Run the internal audit required by ISO 13485:2016, clause by clause — an Excel file with audit questions, an evidence log and automatic scoring.
One-time payment. Instant download. 30-day money-back guarantee.
ISO 13485:2016 requires you to audit your medical device quality management system at planned intervals. Rebuilding the audit checklist from scratch every cycle wastes time and misses requirements. This file gives you the questions, the evidence to sample and a scored result you can present to management.
A sample of the “Detailed checklist” tab. Each row turns a requirement into an audit question with the evidence to sample.
| Reference | Audit question | Evidence to sample | Auditee | Result |
|---|---|---|---|---|
| Product realization | ||||
| 7.3 | Control design and development, including design transfer and files. | Design & development files (DHF) | R&D | Partial |
| 7.5.1 | Control production under defined and validated conditions. | Device master record, process validation | Production | Non-conform |
| Measurement & improvement | ||||
| 8.2.1 | Handle complaints and feedback from the market. | Complaint handling records | Regulatory affairs | To evaluate |
| 8.3 | Control nonconforming product and apply CAPA. | Nonconformity & CAPA records | Quality manager | Partial |
Overall conformity rate, number of open gaps, breakdown by status. Everything updates as you fill in the checklist.
One row per requirement: the point to check, the expected evidence, the owner and a status drop-down.
Charts generated from your entries: score by clause and status breakdown, ready to present to management.
Each gap becomes a dated, assigned action, tracked to closure and ready for your audit.
A free requirements list tells you what the standard asks. This checklist turns it into a working control tool.
| Feature | Free requirements list | Internal audit checklist |
|---|---|---|
| Requirements list | Yes | Yes |
| One detailed row per requirement | No | Yes |
| Point, evidence and owner per requirement | No | Yes |
| Conformity score calculated automatically | No | Yes |
| Dashboard and summary charts | No | Yes |
| Corrective action plan included | No | Yes |
The checklist covers every requirement as an audit question, so nothing is left out of the audit plan.
You record conformity and findings on site. The dashboard scores the result as you go.
Each finding becomes a tracked nonconformity, ready for management review and follow-up.
Audit plan → On-site audit → Findings → Corrective actions
Nothing is left as a heading. Every clause is broken down into the requirements you check off — here is what each one covers.
Download the checklist, put it to work on your real project, and judge it against what you actually need. If it doesn’t fit — or you simply change your mind — email us any time within 30 days and we’ll refund you in full. No forms to fill in, no justification to give, no risk on your side. We’d rather earn a satisfied customer than keep an unhappy one, which is exactly why every QSE Academy download comes with this promise.
Each stage of your project has its checklist. You’re in the right place for this one.
Going further: the complete ISO 13485 documentation kit.
Download the internal audit checklist and conduct your next audit cycle with confidence.
QSE Academy supports quality managers, SMEs, and consultants in accelerating their ISO standards implementation through ready-to-use documentation, targeted training programs, custom documentation services, and compliance tools.
Quality Consultants Group LLC
8206 Louisiana Blvd NE,
Ste A #135
Albuquerque, NM 87113
United States
Secure Payment
© 2026 QSE Academy. All Rights Reserved.
