FDA passes ISO audit

The Food and Drug Administration (FDA) passed the ISO 9001:2015 audit and is now certified for ISO9001:2015, FDA director general Nela Charade G. Puno said.

“This is truly an achievement for us,” Puno said,  as she commended FDA personnel for nailing the ISO audit conducted by TUV Rheinland and the Quality Management Systems Team of FDA.

“It also highlights FDA’s commitment of ensuring that our stakeholders and the Filipino public we serve are provided with the best possible service for all of the work we do as the government agency regulating the safety and efficacy of drugs, food, cosmetics and health products and devices,” Puno said.

The FDA regulates four industries—cosmetics, medical services, drugs, and food and beverages—covering a market size of P243 billion.

It issues Certificates of Product Registration (CPR) and License to Operate (LTO) for all the products and services under these industries.

FDA passed the requirements for the ISO9001:2015 seal,  meaning it was able to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements.

It was also able to show that it could enhance customer satisfaction through the effective application of the system.

Auditors from TUV Rheinland and the FDA QMS team inspected the various centers and offices of the FDA, using the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking approach.