ISO 13485:2016

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ISO 13485:2016 Certification
Medical Device Quality Management System

What is ISO 13485?

Among the alphanumeric soup of industry standards that govern electronic devices and medical products, ISO 13485 is one of the most important standards for medical device designers and manufacturers. This standard defines a broad range of requirements on quality management system (QMS) for medical devices and equipment.

The current version of the ISO 13485 standard is 13485:2016. ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.
The defination of “ISO 13485 Certified” means an organization has implemented an ISO 13485 Quality Management System and has successfully met all of the requirements in ISO 13485. ISO 13485 evaluates whether your Quality Management System is appropriate and effective while emphasizing the safety and efficacy of medical devices.

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What is the purpose of ISO 13485?

Adopting ISO 13485 provides a practical foundation for manufacturers to address the EU Medical Device Directive (MDD), the EU Medical Device Regulation (MDR), and other regulations, as well as demonstrating a commitment to the safety and quality of medical devices. 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.

The current version of ISO 13485?

The latest revision of ISO 13485 for ISO medical devices is from March 2016. Among the additions to this update are included: a focus on risk, clarification of management responsibilities, clarification of training responsibilities, improvement to the facility requirements. The ISO 13485:2016 standard aligns with the previous version of ISO 9001, ISO 9001:2008. ISO 9001 is an internationally recognized standard for Quality Management Systems (QMS).

By using the ISO 13485 requirements to create your QMS, you can ensure that you have a world-class system for meeting the needs of customers and legislators for your medical devices. ISO 13485 provides you with more than the bare minimum to meet a legal requirement; it provides a whole system that is devoted to helping you make your quality processes better.

Why was ISO 13485 revised and what are the main improvements?

All ISO standards are reviewed every five years to establish if a revision is required in order to keep it current and relevant for the marketplace. ISO 13485:2016 is designed to respond to the latest quality management system practices, including changes in technology and regulatory requirements and expectations. The new version has a greater emphasis on risk management and risk-based decision making, as well as changes related to the increased regulatory requirements for organizations in the supply chain.
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