FDA Earns ISO 9001:2008
Certification for Quality Management System
Press Release/10 May 2013:
The Food and Drug Administration (FDA) today received its ISO 9001-2008 certification for Quality Management System (QMS) from TÜV Rheinland, Philippines, a provider of technical, safety, and certification services worldwide.
“With this award of certification, our plans of a department wide ISO-QMS certification are succeeding eventually. Our efforts towards achieving excellence, minimizing wastage in time, efforts and resources to hurdle over unorganized and unnecessary processes will transform the department into a more organized, motivated and efficient bureaucracy”, Dir. Kenneth Hartigan-Go of FDA stated.
“QMS is important, especially in government service as it promotes, integrity, accountability, proper management of public affairs and public property. It also establishes an effective system in the prevention of graft and corruption within the agency,” Dir. Go added.
According to Go, the ISO-QMS system starts in the documentation of an individual’s task and strictly observing his/her duties accordingly then attaining ways to further improve the job to become more efficient and effective. “It is a continuing process of improving the system to gain a more valuable result,” Dr. Go said.
International Organization for Standardization (ISO) is an international standard related to quality management system (QMS) designed to help organizations guarantee that they will meet the needs of the community, applicable to any organization from all types of business sectors and activities.
The figures 9001:2008 is a model created by the ISO for setting up a valuable and applicable QMS and standards for ensuring quality services, environmental friendliness, safety, reliability, efficiency and interchangeability.
The QMS provides guidelines and requirements for systematizing processes, defining clearer tasks and activities for each respective staff, giving due relevance to customer requirements, and ensuring the provision of work requirements. Because of this, the efficiency, effectiveness, and quality of services are ensured in compliance with statutory and regulatory requirements.
As part of the ISO certification process, the FDA has conducted series of orientations and trainings for all its employees rationalizing the need to institutionalize a Quality Management System (QMS) in the agency certifiable to ISO 9001:2008.
Essential steps needed in the achievement of an ISO certification such as management review, final gap assessment, preparation for certification and third party certification audit were successfully achieved by the FDA.
“With this ISO certification, we expect that the FDA will further improve its services in the licensing, monitoring, and regulating the flow of food, drugs, cosmetics, medical devices, substances hazardous substances and also ensuring the quality and safety of food and drugs in the country,” Dr. Go concluded.