What is BS EN ISO 15188:2013?

Introduction

BS EN ISO 15188:2013 is a standard that specifies the requirements for the competence and quality of medical laboratories. It aims to ensure that medical laboratories provide consistent, reliable, and accurate results for patient care and management. This article provides an of the key aspects covered in the standard.

Scope and Objectives

The scope of BS EN ISO 15188:2013 covers all aspects relevant to medical laboratory activities. It focuses on the management and technical aspects of the laboratory, including personnel competency, equipment calibration, quality control, and result reporting. The primary objective of the standard is to improve patient safety by setting requirements for the entire laboratory testing process.

Key Requirements

One of the core requirements of BS EN ISO 15188:2013 is the establishment of a quality management system (QMS) within the medical laboratory. The QMS should encompass policies, procedures, and processes that ensure the consistent delivery of high-quality results. This includes document control, risk management, and continual improvement.

The standard also emphasizes the importance of personnel competency. Laboratory staff should possess appropriate qualifications, knowledge, and skills to perform their assigned tasks correctly and accurately. Training, competency assessments, and ongoing professional development are essential for maintaining competency.

Benefits and Implementation Challenges

Implementing BS EN ISO 15188:2013 brings several benefits to medical laboratories. Firstly, it improves the reliability and accuracy of test results, leading to better diagnosis and treatment decisions for patients. Secondly, it enhances the credibility and trustworthiness of the laboratory, as compliance with the standard demonstrates a commitment to quality and patient safety. However, some challenges may arise during implementation, such as the need for adequate resources, staff engagement, and managing change within the laboratory.

In conclusion, BS EN ISO 15188:2013 is a crucial standard for medical laboratories that outlines the requirements for competence and quality in laboratory operations. It aims to ensure reliable and accurate results for patient care and management. By implementing this standard, laboratories can improve the quality of their services and contribute to safer healthcare practices.