About This Course
The ISO 13485 Lead Auditor programme prepares you to audit a medical devices quality management system against ISO 13485. Delivered fully self-paced and online, it takes you from QMS fundamentals to planning and leading a complete audit using the principles of ISO 19011 and ISO/IEC 17021-1.
ISO 13485 is the international quality management standard for organisations that design and manufacture medical devices. You’ll learn to gather and weigh evidence, grade nonconformities and report findings that drive improvement — the skills a lead auditor needs for first-, second- and third-party audits.
Course Information
What You Will Learn
Course Curriculum
- Core concepts of Medical Devices Quality Management
- Structure and requirements of ISO 13485
- Regulatory requirements for medical devices
- Design and development controls
- Fundamental audit concepts
- Risk-based audit thinking
- Initiating the audit and defining scope
- Reviewing documentation and planning
- Opening meeting
- Collecting evidence through interviews and sampling
- Drafting audit findings
- Risk management across the product lifecycle
- Grading nonconformities
- Audit conclusions, report and closing meeting
- Follow-up and corrective action
- Traceability, complaints and vigilance
- The competency domains
- Revision and exam technique
- Booking and sitting the PECB exam
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All You Need to Know
This programme suits internal and external auditors, Medical Devices Quality Management managers and consultants, and compliance professionals who audit or oversee a QMS.
A fundamental understanding of ISO 13485 and of audit principles is recommended.
The programme prepares you for the PECB Certified ISO 13485 Lead Auditor exam, which assesses the competency domains for planning, leading and reporting a QMS audit. Completing the training also earns 31 CPD credits.
Frequently Asked Questions
Yes — it is delivered online and self-paced, covering the same competency domains as PECB’s instructor-led programme so you can study around your schedule.
Lead Auditor prepares you to audit a QMS; Lead Implementer prepares you to build and run one.
A fundamental understanding of ISO 13485 and audit principles is recommended.
After passing the exam and meeting PECB’s requirements you can apply for the PECB Certified ISO 13485 Lead Auditor credential.
Yes — the self-paced kit includes one certification exam and one free exam retake.