ISO 13485 Internal Auditor Training
Medical Devices - Quality Management Systems Requirements for Regulatory Purposes
*Internal Auditor Training Certificates will be issued.
THIS COURSE CAN BE COMBINED WITH AS9100 INTERNAL AUDITOR TRAINING.

A sound auditing program is vital to the health and continual improvement of the QMS, and to comply with the requirements of ISO 13485:2016 for certification purposes.
ISO 13485:2016 Internal Auditor Training
WCH offers a two-day internal audit training class to teach internal auditors the requirements of ISO 13485:2016 and the fundamentals of the internal audit process. This class is designed to train personnel to become qualified and confident to conduct internal audits in a positive, constructive, friendly manner. Auditors will learn to:
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Plan and schedule the audits to be conducted.
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Prepare for the specific audits to be conducted using audit preparation tools (i.e., checklists, matrices, documentation, schedules, etc.)
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Conduct internal audits required for QMS system maintenance and compliance, and identify gaps.
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Obtain and review objective evidence of compliance including Management System procedures, work instructions, supporting records, personnel feedback, and implementation practices.
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Provide written reports that identify audit results; positive implementation aspects, nonconformities that require corrective action, as well as, observations and opportunities for improvement.
Auditors will be given several interactive exercises during the class. A certificate will be issued for each student who successfully completes the course.