ISO 13485:2016 Lead Auditor
Lead certification, MDSAP and supplier audits of medical device quality management systems
- Duration
- 40 hours
- Modules
- 11
- Final exam
- 75% to pass
- Certificate
- 36 months
- Lifetime access to the course and your certificate
- Verifiable Certificate of Completion. Certificate valid for 36 months.
- 3 exam attempts, 90 minutes each
- Progress saved to your account on every slide
About this course
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 you will be able to do
- 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
Course outline
- 1
ISO 13485:2016 overview for lead auditors
Certification audits versus regulatory audits, notified bodies and MDSAP auditing organizations, the rules in ISO/IEC 17021-1 and IAF MD 9, and how audit time is determined.
About 45 minutes, then a module quiz
- 2
Clauses 4 and 5 for lead auditors
System requirements, documentation and management responsibility at the depth a lead auditor needs to judge whether a QMS is fit for certification.
About 45 minutes, then a module quiz
- 3
Clauses 6 and 7 for lead auditors
Resources and product realization in depth: competence, infrastructure and contamination control, planning and risk management, design and development, purchasing, production, validation, traceability and measuring equipment.
About 70 minutes, then a module quiz
- 4
Clause 8 for lead auditors
Measurement, analysis and improvement: feedback, complaints, regulatory reporting, internal audit, monitoring, nonconforming product, data analysis and CAPA, with the lead auditor's view on systemic weakness.
About 50 minutes, then a module quiz
- 5
Auditing fundamentals
What an audit is, the principles that make it credible, and what ISO 13485:2016 requires of internal audit at clause 8.2.4.
About 40 minutes, then a module quiz
- 6
Managing the audit programme
Establishing and running an audit programme under ISO 19011 clause 5, and how certification bodies plan audits of a quality management system under ISO/IEC 17021-1.
About 50 minutes, then a module quiz
- 7
The audit process
Planning, preparing, conducting and closing an audit of a quality management system, step by step, with the evidence-gathering techniques auditors rely on.
About 55 minutes, then a module quiz
- 8
Leading the audit team
What the audit team leader is responsible for before, during and after an audit of a quality management system, including auditing top management and handling difficult situations.
About 50 minutes, then a module quiz
- 9
Leading certification, MDSAP and supplier audits
The MDSAP audit model and grading, stage 1 and stage 2, unannounced audits under the MDR, auditing sterile and implantable device manufacturers, and leading second-party supplier audits, with scenarios.
About 70 minutes, then a module quiz
- 10
Nonconformities and root cause
How to recognise, grade and write a nonconformity, and how to judge whether the corrective action under ISO 13485:2016 clause 8.5.2 has dealt with the cause.
About 45 minutes, then a module quiz
- 11
Audit reporting and follow-up
Writing a report people act on, verifying corrective action, closing findings, and turning audit results into input for management review at clause 5.6.
About 35 minutes, then a module quiz
Final examination and certificate
40 questions drawn from the course bank. Score 75% or higher to receive your Certificate of Completion.
More ISO 13485:2016 training
- ISO 13485:2016Introduction
Introduction to ISO 13485:2016
Understand the medical device quality management system standard and the regulations that rely on it
- Duration
- 4 hours
- Level
- Foundation
$149View course - ISO 13485:2016Internal Auditor
ISO 13485:2016 Internal Auditor
Plan, conduct and report internal audits of a medical device quality management system
- Duration
- 16 hours
- Level
- Practitioner
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