Five controlled records from our ISO 13485:2016 Documentation Toolkit, free. Each one is a working template built for a medical device QMS, not a summary of what such a record should contain.
What you’ll receive
| Document | What it is for |
|---|---|
| ISO 13485 Design Review Record Template | Records systematic design and development reviews held at suitable stages, evaluating whether results meet requirements and identifying problems. |
| ISO 13485 Document Change Request Form | A controlled supporting form for raising and approving changes to QMS documents. |
| ISO 13485 MDSAP Readiness Checklist | Confirms that mandatory documented procedures, records and medical-device-specific requirements are established and evidenced before a certification or MDSAP audit. |
| ISO 13485 Nonconformity Report (NCR) Template | Records a nonconformity, its evaluation including risk, the disposition with concession authorisation where applicable, and verification of correction. |
| ISO 13485 Training and Competence Record Template | Records individual training events and competence assessments, including evaluation of training effectiveness. |
Where these fit in ISO 13485
These cover document control, competence records, design and development review, and the handling of nonconforming product — the record types an auditor asks to see — plus a readiness check ahead of certification or an MDSAP audit.
Get the five ISO 13485 templates
Enter your email and confirm it, and the five documents arrive as one ZIP plus five separate PDFs. Links stay live for 14 days. No sales call, no card details.
The rest of the toolkit
These five are a slice of the ISO 13485:2016 Documentation Toolkit, which carries the full documented system — policies, procedures, registers and records — in editable Word and Excel format. See the contents list and sample pages on the product page.