ISO 13485 Quality Management System Assessment for medical device manufacturers and specification developers
ISO 13485 is the International standard for medical device quality management systems. ISOplan USA can audit your quality management practices, focusing on your medical device design, development, production, customer service and assembly.
It is important to certify your medical device quality management systems, since an ISO 13485 Certificate builds trust, but also leads to more efficient processes and work flows.
ISO 13485 Quality Management System Certification Process
The initial certification audit includes a site inspection during which ISOplan USA auditors will determine if your company is eligible for certification. At this time we will also analyze all required quality management documentation. At the end of the site inspection and documentation analysis we will indicate possible deficiencies with ISO 13485.
Following this initial step, we will perform another on-site certification audit to evaluate how your medical device quality management system is applied and to determine its effectiveness.
If your company meets all ISO 13485 criteria, ISOplan USA will issue a Certificate stating that your quality management system complies with ISO 13485 standards for medical devices.