ISO 13485:2016 (QUALITY MANAGEMENT SYSTEM FOR MEDICAL DEVICES)

Our Principal Consultant Mr. Abhimanyu Samrat is also Lead Auditor for ISO 13485:2016 Quality Management System for Medical Devices (QMS-MD), where we have vast experience of this type of Management System.

ISO 13485: 2016 (QMS-MD)

ISO 13485 is a standard that describes the QUALITY MANAGEMENT SYSTEM for design and manufacture of Medical Devices, designed and developed by the International Organization for Standards (ISO). It is mandatory for an organization to effectively implement and maintain the system that adheres to the Standard.

ISO 13485 is considered mandatory even for medical devices that are adhering to Global Harmonization Task Force guidelines. It is also considered to be the initiative for a process to be compliant with European Regulatory requirements.

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

ISO 13485 describes specific requirements for an organization to be compliant, which includes:

• That the top management should be fully aware of regulatory requirements and should promote them within the organization as well
• That there should be proper measures to ensure product safety while maintaining work environment
• That design control and risk management activities should be of a great focus
• That the implantable devices should go through specific inspections and should have specific qualities in terms of traceability
• That the documentation and validation processes for sterile medical devices should be in a specific framework
• That the corrective and preventive actions should be specifically verified for their effectiveness