ISO 13485 Starter Kit
$249Regular price $504
ISO 9001:2026 Complete QMS Documentation Kit
ISO 9001:2026 Complete QMS Documentation Kit
Regular price
$349.00 USD
Regular price
$569.00 USD
Sale price
$349.00 USD
$569 is the combined price of buying the included items separately. You save $220.
Instant download. Editable files. One-organization licence. 30-day money-back guarantee.
Couldn't load pickup availability
- Best for
- Organizations building a first ISO 9001 QMS on the 2026 edition, or rebuilding an outdated one.
- What it gets done
- Quality manual, procedures, forms and registers for clauses 4 to 10 of ISO 9001:2026, ready to adapt.
- What you still do
- Define your scope and processes, adapt and approve the documents, train staff, run the processes and complete an internal audit and management review before certification.
- See it first
- Free gap analysis sample and a worked corrective action 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 9001:2026 template: code
TOOLKIT-UPGRADE, $49 off. - Own the Transition Starter Bundle ($99): code
BUNDLE-UPGRADE, $99 off, the full price you paid. - Own the Transition Toolkit ($199): code
QMSKIT-UPGRADE, $199 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
Templates are faster when the person tailoring them knows the standard. The Lead Implementer Course shows how to build, roll out and maintain an ISO 9001:2026 QMS.
ISO 9001:2026 Lead Implementer Course (Online, Certificate of Completion), $349Certificate of Completion issued by ISO Cloud Consulting. It is not an accredited or third-party qualification.
Also see: ISO 9001:2026 Complete Training Track (4 Courses, 4 Certificates of Completion), $599. Browse the Academy.
Want to learn how to implement ISO 9001:2026 with these templates? ISO 9001:2026 Lead Implementer Course (Online, Certificate of Completion): online, unlimited access, certificate of completion.
A complete, editable ISO 9001:2026 documentation set for a small or mid-sized company: a 33-page quality manual, 20 procedures, 43 forms and registers, an implementation roadmap and all 11 transition tools. 99 files in one download. Built for first-time certification and for companies replacing an overgrown 2015 system.
- Instant download after checkout. Word, Excel and PowerPoint, no macros, no subscription.
- Bought separately, the quality manual ($79) and the 11 transition tools ($489) come to $568. The kit is $349 and adds the 20 procedures and 43 forms, which are not sold on their own.
- 30-day money-back guarantee. If the kit does not fit your business, ask for a refund within 30 days.
- Preview before you buy: the images above show page 2 of the Quality Manual, page 1 of the Control of Documented Information procedure and the NCR Log workbook.
What you get
| Component | Files | What it is |
|---|---|---|
| Start-here roadmap | 1 | A 24-week plan from scope to certification audit, with how to tailor a procedure. |
| Quality manual (QM-01) | 1 | 33 pages, structured to clauses 4 to 10, 2026 changes marked. |
| Procedures (QP-01 to QP-20) | 20 | Context and scope, risks and opportunities, objectives, planning of changes, documented information, competence, infrastructure, calibration, organizational knowledge, communication, sales and contract review, design, purchasing, production, release, nonconforming outputs, corrective action, customer satisfaction, internal audit, management review. |
| Forms and registers | 43 | Word and Excel, numbered to their parent procedure. Registers include dropdowns and worked example rows. Master Document List pre-filled with every file in the kit. |
| Transition Toolkit (11 tools) | 34 | Gap analysis workbook, change matrix, transition plan, internal audit checklist, quality culture pack, risk and opportunity register, change management, context and climate pack, knowledge register, management review pack, awareness training kit. |
Inside the kit: all 99 files
Every file in the download, by folder. Codes match the master document list that ships pre-filled in the kit, so you can cross-reference procedures, forms and registers from day one.
