ISO

FDA Renews ISO Accreditation

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“The Philippine Food and Drug Administration (FDA) has passed with flying colors the recent Surveilance and Follow-up Audit for  conformity to ISO:9001 (2008) by ISO accrediting body TUV Rheinland,” FDA Director General Nela Charade G. Puno said.

TUV Rheinland recently conducted a 3-day surveillance and follow-up audit of FDA Centers and Offices in Muntinlupa, Alabang and its Offices in the National Capital Region, Region V and VII, including Satellite Laboratories in Cebu and Davao.

“We are proud to say that the FDA has maintained the ISO standards for the Certification for licensing of establishments and registration of health products.  We also welcome the inclusion of Post Marketing Surveillance (PMS) under the scope of accreditation.” Puno added.

This resulted in the awarding of the new certificate with the addition of Post Marketing Surveillance under the scope of the ISO accreditation, in addition to licensing and registration.   

Director General Puno pointed out that the FDA’s Quality Management System (QMS)  Committee and the entire FDA organization have maintained an effective QMS that ensures that the FDA products and services, namely the licensing of establishments, registration of health products, and post-market surveillance (inspection and testing) are delivered in compliance with the quality standard of ISO:9001 (2008).  

She challenged the FDA to work hard to increase its efficiency in issuing Licenses to Operate (LTOs) and Certificates of Product Registration (CPRs). At the same time, she warned the public that the FDA will continue to ensure the enforcement of FDA regulations on licensed establishments and unlicensed establishments.

Meanwhile, the FDA is gearing up to comply with ISO:9001 (2015) before the end of the 3rd quarter of the  year in time for another audit in January 2018.   

“The FDA will be embarking on another journey to earn ISO 14001 accreditation, which sets the standard for environmental management systems.  Obtaining ISO 14001 certification is a commitment of the FDA to ensure that that it is compliant with the global standard on environmental laws and regulations.” Puno emphasized.

The FDA is in the process of creating the QEMS Committee to ensure that the FDA resources and reduction of waste are managed well.

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