ISO 13485 Lead Auditor – PECB Accredited

About the course

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.

Training done in collaboration with 

Course Outlines

Who Should Attend?

  • 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.

Course 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.

Course Content

The agenda for this short course is as follows:

Day 1: Introduction to Medical Devices Quality Management Systems (MDQMS) and ISO 13485

Day 2: Audit principles, preparation and launching of an audit

Day 3: On-site audit activities

Day 4: Closing the audit

Day 5: Certification Exam


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



The “PECB Certified ISO 13485 Lead Auditor” exam fully meets the requirements of the PECB Examination and Certification Programme (ECP). The exam covers the following competency domains:

Domain 1: Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

Domain 2: Medical Devices Quality Management System (MDQMS)

Domain 3: Fundamental audit concepts and principles

Domain 4: Preparation of an ISO 13485 audit

Domain 5: Conducting an ISO 13485 audit

Domain 6: Closing an ISO 13485 audit

Domain 7: Managing an ISO 13485 audit program

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

Course Details


40 Hours


Monday – Friday


09.00 till 17.00






  • Course Handouts and Materials
  • Certificate of Attendance
  • Examination

The fee is €1,550 + VAT per person.

The fee includes all course notes and study materials, registration on the PECB platform, certificate of attendance and examination.

Course fees are payable on registration by internet banking or cheque. Bookings are accepted a first-come first-served basis. Places are limited for quality assurance purposes according to the requirements of each course. Please register online via the form on the right of this page or to request information send an email to or call 99377934.

In-House Courses

Offering better value for money, they can be designed to closely match your specific requirements.


ISO 13485 Lead Auditor – PECB Accredited


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. This course is taking place online via a live web platform due to the current health situation.

Course fee: €1550 + VAT per person.