Show the full file list (99 files)
Start here (1 file)
- Start Here implementation roadmap (Word)
Quality manual (1 file)
- QM-01 Quality Manual (Word)
Procedures (QP-01 to QP-20) (20 files)
- QP-01 Context Interested Parties and Scope (Word)
- QP-02 Risks and Opportunities (Word)
- QP-03 Quality Objectives and Planning (Word)
- QP-04 Planning of Changes (Word)
- QP-05 Control of Documented Information (Word)
- QP-06 Competence Training and Awareness (Word)
- QP-07 Infrastructure Maintenance and Work Environment (Word)
- QP-08 Monitoring and Measuring Resources (Word)
- QP-09 Organizational Knowledge (Word)
- QP-10 Internal and External Communication (Word)
- QP-11 Sales Quotation and Contract Review (Word)
- QP-12 Design and Development (Word)
- QP-13 Purchasing and Control of External Providers (Word)
- QP-14 Production and Service Provision (Word)
- QP-15 Release of Products and Services (Word)
- QP-16 Control of Nonconforming Outputs (Word)
- QP-17 Corrective Action and Continual Improvement (Word)
- QP-18 Customer Satisfaction Complaints and Performance Monitoring (Word)
- QP-19 Internal Audit (Word)
- QP-20 Management Review (Word)
Forms and registers (numbered to their parent procedure) (43 files)
- QF-03-01 Quality Objectives Plan (Excel)
- QF-05-01 Master Document List (Excel)
- QF-05-02 Document Change Request (Word)
- QF-05-03 Records Retention Schedule (Excel)
- QF-05-04 External Documents Register (Excel)
- QF-06-01 Training Needs and Plan (Excel)
- QF-06-02 Skills Matrix (Excel)
- QF-06-03 Training Record and Effectiveness Evaluation (Word)
- QF-06-04 New Employee Induction Checklist (Word)
- QF-06-05 Job Description (Word)
- QF-07-01 Equipment and Asset Register (Excel)
- QF-07-02 Preventive Maintenance Schedule and Log (Excel)
- QF-07-03 Breakdown and Repair Report (Word)
- QF-08-01 Calibration Register (Excel)
- QF-08-02 Out of Calibration Impact Assessment (Word)
- QF-10-01 Communication Matrix (Excel)
- QF-11-01 Enquiry and Quotation Review Checklist (Word)
- QF-11-02 Order and Contract Review Record (Word)
- QF-11-03 Order Amendment Record (Word)
- QF-12-01 Design and Development Plan (Word)
- QF-12-02 Design Inputs Outputs and Review Record (Word)
- QF-12-03 Design Verification and Validation Record (Word)
- QF-12-04 Design Change Request (Word)
- QF-13-01 Supplier Evaluation and Approval Form (Word)
- QF-13-02 Approved Supplier List and Performance (Excel)
- QF-13-03 Purchase Requisition and Order Checklist (Word)
- QF-13-04 Incoming Inspection Record (Excel)
- QF-14-01 Job Traveler (Word)
- QF-14-02 Customer Property Register (Excel)
- QF-14-03 Process Validation Record (Word)
- QF-15-01 Final Inspection and Release Record (Word)
- QF-16-01 Nonconformance Report (Word)
- QF-16-02 NCR Log (Excel)
- QF-16-03 Concession and Deviation Request (Word)
- QF-17-01 Corrective Action Request (Word)
- QF-17-02 Corrective Action Log (Excel)
- QF-17-03 Improvement Suggestion (Word)
- QF-18-01 Customer Complaint Form (Word)
- QF-18-02 Complaint Log (Excel)
- QF-18-03 Customer Satisfaction Survey (Word)
- QF-18-04 KPI Dashboard (Excel)
- QF-19-01 Annual Audit Program (Excel)
- QF-19-02 Auditor Competence Record (Word)
Transition Toolkit (all 11 tools) (34 files)
- Gap Analysis Workbook: ISO 9001:2026 Gap Analysis Workbook (Excel)
- Change Matrix: ISO 9001:2015 to 2026 Change Matrix (Excel); ISO 9001:2026 Executive Summary (PDF)
- Transition Plan: ISO 9001:2026 Transition Plan Document (Word); ISO 9001:2026 Transition Plan (Excel)
- Internal Audit Checklist: ISO 9001:2026 Internal Audit Checklist (Excel); Internal Audit Plan (Word); Internal Audit Report (Word)
- Quality Culture and Ethics Pack: Code of Ethical Conduct for Quality (Word); Leadership Evidence Log (Excel); Quality Culture Awareness Briefing (PowerPoint); Quality Culture Self Assessment (Excel); Quality Culture and Ethics Statement (Word); Speak Up Procedure (Word)
- Risk and Opportunity Register: Risk and Opportunity Register (Excel); Risks and Opportunities Procedure (Word)
- Change Management: Change Log (Excel); Change Management Procedure (Word); Change Request and Impact Assessment Form (Word); Change Worked Examples (Word); Post Implementation Review Form (Word)
- Context Interested Parties Climate: Climate Change Relevance Assessment (Word); Context and Interested Parties Register (Excel); QMS Scope Statement Template (Word)
- Organizational Knowledge Register: Organizational Knowledge Register (Excel)
- Management Review Pack: Management Review Agenda and Minutes (Word); Management Review Deck (PowerPoint); Management Review Input Tracker (Excel)
- Awareness Training Kit: ISO 9001:2026 Awareness Quiz (Word); ISO 9001:2026 Leadership Module (PowerPoint); ISO 9001:2026 Staff Awareness Training (PowerPoint); ISO 9001:2026 Toolbox Talk (PDF); Training Attendance and Competence Record (Excel)
- Toolkit guide: Toolkit Start Here Guide (PDF)
Formats: Microsoft Word, Excel and PowerPoint, plus three PDFs. No macros. Open with Microsoft 365, LibreOffice or Google Workspace. Want to test the method on your own system before you buy? Download the free 20-line gap analysis sample; it uses the same layout as the workbook in this kit.
