ISO 13485:2016 Medical Devices Documentation
ISO 13485:2016 is the globally recognized standard for establishing a Quality Management System (QMS) dedicated to the medical devices industry. This training is designed to equip participants with a deep understanding of the standard's requirements, focusing on the creation, management, and control of documented information essential for meeting customer needs and regulatory compliance.
Embark on this essential training to master the documentation controls of ISO 13485:2016 and enhance the quality management of medical devices within your organization.
Benefits
Target group
This course is tailored for professionals involved in the quality management and documentation of medical devices, including:
- Quality Assurance Managers
- Regulatory Affairs Specialists
- Document Controllers
- Process Engineers
- Compliance Officers
Requirements
To fully benefit from this training, participants should have:
- A foundational understanding of ISO 9001:2015 Quality Management Systems.
- Some experience auditing practices is recommended but not mandatory.
No advanced technical skills are required, making this training accessible to anyone looking to enhance their auditing capabilities within the ISO 13485:2016 environment.
Training outline
Other information
For payment and other inquiries, please contact Ms. Ma.Luisa Anne Francisco, Senior Sales Executive (MaLuisa.Francisco@tuv.com | +63 998-840-7850).
Additional Details
- The fees cover training materials and a certificate.
- A 12% VAT is included in the training fees.
Cancellation and Postponement Policy
- TÜV Rheinland Philippines, Inc. holds the authority to delay or cancel public courses. The following points provide further detail:
- Unless a course is cancelled by TÜV Rheinland Philippines, training fees are non-refundable.
- Cancellations made five days or fewer before the scheduled training will not be eligible for a refund. The full training fee will be charged and invoiced.
Delegate Substitution
- If you are unable to attend the training, you may nominate a substitute delegate to attend in your place. Please ensure to inform us of the substitute delegate’s name and title.
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