March 24, 2022
The International Organization for standardization (ISO) is an international body that sets and publishes standards across technical, industrial, and commercial industries. It was started in 1947 and has published about 22,000 different standards since then. These standards are usually not mandatory but may be recommended or made mandatory in a country as a proof of competence and credibility.
ISO 15189 was first published in 2003. It sets the standard for quality that should be maintained in a competent medical laboratory. It applies to full-service as well as specialized medical laboratories such as diagnostic testing laboratories.
The third edition of ISO 15189 was published in 2012 to replace the previous version that had been published in 2007. It is a widely accepted standard for diagnostic testing laboratories in over 60 countries across the globe. ISO 15189 is a mandatory standard in Belgium, France, Hungary, Ireland, and Lithuania. It is also mandatory in Romania, Germany, and Italy in the event that there is a need to make a contract with National Health Insurance. In the U.S., ISO 15189 is not mandatory but voluntary participation is encouraged.
The ISO 15189 standard can be used to guide diagnostic testing laboratories in establishing an effective quality management system (QMS). This will lead to improved efficiency, greater accuracy in test results, and hence credibility. This will also result in staff motivation and will boost stakeholders’ confidence in the laboratory processes.
This standard can help diagnostic testing laboratories achieve the following:
The main aim of ISO 15189 is to set goals for continuous improvement in quality. It empowers laboratory staff to know what to do and how to do it at all times.
ISO 15189 has two categories of requirements: management requirements and technical requirements. This categorization was influenced by the Clinical and Laboratory Standards Institute’s Quality System Essentials.
Management requirements ensure adherence to Quality Management Standards (QMS) and support management reviews and internal audits. They ensure that client needs are continually met and that opportunities for improvement are identified and acted upon before any issues arise.
These management requirements are stipulated in clause 4 which is relevant to a medical laboratory's operations and also meets standards in ISO 9001:2008.
Management requirements include the following:
Technical requirements focus on the implementation of the technical requirements. Unmet technical requirements will highlight a broader issue than that particular technical non-performance and nonconformance to the QMS.
Technical Requirements include the following:
ISO 15189 has several components, each is very important. In this blog, we have highlighted four components that are important for diagnostic testing laboratories.
ISO 15189 is a system-based and process-based quality standard. Proper documentation of these processes reveals gaps and inconsistencies that need to be addressed. Internal audits are vital as they ensure that every aspect of the QMS is covered, processes are efficient and effective, resources are well utilized, and opportunities for improvement are identified and exploited.
Occurrence management is an essential component of ISO 151589. It helps laboratories identify nonconformities using a plethora of resources to be used in carrying out a root cause analysis (RCA). RCA presents diagnostic testing laboratories with an opportunity to come up with solutions for a myriad of problems ranging from mild to complex.
Document control is a major challenge for most laboratories, as highlighted by the College of American Pathologists (CAP) Laboratory Accreditation Program (LAP) inspections. Proper document control ensures that staff members have access to the correct information and standard operating procedures (SOPs), reducing errors and increasing efficiency in processes.
ISO 15189 recommends that laboratories evaluate work processes and highlight potential failures that may affect patient safety. They must modify such processes to eliminate risks and document the steps taken in risk management. Risks need to be categorized based on the probability of occurrence, the severity, and the probable impact on the patient.
The Clinical Laboratory Improvement Amendment (CLIA) is a federal regulatory standard that is applicable to all laboratories performing diagnostic tests on human samples in the US. ISO 15189 incorporates several elements of the CLIA, but is not a substitute for the CLIA. However, ISO 15189 can be used to set the QMS for a CLIA-compliant laboratory. A diagnostic testing laboratory can also use ISO 15189 to meet the technical requirements for CLIA.
A Laboratory Information Management System (LIMS) can be used by diagnostic testing laboratories to support compliance with ISO 15189 by automating and streamlining the management and technical requirements of the standard. A Clinical Diagnostics LIMS can automate the following processes:
A clinical diagnostics LIMS is an automated system that ensures that all quality control protocols are maintained and errors are identified before they occur. A LIMS can also be integrated with other systems to enable real-time sharing of vital information when it is generated and eliminating data silos.
The third version of ISO 15189 which was published in 2012 offers an overarching structure to guide laboratory processes involved in quality management. It focuses on maintaining quality management systems with an overall goal of continuous improvement. With a trusted clinical diagnostics LIMS solution, laboratories can assure a continuous improvement in quality standards and generate accurate, valid, and reproducible test results.