ISO 9001:2026 is published · ISO 13485 templates also available
Editable ISO 9001:2026 and ISO 13485 templates, ready to use today
The Complete QMS Documentation Kit gives you a 33-page quality manual, 20 procedures, 43 forms and registers, an implementation roadmap and all 11 transition tools. Already certified? Start with the Transition Toolkit or the Gap Analysis Workbook. Instant download in Word and Excel, licensed for one organization.
One-time purchase · no subscription · 30-day money-back guarantee
Best sellers
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ISO 9001:2026 Complete QMS Documentation KitBuilding or rebuilding your ISO 9001:2026 system: manual, procedures, forms and all 11 transition tools$349Regular price $568 -
ISO 9001:2026 Transition Toolkit (11 Tools)For ISO 9001:2015 certified companies moving to the 2026 edition$199Regular price $489 -
ISO 13485 Complete QMS KitFor medical device makers building a complete ISO 13485 quality system$449Regular price $1,375 -
ISO 9001:2026 Quality Manual TemplateNeed only the manual? 33 pages in Word, already structured to the 2026 clauses$79
Facts about our templates
- 35 countries our customers have ordered from
- 99 editable files in the ISO 9001:2026 Complete QMS Kit
- Line by line checked against the published ISO 9001:2026, version 1.1 (October 2026)
- 30 days money-back guarantee on every paid template, kit and course
ISO 9001:2026 transition tools
Buy the one tool you need, or get all eleven in the Transition Toolkit and save around 60%.
Three ways to buy ISO 9001:2026 templates
Already certified to the 2015 edition? The Starter Bundle or the Transition Toolkit updates what you have. Building or rebuilding the whole system? The Complete Kit adds the manual, procedures and forms. Upgrade credits mean you never pay twice.
| What is included | Transition Starter Bundle
The three planning tools, for a quick first pass
$99 | Transition Toolkit
Every tool for an in-house 2015 to 2026 transition
$199 | Best sellerComplete QMS Kit
A full QMS: manual, procedures, forms and all 11 tools
$349 |
|---|---|---|---|
| ISO 9001:2015 to 2026 Change Matrix | Included | Included | Included |
| Gap Analysis Workbook (178 lines) | Included | Included | Included |
| Transition Plan Template with Gantt chart | Included | Included | Included |
| Internal Audit Checklist (253 questions) | Not included | Included | Included |
| Risk and Opportunity Register, and Change Management Procedure and Log | Not included | Included | Included |
| Context, Interested Parties and Climate Change Pack, and Organizational Knowledge Register | Not included | Included | Included |
| Management Review Pack, and Quality Culture and Ethical Behavior Pack | Not included | Included | Included |
| Awareness Training Kit (train unlimited staff) | Not included | Included | Included |
| Start-here guide sequencing a 20-week transition | Not included | Included | Included |
| 33-page Quality Manual and 20 procedures (QP-01 to QP-20) | Not included | Not included | Included |
| 43 forms and registers, with a pre-filled Master Document List | Not included | Not included | Included |
| 24-week implementation roadmap for first-time 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?
Building a QMS from scratch?
The Complete QMS Documentation Kit has a 33-page quality manual, 20 procedures, 43 forms and registers, an implementation roadmap and all 11 transition tools. Only need the manual? The Quality Manual Template is $79. Want help tailoring the kit? Add a 60-minute onboarding call with the author for $149.
Start free: ISO 9001:2026 checklists and samples
Download a free checklist, changes summary or gap analysis sample and see the quality of the paid templates first.
Why buy from ISO Cloud Consulting
Written by a quality engineer, not a content mill
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.
ISO 13485 medical device templates
Document control, design controls, CAPA, supplier control, internal audit and ISO 14971 risk management. Preview pages on every kit.
ISO 13485 Complete QMS Kit
ISO 13485 Starter Kit + Expert Check (Kit, Onboarding Call and Document Review)
ISO 13485 Starter Kit
What changed in ISO 9001:2026
The new edition is an evolution, not a rewrite. These are the changes that need action. Checked line by line against the published ISO 9001:2026 (version 1.1, October 2026). Want it taught clause by clause? Take the ISO 9001:2015 to 2026 Transition Masterclass.
Quality culture and ethical behavior
Top management must promote quality culture and ethical behavior, and everyone must be aware of them. Keep evidence of how you do it.
Risks and opportunities, separately
Each now has its own sub-clause. Opportunities need their own evaluation, actions and effectiveness review.
Expanded planning of changes
Planned changes must now cover communication, monitoring and a review of results.
Climate change and interested parties
Decide whether climate change is relevant to your QMS, and which interested-party requirements the QMS will address.
Terms and improvement
Clause 3 now defines 20 core terms. Continual improvement is now clause 10.1, and there is no 10.3.
What stays the same
Clauses 4 to 10, the process approach and PDCA are unchanged. Clause 8 changes are mostly terminology. A quality manual is still not required.
