QMS Lead Auditor based on ISO 13485:2016 and MDSAP Requirements

Learners will plan, conduct, report and follow up on a QMS audit in accordance with ISO 13485:2016 under MDSAP. Learn how to apply the MDSAP audit approach adopted by Auditing Organizations in the MDSAP program.

This course provides the skills and knowledge that many auditors take decades to develop. Learners will plan and prepare audits based on case studies simulating supplier and third‑party audits using MDSAP requirements. They will participate in simulated audit exercises covering planning, preparation and evaluation of evidence, and practice applying ISO 13485:2016 and MDSAP requirements.

The course consists of five days of interactive instruction and auditing sessions, culminating with a comprehensive written examination. Learners will have two hours to complete the exam, which is provided and proctored in a virtual format (additional time will be added for learners who speak English as a second language and are taking the exam in English, and learners with disabilities). Our course requires highly interactive work and ongoing instructor assessment throughout the week.

This course was developed by regulatory authority members from the FDA and other Auditing Organizations who also reside on Technical Committee 210, which updates the ISO 13485 standard, and who also participated in the development of the MDSAP Program itself. As such, the information, tools, and principles used in the course are given first hand to students, removing any uncertainty and conjecture with regard to the intent of the requirements and regulations.

Prior Knowledge and Experience Requirements:

In order to sit the course, learners are required to demonstrate they fulfil the prior knowledge requirements, which includes knowledge of quality management principles and concepts, and the requirements of ISO 13485:2016.

• Knowledge of the requirements of ISO 13485
• Knowledge of the following quality management principles and concepts:
• The Plan, Do, Check, Act (PDCA) cycle.
• The relationship between quality management and customer satisfaction.
• Commonly used quality management terms and definitions within ISO 13485 and ISO 9000 (including 7 quality management principles, see ISO 9000)
• The process approach used in quality management.
• The Model of a Process Based Quality Management System, the structure and content of ISO 9001.
• Knowledge of at least 1 of the MDSAP country-based regulations, or similar e.g. WHO PQ requirements, EU MDR or EU IVDR etc.
• Medical device/IVD auditing background.

Learners will receive a pre-course questionnaire via email to share prior knowledge and experience, which must be completed and returned prior to the course date.

Tutors

Course tutors can include:

Janet Book – Janet has 35 years’ quality experience across blood banking, food, chemicals, pharma and medical devices. She has led internal and supplier audits, developed quality systems and training, and written procedures and audit programs. A Six Sigma Black Belt, she has also taught at Carnegie Mellon and worked in privacy, quality and compliance. She is an ASQ senior member and holds multiple ASQ certifications, including CQA, CQE, CMQ/OE, as well as RABQSA Lead Auditor status.

Brian Ludovico – Brian has over 30 years’ experience in the medical device sector covering quality systems, manufacturing and global regulatory compliance. A former regulator with a major notified body, he helped develop MDSAP and has conducted hundreds of audits and technical reviews. He has led corporate audit programs, created CAPA training and is an IRCA‑qualified trainer. He has also served under the FDA’s Accredited Persons and Third‑Party Review programs and is a board member of ASQ’s New England Biomedical Discussion Group.