Implementing and Transitioning a Laboratory Quality Management System from ISO 15189:2012 to ISO 15189:2022:...

Area of Science:

• Clinical laboratory science
• Quality management systems
• International standards

Background:

• ISO 15189:2022 is crucial for clinical and research laboratories to ensure technical competence and reliable results.
• The Malawi Liverpool Wellcome Research Programme (MLW) laboratories implemented and managed a Quality Management System (QMS) based on ISO 15189.
• This article details the transition process to the updated ISO 15189 standard.

Purpose of the Study:

• To describe the methodology used by MLW laboratories for QMS implementation and transition to ISO 15189:2022.
• To highlight key steps and strategies for successful QMS integration in a research laboratory setting.
• To share practical insights for other laboratories undertaking ISO 15189 implementation.

Main Methods:

• Mentorship, gap analysis, and staff training were central to QMS implementation.
• A quality officer was appointed, supported by leadership, to oversee the process.
• Documentation development, proficiency testing, IQC, and method verification were conducted. Risk-based thinking and patient-centred requirements guided the transition to the new standard.

Main Results:

• Enhanced laboratory performance and improved documentation were observed.
• A stronger culture of quality and teamwork was established within the laboratories.
• The experience provided practical insights for ISO 15189 implementation tailored to organizational context.

Conclusions:

• Successful QMS implementation requires a comprehensive, system-wide approach and strong teamwork.
• Ongoing assessments, adequate resources (human and financial), and continuous training are essential.
• Mentorship from QMS professionals is vital for fostering a culture of continuous improvement.