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Third Party Audit

Quality Management System

Medical Device Quality Management System Certification

ITC Zenith provides audit and certification services as per ISO 9001 Quality Management Systems and ISO 13485 Medical Devices -Quality Management Systems to organizations manufacturing or trading Medical Devices and In-Vitro Diagnostic Devices.

Our audits empower organisations to monitor and improve their management system processes. This leads organizations to compete and grow at national and international levels.

Goods Distribution Practice Medical Device
GDPMD specifies the requirements for a quality management system to be established, implemented and maintained by an establishment in carrying out activities in medical device supply-chain to comply with Malaysian medical device regulatory requirements as stipulated in Medical Device Act 2012 (Act 737). GDPMD requires an establishment to demonstrate its ability to maintain quality, safety and performance of medical devices in compliance with the Malaysian medical device regulatory requirement throughout the supply-chain. It shall be used by both the internal and external parties to determine the ability of an establishment to meet the requirements specified within.

The certification to GDPMD is to be conducted by the registered conformity assessment body. The design and implementation of GDPMD by an establishment is dependent on the types and categories and classification of medical device, size and structure of the establishment, the processes employed it deals with. It is not the intent of the GDPMD to imply uniformity in the structure of the quality management systems or uniformity of documentation.

Certification to GDPMD does not imply compliance to any written laws. It is the responsibility of the establishment to ensure that they are in compliance with all applicable laws in Malaysia. In the event of any contradiction between the requirements of GDPMD and any written law, the latter shall take precedence.