Recertification Audit ISO 13485:2016 (Medical Device) Quality Management System 2018

Recertification Audit  ISO 13485:2016 (Medical Device) Quality Management System  26th – 28th November 2018

Kubang Kerian – 26th November 2018, the Recertification Audit EN ISO 13485:2016 (Medical Device) Quality Management System was successfully audited by Mr. Abdul Rahman Abdul Ghani from TUV Rheinland Malaysia Sdn Bhd. The main purpose of this 3-days session is to audit the implementation of quality system within the operation of IVD Unit at INFORMM, Kelantan as required by EN ISO 12385:2016 standard. The Audit session was successfully completed without Non-Conformances (NCs) and observations (OBVs). The new scopes for this new certification are “Design and Development, Manufacture and Distribution of Dipstick Kit for Typhoid and Paratyphoid Diseases Detection in Clinical Laboratory”.