What is EN ISO 13485:2012/AC:2019 ?

EN ISO 13485:2012/A2:2019 is an essential international standard for medical device manufacturers, providing a framework for establishing and maintaining a comprehensive quality management system (QMS) that meets both customer and regulatory requirements. This standard is based on ISO 9001 and is designed to help organizations ensure the safe and effective performance of medical devices.

The primary purpose of EN ISO 13485:2012/A2:2019 is to establish and maintain an effective QMS that demonstrates compliance with applicable regulatory requirements. It helps organizations in the medical device industry to effectively control their operations, minimize risks, and deliver safe and reliable products consistently.

EN ISO 13485:2012/A2:2019 emphasizes both customer and regulatory requirements, requiring organizations to put processes in place to address these needs. Some of the key requirements of this standard include:

The organization's management system must be designed to ensure that it meets the requirements of ISO 9001 and other applicable regulations.

The organization must establish and maintain a written QMS that is regularly reviewed and updated.

The organization must ensure that its QMS is integrated into its overall business strategy and operations.

The organization must conduct risk assessments to identify potential risks to its products and to develop mitigation strategies.

The organization must implement and maintain controls to manage and monitor its risks.

The organization must maintain records and documentation to demonstrate its compliance with the QMS and applicable regulations.

The organization must conduct regular audits of its QMS to ensure that it is effective and meets the requirements of ISO 9001 and other applicable regulations.

By implementing the requirements of EN ISO 13485:2012/A2:2019, medical device manufacturers can demonstrate their commitment to quality and their ability to consistently provide safe and reliable products. It is also a valuable tool for companies to improve their internal processes and enhance overall business performance.