What is BS EN ISO 8486:2010 ?

EN ISO 27290:2011 is a technical standard that outlines the requirements for a quality management system in medical laboratories. This standard was published by the International Organization for Standardization (ISO) and the European Committee for Standardization (CEN) and is designed to ensure that medical laboratories meet certain standards in their operations.

The standard has several key requirements that medical laboratories must comply with in order to implement a quality management system that meets international best practices. These requirements include:

Management Responsibility: The laboratory must have a clear and defined management structure that outlines the roles and responsibilities of all personnel involved in the laboratory's operations.

Resource Management: The laboratory must have a comprehensive understanding of its resources, including personnel, equipment, and supplies, and ensure that these resources are effectively managed.

Process Control: The laboratory must have a clear and defined process for ensuring that its operations are in compliance with the relevant regulations and guidelines.

Continual Improvement: The laboratory must have a process for evaluating its performance and identifying opportunities for improvement.

By implementing EN ISO 27290:2011, medical laboratories can enhance the quality of their services, improve patient safety, and reduce the risks associated with their activities.