ISO 7101-2023-Healthcare Quality Management System
ISO 7101-2023-Healthcare Quality Management System
Patient safety, infection prevention and medication safety governed by one quality system rather than a shelf of unconnected policies.
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Written by practising auditors with 20+ years in the field.
By document type
| Category | Files |
|---|---|
| Manuals | 2 |
| Policies | 1 |
| Procedures & SOPs | 16 |
| Forms & Records | 16 |
| Checklists & Audit Tools | 8 |
| Training & Awareness | 3 |
| Guides & Work Instructions | 4 |
Key documents
| Reference | Document | Format |
|---|---|---|
| AGS-QM-01 | Quality Manual | Word |
| AGS-POL-01 | Healthcare Quality Policy | Word |
| AGS-QP-10 | Patient Safety & Incident Management | Word |
| AGS-QP-14 | Infection Prevention & Control | Word |
| AGS-QP-15 | Medication Safety | Word |
| AGS-CL-01 | ISO 7101 Internal Audit Checklist | Word |
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Overview
ISO 7101:2023 is the first international standard dedicated to quality management systems for healthcare organisations, setting requirements that support sustainable delivery of health services, patient safety and continual improvement in clinical and organisational performance. It applies to hospitals, clinics, primary care providers and other bodies delivering health services, whatever their ownership or funding model, and is built on the Annex SL structure with the process approach, risk-based thinking and the Plan-Do-Check-Act cycle, so it integrates readily with ISO 9001.
What distinguishes it is where the emphasis falls: patient safety, people-centred care, health equity, clinical governance, workforce competence and wellbeing, and the culture of quality inside care settings. The documentation follows that emphasis, placing a healthcare quality policy and manual over procedures for patient safety and incident management, people-centred care, infection prevention and control, medication safety, waste management and facilities maintenance. Ward-level tools make the system visible on the floor: safety rounds, infection prevention checks, medication safety checks, facility inspection, incident reporting and service user feedback.
What this system covers
- Patient safety and incident management — reporting, investigation and the corrective action that follows
- Infection prevention and control — responsibilities, routine checks and the records that evidence them
- Medication safety — the controls and verification checks recorded around the handling of medicines
- People-centred care and feedback — service user feedback and complaints, with guidance on care designed around the person
- Clinical governance and risk — risk register, quality objectives, internal audit and management review
- Workforce competence — training plans, competence matrices, needs assessment and orientation
- Facilities, maintenance and waste — safety rounds, facility inspection, maintenance logging and waste handling
Who it's for
Aimed at hospital quality directors, patient safety leads and clinic managers who need a recognised framework their board, ministry or funder will accept, and who are often working towards assessment by an accredited certification body. It also fits a provider that has learned from a serious incident that its safety controls were real in practice but undocumented on paper.
Everything you get
Every toolkit gives you a full set of working documents for your standard, ready to edit and use.
Native Microsoft files. Add your logo and adapt every document to how you work.
Your full toolkit arrives as a ZIP the moment payment clears.
One purchase covers everyone in your organisation. No per-seat fees.
Built by people who run real audits, so the content matches what assessors check.
One payment, perpetual licence for your organisation. No subscriptions, no renewals.
Full refund if your files are faulty, incomplete or not as described and we can't put it right
Frequently asked questions
What exactly do I receive?
A downloadable ZIP containing the full set of ready-to-use documents for this toolkit — manuals, procedures, forms, records, checklists, guidance and training material, all in editable Word and Excel format. The exact document count is shown at the top of this page.
Are the documents really editable?
Yes. Every file is native Microsoft Word or Excel — no locked PDFs. Add your logo, change wording, and tailor the content to your organisation. The toolkit is yours to keep and reuse.
Does this certify my organisation?
No. These are documentation toolkits aligned to the relevant standard to help you prepare. Certification itself is issued by an accredited certification body after their audit. Our toolkits give you a strong, audit-ready starting point.
How is it delivered?
Instantly and digitally. There's no physical shipment — you download the files right after payment and receive a backup link by email.
Do I get updates?
Yes. If we revise this toolkit, you're entitled to the updated version at no extra cost — just contact us with your order details.
What is your refund policy?
These are digital products, so once a toolkit has been downloaded we cannot take it back. If you have not downloaded yet, contact us and we will cancel the order and refund you in full. We also refund in full if the files are damaged, incomplete, or not what the product page described.
Cannot find your standard?
Tell us which scheme you work to. We will point you to the right toolkit.
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