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.
Audit Program <Company Name> 2023 - 2026
1. General Information
| 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”> |
2. Audit Program Plan
| 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 |
Template Copyright openregulatory.com. See template license.
Please don’t remove this notice even if you’ve modified contents of this template.
Template Copyright openregulatory.com. See template license.
Please don’t remove this notice even if you’ve modified contents of this template.