ISO 13485 Lead Auditor (5 days)

Mastering the Audit of a Quality Management System (QMS) based on ISO 13485

This five-day intensive course enables participants to develop the necessary expertise to audit a Quality Management System (QMS) based on ISO 13485:2003 and to manage a team of auditors by applying widely recognized audit principles, procedures and techniques. During this training, the participant will acquire the necessary knowledge and skills to proficiently plan and perform internal and external audits in compliance with the certification process of the ISO 19011 and ISO 17021 standards. Based on practical exercises, the participant will develop the skills (mastering audit techniques) and competencies (managing audit team and audit program, communicating with customers, conflict resolution, etc.) necessary to efficiently conduct an audit.

Who should attend?

  • Internal auditors
  • Auditors wanting to perform and lead Quality Management System (QMS) certification audits in the medical device industry
  • Project managers or consultants wanting to master the Quality Management System audit process
  • Persons responsible for the quality or conformity in an organization
  • Members of a quality team
  • Expert advisors in Quality Management Systems
  • Regulatory affairs managers
  • Technical experts wanting to prepare for a Quality audit function in the medical device industry

Learning objectives

  • To acquire expertise to perform an ISO 13485 internal audit following ISO 19011 guidelines
  • To acquire expertise to perform an ISO 13485 certification audit following ISO 19011 guidelines and ISO 17021 specifications
  • To acquire the expertise necessary to manage a QMS audit team
  • To understand the operation of an ISO 13485 conformant Quality Management System
  • To understand the relationship between a Quality Management System and compliance with customer and regulatory requirements
  • To improve the ability to analyze the internal and external environment of an organization, and audit decision-making in the context of a QMS

Course Agenda

Day 1: Introduction to Quality Management System (QMS) concepts as required by ISO 13485

  • Normative frameworks and methodologies related to Quality and Medical Devices
  • Fundamental principles of Quality and Medical Devices
  • ISO 13485 certification process
  • Quality Management System (QMS)
  • Detailed presentation of the clauses 4 to 8 of ISO 13485

Day 2: Planning and Initiating an ISO 13485 audit

  • Fundamental audit concepts and principles
  • Audit approach based on evidence
  • Preparation of an ISO 13485 certification audit
  • QMS documentation audit
  • Conducting an opening meeting

Day 3: Conducting an ISO 13485 audit

  • Communication during the audit
  • Audit procedures: observation, document review, interview, sampling techniques, technical verification, corroboration and evaluation
  • Audit test plans
  • Formulation of audit findings
  • Documenting nonconformities

Day 4: Concluding and ensuring the follow-up of an ISO 13485 audit

  • Audit documentation
  • Quality review
  • Conducting a closing meeting and conclusion of an ISO 13485 audit
  • Evaluation of corrective action plans
  • ISO 13485 Surveillance audit
  • ISO 13485 Internal Audit management program

Day 5: Certification Exam


ISO 13485 Foundation Certification or basic knowledge of ISO 13485 is recommended

Educational approach

  • This training is based on both theory and practice:
    • Sessions of lectures illustrated with examples based on real cases
    • Practical exercises based on a full case study including role playing and oral presentations
    • Review exercises to assist the exam preparation
    • Practice test similar to the certification exam
  • Benefit from the practical exercises, the number of training participants is limited


  • The "Certified ISO 13485 Lead Auditor" exam fully meets the requirements of the PECB Examination and Certification Program (ECP). The exam covers the following competence domains:
    • Domain 1: Fundamental principles and concepts of Quality and Medical Devices
    • Domain 2: Quality Management System (QMS)
    • Domain 3: Fundamental Audit Concepts and Principles
    • Domain 4: Preparation of an ISO 13485 audit
    • Domain 5: Conducting of an ISO 13485 audit
    • Domain 6: Closing an ISO 13485 audit
    • Domain 7: Managing an ISO 13485 audit program
  • The "Certified ISO 13485 Lead Auditor" exam is available in different languages (the complete list of languages can be found in the examination application form)
  • Duration: 3 hours
  • For more information about the exam, refer to PECB section on ISO 13485 Lead Auditor Exam


  • After successfully completing the exam, participants can apply for the credentials of Certified ISO 13485 Provisional Auditor, Certified ISO 13485 Auditor or Certified ISO 13485 Lead Auditor depending on their level of experience. Those credentials are available for internal and external auditors
  • A certificate will be issued to participants who successfully passed the exam and comply with all the other requirements related to the selected credential.
  • For more information about ISO 13485 certifications and PECB certification process, refer to PECB section on ISO 13485 Lead Auditor Certification

    General Information

    • Exam and certification fees are included in the training price
    • A student manual containing over 450 pages of information and practical examples will be distributed to participants
    • A participation certificate of 31 CPD (Continuing Professional Development) credits will be issued to participants
    • In case of failure of the exam, participants are allowed to retake the exam for free under certain conditions

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