ISO 13485 Starter Kit
$249Regular price $504
ISO 13485 Complete QMS Kit
ISO 13485 Complete QMS Kit
Regular price
$449.00 USD
Regular price
$1,375.00 USD
Sale price
$449.00 USD
$1,375 is the combined price of buying the included items separately. You save $926.
Instant download. Editable files. One-organization licence. 30-day money-back guarantee.
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- Best for
- Device manufacturers and virtual manufacturers building a full ISO 13485:2016 QMS for certification, or replacing a patchy one.
- What it gets done
- Every procedure, form and register for clauses 4 to 8, plus the ISO 14971 risk management file, gap assessment, process validation and software validation kits, already cross-referenced.
- What you still do
- Set your scope and device classification, add your company and product details, decide which optional processes apply, approve the documents, train staff and run each process long enough to build records. Typical first draft: 6 to 12 weeks for a small team.
- See it first
- Free sample pages and a worked CAPA example.
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.
Optional add-ons, training and free samples
Optional add-on
60-minute onboarding call with the author, $149
Tailor this kit to your company on a video call, then get written next steps within two business days. Book within 90 days; if we cannot agree a time, it is refunded.
What the call coversSomething went wrong. Add the call from its own page.
Already own part of this? Upgrade credits
- Own any single ISO 13485 kit: code
STARTER-UPGRADE, $79 off. - Own the ISO 13485 Starter Kit ($249): code
COMPLETE-UPGRADE, $249 off, the full price you paid.
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 kit with up to 10 clients, with your own or your client's branding: consultant edition.
Train your team on this
Implementing ISO 13485 takes more than documents. The Lead Implementer Course shows how to set up, run and maintain the QMS these templates support.
ISO 13485:2016 Lead Implementer Course (Online, Certificate of Completion), $399Certificate of Completion issued by ISO Cloud Consulting. It is not an accredited or third-party qualification.
Also see: ISO 13485:2016 Complete Training Track (3 Courses, 3 Certificates of Completion), $599. 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.
Everything on this site for ISO 13485 in one download, now including the two regulatory kits that take a certified system to the US and EU markets. Seventeen kits, 298 files, eleven training modules and worked examples for one fictional device across every kit, organised in numbered folders with a roadmap that sequences the work from gap assessment to certification readiness.
Kits included (17 kits, 298 files: 180 Word, 87 Excel, 9 slide decks with 124 slides, 22 PDF)
- Gap Assessment Workbook (71 areas, 4 files)
- Quality Manual and Management System Kit (23 files)
- Document Control and Records Kit (20)
- CAPA and Nonconformance Kit (13)
- Internal Audit Kit (13)
- Training and Competence Kit, 8 modules (41)
- ISO 14971:2019 Risk Management File Kit with the calculated workbook and worked example (19)
- Design Controls and DHF Kit (39)
- Supplier Control Kit (12)
- Production and Traceability Kit (29)
- Process Validation IQ/OQ/PQ Pack with sterilisation templates (29)
- Equipment, Calibration and Work Environment Kit (24)
- Software Validation Kit (8)
- Complaint Handling, PMS and Vigilance Kit (30)
- Medical Device File and Labelling Kit (13)
- New: FDA QMSR Transition Kit: QMSR gap workbook, terminology map, 820.35 complaint and servicing records, 820.45 labelling control, transition plan (5)
- New: EU MDR Technical Documentation & GSPR Kit: Annex II/III index, GSPR checklist, PMS plan, PSUR, declaration of conformity (6)
How it's organised
Folders 01 to 17 in implementation order, each with a Start Here guide and a worked example; a "What changed in the November 2026 edition" note at the top level; training modules stored once in kit 06.
How do ISO 13485, FDA QMSR and EU MDR line up?
