ISO 13485:2016 Medical Devices Quality Management Systems Lead Auditor Course
✅ 100% Online & Self-Paced
✅ Exemplar Global Recognised Training Provider
✅ Based on ISO 13485:2016 & ISO 19011:2026
✅ Practical Templates, Guides & Learning Resources Included
✅ Internationally Recognised Certificate of Completion
✅ No Prior Auditing or Management Systems Experience Required
Develop the knowledge and practical skills to plan, conduct, lead and report first, second and third-party Medical Devices Quality Management System (MDQMS) audits in accordance with ISO 13485:2016 and ISO 19011:2026.
This course provides comprehensive training on the complete audit process, enabling you to confidently lead audit teams, assess compliance with ISO 13485 requirements, identify nonconformities, and drive continual improvement. It is ideal for professionals involved in the design, manufacture, supply or regulation of medical devices, as well as those seeking to become Lead Auditors.
What's Included
Upon enrolment, you'll receive immediate access to practical learning materials, workshops and downloadable resources, including:
- Clause-by-clause explanation of ISO 13485:2016
- Practical workshops and knowledge checks
- ISO 13485 Audit Checklist
- Documentation Requirements Guide
- Overview of ISO 14971:2019 – Medical Device Risk Management
- Cleanroom Technologies and Validation
- Biological Evaluation of Medical Devices
- Process Approach Guide
- Risk Management Guide
- Risk-Based Thinking Guide
- Sample Audit Plan
- Sample Audit Report
- Auditor Meeting Guide
- Downloadable templates and reference materials
Certificate
Upon successful completion, participants will receive an Internationally Recognised Certificate of Completion issued by an Exemplar Global Recognised Training Provider (formerly RABQSA).
Standards Covered
- ISO 19011:2026– Guidelines for Auditing Management Systems
- ISO 13485:2016 – Medical Devices – Quality Management Systems
- ISO 14971:2019 – Medical Devices – Application of Risk Management to Medical Devices (Overview)
Exemplar Global Competency Units
This course satisfies the following Exemplar Global competency units:
- TL – Management Systems Lead Auditors
- AU – Auditing Management Systems (ISO 19011:2026)
- MD – Medical Devices Quality Management Systems (ISO 13485:2016)
