Breathe BioMedical (BBM) just completed another successful annual surveillance audit for our ISO 13485 certified quality management system (QMS). This certification is an international standard for quality systems for medical device manufacturers across the globe. ISO 13485 demonstrates, by third party review, that BBM’s full end-to-end QMS meets the highest standard for safety and quality. BBM is one of few companies that has ISO 13485 certification in Atlantic Canada. BBM is proud to have obtained and maintained ISO certification since 2021.
Every year, ISO 13485 certification requires passing an external audit by an accredited auditing organization. Last month, an auditor arrived on-site at our facility in Moncton, New Brunswick to complete a surveillance audit of our QMS. The audit was successful, and we are pleased to share that we have achieved continued certification.
The International Organization of Standardization (ISO) highlights this statement on their website, “safety and quality are non-negotiable in the medical devices industry, that’s why we developed ISO 13485.” They go on to say, “this internationally agreed standard sets out the requirements for a quality management system specific to the medical devices industry.”
“ISO 13485 is internationally recognized by the medical device industry and plays a significant role in the design and manufacture of medical devices – the two main aspects of our work here at BBM,” says Breathe BioMedical Chief Regulatory Officer, Sandra Veenstra. “Having our QMS independently audited helps demonstrate BBM’s commitment to quality and also our ability to meet applicable regulatory requirements.”
A huge thank you to our regulatory and quality team who worked extremely hard to prepare for the audit and support the auditor during the two-day assessment. We also want to acknowledge our entire team for the work they do all year to ensure quality within our organization.