Preparation for Audits and Certifications
Obtaining and maintaining certifications such as ISO 13485 (for medical devices) and ISO 9001 (for quality management) requires a well-structured and thoroughly documented system capable of demonstrating compliance with all regulatory requirements. Internal and external audits play a central role in this process.
We offer full support in preparing for, conducting, and following up on audits and certification processes, helping your organization achieve or maintain compliance with the quality management systems required by the sector.
Our services include
Preparation for certification, maintenance, or transition audits
Preparation for certification, maintenance, or transition audits, focusing on ISO 13485 and ISO 9001
Internal audits
Conducting internal audits
Support in addressing non-conformities
Support in addressing non-conformities and recommendations issued by certifying bodies
Assistance during external audits
Assistance during external audits, providing real-time technical and documentary support
Supporting documentation for the management system
Preparation or review of supporting documentation for the management system, including audit reports, action plans, and mandatory records
