ISO Certifications

Certified Quality. Every Repair.

When a medical device leaves your facility for repair, you need more than a promise — you need proof. ISO certification is the internationally recognized standard for quality management, providing independent, third-party verification that a repair partner operates with documented processes, traceable outcomes, and a genuine commitment to continuous improvement. At BMES, we hold dual ISO certifications that together cover both general quality management excellence and the specific demands of the medical device industry.

ISO 9001:2015 Quality Management Systems

ISO 9001 is the world's most widely recognized quality management standard, with more than one million certificates issued to organizations in 189 countries. Earning this certification means BMES has established — and is held accountable to continuously improving — a formal quality management system (QMS) built around consistent service delivery, customer satisfaction, and risk-based thinking.

For you, it means every repair follows documented procedures, every technician is accountable to a defined process, and every outcome is traceable. Nothing is left to chance. ISO 9001:2015 is the foundation of how we operate.

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ISO 13485:2016 Medical Devices: Quality Management Systems

ISO 13485 is designed to be used by organizations involved in the design, production, installation, and servicing of medical devices and related services. It builds on the principles of ISO 9001 while adding requirements specific to the medical device sector — including device traceability, regulatory compliance, and risk management practices oriented toward patient safety.

For a depot repair company like BMES, ISO 13485:2016 certification means our servicing processes meet the same quality management framework referenced by regulatory bodies worldwide. When you ship a device to BMES, it's handled under a certified system built for exactly this purpose.

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