> medical devices training>Auditing a Medical Devices Quality Management System


Note: this course does not give a formal auditing qualification (AU). It is aimed at giving attendees an in-depth explanation of the requirements of the ISO 13485 standard and how to apply them in the context of an audit. To obtain an auditing qualification, it is suggested that you take “Conducting and Leading Medical Devices Management System Audits” or the 3-day “ISO 13485:2016 Medical Devices Internal Auditor” course. 

  • 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
  • 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
  • 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

SAI Global Assurance Learning is an Exemplar Global certified training provider for the following Exemplar Global competency units: Exemplar Global – MD – Medical Device Management Systems.

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

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