Quality Management System

ISO 13485 LEAD AUDITOR TRAINING

Based on Quality Management System

Based on Quality Management System

WHAT YOU’LL GAIN FROM THE ISO 13485 LEAD AUDITOR TRAINING COURSES?

  • Explain the key concepts and principles of ISO 13485:2016
  • Describe the purpose of ISO 13485:2016, including the interaction with appropriate medical device regulatory authority requirements, quality management systems standards, and third-party certification
  • Explain the business benefits of a quality management system
  • Explain the role and responsibilities of an auditor in planning, conducting, reporting, and following up on a quality management system audit in accordance with ISO 19011 and ISO/IEC 17021
  • Plan, conduct, report, and follow-up an audit of a Medical Device Quality Management System to establish conformance with ISO 13485:2016 and applicable medical device regulatory requirement documents in accordance with ISO 19011 and ISO/IEC 17021

ABOUT THE ISO 13485 LEAD AUDITOR TRAINING COURSE

This ISO 13485 lead auditor training program for medical devices - Quality Management System (QMS) (requirements for regulatory purposes) - aims to provide learners with the knowledge and skills required to perform first, second, and third-party audits of Medical Device Quality Management Systems (MD-QMS) against ISO 13485 and applicable international regulatory standards in accordance with ISO 19011, ISO/IEC 17021.

TRAINING DURATION

5-day instructor-led training

WHO SHOULD ATTEND

This course is specially designed for:

  • Medical device quality management professionals who want to become lead auditors
  • Individuals in organisations involved in the design, development, manufacturing, and distribution of medical devices
  • Management representatives
  • Quality directors, managers, and engineers
  • Consultants

PRE-REQUISITES

  • Prior knowledge of the requirements of ISO 13485 and implementation experience with the adoption of ISO 13485 standard
  • Or internal audit experience of the ISO 13485 standard

EXAMINATION AND CERTIFICATION

There will be an examination at the end of the course. A pass is required for certification to be awarded. This certificate is globally recognised and respected and will demonstrate your competence in ISO 13485:2016 lead auditing.


CONTACT US

Get in touch with us to know more.

Email: [email protected]

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