ISO 13485 Certification
ISO 13485 is a voluntary international standard for quality management system for medical devices. It provides requirements to control the quality of the design and manufacture of medical devices in compliance with law and customer needs.
All the requirements are applicable to organizations of all types and sizes unless otherwise specified. The organization does not need to be actively manufacturing medical devices to seek this certification.
Benefits of ISO 13485 Certification
- Improved risk management.
- Improved reputation and credibility.
- Increased customer satisfaction.
- Promotes continual improvement.
- Reduces waste.
How to get certified?
- Study and understand the ISO 13485 standard.
- Conduct risk assessment and gap analysis.
- Formulate a plan for the management system.
- Train the organization and implement the system.
- Document the process.
- The organization is audited and conformity is tested.
- If there are no nonconformities, the certificate is issued.
- If there are nonconformities, then the organization must present an improvement plan.
- When appropriate improvements are made, certificate is issued.
How can we help you?
At Bureau of Global Certifications, our aim is to help you manufacture products that excel in quality and are safe to sell. We offer you one place to get all the required certification your product needs to reach its potential and place in the market. Our services are just a click away!