What is EN ISO 13485:2015 ?

EN ISO 13485:2015 and ISO 13485:2016 are both international standards that relate to the quality management systems of medical devices. EN ISO 13485:2015 is a more recent standard that outlines the requirements for a quality management system specifically designed for medical devices, while ISO 13485:2016 is an older standard that specifies the criteria for a quality management system for medical devices. Both standards are designed to ensure that medical device manufacturers establish and maintain a quality system that consistently meets customer and regulatory requirements.

The primary purpose of EN ISO 13485:2015 is to facilitate harmonization in the medical device industry by establishing a globally accepted framework for quality management systems. Adherence to this standard helps organizations demonstrate their commitment to consistently meeting customer and regulatory requirements. It provides the foundation for legal compliance and enhances patient safety.

ISO 13485:2016 is an international standard for medical devices that specifies requirements for quality management systems that are specific to the medical device industry. The main purpose of this standard is to ensure that medical device manufacturers establish and maintain a quality system that consistently meets customer and regulatory requirements. This standard sets out the criteria for a quality management system and helps organizations demonstrate their ability to provide safe and effective medical devices.

Key Requirements of EN ISO 13485:2015 and ISO 13485:2016

Both EN ISO 13485:2015 and ISO 13485:2016 have several key requirements that medical device manufacturers must adhere to in order to establish and maintain a quality management system that meets the requirements of the standard. Some of the key requirements of EN ISO 13485:2015 and ISO 13485:2016 include:

* The organization must have a clear and defined quality policy that meets the requirements of ISO 13485:2016.

* The organization must have a system for monitoring and controlling the performance of its quality management system.

* The organization must have a process for documenting and updating its quality management system.

* The organization must have a system for ensuring that its quality management system is regularly reviewed and updated.

* The organization must have a process for ensuring that it has implemented the requirements of ISO 13485:2016 and that it has demonstrated its ability to meet the requirements of the standard.

Conclusion

EN ISO 13485:2015 and ISO 13485:2016 are both important standards that medical device manufacturers must adhere to in order to establish and maintain a quality management system that meets the requirements of these standards. By establishing clear and defined requirements for a quality management system, these standards help organizations ensure that they are consistently meeting customer and regulatory requirements and providing safe and effective medical devices.