ISO 13485 Internal Audit Kit
ISO 13485 Internal Audit Kit
Regular price
$79.00 USD
Regular price
Sale price
$79.00 USD
Instant download. Editable files. One-organization licence. 5-day fit guarantee.
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This kit is one of six in the ISO 13485 Starter Kit. Get all six for $249 instead of $504 bought separately.
See the ISO 13485 Starter KitNot ready to buy? Get free sample pages from this kit
5-day fit guarantee. If it does not fit your QMS, ask for a refund within 5 days. Conditions.
Everything to plan, run and report internal audits under clause 8.2.4, including a clause-by-clause ISO 13485 audit checklist in Excel with the evidence to sample for each requirement.
What's inside (11 files)
- Procedure: Internal Audit SOP.
- Audit Programme and Records: Annual Audit Programme; Audit Plan Template; Audit Report Template; Auditor Qualification Log.
- Checklist: ISO 13485 Internal Audit Checklist (71 requirement areas, findings log).
- Training: Internal Auditing training module (slides, trainer guide, workbook, assessment).
How to use it
- Adapt the Internal Audit SOP and set audit frequency by process risk and past results.
- Build the year's programme in the Annual Audit Programme.
- For each audit, prepare an audit plan, filter the checklist to the clauses in scope, and record evidence.
- Write the report, raise findings as CAPAs and verify them.
- Qualify auditors with the log and the training module; nobody audits their own work.
Who it's for
Quality managers and internal auditors planning an audit programme or preparing for certification.
Good to know
- Instant download. Editable Microsoft Office files, no macros.
- Includes a Start Here guide with the contents and how to use them.
- Licensed for one organization, including its sites.
- Templates don't reproduce ISO standards. You need your own licensed copies.
- Also in the ISO 13485 Starter Kit and the Complete QMS Kit, which cost less than buying kits separately.
What every download includes
Instant downloadLink on the confirmation page and by email within minutes.
Fully editableWord, Excel and PDF. No macros. Works in Microsoft 365 and Google Workspace.
5-day fit guaranteeIf the files do not fit your QMS, ask for a refund within 5 days. Conditions apply.
Free updatesRevised files for this edition of the standard are sent to you at no charge. One-organization licence.
Templates refer to clause numbers and describe requirements in our own words. They do not reproduce the text of any ISO standard, so you need your own licensed copy. Templates support your system; they do not guarantee certification.
Questions about ISO 13485 Internal Audit Kit
How will I receive the files?
A download button appears on the order confirmation page and the same link is emailed to you within a few minutes. Bundles arrive as one ZIP file.
Can I get a refund?
Yes. With our 5-day fit guarantee, if the files do not fit your quality management system you can ask for a full refund within 5 days of your order. It applies once per customer and organization, covers the whole product, and requires you to confirm you have deleted the files. We also refund non-delivery, defective files, wrong items and duplicate purchases within 30 days. Read the full refund policy.
Can I see the files before I buy?
Yes. The images above show real pages from the files, and most kits have free sample pages you can download with your email address.
Can I use the templates with more than one company?
Each purchase is licensed to one organization. Consultants and groups need one licence per client or legal entity. See the licence agreement.
Also transitioning to ISO 9001:2026?
Many medical device manufacturers hold both certifications. If your quality system needs to cover the 2026 update to ISO 9001 as well as ISO 13485, these cover the same ground for the base standard.
