Introduction

ISO 15189 described the quality and competence of the medical laboratories at the international level. Recently, the health sector in Nepal was developed enough to provide diagnostic service provisions by applying internationally recognized standards. ISO 15189 Laboratory Accreditation provides an entry to the international arena with aspirations regarding standardization. It brings improvements in the performances regarding accuracy and speed and more faith among patients.

Therefore, the paper brings out the importance, process of accreditation, challenges, and benefits of ISO 15189 accreditation to Nepal.

Briefing on the ISO 15189 Certificate

ISO 15189 generally stands for the international standard that dictates the requirements necessary for the competence and quality of medical laboratories. Some of the key elements which make up the aspect of the certification include:

  1. QMS: Quality Management System (Process for optimization of efficiency while maintained/ensured accuracy.).
  2. The competency of the laboratory personnel, and the methods adopted for testing should be validated.
  3. Reliable laboratory practice: For delivery of consistent results with quality, the procedures must be standardized and followed.

ISO 15189 certification is therefore cardinal to laboratories that mean business in improving service and intend to go global.

Importance of ISO 15189 Certification in Nepal

This only means that the health sector in Nepal is booming and enhances the need to avail appropriate and recognized laboratory services. The major benefits that are related to the ISO 15189 certification are mentioned below.

  1. Improved Diagnostic Accuracy

Standardization of the test procedures would reduce the scope of error and hence ensure that proper and credible diagnostic results are delivered.

  1. Increased Credibility of Laboratories

Confidence will be gained in ISO-accredited laboratories by health professionals, patients, and regulatory authorities.

  1. Legal Compliance

Due fulfillment of all national and international regulations contributes to the development of laboratory work and keeps it from any sort of legal disputes.

  1. Operational Efficiency

Following the best practices smooths the operation of the laboratory, amplifies resources, and increases cost-cutting.

  1. International Recognition

ISO 15189 certification will enable collaboration between the laboratories and any global health care institution in collaboration, getting involved in various research works.

Steps for ISO 15189 Certification in Nepal

It has some structured steps for achieving the compliance standards by ISO 15189:

  1. Understanding ISO 15189 Standards

Understand what the standard requires and identify shortcomings.

  1. Gap Analysis

A review was done in an apt manner in order to realize the deficiencies a laboratory is going through currently pertaining to process as well as workflow.

  1. Quality Management System

The properly organized QMS ensures maintenance of compliance with regard to ISO 15189 and generally enhances efficiency.

  1. Training Laboratory Personnel

Staff competency and compliance is ensured with regular training in an internationally benchmarked training criteria program.

  1. Internal Audits and Corrective Actions

These non-conformities and corrective measures upon their findings may be brought out by the periodic internal audits.

  1. External Assessment by the Accreditation Bodies

A formal assessment whether this laboratory conforms to all the criteria under ISO 15189 criteria will be decided

  1. Certification and Ongoing Monitoring

The laboratories which are thus accredited shall also maintain their accreditations through periodic audits and process improvements.

ISO 15189 Implementation Challenges in Nepal

Certain issues or challenges the Nepalese laboratories are facing in their journey towards accreditation include:

  1. Expensive to implement, huge investment is needed to develop infrastructure and train on this certification's documentation.
  2. Most of the laboratory professionals are unaware of the ISO 15189 accreditation process as well as the benefits related to such a program
  3. Human resources in the field of laboratory quality management experts are not available within the country.
  4. Policy and Legal Issues: National policies have to fall in line with international standards; this calls for coordination.
  5. Resistance to Change: Traditionalist laboratories may be a little resistant towards accepting new uniform procedures.

Advantages of ISO 15189 Accreditation for the Nepalese Healthcare System

ISO 15189 has a lot of benefits to concerned stakeholders.

  1. Laboratories: The certification increases their prestige and ensures high-quality service output and increases their efficiency.
  2. Accurate test results for the proper treatment of the patients
  3. The trust level of the health care provider in the laboratory diagnosis enhances and thereby the clinical decision becomes sound.
  4. Standardization maturity of health care at the national level is found along with the policy adjustments. 

Future of ISO 15189 Certification in Nepal

ISO 15189 relevance will be going to go upwards as Nepal goes ahead to build up the health care sector of the country. Major trends identification is likely ahead encompasses:

  1. Government and Industry: Continuous promotional camps in Lab Accreditation Sectors.
  2. Technological advancement: Automation, greater use of digital health solutions for diagnosis
  3. International collaborations: Strong partnership forged ahead with International HealthCare Institutions
  4. People have a higher demand for quality Diagnosis Services.

Conclusion

ISO 15189 no doubt would raise the bar for Nepal's medical laboratories in diagnostic accuracy of the tests, its credibility, and efficiency in operation. The challenge to reach it might be very hard; still, the benefit afterwards far offsets the initial cost to be spent for the process. Laboratories will strive along with co-operation provided by the accreditation bodies and professionals for quality management for smooth certification.

This will finally get accredited labs for an ISO 15189 standard to have better health care and international standing, and lastly a better national health system. Visit https://www.abishekadhikari.com.np/ to learn more about ISO.