ISO 13485 Software Validation Kit (QMS & Production Software)
ISO 13485 Software Validation Kit (QMS & Production Software)
Regular price
$59.00 USD
Regular price
Sale price
$59.00 USD
Instant download. Editable files. One-organization licence. 5-day fit guarantee.
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This kit is one of 15 in the ISO 13485 Complete QMS Kit: every kit for $449 instead of $1,375 bought separately.
See the ISO 13485 Complete QMS 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.
Validate the software you use for quality records and production, in proportion to risk, as ISO 13485 clauses 4.1.6 and 7.5.6 require. Includes a production software protocol aligned with FDA's 2025 Computer Software Assurance guidance.
What's inside (6 files)
- Inventory and Planning: Software Inventory Register.
- Protocols and Reports: Production Software Validation Protocol; Software Validation Report; Software Validation Summary; URS and Validation Protocol.
How to use it
- List every software application used in the QMS, production and measurement in the inventory.
- Rate each one by risk and decide the level of assurance needed.
- Write user requirements and the validation protocol; test high-risk functions with scripted tests.
- Record results in the validation report and summary.
- Revalidate after upgrades, configuration changes or a change of intended use.
Who it's for
Any organization using software for quality records, production or measurement (eQMS, ERP, spreadsheets, test software).
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 Complete QMS Kit, which costs 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 Software Validation Kit (QMS & Production Software)
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.
