Kartsana has obtained ISO 13485 certification. This international standard certifies quality and safety in the design, manufacture and marketing of medical devices.
Obtaining ISO 13485 certification highlights Kartsana’s commitment to excellence and continuous improvement, ensuring that its products comply with the most demanding regulations in the sector and guaranteeing quality and safety at every stage of the production process,
The certification specifically covers the design, manufacture and marketing of the following products:
- Stretchers for ambulances and special vehicles.
- Evacuation chairs
- Rails for ambulances
- Accessories for stretchers
The process of obtaining ISO 13845 has been audited and processed together with SGS, the world’s leading company in business inspection and certification.
What is ISO 13485?
ISO 13485 is an internationally recognised standard that sets out the requirements for a quality management system specific to the medical device industry. Published by the International Organization for Standardization (ISO), it focuses on ensuring that medical products are developed, manufactured and distributed under strict quality and safety controls.
Key requirements include:
- Thorough documentation of processes and procedures.
- Rigorous management of risks associated with products.
- Quality control at all stages of manufacturing.
- Strict traceability of components and finished products.
- Compliance with applicable regulatory standards worldwide.
What does obtaining ISO 13485 certification mean for Kartsana?
Obtaining ISO 13485 certification represents a significant milestone in our track record and commitment to excellence. This achievement demonstrates that Kartsana adopts best practices to ensure safe, reliable and high-quality products.
In addition, this certification strengthens the company’s position for future challenges by:
- It reinforces the confidence of customers and partners in the quality and safety of Kartsana’s products.
- It facilitates access to new international markets that require compliance with specific regulations.
- Improves operational efficiency by standardising processes and continuous risk management.
- Ensures full traceability of products from design to distribution.
Thanks to the whole Kartsana team
From Kartsana, we would like to express our sincere thanks to all our employees. This important achievement has been possible thanks to their dedication, effort and daily commitment to quality and excellence. Their professionalism and teamwork have been fundamental to achieve this recognition. Thank you all for making it possible!
