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Lead Auditor for ISO 13485

This course covers the fundamental skills required by a Lead Auditor. By the end of this course, participants will have a strong foundational knowledge in the writing of procedures and engineering a process to work within a Quality Management System (QMS).

Course Details

The aims and learning outcomes of this course are:

  • To understand the structure, clauses, concepts, and definitions of ISO 13485:2016 and, where applicable, ISO 17021.
  • To learn how to lead the audit process. 
  • To understand the roles and responsibilities of the Lead Auditor and the skills required to conduct a robust audit.
  • To gain the skills required to plan, conduct, report and follow-up an audit in accordance with ISO 19011.

Following completion of this course, participants should:

  • Understand what is required of them as a Lead Auditor and what their role entails.
  • Be able to construct an audit plan.
  • Possess the skills and knowledge to carry out an effective and robust audit, drawing on the correct work documents and evidence within the Quality Management System (QMS).
  • Understand audit trails, nonconformities, grading, exclusions, and non-applications.

This course is held on-site over four or five days, depending on whether a certificated exam is required.  All participants will fully engage with the lecturer through both group and individual exercises and direct participation throughout the course.  Exercises are included to ensure the course contents are fully understood and the opportunity is always available for participants to ask questions. 

This course explores the skills and knowledge required for individuals to become effective Lead Auditors and includes the following topics:

  1. Introduction.
  2. Preparation.
  3. Beginning the audit.
  4. Auditing.
  5. Concluding the audit.
  6. Exam (optional).