ISO 13485:2016 MEDICAL DEVICES & INTERNAL AUDITOR TRAINING

ISO Standard
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    SQI
  • 14 hours

Objectives

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.

Duration

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.

Key Benefits

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.

Course Fees

Member: S$444.05
Non-Member: S$465.45

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.

Course Content

Total Training Hours: 14 hours
  •   The course includes a high level of interactivity during training on: 0/5

    • Lecture1.1
      Interpret all clauses of ISO 13485:2003
    • Lecture1.2
      Understand differences between ISO 13485:2003 and ISO 13485:2016
    • Lecture1.3
      Understand the Quality Management Principles
    • Lecture1.4
      Apply principles of the ISO 19011 to the auditing process
    • Lecture1.5
      Plan, conduct and report effective internal audits to the ISO 13485:2016

Trainer

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SQI
ISO 13485 MEDICAL DEVICES & IA