Implementing ISO 13485:2003
Course Dates
12 November 2010 - 12 November 2010Implementing ISO 13485:2003 - The Medical Device Quality Management Standard
Training Benefits will include:
• What is ISO13485 and why is it required?
• How to implement ISO 13485 into the Quality System
• Implementation of the standard - Organisation/People Considerations
• Updates from ISO 9001
• Internal Audits of ISO 13485
• The process-clause matrix
• How to bring real business value from the standard
• The Notified Body audit process
• Responding to Notified Body observations
• Integrating the audit process to Management Review
• Integrating risk management
• Practical auditing workshops
Every participant will have the opportunity to identify their key requirements in advance of the course.
Free individual follow up consultation will be available post training from your course tutor.
Who should attend?
Personnel in Quality, Regulatory and Suppliers to the medical device industry who are responsible for managing, implementing and monitoring ISO13485 Quality systems or subsystems.
COST
€395 per person. This cost is inclusive of course manual, lunch and refreshments. This course is also available in-house, please contact us for rates.
VENUE:
First Polymer Training, Athlone or in-house.
DURATION:
One Day
Public course commences at 9.15am and finishes at 5.00pm
CONVENIENT HOTELS (w/parking)
Creggan Court Hotel, Athlone Tel: 090-6477777 (2 mins by car)
Radisson SAS,
Northgate Street, Athlone.
(Book through us for a special rate)
