ISO 13485:2016
PQMS Academy Course
ISO 13485:2016
Medical Devices Quality Management System Training
Build practical understanding of ISO 13485:2016 requirements for medical device quality management systems, auditing practices, compliance expectations, and process-based improvement.
Lead Auditor Training
Designed for learners preparing to plan, lead, conduct, report, and follow up on ISO 13485 audits.
Internal Auditor Training
Designed for learners responsible for internal audits, quality system checks, and audit readiness.
Who This Training Is For
- Quality assurance and quality control professionals
- Regulatory affairs professionals
- Internal auditors and audit team members
- Medical device manufacturing and operations personnel
- Managers responsible for QMS compliance and audit readiness
What Learners Will Cover
ISO 13485 Requirements
Quality management system structure, documentation, management responsibility, resource management, product realization, and measurement.
Audit Planning
Audit objectives, scope, criteria, schedules, checklists, process approach, and risk-based preparation.
Audit Execution
Interviewing, evidence collection, audit trails, objective evidence, nonconformity identification, and professional audit conduct.
Reporting & Follow-Up
Audit findings, corrective action expectations, reporting clarity, verification, and continual improvement.
Course Outcomes
- Understand the structure and intent of ISO 13485:2016
- Recognize medical device QMS audit requirements
- Apply audit principles to practical quality system scenarios
- Identify nonconformities and communicate findings clearly
- Support audit readiness and quality system improvement
Interested in ISO 13485:2016 Training?
Contact PQMS Academy for course availability, scheduling, learner registration, and custom group training options.
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