Introduction

ISO 15189 Certification can be termed as any medical laboratory in the world which is well-equipped to offer qualitative service reliably for diagnosis. With each rise in health infrastructure within the country, there is a felt need for an accredited laboratory. ISO 15189 helps to heighten credibility in laboratories, standards of operation, and levels of trust by patients.

The following article portrays the importance, process for certification, challenges, and implications of ISO 15189 certification in Nepal.

What is ISO 15189 Certification?

ISO 15189 represents the international standard that defines both the quality and competence requirements of medical laboratories. It addresses the following:

1. Quality Management System: Systematic process for precision and effectiveness.

2. Technical Competence: Proper education, validated testing procedures, and well-maintained equipment.

3. Reliable Laboratory Practices: Systematic procedures to give consistent and precise results.

It thus forms the bare minimum requirement that any laboratory should be willing to give in the offering of quality healthcare services.

Why is ISO 15189 Certification Important in Nepal?

As a result of the increasing dependence on laboratory diagnosis by Nepal, some of the key added advantages of accreditation, not limited to, include:

1. Better Diagnostic Accuracy

Standardized methodologies reduce errors in testing and result in more reliability.

2. Improved Laboratory Standing

This, in turn, enhances their credibility and reliability before the patients, health service providers, and even the very regulatory authorities.

3. Legal Compliance

Accreditation to national and international standards or regulations smoothens the working of laboratories.

4. Operational Excellence

The achieved best practices further increase productivity by reducing unnecessary wastes and allow workflow simplification.

5. International Recognition

ISO-certified laboratories can collaborate globally and engage themselves in multiple research projects.

Steps towards ISO 15189 Certification in Nepal

This is the step-by-step procedure for the certification listed as follows:

1. Understanding the Requirements of ISO 15189

The labs go through the standard and accordingly align the operation.

2. Gap Analysis

This helps to know about deficiencies regarding areas that are supposed to be improved prior to certification.

3. Quality Management System Implementation 

The adequate QMS allows following guidelines as proposed by ISO 15189.

4. Competency Development through Laboratory Personnel Training

Training enhances the competencies of personnel, and it is through this training that technical competency is developed for the personnel to acquire.

5. Internal Audits and Corrective Actions

Internal audits are done occasionally with the aim of bringing forth the non-conformities for developing necessary improvements.

6. External Audit by an Accreditation Body

A formal audit is performed in order to check if there is achieved conformance to requirements stipulated under ISO 15189.

7. Certification and Continuing Compliance

Certification follow-through includes periodic audits and continuous improvement.

Challenges of ISO 15189 Implementation in Nepal

Shared challenges within Nepalese laboratories:

1. Infrastructure and training are very costly to invest in. Besides that, there is a lack of awareness amongst laboratories regarding the benefits that may accrue from and requirements of ISO 15189.
2. Laboratory quality management experts are not available within the country.
3. All the available regulatory mechanisms cannot meet newly emerging demands right away to support an internationally recognized health care system.
4. Traditional Resistance against changing old laboratories set up for new working protocols.

Benefits to Nepal Health System through ISO 15189

Accreditation according to ISO 15189 will Contribute to the:

Improvement of laboratories : through better Service and Quality of given service

a. Patient Safety: Ensuring quality test results leading to proper decisions for better Treatment.

b. Healthcare Provider Confidence: There is more trust in the accuracy of the diagnosis.

c. Government Initiatives: The result of national healthcare development plans.

The Future of ISO 15189 Certification in Nepal

ISO 15189 certification is going to play a very important role in the development of health in Nepal. The key trends to watch out for include:

1. Government and Institutional Support: Having a maximum number of laboratories accredited.

2. Incorporating Automation and Digital Health Tools in Diagnostic Services.

3. Building good rapport with international health organizations.

4. Greater Public Awareness: Towards that end, more patients would get quality diagnostic services.

Conclusion

It is here that ISO 15189 becomes an important landmark in the history of the evolution of medical laboratory standards in Nepal. Although the road to accreditation might be thick with obstacles, there do exist long-term returns on investment as far as improvement in patient care, operational efficiency, and international recognition are concerned. ISO 15189 Certification builds up the credibility of laboratories aiming for excellence and hence is a contribution toward changing health care parameters in Nepal.

ISO 15189 certification will surely place Nepalese laboratories amongst the best for offering medical diagnosis, hence assured better health among their people. Visit https://www.abishekadhikari.com.np/ to learn more about ISO.