LUTHER VERITAS

ISO 13485

Medical Devices - Quality Management System

WHAT IS ISO 13485?

ISO 13485 is the best internationally-accepted model a medical device organization can implement to help demonstrate compliance to laws and regulations of the medical device industry. ISO 13485 is the quality management system standard accepted as the basis for CE marking medical devices under European Directives.

ISO 13485 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.

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 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.

Why is ISO 13485 important for your organization?

These days, medical device manufacturers often insist that their suppliers and service providers are certified to ISO 13485 as a pre-requisite for doing business. ISO 13485 certification is, therefore an increasingly important differentiator for organisations looking to improve their marketability.

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Whilst the primary objective of ISO 13485 certification is to facilitate harmonised QMS requirements for regulatory purposes within the medical device sector, companies also value ISO 13485 certification for the increased confidence it gives patients and other stakeholders through its implicit promise of quality, consistency, and continuous improvement.

What are the benefits of ISO 13485?

Whether you are looking to operate internationally or expand locally, ISO 13485 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