- 14 hours
ISO 13485:2016 specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
- The functions & requirements of the ISO 13485:2016 Medical Devices standard.
- The understanding & implementing of the ISO 13485 Medical Devices standard effectively as to work instructions / standard operation procedure manuals requirements.
- Using ISO 13485 Medical Devices standard to drive towards becoming a quality class organisation.
2 days | 9am – 5pm | 14 hours
Who should attend
Managers, executives, supervisors and management staff who want to gain knowledge on ISO 13485:2016 Medical Devices and staff who are likely or currently involved in implementing and maintaining ISO 13485:2003 and key personnel assigned for internal audits, management representatives (MR), etc.
A trained-combined system Internal Auditor with the skill set to:
- Conduct an internal audit of the ISO 13485 management system.
- Enable your business to remain compliant with the requirements of the ISO 134845.
- Follow through complex audit trails and identify any possible management systems discrepancies.
- Identify any gaps that threaten the effectiveness of your management systems.
Registration Fee of S$17.12 apply.
SDF funding & SkillsFuture applicable
All fees stated are inclusive of 7% GST
Award of Certificate
Certificate of Completion will be issued to participants who have attended at least 75% of the course.
The course includes a high level of interactivity during training on:
- Interpret all clauses of ISO 13485:2003
- Understand differences between ISO 13485:2003 and ISO 13485:2016
- Understand the Quality Management Principles
- Apply principles of the ISO 19011 to the auditing process
- Plan, conduct and report effective internal audits to the ISO 13485:2016