ISO 13485:2016
ISO 13485:2016 Lead Auditor
Lead certification, MDSAP and supplier audits of medical device quality management systems
Lead Auditor · 40 hours · Certificate valid 36 months
Leading an ISO 13485:2016 audit means more than knowing the standard. You manage an audit programme, plan multi-day audits, direct a team, interview top management, classify findings under rules that differ between certification bodies, notified bodies and MDSAP auditing organizations, and tell a client plainly what the evidence means for its certificate and its market access.
This course takes the clause knowledge of an experienced internal auditor to lead auditor depth. Four modules work through clauses 4 to 8 with the questions a lead auditor asks: is the scope right, are the exclusions genuine, is top management governing, is verification evidence credible, are complaints reaching regulators on time.
Shared modules cover auditing fundamentals, managing the audit programme, the audit process from stage 1 to recertification, leading the audit team, nonconformities and root cause, and reporting and follow-up.
A dedicated module covers the MDSAP audit model and 1 to 5 grading, stage 1 and stage 2 audits, unannounced audits under the EU MDR, auditing sterile and implantable device manufacturers and leading second-party supplier audits, with scenario discussions throughout.
The course closes with a 40-question timed examination drawn from a bank of 80.
What people learn
- Distinguish certification audits, notified body audits, MDSAP audits and FDA inspections and apply the rules of each
- Apply ISO/IEC 17021-1 and IAF MD 9 requirements for impartiality, competence, technical areas and audit time
- Audit clauses 4 to 8 of ISO 13485:2016 at a depth sufficient to judge fitness for certification
- Plan and manage an audit programme and lead stage 1, stage 2, surveillance, recertification and unannounced audits
- Lead an audit team, allocate work, manage conflict and conduct opening and closing meetings with top management
- Classify nonconformities as major or minor and grade them 1 to 5 under the MDSAP system
- Audit sterile and implantable device manufacturers, including sterilization, sterile barrier, cleanroom and traceability controls
- Lead second-party supplier audits against quality agreements and report findings that drive decisions