ISO 13485 Medical Devices – Quality Management System Lead Auditor Course

Course Overview:

MacLead’s ISO 13485:2015 Medical Devices – Quality Management System Lead Auditor Training course aimed to understand the concepts of the ISO 9001:2015 standard along with the principles and best practices of leading management systems and process audits in accordance with ISO 19011 and 17021.  Our active Lead Auditors, who are also highly experienced and qualified Lead Tutors, explain the clauses of ISO 9001:2015 in detail and will guide you to gain the knowledge and skills required to undertake and lead a successful management systems Internal and External audits. Participants gain necessary auditing skills through a balance of formal classroom tutorials, role playing, group workshops, and open forum discussions

Accreditation & Certification 

At the end of the Course, Competency Assessment and Research Council (CARC) an initiative of MacLead Certifications shall conduct examination as per ISO 17024. On successful completion candidates shall be awarded with “Successfully Completed (Passed)” Others Participants shall be awarded with certificate of participation.

Who should attend?

  • Auditors seeking to Involve, Perform and Lead Medical Devices Quality Management System Certification Audits
  • Who require a detailed knowledge of ISO 13485 requirements?
  • Who are involved in preparing their organization for implementation of ISO 13485 and its eventual assessment by customers or certification body against ISO 13485 requirements?
  • Who wish to become effective internal auditors within their organization
  • Expert advisors in Medical Devices Quality Management
  • Existing auditors and assessors in other management systems

 Learning Objectives

  • Interpret the ISO 13485 standard in the context of audit
  • Learn the purpose of a Medical Devices quality management system, systems standards, management system audit and of third-party certification
  • To Plan and conduct an audit in accordance with guidelines as per ISO 19011, gather objective evidence via various methods and determine conformity to the requirements of Quality Management Systems.
  • The role of an auditor to plan, conduct, report and follow up an ISO audit in accordance with ISO 19011 and 17021.
  • The difference between legal compliance and conformance with ISO standards.
  • The process of conducting, Follow up and reporting an audit


A basic understanding of ISO 13485 and comprehensive knowledge of audit principles


Each Participants will receive CARC recognized certificate(s) upon successful completion of the course

Training Courses related to ISO 13485:2015

Course Fee: 25,000 INR
Course Duration: 5 Days

Course Fee: 15,000 INR
Course Duration: 2 Days

Course Fee: 10,000 INR
Course Duration: 2 Days

Course Fee: 10,000 INR
Course Duration: 2 Days