Four steps to ISO 9001:2026
Our transition plan assumes about 20 weeks of part-time work by default for a small or mid-sized company already certified to the 2015 edition. Want help? Transition consulting starts with a fixed-price USD 1,950 gap assessment and does not guarantee certification.
Assess
Read the change matrix and score your system with the gap analysis workbook. Filter to the flagged lines for a quick first pass.
Plan
Approve the transition plan with owners and dates. Log it as a planned change under clause 6.3.
Update
Refresh context, risks and opportunities, change control, knowledge and culture records using the templates.
Verify
Train your people, audit against the 2026 edition, hold management review and book the transition audit. The ISO 9001:2026 Internal Auditor course covers the audit step.
Choose your standard
Editable Word and Excel templates. Instant download. Pick your standard.
Latest ISO 9001:2026 guidance
ISO 9001:2026 deep dives: the ten-video series in order
Read the guide →
ISO 9001:2026 for Small Businesses: A Practical Transition Guide
Read the guide →
ISO training courses with a certificate of completion
Self-paced online courses for ISO 9001:2026 and ISO 13485:2016: Foundations, Transition, Internal Auditor and Lead Implementer. Unlimited access, a 100% pass mark on every lesson quiz, worksheets with model answers and a final exam. Certificates of completion are issued by ISO Cloud Consulting, a new training provider that plans to apply for international recognition of its certificates before the end of 2027.
QMS Workspace: run ISO 9001:2026 from one offline file. Full $499, Lite $99
Prefer software to documents? QMS Workspace is a single file on your own computer with a gap assessment, 14 connected registers, internal audits, management review and 99 editable templates. Pay once, no subscription, nothing sent anywhere. Full runs everything, including the transition tracker for all 67 changes. Lite starts you with the gap assessment and a 25-document register, and opens in Full with nothing to retype. Ten captioned video tutorials are available now, with six more in production.
Questions, answered
What if the templates do not fit our QMS?
Look at the preview pages on each product first. If a paid product still does not fit, our 30-day money-back guarantee lets you ask for a full refund within 30 days of your order, once per organization. You confirm you have deleted the files and that is it. Conditions apply.
Who writes and checks the templates?
One person: the founder, an industrial engineer with senior quality and operations roles in regulated medical device manufacturing. Every template is written and checked by him against the published standard, and he answers support email himself. The method is set out on the how we review templates page.
What file formats do I get?
Editable Word, Excel and PowerPoint files, plus PDF summaries. There are no macros, and the spreadsheets also work in Google Sheets. QMS Workspace is a single HTML file that opens in your browser.
What happens when a template is updated?
Updates within the edition you bought are free. If we correct or improve a template you own, you get the revised file at no cost and we tell you by email. If a new edition of the standard is published, the revised templates are a new product, and we give existing customers a credit towards it. Every change is listed on the template updates and version history page.
When was ISO 9001:2026 published and when is the deadline?
ISO 9001:2026 was published in September 2026. Under the transition rules set by accreditation bodies, ISO 9001:2015 certificates stop being valid three years after publication (September 2029). Confirm your own audit dates with your certification body.
What are the main changes in ISO 9001:2026?
Quality culture and ethical behavior in leadership and awareness, separate sub-clauses for risks and for opportunities, expanded planning of changes, climate change as a context issue, and quality terms defined inside the standard. The clause structure is unchanged.
Can we transition without a consultant?
If you are already certified to the 2015 edition, usually yes. The changes are limited and the structure is the same. Our templates are written so a quality manager can complete them in-house, and the Transition Masterclass teaches the changes clause by clause.
Do the templates include the text of the standard?
No. ISO standards are copyrighted. The templates refer to clause numbers and describe requirements in our own words, so you need your own licensed copy of ISO 9001:2026.
Will templates guarantee certification?
No supplier can honestly promise that. Templates and software give you an auditable structure. The audit result depends on how your organization runs the system and the records it keeps.
Do your ISO training courses include a certificate?
Yes. Each online course ends with a final exam, and you receive a certificate of completion from ISO Cloud Consulting when you pass. Access is unlimited and every lesson quiz must be passed at 100%. ISO Cloud Consulting is a new training provider and its certificates are not yet accredited by an external body; it plans to apply for international recognition before the end of 2027. See the courses.
What is QMS Workspace?
QMS Workspace is browser-based quality management software for ISO 9001:2026. It runs from a single file on your computer, works offline and stores everything in a project file you own. The Full edition ($499) has 14 connected registers, audits, management review and 99 templates. Lite ($99) has the gap assessment and a 25-document register. Both are one-time purchases. Compare them.
Ready to move to ISO 9001:2026?
Start with a free checklist, or go straight to the Complete QMS Kit. Prefer expert help? Book a remote consulting call. Learning on your own? See the online courses.
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