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Accréditation Sans Frontières

International Accreditation of Healthcare Facilities

ISO 9001 Ready

Ready for ISO 9001 — documented, trained, prepared. Certified by someone else.

A separate ASF product for ambulatory clinics and hospitals: 190 bilingual documents generated for your organization, a training matrix by role, and consultancy counted in the open

Six facility types live: ambulatory clinic, hospital, dental, aesthetic & cosmetic, fitness & wellness, hospitality & hotel · EN / KA

ISO 9001:2026 update. ISO published the sixth edition of ISO 9001 on 16 September 2026; it replaces ISO 9001:2015. The ten-clause structure is unchanged and most requirements are the same. ISO 9001 Ready document packs and courses were built to ISO 9001:2015 and are being updated to the 2026 edition. The update covers separate registers for risks and for opportunities, quality culture and ethical behaviour, planning of changes, a defined objective for every internal audit, and the new management review input. Document and course titles that name the 2015 edition will change when the updated files are released. Certification to ISO 9001:2015 remains valid during the transition period set by the accreditation system.
The line that never moves. ASF prepares organizations for ISO 9001. ASF does not certify them. The ISO 9001 certificate is issued by an independent, accredited certification body of the organization’s choice — ASF’s role stops at readiness. This product is separate from ASF Accreditation, and buying one has no bearing on the other.
190
documents across four stages — 106 universal, the rest added only when your intake says the service exists
1.47M
ISO 9001:2015 certificates held worldwide, 2024 — ISO Survey, iso.org
EN/KA
every procedure and form bilingual, from the first SOP to the master index
Abstract close-up of a modern glass and steel office building facade at dusk, representing structured quality management
Photo: Willem Chan / Unsplash
01

What it is

ISO 9001 asks an organization to show that its quality management system exists, is documented, is followed and is improved. For a clinic that is a mountain of paperwork: procedures for governance, infection prevention, medication, records, complaints, suppliers, emergencies — and the forms that prove each is used. ASF has written that mountain once per facility type, in English and Georgian — 190 documents for an ambulatory clinic, up to 257 for a hospital — each with a real document-control block and real citations, plus the master index and a full-pack audit.

ISO 9001 Ready turns that library into your organization’s own documentation, then helps your people learn to run it, then helps you close the gaps before your certification audit. Four stages, each optional after the first, each priced separately and openly once you have chosen your scope.

02

Four stages

Free · then optional
A free online readiness self-assessment (twenty minutes) followed by a short call to walk through the results together. Optionally, a paid on-site assessment that verifies the self-assessment and produces a real gap report.

Start the self-assessment →

Reviewed, then generated
An intake questionnaire — your identity, your services, your responsible persons — reviewed by ASF for completeness, then a documentation pack generated for your organization: every SOP and form filled with your names, dates and logo. Nothing generic reaches you.

The intake →

By role
A role-by-role training matrix built from the responsibility tables inside the documents themselves, delivered through the ASF Academy — online, blended or in person by role.

The matrix →

Counted, not quoted
Structured sessions with a transparent count: a base of two, one per additional module, one per three to four unresolved gaps, and an optional pre-certification review before your own ISO 9001 audit.

The formula →

03

What is in the pack

190 documents. 106 are universal — every organization receives them. The rest are included only when the intake says the service exists.

Stacks of paper documents and file folders on an office desk, representing SOPs, procedures and forms being organised
Photo: Wesley Tingey / Unsplash
Tier 1
QMS core set — quality policy, scope, objectives, clause map, every organization’s starting point.

See the list →

Tier 2
Governance — nonconformity, internal audit, management review, document control, risk, suppliers, complaints, competence.

See the list →

Tier 3
General clinical — infection prevention, sterilization, patient safety, medication, health information, HR.

See the list →

Patient Rights
Informed consent, complaints, dignity and privacy, advance directives — the patient-facing half of Tier 3.

