ISO 13485:2016 Internal Auditor Certification Programme
Two-day internal auditor training with 30-question exam and certificate
Online ISO 13485 training and internal auditor certification for medical device professionals.
A two-day internal auditor programme for ISO 13485:2016 across 24 lessons. Day 1 builds the standard knowledge an auditor needs — QMS foundations, documentation, management responsibility, resources, product realisation and design controls. Day 2 turns that into auditing practice: audit trails for purchasing, production, calibration and Clause 8, the ISO 19011 mandate and competence model, risk-based audit programmes, audit planning and checklists, interviewing and evidence sampling, grading and writing defensible nonconformities, reporting and follow-up. Eight applied lessons then work through full case studies — purchasing at a catheter plant, an infusion pump software release, sterile production and packaging validation, a field safety corrective action, a twelve-scenario finding-writing workshop, distributor and remote audits, the risk management and post-market interface, and a complete five-hour mock audit with a model report. Requires 5 hours of study on each of two separate days, then a 30-question examination at 80% to earn a verifiable certificate.
Day 1 — the standard
Clauses 4–8 plus ISO 19011 auditing principles.
Day 2 — the audit
Planning, checklists, evidence, findings and reporting.
Exam opens after 2 days
5 hours of study on each of two separate days.
One-time payment · lifetime access · certificate included
- 24 lessons across 2 days
- 5 hours of study each day
- 30-question final exam
- Certificate at 80% pass
How the 2 days work
Study time is counted automatically while a lesson is open, and saved to your account.
Day 1 — 5 hours
Lessons 1–8: the standard clause by clause, plus auditing principles.
Day 2 — 5 hours
Lessons 9–16: planning, checklists, evidence, findings and reporting. Must be a different calendar day.
Exam unlocks
30 multiple-choice questions, opened only after both 5-hour days are complete.
Certificate at 80%
Score 80% or more and your verifiable certificate is issued instantly.
What you get
24 auditor lessons
Checklists, tables, flowcharts and worked audit examples.
4 checkpoint quizzes
Test your recall after modules 4, 8, 12 and 16.
30-question exam
Final assessment with a 80% pass mark.
Verifiable certificate
Download instantly on passing, with a unique verification ID.
How enrolment works
Sign in
Use the email address that should receive programme access.
Pay securely
Use the Enroll Now button to pay ₹499 through Cashfree.
Access activated
We verify the payment and switch on access for your registered email.
Who this programme is for
New and practising internal auditors; QA and RA professionals; supplier quality and production engineers preparing to audit; consultants and QMS implementers; managers accountable for the internal audit programme
Curriculum
Full lesson content unlocks once your access is granted.
2 days · exam · certificate