Gabriel Iso

ISO Certification Auditor

Silver Surgical Complex (Pvt) Ltd, • Freiberufler

Feb 2021 - Oct 2025 • 4 yrs 8 mos

01. Conducted first-party, second-party, and third-party audits in compliance with ISO 9001 (Quality Management System), ISO 13485 (Medical Devices Quality Management System), ISO 14001 (Environmental Management System), and ISO 45001 (Occupational Health & Safety Management System). 02. Assessed organizational processes, documentation, and operational controls to ensure compliance with applicable ISO standards and regulatory requirements. 03. Planned and executed audit programs, including audit scope definition, risk assessment, and audit scheduling. 04 Identified non-conformities, observations, and opportunities for improvement, and documented findings in detailed audit reports. 05. Conducted opening and closing meetings with top management, clearly communicating audit results and recommendations. 06. Verified implementation and effectiveness of corrective and preventive actions (CAPA) to ensure continual improvement. 07. Evaluated risk management processes, especially in alignment with ISO 13485 requirements for medical device quality systems. 08. Ensured environmental aspects and occupational health & safety risks were properly identified and controlled as per ISO 14001 and ISO 45001. 09. Provided technical guidance and training to clients on ISO standards implementation, documentation, and compliance strategies. 10. Maintained audit records and ensured confidentiality, impartiality, and integrity in all audit activities.