Quality Management Systems Lead Auditor Training, Incorporating ISO 13485:2016 and MDSAP Requirements (CQI/IRCA Certified*)

Virtual Learning

November 8 – 12, 2021

Course Overview

This five-day course provides the skills and knowledge that have taken many experienced auditors decades to develop. During the course, you will plan and prepare audits based upon case studies that simulate both supplier and third-party audits utilizing the MDSAP audit requirements. Throughout the course, you will participate in simulated auditing exercises that include planning, preparation and evaluation of audit evidence. You will also practice the application of ISO 13485:2016 and the MDSAP requirements.

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. While the instruction will include discussions of the EU MDR requirements, the incorporation of EU MDR into the accreditation is currently pending.

The course consists of 4 days of interactive instruction and auditing sessions followed by a comprehensive written examination on day 5. Students will have 2 hours to complete the exam, which is provided and proctored in a virtual format (2.5 hours for non-native English-speaking students). Our course requires highly interactive work and ongoing instructor assessment throughout the week.

Students should be entering the Lead Auditor course with a basic understanding of the ISO 13485 Quality System Requirements, so a mandatory prerequisite reading and competency assessment will be provided upon enrolment. These prerequisites must be completed in advance of the course start date.

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.