On December 5, 2018, during the 2nd anniversary celebration of its establishment, Vinmec Ha Long International General Hospital received the ISO 15189:2012 certification for its Laboratory Department. To date, Vinmec Ha Long is one of the few hospitals nationwide and in Quang Ninh to achieve this certification for three laboratory specialties: Hematology, Biochemistry, and Microbiology.
The Laboratory Department of Vinmec Ha Long International General Hospital was established when the hospital began its operations. The department consists of three main sections: Hematology – Blood Transfusion, Biochemistry, and Microbiology.
The department is equipped with a full range of synchronized and modern laboratory equipment, including: an automatic biochemistry and immunology testing system, an automatic hematology testing system, an automatic blood culture machine, an automatic identification and antibiotic susceptibility testing machine, and more.
Since 2017, with the goal of enhancing the quality of laboratory services and increasing patient trust, the Laboratory Department at Vinmec Ha Long International General Hospital has actively worked on improving organizational structure, developing technical processes, managing results, mastering modern equipment, and ensuring compliance with five-star service standards. It has achieved ISO 15189:2012 certification, becoming a laboratory that provides "accurate, timely, objective, and reliable" testing services.
To effectively operate the laboratory equipment system and provide testing services that ensure "accuracy, timeliness, objectivity, and reliability," the staff at the Laboratory Department of Vinmec Ha Long have made a determined effort to build a quality management system that meets the standards of ISO 15189:2012. This comprehensive quality management system covers all three stages: pre-testing, testing, and post-testing. The goal is to deliver the fastest and most accurate results to patients, helping doctors provide effective treatment.
With remarkable efforts, the Laboratory Department was granted the ISO 15189:2012 certification on November 29, 2018, after 1.5 years of preparation, without the need to hire external consultants.
Vinmec Ha Long Laboratory set a challenging goal to achieve the ISO 15189:2012 certification just 1.5 years after its establishment. Under the leadership of Dr. Doan Thi Hong Han, Head of the Laboratory Department—who has over 30 years of experience in the field of laboratory testing and is an expert in advising and evaluating the quality of laboratory services for the Ministry of Health—the department successfully achieved this goal on time. Not only did the laboratory ensure the provision of testing services to its clients, but it also built and implemented an efficient quality management system, making this an outstanding achievement for the department. The ISO 15189:2012 certification further affirms the safety and effectiveness of the healthcare services that Vinmec Ha Long committed to from its very first day of operation, as shared by Dr. Pham Hong Ha, Director of Vinmec Ha Long General Hospital.
What is ISO 15189:2012?
- ISO 15189:2012 (equivalent to the national standard TCVN 15189:2014) is the standard that outlines the requirements for the competence and quality of medical laboratories. This standard is based on the requirements of ISO/IEC 17025 and ISO 9001, with additional specific requirements for ensuring quality in the medical testing field.
- ISO 15189:2012 “Medical laboratories – Requirements for quality and competence” was issued on November 1, 2012, replacing the previous ISO 15189:2007 standard. The new version includes stricter criteria aimed at gradually improving technical expertise and management capabilities.
- ISO 15189 includes 15 management requirements similar to those found in the ISO/IEC 17025 standard and the management system requirements in ISO 9001:2008. It also includes 10 technical requirements related to ensuring quality in laboratory operations, such as: competence and skill of laboratory personnel, environmental condition control, equipment management, pre-testing preparations, and testing process control.
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