ATAUDITOR TRAINING · ISO INTERNATIONAL SERVICES
specialty Programme · 2-Day Intensive
Specialty: ISO 13485 Medical Devices QMS Lead Auditor
Audit design, production, installation and service of medical devices to ISO 13485.
01Programme Overview
ISO 13485 is the global QMS standard for medical device manufacturers. Learn to audit design controls, risk management (ISO 14971), validation, sterilisation, complaint handling, post-market surveillance and regulator alignment (FDA QSR, EU MDR).
Delivery
Hybrid · Live + Simulation
02Learning Outcomes
On completion, candidates will be able to:
- Audit a medical-devices QMS against ISO 13485:2016
- Trace design controls from inputs to outputs to verification & validation
- Sample risk management evidence against ISO 14971
- Audit complaint handling, vigilance and post-market surveillance
- Reconcile ISO 13485 with FDA 21 CFR 820 and EU MDR expectations
03Course Outline
A blended pathway combining lecture (4), lab (1), and simulation (1) modules across 2 days. Assessed components are marked.
Day 1
09:00 — 10:30 · lecture
13485 Foundations & Regulatory Landscape
Why 13485 is risk-centric (not Annex-SL aligned), and how it sits inside FDA QSR and EU MDR.
10:45 — 12:30 · lab
Design Controls & Design History File
Trace a representative product from design inputs through verification and validation to a defensible DHF.
13:30 — 15:30 · lecture
Risk Management (ISO 14971) & Process Validation
Audit risk-management files, sterilisation validation, software validation and special-process controls.
Day 2
09:00 — 11:00 · lecture
Production, Servicing & Identification / Traceability
Audit production controls, UDI implementation, servicing records and identification.
11:15 — 13:00 · lecture
Complaints, Vigilance & Post-Market Surveillance
Audit complaint handling, MDR/MDV reporting, CAPA, PMCF and trend analysis.
15:00 — 16:00 · exam
Final Knowledge Assessment
Multiple-choice assessment covering every clause area introduced in Specialty: ISO 13485 Medical Devices QMS Lead Auditor. Pass mark 70%.
16:00 — 18:00 · simulation
Closeout: Live Audit & NCR Drafting
Live War Room simulation tied to Specialty: ISO 13485 Medical Devices QMS Lead Auditor. Conduct an AI-driven interview, evidence-gather, then draft a defensible NCR.
04Assessment Outline
Candidates are assessed against IAF / ISO/IEC 17021-1 personnel competence criteria. Assessment is layered — written examination, practical NCR simulation, and witnessed audit closeout — modelled on certification body witness protocols.
Written Examination
13 Questions
Closed-book, clause-anchored multiple choice. 70% pass mark. Single re-sit included.
Practical Closeout Simulation
1 Scenario
Live NCR drafting, opening/closing meeting facilitation, evidence triangulation, rubric-scored by lead assessor.
Continuous Calibration
In-Module Labs
1 lab modules with formative feedback; instructor calibration on rubric drift.
Credential Issue
Digital Credential + Transcript
Verifiable digital credential issued within 5 working days of successful closeout. PDF transcript supplied for CPD logging with CQI/IRCA, Exemplar Global, JRCA.
Assessed Modules
- Day 2 · Final Knowledge Assessment (exam)
- Day 2 · Closeout: Live Audit & NCR Drafting (simulation)
05A Globally Recognised Credential
Audit anywhere. Certify everywhere.
The Auditor Training credential is engineered against the IAF Multilateral Recognition Arrangement (MLA), aligning competence with conformity assessment bodies in 100+ economies — so the assessor you train in Sydney is the assessor that's accepted in Frankfurt, Singapore, São Paulo or Toronto.
IAF MLA Aligned
International Accreditation Forum
Course architecture mapped to ISO/IEC 17021-1 §7 personnel competence criteria — the framework underpinning IAF signatories worldwide.
CQI / IRCA Pathway
Chartered Quality Institute
Module taxonomy and assessor rubric mirror CQI/IRCA certified course requirements, providing a direct pathway for IRCA QMS / EMS / OH&S auditor registration.
Exemplar Global Recognised
Americas & Asia-Pacific
Transcripts are formatted for Exemplar Global CPD logging — accepted across Exemplar Global TPECS units (AU, QM, EM, OH).
JRCA Compatible
Japan & East Asia
Clause-anchored evidence taxonomy is compatible with JRCA registration pathways for ISO 9001 / 14001 / 45001 auditors.
Total Investment
A$1,950
Per seat. Includes courseware, simulation access, examination, single re-sit, and digital credential. Group rates available for cohorts of 6+.
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Authorised — Steven Asnicar, Master Assessor
Accepted — Client Signature & Date