What can be excluded from ISO 13485 ?

ISO 13485 is a specific standard that focuses on the quality management system for medical devices industry. It is designed to ensure that medical device organizations meet regulatory requirements, enhance customer satisfaction, and control sterile environments. While ISO 9001 is a general standard that outlines the requirements for a quality management system in all types of organizations, ISO 13485 has more specific requirements for the medical device industry.

ISO 13485 is an essential standard for organizations involved in the medical device industry because it helps them to ensure the safety and effectiveness of their products. This standard places a greater emphasis on regulatory compliance, risk management, and the control of sterile environments. Compliance with ISO 13485 is crucial for organizations to avoid penalties and legal action, and it also helps to establish them as a reliable supplier of medical devices.

ISO 13485 certification demonstrates a company's dedication to ensuring the safety and effectiveness of medical devices. It also helps organizations align with regulatory requirements in different markets, enhance product reliability, and establish robust processes for design, development, and production of medical devices.

In summary, ISO 13485 is a specific standard that focuses on the quality management system for medical devices industry. It is designed to ensure that medical device organizations meet regulatory requirements, enhance customer satisfaction, and control sterile environments. Obtaining ISO 13485 certification demonstrates a company's commitment to ensuring the safety and effectiveness of medical devices and also helps to establish them as a reliable supplier of medical devices.