ISO 13485:2016 (Medical Device) QMS Audit

Kubang Kerian – 22nd February 2018, The In-Vitro Diagnostic (IVD) Unit at INFORMM Kelantan led by Associate Professor Dr. Aziah Ismail, Deputy Director R&I of INFORMM successfully completed the 2nd Surveillance Audit session for ISO 13485:2016 (Medical Device) Quality Management System.

The auditing session was conducted by experienced auditor of certification authorized body (CAB), Mr. Abdul Rahman Abdul Ghani from TUV Rheinland Malaysia Sdn Bhd. The main purpose of the two-day session was to thoroughly audit the implementation of the quality system initially reported for the IVD Unit. 

In this audit, no Non-Conformance (NC) was issued. In fact, all corrective and preventive actions (CAPA) reported earlier as Non-Conformity Report (NCR) issued during the 1st Surveillance Audit of ISO 13485 QMS session on 24th – 25th October 2017 were successfully checked and approved by the auditor. The auditor also highlighted a few Opportunity for Improvements (OFIs) and strengths that need to be done in order to ensure the ISO 13485 QMS can be operated efficiently.

Overall, the auditor officially remarked that the In-Vitro Diagnostic (IVD) Unit, INFORMM Kelantan is ready for the Recertification Audit expected in October 2018.