What is EN ISO 27189:2011 ?

EN ISO 27189:2011 and EN ISO 27159:2011 are both international standards that provide guidelines and requirements for various industries. EN ISO 27189:2011 is a technical standard for the implementation of a quality management system in the field of medical devices, while EN ISO 27159:2011 is an international standard for the management of information security in the automotive industry.

EN ISO 27189:2011 is designed to establish a framework for a quality management system that focuses on the specific needs of the medical device industry. It 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 this standard, organizations can enhance their ability to consistently provide safe and effective medical devices that meet customer expectations.

Compliance with EN ISO 27189:2011 also helps manufacturers demonstrate their commitment to quality and regulatory compliance, which is crucial for market access and customer trust.

EN ISO 27159:2011, on the other hand, 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 primary purpose of EN ISO 27159:2011 is to ensure the protection of sensitive information stored or processed within automotive IT systems. It aims to establish a framework that enables organizations in the automotive industry to address information security risks effectively.

In conclusion, EN ISO 27189:2011 and EN ISO 27159:2011 are both important international standards that provide guidelines and requirements for various industries. They help organizations to improve their performance and achieve better results.