PAB’s Assessment Team: Mr. Marlon Macadamia (center), Dr. Marissa Orillaza (right), Ms. Katrina Talle (left), and Ms. Leah Flores with Panaga Health personnel and PSABD representatives, posing for a photo after the assessment’s closing meeting.

The Department of Trade and Industry-Philippine Accreditation Bureau (PAB) has made many firsts this year. Following its granting of accreditation to Seri Damai Services Sdn Bhd as the first Inspection Body in Brunei under ISO/IEC 17020 on June 14, 2024, it has yet again achieved two significant milestones in enhancing global laboratory standards.

PAB granted its first-ever ISO 15189:2022 accreditation to Clinical Laboratory Services, Panaga Health, in Brunei Darussalam, solidifying PAB’s role in driving quality medical testing services beyond the Philippines. Additionally, Hi-Precision Diagnostics Center Inc., Main Branch in Quezon City, became its first laboratory in the Philippines to transition to the latest version of ISO 15189, demonstrating a firm commitment to the highest international standards in medical testing. 

Why ISO 15189:2022 Matters?

ISO 15189:2022 outlines the international requirements for quality and competence in medical laboratories, directly impacting patient care through reliable testing that forms the backbone of diagnostic decisions. This standard reinforces laboratory credibility and harmonizes testing procedures globally, ensuring patients receive accurate, consistent results across international borders. PAB’s accreditation scheme under ISO 15189:2022 attests to its accredited laboratories’ adherence to the latest quality management practices, risk management, and patient safety protocols. 

PAB’s accreditation of Panaga Health in Brunei is a landmark achievement, acknowledged by Brunei’s national accreditation body, Pusat Standard dan Akreditasi Brunei Darussalam (PSABD). The accreditation of Panaga Health, serving Brunei Shell Petroleum and its surrounding community, affirms that the laboratory adheres to a rigorous quality management system that aligns with international best practices. 

Hi-Precision Diagnostics Center, Inc., Main Branch Leads Transition to ISO 15189:2022

Management and staff of Hi-Precision Diagnostics Center, Inc., Main Branch, alongside PAB’s Mr. Marlon Macadamia and Ms. Katrina Talle, and Technical Assessors Dr. Marissa Orillaza, Herbert Pascual, Josefina Soriano, Gina Noble, and Marienella Galit, pose for a photo after a successful assessment.

Hi-Precision Diagnostics Center, Inc., Main Branch, has become the first PAB-accredited Philippine medical laboratory to transition from ISO 15189:2012 to ISO 15189:2022. By meeting the new requirements, Hi-Precision further underscores that its facility is committed to precision, patient safety, and regulatory adherence. 

The Importance of Transitioning to ISO 15189:2022

The new standard’s alignment with ISO/IEC 17025:2017 facilitates streamlined, efficient operations and increased emphasis on risk management. The updates that focus on risk mitigation help laboratories proactively address potential issues. Requirements for point-of-care testing (POCT), previously in ISO 22870, have also been incorporated in this updated version.

According to the website of the National Community Pharmacists Association, a U.S.-based organization, Point-of-Care Testing (POCT) is a method that produces rapid and reliable results, aiding in the identification and monitoring of acute infections or chronic diseases. POCT involves conducting screenings and tests at or near the point of care, delivering actionable results within minutes. The primary goals of POCT include identifying diseases, monitoring disease progression, modifying patient behavior, and reducing barriers to care.

The shift to ISO 15189:2022 by December 2025 is essential for all accredited medical laboratories, to signify a more proactive step toward improved patient care and operational efficiency. This transition is expected to enhance patient care further, ensure reliable testing crucial for accurate diagnoses and treatment plans, and streamline processes.

Release Date: 07 November 2024.

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