ISO 13485 Starter Kit + Expert Check (Kit, Onboarding Call and Document Review)
ISO 13485 Starter Kit + Expert Check (Kit, Onboarding Call and Document Review)
$747 is the combined price of buying the included items separately. You save $148.
One-organization licence · Free updates for this edition · Email support· Purchase terms
Instant download. Editable files. One-organization licence. 30-day money-back guarantee.
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- 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 on the confirmation page and in your inbox within minutes. 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 KitUpgrade 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.
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
The ISO 13485 Starter Kit, a 60-minute onboarding call and a fixed-scope review of your five highest-risk documents, in one order. Bought separately these cost $747. This package is $599.
Who it is for: a small medical device company, importer or distributor building its first ISO 13485:2016 system, where a full-time consultant is out of budget but you still want a senior quality engineer to check your work before the certification body sees it.
What you get
- ISO 13485 Starter Kit ($249): the six kits most organisations need first. Quality manual and management review, document control and records, CAPA and nonconformance, internal audit, training and competence with eight ready modules, and the 71-area gap assessment workbook with its dashboard. Instant download, editable Microsoft Office files, no macros.
- 60-minute onboarding call ($149): a remote working session to map the kit to your products, sites and regulatory pathway, agree what to customise and set a realistic timeline to certification. Booked within 90 days of purchase; you receive written next steps afterwards.
- Fixed-scope document review ($349): send up to five adapted documents (for example your quality manual, CAPA procedure, document control SOP, internal audit checklist and training matrix). You get a written review against ISO 13485:2016 with clause references and the exact changes to make, within five business days of receiving all files, plus one re-review within 30 days.
How it works
- Download the Starter Kit immediately after checkout and read the Start Here guide.
- Book the onboarding call from the link in your order email; use it before you start customising, or once you have questions.
- When five documents are ready, email them for review. One round of written feedback and one re-review are included; a second call to walk through the findings can be added at the advisory rate.
Why a kit plus a review, not a consultant
Most small device companies do not need someone to write their system for them. They need a structure that is already cross-referenced, and an experienced second pair of eyes at the two points where audits are lost: the first customisation decisions, and the finished documents. That is what this package covers, for less than a day of typical consulting fees.
Good to know
- 30-day money-back guarantee on the kit. The call is refundable until 24 hours before the booked time; the review is refundable until documents are sent.
- Licensed for one organisation, including its sites.
- Templates do not reproduce ISO standards. You need your own licensed copy of ISO 13485:2016.
- Already own the Starter Kit? Email us with your order number for a credit against this package.
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
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 Starter Kit + Expert Check (Kit, Onboarding Call and Document Review)
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.