ISO 13485:2016 Medical Devices Quality Management Systems
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
The standard is applicable to all manufacturers and providers of medical devices, components, contract services and distribution of medical devices.
Requirements of ISO 13485:2016
• Clause 4: Quality management system
• Clause 5: Management responsibility
• Clause 6: Resource management
• Clause 7: Product realization
• Clause 8: Measurement, analysis and improvement
Benefits of ISO 13485:2016
• Increase access to more markets worldwide
• Savings in cost from reduction of defects and rejects
• Meet relevant regulatory requirements and customer expectations
• Demonstrate ability to produce safer and more effective medical devices
• Improve operation efficiency through continual improvement processes
How can ELITE assist you?
ELITE provides ISO 13485 system training and consultancy services. We offer specialized expertise and extensive practical experience to assist client in developing management systems from the initial concept to establishment and successful implementation of the management systems.
We use the following consultation approach to assist you in achieving certification:
1. Identify areas requiring improvement or development within your current Management System
2. Prepare a strategic action plan, in conjunction with your company personnel, to address those improvement areas and assist with the communication of these requirements to key personnel at all levels
3. Provide system-related trainings for your company personnel to create awareness and provide them with the necessary knowledge and skills in the implementation of systems
4. Provide assistance and advice on the development and implementation of systems, including preparation of documentation
5. Advise and assist, if required, with the preparation and submission of applications to your certification body
6. Assist with the development of internal auditing procedures and training
7. Conduct internal audit to ensure the effective implementation of the management system prior to final audit by your certification body
8. Conduct Management Review Meeting to review performance of management system and identify areas for improvement prior to final audit by your certification body