- 9.00 - 9.15 Course outline
- 9.15 - 10.00 Audit methods presentation
- 10.15 - 10.30 Tea break
- 10.30 - 11.30 Case study - Celsion Corporation
- 11.30 -11.45 Audit questioning techniques presentation
- 11.45 -12.30 Combined flow-chart & checklist exercise
- 12.30 - 12.40 NCR completion details presentation
- 12.40 - 13.00 Audit NCR report
- 13.00 - 13.30 Lunch
- 13.30 - 14.30. Audit of philosophy presentation
- 14.30 - 15.30 Case study -
- 15.30 - 15.45 Tea-Break
- 15.45 - 16.15 Fact or inference exercise
- 16.15 - 17.00 Quality policy KPI development (Friborg QP)
What is an ISO 13485 Foundation Course?
A highly interactive ISO 13485 foundation training course that is designed to give delegates a sound knowledge of the requirements of ISO 13485 and the fundamentals of a medical device management system.
Other levels of the course plan (Lead Implementer, Auditer) are available on request. Just ask us.
Who should attend?
- People new to ISO looking to gain the knowledge of the clauses of ISO 13485
- Those who already work as an auditor, but need a refresher
- Those looking to attend an auditing course, but do not have the necessary prior knowledge
- ISO 13485 specifically requires that staff are trained and competent, this course satisfies this requirement.
What will you learn?
A detailed understanding of:
- Differences & similarities between ISO13485:2016 & ISO9001:2015
- Management system principles
- Management system structures
- Quality terminology relating to medical devices
- Interpreting the requirements of the ISO 13485: 2016 Standard
- The Process Approach
- Continual Improvement
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