CQI/IRCA-Certified QMS Lead Auditor Based on ISO 13485:2016 and MDSAP Requirements


Virtual Learning
July 18 – 22, 2022

5 days

Virtual Learning
September 19 – 23, 2022

5 days

Virtual Learning
November 14 – 18, 2022

5 days


Students will plan, conduct, report and follow up on a QMS audit in accordance with ISO 13485:2016, MDSAP and EU MDR requirements. Learn how to apply the MDSAP auditing strategies adopted by Auditing Organizations in the MDSAP program, to identify and grade nonconformities and to prepare an audit report in accordance with MDSAP criteria.

This CQI and IRCA medical device lead auditor certified course is currently certified to include ISO 13485:2016 and MDSAP requirements. While the instruction includes discussions of the EU MDR requirements, the incorporation of EU MDR into the accreditation is currently pending.

About This Course

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

The course consists of five days of interactive instruction and auditing sessions followed by a comprehensive written examination on day six. Students will have two 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 QMS Lead Auditor course with a basic understanding of the ISO 13485 quality system requirements, so mandatory prerequisite reading and a competency assessment will be provided on enrollment. These prerequisites must be completed in advance of the course start date.

Key Learning Objectives

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 criteria

This course represents one vital step required to become a certified CQI/IRCA Lead Auditor. Find out more.

Who Should Attend

This class is helpful for all management and executive personnel with responsibility for medical device regulatory lifecycles, involvement with the design and implementation of quality management systems or involvement with product design and development.

Course Tutors

Course tutors can include:

Robert Ruff - Rob has over 30 years’ experience in the medical device and public health sectors, including completing a long, distinguished career with the U.S. FDA. His extensive regulatory experience includes co-authoring the MDSAP Audit Model and the Quality System Inspection Technique (QSIT). He also developed FDA’s computer-based training for QSIT, the Quality System Regulation and the Medical Device Reporting Regulation.

James Pink - James Pink has over 20 years of experience in the medical devices industry including 10 years as a health care technology expert and lead auditor for a leading European notified body. He began his career as a product designer in the oil tools industry moving into medical physics and clinical engineering at the Royal Hallamshire Hospital in Sheffield, UK. His industry experience includes managing product development and quality assurance programs for active and non-active implantable and combination products. Mr. Pink is a contributor to several medical device standards committees including ISO 13485, ISO 14971 and various product-related standards.

Janet Book - Janet Book has worked in the field of quality for over 35 years in various industries, including blood banking, food processing, quality consulting, chemicals, pharmaceuticals and medical devices, with both large and small companies.

She has conducted internal and supplier audits using many different industry-specific standards and regulations. She also has vast experience writing quality procedures, developing quality management systems, and developing and presenting quality-related training and seminars. Ms. Book is a senior member of the American Society for Quality (ASQ), an ASQ Certified Quality Auditor (CQA), an ASQ Certified Quality Engineer (CQE), an ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE) and a RABQSA Quality Systems Lead Auditor.