Introduction
ISO 15189 certification is global recognition of medical laboratory accreditation. ISO 15189 certification guarantees medical laboratories the highest quality, accuracy, and dependability of diagnostic examinations. In Nepal, where there is a lack of developed health infrastructure, ISO 15189 certification is an attempt towards improved laboratory services and patient care. This article reflects on the relevance, advantages, disadvantages, and process of ISO 15189 certification in Nepal.
Understanding ISO 15189
ISO 15189 is a global standard that is published by the International Organization for Standardization (ISO). ISO 15189 lays down the quality and competence requirements of medical laboratories and contains the components of ISO 9001 (Quality Management System) and ISO/IEC 17025 (Testing Laboratory Competence and Calibration). The certification of ISO 15189 will verify laboratory work in the best possible way and with the test result's reproducibility.
The Most Important Reasons for Implementation of ISO 15189
- Provision of accurate and repeatable laboratory test reports.
- Enhancing technical competence and efficiency of the laboratory.
- Standardization of laboratory practice in a bid to enhance consistency.
- Building patient confidence in laboratory testing.
- Making laboratory practices conform to regional and global health care standards on a daily basis.
Why ISO 15189 Certification in Nepal is Needed
Since Nepal is in the process of establishing its health infrastructure, it needed quality laboratories. ISO 15189 enables the laboratory to achieve an international standard as well as confidence building.
Major advantages:
1. Consistent and reproducible test results
ISO 15189 laboratories follow rigorous quality control measures to achieve precise and reproducible test results.
2. Improved Patient Safety
Standardized tests minimize the diagnostic error to a large extent, which improves patient treatment as well as outcome.
3. Adherence to National and International Standards
ISO 15189 accredited laboratory compliance with regulations reduces business and legal risk.
4. Increased International Acceptance and Credibility
Laboratories that are accredited enjoy very high esteem among health professionals, patients, and even international organizations.
5. Process Efficiency and Systematic Improvement
Quality management system (QMS) implementation streamlines workflow, improves efficiency in resource utilization, and improves overall efficiency.
Steps Towards ISO 15189 Certification in Nepal
ISO 15189 certification is attained through incremental effort and investment in quality improvement.
1. Familiarization with ISO 15189 Requirements
Management staff and laboratory staff become familiar with the standard and best practice requirements.
2. Gap Analysis
Gap analysis verifies loopholes identified in existing practice in the laboratory against the ISO 15189 standards, which are used as guidelines in improvement needed.
3. Training Staff and Developing Competency
Staff training on the concept of quality management and best practice for effective implementation
4. Installation of Quality Management System (QMS)
Effective QMS includes documentation of process, risk management process, and internal quality control.
5. Internal Audits and Follow-up Actions
Notification of site visit by regular internal audit results in detection of non-conformities and provides opportunity for remedial action before actual assessment.
6. External Evaluation and Accreditation
Agency assessment, accredited, guarantees compliance of laboratories by site visit and document checking.
7. Certification and Continuous Monitoring
After certification, laboratories must monitor and regulate processes to ensure they remain in compliance at all times with continuous quality improvement.
Challenges in Getting ISO 15189 Certification
Despite being helpful, ISO 15189 certification in Nepal also faces challenges:
- Financial Limitations: Instrument modernization, training, and accreditation are very costly.
- Shortage of Human Resource: Trained quality management staff are scarce, and their absence will cause a delay in the certification process.
- Resistance to Change: Laboratory staff will resist changing the new methods of doing business and quality control procedures.
- Infrastructural Constraints: Some laboratories will need equipment to be replaced, buildings to be renovated, and process flow to be streamlined to the ISO 15189 standards.
Conclusion
ISO 15189 certification is the norm to which the Nepalese medical laboratories must adhere in order to make them reliable and world-class. It enforces compliance with global health standards, makes diagnosis more precise, and earns the trust of the patients. It is challenging but worthwhile due to its long-term benefits. Through improvement and quality as their cornerstone, Nepalese labs can be world-class and serve as the model for having a better health system.
Visit https://www.abishekadhikari.com.np/ to learn more about ISO.
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