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About the Course:  

This course offered publicly, on site or on line will give all participants a better understanding of the ISO 13485:2016  Medical Device – Quality Management System standard requirements along with activities involved in auditing of Quality Management Systems (QMS) including the preparing, performing, reporting & follow up of audit findings in accordance with the requirements outlined in the ISO 19011:2018 standard.  Through presentations, group discussions and exercises administered by our professional instructors, all participants will lean how to comfortably carry out effective Quality Management System internal audits to enhance overall quality performance.

Overall Course Objectives:

• To provide an introduction to the International Organization of Standardization (ISO).
• To provide a basic understanding of the Process Approach and P-D-C-A Methodology.
• To provide a clear interpretation of the ISO 13485:2016 standard requirements.
• To provide a clear understanding of conducting QMS internal audits in accordance with the ISO 19011:2018 standard requirements.
• To explain and demonstrate the techniques involved in planning, preparing, performing, reporting and follow-up of QMS internal audits.
• To give course participants sufficient basic training to be able to:
  • develop, implement, and effectively maintain an QMS audit program.
  • participate in QMS management system auditing.
  • effectively document audit results.

Pre-Requisite Requirements:

All participants should have somewhat of an understanding of the requirements of the ISO 13485:2016 standard or a past revision (e.g. ISO 13485::2003).                                                                                         

**Please note: These requirements are only suggested, however, not necessary!

Course Documentation:

All participants will receive a complete ISO 13485:2016 Internal Auditor course training manual and, upon successful completion, receive a Certificate of Achievement in ISO 13485:2016 Quality Management Systems Auditing.

Course Dates:

**Please Note:  All dates above are tentative upon receipt of course confirmation from ISO Atlantic Consulting Inc

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