As a leader in the medical device development industry, CLEIO has held ISO 13485 certification since 2020 to ensure the quality and compliance of its services.
This certification requires passing a surveillance audit annually and a recertification audit every three years. In early February 2023, a BSI auditor came on-site to conduct a thorough examination of our quality management system (QMS).
After five days of auditing, our certification was successfully renewed, bringing good news to our entire team and recognition of the quality of the work we achieve daily for our customers.
ISO 13485, a standard that guides and supervises the development of medical devices
The medical sector is one of the most regulated industries in product development because patients’ health is directly involved. There are numerous standards to guide and frame the design of medical devices, whether it is a simple toothbrush, a connected prosthesis, or a device installed in a hospital.
ISO 13485:2016 is one of these standards and specifies the quality management system requirements for this industry. It is internationally recognized by the industry and its role is to prove the regulatory compliance of the development process.
For companies that develop medical devices, ISO 13485 certification is more than a guarantee of quality. It proves that the company can meet applicable regulatory and customer requirements. To obtain it, an auditor visits the site and thoroughly evaluates the documentation, development processes, and projects related to the medical device industry.
What the recertification audit focused on
The recertification process for CLEIO took place over five days at our offices in Trois-Rivières and Laval. The objective of this on-site assessment was to verify the effectiveness of our entire quality management system and demonstrate our commitment to continuous improvement to make it evolve.
All aspects of our work were reviewed, including documentation, sales and purchases, our design and development process, confidential medical information management and risk management, the work environment, and more. To do this, the auditor met with all experts involved in the design of medical devices, including project managers, engineers, and designers.
No major non-conformities were identified
At the end of the audit, no major non-conformities were identified. This excellent news proves that our quality management system is robust, logical, and complies with the standard requirements.