What is ISO 13485?
ISO 13485 is a standard that ensures organizations are creating safe and reliable medical devices. This is extremely relevant if you are a company like Baichen creating medical devices like folding power wheelchair. ISO 13485 certification demonstrates that we follow these regulations and are committed to producing safe, high quality products. We can better develop medical devices that work for both doctors and patients with ISO 13485.
How do we use ISO 13485?
Using ISO 13485 at our organization requires an implementation that adheres to worked with with these standards. That means we have to establish what is more important to us, identify any risk, and monitor how we are tracking. ISO 13485 will help Baichen improve our medical devices even further and ensure our compliance. This works to help our company and helps keep our devices safe as well as effective for all.
Process of ISO 13485 Certification
In order for Baichen to achieve ISO 13485 certification, they need to take certain key steps. First we need to draw up a plan that fits the rules. That includes writing down our principles for how we will do things and ensuring all our employees understand what is required for quality. Then we will validate through internal audits what we did right and what we can do better. Lastly, we will welcome a designated auditor to verify that we are following the ISO 13485 guidelines and check our work. By following these steps, Baichen will be able to obtain the ISO 13485 certification and demonstrate that we are serious about quality.
Advantages of ISO 13485 registration
Let's first begin with some benefits of getting ISO 13485 certification for companies just like Baichen and our customers. What it means to us is that we are following the law, that we are making better products. It helps to distinguish us from others, and it allows to gain more customers. ISO 13485 certification comes with the assurance for customers, that says the medical devices that they are using are safe and effective. This trusted partnership between us and our customers ensures our devices like foldable power wheelchair have the utmost quality.
Permanent ISO 13485 certification
Once Baichen receives its initial ISO 13485 certification it is vital to continue to maintain compliance and work towards continual improvement of our devices. That means that we are going to keep checking our work consistently to see where we can improve and address any issues we find. Baichen can use continuous reviewing of our processes to ensure compliance with ISO 13485 and ensure that the high-quality medical devices like folding power chair are continuously obtainable for our clients. By continuing to follow ISO 13485, Baichen demonstrates our commitment to quality and builds trust with the doctors and patients.