ISO 13485 Lead Auditor

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ISO 13485 Lead Auditor training enables you to develop the necessary expertise to perform a Medical Devices Quality Management System (MDQMS) audit by applying widely recognized audit principles, procedures, and techniques.

Course Duration : 31 Hours of study (4 days or 5 days).  CPD / PDU: 31

Overview

At the end of the course, the delegates will gain competencies in

  • Understand the operations of a Medical Devices Quality Management System based on ISO 13485
  • Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks
  • Understand an auditor’s role to: plan, lead and follow-up on a management system audit in accordance with ISO 19011
  • Learn how to lead an audit and audit team
  • Learn how to interpret the requirements of ISO 13485 in the context of a MDQMS audit
  • Acquire the competencies of an auditor to: plan an audit, lead an audit, draft reports, and follow-up on an audit in compliance with ISO 19011

ISO 13485 Lead Auditor Course Dates & Prices

  • Live Virtual Training are instructor-led courses delivered in real-time
  • Easy to Access
  • Works on all devices
  • No classroom training schedule found. Contact us for upcoming schedule
3

Key Benefits

Duration : 31 hour training

Study Kit : Accredited Materials,Case Study & Sample Questions

Accredited by : PECB

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