Introduction
Medical laboratories are the pillars of the health care delivery system that are responsible for making correct diagnoses and right decisions about treatment. ISO 15189 certification implementation is expanding very rapidly in Nepal because health care organizations are seeking to achieve excellence. The article discusses the implementation of ISO 15189 certification, its benefits, and its application in Nepal.
Knowledge on ISO 15189 Certification
ISO 15189 is a global standard for medical laboratory quality and competence requirements alone. ISO 15189 is a quality management and technical proficiency standard for adoption in the laboratory setting, unlike generic quality management standards like ISO 9001.
Why ISO 15189 Certification Is Necessary in Nepal
- Improved Diagnostic Accuracy
ISO 15189 certification offers strict quality control mechanisms to avoid diagnostic errors and improve the validity of test reports.
- Increased Confidence and Trust of Patients and Health Workers
Accreditation laboratories enhance the level of quality, hence building more confidence for patients and health workers.
- National and International Compliance
ISO 15189 allows Nepalese laboratories to adhere to international best practice, as well as national health legislations.
- Optimum Laboratory Efficiency
Proceduralized processes streamline lab activity, minimize errors, and maximize overall efficiency.
- Global Acceptance
Nepali ISO 15189-accredited laboratories gain international recognition, and international collaboration and partnership with them increase.
ISO 15189 Certification Process in Nepal
Step 1: Laboratory Gap Analysis
Determine gaps between laboratory current practice and ISO 15189 standards.
Step 2: Installation of Quality Management System (QMS)
A well-established QMS should have:
- Standard Operating Procedures (SOPs)
- Employee training programs that work effectively
- Laboratory equipment calibration and maintenance
- Internal quality assurance activity
Step 3: Competency Programs and Staff Training
Staff training that provides sufficient knowledge on ISO 15189 standards and best practices.
Step 4: Internal Audits
Internal audits, which are carried out from time to time, enable the identification and correction of possible non-conformities prior to carrying out a formal audit.
Step 5: Choose a Certification and Accreditation Body
Nepalese laboratories can be accredited by local bodies such as the Nepal Bureau of Standards and Metrology (NBSM) or international accreditation bodies.
Step 6: External Assessment and Certification Process
Accreditation of laboratory practice to ISO 15189 for conformity assessment is carried out by an external agency. Certification is achieved after successful evaluation.
Challenges in Achieving ISO 15189 Certification in Nepal
- Inadequate Finance
Equipment investment, training of staff, and certification expenses are burdensome for laboratories.
- Inadequate Awareness and Technical Expertise
Nepalese laboratory professionals will need more awareness and training on the ISO 15189 standard.
- Infrastructure and Equipment Constraints
Laboratory facilities in the rural areas could be surrounded by old equipment, hence making adherence even more difficult.
- Shortage of Trained Laboratory Technicians
Requirement of skilled human resources for laboratory management and quality control is urgent.
Conclusion
ISO 15189 accreditation is a significant step towards laboratory service quality development in Nepal. It enhances the diagnostic reliability, operations efficiency, worldwide acceptability and patient safety. Though there are some minor problems, the long-term benefits of ISO 15189 certification attaining greater trust, improved quality of healthcare, and conformity to international standards are not an investment in vain for Nepalese laboratories. ISO 15189 application for the development of Nepal's healthcare infrastructure will be a move in the right direction towards the improvement of laboratory services and overall quality of healthcare in Nepal.
Visit https://www.isocertificationinnepal.com/ to learn more about ISO.