Who it is for
Companies with 5 to 250 people seeking ISO 9001:2026 certification without a consultant-written system, and certified companies that want a clean, lean document set. Manufacturers and service companies are both covered. If you do not design products, the roadmap tells you which documents to delete.
How to use it
- Follow the roadmap: scope and context first, then core procedures, then records.
- Tailor each procedure with its process owner using the guidance notes. Delete what you do not do.
- Run the system, audit it with the included checklist and hold a management review before your certification audit.
Kit, course or consultant: what it costs
| Route | What you pay | What you get |
|---|---|---|
| Write it yourself | Weeks of a manager's time | A blank page and the standard |
| Buy the parts separately | $568 for the manual and the 11 tools | No procedures or forms, which are only sold in this kit |
| This kit | $349, one payment | 99 editable files and a 24-week roadmap you tailor in-house |
| Kit + Lead Implementer course | Two one-time payments | The files plus a self-paced course on how to implement them, with a certificate of completion |
| Expert help | A fixed-scope document review, or a fixed-price gap assessment | Expert time on top of the kit; see consulting |
After you buy
- Want a head start? Book the 60-minute kit onboarding call and leave with a tailoring plan for your company.
- Adapted the kit yourself, or used AI to draft or update documents? Have an expert check up to five of them: fixed-scope Document Review.
- ISO consultants: use this kit with up to 10 client organizations with the Consultant Multi-Client Licence; each extra client costs about a fifth of a separate licence.
- Training your people: the ISO 9001:2026 Team Training Pack gives five learners an online course and certificate at a lower price per learner.
The standard does not mandate procedures, forms or a manual. This kit is one practical set; the retention periods, scoring scales and frequencies in it are suggestions to edit. Use it with your licensed copy of ISO 9001:2026.
Template version 1.1 (October 2026), checked line by line against ISO 9001:2026 as published on 16 September 2026.
Watch: how this works in practice
Watch: how the documents in this kit fit together, and the master list that controls them.
Watch: Twelve weeks to ISO 9001:2026, week six: documents, and the master list that controls them
ISO 9001:2026 Complete QMS Documentation Kit$34930-day money-back guarantee
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?
What every download includes
Instant downloadLink on the confirmation page and by email within minutes.
Fully editableWord, Excel, PowerPoint and PDF (ZIP download). 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 9001:2026 Complete QMS Documentation Kit
What documents are required for ISO 9001:2026?
The standard requires documented information in several places, for example the scope, quality policy, quality objectives and records that show processes ran as planned. It does not list mandatory procedures or require a quality manual. This kit is a practical set for a small or mid-sized company that you adjust to your own system.
Is there a money-back guarantee?
Yes. Every template product comes with a 30-day money-back guarantee. If the kit does not fit your business, contact us within 30 days of purchase for a refund.
What is the difference between this kit and the Transition Toolkit?
The Transition Toolkit (11 tools, $199) is for a company that already holds ISO 9001:2015 and needs to update an existing system. The Complete Kit includes all 11 of those tools plus the quality manual, 20 procedures and 43 forms and registers, so it is the right choice if you are building a system from the start or replacing one that has grown unmanageable.
How many companies can use the kit?
One licence covers one organization and all of its sites. Consultants who want to use the kit with several clients can add the Consultant Multi-Client Licence, which covers up to 10 client organizations.
Will these documents get us certified?
Documents alone do not. Certification depends on your people following the system and keeping records. The kit gives you a sound starting point, and no honest supplier can guarantee an audit outcome.
How long does implementation take?
It depends on your size and how quickly you can tailor the documents and build operating records. The roadmap is laid out over 24 weeks, which you can stretch or compress. Most teams issue a first controlled version of the manual and core procedures within the first month.
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.
Working in medical devices too?
If your organization is also ISO 13485 certified, these templates apply the same requirement to a medical device quality system.
ISO 13485 Complete QMS Kit
$449Regular price $1,375