Six documents from our ISO 13485 toolkit, free. These are the core documents everything else is built on: two complete and one as a preview of the opening pages, plus working records from the same set.
What you’ll receive
| Document | What it is for |
|---|---|
| ISO 13485 Quality Policy | The quality policy for a medical device QMS, including commitment to regulatory requirements and effectiveness (clause 5.3). |
| 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 Quality Manual (preview: first 6 of 15 pages) | The quality manual: QMS scope and exclusions, roles in the supply chain, documented procedures and process interactions (clause 4.2.2). |
| ISO 13485 Purchasing and Supplier Control Procedure | How suppliers are evaluated, selected and monitored, and purchasing information and verification controlled (clause 7.4). |
| 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 Risk Management File and Risk Assessment FMEA Template | The risk management file index and an FMEA-style risk assessment: hazards, hazardous situations, harm, risk estimation, risk controls, residual risk and verification of control effectiveness, following ISO 14971:2019 (clause 7.1). |
Where these fit in ISO 13485
The set starts at the top of the QMS: the quality policy and quality manual, then supplier control under clause 7.4, with the MDSAP readiness checklist, a design review record and the risk management file and FMEA template from the same set.
Get the six ISO 13485 templates
Enter your email and confirm it, and the six documents arrive as one ZIP plus six 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.
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