ISO 15189: An accreditation in raising the standards of Nepalese Medical Laboratories
Introduction
A new turn that the health sector in Nepal sees is the trend of recognizing medical laboratories as essential components of the healthcare system. More emphasis is also put on quality care and diagnostics. However, for most laboratories in the country, ensuring reliability and meeting global standards remains a challenge. ISO 15189 certification offers an effective solution where the laboratory will be able to establish internationally accepted standards of quality and competence.
This article aims to discuss, in short, the imperative importance of ISO 15189 certification to Nepal in relation to its benefits, challenges, and measures necessary toward its successful implementation.
What is ISO 15189 Certification?
ISO 15189 standard pertains internationally in medical laboratory processes. Technical as well as managerial issues in the lab would be enshrouded in the said standard to accord accurate, correct, and timely results.
While general broad-range certifications, such as ISO 9001, relate to all forms of industries, ISO 15189 addresses the needs of medical laboratories on several points: technical competence of laboratory testing, a strong quality management system, continuous improvement processes, and better satisfaction of patients and providers. This certification against ISO 15189 means that the laboratories follow set standards of high-quality operations and outputs.
Role of Medical Laboratories in Nepal
They are, therefore, the backbone of Nepal's health setup in providing a base for diagnosis, treatment, and even follow-up regarding diseases and the health of its population. Demand has always been growing due to infectious diseases' appearance and re-emergence alongside other lifestyle and health-related threats.
Contrasting with some challenges that the laboratories pose in Nepal, they will include the following:
- Variable standards for testing
Variations within the same test in different laboratories due to a general lack of standardized procedures and accredited laboratories usually lead to the erosion of confidence in diagnostic services.
- Lack of Advanced Technology
Most of the laboratories, especially the ones situated in the rural parts of Nepal depend on outdated equipment and methods which compromise the accuracy of the results.
- Shortage of Skilled Personnel
General shortage of professionally trained personnel proficient in modern diagnostic techniques - main barrier in offering quality services.
- Resource Constraints
Poor infrastructure, equipment and training of personnel at laboratories have led to problems with the capabilities of laboratories in offering services at international standards.
- Geographical Challenges
The state, like Nepal, with a general geographic setting of mountainous lands, therefore mostly lacks connectivity in many parts of the country where it is very hard to access such laboratory outlets.
All these are to be improved to increase health outcomes. ISO 15189, on this note, would be a chance for them for adjustments towards more responsiveness within the laboratories in action.
Benefits of ISO 15189 Accreditation in Nepal
- Diagnostic Accuracy
ISO 15189 accreditation means that each test will be carried out by processes that are standardized a priori. The test reports, therefore, will be delivered consistently and precisely, ensuring a diagnostically greater reliability and better decision-making about the correct treatment.
- Increased Patient Confidence
Certification conveys commitment to quality and patient safety, with a bottom line for trust among providers, patients, and their community.
- Operational Efficiency
This QMS accreditation will serve as proof for well-implemented policies in the area of laboratory operation for minimal errors and advanced efficiency in operational matters.
- Improvement of Public Health Outcomes
From this day forward, data on surveillance and outbreak management, and to a great extent even health policy formulation within Nepal, can take an improved lead easily; thereby, value will be created for the nation's public health infrastructure setup.
- Full Recognition Globally
ISO 15189 certification puts the laboratories on a pedestal with laboratories in the rest of the world and enables them to collaborate with any global institution, thus facilitating cross-border exchange programs.
- Capacity Building
The accreditation process involves huge training and development in the laboratory personnel to build up their skills for continuous improvement.
The Certification Process: Steps to Achieve ISO 15189
The steps towards getting ISO 15189 are really structured in nature. In nutshell, they are as follows:
- Initial Assessment
The whole thing needs proper gap analysis to understand those areas wherein the laboratory is not in a position to cater to the requirements of ISO 15189.
- Development of the Quality Management System
Establish and implement a robust QMS comprising standard operating procedures, quality assurance protocols, and documentation systems.
- Staff Training and Development
Quality Assurance Understanding and adoption of the good practices will help the training to the personnel working at the lab about the skill and technical awareness.
- Improvements on Infrastructure and Equipment's
Instate up to date-diagnostic equipment alongside installation of the routine maintenance, besides provision with the enabling environment to work.
- Internal Audit
To be prepared for internal auditing, for audit preparedness besides identifications required by areas
- Invitation to Certification Body
Accredit an accredited certification body to conduct audits for the ISO 15189 accreditation in terms of compliance.
- Continuous Monitoring Higher Levels and Improvement
In order to achieve and maintain compliance through regular review, and renewing the procedures as well as personnel's training for continued excellence.
Challenges for Implementation of ISO 15189 in Nepal
a. Lack of Financial Resources
The cost of infrastructure upgrading, the cost of the equipment, and also the training for most of the laboratories mainly in the countryside areas, is overwhelming.
b. Lack of Awareness
There is a general lack of awareness amongst laboratory managers and healthcare providers about the benefits accruable from ISO 15189 certification and its requirements.
c. Limited Resource Availability
Reasons being: Most of the rural laboratories lack modern equipment, technical expertise and even certification bodies.
d. Resistance to Change
As new systems and procedures are introduced into the prevailing practice, it is seen that resistance from within the staff themselves is possible.
Strategies to Overcome Challenges
- Government Incentives
The Nepal government can provide financial incentives, grants, and subsidies in motivating the laboratories towards accreditation.
- Public-Private Partnerships
Government in collaboration with private sector and international organizations working in this field, can provide financing, training and technical assistance.
- Mass Awareness
Such awareness about the importance and benefits of this certification may be increased through educational programs and workshops.
- Pilot Projects
Demonstrating feasibility through pilot projects in selected laboratories would facilitate wider dissemination of the same.
Future of Medical Laboratories in Nepal
ISO 15189 may prove to be a game-changer for the medical laboratories in Nepal. The international standards would bring much improved performance in the diagnostic activities in the laboratories, instill faith among the patients, and contribute to strengthening the healthcare system as a whole.
More laboratories being accredited would indicate a more prepared Nepal in tackling public health challenges, receiving international collaborations, and improving health outcomes related to care.
Conclusion
Hitherto, ISO 15189 has been a milestone that brought about a change to the quality of medical laboratories in Nepal. This is quite realistically an uphill task: very laborious, tiresome, and costs lots of money. But the benefits accruing from such improvement in patient care plus international recognition make it worth the effort.
ISO 15189 certification, therefore, is not an option but a compulsion for Nepal's healthcare. It opens the door toward reliable, efficient, and world-class diagnostic infrastructure to serve the needs of every citizen. Visit https://www.isocertificationinnepal.com/ for more information about ISO.
