What is EN ISO 13485:2012/AC:2015 ?

EN ISO 13485:2012+AC:2015 is an essential international standard for medical device manufacturers, which outlines the requirements for a quality management system specific to this industry. It is based on ISO 9001 and aims to provide a framework for organizations to establish and maintain a comprehensive quality management system that consistently meets both customer and regulatory requirements.

The primary purpose of EN ISO 13485:2012+AC:2015 is to harmonize regulatory requirements for medical device manufacturers in order to ensure the safe and effective performance of medical devices. By implementing the requirements of EN ISO 13485:2012+AC:2016, organizations can demonstrate their commitment to quality and their ability to consistently provide safe and reliable medical devices.

EN ISO 13485:2012+AC:2016 is also a valuable tool for companies to improve their internal processes and enhance overall business performance. It helps organizations identify and address potential risks, increase efficiency, and minimize errors and defects throughout the entire product lifecycle.

EN ISO 13485:2015 establishment and maintenance of a quality management system is mandatory for medical device manufacturers, and failure to comply with this standard may result in non-conformance conclusions and penalties. Therefore, it is important for medical device manufacturers to take the necessary steps to establish and maintain a qualified quality management system that meets the requirements of EN ISO 13485:2012+AC:2016.

In conclusion, EN ISO 13485:2012+AC:2016 is an essential international standard that outlines the requirements for a quality management system specific to the medical device industry. It provides a framework for organizations to establish and maintain a comprehensive quality management system that consistently meets both customer and regulatory requirements. Adherence to this standard is mandatory for medical device manufacturers and failure to comply with it may result in non-conformance conclusions and penalties. By implementing the requirements of EN ISO 13485:2012+AC:2016, organizations can demonstrate their commitment to quality, safety, and overall business performance.