ISO 13485:2016 Certification
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,
regulatory requirements applicable to medical devices and related services. ISO 13485 is the
internationally recognized standard for quality management systems in the medical device
industry. It is designed and intended for use by organizations for the design and
development, production, installation, servicing and sales of medical devices. It specifies
requirements for a quality management system where an organization needs to demonstrate its
ability to provide medical devices, and that related services consistently meet customer
requirements and applicable regulatory requirements. How can ISO 13485 helps to: Increase
access to more markets worldwide with certification Outline how to review and improve
processes across your organization. Increase efficiency, cut costs and monitor supply chain
performance. Demonstrate that you produce safer and more effective medical devices. Meet
regulatory requirements and customer expectations.
Benefits of ISO 13485 certification:
- Customer satisfaction - through delivery of products that consistently meet customer
requirements as well as quality, safety and legal requirements.
- Reduced operating costs - through continual improvement of processes and resulting
operational efficiencies.
- Improved stakeholder relationships – including staff, customers and suppliers.
- Improved risk management – through greater consistency and traceability of products and
use of risk management techniques.
- Legal compliance – by understanding how statutory and regulatory requirements impact the
organization and its customers.
- Proven business credentials – through independent verification against recognized
standards.
- Ability to win more business – particularly where procurement specifications require
certification as a condition to supply in a highly regulated sector.
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