ISO 13485.2016 Lead Auditor ( Exemplar Global )
  • Medical Device - Quality Management system (Through accredited partner)

  • Start in: 05.08.21

  • End In: 09.08.21

ISO 13485.2016 Lead Auditor ( Exemplar Global )

5500 EGP

  • Overview
  • Lead Tutor

Course Details

ABC 's “ISO 13485:2016 Lead Auditor” competency-based course teaches a general understanding of the concepts of the ISO 13485:2016 standard and the principles and practices of leading management systems and process audits in accordance with ISO 19011:2018, “Guidelines on Auditing Management Systems”. Experienced instructors explain the clauses of ISO 13485:2016 in detail and guide students through the entire audit process, from managing an audit program to reporting on audit results. Qualified instructors will help you to boost your audit capabilities with the latest developments of the new 19011 standard.  Students gain necessary auditing skills through a balance of formal classroom tutorials, group workshops, and open forum discussions.
This course comprises the following three( Exemplar Global)  Competency Units whose outcomes are certified by Exemplar Global:
  • MD - Medical Device Systems
  • AU - Management Systems Auditing
  • TL - Leading Management Systems Audit Teams

Learning Objectives

  • Understand quality management definitions, concepts, and guidelines
  • Understand the requirements of the ISO 13485:2016 standard
  • Understand the roles and responsibilities of the auditor
  • Apply ISO 19011:2018 concepts, new terminology and guidelines
  • Understand the purpose of the ISO 9000 series
  • Recognize the principles, practices, and types of audits
  • Conduct all phases of an audit adopting a risk-based approach
  • Prepare and present effective reports
  • Understand Exemplar Global's certification scheme
  • Understand the role of objectives, scope and criteria in the audit process
  • How to plan audits
  • Conduct audit team selection
  • Initiate the audit and conducting opening meetings
  • Understand audit team leader responsibilities
  • Communicate effectively during the audit
  • Apply the latest auditor techniques and identify appropriate use
  • Conduct on-site activities
  • Prepare audit conclusions
  • Conduct closing meetings
  • Report audit results

Who Should Attend?

  • Individuals interested in conducting first-party, second-party, and third-party audits
  • Management Representatives
  • Quality Directors in Medical Device
  • Managers
  • Engineers
  • Consultants
 Course Venue/Mode

Courses are held through the ABC Academy halls / Online 


(40 Hours)  / 5 Days consecutively

Dr. Mohamed Moustfa

Dr. Mohamed Moustfa

Lead Auditor QMS - EMS - OHS - FSMS - MD

DR. MOHAMED is backed with more than 25 Years of Experience , his career started since his graduation in 1996 in the filed of Food and Agriculture as an agronomist , management system consultant , instructor and ...

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