The real ISO 7101:2023 documentation set: 264 documents and four Excel tools that form a complete healthcare quality management system (HQMS). The Healthcare Quality Management System Manual meets every clause of ISO 7101:2023, and you get five policies, 33 procedures, 16 clinical work instructions, 101 forms each with a completed worked example, and the risk, quality-indicator, audit and competence Excel tools, covering people-centred care, patient safety, medication and surgical safety, infection prevention, diagnostic and transfusion safety, clinical governance, risk and continual improvement, all editable in Word and Excel, so a hospital or clinic can build a quality and patient-safety system and reach certification without hiring a consultant.
Preparing the documentation is the slowest and most confusing part of getting certified to ISO 7101:2023. You have to work out what the standard asks for, decide what to write, and turn it into a manual, procedures and records that an auditor will accept. Done from a blank page it takes months, and paying a consultant to do it can cost thousands.
The ISO 7101:2023 Documentation Toolkit gives you that whole system, already written and ready to edit. It is built by practitioners around the exact structure of the standard, so nothing an auditor expects is missing. You add your company details, adapt anything specific to your operation, and you have a complete, consistent healthcare quality system that is ready for audit. Every single document you receive is listed and explained further down this page, so you know precisely what you are buying before you spend anything.
ISO 7101:2023 is the world first management system standard written specifically for healthcare organisations. The manual and 33 procedures follow it clause by clause, from context, governance and the quality policy to care delivery, patient safety and improvement.
Procedures and work instructions for patient identification, patient safety incident reporting, medication safety, surgical safety, infection prevention and control, falls, pressure ulcers and thromboembolism, diagnostic safety and blood transfusion safety, with matching forms such as the surgical safety checklist, hand hygiene audit and medication reconciliation.
A patient bill of rights acknowledgement, service user voice and feedback log, access and affordability assessment, experience survey and action plan, health literacy and cultural competence records, so care is built around the people who receive it, as ISO 7101 requires.
Quality governance terms of reference, a RACI assignment, a code of conduct, an ethics consultation record, credentialing and privileging, competence evaluation and workforce wellbeing tools, so leadership, ethics and a capable workforce are all covered.
Facility inspection rounds, preventive maintenance, equipment calibration, utility monitoring, emergency and business continuity planning, fire safety, clinical waste segregation and cold-chain monitoring, because a safe environment of care is part of the standard.
All 101 forms come with a matching sample filled form, worked around a realistic healthcare organisation, so your team can see exactly how each clinical and quality record should look before completing its own.
Each tier answers a different question and is approved at a different level, and every requirement is owned in exactly one place.
No hidden contents and no vague claims. Here is the complete document set, with a short description of what each file is for and the clause it helps you meet.
A complete document set, fully editable in Microsoft Office.
The top-level document of the healthcare quality management system. It demonstrates, clause by clause, how the organisation meets ISO 7101:2023, from context, leadership and clinical governance through planning, care delivery, patient safety and clinical risk to performance evaluation and improvement, and traces each requirement to the policy, procedure, work instruction, form, tool and record that satisfies it. This is the document a surveyor or auditor opens first.
The writing is done. You edit instead of authoring from a blank page.
Get a professional system for a fraction of the cost of hiring one.
Mapped clause by clause so every requirement is covered.
Easy to read, easy to adapt, no jargon you have to decode.
Forms and registers capture exactly what an auditor asks to see.
A perpetual licence for your whole team, with free updates.
The full set arrives by email in minutes, in Word and Excel.
Swap the highlighted placeholders for your own company details.
Roll out the procedures and capture evidence on the forms.
Use the internal audit checklist and management review templates.
Face the auditor with a complete, consistent system.
Files sent securely within 24 working hours of payment.
Microsoft Word and Excel, with placeholders to fill in.
If the standard is revised, you get the update free.
One organisation, unlimited internal users, perpetual.
| What matters | From scratch | Hire a consultant | isofolder kit |
|---|---|---|---|
| Time to a full document set | Months | Weeks | The same day |
| Typical cost | Your time | Thousands | $149 once |
| Written by experts | No | Yes | Yes |
| Mapped to every clause | Risky | Usually | Yes |
| You keep full control | Yes | Limited | Yes, fully editable |
| Free updates on revision | No | Extra fee | Included |
isofolder is a team of auditing and consulting professionals with more than 80 years of combined experience. Our kits are written by practitioners and reviewed by working auditors, then refined across many real certification projects. When you buy from us, you are buying a system that has already helped companies pass their audits.
If you ever need a document that is specific to your operation and not already in the kit, our team will prepare it for you.
The documents were well structured and easy to adapt. We cleared our certification audit with no major findings.
Saved us weeks of writing. Everything was mapped to the clauses, so we knew nothing was missing.
Clear, professional and fully editable. Far better value than the consultant quotes we received.
Preview 10 real pages from the ISO 7101:2023 toolkit right here, including a full form and part of an actual procedure. Judge the quality and writing style for yourself, with no sign-up.
Download the complete, editable toolkit and start building an audit ready system in minutes, with a free sample available before you buy.