Which ISO Template Kit Is Right for Me?
Short answer: start from your situation, not the standard number. Pick the line below that sounds most like you, then use the comparison tables to check what is included, what is not, how much work is left, and what support and licence you get.
What is your situation?
We need our first quality management system
Medical devices: the ISO 13485 Complete QMS Kit, or the Starter Kit if you want the core first. Any other industry: the ISO 9001:2026 Complete QMS Kit.
See what happens after you downloadWe are ISO 9001:2015 certified and need to transition
Scope it with the Transition Starter Bundle, or do the whole job with the Transition Toolkit. Your existing QMS stays; you update what changed.
Read the transition guideWe need to fix one process or an audit finding
Buy only the kit for that process: CAPA, internal audit, document control, supplier control, training matrix, IQ/OQ/PQ or risk management. Upgrade later with a credit.
Browse individual kitsI implement systems for clients
Buy the kit plus the Consultant Multi-Client Licence: up to 10 client organizations, with your own or your client's branding.
Read the consultant rights in plain EnglishWe want someone to check or help
Add a 60-minute onboarding call ($149), get a fixed-scope review of up to 5 adapted documents ($349), or hire us for remote consulting.
Ask a question firstWe are not sure where we stand
Run a free gap check first: ISO 13485 Lite or the ISO 9001:2026 sample. AI, SOC 2 and CMMC have free checklists too.
See free samplesISO 13485 options compared
| Single kit (from $49) | Starter Kit ($249) | Complete QMS Kit ($449) | |
|---|---|---|---|
| Best for | Fixing one process or one audit finding | Small companies building the core QMS first | Manufacturers building or replacing a full QMS for certification |
| Included | One process: procedure, forms, logs and guidance | 6 core kits: quality manual and management review, document control, CAPA, internal audit, gap assessment, training and competence | All 15 kits: the 6 core kits plus design controls, ISO 14971 risk file, complaints/PMS/vigilance, supplier control, production and traceability, equipment and calibration, software validation, medical device file and labelling, process validation (IQ/OQ/PQ) |
| Not included | The rest of the QMS | Design, risk file, production, supplier, post-market, validation kits | The ISO standard text, device-specific technical content (test methods, clinical evaluation) |
| Overlap | Each kit is also inside the Starter or Complete Kit | Fully contained in the Complete Kit | Contains everything |
| Work left for you | Adapt one procedure and its records | Adapt the core, approve, train, run the processes | Adapt everything to your devices and scope; most small teams need 6 to 12 weeks to a first full draft |
| Support | Email support on using the templates. Optional onboarding call and document review. | ||
| Licence | One organization, unlimited users and sites. Consultant edition for up to 10 clients. | ||
| Upgrade route | $79 credit toward the Starter or Complete Kit | $249 credit (the full price) toward the Complete Kit | - |
ISO 9001:2026 options compared
| Single template (from $29) | Transition Starter Bundle ($99) | Transition Toolkit ($199) | Complete QMS Kit ($349) | |
|---|---|---|---|---|
| Best for | One specific 2026 requirement | Certified teams scoping the transition | Certified teams doing the full transition | First-time ISO 9001 or a full rebuild |
| Included | One tool, for example the risk and opportunity register or management review pack | Gap analysis workbook, 2015-to-2026 change matrix, transition plan | 11 tools: the Starter Bundle plus templates for each new or changed 2026 requirement | Quality manual, procedures, forms and registers for clauses 4 to 10 |
| Not included | Everything else | The updated documents themselves | A complete new QMS (it updates your existing one) | Transition-specific tools (gap analysis and change matrix are separate) |
| Work left for you | Adapt one tool | Run the assessment and agree the plan | Update affected documents, brief staff, show records at the transition audit | Build and run the whole system, then internal audit and management review |
| Support and licence | Email support; optional onboarding call and document review. One organization licence; consultant edition available. | |||
| Upgrade route | $49 credit toward the Toolkit or Complete Kit | $99 credit (full price) toward the Toolkit or Complete Kit | $199 credit (full price) toward the Complete Kit | - |
Software or templates?
Templates are Word and Excel files you run in your own document system (SharePoint, Google Drive or a file server). QMS Workspace is an offline app for small ISO 9001 teams where one person edits at a time. If several people need to edit and sign records at the same time, use templates in a collaborative system instead. See the QMS Workspace comparison.
Every paid product has the same core terms: one-organization licence, free updates for the edition you bought, email support and a 30-day money-back guarantee. Details on the purchase terms page.