| Criteria | ISO 13485 | ISO 9001 | Remarks |
| Standard Type | Quality Management System (QMS) specific to medical devices | Generic Quality Management System standard, applicable to all industries | ISO 13485 = medical device–focused; ISO 9001 = universal |
| Primary Focus | Safety, regulatory compliance, and quality in medical device design, production, and lifecycle | Customer satisfaction, continual improvement, and product/service quality across industries | ISO 13485 prioritizes regulatory compliance; ISO 9001 prioritizes continuous improvement |
| Regulatory Alignment | Complies with EU MDR, FDA, Health Canada, MHLW Japan, etc. | Not regulatory-specific but widely recognized for general quality management | ISO 13485 is often legally required; ISO 9001 is more voluntary for credibility |
| Risk Management | Mandatory integration of risk management (per ISO 14971) into QMS processes | Risk-based thinking required, but less formalized than ISO 13485 | ISO 13485 has stronger emphasis on medical risk management |
| Documentation | Requires extensive documentation: Design History File (DHF), Device Master Record (DMR), Technical Files | Requires documentation but less strict than ISO 13485 | ISO 13485 is more rigid; ISO 9001 allows flexibility |
| Product Lifecycle | Covers entire device lifecycle: design → development → production → post-market surveillance | Covers product/service lifecycle broadly, not medical-specific | ISO 13485 is lifecycle + compliance-driven; ISO 9001 is broader but less prescriptive |
| Continuous Improvement | Focuses on regulatory compliance and risk reduction rather than continuous improvement | Strong emphasis on Plan-Do-Check-Act (PDCA) and continual improvement | ISO 9001 pushes improvement; ISO 13485 prioritizes compliance and consistency |
| Industry Use | Exclusively used in medical device industry | Used across all industries: manufacturing, IT, services, logistics, etc. | ISO 9001 = global benchmark; ISO 13485 = sector-specific |
| End Goal | Ensure safe, effective, and regulatory-compliant medical devices | Ensure customer satisfaction and quality across industries | Both improve quality but in different contexts |
