Introduction
ISO 15189 certification is an international standard particularly for medical laboratories. It is meant to add value to the quality, reliability, and competence of the laboratory services. With the growing demand for quality and effective healthcare services in Nepal, ISO 15189 certification is a do-or-die for labs that wish to achieve stable and reliable results. This article tells us why it is crucial that ISO 15189 certification take place in Nepal, how it is certified, and how it affects laboratory practice and patient treatment.
What is ISO 15189 Certification?
ISO 15189 is the international standard of the International Organization for Standardization (ISO) establishing quality and competence criteria for medical testing laboratories. The standard is applicable to any kind of medical testing laboratory, clinical chemistry, pathology, microbiology, or molecular diagnostics. There are two domains on which the standard puts its energies:
- Technical Competence: Offering proper testing procedures and standard results.
- Quality Management System (QMS): Applying systematic procedures to deliver repeat services.
ISO 15189 follows other quality management systems like ISO 9001 but particularly addresses the requirements of the medical laboratory.
Implications of ISO 15189 Certification for Nepalese Laboratories
- Improvement in Diagnostic Accuracy: Certification provides excellent-quality laboratories with minimal error rates in testing and diagnosis.
- Patient Safety: Accurate and consistent laboratory tests are an integral part of patient decision-making and therefore ISO 15189 is indispensable for patient care.
- Public Confidence: ISO 15189-certified laboratories inspire more confidence among patients and healthcare providers since they have quality and accuracy.
- Regulatory Compliance: The accreditation enables the laboratories to adopt national and international regulatory standards for fulfilling the requirements of the law.
- International Cooperation: Nepalese ISO 15189-accredited laboratories can cooperate more effectively with foreign research institutes and take part in cross-border clinical trials.
Process of Obtaining ISO 15189 Certification in Nepal
- Gap Analysis: Performed a meticulous analysis to discover the existing laboratory procedures and adapt them to suit the requirements of ISO 15189 and prepare the necessary alterations.
- Implement a Quality Management System (QMS): Develop and maintain a quality QMS for all laboratory functions and quality policy.
- Staff Training: Regular staff training and education of laboratory staff to acquaint them with and conform to the stipulations of ISO 15189.
- Internal Audits: Conduct regular internal audits to establish conformity, reveal gaps, and implement remedial action.
- Select an Accreditation Body: Use an experienced certification organization that has a right to provide ISO 15189 accreditation.
- External Assessment: The accrediting agency conducts full audit, namely document examination, observation of lab practice, and interviewing staff.
- Corrective Action Plan: The laboratories should eliminate non-conformities through a corrective action plan on detection.
- Certification Award: ISO 15189 certification is awarded to the laboratory on successful audit and corrective action.
- Surveillance: The accredited laboratories must undergo surveillance audits every six months to maintain ISO 15189 status.
Problems of Obtaining ISO 15189 Certification in Nepal
- Cost Restraints: Implementation and maintenance of ISO 15189 require immense investment in infrastructure, technology, and training.
- Limited Professional Expertise: Nepalese labs won't possess formal training experts in quality management and technical specifications.
- Use of Resources: Small laboratories lack human and technological resources to use recurring ISO 15189 compliance.
- Sustaining Compliance: It consists of ongoing observation and adapting procedures in a manner that one stays conforming to the ISO 15189 criteria.
ISO 15189 Accreditation Advantage to Nepalese Medical Laboratories
- Improved Quality of Service: Certification is for process standardization, which improves the productivity and efficiency of the lab.
- Improved Patients' Confidence: Patients and clinicians have improved confidence in internationally accredited labs.
- Business Efficiency: ISO 15189 promotes the adoption of efficient procedures, reducing error opportunities and improving laboratory efficiency.
- Competitive Edge in the Market: Accredited labs possess another competitive edge over others in the health sector in the market, including more clients and cooperation requests.
- Research and Development: ISO 15189 accredited labs can undertake quality research studies and international clinical trials.
Maintenance of the ISO 15189 Certification
- Checking and Evaluation: The staff within the lab need to check and evaluate their work continuously with the objective of locating and correcting shortcomings.
- Staff Competency Development: Ongoing training activity ensures laboratory personnel remain current with best practice and novel methods.
- Quality Management Reviews: Regular QMS audits ensure ongoing compliance with regulation and industry best practice.
- Surveillance Audits: Regularly scheduled surveillance audits allow laboratories to confirm ongoing compliance with ISO 15189 and determine areas for improvement.
Accreditation Bodies Offering ISO 15189 in Nepal
Some of the accrediting bodies issuing ISO 15189 certification to Nepalese laboratories are:
- Nepal Bureau of Standards and Metrology (NBSM): Official standards body of Government of Nepal.
- National Accreditation Board for Testing and Calibration Laboratories (NABL): One of the most highly regarded accrediting bodies issuing ISO 15189 certification.
- International Accreditation Service (IAS): One of the most trusted organizations issuing accreditation to medical laboratories.
Conclusion
ISO 15189 accreditation is a milestone towards diagnostic testing quality, accuracy, and dependability in Nepalese medical laboratories. It ensures safety to patients, enhances public confidence, and raises the international competitiveness of the health sector. The long-term benefit of ISO 15189 far exceeds the investment even if certified by the process being difficult upon consideration of fiscal limitations and technical capabilities.
By adopting the ISO 15189 standards, Nepalese statement laboratories can improve the quality of diagnosis, minimize complexity, and offer a window for international collaboration. The pursuit and maintenance of this certification is a solemn promise on the part of any laboratory that wants to be its best in the delivery of healthcare. Visit https://qms.com.np/ to learn more about ISO.
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