ISO 13485 Certified for Medical Devices, Labman

Quality assurance for Labman’s medical devices

Katie Simpson Uncategorized

Working with Lloyd’s Register we are delighted to announce that we have achieved the ISO 13485 certificate of compliance to the international standard for medical device quality management. This means that our quality management system has met the requirements and is both appropriate and effective for designing, developing and manufacturing medical devices.

Striving for excellence in every automated solution, Labman’s multi-disciplinary workforce maintain the highest quality of service at every stage of a project. Working stringently to the ISO 13485 framework ensures we can meet and exceed our customers’ expectations within the medical device industry.

Achieving compliance to the ISO 13485 standard was overseen by Labman’s Quality Assurance Manager, Josie Burton. Here is what she had to say about this fantastic achievement:

“This ISO certification represents an important milestone for Labman, and reflects our ongoing commitment to providing high-quality services within the Medical Device industry and to ensuring that we continue to meet and comply with all relevant regulatory quality standards”

Josie Burton – Quality Assurance Manager, Labman.

ISO 9001 Certified

Like many businesses, we are already ISO 9001 certified by UKAS accredited QA International. ISO 9001 is an internationally recognised standard for quality management and ISO 13485 is based on this same framework, with the addition of specific requirements targeted at developers of medical devices.

This means we can now be involved in the design, production, installation and servicing of medical devices and related services as well as providing technical support to the highest international safety and quality standards.

Check out our Quality Page for more information on our quality management systems.

“Achieving ISO 13485 certification is a significant strategic milestone in Labman’s continued growth. The certification allows us to broaden our product development and product manufacturing services into the medical field. Watch this space!”

Ian Riley – Technical Director, Labman.

For Labman, we will continue to demonstrate our commitment to quality systems. Our employees are experts in identifying and understanding our customer’s needs and expectations by providing continuous support, training and maintenance. The dedication of our workforce combined with an ongoing process of audits, makes certain that the quality management systems are maintained, allowing us to achieve continual success at the highest levels.

ISO 13485 accreditation is a proud achievement for the team at Labman and an excellent demonstration of our commitment to quality management. If you are looking for support for your medical device or have any questions, please contact our team today.