What is EN ISO 14168:2014?

EN ISO 14168:2014 is a set of standards that define the requirements for the quality management system used in medical laboratories. These standards were developed by the International Organization for Standardization (ISO) and the European Committee for Standardization (CEN). They provide guidelines to ensure that medical laboratories maintain consistent and reliable practices, allowing for accurate test results and patient care.

Understanding the Key Elements

The main elements of EN ISO 14168:2014 include scope, normative references, terms, and definitions. The scope defines the boundaries within which the standard applies, outlining what is included and excluded. Normative references refer to other standards or documents that are essential for understanding and applying the requirements. Terms and definitions provide clarity on key vocabulary used throughout the standard.

Implementing the Requirements

EN ISO 14168:2014 outlines specific requirements for the quality management system, including management responsibility, resource management, process management, and continual improvement. Compliance with these requirements ensures that medical laboratories have effective systems in place to identify, monitor, and control potential risks and non-conformities.

Benefits and Impact

Adopting and implementing EN ISO 14168:2014 brings several benefits to medical laboratories. Firstly, it helps in establishing a standardized approach to quality management, ensuring consistent practices across all laboratory processes. This leads to increased accuracy and reliability of test results, enhancing patient safety. Secondly, it facilitates international recognition and harmonization, making it easier for laboratories to participate in interlaboratory activities and exchange data.