Schedule comprehensive audit coverage across multiple years ensuring systematic quality management system verification.
Audit ID | Audit #1 | Audit #2 | Audit #3 |
---|---|---|---|
Date | 2024-03-15 | 2024-09-15 | 2025-03-15 |
Audit Plan ID | AP-2024-001 | AP-2024-002 | AP-2025-001 |
ISO 13485:2016, para. 4.1, 4.21: General QMS requirements | ✓ | ✓ | |
ISO 13485:2016, para. 4.2.2, 5.3, 5.4: Quality manual and QMS planning | ✓ | ||
ISO 13485: 2016, para. 4.2.3: Medical device file | ✓ | ||
ISO 13485:2016, para. 4.2.4, 4.2.5: Control of documents and records | ✓ | ✓ | |
ISO 13485:2016, para. 5.1, 5.2, 5.3., 5.4, 5.5: Management responsibility | ✓ | ||
ISO 13485:2016, para. 5.6: Management review | ✓ | ✓ | |
ISO 13485:2016, para. 6.1, 6.3: Resource management | ✓ | ||
ISO 13485:2016, para. 6.2: Human resources management | ✓ | ||
ISO 13485:2016, para. 6.4: Work environment and contamination control | n/a | n/a | n/a |
ISO 13485:2016, para. 7.1: Planning product realization | ✓ | ||
ISO 13485:2016, para. 7.2: Customer-related processes | ✓ | ||
ISO 13485:2016, para. 7.3: Design and development | ✓ | ✓ | ✓ |
ISO 13485:2016, para. 7.4: Purchasing | ✓ | ||
ISO 13485:2016, para. 7.5: Production and service provision | ✓ | ✓ | |
ISO 13485:2016, para. 7.6: Measuring equipment | ✓ | ||
ISO 13485:2016, para. 8.1, 8.2.1, 8.2.2: Feedback and complaints handling | ✓ | ||
ISO 13485:2016, para. 8.1, 8.2.3: Reporting to authorities | ✓ | ||
ISO 13485:2016, para. 8.1, 8.2.4: Internal auditing | ✓ | ||
ISO 13485:2016, para. 8.1, 8.2.5, 8.2.6: Measurement of products and processes | ✓ | ||
ISO 13485:2016, para. 8.3: Nonconforming products | ✓ | ||
ISO 13485:2016, para. 8.4: Analysis of data | ✓ | ||
ISO 13485:2016, para. 8.5: Improvement | ✓ | ✓ | |
Reg. (EU) 2017/745, Chapter VII, Art. 83-86: Post-Market Surveillance | ✓ | ||
Reg. (EU) 2017/745, Chapter VII, Art. 87-90: Vigilance | ✓ | ||
Reg. (EU) 2017/745, Chapter 61 & Annex XIV: Clinical Evaluation and Post-Market Clinical Follow-up | ✓ |
How often should I update my audit program?
What if I can't cover all QMS processes in three years due to limited resources?
How do I ensure auditor independence in a small organization?
Should I audit all ISO 13485 clauses even if some don't apply to my device?
What happens if my audit program reveals I'm not meeting regulatory requirements?
How does my audit program relate to notified body or FDA inspections?