FDA Awarded New ISO:9001 Certificate with Added Scope on PMS

The FDA Director General, Ms Nela Charade G. Puno, RPh, led the FDA Management Team and Quality Management  System (QMS) Committee during the TUV Rheinland Surveillance and Follow-up Audit to assets the FDA’s conformity to ISO: 9001 (2008) on February 14, 15 and 17, 2017. The audit objectives are to determine if the existing ISO:9001 Certification for licensing of  establishments and registration of heath products are maintained, and to determine possible inclusion of Post Marketing Surveillance (PMS) under the scope of accreditation.

The outcome of the 3-day surveillance and follow-up audit of FDA Centers and Offices in Alabang and in the Regional offices, including Satellite Laboratories in Cebu and Davao, resulted to 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.

During the FDA Flag Ceremony, the FDA DG thanked the QMS Committee and the entire FDA Organization for maintaining an effective QMS that ensures that the FDA products and services, namely the licensing of establishments, registration of health products, and the post-market surveillance (inspection and testing)are delivered in compliance with quality standard of ISO:9001 (2008). She challenged the FDA to work hard to increase its efficiency in issuing LTOs and CPRs, and ensure enforcement of FDA regulations to licensed establishments and unlicensed establishments although regulated by the FDA.

The FDA QMS 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 environment management systems. Obtaining ISO 14001 certification is a commitment of the FDA to ensure that it is compliant with the global standard on environmental laws and regulations. The FDA resources and regulation of waste are managed well.

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