ISO 13485 Lead Auditor quality management training course

From managing an audit program to reporting on results, this lead auditor training course teaches you everything needed to conduct a quality management system (QMS) audit.

Led by experienced instructors over five days, the training is suited to quality managers, directors, engineers, or consultants. It will help you fully identify the benefits of a QMS and explain the role of the auditor.

On completing this stage of your learning journey, you will be able to apply risk-based thinking, leadership and process management and understand the arrangements for BSI certification.

Prerequisites

A good knowledge of the ISO 13485 is recommended prior to starting this course.

Pedagogical objectives

Identify the aims and benefits of an ISO 13485:2016 audit
Plan, conduct and follow up on auditing activities
Build stakeholder confidence by understanding the latest requirements

Skills to be acquired

On completion of this training, participants will be able to:

Gain the skills to plan, conduct, report and follow up an audit in
accordance with ISO 19011
Identify the purpose and benefits of an ISO 13485:2016 QMS
Explain the role of an auditor in planning, conducting, reporting and following up an audit in accordance with ISO 19011 (and ISO 17021 where appropriate)

Targeted audience

Medical device quality professionals interested in conducting first-party, second-party, and/or third-party audits
Management representatives
Quality directors, managers, and engineers
Consultants