What is EN ISO 27199:2011 ?

EN ISO 27199:2011 and EN ISO 27194:2011 are both international standards developed by the International Organization for Standardization (ISO) and the European Committee for Standardization (CEN) respectively. These standards are designed to address specific needs in different industries, with EN ISO 27199:2011 focusing on information security in the automotive industry and EN ISO 27194:2011 on quality management in the medical device industry.

EN ISO 27199:2011 is an international standard that provides guidelines and requirements for the management of information security in the automotive industry. It specifically focuses on the security aspects related to information technology systems used in vehicles. The standard aims to establish a framework that enables organizations in the automotive industry to effectively manage information security risks and ensure the protection of sensitive information stored or processed within automotive IT systems.

The primary purpose of EN ISO 27199:2011 is to ensure the protection of sensitive information stored or processed within automotive IT systems. It aims to establish a framework that enables organizations to address information security risks effectively and ensure compliance with relevant regulations and standards. By implementing this standard, organizations can enhance their ability to consistently provide safe and effective medical devices that meet customer expectations.

EN ISO 27194:2011 is a technical standard that provides guidelines and requirements for the implementation of a quality management system in the field of medical devices. It aims to ensure that organizations involved in the design, development, production, installation, and servicing of medical devices follow best practices to meet customer and regulatory requirements. The standard provides guidance on how to effectively manage various aspects of the medical device lifecycle, including design, manufacturing, risk management, and post-market activities.

By implementing EN ISO 27194:2011, manufacturers can enhance their ability to consistently provide safe and effective medical devices that meet customer expectations. Compliance with this standard also helps manufacturers demonstrate their commitment to quality and regulatory compliance, which is crucial for market access and customer trust.