ISO 13485:2016 Medical Device QMS Lead Auditor
Introduction
The ISO 13485:2016 MDQMS Lead Auditor Certification is an advanced, globally recognized qualification designed for professionals responsible for auditing the Quality Management Systems (QMS) of organizations involved in the design, production, installation, and servicing of medical devices.
Qualification Topics
- Introduction to Medical Devices & ISO 13485
- ISO 13485:2016 Requirements in Depth
- Regulatory Framework (as applicable)
- Introduction to MDQMS Auditing
- Audit Planning & Preparation
- Conducting the Audit
- Identifying Nonconformities
- Audit Reporting
- Corrective Actions & Follow-up
Qualification Benefits
- Understand ISO 13485:2016 requirements in detail
- Conduct internal, supplier & certification audits
- Lead audit teams effectively and professionally
- Evaluate compliance with medical device regulatory requirements
- Identify risks, gaps & improvement opportunities in QMS
- Prepare complete audit plans, checklists & reports
- Ensure product safety, sterility & regulatory conformance
- Support ISO 13485 certification readiness
- Advance professionally in quality, regulatory, and auditing careers
Examination and Certification Method
| Assessment Method | Description |
|---|---|
| Written Examination | MCQs & case-based questions on ISO 13485 & auditing |
| Case Study Assessment | Evaluate medical device audit scenarios |
| Practical Audit Simulation | Mock audit with interviews & evidence review |
| Audit Report Submission | Full audit report based on simulated MDQMS audit |
| Continuous Assessment | Participation, teamwork, exercises & role-play |
Certification Awarded
ISO 13485:2016 MDQMS Lead Auditor Certificate (Validity for 05 years)