The healthcare industry operates under rigorous standards to ensure the accuracy, reliability, and timeliness of medical diagnoses and treatment. Among these, ISO 15189 has emerged as a cornerstone in the domain of medical laboratories. This international standard specifies the quality and competence requirements particular to medical laboratories, playing a pivotal role in ensuring consistent and reliable patient care. Understanding ISO 15189 ISO 15189, titled "Medical laboratories — Requirements for quality and competence," was first published by the International Organization for Standardization (ISO) in 2003. This standard is specifically tailored to medical laboratories, drawing from the general requirements of ISO/IEC 17025 (testing and calibration laboratories) and ISO 9001 (quality management systems). It serves as a framework for laboratories to develop robust management systems, ensure technical competence, and consistently generate valid results. The standard cov...
In today's rapidly changing business landscape, organizations face a myriad of risks that can hinder their success and sustainability. Recognizing the need for a systematic approach to risk management, the International Organization for Standardization (ISO) developed ISO 31000. This standard provides organizations with a framework to identify, assess, and manage risks effectively. In this blog post, we will explore the key principles and guidelines outlined in ISO 31000 and understand their significance in enhancing risk management practices. What is ISO 31000? ISO 31000 is an international standard that provides a framework and a process for managing risk. It helps organizations identify, assess, and treat risks that could affect their objectives, performance, or reputation. ISO 31000 also helps organizations create a risk-aware culture, where everyone is responsible for managing risk. What is the risk? Risk is the effect of uncertainty on objectives. It can be positive...