CQI/IRCA-certified QMS Lead Auditor based on ISO 13485:2016 and MDSAP Requirements
January 31 – February 4, 2022
This course consists of 5 days instruction followed by a 2-hour exam on the 6th day. Students will plan, conduct, report, and follow-up on a QMS audit in accordance with ISO 13485:2016, MDSAP, and EU MDR requirements. Throughout the course, students will learn how to apply MDSAP auditing strategies, adopted by Auditing Organizations in the MDSAP program, and learn to identify and grade nonconformities and prepare an audit report in accordance with MDSAP criteria.This course is currently certified to include ISO 13485:2016 and MDSAP requirements. Inclusion of EU MDR requirements in the accreditation is pending.
By the end of this training, students will:
• Understand how to: plan, conduct, report and follow up on a QMS
audit in accordance with ISO 19011, ISO 13485:2016 and MDSAP;
• Apply the MDSAP audit strategies adopted by Auditing
Organizations in the MDSAP program;
• Identify nonconformities, apply accurate grades to
nonconformities in accordance with the MDSAP grading system;
and prepare an audit report in accordance with the MDSAP
Who Should attend
This course is vital for medical device quality professionals with responsibility for conducting or implementing internal audits, supplier audits, corporate audits or third-party audits. Quality directors, regulatory managers and those responsible for managing internal, corporate, supply chain or registration audit programs will also benefit from this course.