ISO 13485 Lead Auditor

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ISO 13485 Lead Auditor

Learn how to improve the quality of medical devices manufactured by a company
Learn how to promote harmonisation of regulatory requirements for manufacturers
Learn how to obtain quality objectives from the manufacturer and pass them to the organisation
Learn how to engage management actively and undertake management system activities
Learn how to provide access and evidence in accordance with regulatory requirements

Overview

Off the shelf (OTS)

This highly interactive course enables individuals to plan, lead, and report audits within their own organisation, with their suppliers and with third-party organisations. This course will benefit our delegates by ensuring that they are able to conduct effective audits in any auditing situation.

This will be achieved through the attainment of the relevant skills in planning, coordinating, reporting, and reviewing with regards to QMS auditing. It is essential that our candidates understand the role of an ISO 13485 Lead Auditor and can explain their role in terms of the entire auditing process outlined in this course. At the end of the course, delegates will be required to sit an exam to become certified.