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Become an ISO 13485:2016 Lead Auditor

Gain the knowledge and skills to audit medical device quality management systems with QMII’s Exemplar Global-recognized training: Online or in-classroom, built for real impact.

Receive post-course support and join a thriving alumni network of systems thinkers and lead auditors with QMII’s industry leading “Alumni for Life” program.

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Why ISO 13485:2016 Lead Auditor Training Matters

ISO 13485:2016 is the international standard for quality management systems specific to medical device manufacturers and organizations in FDA-regulated industries. QMII’s 4-day ISO 13485 Lead Auditor Training equips professionals with the skills to plan, conduct, and report audits in line with ISO 13485 requirements. You’ll learn to evaluate medical device QMS effectiveness, identify risks, and add value through audits that support continuous improvement and compliance.

Why Choose QMII

What Makes QMII’s ISO 13485 Auditor Training Different

  1. Certified by Exemplar Global with credits that apply toward other lead auditor certifications.
  2. 4-day program with workshops, modular tests, and practical audit simulations.
  3. Certificate of Attainment for three Exemplar Global training units: 13485, Auditor, Team Lead.
  4. Field-experienced instructors with FDA-regulated industry expertise.
  5. Flexible delivery: classroom, virtual instructor-led, or onsite for corporate teams.
  6. Comprehensive materials and exam included.

Who Should Attend This Training?

ISO 13485 Auditor Training is suitable for:

1. Medical device professionals responsible for quality or compliance.
2. Professionals in FDA-regulated industries (buyers, auditors, managers).
3. Quality professionals and improvement specialists.
4. Individuals seeking Exemplar Global Lead Auditor certification.
5. Internal, supplier, or third-party auditors.
6. Leaders and professionals wanting to integrate QMS requirements with business objectives.

Key Learning Objectives

QMII provides comprehensive services for conformance;

  1. Interpret and apply ISO 13485:2016 requirements.
  2. Apply ISO 14971 risk management to medical device QMS.
    Ensure compliance with FDA and global regulatory requirements.
  3. Plan and lead 1st, 2nd, and 3rd party audits.
  4. Manage risk, validate software, and ensure supplier compliance.
    Develop flexible and reliable systems in changing environments.
  5. Communicate roles, responsibilities, and resources across the organization.
  6. Relate QMS capabilities to customer, top management, and shareholder expectations.

Class Agenda - Hands-On Learning

1
Day 1
  • Lecture: Intro to Management Systems
  • Lecture: Quality Standards Including 13485
  • Workshop: Terms and Definitions ISO 19011
  • Lecture: ISO 13485
  • Workshop: Analyzing Processes
2
Day 2
  • Exam: ISO 13485 Self Study
  • Workshop: ISO 13485 Clauses
  • Lecture: Auditing Management Systems
  • Lecture: Developing Process-Based Management Systems
  • Lecture: Audit Planning and Preparation
  • Exam: 13485 Test
3
Day 3
  • Workshop: ISO 13485–Review System Docs and Prep Audit Schedule
  • Workshop: ISO 13485–Reviewing Processes and Prep Checklists
  • Lecture: Performing Lead Audit Investigation
  • Workshop: Verifying Facts
  • Lecture: Concluding the Audit
  • Workshop: ISO 13485–Determining Nonconformities
4
Day 4
  • Workshop: Writing Nonconformity Statements
  • Workshop: ISO 13485–Interviewing Auditees
  • Workshop: Closing Meeting Preparation
  • Workshop: Report Writing

Certification & Recognition

Upon successfully completing the 4-day training and assessments, participants earn a Certificate of Attainment for the following Exemplar Global training units:

  1. 13485 – Medical Devices Management Systems
  2. AUDITOR – Management Systems Auditing
  3. TEAM LEAD – Leading Management Systems Audit Teams

This course is recognized by Exemplar Global as meeting the training requirements for ISO 13485:2016 Lead Auditor certification. These credentials can also be used toward future certifications like ISO 14001 Lead Auditor and other management system standards.

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Frequently Asked Questions

Quality managers, auditors, regulatory affairs professionals, and anyone involved in the design, manufacture, or distribution of medical devices.

Course length varies — typically 2 days for overview, 3 days for internal auditor, and 4 days for lead auditor training.

Yes. The Certificate of Attainment is recognized by Exemplar Global.

While the focus is ISO 13485, QMII’s instructors draw connections to FDA Quality System Regulation requirements where relevant.

Yes. QMII offers customized onsite delivery for medical device QMS training globally.