System (QMS).
In practice, the improvement happens through persistent monitoring throughout the organization and initiating corrective and preventive actions when necessary. The backbone of the QMS are effective and interactive processes that support the organization not only to meet the requirements set by authorities but also the values we have committed to ourselves as your partner.
Innokas quality management system has ISO13485:2016 and it is utilized as a standard of our operations. Generally, ISO 13485 is a standard for managing the quality of medical devices and applies to organizations engaged in designing, producing, and servicing medical devices. ISO 13485 certified company is committed to regulatory compliance, ongoing risk management across the device's lifecycle, and a focus on documentation, traceability, and quality control on any device.
While quality is the mindset of every Innokas team member, the QMS team oversees the company's quality management system and ensures its operations stay on track. Contact our Head of QMS to learn more.
