LHM Engineering Achieves ISO 13485 Certification for Medical Device Manufacturing

LHM Engineering is proud to announce that we have achieved ISO 13485:2016 certification, marking a major milestone in our commitment to quality and precision in the medical device industry. This certification demonstrates that our quality management system meets the rigorous international standards required for the manufacture and traceability of medical components and assemblies.

What Is ISO 13485?

ISO 13485 is an internationally recognized quality management standard specifically designed for organizations involved in the medical device lifecycle, from design and development to production, installation, and servicing. Certification to ISO 13485 ensures that a company’s processes consistently meet both customer and regulatory requirements, emphasizing risk management, process control, and continuous improvement.

What Is the Process for Certification?

Achieving initial ISO 13485 certification is a two-stage process designed to verify that a company’s quality management system meets the stringent requirements for medical device manufacturing. At LHM Engineering, this process was conducted by NQA, an ANAB-accredited certification body recognized for its rigorous audit standards.

Our certification journey began with Stage 1 with an onsight visit in early October 2024, during which NQA reviewed our documented quality management system to ensure that all required procedures and records were properly established. This stage focused on confirming that our processes were effectively implemented and ready for formal assessment.

Following the successful completion of Stage 1, we advanced to Stage 2 in early November 2024, when NQA performed a comprehensive and multi-day on-site audit. This phase involved an in-depth review of our day-to-day operations, employee training, and adherence to quality procedures across every aspect of manufacturing.

We are proud to share that LHM Engineering completed the certification audit with zero findings, a testament to the strength of our quality system and the commitment of our team.

With ISO 13485 certification now officially achieved, LHM Engineering will undergo yearly on-sight surveillance audits by NQA to demonstrate our continued commitment to quality.

Advanced Machining Capabilities for Medical Applications

LHM Engineering’s expertise in complex 5-axis machining, tight-tolerance components, and challenging materials makes us an ideal manufacturing partner for surgical tools, laboratory equipment, and precision medical assemblies. Our integrated quality management system ensures full material and process traceability, validated inspection methods, and strict control of every stage of production.

By combining advanced manufacturing with ISO 13485 certification, LHM Engineering continues to deliver on our mission: enabling our customers to innovate confidently, accelerate their product development, and bring life-changing technologies to the market.