ISO 13485 Certification & Consultation
ISO 13485 Medical Devices- Quality Management System
ISO 13485 is an international standard that specifies the quality management system necessities for organizations committed medical devices at any stage of the product lifecycle. This is able to embrace the planning, development, production, storage, distribution, installation, service and technical support of the device. The ISO 13485:2016 revision is the third edition of the standard and supersedes the previous ISO 13485:2013. This latest revision of the standard contains substantial updates relating to risk-based quality processes, supplier management, and strict adherence to regulative necessities. This standard is also applied to parties that offer material, product or services to the organization and is applicable to organizations of all sizes massive and little. Additionally, any processes needed to get or maintain compliance with the ISO 13485:2016 standard that’s not performed inside the organization, remain the responsibility of the organization and should be enclosed among the quality management system. The organization should monitor, management and guarantee correct maintenance of the external processes.