Auditing a Medical Devices Quality Management System ISO 13485:2016 Course - North America
This course aims 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.
Duration: 2 Days | Cost: $1249 USD | CEUs: 2.4
Our course, Auditing a Medical Devices Quality Management System ISO 13485:2016, meets 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.
This course 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.
Note: this course does not give a formal auditing qualification (AU).
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Exemplar Global - MD - Medical Device Management Systems.
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
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