What is an ISO 13485:2016 Quality Management System?

ISO 13485 is a stand-alone QMS standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series. ISO 13485 adapts the ISO 9000 process-based model for a regulated medical device manufacturing environment. While ISO 13485:2016 is based on the ISO 9001 process model concepts of Plan, Do, Check, Act, it is designed for regulatory compliance. It is more prescriptive in nature and requires a more thoroughly documented quality management system.

ISO 13485:2016 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.

What are the benefits of being certified to ISO 13485:2016

• Whether you are looking to operate internationally or expand locally, ISO 13485:2016 Certification can help you improve overall performance, eliminate uncertainty, and widen market opportunities. Companies with this certification communicate a commitment to quality to both customers and regulators.
• 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.