FDA's Quality Management System Regulation (21 CFR Part 820) took effect on 2 February 2026 and incorporates ISO 13485:2016 by reference, so one ISO 13485 system can serve both. In the EU, manufacturers must meet Article 10(9) of Regulation (EU) 2017/745, and EN ISO 13485:2016/A11:2021 appears in the Commission's list of harmonised standards for that regulation. The table shows where common topics sit. The EU column is our subject-matter reading of Article 10(9); the official clause-to-article correspondence is in the annexes of EN ISO 13485:2016/A11:2021. A dash means we have not verified an entry.
| Topic | ISO 13485:2016 | FDA QMSR (21 CFR 820) | EU MDR 2017/745 |
|---|---|---|---|
| Quality management system | 4.1, 4.2 | 820.10(a): document a QMS that complies with applicable ISO 13485 requirements | Article 10(9): QMS must address at least items (a) to (m) |
| Risk management | 7.1 | Through ISO 13485 (820.10(a)) | Article 10(9)(e) |
| Design and development | 7.3 | 820.10(c): Class II, Class III, listed Class I and software-automated devices | Article 10(9)(g), product realisation |
| Design file (formerly DHF) | 7.3.10 | DHF term eliminated; content expected under 7.3.10 | Article 10(9)(g) |
| Medical device file (formerly DMR) | 4.2.3 | DMR term eliminated; content sits in the medical device file | – |
| Unique device identification and traceability | 7.5.8, 7.5.9 | 820.10(b)(1) and (b)(2); 820.10(d) for implantable and life-sustaining devices; 820.35(c) | Article 10(9)(h), UDI |
| Labelling and packaging | 7.5.1, 4.2.5 | 820.45 | – |
| Servicing records | 7.5.4 | 820.35(b) | – |
| Complaint handling | 8.2.2 | 820.35(a) complaint records | Article 10(9)(i), post-market surveillance |
| Reporting to authorities, advisory notices | 8.2.3, 7.2.3, 8.3.3 | 820.10(b)(3) (Part 803) and (b)(4) (Part 806) | Article 10(9)(k), serious incidents and field safety corrective actions |
| Corrective and preventive action | 8.5.2, 8.5.3 | Former 820.100 removed; ISO 13485 clauses apply | Article 10(9)(l) |
Read next: FDA QMSR explained, QMSR and ISO 13485 alignment and the CAPA, design controls and quality manual pages.
Sources: eCFR, 21 CFR Part 820; FDA, QMSR; Federal Register, 2 February 2024 (clauses 4.2.3, 7.1, 7.3.10, 8.5.2, 8.5.3); Regulation (EU) 2017/745, Article 10(9); Implementing Decision (EU) 2021/1182, as amended; BSI on the A11:2021 annexes. This is general information, not legal advice. Check requirements against your own licensed copy of ISO 13485.
Who it's for
Manufacturers and contract manufacturers implementing the full standard, companies replacing a patchwork of documents with one consistent system, and consultants who want every kit under one licence (add the multi-client licence for up to ten clients).
Good to know
- Instant download. Editable Word, Excel and PowerPoint, no macros. Licensed for one organisation including its sites.
- November 2026 edition: ISO 14971:2019 and FDA QMSR (21 CFR Part 820, effective 2 February 2026) references throughout; market-neutral role titles; worked examples in every kit.
- Templates describe requirements in our own words and do not reproduce ISO text; you need your own copies of ISO 13485:2016 and ISO 14971:2019.
- Own a single kit? Code STARTER-UPGRADE takes $79 off. Own the Starter Kit? Code COMPLETE-UPGRADE takes $249 off, so you pay the difference.
- 30-day money-back guarantee if it does not fit your QMS.
Watch: how this works in practice
Watch: A small medical device manufacturer can build a working ISO 13485 quality system in about sixteen weeks, if the work is sequenced properly and leadership protects the time. Building an ISO 13485 system in sixteen weeks for a small manufacturer.
ISO 13485 Complete QMS Kit$44930-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 Complete QMS Kit
What is in the ISO 13485 Complete QMS Kit?
All 17 ISO 13485 template kits: gap assessment, quality manual, document control, CAPA, internal audit, training with 8 modules, ISO 14971 risk management file, design controls and DHF, supplier control, production and traceability, process validation, equipment and calibration, software validation, complaint handling and PMS, medical device file and labelling, FDA QMSR transition and EU MDR technical documentation. 298 files, 11 training modules and a worked example in every kit.
How long does it take to build the QMS with it?
A small team typically completes a first draft in six to twelve weeks: set the scope, add company and device details, decide which processes apply, approve the documents, train staff and run each process long enough to generate records.
Does it cover FDA QMSR and EU MDR as well as ISO 13485?
Yes. The FDA QMSR Transition Kit and the EU MDR Technical Documentation and GSPR Kit are included, and every procedure was revised in November 2026 for the QMSR.
Is there an upgrade from the Starter Kit?
Yes. Starter Kit buyers get $249 off with the upgrade code in their download.
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.
