ISO 13485:2016 Certification
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The ISO 13485:2016 is Medical Device Quality Management System Certification Standard which is applicable to all type of Industry irrespective of their size and activity and region.
ISO 13485:2016 high Level Structure helps to stay consistency, alignment totally different management system standards, supply matching sub-clauses against the top-ranking structure and apply common language across all standards.
The key Features for ISO 13485:2016 standards are:
- The emphasis on leadership
- The focus on risk management
- Emphasis on objectives activity and alter
- Communication and awareness
- Fewer prescriptive necessities