See the list →

Tier 4
Laboratory and diagnostics — included when your organization has an in-house laboratory or imaging.

See the list →

Tiers 5, 6, C
Oncology, pediatrics, dialysis — each included only when the service is in scope.

See the list →

Tier 7
Cross-cutting — emergency preparedness, suppliers, complaints, data protection, telehealth, international patients, equipment.

See the list →

Index
The document map, the records and forms index, and the full-pack quality audit report.

See the list →

Document library size by facility type

Each facility-type library is its own complete, independently indexed document set, sized to the complexity and risk profile of that setting — not a shared template cut down.

Ambulatory clinic
190
Hospital
257
Dental clinic
129
Aesthetic clinic
127
Fitness & wellness
103
Hospitality & hotel
119

See each library’s own document index for the full breakdown by document type and stage.

04

Two products, two buyers

ISO 9001 Ready is for you if

You want a globally portable, sector-neutral quality credential — for tenders, insurers, international partners or your own governance — and you need the management system documented properly, in Georgian and English, without writing 190 documents from scratch. You may have no interest in healthcare accreditation at all. That is fine.

ASF Accreditation is for you if

You want healthcare-specific recognition of the safety and quality of care — assessed against published clinical standards by surveyors who walk your wards. It is a different product for a different purpose, at france-asf.fr/standards. Some organizations want both; neither requires the other.

05

Roadmap, stated plainly

Six facility types are complete and live on this page: ambulatory clinic, hospital, dental clinic, aesthetic & cosmetic clinic, fitness & wellness centre, and hospitality & hotel. Laboratories are a separate, already-live product — ISO 15189 Ready — not a future phase of this one. Further facility types beyond these six are unscoped. Pricing is published only once the structure is confirmed in use; nothing on these pages is a quote.

06

Why ISO 9001 Ready

Six things that are true because they are built into how the product works, not because we say so.

Time
Months saved, not spent
Writing a quality management system from scratch typically takes an organization 3–6 months. ISO 9001 Ready generates your bilingual pack from a library already written — in minutes, not months.
Scope
Sized to your facility, not a template
103 to 257 documents depending on facility type, across six categories — ambulatory clinic, hospital, dental, aesthetic, fitness & wellness, hospitality — each its own independently indexed library.
Language
Bilingual from the first draft
Every procedure, form and index exists in English and Georgian together, from the SOP to the master index — not translated after the fact.
Independence
No conflict of interest
ASF prepares your documentation. ASF does not certify you. The people who wrote your system have no stake in your audit result — the certificate comes from an independent accredited body of your choice.
Delivery
100% remote by default
Self-assessment, consultancy sessions and training are delivered online. On-site visits are the exception, only where travel genuinely changes the result, and are charged at cost.
Guarantee
The Readiness Guarantee
If our readiness assessment says you’re ready and the certification audit still finds you’re not, the extra consultancy sessions to close the gap are on us. We can’t guarantee an independent auditor’s decision — we can guarantee our own work.
07

Your toolkit — six working tools, not a brochure

Every stage above is a real, working tool you can open right now — not a PDF to request. Verified live as of this page's last update.

Self-Assessment
Free, twenty-minute readiness check that ends with a call to walk through your results.

Start the check →

Intake
Tell us your organization and services; ASF reviews it for completeness before anything is generated.

Open the intake →

Generation Platform
Six evidence stages per document, a live implementation plan, and your assessor's own login.

See the platform →

Training Catalogue
40 courses on the ASF Academy, matched role by role to your own training matrix.

Browse courses →

Consultancy & Assessments
Structured sessions with a transparent, counted formula — never a hidden day-rate.

See the formula →

Order
Choose your facility type and stage, and check out directly — pricing shown plainly at checkout.

Order now →

Start where everyone starts

The free readiness self-assessment takes twenty minutes and ends with a call.

Start the self-assessment

© 2026 Accréditation Sans Frontières · PHIG · Sheni Network