Audit Management
Comprehensive Audit Services: Internal & Supplier Audits
At Global Medtech Solutions, we are committed to helping organizations maintain the highest standards of quality and compliance through our expert Internal Audits and Supplier Audits services. Whether you need to assess your internal processes or evaluate supplier performance globally, our experienced auditors deliver actionable insights to enhance operational efficiency and regulatory compliance.
Internal Audit Services
Internal audits are essential for identifying gaps, ensuring compliance, and driving continual improvement. Our team conducts meticulous internal audits tailored to your organization’s specific requirements.
Our Internal Audit Expertise Includes
- ISO 9001:2015 Audits: Evaluating compliance with quality management system standards.
- ISO 13485:2016 Audits: Ensuring adherence to medical device-specific quality standards.
- Regulatory Compliance Audits: Assessing readiness for FDA, EU MDR, MHRA, and other global regulatory requirements.
- Gap Analysis: Identifying weaknesses and opportunities for improvement within your existing systems.
- CAPA Effectiveness Audits: Reviewing corrective and preventive actions to ensure sustained improvements.
Supplier Audit Services
Maintaining a reliable and compliant supply chain is critical to business success. With expertise in conducting supplier audits worldwide, we help organizations ensure that their suppliers meet the highest quality and regulatory standards.
Our Supplier Audit Expertise Includes
- Quality System Audits: Evaluating supplier compliance with global standards like ISO 9001 and ISO 13485.
- Process Audits: Assessing manufacturing processes for consistency and quality.
- Risk-Based Audits: Prioritizing high-risk areas to prevent supply chain disruptions.
- Regulatory Compliance Audits: Ensuring suppliers align with FDA, EU MDR, MHRA, and other global regulations.
- Performance Improvement: Providing actionable recommendations to enhance supplier reliability.