ISO 13485:2016 for Medical Devices

This is internationally recognized quality management system that specifies a requirement for a quality management system. ISO 13485:2016 provides an extensive framework to meet the extensive requirements for a medical device quality management system. This helps in defining the requirements for a QMS which show an organization’s ability to provide medical devices and related services that meet customer’s requirement. Medical device manufacturer, suppliers and external parties follow this standard to demonstrate adherence to regulatory requirements, improve processes, manage risk and provide confidence to patients and users.

These standards are reviewed to check if any revision is required in order to keep it current and up to date for the marketplace. This standard is revised to respond to latest quality management system practices that include changes in technology and regulatory requirements. The standard for medical devices is an effective solution to meet the requirements of the QMS. Various organizations that adopt the ISO 13485 standard get the practical foundation to address the medical device directives, regulations, and responsibilities. These manufacturers also demonstrate a commitment to the safety and quality of medical devices.

ISO 13485 Certification is not a requirement of this standard. Various organizations can take benefits by implementing the standard without undergoing the certification process. Third party certification (Certified from the ISO) will demonstrate to the regulators that you have met all the requirements of the standard.

Purpose of ISO 13485 Standards

The purpose of this standard is to focus on how companies should manage the decisions related to purchasing, design, development, production control activities and other aspects of the quality management system. This latest or revised version emphasis on the risk-based decision making as well as changes related to the increased regulatory requirements for companies. The standard supports the medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. One can plan, document and implement corrective action and preventive action without any delay. This ensures the deliverable medical devices are safe for their intended purpose.

Benefits of Being Certified to ISO 13485

This can help the manufacturers to improve overall performance, eliminate uncertainty and increase the market opportunities. The companies having this certification offer a commitment to the quality to both customers and regulators. Benefits of adopting this standard are as:

• This is helpful in defining a procedure to review and improve the processes across your organization.
• You can meet regulatory requirements and customer expectations.
• Provides guidelines how to prepare for the new standard.
• ISO certification demonstrates that you have produced safe and more effective medical devices.
• One can increase efficiency and improve the supply chain performance.
• Having certification means increased access to more markets across the world.
• Helps in managing risk effectively.

These standards are applicable to all types of organizations including hospital, trading, manufacturing, healthcare and service companies etc. Having ISO 13485 certification allow the medical device manufacturer to meet quality system requirement of the device.