ISO 13485 Training Programs
Welcome to Quality Academy’s ISO 13485 training programs. ISO 13485 is the international standard for quality management systems (QMS) specific to the medical device industry. It provides a framework for organizations involved in the design, production, installation, and servicing of medical devices to ensure the consistent quality and safety of their products. Whether you’re new to ISO 13485 or looking to lead audits in the medical device sector, our comprehensive training programs cater to professionals at all levels.
Feature/Criteria
Foundation Course
Internal Auditor Course
Lead Auditor Course
Target Audience
Beginners new to ISO 13485- Employees needing basic understanding- Professionals exploring quality management in the medical device industry
Quality professionals in the medical device industry responsible for internal audits- Managers seeking to assess QMS compliance- Team members tasked with conducting audits
Experienced auditors aiming to lead medical device QMS audits- Quality managers responsible for audit processes- Consultants involved in ISO 13485 certification
Prerequisites
None
Basic understanding of ISO 13485- Completion of Foundation course recommended
Basic understanding of ISO 13485- Completion of Foundation course recommended
Course Objectives
Grasp the fundamentals of ISO 13485- Understand the structure of QMS in the medical device industry- Learn the benefits of ISO 13485 certification
Audit planning and preparation- Conducting audits and gathering evidence- Reporting non-conformities- Follow-up and corrective actions
Master the audit process from planning to reporting- Lead audit teams in compliance with ISO 19011 and ISO 13485- Manage audit findings and ensure QMS improvement
Course Duration
8 hours
16 hours
40 hours
Course Content
Overview of ISO 13485:2016- Key concepts of quality management for medical devices- Introduction to risk-based thinking- Leadership and regulatory compliance
Audit planning and preparation- Conducting audits and gathering evidence- Reporting non-conformities- Follow-up and corrective actions
Detailed ISO 13485:2016 requirements- Managing an audit team- Advanced interviewing techniques- Preparing for certification audits
Assessment
None
Practical exercises and assessments- In-course assessment of audit skills
Final exam (CQI and IRCA certified)- Practical audit assessment- Continuous evaluation throughout the course
Certification
Certification of Completion
Certification of Achievement (CQI and IRCA)
Certification of Achievement (CQI and IRCA)
Ideal for
Entry-level professionals- Support staff- Employees needing basic medical device QMS knowledge
Quality managers in the medical device industry- Internal auditors- Team members involved in QMS maintenance
Senior auditors- Quality leaders- Consultants and professionals aiming to lead audits in the medical device sector
Next Steps
Progress to Internal Auditor Course
Progress to Lead Auditor Course
Advanced auditing roles- Consultancy and leadership in medical device quality management
By choosing Quality Academy’s ISO 13485 training programs, you’re taking a significant step towards ensuring the quality and safety of medical devices within your organization. Whether you’re gaining foundational knowledge, conducting internal audits, or leading audit teams, our expert-led courses will provide you with the essential skills and knowledge to achieve and maintain ISO 13485 certification.
Need help choosing the right course? Contact our team for more information and personalized advice.
