ISO 13485:2016 Lead Auditor Training
Lead third-party certification audits of medical device quality management systems against ISO 13485:2016 — clause depth where auditors fail, audit time and team competence, and Stage 1 through to the certification recommendation.
29
Lessons
~16h
Study time
30
Exam questions
Earns a QR-verifiable Certificate of Training
Overview
About this course
ISO 13485:2016 is the standard that medical device manufacturers, contract sterilisers, component suppliers and distributors are certified against worldwide. It is not built on Annex SL: it carries the ISO 9001:2008 architecture forward deliberately, threads applicable regulatory requirements through almost every clause, and replaces continual improvement with an obligation to maintain the system's effectiveness. Auditing it well demands judgement about design files, process validation, vigilance timescales and whether a corrective action actually worked.
This course is for certification-body auditors, senior QA and regulatory professionals and consultants serving device manufacturers and distributors, who already know the clauses at internal auditor level. It goes deep where lead auditors fail — the design and development file and design changes, validation of sterilisation, cleanroom and software processes, supplier controls proportionate to risk, the medical device file, complaints and reporting to regulatory authorities, advisory notices and recalls, CAPA effectiveness, and the ISO 14971 risk thread that runs through every clause.
It then turns to lead audit practice: audit time and technical competence under IAF MD 9, Stage 1 and Stage 2 under ISO/IEC 17021-1:2015, leading a team that includes technical experts, sampling across product families, grading findings, the report and the certification recommendation, and the surveillance and recertification cycle. Competence is treated against ISO 19011:2018 clause 7 including the boundary with consultancy, and the certificate is placed against MDSAP, the EU MDR, the US FDA quality system regulation and GCC registration — an ISO 13485 certificate is not a market authorisation.
Assessment is a 30-question online exam with a 70% pass mark. Successful learners receive a verifiable SKEDMIA certificate. Approximately 16 hours of self-paced study.
Practise the audit before you do it for real
Reading a clause and auditing against it are different skills. Enrol on this course and you also get 6 months of AuditVerse, our interactive practice platform — you work through ISO audit scenarios, decide what to sample, and see how a finding holds up when it is challenged.
Sign in with the same email address and password you use here. Access runs for 6 months from the day you enrol, and there is nothing to buy or activate.
Open AuditVerseWhat you earn
A certificate anyone can verify in seconds
Score 70% or better on the final exam and Skedmia issues your Certificate of Training with a unique certificate number. Every certificate carries a QR code that resolves to our public register, so an employer or auditor can confirm it is genuine without contacting anyone.
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Syllabus
Course content
10 modules · 29 lessons · ~16h
01Module 1 — ISO 13485:2016 in Context — Lineage, Applicability and the Regulatory Landscape3 lessons
- Not Annex SL — the Architecture and Intent of ISO 13485:201633 min
- Role, Device Type and Applicability — Clause 1.2 and the Certificate ScopePreview35 min
- What the Certificate Is and Is Not — MDSAP, EU MDR, FDA and GCC35 min
02Module 2 — Risk Management as the Spine — ISO 14971:2019 Across the QMS3 lessons
- ISO 14971:2019 for Auditors — Process, File and Benefit-Risk32 min
- The Risk Thread Through ISO 13485 — A Clause Map35 min
- Auditing Risk-Based Decisions — Evidence and Findings35 min
03Module 3 — QMS Foundations in Depth — Clauses 4 to 6 and the Medical Device File3 lessons
- Clause 4.1 and 4.2 — Processes, Outsourcing and Documentation Architecture34 min
- The Medical Device File, Documents and Records — 4.2.3 to 4.2.535 min
- Management Responsibility and Resources — Clauses 5 and 635 min
04Module 4 — Design and Development — Clause 7.3, Design Changes and the Design File3 lessons
- Design Planning, Inputs and Outputs — 7.3.2 to 7.3.431 min
- Review, Verification, Validation and Transfer — 7.3.5 to 7.3.840 min
- Design Changes and the Design File — 7.3.9, 7.3.10 and Non-Application35 min
05Module 5 — Purchasing, Production and Validation — Clauses 7.4 to 7.63 lessons
- Supplier Controls Proportionate to Risk — Clause 7.435 min
- Production and Service Provision — Clause 7.540 min
- Validation of Processes and Software — 7.5.6, 7.5.7, 4.1.6 and 7.640 min
06Module 6 — Feedback, Complaints and Vigilance — Clause 8.2 and Regulatory Reporting3 lessons
- Feedback and Post-Market Information — Clause 8.2.132 min
- Complaint Handling and the Complaint File — Clause 8.2.235 min
- Reporting to Authorities, Advisory Notices and Recalls — 8.2.3 and 8.3.335 min
07Module 7 — Nonconformity, CAPA and Improvement — Auditing Effectiveness, Not Closure3 lessons
- Control of Nonconforming Product — Clause 8.332 min
- Analysis of Data, Monitoring and Internal Audit — 8.2.4 to 8.2.6 and 8.435 min
- CAPA — Auditing Whether It Worked40 min
08Module 8 — The Certification Framework — ISO/IEC 17021-1, IAF MD 9 and Auditor Competence3 lessons
- The Certification Framework and Cycle — ISO/IEC 17021-1:201533 min
- Audit Time and the Audit Programme — IAF MD 935 min
- Auditor Competence and Impartiality — ISO 19011:2018 Clause 735 min
09Module 9 — Leading the Certification Audit — Stage 1 to Recommendation and Follow-Up3 lessons
- Stage 1 and Stage 2 — Planning, Team and Sampling32 min
- Auditing the Hard Places — Cleanroom, Sterilisation and Outsourced Processes40 min
- Findings, Report, Recommendation and Follow-Up40 min
10Course materials & downloads2 lessons
- ISO 13485:2016 versus ISO 9001:2015 — Structural and Requirement Differences (PDF)
- Lead Auditor Evidence Checklist — Design File, Validation, Complaints, Vigilance and CAPA (PDF)
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