FDA Inspections and ISO Audits

1. FDA Inspections and ISO Audits Understanding FDA 21 CFR Part 820 & ISO 13485:2016

2. Introduction to Audits and Inspections • Compliance is critical in medical device manufacturing • Audits and inspections verify quality system effectiveness • Focus on product safety and regulatory compliance • Required throughout the device lifecycle • Supports patient safety and risk control • Key requirement for global market access

3. What Is an ISO Audit? • Independent and systematic assessment • Evaluates Quality Management System effectiveness • Conducted by accredited certification bodies • Evidence-based review of processes and records • Focus on continual improvement • Required for ISO 13485 certification

4. What Is an FDA Inspection? • Regulatory inspection conducted by the US FDA • Performed by FDA investigators • Verifies compliance with US laws and regulations • Reviews facilities, records, and manufacturing processes • Enforcement-driven activity • Findings may result in regulatory actions

5. Key Differences – FDA Inspection vs ISO Audit • Regulatory enforcement vs certification assessment • FDA investigators vs third-party auditors • Mandatory for US market vs voluntary certification • Legal authority vs conformity assessment • Outcomes include Form 483 vs audit findings • Different consequences for non-compliance

6. Overview of ISO 13485:2016 • International Quality Management System standard • Applies to full medical device lifecycle • Risk-based approach to quality management • Emphasis on regulatory compliance • Focus on documentation and process control • Widely accepted for global market entry

7. Overview of FDA 21 CFR Part 820 • FDA Quality System Regulation (QSR) • Mandatory for medical devices sold in the US • Based on Current Good Manufacturing Practices • Covers design controls and production processes • Requires complaint handling and CAPA • Enforced through FDA inspections

8. Relationship Between ISO 13485 & FDA 21 CFR Part 820 • Shared quality management principles • Strong alignment in risk management concepts • ISO 13485 supports FDA inspection readiness • Structural and documentation similarities • FDA has additional regulatory expectations • Gap assessment often required

9. Benefits of an Integrated QMS Approach • Improved FDA inspection readiness • Reduced compliance and enforcement risk • Streamlined documentation management • Supports multi-market regulatory compliance • Enhances product safety and quality • Improves operational efficiency

10. Key Takeaways & Reference • FDA inspections and ISO audits serve different roles • ISO 13485 focuses on system certification • FDA inspections are legally enforceable • Integrated QMS strengthens compliance posture • Structured preparation reduces regulatory risk Reference:https://operonstrategist.com/fda-inspections-and-iso-audits-fda-21-cfr-part-820-and-iso-13485/?utm_source=google&utm_medium=off-page&utm_campaign=offpage8