This template is best used within an Excel or Sheets document. Typically, an audit program encompasses all ISO 13485 requirements over a minimum duration of three years.
Audit Program \ 2021 – 2024
1. General Information
| Auditing Period | 01/2023 – 01/2026 |
|---|---|
| Audit Objective | \<e.g., “13485 compliance,” “preparation for MDR conformity assessment,” or “supplier surveillance”> |
| Opportunities and Risks | \<e.g., opportunities – “small company aiming for external audit to address potential blind spots”> |
2. Audit Program Overview
| Audit ID | #1 | #2 | #3 | (…) | |
|---|---|---|---|---|---|
| Date | \<dd.mm.2023> | \<dd.mm.2024> | \<dd.mm.2025> | \<dd.mm.2026> | |
| Lead Auditor | (…) | (…) | (…) | (…) | |
| ISO 13485:2016, para. 4.1, 4.21: General QMS requirements |
x | x | |||
| ISO 13485:2016, paras. 4.2.2, 5.3, 5.4: Quality manual and QMS planning |
x | x | |||
| ISO 13485:2016, para. 4.2.3: Medical device file |
x | x | |||
| ISO 13485:2016, paras. 4.2.4, 4.2.5: Document and record control |
x | x | |||
| ISO 13485:2016, paras. 5.1, 5.2, 5.3, 5.4, 5.5: Management responsibility |
x | x | |||
| ISO 13485:2016, para. 5.6: Management review |
x | x | |||
| ISO 13485:2016, paras. 6.1, 6.3: Resource management |
x | x | |||
| ISO 13485:2016, para. 6.2: Human resources management |
x | x | |||
| ISO 13485:2016, para. 6.4: Work environment and contamination control |
n/a | n/a | n/a | n/a | |
| ISO 13485:2016, para. 7.1: Planning product realization |
x | ||||
| ISO 13485:2016, para. 7.2: Customer-related processes |
x | ||||
| ISO 13485:2016, para. 7.3: Design and development |
x | ||||
| ISO 13485:2016, para. 7.4: Purchasing |
x | ||||
| ISO 13485:2016, para. 7.5: Production and service provision |
x | ||||
| ISO 13485:2016, para. 7.6: Measuring equipment |
x | ||||
| ISO 13485:2016, paras. 8.1, 8.2.1, 8.2.2: Feedback and complaint management |
x | ||||
| ISO 13485:2016, para. 8.1, 8.2.3: Reporting to authorities |
x | ||||
| ISO 13485:2016, para. 8.1, 8.2.4: Internal auditing |
x | ||||
| ISO 13485:2016, paras. 8.1, 8.2.5, 8.2.6: Product and process measurement |
x | ||||
| ISO 13485:2016, para. 8.3: Nonconforming product management |
x | ||||
| ISO 13485:2016, para. 8.4: Data analysis |
x | ||||
| ISO 13485:2016, para. 8.5: Improvement |
x | ||||
| Reg. (EU) 2017/745, Chapter VII, Art. 83-86: Post-market surveillance |
x | ||||
| Reg. (EU) 2017/745, Chapter VII, Art. 87-90: Vigilance |
x |