ISO 15189 Certification in Nepal: Better Laboratory Quality and...

ISO 15189 Certification in Nepal: Better Laboratory Quality and Patient Safety

Posted 2025-03-05 13:48:37

Introduction

ISO 15189 certification is a global standard for quality and competence of medical laboratories. Medical testing in Nepal is as much a necessity now as ever before. ISO 15189 certification ensures that the laboratories are abiding by the standards and delivering services to international best practice standards. This article discusses why it is important in Nepal, how it is achieved, and the benefits to the laboratory and the patients.

Understanding ISO 15189 Certification

ISO 15189 is a global standard specifically developed for medical laboratories. It covers both the technical competence and quality management system (QMS) required for effective laboratory performance. The standard takes the general requirements of ISO/IEC 17025 (testing and calibration) and ISO 9001 (quality management), but with adjustments to address the specific requirements of medical testing.

The main aims of ISO 15189 are:

Ensure Correct Test Results: There needs to be strong procedures in achieving precise and replicable results from the laboratories.
Standardize Lab Procedures: Provides standard ways of working and presenting.
Improve Patient Care: Provides correct and timely results of great significance in diagnosis and therapy in medicine.

Why ISO 15189 Certification Is Significant to Nepal

Nepal's healthcare system is highly reliant on medical labs for accurate diagnoses. Although there is growing demand for quality healthcare, ISO 15189 accreditation can be a huge blessing for the labs as well as for ordinary people.

Enhanced Diagnostic Consistency: Ensures test results are consistent at the lab level and minimizes chances of wrong diagnoses.
People's Trust: Certification provides greater people's trust in laboratory service, which is translated into trust in the health system.
International Standards Compliance: Makes the labs international in standards and in the ability to work internationally.
Patient Safety: Provides safety through proper diagnosis through accredited services.
Competitive Advantage: Competency puts the lab to a position where it positions itself competitive in the country's growing health care market.

Procedure to Obtain ISO 15189 Certification in Nepal

Gap Analysis: Systematic assessment of practices based on what is being followed presently against best practices which are needed as per ISO 15189, areas which need improvement.
Implement a Quality Management System (QMS): Install a QMS to formalize and document all the work carried out in the laboratory, e.g., handling samples, calibration of equipment, and the layout of the report.
Train Laboratory Staff: Train staff in accordance with ISO 15189 requirements, e.g., laboratory best practice and quality control.
Conduct Internal Audits: Conduct internal audits of the monitoring process, detection of non-conformities, and correction of them.
Choose an Accreditation Agency: Choose a reliable accreditation agency like the Nepal Bureau of Standards and Metrology (NBSM) or the National Accreditation Board for Testing and Calibration Laboratories (NABL).
Perform External Evaluation: The external evaluation must be done by the accreditation agency in an extensive review of the processes, laboratory documents, and ISO 15189 compliance.
Address Non-Conformities: Take remedial action on all the defects identified during the external audit.
Certification and Monitoring: Following verification of compliance, the lab is certified to ISO 15189. Regular surveys ensure sustained compliance with the standard.

Problems Faced by Laboratories in Nepal

Restricted Resources: Purchase of infrastructure, equipment, and training is required to attain and maintain ISO 15189 certification, which might be out of reach for small labs.
Technical Competence: Experts who have the experience of executing ISO 15189 and quality management in a laboratory are not in sufficient number.
Sustained Compliance: Sustained compliance includes regular monitoring and updation procedures in an effort to match evolving standards.
Administrative Complexity: Managing documents and ensuring a healthy QMS involves gargantuan administrative work.

Advantage of ISO 15189 Certification for Labs in Nepal

Quality Assurance: The laboratory procedure and results are certified to the highest standards worldwide.
Operational Efficiency: Well-designed workflow and standard practice reduce errors and improve laboratory performance.
Market Recognition: Accredited laboratories are better recognized, having more clients and cooperation.
Enhanced Patient Care: Correct test results result in better medical decisions and patient care.
International Cooperations: ISO 15189 accreditation allows joining international clinical research and diagnostics.

Maintaining ISO 15189 Certification

Monitoring Continuously: Continuous monitoring and evaluation of the laboratory processes for gaps and constant improvement.
Training and Development: Provide regular training programs for employees on latest techniques and standards.
Quality Reviews: Conduct regular reviews of the QMS to ensure compliance with the latest ISO 15189 requirements.
Surveillance Audits: Conduct regular surveillance audits to ensure continued conformity and areas of improvement.

Accreditation Bodies Offering ISO 15189 Certification in Nepal

Nepal laboratories requiring ISO 15189 certification can collaborate with well-known accreditation bodies such as:

Nepal Bureau of Standards and Metrology (NBSM): Nepal national government standards organization.
National Accreditation Board for Testing and Calibration Laboratories (NABL): Internationally accredited issuing authority for ISO 15189 accreditation.
International Accreditation Service (IAS): Issues global accreditation to medical laboratories.

Conclusion

ISO 15189 certification is responsible for improving Nepalese medical laboratory quality and reliability. Conformity with the standards by laboratories can improve diagnostic efficiency, patient care, and public confidence in laboratories' ability. Despite the certification being difficult because of the unavailability of resources and technicality, long-term benefits are more than challenges.

With the transforming health care scenario in Nepal, ISO 15189-certified labs will be leading the class-of-the-world diagnostic centers. Pursuing and maintaining the certification says everything about the quality of a laboratory along with the laboratory's stature as a competent collaborator of the country's health care. Visit https://qms.com.np/ to learn more about ISO.