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Lead Auditor Training for ISO 13485


Learn how to assess compliance with ISO 9001:2000 and ISO 13485:2003 from STAT-A-MATRIX experts. Based on our ISO 9001:2000 RABQSA-certified IATCA QMS lead auditor training course, this interactive course covers the ISO 13485:2003 and ISO 9001:2000 requirements for quality management systems.

Get your lead auditor training from the seminar experts—STAT-A-MATRIX has been training lead auditors longer than any other training organization.

Extended evening hours may be expected during the first four days of training.


Workshop Topics

  • Overview of auditing
  • Interpretation of ISO 13485:2003
  • Quality system documentation
  • Quality manual and procedures
  • The audit cycle and ISO 19011
  • Preaudit activities—opening meeting and checklists
  • Auditing practices; the psychology of auditing
  • Nonconformity reporting
  • Performing the audit
  • Closing meeting
  • Process auditing
  • Report writing
  • Final report
  • Follow-up and corrective action
  • Final examination (2 hours)

This course and the associated examination provide the necessary body of knowledge and assessment techniques to cover the requirements for registration, when combined with appropriate documentation of education, professional experience, and auditor practice. Certified in the United States by RABQSA International, this course meets the training portion of the requirements for certification of individual Quality System Provisional Auditors, Auditors, and Lead Auditor and meets the IATCA requirements for QMS Senior Auditor training.

NOTE: To attain registration as an IATCA QMS Auditor, IATCA QMS Senior Auditor, QMS Auditor, or QMS Lead Auditor, you must pass the written final examination, earn a passing grade in the course continuous assessments, and meet prescribed professional requirements, including a number of actual audits.

This training course is an RABQSA-certified IATCA course and meets the training requirements for certification of individual IATCA QMS Auditors, IATCA QMS Senior Auditors, QMS Auditors, and QMS Lead Auditors. “Successful completion” satisfies the training requirements for individual auditor certification by IATCA accrediting bodies such as IRCA, RABQSA, JAB, and CRBA.


During five rigorous days, you will cover background of the ISO 9000 and ISO 13485 standards, and go through every phase of the audit—from planning to conduct to follow-up so you will be able to lead your own audits efficiently and effectively.

  • QA System Assessment—A proactive approach to quality assurance in the medical device industry. Covers elements that comprise a total quality system, including policy, manual, procedures, and instructions.
  • Understanding the Requirements—Discuss the requirements of ISO 9001, as well as those of ISO 13485:2003 and their relationship to ISO 9001; includes discussion of applicable industry regulations.
  • The Audit Cycle—Using ISO 19011, with practical hands-on workshops, you are introduced to audit functions: preaudit activities; conducting the audit (assessment); postaudit and follow-up activities.
  • Preaudit Activities—Using interactive workshops (syndicated activities), learn to plan audit activities, develop checklists, perform preassessment visits, and conduct opening meetings.
  • Conducting the Audit (Assessment)—Use hands-on workshops to learn how to collect objective evidence. Covers active listening and questioning techniques, as well as methods to help handle confrontations.
  • Postaudit and Follow-Up Activities—Through workshops and assignments, learn how to conduct closing meetings, write effective audit reports, issue nonconformance forms and corrective action reports, assess corrective action, close out nonconformances, and conduct surveillances.

Target Audience

Although originally designed to train third-party auditors, most of the participants lead their company's quality system iimplementation and/or audit programs.  Ideal for anybody involved in a supplier quality assurance program.

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Time Requirement


Instructor-Led 5 days


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