What is EN ISO 13485:2012/AC:2020 ?

EN ISO 13485:2012/A2:2019 is an essential international standard for medical device manufacturers, providing a framework for organizations to ensure the safety, efficacy, and reliability of their products in the healthcare industry. This standard is based on ISO 9001 and outlines the requirements for a quality management system specific to the medical device industry.

The primary purpose of EN ISO 13485:2012/A2:2019 is to establish and maintain an effective quality management system (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 QMS should be integrated and include all relevant functions and processes related to the management of the product development process, from design and manufacturing to distribution and support.

* The QMS should be based on a risk-based approach and identify potential risks and opportunities for improvement.

* The QMS should be regularly reviewed and updated to ensure continued compliance with regulatory requirements and to address any changes in the product development process.

* The QMS should be applicable to all personnel involved in the product development process, including design, manufacturing, quality control, and distribution.

* The QMS should be regularly reviewed and evaluated by management to ensure continued compliance and effectiveness.

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 also helps organizations identify and address potential risks, increase efficiency, and minimize errors and defects throughout the entire product lifecycle..