When it comes to health, trust is crucial. Trust in healthcare providers and certainly trust in the safety and quality of the medical devices they use. With certification according to the international standard ISO 13485, you demonstrate your ability to provide medical devices and related services that meet customer requirements and applicable regulations.
For whom is ISO 13485 certification intended?
ISO 13485 applies to organisations involved in the manufacturing of medical devices: from design and development, production, storage and distribution to installation or maintenance of medical devices (and related activities), regardless of size or business type. ISO 13485 certification is also often required for suppliers in the field of, among other things, the distribution and sterilisation of medical devices. In addition, healthcare institutions may also have to deal with this if they develop medical devices themselves.
The standard NEN-EN-ISO 13485 contains requirements for a quality management system that can be used by organisations that provide services related to the lifecycle of a medical device. This includes development, production, sales, transport, installation, maintenance and decommissioning, but also related services such as sterilisation and testing. ISO 13485 follows a structure that makes the standard eminently applicable alongside other management systems, such as ISO 14001 for environmental management or the ISO 9001 quality standard.
ISO 13485 certification by Kiwa
In the healthcare sector, no compromises can be made when it comes to safety and quality. After all, medical aids can literally mean the difference between life and death. With increasingly stringent requirements and ever higher expectations from customers and organizations throughout the supply chain, it is crucial to be in control of quality management processes in this area. You can prove that with ISO 13485 certification.
What are the main benefits of ISO 13485 certification?
- Legal compliance;
- Limiting risks;
- Lowers operational costs;
- Monitors customer satisfaction regarding products;
- Maintain a minimum quality level and improve where necessary.
ISO 13485 and the MDR
The ISO 13485 quality standard helps suppliers of medical devices and related services to comply with the Medical Devices Regulation (MDR). This new European regulation applies since 26 May 2021 and ensures:
- Additional requirements for market participants;
- New risk classification and extension of scope;
- More transparency for patients and better traceability;
- Stricter rules for certain products.