The Research Institute for Tropical Medicine (RITM) through its Quality Assurance Office (QAO) led the 1st External Surveillance Audit for ISO 9001:2015 Certification last April 4-5.
The two-day audit was facilitated by TÜV Rheinland auditors namely Mr. Ronnie Alonzo, Mr. John Faustorilla Jr., and Ms. Kharen Concepcion. Auditee representatives from the Laboratory Research Division, Clinical Research Division, Biologicals Manufacturing Division, Administrative Division, and Committees under the Office of the Director and Office of the Assistant Director attended the Opening Meeting at the RITM Auditorium on April 4.
“We are truly excited to have this External Audit. Hinintay po naming talaga yan (laughs),” exclaimed RITM Director Dr. Socorro Lupisan for her opening remarks. “The new ISO 9001:2015 standard is a new learning process for us. [But] we hope that you’ll be able to know more about our institute as you review our processes,” added Dr. Lupisan.
The audit is the 1st follow-up visit for the management system conformity assessment of RITM following its ISO 9001:2015 certification last July 7, 2017.
“I can say that little by little we are improving because of the ISO standards and we are very much appreciative of that,” said RITM-QAO Head Dr. Edison Alberto. He also added, “[To our auditors] we will make sure to make use of whatever findings you might have for our improvement.”
During the two-day audit, the auditors examined the actual process flow of sample operations in individual areas of the Institute. The conformity of the process flows with the requirements of the ISO 9001:2015 standards and the descriptions in the management documentation were also reviewed.
The Initial Audit Summary Report submitted by the auditors indicated positive observation for the following unit/department sites: Health and Emergency Response, Awards and Recognition, National Accreditation, Emergency Preparedness, Customer Satisfaction, Continuous Improvement (Dietary), Research and Innovation Office, and Institutional Review Board.
The audit also identified 23 opportunities for improvement (OFI) for RITM. Based on the OFIs, the recommendations include but are not limited to improvement on the detection, identification, and management of risks, establishment of a database system for monitoring of activities (e.g., calibration, maintenance, work order, service order), and strengthening of work flows and competency requirements for employees.
Most importantly, the auditors did not find any nonconformities on the processes of RITM and concluded that RITM has established and maintain an effective system to ensure compliance with its policy and objectives. The audit team confirmed that RITM’s management complies with, adequately maintain and implements the requirements of the ISO 9001:2015 standards. The auditor therefore recommended the maintenance of the existing certificate of RITM.
The auditors are expected to conduct visits to ensure the management of OFIs identified in the report.
by Ma. Patricia M. Lansang, Communication and Engagement Office [RITM Web Team]