| Training |
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| (a) ISO 13485 Auditor Training Program for 5 days |
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| Day 1 OF 5 |
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| TIME |
CONTENT |
| 9:00 |
Course Objective and Introductions |
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Fundamentals of Quality management System and the ISO 13485 Family of Standards |
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Exercise 1 : Pre-Course test feedback |
| 10:30 |
Break |
| 10:45 |
Overview of ISO 13485 |
| 1:00 |
Lunch |
| 2:00 |
Overview of ISO 13485 (continued) |
| 3:30 |
Break |
| 3:45 |
Overview of ISO 13485 (continued) |
| 5:00 |
End of Day 1 |
|
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| Day 2 OF 5 |
| |
| TIME |
CONTENT |
| 9:00 |
Regulations and ISO 13485 |
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ISO 13485 and ISO/ TR 14969 |
| 10:30 |
Break |
| 10:45 |
ISO 13485, ISO 14971 and Risk Management |
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Documentation and Records |
| 1:00 |
Lunch |
| 2:00 |
Introduction to Management System Audits |
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Audit Planning and Preparation |
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Workshops On Audit Planning and Preparations |
| 3:30 |
Break |
| 3:45 |
Workshops on Audit Planning and Preparations (continued) |
| 5:00 |
End of Day 2 |
|
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| Day 3 OF 5 |
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| TIME |
CONTENT |
| 9:00 |
Performing the Audit: Opening Meeting and Audit Investigation |
| |
Workshops on Performing the Audit |
| 10:30 |
Break |
| 10:45 |
Workshops on Performing the Audit (continued) |
| 1:00 |
Lunch |
| 2:00 |
Exercise: Auditing the Quark Medical Case Study |
| 3:30 |
Break |
| 3:45 |
Exercise: Auditing the Quark Medical Case Study (continued) |
| 5:00 |
End of Day 3 |
|
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| Day 4 OF 5 |
| |
| TIME |
CONTENT |
| 9:00 |
Performing the Audit: Observations and Nonconformities |
| |
Workshop on Observations and Nonconformities |
| 10:30 |
Break |
| 10:45 |
Conducting the Closing Meeting |
| |
Workshop on Closing Meeting |
| 1:00 |
Lunch |
| 2:00 |
Completing the Audit |
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Conducting Follow-Up |
| 3:30 |
Break |
| 3:45 |
Auditor |
| |
Exam Briefing |
| 5:00 |
End of Day 4 |
|
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| Day 5 OF 5 |
| |
| TIME |
CONTENT |
| 9:00 |
Corrective Action and Follow Up |
| |
Workshop On Corrective Action and Follow Up |
| 10:30 |
Break |
| 10:45 |
Auditor Attributes and etiquette |
| 12:00 |
Lunch |
| 2:30 |
Examination |
| 5:00 |
Course Close |
|
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- Workshops & Exercises to reinforce topics delivered will be conducted at suitable junctures during the course.
- Home assignments may be given - participants are required to complete these at within the assigned time frame.
- Each course day is scheduled to end at 5 pm - however time might extend beyond this to accomadate the course facilitation process.
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