Course Details

The ISO 13485 Lead Auditor training enables you to develop the necessary expertise to perform a Medical Device Quality Management System (MDQMS) audit by applying widely recognized audit principles, procedures, and techniques. During this training course, you will acquire the knowledge and skills to plan and carry out internal and external audits in compliance with ISO 19011 and the certification process according to ISO/IEC 17021-1. Through extensive examination of your knowledge and personal attributes, Medical Device Management Systems Lead Auditor training can give you proof of your competence to effectively audit management systems of organizations that produce medical devices and gives you the assurance that your audits will be accepted globally.

Who should attend?

Auditors seeking to perform and lead Medical Device Quality Management System (MDQMS) certification audits. Managers or consultants seeking to MDQMS audit process. Individuals are responsible for maintaining conformance with MDQMS requirements. Technical experts seeking to prepare for an MDQMS audit. Expert advisors in Medical Device Quality Management System (MDQMS).

Accredited Course(s):

4777674: Five (5) Day Lead Auditor Course certified by Exemplar Global (https://exemplarglobal.org/).

4777675: Two (2) Day Internal Auditor Course certified by Exemplar Global.

4777676: One (1) Day Awareness Course certified by Exemplar Global.

Certification;

After successfully completing the exam, you will be eligible to become an Exemplar Global accredited audit professional*.

General information;

Certification fees are included in the exam price. Training material shall be provided. In case of exam failure, you can retake the exam within 12 months free of charge.