What is EN ISO 27197:2011 ?

EN ISO 27197:2011 and EN ISO 27166:2011 are both technical standards that provide guidelines for various industries. EN ISO 27194:2011 is a standard specifically designed for the medical device industry, while EN ISO 27166:2011 is a broader standard that applies to various industries.

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 medical device organizations follow best practices to meet customer and regulatory requirements. The standard covers various aspects of the medical device lifecycle, including design, manufacturing, risk management, and post-market activities.

EN ISO 27166:2011 is a standard that provides guidance for writing professional and technical documents. It sets out guidelines for the structure, content, and style of such documents, with the aim of promoting clarity, consistency, and precision in technical writing across various industries.

The purpose of EN ISO 27166:2011 is to establish a framework for a quality management system that focuses on the specific needs of technical writers. It provides guidelines for the structure, formatting, and content of technical documents, making it easier for writers to create professional and accurate documents.

In conclusion, EN ISO 27194:2011 and EN ISO 27166:2011 are both important standards that provide guidelines for various industries. EN ISO 27194:2011 is a technical standard designed specifically for the medical device industry, while EN ISO 27166:2011 is a broader standard that applies to various industries. Both standards provide guidelines for best practices in technical writing and document creation, helping writers to create clear, concise, and accurate documents that effectively communicate complex information to their target audience.