ISO 13485:2016 Lead Auditor EN

Gain the confidence to effectively audit a QMS in accordance with internationally recognized best practice techniques. Demonstrate your commitment to the quality of medical devices by transforming existing auditor skills to ISO 13485:2016. Consolidate your expertise with the latest developments and contribute to the continuous improvement of the business.You’ll grasp the key principles and practices of effective QMS audits in line with ISO 13485:2016 and ISO 19011 'Guidelines for auditing management systems'. Using a step-by-step approach, you’ll be guided through the entire audit process from initiation to follow-up. Over 5 days, you’ll gain the knowledge and skills required to undertake and lead a successful management systems audit. Learn to describe the purpose of an ISO 13485:2016 QMS audit and satisfy third-party certification. Acquire the skills to plan, conduct, report and follow up a QMS audit that establishes conformity and enhances overall organizational performance.   Course Outcomes   You will learn 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 to plan, conduct, report and follow up an audit in accordance with ISO 19011 (and ISO 17021 where appropriate)