A Quality Management System (QMS) is a framework that organizations use to ensure their products and services are consistent, safe and effective, and that they meet all user requirements.

BioSystems operates under internationally recognized standards and regulations such as:

• ISO 9001, which focuses on overall quality management (since 1996).

• ISO 13485, specifically designed for medical devices and in vitro diagnostics (since 2004).

• Regulation (EU) 2017/746, a regulation of the European Union on the placing on the market and putting into service of in vitro diagnostic medical devices (IVD).

These certifications and regulations are not just labels: they require continuous audits, strict documentation, and ongoing improvement.

While certifications like ISO 9001 and ISO 13485 provide the framework, the real value lies in how quality is embedded into the company culture.

At BioSystems, quality is:

• Proactive, not reactive.

• Integrated across teams.

• Focused on delivering value to the end user.

Quality at BioSystems is built into every stage of the product lifecycle:

• Design and development, ensuring that our analytical systems are scientifically and technically sound.

• Manufacturing, controlling all the processes to guarantee consistency lot after lot, unit after unit.

• Testing and validation, verifying that our systems perform reliably under real-world conditions.

• Storage, distribution, installation and support, ensuring that our systems arrive and perform as expected, throughout their entire lifespan.

This end-to-end approach is often called a “closed quality loop”, where feedback continuously improves our future products and services.

For laboratory professionals, clinicians, and ultimately patients, our Quality system translates into very tangible benefits:

1. Reliable results you can trust

Consistency is critical in Clinical Analysis. A robust QMS ensures that:

• Results are consistent and reproducible over time.

• Instruments and reagents behave predictably.

• Variability is minimized.

This reliability is essential for accurate clinical decisions.

2. Safety and regulatory compliance

Medical in vitro diagnostic products must meet strict regulatory requirements. BioSystems Quality system ensures:

• Compliance with international regulations.

• Rigorous risk management.

• Full traceability of materials and processes.

For users, this means greater confidence in both the product and its safety.

3. Faster problem resolution

No system is perfect, but a strong QMS ensures that when issues arise:

• They are detected quickly.

• Root causes are identified.

• Corrective and preventive actions (CAPA) are implemented.

This leads to faster resolutions and fewer disruptions in the laboratory.

4. Continuous improvement

Quality systems are not static. Through audits, performance monitoring and customer feedback, BioSystems continuously improves its products and processes.

For users, this means:

• Better performance over time.

• Updated solutions aligned with evolving needs.

• Ongoing innovation grounded in real-world use.

5. Better user experience

Quality is not only about technical performance. It also includes:

• Ease of use.

• Clear documentation.

• Reliable technical support.

All of these elements are managed within the QMS to improve the overall user experience.