Precision and Patient Safety: ISO 13485:2016 Certification

An IQS audit is characterized by technical depth and clinical relevance. We ensure your system is robust enough to withstand both ISO certification and government regulatory inspections. 

1. Technical Documentation Review: We audit your Design History Files (DHF) and Device Master Records (DMR) to ensure they meet international technical standards.
2. Cleanroom & Environment Audit: Our auditors evaluate your production environment to verify controls for cleanliness, temperature, and humidity, as applicable to your device class.
3. Supplier & Outsourcing Control: We examine how you qualify and monitor your suppliers, ensuring that the "quality chain" remains unbroken.
4. Corrective and Preventive Action (CAPA): A deep-dive into your CAPA system to ensure that quality issues are not just recorded, but systematically resolved to prevent recurrence.

•  Multidisciplinary Technical Insight: Because IQS is backed by the engineering expertise of Safety Imperium, we understand the mechanical, electrical, and material science behind your medical devices.
• Customized Lead-Sheet Templates: We deliver audit findings in a clear, categorized format that aligns with FDA and ISO requirements, making it easier for your Quality Assurance team to implement changes.
• Focus on Product Efficacy: Our audits prioritize "Patient Safety" above all else, identifying potential failure points in the manufacturing or sterilization process before they reach the market.
• Global Market Access: ISO 13485 certification from IQS is a vital step for manufacturers looking to export devices to international markets that require a certified QMS.