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. 30-day money-back guarantee.
Couldn't load pickup availability
- Best for
- Any company using software in the QMS, production or measurement that needs clause 4.1.6, 7.5.6 or 7.6 validation evidence.
- What it gets done
- Software inventory with risk rating, URS, validation protocol and report, production software protocol and a worked example.
- What you still do
- Inventory your software, risk-rank it, write the URS for the high-risk items and execute the protocol.
- See it first
- Free sample pages.
One-organization licence · Free updates for this edition · Email support· Purchase terms
- 30-day money-back guarantee. If it does not fit your QMS, email us within 30 days for a full refund. Conditions.
- Know what you are buying. The images above are real, unedited pages from the download, and a free sample is a few lines down.
- Secure checkout, instant access. Card, PayPal, Apple Pay, Google Pay or Shop Pay. Your download link is emailed to you within minutes of checkout, and you can re-download from your order confirmation at any time. Sold by ISO Cloud Consulting LLC, USA.
- Ask the author before you buy. Email a question and the person who wrote the files replies within 2 business days.
Upgrade and save
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 KitOptional add-ons, training and free samples
Upgrade credit if you buy a bigger kit later
- If you move up to the ISO 13485 Starter Kit or Complete QMS Kit later: code
STARTER-UPGRADE, a fixed $79 off.
Credits are fixed amounts. Where the credit equals the price of what you own, you pay only the difference; otherwise the credit is the amount shown. Use the same email address as your first order; one credit per order and per customer, not combinable with other discounts.
ISO consultant? Use this template with up to 10 clients, with your own or your client's branding: consultant edition.
Train your team on this
Make sure the whole team understands the requirement behind these records. The ISO 13485 Foundations Course is online and self-paced.
ISO 13485:2016 Foundations Course (Online, Self-Paced, Certificate of Completion), $99Certificate of Completion issued by ISO Cloud Consulting. It is not an accredited or third-party qualification.
Also see: ISO 13485:2016 Lead Implementer Course (Online, Certificate of Completion), $399. Browse the Academy.
Want to learn how to implement ISO 13485 with these templates? ISO 13485:2016 Lead Implementer Course (Online, Certificate of Completion): online, unlimited access, certificate of completion.
Not ready to buy? Get free sample pages from this kit
Before you buy
- Who wrote it: Ishan Maharaj, an industrial engineer (BSc Eng Hons, MSc Engineering Management) who builds and runs certified ISO 9001 and ISO 13485 quality systems. See the ISO 9001 and ISO 13485 case studies.
- Buying for a company? Need a quote or invoice for a purchase order first? Email hello@isocloudconsulting.com and we will send one.
- Not sure it fits? Email the same address with your company size and scope, and get a straight answer from the person who wrote the files.
Every spreadsheet, eQMS, label printer and ERP module that touches the QMS or production must be validated in proportion to its risk, and most small companies have never written the record. This kit gives you the inventory, the protocol and report, a production software protocol that follows FDA's computer software assurance approach, and a worked example that validates the most common case: a CAPA register in Excel.
What's inside (8 files: 7 Word, 1 PDF)
- Inventory and planning (1): Software Inventory Register with risk classification and validation approach per item.
- Protocols and reports (4): URS and Validation Protocol; Software Validation Report; Software Validation Summary; Production Software Validation Protocol.
- Worked example (Word): inventory entry and validation summary VAL-SW-003 for a CAPA register spreadsheet with eight test cases, residual-risk controls and re-validation triggers.
- Start Here guide and the November 2026 edition note.
How to use it
- List every piece of software used in the QMS or production and classify its risk.
- Validate high and medium risk items with the protocol; justify low-risk items in the register.
- Keep the summary with the software file and re-validate on change.
Who it's for
Companies running the QMS on Microsoft 365, SharePoint, Google Workspace or spreadsheets, and anyone with a finding on clause 4.1.6. Running your QMS this way? See our digital QMS builds.
Good to know
- Instant download. Editable Word, Excel and PowerPoint, no macros. Licensed for one organisation including its sites; consultants can add the multi-client licence.
- November 2026 edition: every file cites ISO 14971:2019 and the FDA QMSR (21 CFR Part 820 as amended, effective 2 February 2026); role titles are market-neutral; a "What changed" note is in the download.
- Templates describe requirements in our own words and do not reproduce ISO text; you need your own copy of ISO 13485:2016.
