The Memorandum of Agreement between the Department of Trade and Industry-Philippine Accreditation Bureau (DTI-PAB), Department of Health (DOH), and Food and Drug Administration (FDA) is paving the way for international competence recognition as National Reference Laboratories (NRLs) gear up for accreditation. Through this agreement, all NRLs are required to be accredited by DTI-PAB for relevant standards such as ISO 15189, and ISO/IEC 17043.

As an initial activity, the Department of Health-Office for Health Laboratories (DOH-OHL), organized an in-person orientation on ISO 15189 -Requirements for quality and competence in Medical Laboratories, and ISO/IEC 17043 – General requirements for the competence of proficiency testing providers on August 30, 2023, at the Philippine Blood Center, Quezon City. The objective of the orientation is to prepare NRLs to be accredited by DTI-PAB on relevant ISO standards. The NRL’s Heads and technical staff took part in this activity.

PAB-Laboratory accreditation Division (LAD) Assistant Chief, Marlon Macadamia, highlighted the vital role of accreditation and provided an overview of ISO 15189, while PAB-LAD Chief Ms. Michelle Esteban, discussed the overview of ISO/IEC 17043 and the accreditation process. The activity resulted in a constructive discussion that clarified issues and concerns about how long the accreditation process will take, accreditation fees, required documentation, and requirements for approved signatories.

Participants from different National Reference Laboratories together with DTI-PAB representatives pose for a group photo after the successful Orientation on ISO 15189 and ISO/IEC 17043 at Philippine Blood Center, Quezon City.

Adherence of conformity assessment bodies like DOH-NRLs to both regulatory requirements and international standards is seen not only to improve compliance and rationalize regulations, but ultimately help in ensuring compliant, high quality and standardized health care services available for all.

The activity facilitated by the DOH-OHL is expected to produce a plan of action relative to compliance with requirements of the relevant standard and design approaches to gauge progress in attaining accreditation from DTI-PAB.

Apart from its initiatives in the health sector, DTI-PAB also works with other regulators and government agencies to harmonize the conformity assessment activities, to eliminate redundancies in requirements and processes that could help industries better comply with regulations and provide high quality services to the public.

For more information about PAB’s projects and initiatives, please visit our website through this link: https://www.dti.gov.ph/pab/

Release Date: 05 September 2023

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