Laboratories play a critical role in healthcare, providing the foundation for accurate diagnosis and patient care. To ensure the quality and competence of these laboratories, international standards are continually updated and refined.

The ISO 15189 standard, which governs medical laboratories’ quality and competence, has recently seen significant changes. In this article, we will explore the differences in the new ISO 15189 standard and guide you on how to transition to it effectively.

Understanding ISO 15189: The Basics

The International Organisation for Standardisation (ISO) developed ISO 15189 to set the framework for medical laboratories’ quality management systems. It outlines specific requirements to ensure the accuracy, reliability, and competence of testing and calibration processes. This standard is used worldwide to maintain high standards in clinical laboratories.

Key Differences in the New ISO 15189 Standard

The latest iteration of ISO 15189, published in 2021, introduces several significant changes aimed at enhancing the standard’s applicability and effectiveness. These changes include:

• Emphasis on Risk Management: The new standard places a stronger emphasis on risk management. Laboratories are required to establish and maintain a risk management process, incorporating it into their quality management system. This approach allows labs to identify, evaluate, and mitigate potential risks that could impact the quality of their services.
• Expanded Scope: The scope of ISO 15189 has been expanded to encompass all types of medical laboratories, including those not directly involved in patient testing, such as research and forensic laboratories. This broader scope ensures that the standard remains relevant to evolving laboratory practices.
• Enhanced Clarity and Flexibility: The new standard provides greater clarity on specific requirements while allowing for more flexibility in implementation. This flexibility is particularly valuable for laboratories that may need to adapt the standard to their unique circumstances.
• Updated Terminology: ISO 15189:2021 introduces updated terminology that aligns more closely with other international laboratory standards, improving consistency and understanding across the industry.

Transitioning to the New ISO 15189 Standard

The transition to the new ISO 15189 standard can be a seamless process if approached methodically. Here are steps to consider during the transition:

• Familiarise Yourself with the Changes: Begin by thoroughly reviewing the updated standard and gaining a comprehensive understanding of the changes and their implications for your laboratory. This may involve internal training and consultation with quality management experts like Genial.
• Gap Analysis: Conduct a gap analysis to identify areas where your laboratory’s current practices differ from the new standard’s requirements. This step is crucial for understanding the work needed for compliance.
• Update Documentation: Revise and update your quality management system documentation, including policies, procedures, and manuals, to align with the new standard’s requirements. Ensure that these documents are easily accessible to all staff using Genial’s iPassport system.
• Staff Training and Awareness: Organise training sessions for laboratory personnel to ensure they are aware of the changes and how they impact their daily work. Employees should understand their roles in implementing the updated quality management system.
• Risk Management Integration: Implement a risk management process within your laboratory’s operations. This includes identifying potential risks, assessing their impact, and developing strategies to mitigate them.
• Internal Audits: Conduct internal audits to evaluate your laboratory’s compliance with the new standard. Internal audits provide opportunities for continuous improvement and the identification of areas needing further adjustment.
• Seek External Assistance: If necessary, consider seeking the assistance of external consultants or accreditation bodies with expertise in ISO 15189 to guide your laboratory through the transition process.
• Prepare for Accreditation Assessment: Prepare your laboratory for accreditation assessment by a relevant accreditation body. Ensure all documentation and processes align with the new standard’s requirements using Genial’s iPassport system.

The new ISO 15189 standard brings important changes to the quality management systems in medical laboratories. While these changes may require effort to implement, they are essential for enhancing the quality and reliability of laboratory services. By understanding the key differences in the new standard and following a structured transition process, laboratories can ensure they continue to meet the highest standards of quality and competence in patient care. Embracing these changes can ultimately lead to better patient outcomes and improved healthcare delivery.

iPassport offers a cloud-based quality management suite designed to help digitise, streamline and improve the day to day management of quality and compliance.

It provides you with the tools to meet your regulatory compliance requirements – from document control, through nonconformities to risk management ensuring you have the smoothest pathway through to your certification or accreditation needs.

What can iPassport really do for you?

• Achieve and maintain accreditation
• Maintain inspection readiness
• Improve quality and testing safety through consistent processes
• Improve operational efficiency
• Ensure operations comply with regulatory requirements
• Save time & money

System benefits

• Never miss a document review
• Never work to outdated documentation
• Eliminate non-conforming events
• Evidence of regulatory compliance available at your fingertips
• Improved internal communication, collaboration & efficiency
• Improved reputation as a reliable and efficient test provider
• Become more valuable to the larger organisation

If you’d like support around your transition to the new ISO 15189 Standard or for your free iPassport demo, please contact us.