- Also included in the ISO 13485 Complete QMS Kit.
- 30-day money-back guarantee if it does not fit your QMS.
ISO 13485 Software Validation Kit (QMS & Production Software)$5930-day money-back guarantee
Three ways to buy ISO 13485 templates
Start with the gap assessment, build the core system with the Starter Kit, or get every kit at once. Upgrade credits mean you never pay twice for the same kit.
| What is included | Gap Assessment Workbook See where you stand before you commit $49View Gap Assessment Workbook | Starter Kit
Core system: 6 kits for clauses 4 to 6 and 8
$249 | Best valueComplete QMS Kit
All 15 kits, including design, risk and production
$449 |
|---|---|---|---|
| Gap assessment, 71 requirement areas with action plan | Included | Included | Included |
| Quality manual and management review kit | Not included | Included | Included |
| Document control and records kit | Not included | Included | Included |
| CAPA and nonconformance kit | Not included | Included | Included |
| Internal audit kit | Not included | Included | Included |
| Training and competence kit (8 modules) | Not included | Included | Included |
| Design controls and DHF kit, ISO 14971 risk management file kit | Not included | Not included | Included |
| Supplier control, production and traceability, equipment and calibration kits | Not included | Not included | Included |
| Software validation, medical device file and labelling kits | Not included | Not included | Included |
| Complaint handling, PMS and vigilance kit, plus the process validation IQ/OQ/PQ pack | Not included | Not included | Included |
| Start-here roadmap to certification | Not included | Not included | Included |
| Optional 60-minute onboarding call with the author | Not included | Included | Included |
| 30-day money-back guarantee, instant download, one-organization licence, free updates for this edition | Included | Included | Included |
Prices in USD. Crossed-out prices are the combined price of the included items bought separately. Own a smaller kit already? Upgrade credits are listed on each product page. Still unsure? Which kit is right for me?
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.
30-day money-back guaranteeIf the files do not fit your QMS, ask for a full refund within 30 days. Conditions apply.
Free updatesRevised files for this edition of the standard are sent to you at no charge. We email you the new files. Version history.
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. Licence, updates and refunds in one place: purchase terms. Sold by ISO Cloud Consulting LLC.
Questions about ISO 13485 Software Validation Kit (QMS & Production Software)
Which software has to be validated under ISO 13485?
Clause 4.1.6 covers software used in the QMS (document control, CAPA, training and complaint systems, spreadsheets with formulas), and clauses 7.5.6 and 7.6 cover production and measurement software. The inventory sheet helps you list and risk-rank all of it.
Does the kit include a validation protocol and report?
Yes. User requirement specification, validation protocol with test cases, validation report, production software protocol and a software inventory with risk rating, plus a worked example for a spreadsheet.
Does it work for SharePoint or an eQMS?
Yes. The protocol validates configured functions such as controlled publishing, versioning, retrieval and workflow gates, which is exactly what an auditor asks for on a SharePoint or Google Workspace QMS.
Is this current for ISO 13485:2016 and the FDA QMSR?
Yes. ISO 13485:2016 is the current edition (confirmed by ISO in 2026) and the kit was revised in November 2026 for the FDA Quality Management System Regulation (21 CFR Part 820, in force since 2 February 2026) and EU MDR 2017/745. Revised files for this edition are sent to existing buyers free.
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 30-day money-back guarantee, if the files do not fit your quality management system you can ask for a full refund within 30 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. You can also see a fully worked example of a procedure and its linked records.
Will I get updates?
Yes, for the edition of the standard this product covers. Corrections, amendments and guidance changes for that edition are sent to you free, by email, for as long as we sell the product. If the standard is replaced by a new edition, the new kit is a separate product and existing buyers get an upgrade discount. See the version history.
Can I use the templates with more than one company?
Each purchase is licensed to one organization (one legal entity). Consultants can use one product with up to 10 client organizations with the Consultant Multi-Client Licence, including applying their own or the client's branding. See consultant rights and the licence agreement.
Who wrote these templates
Ishan Maharaj
Founder and Principal Consultant
BSc Engineering (Industrial) Honours and MSc Engineering Management
An industrial engineer who has worked in regulated medical device manufacturing throughout his career, in senior operations and quality leadership roles since 2019. Every template on this site was written and checked by him against the published standard, and the same person answers your questions.
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.
