If your business utilizes precision medical machining methods, it’s important to produce high quality products and materials. In addition, your quality management system should meet ISO 13485 standards. But what is a medical device and why is ISO so important? Let’s go over the basics to give you a better understanding.
What Qualifies as a Medical Device?
Many devices used in the healthcare industry qualify. For example, this includes tools, instruments and machines used for testing, diagnosing and administering treatment to patients. This also includes all kinds of implant devices and in vitro equipment. If you are manufacturing something used by medical professionals, it probably qualifies.
The Importance of Quality
Many items made for healthcare may have the power of life and death. For example, if a heart monitoring device malfunctioned and provided the wrong readings, a patient could die of a heart condition. However, when properly diagnosed most heart problems can be corrected and the patient may live a long and productive life. This is only one example of the importance of thousands of devices used in the healthcare industry today and why quality is of the utmost importance. Precision medical machining processes have to work correctly and everything needs to be properly inspected along the way.
What about ISO 13485?
ISO stands for International Organization for Standardization. It sets world standards for a wide range of quality management systems. ISO 13485 is specific to the medical device industry. In order to qualify for this certification a company must meet specific standards of quality and be able to prove it to the proper authorities. This is considered one of the best ways to ensure safety and quality for millions of people needing healthcare devices today and in the future. After all, there is no room for error with many of these devices.
Is ISO 13485 Mandatory?
In the United States, ISO certification is not considered mandatory. However, anyone manufacturing devices (and this includes precision medical machining services) must have a quality certification from a recognized body overseeing the industry and the simplest and most effective method is ISO 13485. This qualification is accepted worldwide and it is something which most customers are looking for when they choose a medical device manufacturer.
What Does ISO 13485 Cover?
This certification covers a complete qualify management system. For example:
* Work environment safety
* Inspection requirements
* Risk management
* Design control
* Documentation
* Validation processes
* Preventative actions
* Corrective actions
This gives you a general idea of the process. However, it’s best to check with ISO 13485 directly to get the most up to date and pertinent information.
