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ISO 22000
ISO 9001
ISO 14001
ISO 13485
ISO 17025
ISO 17799
ISO 15189
TS 16949
OHSAS 18001
GDPMD
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Training
 
(a) ISO 13485 Auditor Training Program for 5 days
 
Day 1 OF 5

 

TIME CONTENT
9:00 Course Objective and Introductions
  Fundamentals of Quality management System and the ISO 13485 Family of Standards
  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
 
Day 2 OF 5
 
TIME CONTENT
9:00 Regulations and ISO 13485
  ISO 13485 and ISO/ TR 14969
10:30 Break
10:45 ISO 13485, ISO 14971 and Risk Management
  Documentation and Records
1:00 Lunch
2:00 Introduction to Management System Audits
  Audit Planning and Preparation
  Workshops On Audit Planning and Preparations
3:30 Break
3:45 Workshops on Audit Planning and Preparations (continued)
5:00 End of Day 2
 
Day 3 OF 5
 
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
 
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
  Conducting Follow-Up
3:30 Break
3:45 Auditor
  Exam Briefing
5:00 End of Day 4
 
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
 
  • 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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