This template is best implemented in an excel / sheets file. Note that an audit program most commonly covers all ISO 13485 requirements in the course of three years at minimum.
| Auditing Interval | 01/2023 - 01/2026 |
|---|---|
| Auditing objective: | <e.g. “13485 compliance” or “preparation for MDR conformity assessment” or “supplier surveillance”> |
| Chances and risks: | <for example: chances - “small company, planning to be audited by an external party to avoid blind spots”> |
| 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, para. 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, para. 4.2.4, 4.2.5: Control of documents and records |
x | x | |||
| ISO 13485:2016, para. 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, para. 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, para. 8.1, 8.2.1, 8.2.2: Feedback and complaints handling |
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, para. 8.1, 8.2.5, 8.2.6: Measurement of products and processes |
x | ||||
| ISO 13485:2016, para. 8.3: Nonconforming products |
x | ||||
| ISO 13485:2016, para. 8.4: Analysis of data |
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 |
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