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ISO 15189 : Building Credibility and Efficiency in Medical Labs

ISO 15189 efficiency

The medical field is one of the most valuable industries in our society today. A big part of this field relies on researches and data collection which happen mostly in medical laboratories. Due to the critical value of laboratory tests, a quality management system was developed by the International Organization for Standardizations’ Technical Committee 212 and is called ISO 15189. In line with ISO’s quality management system standards such as the ISO 9001 and ISO/IEC 17025, ISO 15189 aims to provide efficiency and accuracy in any medical laboratory procedures. These procedures range from proper patient guidance in utilizing laboratory services, procedures involving collection of patient samples, testing procedures in emergency cases and staff trainings on laboratory role in the treatment of patients.

Similar to ISO 9001, compliance certification for ISO 15189 requires a quality manual documenting procedures done in the medical laboratory. Since medical laboratories are critical in caring and treating patients, quality and accuracy are expected in lab test results for it may mean life or death for a medical patient. Majority of medical laboratories that passed the ISO audit and given certification are utilizing specially designed software based on ISO quality standards. Having such software and a solid quality management in place, medical laboratory processes became more efficient by having reduced turnaround time. This resulted in a significant increase in the overall productivity and performance of the labs.

The implementation of ISO 15189 requires careful planning and transition to the ISO quality management system. Document control and staff training are highly critical to ensure that the lab will pass the ISO audit and secure ISO 15189 compliance certification. This period is very critical since medical laboratories will have to continue medical tests even in the midst of transition.

Being accredited as an ISO 15189 compliant medical laboratory can definitely affect the confidence of patients and healthcare regulators. With an internationally recognized quality management system in place, healthcare regulators tend to support medical laboratories with competent, reliable and safe procedures. Patients tend to trust medical labs that are recognized to be credible in the industry, provide accurate results and deliver efficient service through systematic procedures. Meanwhile, medical laboratories become more effective in their role in the medical field, gaining higher credibility not only from medical professionals but also from their own patients.

Due to the sensitivity of the implementing ISO 15189, it is advisable that medical laboratories that intened to be ISO 15189 compliant should hire an ISO consultant before the ISO audit. An ISO consultant can be a significant contributor in ensuring that the ISO quality management system required in ISO 15189 is implemented without disrupting the continuous operations of the medical laboratory, making the transition seamless and in order.

Accredited ISO 15189

ISO 15189 is increasingly becoming a demand in the medical field. The integrity of a medical laboratory’s efficiency may be highly dependent on being accredited as an ISO 15189 compliant. So if you are planning to have your medical laboratory certified, talk to an ISO consultant and find out how you can implement the ISO quality management system for medical laboratories. Click here for more information.

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Bhaskar Kotte

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