ISO 13485 Certification in Quality Management System


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ISO 13485 is also one of the Quality Management System standards so you can easily implement it in your organizations. It has similar requirements as ISO 9001 and also includes its additional requirements. Both the standards are focused only in the development of high-quality products. But the major difference is, the ISO 9001 ensures customer satisfaction with quality products and services whereas the ISO 13485 standard includes requirements to improve the quality of medical devices and equipment.

The ISO 13485 standard provides guidelines for the manufacturers to improve the quality of medical devices from the manufacturing process, installation to servicing process. Also, it ensures the medical devices are safe and are made for their intended purpose.

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