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

The course consists of four days of interactive instruction and auditing sessions, culminating with a comprehensive written examination on the fifth day. Learners will have two hours to complete the exam, which is provided and proctored in a virtual format. 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.

By the end of this training, learners will be able to:

• Describe the purpose of:
  • Quality management system
  • Quality system standards
  • Management system audit
  • Third-party certification
• Explain the role of an auditor to plan, conduct, report and follow up a quality management system audit in accordance with ISO 19011
• Plan, conduct, report and follow up an audit of a quality management system to establish conformity (or otherwise) with ISO 13485

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.

This class is helpful for all personnel involved in preparing, conducting, managing, participating in, or otherwise facilitating internal, supplier, or regulatory audits and their outcomes, as well as executive personnel with responsibility for the design and implementation of any aspect of a quality management system.

Course tutors can include:

Janet Book - Janet Book has worked in the field of quality for the past 35 years in a wide variety of industries, including blood banking, food processing, quality consulting, chemical, pharmaceuticals and medical devices. She has conducted internal and supplier audits utilizing many different industry-specific standards, due diligence evaluations as well as capability assessments. She has been involved with writing quality procedures; developing supplier, internal and corporate audit programs; developing quality management systems; and developing and presenting quality-related training and seminars. Janet is a certified Six Sigma Black Belt and served as an adjunct professor at Carnegie Mellon University. Recently, she earned her Certificate in Privacy Law and Cyber Security and worked in privacy providing guidance on quality, regulatory and compliance functions. She 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 an RABQSA Quality Systems Lead Auditor.