Quality Assurance
ISO 13485 certified quality management ensuring the highest standards across all our manufacturing processes and services.
Quality management is the cornerstone of our services. Since 1987, we have developed and continuously improved a robust quality system with procedures for all workflows.
From development, through raw material handling, to our final products. We use modern high-end measuring equipment and machines in all processes.
We are certified in: ISO 13485, ISO 14001, and ISO 45001.
We strive for Right-First-Time principles and solve problems by finding the root-cause, thereby living up to the high quality expected by our customers.
ISO 13485
ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. This standard ensures controls are in place throughout the product lifecycle.
ISO 14001
ISO 14001 sets out the criteria for an environmental management system that helps organizations minimize their environmental impact and comply with applicable laws and regulations. This standard provides a framework for environmental protection, response to climate change, and sustainable resource use through efficient processes and continual improvement.
ISO 45001
ISO 45001 specifies requirements for an occupational health and safety management system, providing a framework for managing risks and improving workplace safety. This standard helps organizations proactively prevent work-related injury and ill health, and provide safe and healthy workplaces.