ISO 15189 - Introduction

ISO 15189 standard, Medical laboratories - Requirements for quality and competence, hereafter referred to as ISO 15189, was first published in 2003 and revised in 2007 and again in 2012. ISO 15189: 2012 can be used by medical laboratories in developing their quality management systems and assessing their own competence. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies.ISO 15189 encourages full involvement and utilization of the abilities of all employees at all levels to improve the organization. In a laboratory accredited to ISO 15189, the goal is continual improvement, and for staff to know exactly what to do, how to do it, who is in charge of a process, and where to find all information necessary to perform their tasks.

ISO 15189-Benefits

There are numerous benefits of implementing ISO 15189. These include: 

• Create systems that are as failure resistant as possible, will catch mistakes before they become a problem, and reduce errors by getting things right the first time.
• Remain competitive in the global economy
• Reducing downtime and the costs of disruption to operations
• Ensure quality is the driving force behind business success and failure
• Identify opportunities for improvement at all times

ISO 15189: 2012- standard

ISO 15189 is a comprehensive standard, offering an overarching structure to laboratory operations. It applies to all divisions of a medical laboratory, regardless of the services it provides or the way it is organized; the standard is as relevant in a full-service medical laboratory as it is in a laboratory providing services exclusively for either clinical or anatomic pathology. It is not prescriptive in the sense that it does not specify how to address a particular requirement or clause. Its focus and importance lies in encouraging users to maintain an effective quality management system integrated across all parts of their operation, with a goal of continual improvement.