ISO 13485 Lead Auditor

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Course Overview

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.

During this training course, you will acquire the knowledge and skills to plan and carry out internal and external audits in compliance with ISO 19011 and ISO/IEC 17021-1 certification process.

Based on practical exercises, you will be able to master audit techniques and become competent to manage an audit program, audit team, communication with customers, and conflict resolution.

After acquiring the necessary expertise to perform this audit, you can sit for the exam and apply for a “PECB Certified ISO 13485 Lead Auditor” credential. By holding a PECB Lead Auditor Certificate, you will demonstrate that you have the capabilities and competencies to audit organizations based on best practices.

Learning Objectives

  • 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

Educational approach

  • This training is based on both theory and best practices used in MDQMS audits
  • Lecture sessions are illustrated with examples based on case studies
  • Practical exercises are based on a case study which includes role playing and discussions
  • Practice tests are similar to the Certification Exam


A fundamental understanding of ISO 13485 and comprehensive knowledge of audit principles.

Target Audiance

  • Auditors seeking to perform and lead Medical Devices Quality Management System (MDQMS) certification audits
  • Managers or consultants seeking to master a Medical Devices Quality Management System audit process
  • Individuals responsible for maintaining conformance with Medical Devices Quality Management System requirements
  • Technical experts seeking to prepare for a Medical Devices Quality Management System audit
  • Expert advisors in Medical Devices Quality Management

Schedule Dates

ISO 13485 Lead Auditor
11 March 2024 - 15 March 2024
ISO 13485 Lead Auditor
17 June 2024 - 21 June 2024
ISO 13485 Lead Auditor
23 September 2024 - 27 September 2024
ISO 13485 Lead Auditor
23 December 2024 - 27 December 2024

Course Content

  • Introduction to Medical Devices Quality Management Systems (MDQMS) and ISO 13485

  • Audit principles, preparation and launching of an audit

  • On-site audit activities

  • Closing the audit

  • Certification Exam


An ISO 13485 Lead Auditor is a professional who has undergone specialized training and certification to conduct audits of Quality Management Systems (QMS) for Medical Devices based on the ISO 13485 standard. These auditors possess advanced knowledge and skills in auditing principles, techniques, and practices specific to the medical device industry. They lead audit teams, assess the effectiveness of an organization’s QMS for medical devices, identify non-conformities, and provide recommendations for improvement.

ISO 13485 Lead Auditor certification is ideal for experienced auditors, quality assurance professionals, regulatory affairs specialists, and individuals responsible for auditing QMS within organizations manufacturing, distributing, or servicing medical devices. It is also valuable for consultants and auditors seeking to specialize in medical device quality management and compliance with ISO 13485 requirements.

ISO 13485 Lead Auditor training covers a comprehensive range of topics, including advanced auditing principles, ISO 13485 requirements specific to medical devices, audit planning and preparation, audit techniques and methodologies, conducting audit interviews, collecting and analyzing audit evidence, reporting audit findings, writing non-conformity reports, audit follow-up, and auditor competency development. Participants also learn about the role of auditors in promoting continual improvement and maintaining audit integrity within the medical device industry.

Obtaining ISO 13485 Lead Auditor certification offers several benefits, including:

  • Recognition as a qualified auditor with specialized expertise in auditing Quality Management Systems for Medical Devices in accordance with ISO 13485 standards.
  • Enhanced auditing skills, including planning, conducting, and reporting audits effectively, while ensuring compliance with regulatory requirements.
  • Increased confidence in identifying non-conformities, assessing risks, and recommending corrective actions to enhance the effectiveness of QMS for medical devices.
  • Expanded career opportunities in auditing, quality management, regulatory affairs, and compliance within the medical device industry.
  • Contribution to the enhancement of product quality, safety, and regulatory compliance, ultimately leading to improved patient safety and customer satisfaction.
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