Nepal strengthens laboratory quality management with internal auditor and lead assessor training

 The Ministry of Health and Population (MoHP), in collaboration with WHO Country Office for Nepal, successfully conducted an internal auditor and lead assessor training program to enhance national laboratory quality management capacity.

This initiative aligns with ISO 15189:2022 accreditation standards, a globally recognized benchmark for medical laboratories, marking a significant step in improving Nepal's diagnostic accuracy and public health response.

A key component of ISO 15189 compliance is internal auditing, which requires properly trained internal auditors within the country. Therefore, training on ISO 15189 internal auditing is vital for educating individuals about the standard's requirements and principles.

Dr Bhupendra Kumar Rana, Quality & Accreditation Institute (QAI), facilitating the trainings in Bagmati province, Nepal. Photo credit: WHO Nepal/S.G. Amatya

Facilitated by Dr Bhupendra Kumar Rana of Quality and Accreditation Institute, the training covered key principles of the international standard, including critical components such as risk-based thinking, continuous improvement and effective communication.

The training was conducted in two phases: the Internal Auditor Training was held from 1-10 December and the Lead Assessors Training was held from 11-12 December. The internal auditor training was a five-day package conducted in two different batches.

Both sessions were designed to build the capacity of laboratory personnel from national and subnational public health and federal hospitals, aligned with the recommendations of the Joint External Evaluation (JEE) to strengthen laboratory quality management system and to boost Nepal’s capacity for disease surveillance, diagnosis and response to health emergencies. WHO personnel were also trained.

Participants from the internal auditor training (top) and lead assessors training (bottom). Photo credit: WHO Nepal/S.G. Amatya

Following evaluations in the training, a total of 42 participants were successfully certified as internal auditors. Participants who met the required passing criteria advanced to the lead assessor training, and a total of 12 participants were successfully qualified as lead assessors and were awarded certification, establishing a certified pool of professionals to enhance laboratory practices across Nepal.

The internal auditors can now evaluate a laboratory's internal quality management system (QMS) to ensure compliance with ISO 15189:2022. They can effectively identify any non-conformities, opportunities for improvement in processes, procedures and practices, ensuring the laboratory's operations align harmoniously with established policies and standards. This proactive approach enables continuous improvement and readiness for external assessments.

Practical sessions held during the lead assessors training. Photo credit: WHO Nepal/S.G. Amatya

Furthermore, the qualified lead assessors can now oversee the accreditation process during an external audit. These individuals can lead a team of assessors, coordinating and managing the entire assessment process, ensuring that the laboratory meets the ISO 15189:2022 accreditation requirements.

From left: Dr Ranjan Raj Bhatta, Director of National Public Health Laboratory, Ministry of Health and Population; Professor Arunkumar Govindakarnavar, Technical Officer (Public Health Laboratories) at WHO Nepal; and Dr Kenza Bennani,  Ag WHO Representative/Team Lead for Communicable Diseases Surveillance (CDS)  Programme Team at WHO Nepal providing their remarks during the trainings. Photo credit: WHO Nepal/S.G. Amatya

“In a world increasingly challenged by emerging pathogens, laboratories play a crucial role in emergency preparedness and response. These trainings have contributed to boosting confidence in our medical laboratories by empowering national professionals and networks. Moving forward, we must strive to uphold and sustain these standards,” said Dr Ranjan Raj Bhatta, Director of NPHL.

“Nepal has made significant strides in its diagnostics capabilities since the COVID-19 pandemic. Ensuring service quality is now vital for effective laboratory-supported public health responses, accurate diagnoses and effective treatment plans. I am confident the trained cohort will uphold international standards, improving efficiency, patient safety and health outcomes across Nepal,” said Dr Rajesh Sambhajirao Pandav, WHO Representative to Nepal.

WHO will continue supporting initiatives to foster stepwise quality improvement and accreditation for national and subnational laboratories, ensuring Nepal’s laboratories remain equipped and prepared to address emerging health challenges.

The workshop was supported by USAID’s Global Health Security and Pandemic Influenza Preparedness Program.

source - https://www.who.int/nepal/news/detail/13-01-2025-nepal-strengthens-laboratory-quality-management-with-internal-auditor-and-lead-assessor-training