Reliability and Compliance:
New ISO 9001 and ISO 13485 certifications
Reliability and Compliance:
The Importance of ISO 9001 and ISO 13485 Certifications
Excellence in Process Management
ISO 9001 certification ensures that the company has a structured, reliable and controlled system to manage quality. The adoption of this standard results in a systematic approach that defines, documents and manages every operational phase, from the process approach through to supplier management.
The application of the planned regulations leads to greater predictability of delivery times, optimal use of resources and decisions based on concrete data, it also ensures careful management of suppliers and raw materials, guaranteeing quality and traceability along the entire supply chain. In a sensitive sector such as the medical sector, having an ISO 9001 certification means relying on a company that not only complies with international regulations, but that places safety, customer satisfaction and the constant pursuit of excellence at its core.
Safety and Traceability in the Medical Sector
ISO 13485 certification is the specific regulation for the medical device sector. It is a rigorous system that ensures that every phase of a product’s life cycle, from design to production, is documented, traceable and complies with the most stringent international regulations.
This standard in fact ensures that products are manufactured through controlled processes, documented and subjected to careful risk management, as well as compliant labeling and key data storage requirements, such as production dates and quality control results, ensuring complete traceability.
By choosing FL Medical products, the laboratory can count on safe, controlled devices that comply with the most stringent regulations, to protect both patients and healthcare workers. This offers the guarantee of greater reliability, reducing the risks of defective supplies, and ensuring structured and professional management in every situation.
