Following a recent in-depth audit of our quality systems and processes, K2 representatives Mark Smith and John Paul Jones were delighted to be presented with an ISO 13485 quality certificate by the British Standards Institute.
Taken from the ISO 13485 page of the BSI website:
“When it comes to medical device manufacturing, patient safety greatly depends on the quality and consistency of medical products, and ensuring effectiveness, control and maintenance of your QMS is critical to customers, stakeholders, patients and users, and regulatory agencies.
The value of ISO 13485 is not just in the implementation, but also in providing a tool for a thorough audit to test the effectiveness of the system. It provides the manufacturer with a higher level of confidence in the ability to consistently achieve and maintain compliance with regulatory requirements. It can also help to minimize surprises and failures which might adversely affect patient safety and damage a manufacturer’s reputation.”
Quality, safety and reliability are key to everything that we do and stand for here at K2, and we’re proud to demonstrate our commitment to those principles through our industry-recognised accreditations.
For more information and to get in touch, please contact us.