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- ISO 9001 QMS
- ISO 14001 EMS
- OHSAS 18001 SMS
- ISO/TS 16949
- ISO 13485
- Supplementary Courses
- Value Added Courses
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We also Deal With
ISO 13485 QMS
ISO 13485 QMS for Medical Devices
Course Objectives
This one-day course will allow participants to understand the requirements of ISO 13485, quality management system for medical devices.
Upon completion of this course, participants will have a good understanding on the requirements as well as the implementation phases.
Course Content
• Introduction to ISO 9001 & ISO 13485
• Relation between ISO 9001 to ISO 13485
• ISO 13485 requirements
• Cross reference to ISO 14971
• Quality Management System
• Management Responsibility
• Resource Management
• Product Realisation
• Measurement, analysis and improvement
Who should attend
Personnel who are involved in quality management, management system, project engineering and production planning & control are encouraged to attend.
Course Objectives
This one-day course will allow participants to understand the requirements of ISO 13485, quality management system for medical devices.
Upon completion of this course, participants will have a good understanding on the requirements as well as the implementation phases.
Course Content
• Introduction to ISO 9001 & ISO 13485
• Relation between ISO 9001 to ISO 13485
• ISO 13485 requirements
• Cross reference to ISO 14971
• Quality Management System
• Management Responsibility
• Resource Management
• Product Realisation
• Measurement, analysis and improvement
Who should attend
Personnel who are involved in quality management, management system, project engineering and production planning & control are encouraged to attend.
