Gain the knowledge and practical skills required to understand, implement, and maintain an ISO 13485:2016 Quality Management System for medical device manufacturing and distribution activities.
✅ Practical and application-focused training program
✅ Experienced and qualified instructors
✅ Certificate of Completion awarded upon successful completion
GET 10% OFF – REGISTER EARLY
The ISO 13485:2016 Training Course is designed to equip participants with the fundamental knowledge and practical skills required to understand, implement, maintain, and audit a Quality Management System (QMS) for medical devices. The program is divided into two modules: ISO 13485 Awareness Training and ISO 13485 Internal Auditor Training, enabling participants to progressively develop the competencies needed to support and improve the effectiveness of the system.
The first three sessions focus on building a strong understanding of ISO 13485:2016, including its requirements, structure, and application within a Medical Device Quality Management System.
This session provides participants with a comprehensive overview of ISO 13485:2016, including its structure, core concepts, terminology, and regulatory considerations applicable to the medical device industry.
This session focuses on the key clauses of ISO 13485:2016, helping participants understand the requirements that organizations must meet to establish and maintain an effective Quality Management System.
This session provides practical guidance on operating and maintaining an ISO 13485 Quality Management System, with a focus on process control, monitoring, and continual improvement.
The following three sessions focus on developing internal auditing skills, including audit planning, audit execution, reporting, and follow-up activities within an ISO 13485 Quality Management System.
This session introduces the principles of internal auditing and the key steps required to prepare for an effective audit. Participants will learn how to establish an audit program, prepare audit documentation, and understand the responsibilities of an internal auditor.
This session focuses on the audit execution process, including evidence collection, identifying audit findings, and managing corrective actions to ensure the continued effectiveness of the ISO 13485 Quality Management System.
The final session evaluates participants’ understanding of ISO 13485:2016 and reinforces the key concepts covered throughout the training program before course completion.
SQS Global does not apply a standardized training framework for all participants. Each ISO 13485:2016 training program is tailored to the organization’s specific objectives, operational context, and competency requirements, ensuring participants gain relevant knowledge and practical skills that can be effectively applied within their Quality Management System and business operations.
SQS Global offers flexible ISO 13485 training solutions, allowing organizations and individuals to select the most suitable format based on their objectives, budget, and number of participants.
Training is conducted at the client’s facility, allowing participants to learn within their actual operational environment and directly relate course concepts to day-to-day activities.
✅ Reduced travel time and costs
✅ Suitable for group training programs
✅ Customized to organizational needs
Participants attend instructor-led training at SQS Global’s facilities, benefiting from a professional learning environment, practical knowledge exchange, and direct interaction with experienced trainers.
✅ Regularly scheduled training sessions
✅ Professional learning environment
✅ Direct access to experienced trainers
Participants can join the training remotely from any location while benefiting from structured learning, real-time discussions, and continuous engagement throughout the course.
✅ Flexible schedule and location
✅ Reduced travel expenses
✅ Real-time interaction with trainers
This training course is designed for individuals and organizations involved in the implementation, operation, maintenance, or continual improvement of a Medical Device Quality Management System (MDQMS) in accordance with ISO 13485:2016, including:
Through the ISO 13485:2016 Training Course, participants gain the knowledge, practical skills, and industry insights required to support the implementation, maintenance, and internal auditing of a Medical Device Quality Management System.
✅ Understand the requirements and clauses of ISO 13485:2016
✅ Understand the principles of a Medical Device Quality Management System
✅ Understand documentation, record control, and risk management requirements
✅ Learn how to implement and maintain an ISO 13485 Quality Management System
✅ Conduct internal audits in accordance with ISO 19011 guidelines
✅ Identify nonconformities and monitor corrective actions effectively
✅ Apply knowledge directly within medical device organizations
✅ Learn from real-world implementation experience and industry best practices
✅ Enhance quality management capabilities and operational effectiveness
Upon successful completion of the course and final assessment, participants will receive a Certificate of Completion issued by SQS Global. In addition to the training program, participants have the opportunity to interact directly with experienced professionals, discuss practical challenges, and gain valuable insights into Quality Management System implementation within medical device organizations.
As an added benefit, individuals and organizations participating in the training course may be eligible for preferential pricing and exclusive incentives when engaging SQS Global’s consulting, implementation, or ISO 13485 certification support services.
VIE