(Article Written by Casey Torname)
Every year, ISO certifications become more thorough and meticulous. Even so, Foxx Life Sciences has matched that status for the last 12 years.
Here at Foxx, safety and quality are non-negotiable and are a big focus from the ground up. Throughout our products' life cycle, our goal is to ensure quality that exceeds industry standards.
“Foxx Life Sciences is seeing huge benefits with the implementation of ISO 13485:2016 Quality Management System in our entire organization. One of the key benefits we are seeing is ‘Evidence-based decision making’ by the functional and executive management, as our system is collecting the facts and data on a continual basis which are being used to make decisions that can align better with the strategic goals and objectives of the company. We are also seeing ‘Increased employee involvement’ as ISO 13485 implementation forces all employees to look for a way to enhance the processes, work with proper documentation and control. Everyone understands their roles and they become more engaged. This results in higher operational efficiency and productivity with added benefit of enhanced customer satisfaction.” Says Senior Vice President of Global Quality & Regulatory Compliance, Syed Rehan A. Rizvi.
ISO 13485: 2016, Medical devices – Quality management systems – Requirements for regulatory purposes, is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry. To become ISO 13485 QMS certified, best practices in each step of a product’s life cycle must be demonstrated through quality management processes, including service and delivery. Strict guidelines and standards must be met and displayed as effective.