Auditing A Medical Devices Quality Management System ISO 13485:2016 – May 05-06, 2025 (EST)

• To provide an in-depth review of the requirements of the ISO 13485:2016 standard and how they are applied in the context of an audit
• To meet the training requirements for the Exemplar Global (TPECS) Auditor Certification Program, Competency Unit MD
• This course can be taken individually or combined with the Conducting and Leading Medical devices management system audits course to form a four-day lead auditor course, depending on individual objectives

• Understand the intent and requirements of the ISO 13485:2016 Standard in the context of a quality management system audit
• Understand the relationship between the applicable regulatory requirements and ISO 13485
• Explain the concepts of the process approach, Plan-Do-Check-Act, process-based activities and associated inputs, outputs, controls, and resources
• Understand how to evaluate the effectiveness of an entire quality management system, including process, customer focus and improvement to meet regulatory requirements
• Evaluate, using risk-based thinking, the effectiveness of an entire quality management system as applied to medical devices
• Throughout the course a series of activities will provide the opportunity for attendees to demonstrate the knowledge they have gained

• Studying the current published version of ISO 13485 prior to attending this course is recommended

• Individuals who want to obtain a formal qualification in the application of Medical Devices to add to their auditing experience
• Individuals leading their companies to ISO 13485 certification
• Business Managers, Quality Managers, Engineers, Compliance Officers, and Consultants
• Individuals who want to become a Certified Medical Device Quality Management Systems Auditor through their relevant certifying body such as Exemplar Global

SAI Global Assurance Learning operates as Intertek and is a certified training provider for the following Exemplar Global competency unit(s):

• Exemplar Global – MD – Medical Devices Management Systems