ISO 9001:
COVVI earned the ISO 9001 certification in Spring 2024, which is an internationally recognised standard for creating, implementing, and maintaining a Quality Management System for a company. Quality Management Systems are the foundation of quality assurance activities and securing the coveted ISO 9001 certification is a testament to our commitment to provide products and services that meet customer and regulatory needs and continually improve customer satisfaction.
ISO 13485:
COVVI also obtained the ISO 13485 certification in Spring 2024 which is an international standard that outlines the requirements for a Quality Management System in the medical device industry. It covers the entire life cycle of a medical device ensuring that is safe and effective for its intended use.
What is the ISO?:
The International Organization for Standardization is one of the oldest, non-governmental, international organisations. It brings global experts together to agree on the best ways of doing things. From climate change to artificial intelligence, their mission is to make lives easier, safer and better – for everyone, everywhere. These international standards ensure that the products and services you use daily are safe, reliable, and of high quality. They also guide businesses in adopting sustainable and ethical practices, helping to create a future where your purchases not only perform excellently but also safeguard our planet. In essence, standards seamlessly blend quality with conscience, enhancing your everyday experiences and choices.
Javid J K, Quality Manager at COVVI, said “I joined the business with an inspiring vision of COVVI, where safety and quality are non-negotiable. This enabled us to go beyond the limits and have the electronic quality management system needed to achieve the ISO 13485 and ISO 9001 certifications. In gaining compliance with the standard requirements, COVVI chose a reliable partner – BSI- a global leader in Certification, Training and Testing delivering high-quality services to help companies meet the growing challenges of quality, safety, environmental protection, and social responsibility. COVVI underwent a rigorous evaluation process, which included quality management system development, a management system documentation review, an audit and an initial assessment which was very successful as no major non-conformances were identified. We achieved this on our first attempt, after over six months of hard work, and this milestone towards full certification is the result of a very strong team effort. Quality is in our DNA, and we look forward to delighting our customers by exceeding their needs and expectations, always complying with the specifications and regulations.”
ISO 13485 is generally harmonised with ISO 9001. After achieving both certifications in April 2024, Simon Pollard, CEO of COVVI, said the following about what this means for COVVI: “This is an amazing achievement from an amazing team. It took over six months of hard work to make sure we met and continue to meet the strict requirements set out by ISO and it is a huge accolade to secure both the 9001 and 13485 accreditations which is a huge tribute to the efforts undertaken from everyone involved from COVVI. Achieving this milestone demonstrates my commitment as the CEO and to the importance of Quality Management Systems and regulatory compliance.
Our dedication to meeting these international standards, enhancing customer satisfaction, and continually improving our overall processes is a huge undertaking. I can’t emphasise how important high levels of quality assurance are to the very foundation of COVVI, and that the whole team is able to consistently produce world-leading products and services in the prosthetics and robotics industry.”