ISO 13485 TRAINING COURSES
ISO 13485:2016 sets quality management system requirements for organisations involved in medical devices. Explore training that helps you understand the standard, conduct internal audits, implement a medical device quality management system, or lead audits. Choose the level that matches your responsibilities and experience.
CONSISTENT QUALITY
Build clear, repeatable processes throughout the medical device lifecycle.
REGULATORY FOCUS
Understand how quality processes support applicable regulatory requirements.
RISK MANAGEMENT
Address risks that can affect device quality and patient safety.
CONTINUAL IMPROVEMENT
Use audits, feedback and corrective actions to improve the system.
Foundation
Who it is forProfessionals new to ISO 13485 and medical device quality management.
What you will learnThe purpose, structure and key requirements of an ISO 13485 quality management system.
PrerequisiteNone.
Duration8 hours.
Typical next stepInternal Auditor or Lead Implementer.
Internal Auditor
Who it is forQuality professionals and team members responsible for internal audits.
What you will learnPlan and conduct internal audits, gather evidence, report findings and follow up actions.
PrerequisiteBasic understanding of ISO 13485 recommended.
Duration16 hours.
Typical next stepLead Auditor for those intending to lead audit teams.
Lead Implementer
Who it is forManagers, quality professionals and consultants responsible for establishing or improving a medical device quality management system.
What you will learnPlan, implement, maintain and improve a quality management system based on ISO 13485.
PrerequisiteBasic ISO 13485 knowledge recommended.
Duration5 days.
Typical next stepLead implementation and ongoing improvement within an organisation.
Lead Auditor
Who it is forExperienced auditors and quality professionals intending to lead audits.
What you will learnPlan and lead audits, evaluate evidence, manage an audit team and report findings.
PrerequisiteISO 13485 knowledge and familiarity with auditing principles recommended.
Duration40 hours.
Typical next stepAdvanced medical device quality auditing responsibilities.
READY TO CHOOSE YOUR TRAINING?
Individual learners can explore available courses and dates in the training catalogue.
Organisations can request a training solution for their team.
ISO 13485 TRAINING FAQS
Find answers about course levels, implementation, auditing and training options.
