Compliance & standards

COMPLIANCE & STANDARDS

Working to international standards

Compliance provides the framework that makes quality demonstrable, as an integral part of our processes.

We work in accordance with:

ISO 9001 (quality management)
ISO 13485 (medical device applications)
ISO 14001 (environmental management)
UL certification, where applicable

These standards guide how processes are set up, monitored, and continuously improved.

GMP-aligned work methods

For applications such as medical and food-grade products, we work according to GMP-aligned principles.

This means:

controlled production environments
documented and validated processes
strict hygiene and handling guidelines

This safeguards not only quality, but also reproducibility and reliability in scaled production.

Audits and documentation

Being able to demonstrate compliance is essential. Not only for certification, but also to provide confidence in how a process is set up and controlled.

That is why process steps, validations, and changes are fully documented and traceable. Internal and external audits verify whether work methods continue to align with the standards and agreements that apply to the application. Not as a one-time snapshot, but as an integral part of the process.

Training and procedures

A standard or system is only as strong as the people who use it. That is why we invest in training, knowledge building, and clear work instructions.

Operators and engineers know what is expected of them — and, above all, why. That combination of understanding and discipline ensures that processes are not only performed correctly, but also remain consistent and reproducible — even over the long term.

Customer-specific

requirements (CSR)

Every market has different requirements. In medical, food-grade, or high-performance applications, the bar is higher and often more specific.

We translate those requirements into process design, validation, and documentation. This sometimes requires adjustments to the work method, environment, or technology. We work together on this, with a dedicated point of contact and a willingness to invest in what is needed to deliver a product solution in a controlled and compliant way.