Quality is desired everywhere. But when it comes to medical devices, it is much more critical to set other unique requirements for the medical devices given the reliability needed. Medical devices are designed and manufactured to save a life. Any fault in the design or manufacturing process can lead to the mass loss of human lives. To avoid this, ISO set up an international standard for the manufacture of medical devices.
ISO 13485 outlines the basic requirements for a quality management system that all the people involved in the manufacture and supply of medical devices must comply with before they are certified to offer such services. That is exactly what this is about. By extension. ISO 13485 also has specific requirements for the production, distribution, and storage of all medical devices.
Every organization or companies that are involved at any part of the supply chain mentioned above need to comply with the ISO 13485 regardless of the size except where it is explicitly exempted. For instance, a company that is only responsible for the distribution of medical services is not liable to comply with the design and production requirements. However, they have a role to play in ensuring that they source their medical devices from reputable companies that are ISO certified.
Just like all other ISO Standards that we have talked about so far, this too needs certification. After implementing a quality management system as specified, you need to apply for certification so that you can leave a mark in the global market.