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Auditing a Medical Devices Quality Management System ISO 13485:2016

SAI Global
Training overview
2 days
Classroom / Public

Course description

Auditing a Medical Devices Quality Management System

This course provides an in-depth review of the requirements of the ISO 13485:2016 standard and how they are applied in the context of an audit. This course meets the training requirements for the Exemplar Global (TPECS) Auditor Certification Program, Competency Unit MD, and 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

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Who should attend?

  • 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

Training Content

  • 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

About SAI Global

sai global

SAI Global

At SAI Global, we understand the challenges of building stakeholder trust and confidence for companies at all stages of maturity. We work with organizations to help them meet stakeholder expectations for quality, safety, sustainability, integrity and desirability in any market...


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SAI Global



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