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

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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.

•  Prepare for the specific audits to be conducted using audit preparation tools (i.e., checklists, matrices, documentation, schedules, etc.)

• Conduct internal audits required for QMS system maintenance and compliance, and identify gaps.

• Obtain and review objective evidence of compliance including Management System procedures, work instructions, supporting records, personnel feedback, and implementation practices.

• 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. 

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