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 for certification purposes.

WCH offers a two-day internal audit training class to teach internal auditors the requirements of ISO 13485 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:

  • 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 Management 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.  

Additionally, Internal Auditors will become a proponent for the success of their own area, while being able to audit other areas within the company (auditors cannot audit their own work.) 

This collaboration encourages communication and relationship building across all involved departments / areas.

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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AS9100 - IATF 16949 - ISO 9001 - ISO 13485 - ISO 14001 - ISO 17025 - ISO 22000 - ISO 27001 - ISO 45001

Blueprint Reading, cGMP, Core Tools, QA Inspector, Statistical Process Control, Supplier Audits

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