ISO 13485:2016 – Medical devices -Quality management systems
For organizations involved in one or more life-cycle of a medical device, ISO 13485 standard specifies the requirements for quality management systems, including design and development, storage and distribution, production, installation, servicing and final decommissioning and disposal of medical devices, and design and development, or provision of associated activities (e.g. technical support).
Why ISO 13485?
If you are looking to expand globally or locally, ISO 13485 certification can help you improve your overall performance, reduce uncertainty, and increase your market domain.
- Increase in market globally
- Well identified and defined processes in the organization
- Identify the possible uncertainty (risks) under 3 levels – organization, department and process
- Practice the controls defined to eliminate/reduce the above defined risks
- Demonstrate that your production results in safer and more effective medical devices
Steps Involved in Implementation
The certification of your quality management system takes place in the following steps. Our experts will be at your disposal during the whole process as competent contacts.
- Preliminary audit (optional)
- GAP Analysis (optional)
- Certification audit: Examination of your documentation and a demonstration of the practical application
- Issue of certification
- Annual surveillance audit
- Re-certification before the end of three years